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Objectives: To determine the frequency of use of the core outcome domains published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in burning mouth syndrome (BMS) randomized controlled trials (RCTs). Methods: This systematic review, conducted as part of the World Workshop on Oral Medicine VII (WWOM VII), was performed by searching the literature for studies published in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar from January 1994 (when the first BMS definition came out) through October 2017. Results: A total of 36 RCTs (n = 2,175 study participants) were included and analyzed. The overall reporting of the IMMPACT core and supplemental outcome domains was low even after the publication of the IMMPACT consensus papers in 2003 and 2005 (mean before IMMPACT consensus publication = 2.6 out of 6; mean after IMMPACT publication = 3.8 out of 6). Use of validated assessment tools recommended by the IMMPACT consensus was scarce (1.9 out of 6). None of the RCTs reviewed cited the IMMPACT consensus papers. Conclusions: The underreporting of IMMPACT outcome domains in BMS RCTs is significant. Raising awareness regarding the existence of standardized outcome domains in chronic pain research is essential to ensure more accurate, comparable, and consistent interpretation of RCT findings that can be clinically translatable. [ABSTRACT FROM AUTHOR]

Background: The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients.Main Body: This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources.Conclusion: Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level. [ABSTRACT FROM AUTHOR]

In the Nordic countries, as in the rest of the world, particle therapy as a radiotherapy modality, is evolving, albeit the hard evidence for the clinical benefit still is scarce. However, a common goal for the Nordic countries is to include a minimum of 80% of the patients treated with particle therapy into clinical trials. In this paper, we summarize the current status of clinical trials involving particle therapy in the Nordic countries, with an overview of both active and coming trials. So far, one is closed for inclusion and data are being analyzed, seven trials are actively recruiting patients and several more trials are underway. No common Nordic trial has yet been designed, nor is in the planning phase, and the authors will discuss the obstacles as well as the opportunities a common Nordic platform may represent. [ABSTRACT FROM AUTHOR]

During the last decade Sweden has invested in a national infrastructure for collection of structured clinical data in the form of healthcare registries (in Sweden known as Kvalitetsregister). These data can be combined with other public data using the national personal identifiers that are issued to Swedish citizens. The healthcare registries have an almost complete coverage of Swedish healthcare, and a large network of clinicians is involved in the quality assurance and continuous improvement of healthcare using these registries. Uppsala Clinical Research Center (UCR) has been a technology provider of large-scale national registries and has a strong background in clinical trial management. This effort combines the areas of healthcare registries and clinical trials into a novel way of performing clinical trials to be able to: 1) run clinical trials as an integrated part of normal clinic workflow; and 2) leverage the nationwide network of outcome reporting. This strategy was shown to be successful in the TASTE (Thrombus Aspiration in Myocardial Infarction) study. When TASTE had been published, the New England Journal of Medicine wrote a perspective on the study calling it 'The randomized registry trial—the next disruptive technology in clinical research?' Since then several studies have been conducted in this way with great success. UCR has been appointed, by Clinical Studies Sweden and the Swedish Research Council, to develop the Swedish national guidelines for registry-based randomized clinical trials in order to ensure the possibility for more organizations to run this kind of study. This paper describes key concepts of register-based randomized clinical trials and the development of Swedish national guidelines. [ABSTRACT FROM AUTHOR]

Objective:This paper reports on how the clinical consultation in primary care is performed under the new premises of patients’ daily self-reporting and self-generation of data. The aim was to explore and describe the structure, topic initiation and patients’ contributions in follow-up consultations after eight weeks of self-reporting through a mobile phone-based hypertension self-management support system. Design:A qualitative, explorative study design was used, examining 20 audio- (n = 10) and video-recorded (n = 10) follow-up consultations in primary care hypertension management, through interaction analysis. Clinical trials registry: ClinicalTrials.gov NCT01510301. Setting:Four primary health care centers in Sweden. Subjects:Patients with hypertension (n = 20) and their health care professional (n = 7). Results:The consultations comprised three phases: opening, examination and closing. The most common topic was blood pressure (BP) put in relation to self-reported variables, for example, physical activity and stress. Topic initiation was distributed symmetrically between parties and BP talk was lifestyle-centered. The patients’ contributed to the interpretation of BP values by connecting them to specific occasions, providing insights to the link between BP measurements and everyday life activities. Conclusion:Patients’ contribution through interpretations of BP values to specific situations in their own lives brought on consultations where the patient as a person in context became salient. Further, the patients’ and health care professionals’ equal contribution during the consultations showed actively involved patients. The mobile phone-based self-management support system can thus be used to support patient involvement in consultations with a person-centered approach in primary care hypertension managementKey points  The clinical consultation is important to provide opportunities for patients to gain understanding of factors affecting high blood pressure, and for health care professionals to motivate and promote changes in life-style.This study shows that self-reporting as base for follow-up consultations in primary care hypertension management can support patients and professionals to equal participation in clinical consultations.Self-reporting combined with increased patient–health care professional interaction during follow-up consultations can support patients in understanding the blood pressure value in relation to their daily life.These findings implicate that the interactive mobile phone self-management support system has potential to support current transformations of patients as recipients of primary care, to being actively involved in their own health. [ABSTRACT FROM PUBLISHER]

Objective: Despite close to all-embracing access to child healthcare, health divides exist among children in Sweden. Home visits to families with new-born babies are a cost-effective way to identify and strengthen vulnerable families. An extended postnatal home visiting programme has been implemented in a disadvantaged suburb in Stockholm with positive results. Design: Longitudinal, prospective study and register study from medical records. Setting: A vulnerable rural area in Sweden. Intervention: A parent advisor from the social services and a midwife performed an extended home visiting programme during the end of pregnancy to mothers of children born between 1 May 2018 and 31 May 2019. During these children's first 15months, three additional home visits were made by a parent advisor and a child healthcare nurse. The aim of the study is to evaluate the effect of the intervention on the health of the children and the mothers. Subjects: All firstborn children at the study site (N=30 study, N=55 control group). Main outcome measures: The proportion participating in visits to the child and maternal healthcare services, children being breastfed and receiving childhood vaccinations. Results: There were fewer absentees in the study group during routine check-up visits (93 vs. 84%). More mothers in the study group attended the check-up with the midwives (90 vs. 80%). More children in the study group were breastfed (90 vs. 67%) and received all vaccinations (100 vs. 96%). Conclusion: Supplementing the extended home visiting programme with a visit at the end of pregnancy seems to contribute to fewer absentees at routine visits for both mothers and children; furthermore, more children were breastfed and vaccinated compared with the control group. [ABSTRACT FROM AUTHOR]

Aim: The aims of this study were (1) to identify older patients' risk factors for drug‐related readmissions and (2) to assess the preventability of older patients' drug‐related revisits. Methods: Post hoc analysis of a randomized clinical trial with patients aged ≥65 years at eight wards within four hospitals in Sweden. (1) The primary outcome was risk factors for drug‐related readmission within 12 months post‐discharge. A Cox proportional hazards model was made with sociodemographic and clinical baseline characteristics. (2) Four hundred trial participants were randomly selected and their revisits (admissions and emergency department visits) were assessed to identify potentially preventable drug‐related revisits, related diseases and causes. Results: (1) Among 2637 patients (median age 81 years), 582 (22%) experienced a drug‐related readmission within 12 months. Sixteen risk factors (hazard ratio >1, P < 0.05) related to age, previous hospital visits, medication use, multimorbidity and cardiovascular, liver, lung and peptic ulcer disease were identified. (2) The 400 patients experienced a total of 522 hospital revisits, of which 85 (16%) were potentially preventable drug‐related revisits. The two most prevalent related diseases were heart failure (n = 24, 28%) and chronic obstructive pulmonary disease (n = 13, 15%). The two most prevalent causes were inadequate treatment (n = 23, 27%) and insufficient or no follow‐up (n = 22, 26%). Conclusion: (1) Risk factors for drug‐related readmissions in older hospitalized patients were age, previous hospital visits, medication use and multiple diseases. (2) Potentially preventable drug‐related hospital revisits are common and might be prevented through adequate pharmacotherapy and continuity of care in older patients with cardiovascular or lung disease. [ABSTRACT FROM AUTHOR]

