Search

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]

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]

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]

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]

The aim of this paper was systematically to evaluate the caries-preventive effect of professional fluoride varnish treatments. A search of the literature for articles published between 1966 and August 2003 was carried out in electronic databases, reference lists of articles, and selected textbooks in accordance with the strategy of the Swedish Council on Technology Assessment in Health Care. Out of 302 identified papers, 24 randomized and controlled clinical trials comparing fluoride varnish with placebo, no active treatment or other fluoride preventive regimens of at least 2 years' study duration were included. The trials that met the inclusion criteria were assessed independently and systematically by at least two reviewers and scored from A to C according to predetermined criteria for methodology and performance. The main outcome measure was the preventive fraction expressed as a percentage. The results displayed limited evidence (evidence level 3) for the caries preventive effect of topical applications of fluoride varnishes in permanent teeth. The average prevented fraction was 30% (0-69%) when compared with untreated controls. Inconclusive evidence (evidence level 4) was found for fluoride varnish treatment in the primary dentition and in adults. This systematic review reinforces the need for future clinical research of high quality, incorporating modern concepts of clinical performance and evaluation to assess dental caries control using professional fluoride varnish. [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: The aim of this study was to compare maternal labour and birth outcomes between women who gave birth on a birth seat or in any other position for vaginal birth and further, to study the relationship between synthetic oxytocin augmentation and maternal blood loss, in a stratified sample. Methods: A re-analysis of a randomized controlled trial in Sweden. An on-treatment analysis was used to study obstetrical outcomes for nulliparous women who gave birth on a birth seat (birth seat group) compared to birth in any other position for vaginal birth (control group). Data were collected between November 2006 and July 2009. The outcome measurements included perineal outcome, post partum blood loss, epidural analgesia, synthetic oxytocin augmentation and duration of labour. Results: The major findings of this paper were that women giving birth on the birth seat had shorter duration of labour and were significantly less likely to receive synthetic oxytocin for augmentation in the second stage of labour. Significantly more women had an increased blood loss when giving birth on the birth seat, but had no difference in perineal outcomes. Blood loss was increased regardless of birth position if women had been exposed to synthetic oxytocin augmentation during the first stage of labour. Conclusions: The results of this analysis imply that women with a straightforward birth process may well benefit from giving birth on a birth seat without risk for any adverse obstetrical outcomes. However it is important to bear in mind that, women who received synthetic oxytocin during the first stage of labour may have an increased risk for greater blood loss when giving birth on a birth seat. Finally it is of vital importance to scrutinize the influence of synthetic oxytocin administered during the first stage of labour on blood loss postpartum, since excessive blood loss is a well-documented cause of maternal mortality worldwide and may cause severe maternal morbidity in high-income countries. [ABSTRACT FROM AUTHOR]

A systematic review of chemotherapy trials in several tumour types was performed by The Swedish Council of Technology Assessment in Health Care (SBU). The procedures for the evaluation of the scientific literature are described separately (Acta Oncol 2001; 40: 155-65). This overview of the literature on chemotherapy in the treatment of gastric cancer is based on 153 scientific papers including one meta-analysis, 18 reviews, 60 randomised studies and 57 prospective studies. The trials consist of 12 367 patients. The conclusions reached can be summarized into the following points: •A meta-analysis of 21 randomised adjuvant studies revealed a statistically significant survival benefit. The Odds Ratio (OR) is 0.84 (95% confidence interval, 95% CI, 0.74-0.96). However, by analysing Western world and Asian studies separately, a statistically significant difference can be noticed; the Western world studies showed an OR of 0.96 (95% CI 0.83-1.12) and the Asian an OR of 0.58 (95% CI 0.44-0.76). The cause of this difference is not apparent. There is not sufficient evidence to recommend adjuvant chemotherapy as routine treatment in the Western world. •Preoperative chemotherapy given to patients with non-resectable tumours or locally advanced potentially resectable tumours has achieved resectability rates of 40-100% and potentially curative resections in 37-80%. One out of two randomised studies showed a significant survival benefit, but reported data are not convincing. Experimental data in favour of preoperative therapy has not yet been confirmed in randomised clinical studies. Therapy is only justified in controlled clinical trials. •Published studies on the use of intraperitoneal chemotherapy are few and not conclusive regarding the efficiency and safety. This method of drug administration is, accordingly, justified only in controlled clinical trials. •In advanced gastric cancer, phase II studies have indicated better response rates using drug combinations than using single drug regimens, differences that have not, however, been convincingly demonstrated in randomised studies. No firm conclusions can be drawn regarding the superiority for any of the studied drug combinations with respect to response or survival gain. •A statistically significant survival benefit has been shown in trials comparing drug combinations with a best supportive care arm in the treatment of advanced gastric cancer. However, the number of included patients is small. The median survival benefit in advanced disease is in the range of three to nine months. •The use of chemotherapy in advanced gastric cancer is justified in selected patients, e.g. in younger patients in good performance status, low tumour burden and no other serious medical condition after adequate information of potential gains and risks. •The influence of chemotherapy on quality of life in advanced gastric cancer has been reported in only a few studies. It appears that about 50% of the patients have a clinically relevant relief of tumour-related symptoms and thereby improved quality of life. In one study, quality-adjusted survival was estimated to a median of six months in the treated patients compared with two months in the controls. •The quality of the literature addressing chemotherapy for gastric cancer is frequently poor with few properly designed randomised trials. In a number of randomised multi-centre adjuvant studies the inclusions rates are remarkably low, which reduces the scientific value of the studies. [ABSTRACT FROM AUTHOR]