Background: Uveal melanoma is the most common primary intraocular tumor in adults. In Sweden, at least 100 patients are diagnosed with the disease each year. Almost half of the patients develop metastases, with a median survival time of 1 year once metastases are detected. The primary ocular tumor is typically treated with either enucleation or brachytherapy, and no adjuvant treatment is added. Melatonin is an indolamine hormone that has improved survival in previous trials with patients diagnosed with various cancers, including advanced cutaneous melanoma. Side effects have been mild. We aim to investigate if adjuvant treatment with melatonin for 5 years following diagnosis of non-metastasized uveal melanoma can decrease the occurrence of metastases. Methods: An open-label, prospective, 5-year randomized clinical trial (RCT) will be conducted at St. Erik Eye Hospital. One hundred patients recently diagnosed with non-metastatic uveal melanoma will be randomized to either treatment with adjuvant melatonin 20 mg (4 tablets of 5 mg) at 10 pm for 5 years, or to standard follow-up (control group). The primary outcome measurement is the relative risk for having developed metastases 5 years after randomization. The secondary outcomes are overall survival, risk of developing other cancers, overall survival after detection of metastases, and differences in the occurrence of adverse events (AE) and serious adverse events (SAE) between the groups. Discussion: Melatonin has been found to positively impact our immune system, inhibit angiogenesis, stimulate apoptosis in malignant cells, and act as a potent antioxidant. Previous clinical trials have used similar doses of melatonin with positive results, particularly in advanced stages of cancer. Previous animal and human studies have found the toxicity of the hormone to be low. Considering the potential benefits and limited risks of melatonin, as well as its global availability, it may be a suitable candidate for an adjuvant treatment in patients with uveal melanoma. Trial registration: Our trial protocol has been approved and registered by the Swedish Medical Products Agency on June 22, 2022 (EudraCT 2022–500,307-49–00). Our trial registration number is NCT05502900, and the date of registration is August 16, 2022. [ABSTRACT FROM AUTHOR]

This initial open feasibility trial reports on feasibility and preliminary effectiveness of the manualized, group-based psychoeducational intervention for grandparents of preschool-aged children with ASD provided by the outpatient habilitation services in Stockholm, Sweden. One hundred and twenty non-custodial grandparents participated in a 6-h intervention program. The study demonstrated good feasibility: 114 (95%) grandparents completed both pre- and post-intervention measures and evaluations and reported high intervention acceptability. The results also indicated that grandparents increased their knowledge about ASD from pre-intervention to post-intervention, gained skills about strategies of supporting their grandchildren and adult children, and appreciated the opportunity to meet and share experiences with other grandparents. Follow-up with a randomized controlled trial design is needed to firmly establish efficacy of this intervention. [ABSTRACT FROM AUTHOR]

While rates of child maltreatment increased during the Covid-19-pandemic, face-to-face interventions to support families got difficult to carry out due to restrictions. Meanwhile, many services do not have access to parenting programs designed for digital or remote delivery. A solution employed by some services was to use video conferencing (VC) to deliver their regular parenting programs. This study examined the effectiveness of the universal group-based parenting program ABC offered through VC instead of on-site meetings during the pandemic. Pre and post measurements were collected from 469 parents participating in either 1) ABC with VC meetings only, 2) on-site meetings only, or 3) blended – a combination of VC and on-site sessions. In addition, 74 group leaders completed a survey about their experiences of VC groups. Analyses showed general improvements in parent practices and child conduct over time, but no differences in effectiveness depending on the format of the parent group (VC, blended, or on-site). Qualitative analyses of group leaders' experiences revealed four key-themes pertaining to both challenges (e.g., concerns about parents' ability to benefit and learn parenting skills) and benefits (e.g., reaching parents who would not have been able to attend physical meetings) of VC groups. Overall, this study showed no significant differences in outcomes between the VC, blended, or on-site format of delivery. There are however limitations of this trial, and results should be considered preliminary. Effectiveness and potential negative consequences of replacing interventions intended to be delivered on-site with VC alternatives need to be further investigated in future trials. Highlights: While the pandemic put families at strain, on-site support programs got difficult to deliver due to pandemic restrictions. In Sweden, clinics offered the universal parenting program ABC through video conferencing (ABC-VC). This study examined outcomes of ABC conducted by VC versus on-site, and how group leaders experienced ABC-VC. Improvements in parenting skills and children's behaviors were similar for parents receiving ABC on-site and by VC. Video conferencing can be a way to reach more families. Meanwhile, some parents may benefit more from an on-site group. [ABSTRACT FROM AUTHOR]

Background: Implementing effective antenatal care models is a key global policy goal. However, the mechanisms of action of these multi-faceted models that would allow widespread implementation are seldom examined and poorly understood. In existing care model analyses there is little distinction between what is done, how it is done, and who does it. A new evidence-informed quality maternal and newborn care (QMNC) framework identifies key characteristics of quality care. This offers the opportunity to identify systematically the characteristics of care delivery that may be generalizable across contexts, thereby enhancing implementation. Our objective was to map the characteristics of antenatal care models tested in Randomised Controlled Trials (RCTs) to a new evidence-based framework for quality maternal and newborn care; thus facilitating the identification of characteristics of effective care.Methods: A systematic review of RCTs of midwifery-led antenatal care models. Mapping and evaluation of these models' characteristics to the QMNC framework using data extraction and scoring forms derived from the five framework components. Paired team members independently extracted data and conducted quality assessment using the QMNC framework and standard RCT criteria.Results: From 13,050 citations initially retrieved we identified 17 RCTs of midwifery-led antenatal care models from Australia (7), the UK (4), China (2), and Sweden, Ireland, Mexico and Canada (1 each). QMNC framework scores ranged from 9 to 25 (possible range 0-32), with most models reporting fewer than half the characteristics associated with quality maternity care. Description of care model characteristics was lacking in many studies, but was better reported for the intervention arms. Organisation of care was the best-described component. Underlying values and philosophy of care were poorly reported.Conclusions: The QMNC framework facilitates assessment of the characteristics of antenatal care models. It is vital to understand all the characteristics of multi-faceted interventions such as care models; not only what is done but why it is done, by whom, and how this differed from the standard care package. By applying the QMNC framework we have established a foundation for future reports of intervention studies so that the characteristics of individual models can be evaluated, and the impact of any differences appraised. [ABSTRACT FROM AUTHOR]

[Display omitted] • Probiotic dairy products may modify the oral microbiota (reductions in S. mutans counts). • Probiotic dairy products may reduce caries development and periodontal disease, and improve gingival health. • The main probiotic dairy products in dentistry are milk, fermented milk, yogurt, kefir, curd, and cheese. • Probiotic effect lasted 2–4 weeks after discontinuing consumption. • Probiotic dairy products are promising alternatives to improve oral health. The oral environment is an essential part of the human microbiome. The consumption of probiotic products may improve the oral microbiota and reduce the risk of diseases. This paper presents a bibliometric and critical review of randomized clinical trials (RCTs) that used probiotics to analyze oral parameters in humans. RCTs carried out with no age, gender, and ethnicity restrictions and published in the pre-COVID-19 period were included. Furthermore, the utilization of probiotic dairy products to improve oral health is discussed. The bibliometric review demonstrated that 'Microbiology,' 'Dental caries,' and ' Streptococcus mutants' were the most highlighted keywords. Furthermore, Sweden and India have the highest number of publications. The most prevalent outcomes were 'salivary parameters,' 'periodontal disease,' and 'dental caries.' The most used vehicles for probiotic administration were pharmaceutical formulas and dairy products. The administration of probiotic dairy products could modify the oral microbiota (reductions in S. mutans counts), influence the caries development and periodontal disease in children, adolescents, adults, and the elderly, and improve gingival health. The main probiotic dairy products investigated were milk, fermented milk, yogurt, kefir, curd, and cheese. Lacticaseibacillus paracasei SD1 was the most used probiotic culture. The studies demonstrated that the probiotic effect lasted 2–4 weeks after discontinuing consumption. However, the results depended on the subject type, study design, probiotic strain and concentration, and dairy product type. In conclusion, probiotic dairy products are promising alternatives to improve oral health. [ABSTRACT FROM AUTHOR]

Background: Management of intermittent claudication should include secondary prevention to reduce the risk of cardiocerebrovascular disease. Patient adherence to secondary prevention is a challenge. The aim of this study was to investigate whether a person-centred, nurse-led follow-up programme could improve adherence to medication compared with standard care. Methods: A non-blinded RCT was conducted at two vascular surgery centres in Sweden. Patients with intermittent claudication and scheduled for revascularization were randomized to the intervention or control (standard care) follow-up programme. The primary outcome, adherence to prescribed secondary preventive medication, was based on registry data on dispensed medication and selfreported intake of medication. Secondary outcomes were risk factors for cardiocerebrovascular disease according to the Framingham risk score. Results: Some 214 patients were randomized and analysed on an intention-to-treat basis. The mean proportion of days covered (PDC) at 1 year for lipid-modifying agents was 79 per cent in the intervention and 82 per cent in the control group, whereas it was 92 versus 91 per cent for antiplatelet and/or anticoagulant agents. The groups did not differ in mean PDC (lipid-modifying P= 0.464; antiplatelets and/or anticoagulants P=0.700) or in change in adherence over time. Self-reported adherence to prescribed medication was higher than registry-based adherence regardless of allocation or medication group (minimum P<0.001, maximum P=0.034). There was no difference in median Framingham risk score at 1 year between the groups. Conclusion: Compared with the standard follow-up programme, a person-centred, nurse-led follow-up programme did not improve adherence to secondary preventive medication. Adherence was overestimated when self-reported compared with registry-reported. [ABSTRACT FROM AUTHOR]

Background/Aim: Anastomotic leakage (AL) after anterior resection for rectal cancer occurs in up to 26% of patients. In the last decade, endoscopic vacuum therapy (EVT) has gained interest as a treatment option for AL. This study aimed to compare the clinical success rate of EVT versus transanal drainage (TD) in AL treatment and investigate whether the frequency of bowel continuity differed. Patients and Methods: Patients treated for rectal cancer at the Skåne University Hospital, Sweden between 2009-2018 were identified through the Swedish Colorectal Cancer Registry (SCRCR). Patient characteristics, operative and AL data were retrieved by SCRCR and chart review. Results: Out of 1,095 patients subjected to rectal cancer surgery, 361 patients had undergone anterior resection. AL occurred in 39 patients, of these 14 patients were treated with EVT and 17 with TD. Bowel continuity was achieved in 50% of patients treated with EVT and 65% of patients treated with TD (p=0.28). The patients were under treatment for a median period of 24.5 days (IQR=11-36 days) when treated with EVT and 37 days (IQR=17-51 days) with TD. Conclusion: No superiority of EVT treatment could be shown in restoring bowel continuity. This questions the role of EVT in AL treatment after anterior resection. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effects of a person‐centred and thriving‐promoting intervention on nursing home residents´ experiences of thriving and person‐centredness of the environment, and to evaluate if the effects varied between female and male residents. Design: A multi‐centre, non‐equivalent controlled group before‐after intervention design. Methods: Six nursing homes in Australia, Norway and Sweden were allocated to either intervention or control group. The intervention comprised a staff educational programme. A survey using proxy‐ratings by staff was administered before (T0), immediately after (T1) and six months after (T2) the intervention. The sample varied between 205 and 292 residents. Linear regression models were used to explore effects. Results: Statistically significant effects were found on experiences of thriving and person‐centredness of the environment. These effects were significant for male residents but not for female residents. The results emphasize the importance of individually tailored social and recreational activities. [ABSTRACT FROM AUTHOR]

Schools are institutions responsible for teaching children new skills and knowledge, the ability to think about future targets, and, when problems become complex, how to apply explorative thinking and inborn creativity to solve them. Even so, scholars point to the fact that school curriculums do not support ways to facilitate explorative learning or creativity for problem-solving. To successfully devise solutions never considered before, children need support with programs enabling them to facilitate openness for experience intellectually. This study suggests that dance activities should become regular in the curriculum as a strategy for maintaining schoolchildren's cognitive flexibility. [ABSTRACT FROM AUTHOR]

Background: There is a shortage of high-quality studies regarding choice of mesh in open anterior inguinal hernia repair in relation to long-term chronic pain. The authors hypothesized that heavyweight compared with lightweight mesh causes increased postoperative pain. Methods:An RCT was undertaken between 2007 and 2009 at two sites in Sweden. Men aged 25 years or older with an inguinal hernia evaluated in the outpatient clinic were randomized in an unblinded fashion to heavyweight or lightweight mesh for open anterior inguinal hernia repair. Data on pain affecting daily activities, as measured by the Short-Form Inguinal Pain Questionnaire 9-12 years after surgery, were collected as the primary outcome. Differences between groups were evaluated by generalized odds and numbers needed to treat. Results:A total of 412 patients were randomized; 363 were analysed with 320 questionnaires sent out. A total of 271 questionnaires (84.7 per cent) were returned; of these, 121 and 150 patients were in the heavyweight and lightweight mesh groups respectively. Pain affecting daily activities was more pronounced in patients randomized to heavyweight versus lightweight mesh (generalized odds 1.33, 95 per cent c.i. 1.10 to 1.61). This translated into a number needed to treat of 7.06 (95 per cent c.i. 4.28 to 21.44). Two reoperations for recurrence were noted in the heavyweight mesh group, and one in the lightweight mesh group. Conclusion:A large-pore lightweight mesh causes significantly less pain affecting daily activities a decade after open anterior inguinal hernia repair. [ABSTRACT FROM AUTHOR]

To examine antimicrobial management of brain abscess and prioritize future trials. Self-administered, Internet-based survey of practices for treatment of community-acquired bacterial brain abscess among infectious diseases (ID) specialists in France, Sweden, Australia, and Denmark during November 2019. Respondents were also asked to rank future randomized controlled trials (RCTs) from 1 (high priority) to 6 (low priority). 310 ID specialists (45% female) from France (35%), Sweden (29%), Australia (25%), and Denmark (11%) participated in the survey, primarily from university hospitals (69%) with an on-site neurosurgical department (61%). Preferred empiric intravenous (IV) antimicrobials were cefotaxime (154/273, 56%) or ceftriaxone (68/273, 25%) combined with metronidazole for a median of 4 weeks (IQR 4–6), 4 weeks (IQR 2–4), and 6 weeks (IQR 4–6) for aspirated, excised, and conservatively treated patients, respectively. Early transition to oral antimicrobials (i.e., < 4 weeks of IV antimicrobials) was used by 134/269 (50%), whereas consolidation therapy with oral antimicrobials after a standard IV regimen (i.e., 4–8 weeks) was used by 123/264 (47%). Median prioritization scores for future RCTs were as follows: 1 (IQR 1–2) for an early transition to oral antimicrobials and duration of therapy, 3 (IQR 2–4) for comparisons of antimicrobial regimens, use of adjunctive dexamethasone, and neurosurgical aspiration versus excision, and 4 (IQR 3–5) for intracavitary antimicrobial instillation and drainage, and for prophylactic anti-epileptic therapy. Willingness to include patients into RCTs reflected prioritization scores. Duration of intravenous antimicrobial treatment and use of oral antimicrobials varies substantially among ID specialists. RCTs are needed to define optimal treatment of brain abscess. [ABSTRACT FROM AUTHOR]

Background: The number of clinical trials in body dysmorphic disorder (BDD) has steadily increased in recent years. As the number of studies grows, it is important to define the most empirically useful definitions for response and remission in order to enhance field-wide consistency and comparisons of treatment outcomes across studies. In this study, we aim to operationally define treatment response and remission in BDD. Method: We pooled data from three randomized controlled trials of cognitive-behavior therapy (CBT) for BDD (combined n = 153) conducted at four academic sites in Sweden, the USA, and England. Using signal detection methods, we examined the Yale-Brown Obsessive Compulsive Scale modified for BDD (BDD–YBOCS) score that most reliably identified patients who responded to CBT and those who achieved remission from BDD symptoms at the end of treatment. Results: A BDD–YBOCS reduction ⩾30% was most predictive of treatment response as defined by the Clinical Global Impression (CGI) – Improvement scale (sensitivity 0.89, specificity 0.91, 91% correctly classified). At post-treatment, a BDD–YBOCS score ⩽16 was the best predictor of full or partial symptom remission (sensitivity 0.85, specificity 0.99, 97% correctly classified), defined by the CGI – Severity scale. Conclusion: Based on these results, we propose conceptual and operational definitions of response and full or partial remission in BDD. A consensus regarding these constructs will improve the interpretation and comparison of future clinical trials, as well as improve communication among researchers, clinicians, and patients. Further research is needed, especially regarding definitions of full remission, recovery, and relapse. [ABSTRACT FROM AUTHOR]

Technology developments and demand for flexibility in health care and in contact with the health care system are two factors leading to increased use of eHealth solutions. The use of eHealth has been shown to have positive effects in people with chronic obstructive pulmonary disease, but the full potential for this group needs to be explored. Therefore, the aim was to evaluate the feasibility of an eHealth tool used for exercise training and online contacts for people with severe chronic obstructive pulmonary disease. The 10-week intervention included an eHealth tool for exercise training in home environment and regular online contacts, as well as weekly e-rounds for health care professionals. Seven of the nine participants completed the study. The eHealth tool was found to be feasible for e-rounds, exercise training and online contacts. Participants could manage the tool and adhere to training; positive effects were shown, and no adverse events occurred. Technical functions need to be improved. [ABSTRACT FROM AUTHOR]

Background: Biofilm formation on endotracheal tubes (ETTs) is an early and frequent event in mechanically ventilated patients. The biofilm is believed to act as a reservoir for infecting microorganisms and thereby contribute to development and relapses of ventilator-associated pneumonia (VAP). Once a biofilm has formed on an ETT surface, it is difficult to eradicate. This clinical study aimed to compare biofilm formation on three widely used ETTs with different surface properties and to explore factors potentially predictive of biofilm formation.Methods: We compared the grade of biofilm formation on ETTs made of uncoated polyvinyl chloride (PVC), silicone-coated PVC, and PVC coated with noble metals after > 24 h of mechanical ventilation in critically ill patients. The comparison was based on scanning electron microscopy of ETT surfaces, biofilm grading, surveillance and biofilm cultures, and occurrence of VAP.Results: High-grade (score ≥ 7) biofilm formation on the ETTs was associated with development of VAP (OR 4.17 [95% CI 1.14-15.3], p = 0.031). Compared to uncoated PVC ETTs, the silicone-coated and noble-metal-coated PVC ETTs were independently associated with reduced high-grade biofilm formation (OR 0.18 [95% CI 0.06-0.59], p = 0.005, and OR 0.34 [95% CI 0.13-0.93], p = 0.036, respectively). No significant difference was observed between silicon-coated ETTs and noble-metal-coated ETTs (OR 0.54 [95% CI 0.17-1.65], p = 0.278). In 60% of the oropharyngeal cultures and 58% of the endotracheal cultures collected at intubation, the same microorganism was found in the ETT biofilm at extubation. In patients who developed VAP, the causative microbe remained in the biofilm in 56% of cases, despite appropriate antibiotic therapy. High-grade biofilm formation on ETTs was not predicted by either colonization with common VAP pathogens in surveillance cultures or duration of invasive ventilation.Conclusion: High-grade biofilm formation on ETTs was associated with development of VAP. Compared to the uncoated PVC ETTs, the silicone-coated and noble-metal-coated PVC ETTs were independently associated with reduced high-grade biofilm formation. Further research on methods to prevent, monitor, and manage biofilm occurrence is needed.Trial Registration: ClinicalTrials.gov NCT02284438 . Retrospectively registered on 21 October 2014. [ABSTRACT FROM AUTHOR]

Study Question: Are obstetric and perinatal outcomes in pregnancies after fresh blastocyst transfer (BT) comparable with those born after fresh cleavage stage transfer (CT) and spontaneous conception (SC)?Summary Answer: Fresh BT is associated with a higher risk of placental and perinatal complications.What Is Known Already: BT optimizes the selection of top-quality embryos and increases pregnancy and live birth rates per transfer compared to CT. However, concerns have been raised as extended culture duration may increase obstetric complications and impair perinatal outcomes. Previous studies have shown a higher risk of preterm birth (PTB) among infants born after BT compared with CT. Pregnancies after BT are also prone to a higher risk of same-sex twins after single embryo transfer (SET).Study Design, Size, Duration: A retrospective register-based cohort study used data from Denmark, Norway and Sweden including three cohorts: 56 557 singletons and 16 315 twins born after fresh IVF/ICSI cycles and 2 808 323 SC singletons in Denmark (birth years 1997-2014), Norway (2010-2015) and Sweden (2002-2015). Of the fresh IVF/ICSI singletons, 4601 were born after BT and 51 956 after CT. The twin cohort consisted of 884 fresh IVF/ICSI children born after BT and 15 431 fresh IVF/ICSI children born after CT.Participants/materials, Setting, Methods: Data were obtained from a large Nordic cohort of children born after ART and SC initiated by the Committee of Nordic ART and Safety (CoNARTaS). The CoNARTaS cohort was established by cross-linking National ART-, Medical Birth-, and National Patients Registers using the unique personal identification number, allocated to every citizen in the Nordic countries. Obstetric and perinatal outcomes after BT, CT and SC were compared using logistic regression analysis. For perinatal outcomes, we calculated gestational age based on the date of oocyte pick-up (OPU) and in sensitivity analyses on data from Denmark and Norway, we also calculated gestational age based on the second-trimester ultrasonography (US) scan. Risk of pregnancies with same-sex twins after SET was used as a proxy for risk of monozygotic twins. Adjustments were made for child's sex, birth year, parity (0 or >1), maternal age, body mass index, smoking, educational level, fertilization method (IVF/ICSI), the number of aspirated oocytes, SET and country. Information on educational level and the number of aspirated oocytes was not available for Norway. Children born after frozen embryo transfer were not included. The birth cohorts were restricted according to the year in which BT was introduced in the different countries.Main Results and the Role Of Chance: A higher risk of placenta previa was found in singleton pregnancies after BT compared with CT (adjusted odds ratio [aOR] 2.11 [95% CI 1.76; 2.52]). Singletons born after BT had a higher risk of PTB (aOR 1.14 [95% CI 1.01; 1.29]) compared with CT singletons, when estimated based on OPU. Furthermore, an altered male/female ratio (aOR 1.13 [95% CI 1.06; 1.21]) with more males following BT compared with CT was seen. Risk of same-sex twins after SET was higher after single BT compared with single CT (aOR 1.94 [95% CI 1.42; 2.60]).Limitations, Reasons For Caution: Residual confounding cannot be excluded, in particular related to duration and cause of infertility that we could not adjust for due to lack of reliable data.Wider Implications Of the Findings: Extended embryo culture to the blastocyst stage has the potential to compromise obstetric and perinatal outcomes in fresh cycles. These results are important since an increasing number of IVF/ICSI treatments are performed as BT.Study Funding/competing Interest(s): NORDFORSK (project no: 71450). The Research Fund of Rigshospitalet, Copenhagen University Hospital. ReproUnion Collaborative study, co-financed by the European Union, Interreg V ÖKS. Grants from Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (LUA/ALF 70940), Hjalmar Svensson Research Foundation. The Research Council of Norway through its Centres of Excellence funding scheme, project number 262700. None of the authors has any conflicts of interests to declare regarding this study.Trial Registration Number: ISRCTN11780826. [ABSTRACT FROM AUTHOR]

Background: Urethral Pain Syndrome (UPS) in women is a recurrent urethral pain without any proven infection or other obvious pathology. There are few studies on UPS, and evidence-based treatment is lacking. The primary aim was to study what treatments are used, and to compare the treatment tradition of UPS in Sweden in 2018, with what was used in 2006. Methods: A questionnaire on the treatment of women with UPS was sent to all public gynecology, urology, gynecologic oncology and venereology clinics, and one public general practice in each county in Sweden in 2018. Private practice clinics in gynecology responded to the survey in 2017. Comparisons were made with the same survey sent to gynecology and urology clinics in 2006. Findings: Of 137 invited clinics in 2018, 99 (72.3%) responded to the survey. Seventy-seven (77.8%) of them saw women with UPS and 79.2% (61/77) of these clinics treated the patients using 19 different treatment methods. Local corticosteroids and local estrogens were the methods most used. Treatments were similar in gynecology and urology clinics in 2006 and 2018, although strong corticosteroids had increased in use in the treatment regimens of 2018. More than half of the clinics used antibiotics. Interpretation: Since there is no evidence-based treatment of UPS, a wide spectrum of treatments is used, and different specialties use different treatment strategies. Despite the lack of proven infection, a large number of clinics also treated the syndrome with antibiotics. There is thus a need for well-designed randomized controlled clinical trials to find evidence-based treatments of UPS. [ABSTRACT FROM AUTHOR]

People with psychotic disorders experience to a great extent avoidable physical illnesses and early mortality. The aim of the study was to investigate the potential effects for this group of participating in a lifestyle intervention. A multi-component nurse-led lifestyle intervention using quasi-experimental design was performed. Changes in biomedical and clinical measurements, self-reported health, symptoms of illness and health behavior were investigated. Multilevel modeling was used to statistically test differences in changes over time. Statistically significant changes were found in physical activity, HbA1c and waist circumference. A lifestyle intervention for people with severe mental illness can be beneficial for increasing physical activity. [ABSTRACT FROM AUTHOR]

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Objective: To conduct a systematic review analyzing disease definitions and diagnostic criteria used in randomized controlled trials (RCTs) involving burning mouth syndrome (BMS). Methods: A systematic search conducted in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar that included RCTs on BMS published between 1994 and 2017 was performed. Results: Considerable variability in BMS disease definitions and diagnostic criteria used created substantial heterogeneity in the selection of participants and weakened the rigor of the 36 RCTs identified. The analyzed RCTs routinely under‐reported the methods used to rule in or out study participants and the number of individuals excluded from BMS RCTs. Conclusions: Our findings indicate that a large proportion of participants enrolled in these studies may have had an underlying condition that could have explained their BMS symptoms. Thus, outcomes of therapeutic interventions from these BMS RCTs should be interpreted with caution due to heterogeneous disease definitions and diagnostic criteria. In order to improve the quality of clinical trials, future research should focus on establishing consensus for a single definition of BMS that includes specific inclusion and exclusion criteria that should be used to select study participants for clinical trials. [ABSTRACT FROM AUTHOR]

Even though there are documented benefits of direct intensive intervention for children with speech sound disorders (SSDs), the intensity given at Swedish Speech Language Pathology services rarely exceeds once a week. Also, indirect therapy approaches are commonly employed. The purpose of the present case study was to investigate the effects of an intensive specialist therapy, based on non-linear phonological analysis and motor learning principles. The participant was a boy aged 4:10 years with severe SSD, who previously had received indirect therapy from age 3 with, very limited results. A single subject ABA design was used. At baseline, whole word match was 0%, Word shape CV match was 39% and PCC was 22, 7%. He had no multisyllabic words, no consonant clusters and no established coronals. Intervention was given 4 days weekly for 3 weeks in two periods with a 7-week intervening break and a post therapy assessments. Therapy was focused on establishing multisyllabic words, iambic stress pattern, clusters and coronals with the principle of using already established elements for targeting new elements. At post therapy assessment, whole word match was 39%, word shape CV match was 71% and PCC 69.1%. Multisyllabic words (86%), coronals (82%) and word initial clusters (80%) were established. Without being targeted, back vowels were also present and segment timing improved. The strong treatment effects of this study demonstrate that at least severe cases of SSD require the clinical knowledge and skills that only a SLP can provide and that frequent direct therapy is both beneficial and needed. [ABSTRACT FROM AUTHOR]

Background: The use of a preoperative single dose of antibiotics as routine in conjunction with implant surgery is controversial, in light of the unclear effect on early implant failure rate and risk for development of resistant bacterial strains. Purpose: This randomized clinical trial compared the early implant failure rates in two different patient cohorts: One group receiving a single dose of preoperative antibiotics (AB group) and one group receiving no antibiotics, prior to implant surgery (noAB group). Materials and Methods: Patients were referred for treatment at four specialist clinics in the county council of West Sweden, Vastra Gotaland and randomly assigned into one of the two groups. A total of 447 patients received 963 implants were included in the study. Of these, 223 patients (535 implants) belonged to the AB‐group and 224 patients (428 implants) to the noAB‐group. Four commercial implant brands were utilized, albeit one system was only represented with four implants. The outcome was evaluated after 4 months using either a one‐stage or two‐stage procedure. The surgical procedures were performed by experienced implant surgeons and the surgical protocol for implant placement follows standard. Failure was defined as removal of an implant for any reason. The study outcomes were statistically analyzed to evaluate the differences between the two groups. Results: Twelve implants failed in 11 patients for the AB group, and 32 implants failed in 29 patients for the noAB group. Preoperative antibiotics, AB group, had significantly (P < 0.0011) lower implant failure 2.2% compared to 7.5% in the noAB group analyzed on implant level adjusted for dependence within patients, OR = 0.30, 95% confidence interval (0.14‐0.62). Conclusion: Administration of a single dose of antibiotics in conjunction with implant placement surgery resulted in a statistically significant lower early implant failure rate compared to when no antibiotics were used. [ABSTRACT FROM AUTHOR]

Background: The objective of the present study was to evaluate effectiveness, complications and cost-effectiveness of any surgical or non-surgical treatment for radius or ulna fractures in elderly patients. Secondary objectives were to analyze present treatment traditions of distal radius fractures (DRF) in Sweden and to calculate resource usage for its treatment. Methods and findings: The assessment contains a systematic review of clinical and health economic studies comparing treatment options for radius or ulna fractures. The results regarding the effectiveness of the treatments are summarized in meta-analyses. In addition, the assessment contains a cost analysis for different treatment options commonly used for DRF care, and an analysis of registry data on the incidence and treatment of DRF. In total 31 randomized controlled trials were included in meta-analyses. When comparing functional outcome for plate fixation versus non-surgical treatment for DRF, there were no clinically important differences at one-year follow-up (mean difference [MD], -3.29, 95% CI, -7.03; 0.44). Similar results were found when comparing plating and percutaneous methods with respect to functional outcome (standardized mean difference [SMD], -0.07, 95% CI, -0.21; 0.07) and grip strength (MD, -3.47, 95% CI, -11.21; 4.28). There were no differences for minor complications, (risk difference [RD], -0.01, 95% CI, -0.07; 0.05) whereas major complications were less common for the percutaneous group, (RD, 0.02, 95% CI, 0.02; 0.03). Given the low number of studies, the evidence above was rated as moderate certainty. The cost for plate fixation versus plaster cast was estimated to 1698 compared to 137 US dollars. For DRF, plate fixation increased in Sweden between 2005 and 2013, and was the most common surgical method in 2013. Conclusions: Surgical treatment of moderately displaced distal radius fractures in elderly patients offers no clear benefit compared to non-surgical treatment. Plating procedures have become more common during the second millennium and involve higher costs and higher risk of major complications than percutaneous options. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to investigate the feasibility and cost-utility of a school-based cognitive–behavioral (CB) depression prevention program. Methods: A quasi-experimental trial with an intervention group and a control group, with follow-up measurements obtained at three and 12 months after baseline, was conducted. The setting was six Swedish municipalities. The participants were students in grade 8 (median age: 14). A total of 462 students (79% girls) were allocated to the school-based CB prevention program, and 486 students (46% girls) were allocated to the control group. The school-based CB prevention program, Depression in Swedish Adolescents (DISA), was presented by school health service staff and teachers once per week for 10 weeks. Results: The main outcome measures were self-reported depressive symptoms and self-rated health; the secondary outcome measures were adherence and cost-utility. The intervention group decreased their self-reported depressive symptoms (as measured by the Center for Epidemiological Studies Depression Scale) and improved their self-rated health (as measured by the visual analog scale) at the 12-month follow-up more than the control group (p < .05). Conclusions: Given the challenges of conducting a study in a complex, everyday school setting with baseline differences between the intervention and control group, it is difficult to make accurate interpretations of the effectiveness of the intervention. However, with these limitations in mind, the results indicate that the DISA program is a feasible school-based prevention program. [ABSTRACT FROM AUTHOR]

Uppsala Clinical Research Center (UCR) is a non-profit organization that provides service for clinical research aiming for development and improvement of health care in Sweden and worldwide. UCR was started in 2001 with the ambition to shift the focus of clinical research from new medications or devices launched by the industry to problem-based research on issues identified in clinical reality, for example through the national quality registries. In order to accomplish these goals, UCR has established services in: 1) clinical trials of new and old methods in health care; 2) quality development of the health care system supported by internet-based national quality registries; 3) biostatistics, epidemiology, and data management; 4) biobanking of biological materials (Uppsala Biobank); 5) high-throughput biochemical analyses (UCR laboratory); and 6) academic leadership by the members of the UCR research faculty. The UCR clinical trials group provides services for investigator-driven projects in all areas of health care, for global mega-trials on new pharmaceutical treatments and devices, for biobanking including biomarker and genetics analyses, and for clinical events adjudication in national as well as global mega-trials. During the last few years, UCR has been a pioneer in establishing the registry-based randomized clinical trial (R-RCT), which today is an international model on how to perform cost-effective pragmatic randomized trials in the real-world environment. In 2002, UCR started the first national competence center for national quality registries, which pioneered the development of the current internet-based technologies for registering, reporting, and supporting continuous systematic improvement of health care. UCR is currently harboring around 20 national quality registries in all areas of health care. Today, UCR is the leading European center for registry-based quality development and evaluation of new medical treatments in cardiovascular care and has started to support other European countries in implementing the UCR registry platform in order to improve quality of care in the European Union. [ABSTRACT FROM AUTHOR]

Objectives: Studies show that regular exercise in combination with nutritional support can be effective in managing sarcopenia, which is age-related involuntary loss of skeletal muscle mass and strength. Qualitative investigations of participants’ experiences from interventions in this domain are scarce. In this study, we explored older persons’ experiences from an intervention designed to prevent sarcopenia, with the aim of capturing the participants’ thoughts and opinions.Design: A qualitative study embedded in the multicenter randomized clinical trial The Vitality and Vigor in the Elderly study, VIVE2. Focus group interviews were conducted. Manifest and latent content analyses were performed.Participants: Community dwelling older adults (n=20) 71-86 years of age with minor limitations in mobility.Results: The experiences from the intervention were categorized and interpreted in one overall theme “Feeling more self-confident, cheerful and safe”. The theme encompasses the categories psychological effects of participating in the intervention, physical effects of participating in the intervention, the importance of social support and the importance of a tailored set-up. The participants described their motives for participating in the intervention as being based on concerns regarding the negative health effects of continuing a sedentary lifestyle, difficulties of getting started on their own and lack of confidence in accomplishing change on their own. Participants also expressed that one main objective for participating was to lose weight.Conclusion: In this study we have captured the experiences of older adults with minor mobility limitations who participated in a lifestyle intervention. The experiences are interpreted in one overall theme “Feeling more self-confident, cheerful and safe”. The central understanding of the participants’ experiences was that the intervention affected them in several ways, both psychologically and physically, and that supporting factors included the social support, which became a prerequisite for success. A noticeable finding was the discrepancy between the motive of the participants, to lose weight, and the aim of the study, to improve muscle function. The expectation to lose weight seems to reflect what is commonly known as to be healthy. To our knowledge, at least in Sweden, there are no campaigns or public information highlighting the risks of sarcopenia and the complex issue of if, and when weight loss is desirable for older individuals. This finding highlights the importance of providing such information to this target group. The findings in this study provide valuable knowledge for research teams, practitioners and decision makers when designing and setting objectives for health-promoting interventions for older individuals. [ABSTRACT FROM AUTHOR]

Objective: To determine whether superior hypogastric plexus block performed during abdominal hysterectomy decreases postoperative opioid consumption and pain.Design: A randomised, double-blind, placebo-controlled, clinical trial.Setting: A county hospital in Sweden.Population: Sixty-eight women scheduled for total abdominal hysterectomy for a benign indication.Methods: Twenty ml of ropivacaine 7.5 mg/ml or saline was injected retroperitoneally in the area of the superior hypogastric plexus during the hysterectomy. The participants were individually randomised to either intervention. The participants, caregivers, and those assessing the outcomes were blinded to group assignment.Main Outcome Measures: The primary outcomes were postoperative opiate consumption and patients' self-assessment of pain (VAS scores). Secondary outcomes were mobilisation and side effects related to opiate consumption.Results: The trial was completed with 38 women randomised to ropivacaine and 37 women randomised to saline. Analysis was performed on 35 women in the ropivaciane group and 33 women in the saline group. The postoperative opioid consumption was significantly lower in the ropivacaine group than in the placebo group (median 55.8 and 72.4 mg, respectively, P = 0.032). The proportion of women scoring VAS <4 at 2 hours after block was significantly higher in the ropivacaine group (63%) than in the placebo group (25%) (P = 0.015). No side effects or important adverse events occurred during the trial.Conclusions: The superior hypogastric plexus block is a new method in this context and a promising contribution to postoperative pain treatment after abdominal hysterectomy.Tweetable Abstract: Superior hypogastric plexus block during abdominal hysterectomy lowers opioid consumption. [ABSTRACT FROM AUTHOR]

Background: Interpersonal psychotherapy (IPT) and cognitive behavioral therapy (CBT) are both evidence-based treatments for major depressive disorder (MDD). Several head-to-head comparisons have been made, mostly in the United States. In this trial, we compared the two treatments in a small-town outpatient psychiatric clinic in Sweden. The patients had failed previous primary care treatment and had extensive Axis-II comorbidity. Outcome measures were reduction of depressive symptoms and attrition rate.Methods: Ninety-six psychiatric patients with MDD (DSM-IV) were randomized to 14 sessions of CBT (n = 48) or IPT (n = 48). A noninferiority design was used with the hypothesis that IPT would be noninferior to CBT. A three-point difference on the Beck Depression Inventory-II (BDI-II) was used as noninferiority margin.Results: IPT passed the noninferiority test. In the ITT group, 53.5% (23/43) of the IPT patients and 51.0% (24/47) of the CBT patients were reliably improved, and 20.9% (9/43) and 19.1% (9/47), respectively, were recovered (last BDI score <10). The dropout rate was significantly higher in CBT (40%; 19/47) compared to IPT (19%; 8/43). Statistically controlling for antidepressant medication use did not change the results.Conclusions: IPT was noninferior to CBT in a sample of depressed psychiatric patients in a community-based outpatient clinic. CBT had significantly more dropouts than IPT, indicating that CBT may be experienced as too demanding. Since about half the patients did not recover, there is a need for further treatment development for these patients. The study should be considered an effectiveness trial, with strong external validity but some limitations in internal validity. [ABSTRACT FROM AUTHOR]

Rationale: Blood pressure reduction in response to antihypertensive agents is less for patients with obstructive sleep apnea (OSA). Increased sympathetic and inflammatory activity, as well as alterations in the renin-angiotensin-aldosterone system, may play a role in this context.Objectives: To address the cardiovascular mechanisms involved in response to an angiotensin II receptor antagonist, losartan, and continuous positive airway pressure (CPAP) as add-on treatment for hypertension and OSA.Methods: Newly diagnosed hypertensive patients with or without OSA (allocated in a 2:1 ratio for OSA vs. no OSA) were treated with losartan 50 mg daily during a 6-week two-center, open-label, prospective, case-control, parallel-design study. In the second 6-week, sex-stratified, open-label, randomized, parallel-design study, all subjects with OSA continued to receive losartan and were randomly assigned to either CPAP as add-on therapy or to no CPAP (1:1 ratio for CPAP vs. no CPAP). Study subjects without OSA were followed in parallel while they continued to take losartan. Blood samples were collected at baseline, after 6 weeks, and after 12 weeks for analysis of renin, aldosterone, noradrenaline, adrenaline, and inflammatory markers.Measurements and Main Results: Fifty-four patients with OSA and 35 without OSA were included in the first 6-week study. Losartan significantly increased renin levels and reduced aldosterone levels in the group without OSA. There was no significant decrease in aldosterone levels among patients with OSA. Add-on CPAP treatment tended to lower aldosterone levels, but reductions were more pronounced in measures of sympathetic activity. No significant changes in inflammatory markers were observed following treatment with losartan and CPAP.Conclusions: Hypertensive patients with OSA responded to losartan treatment with smaller reductions in aldosterone compared with hypertensive patients without OSA. Sympathetic system activity seemed to respond primarily to add-on CPAP treatment in patients with newly discovered hypertension and OSA. Clinical trial registered with www.clinicaltrials.gov (NCT00701428). [ABSTRACT FROM AUTHOR]

Background: We implemented a novel method for providing contextual adverse event rates for a randomised controlled trial (RCT) programme through coordinated analyses of five RA registries, focusing here on cardiovascular disease (CVD) and mortality.Methods: Each participating registry (Consortium of Rheumatology Researchers of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (SRR) (Sweden), Norfolk Arthritis Register (NOAR) (UK), CORRONA International (East Europe, Latin America, India) and Institute of Rheumatology, Rheumatoid Arthritis (IORRA) (Japan)) defined a main cohort from January 2000 onwards. To address comparability and potential bias, we harmonised event definitions and defined several subcohorts for sensitivity analyses based on disease activity, treatment, calendar time, duration of follow-up and RCT exclusions. Rates were standardised for age, sex and, in one sensitivity analysis, also HAQ.Results: The combined registry cohorts included 57 251 patients with RA (234 089 person-years)-24.5% men, mean (SD) baseline age 58.2 (13.8) and RA duration 8.2 (11.7) years. Standardised registry mortality rates (per 100 person-years) varied from 0.42 (CORRONA) to 0.80 (NOAR), with 0.60 for RCT patients. Myocardial infarction and major adverse cardiovascular events (MACE) rates ranged from 0.09 and 0.31 (IORRA) to 0.39 and 0.77 (SRR), with RCT rates intermediate (0.18 and 0.42), respectively. Additional subcohort analyses showed small and mostly consistent changes across registries, retaining reasonable consistency in rates across the Western registries. Additional standardisation for HAQ returned higher mortality and MACE registry rates.Conclusions: This coordinated approach to contextualising RA RCT safety data demonstrated reasonable differences and consistency in rates for mortality and CVD across registries, and comparable RCT rates, and may serve as a model method to supplement clinical trial analyses for drug development programmes. [ABSTRACT FROM AUTHOR]

Background The present study aimed to assess dietary intake and evaluate the degree of agreement of group-level dietary intake as measured by 24-h recall against a 4-day diet record among postpartum women with overweight and obesity. Methods A cross-sectional study was conducted of 110 Swedish women with a body mass index of ≥27 kg m−2 at 6-15 weeks postpartum who were recruited to a weight loss trial and randomised to diet intervention or control. One 24-h recall was conducted among all women prior to randomisation. In addition, women subsequently randomised to diet intervention also conducted a 4-day diet record before receiving dietary treatment ( n = 54). Paired tests were used to evaluate agreement of group-level dietary intake as measured by 24-h recall against 4-day diet record among women randomised to diet intervention. Results Women reported a median (25th and 75th percentiles) energy intake of 9.1 (6.9, 11.7) MJ day−1 and an intake of fibre, vitamin D, folate and iron below the recommended intake as assessed by 24-h recall prior to randomisation ( n = 110). Group-level median intakes of energy (9.9 versus 10.0 MJ day−1), fibre (21.9 versus 21.3 g day−1), vitamin D (4.8 versus 6.5 μg day−1), folate (296 versus 287 μg day−1), iron (11.0 versus 11.3 mg day−1) and calcium (915 versus 968 mg day−1) did not differ significantly between the methods; however, the record captured a higher energy-adjusted intake of fat, saturated fat and alcohol, as well as a lower intake of carbohydrates, compared to the recall ( n = 54). Conclusions We found no difference in group-level estimates of energy or micronutrients between the recall and the record; however, there were some differences for macronutrients. [ABSTRACT FROM AUTHOR]

Purpose: Specific combinations of dietary fiber (DF) have been observed to result in improved glucose tolerance at a subsequent standardized breakfast. Arabinoxylan oligosaccharides (AXOS) are considered as DF with prebiotic potential, but so far no studies have investigated their metabolic effects in humans. This randomized cross-over study evaluated the overnight impact of breads containing AXOS-rich wheat bran extract and resistant starch (RS, Hi-Maize), separately or combined, on glucose tolerance, related metabolic parameters and markers of gut fermentation in healthy subjects. Methods: Evening reference and test products were: (1) reference white wheat flour bread (WWB), WWB supplemented with (2) AXOS and RS (WWB + AXOS + RS), (3) an increased content of either AXOS (WWB + hiAXOS) or (4) RS (WWB + hiRS). At the subsequent standardized breakfast, blood was sampled for 3 h to monitor glucose, insulin, nonesterified fatty acids, glucagon-like peptide (GLP)-1 and GLP-2. Breath hydrogen (H) and short chain fatty acids (SCFA) were measured as markers of gut fermentation, and subjective appetite was rated using visual analog scales. Results: Dose-dependent decreases in glucose responses were observed with increased AXOS over the duration of 3 h. Insulin sensitivity index was improved in the morning after the WWB + hiAXOS evening meal. An increase in breath H concentration and circulating SCFA was observed in the morning after both evening meals containing AXOS. Conclusion: The present study indicates that AXOS have the potential of improving glucose tolerance in an overnight perspective and suggested mechanisms are improved insulin sensitivity and increased gut fermentation. [ABSTRACT FROM AUTHOR]

Background: The histologic grade (HG) of breast cancer is an established prognostic factor. The grade is usually reported on a scale ranging from 1 to 3, where grade 3 tumours are the most aggressive. However, grade 2 is associated with an intermediate risk of recurrence, and carries limited information for clinical decision-making. Patients classified as grade 2 are at risk of both under- and over-treatment.Methods: RNA-sequencing analysis was conducted in a cohort of 275 women diagnosed with invasive breast cancer. Multivariate prediction models were developed to classify tumours into high and low transcriptomic grade (TG) based on gene- and isoform-level expression data from RNA-sequencing. HG2 tumours were reclassified according to the prediction model and a recurrence-free survival analysis was performed by the multivariate Cox proportional hazards regression model to assess to what extent the TG model could be used to stratify patients. The prediction model was validated in N=487 breast cancer cases from the The Cancer Genome Atlas (TCGA) data set. Differentially expressed genes and isoforms associated with HGs were analysed using linear models.Results: The classification of grade 1 and grade 3 tumours based on RNA-sequencing data achieved high accuracy (area under the receiver operating characteristic curve = 0.97). The association between recurrence-free survival rate and HGs was confirmed in the study population (hazard ratio of grade 3 versus 1 was 2.62 with 95 % confidence interval = 1.04-6.61). The TG model enabled us to reclassify grade 2 tumours as high TG and low TG gene or isoform grade. The risk of recurrence in the high TG group of grade 2 tumours was higher than in low TG group (hazard ratio = 2.43, 95 % confidence interval = 1.13-5.20). We found 8200 genes and 13,809 isoforms that were differentially expressed between HG1 and HG3 breast cancer tumours.Conclusions: Gene- and isoform-level expression data from RNA-sequencing could be utilised to differentiate HG1 and HG3 tumours with high accuracy. We identified a large number of novel genes and isoforms associated with HG. Grade 2 tumours could be reclassified as high and low TG, which has the potential to reduce over- and under-treatment if implemented clinically. [ABSTRACT FROM AUTHOR]

Background: In Sweden, migrants from countries considered to have a high burden of certain infectious diseases are offered health screening to prevent the spread of these diseases, but also identify their health needs. However, very little is known about their experiences and perceptions about the screening process. This study aimed at exploring these perceptions and experiences in order to inform policy and clinical practice.Method: Using an interpretive description framework, 26 new migrants were interviewed between April and June 2013 in four Swedish counties. Thematic analysis was used to analyze data.Results: The three themes developed include: new country, new practices; new requirements in the new country; and unmet needs and expectations. Participants described what it meant for them to come to a new country with a foreign language, new ways of communicating with caregivers/authorities and being offered health screening without clarification. Participants perceived health screening as a requirement from the authorities to be fulfilled by all newcomers but conceded that it benefits equally the host society and themselves. However, they also expressed concern over the involvement of the Migration Board staff and feared possible collaboration with health service to their detriment. They further stated that the screening program fell short of their expectations as it mainly focused on identifying infectious diseases and overlooked their actual health needs. Finally, they expressed frustration over delay in screening, poor living conditions in reception centers and the restrictive entitlement to care.Conclusions: Migrants are aware of their vulnerability and the need to undergo health screening though they view it as an official requirement. Thus, those who underwent the screening were more concerned about residency rather than the actual benefits of screening. The issues highlighted in this study may limit access to and uptake of the screening service, and compromise its effectiveness. To maximize the uptake: (1) linguistically and culturally adapted information is needed, (2) other screening approaches should be tried, (3) trained medical interpreters should be used, (4) a holistic and human right approach should be applied, (5) the involvement of migration staff should be reconsidered to avoid confusion and worries. Finally, to improve the effectiveness, (6) all migrants from targeted countries should be offered screening and efforts should be taken to improve the health literacy of migrants and the living conditions in reception centers. [ABSTRACT FROM AUTHOR]

Background: Yoga exercises are often used as a form of body and mind exercise to increase performance. However, knowledge about the physiologic effects of performing high-intensity Hatha yoga exercises over a longer time period remains limited. Objective: To investigate the effects of high-intensity yoga (HIY) on cardiovascular fitness (maximal oxygen consumption, estimated from the Cooper running test), ratings of perceived exertion (RPE), heart rate (HR), heart rate recovery (HRR), blood pressure (BP), adipocytokines, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), and glycosylated hemoglobin (HbA1c) in healthy students. Methods: The 44 participants (38 women and 6 men; median age, 25 years [range, 20-39 years]) were randomly assigned to an HIY or a control group. The HIY program was held for 6 weeks (60 minutes once a week). Cardiovascular fitness, RPE, HR, HRR, BP, adipocytokines, HbA1c, ApoA1, and ApoB were measured at baseline and after 6 weeks in both groups. Results: HIY had no significant effects on cardiovascular fitness (mean dose: 390 minutes [range, 210-800 minutes]), HR, HRR, BP, or any of the blood parameters. However, ApoA1 (1.47 ± 0.17 to 1.55 ± 0.16 g/L; p = 0.03) and adiponectin (8.32 ± 3.32 to 9.68 ± 3.83 mg/L; p = 0.003) levels increased significantly in the HIY group after 6 weeks. Conclusions: Six weeks of HIY did not significantly improve cardiovascular fitness. However, ApoA1 and adiponectin levels increased significantly in the HIY group. This finding suggests that HIY may have positive effects on blood lipids and an anti-inflammatory effect. [ABSTRACT FROM AUTHOR]

Background: Problems related to pain during vaginal penetration are complex and the etiology is multi-factorial. It was the aim of the present study to measure whether treatment using desensitization exercises and cognitive behavioral therapy (CBT) for women with provoked vulvodynia (PVD) could increase sexual interest, sexual satisfaction and response whilst decreasing experiences of sexual pain.Methods and Outcome Measures: Sixty women suffering from PVD were treated during a 10-week period with a combination of mucosal desensitization and pelvic floor exercises and CBT. The McCoy Female Sexuality Questionnaire (MFSQ) was used to measure efficacy of the treatment. The Hospital Anxiety and Depression Scale (HADS) was used to measure psychological distress. The primary outcome measurements were changes in scores for the MFSQ and changes in individual items on the MFSQ directly after treatment completion. Secondary outcome measurements were changes in the MFSQ items 6 months after treatment and changes in HADS sub-scales 6 months after treatment. Statistical comparisons of answers to the MFSQ were carried out using the Wilcoxon signed rank test (paired). Validity of the MFSQ in this study was measured by testing one global question about sexuality and total scores on MFSQ using Spearman's correlation test.Results: Study participants reported a statistically significant increase in sexual fantasies, increased sexual pleasure, excitement and vaginal lubrication after treatment was completed. PVD occurred less often which resulted in significantly less avoidance of sexual intercourse, increased frequency of masturbation and intercourse. All improvements were sustained at 6 months after treatment ended. Two questions showed no significant changes, these pertained to the individual's contentment with her partner as a lover and a friend. The anxiety sub-scale of the HADS showed a significantly decreased level of anxiety at 6 months follow-up but no change in the scores on the depression sub-scale.Conclusion: Treatment for PVD using desensitization exercises and cognitive behavioral therapy significantly improved sexual interest, response and activity and decreased the experience of pain. Larger studies and RCTs are required in order to draw conclusions about treatment and long term effects should be studied. Partners should be encouraged to participate in treatment regimes.Trial Registration: The study is registered with ISRCTN registry, ID ISRCTN40416405. [ABSTRACT FROM AUTHOR]

Purpose: The aim was to compare postprandial lipid, insulin and vitamin D responses after consumption of three otherwise identical meals served either with baked herring, pickled herring or with baked, minced beef. Methods: Seventeen healthy, overweight men (mean age 58 years, BMI 26.4-29.5 kg/m) consumed standardized lunches together with baked herring, pickled herring or baked, minced beef on three occasions in a crossover design. Blood samples were taken just before and up to 7 h after the meal. The postprandial response was measured as serum concentrations of triglycerides (TG), total cholesterol and lipoproteins (LDL, HDL and VLDL), insulin, 25-OH vitamin D and plasma fatty acid composition. Results: There was no difference in postprandial lipid responses between the two herring meals, whereas a slower TG clearance was observed after the baked, minced beef meal. The 150 g servings of baked and pickled herring provided 3.3 and 2.8 g of long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFA), respectively, which was reflected in a substantial postprandial increase in plasma LC n-3 PUFA levels. The pickled herring contained 22 % sugar and consequently gave a higher insulin response compared with the other two meals. Conclusions: Both pickled and baked herring are good sources of LC n-3 PUFA in the diet, but the presence of sugar in pickled herring should be taken into consideration, especially if large amounts are consumed. The faster postprandial TG clearance after a meal with baked herring compared with baked beef supports previous studies on the beneficial effects of herring on cardiovascular health. [ABSTRACT FROM AUTHOR]

It is necessary to carry out randomised clinical cancer trials ( RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation. The aims of this study were to (1) describe motives associated with participation in RCTs, (2) assess if patients comprehend the information related to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96 cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology, Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate 92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care. Two main reasons for participation were identified: personal hope for a cure and altruism. Patients show adequate understanding of the information provided to them in the consent process and participation entails high patient satisfaction. [ABSTRACT FROM AUTHOR]

Objective: The aim of this exploratory randomised controlled trial (RCT) was to evaluate three different occupation-focused interventions for well older people by estimating effect sizes for leisure engagement and ability in activities of daily living (ADL) and thereby identifying the most effective interventions. Methods: One hundred and seventy seven persons, 77-82 years old, living alone and without home help, were randomized to a control group (CG), an individual intervention (IG), an activity group (AG), and a one-meeting discussion group (DG). All interventions focused on occupational engagement and how persons can cope with age-related activity restrictions in order to enhance occupational engagement. Data were collected by blinded research assistants at baseline, three, and 12 months. Ordinal outcome data were converted, using Rasch measurement methods, to linear measures of leisure engagement and ADL ability. Standardized between-group effect sizes, Cohen's d, were calculated. Results: While all groups showed a decline in leisure engagement and ADL over time, the IG and the DG were somewhat effective in minimizing the decline at both three and 12 months. However, the effect sizes were small. Conclusions: The findings indicate that occupation-focused interventions intended to minimize a decline in leisure engagement and ADL were sufficiently promising to warrant their further research. [ABSTRACT FROM AUTHOR]

The article focuses on increasing use of human growth hormone (hGH) for treating children with GH deficiencies through collecting human pituitaries from man in Sweden. Topics discussed include development of GH using recombinant DNA technology by Swedish scientists, marketing efforts of GH producing companies such as focusing on physicians and paediatric endocrinologists; and better treatment from the use of recombinant DNA technology produced biosynthetic GH.

To evaluate the implant and prosthetic of two implants with different surfaces and neck design. Enrolled patients received bone level, 12° conical connection implants (Nobel Parallel, Nobel Biocare; NOBEL group) with anodized surface (TiUnite) and roughness of 1.35 μm, or transmucosal implant system (Prama, Sweden and Martina; PRAMA group) with convergent collar, ZIrTi surface, and roughness 1.4–1.7 μm. Both implants were made of pure grade IV titanium, with similar diameter and length, chosen according to the dentistry department availability and patient's request. After early prosthesis delivery, patients were filled for at least one year. Outcome measures were: implant and prosthetic survival and success rates, physiological marginal bone remodeling, periodontal parameters and pink esthetic score (PES). Results: Fifteen patients were allocated and treated in each group. At the one-year follow-up, three patients dropped out, one in the NOBEL group and two in the PRAMA group. During the entire time of investigation, all implants survived and the prostheses were successful. No statistically significant differences were found in term of marginal bone loss, periodontal parameters, and aesthetics (p > 0.05). Conclusion: With the limitations of the present study, both implant systems showed successful clinical results. Finally, many other clinical and surgical variables may influenced marginal bone levels, implant survival, and periodontal parameters. More homogenous clinical trials with larger samples are needed to confirm these preliminary conclusions. [ABSTRACT FROM AUTHOR]

Background A blood test for S100B can be used to rule out intracranial complications after minor head injury and thereby reduce the need for computed tomography (CT) examinations. The aim of this study was to investigate the clinical importance of a possible influence of seasonal variation on S100B. Methods The individual seasonal variation of S100B in 69 healthy volunteers living at latitudes with extremely variable seasonal exposure to sunlight was investigated. Results The mean serum concentration of S100B was 13% higher in August than in February, but however, not statistically significant (p = 0.068). A good agreement between summer and winter S100B values was confirmed by Bland-Altman analysis and a significant correlation (r = 0.317, p = 0.008) was shown between summer and winter S100B values. Conclusion This study did not show any clinical importance of seasonal variation of S100B that may influence the decision of CT scanning patients with head injuries. [ABSTRACT FROM AUTHOR]