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The effectiveness of abdominal compression for motion management in hepatobiliary-pancreatic (HPB) radiotherapy has not been systematically evaluated. A systematic review was carried out using PubMed/Medline, Cochrane Library, Web of Science, and CINAHL databases up to 1 July 2021. No date restrictions were applied. Additional searches were carried out using the University of Manchester digital library, Google Scholar and of retrieved papers' reference lists. Studies conducted evaluating respiratory motion utilising imaging with and without abdominal compression in the same patients available in English were included. Studies conducted in healthy volunteers or majority non-HPB sites, not providing descriptive motion statistics or patient characteristics before and after compression in the same patients or published without peer-review were excluded. A narrative synthesis was employed by tabulating retrieved studies and organising chronologically by abdominal compression device type to help identify patterns in the evidence. The inclusion criteria were met by 6 studies with a total of 152 patients. Designs were a mix of retrospective and prospective quantitative designs with chronological, non-randomised recruitment. Abdominal compression reduced craniocaudal respiratory motion in the majority of patients, although in four studies there were increases seen in at least one direction. The influence of patient comorbidities on effectiveness of compression, and/or comfort with compression was not evaluated in any study. Abdominal compression may not be appropriate for all patients, and benefit should be weighed with potential increase in motion or discomfort in patients with small initial motion (<5 mm). Patient factors including male sex, and high body mass index (BMI) were found to impact the effectiveness of compression, however with limited evidence. High-quality studies are warranted to fully assess the clinical impact of abdominal compression on treatment outcomes and toxicity prospective in comparison to other motion management strategies. [ABSTRACT FROM AUTHOR]

Given the potentially fatal consequences of inadequate adherence with oral anticancer treatment in persons with cancer, understanding the determinants of adherence is vital. This paper aims at identifying psychosocial determinants of adherence to oral anticancer treatment. We reviewed the literature on psychosocial determinants of adherence with oral anticancer treatment, based on published literature in English, from 2015 to present. Literature searches were performed in PubMed, Embase, Web of Science, Cochrane library, Emcare, and PsychINFO, with 'cancer', 'medication adherence', 'psychology', and 'oral anticancer treatment' as search terms. The obtained 608 papers were screened by two independent reviewers. In the 25 studies identified, illness perceptions, medication beliefs, health beliefs, and depression were found to be the major psychosocial determinants of adherence to oral anticancer treatment; sociodemographic and clinical characteristics were found to be of no major importance. The quality of the identified studies as assessed by two independent reviewers was found to be acceptable overall. The majority of papers were from North America and focused on patients with breast cancer; sample size varied from 13 to 1371; adherence was assessed with questionnaires derived from various theoretical models, pill counts and electronic pharmacy records; illness perceptions reflecting adaptive coping, and medication beliefs reflecting high necessity and low concerns were found to be associated with adherence. Psychosocial concepts are major determinants of adherence with oral anticancer treatment. 'Beliefs about medicines' and 'illness perceptions' in particular determine adherence with this treatment. Studies aiming at impacting adherence would benefit from interventions with a solid basis in behavioral theory in order to help health care providers explore and address illness perceptions and medication beliefs. Pre-consultation screening of adherence behavior may be a helpful supportive approach to improve adherence. Blaming the victim ('patients should be educated about the importance of adherence') is better replaced by encouraging health professionals to identify and address maladaptive psychosocial determinants of adherence. [ABSTRACT FROM AUTHOR]

Background and purpose — The trochanteric stabilizing plate (TSP) may be used as an adjunct to a sliding hip screw (SHS) in the treatment of trochanteric fractures to increase construct stability. We performed a scoping review of the literature to clarify when and how the TSP may be useful. Methods — A systematic search was performed in 5 databases and followed by a backwards-and-forwards citation search of the identified papers. 24 studies were included. Results — 6 biomechanical studies and 18 clinical studies were included in the review. The studies presented mainly low-level evidence. All studies were on unstable trochanteric fractures or fracture models. Due to the heterogeneity of methods and reporting, we were not able to perform a meta-analysis. In the biomechanical trials, the TSP appeared to increase stability compared with SHS alone, up to a level comparable with intramedullary nails (IMNs). We identified 1,091 clinical cases in the literature where a TSP had been used. There were 82 (8%) reoperations. The rate of complications and reoperations for SHS plus TSP was similar to previous reports on SHS alone and IMN. It was not possible to conclude whether the TSP gave better clinical results, when compared with either SHS alone or with IMN. Interpretation — The heterogeneity of methods and reporting precluded any clear recommendations on when to use the TSP, or if it should be used at all. [ABSTRACT FROM AUTHOR]

Background: Cancer-related cognitive impairment (CRCI) is a commonly reported complaint among non-CNS cancer patients. Even subtle CRCI may have detrimental effects on quality of life and identifying patients at increased risk for CRCI to improve survivorship care is important. In the present paper, we systematically reviewed available studies of possible genetic risk factors for developing CRCI. Methods: Keyword-based systematic searches were undertaken on 24 July 2018 in PubMed, Web of Science, The Cochrane Library, and CINAHL. Three authors independently evaluated full-texts of identified papers and excluded studies with registration of reasons. Seventeen studies reporting results from 14 independent samples were included for review. Two authors independently quality assessed the included studies. The review was preregistered with PROSPERO (CRD42018107689). Results: Ten studies investigated apolipoprotein E (APOE), with four studies reporting that carrying at least one risk allele (APOE4 (ε4)) was associated with CRCI, while six studies found no association. The remaining identified genetic risk variants associated with CRCI located in: COMT, four DNA repair genes, five oxidative stress genes, 22 genes related to breast cancer phenotype, and GNB3. No associations were found between CRCI and genes coding for interleukin-6 (IL6), tumor necrosis factor alpha (TNF), interleukin 1 beta (IL1B), and brain-derived neurotropic factor (BDNF). With the exception of APOE, the genetic risk factors had only been investigated in one or two studies each. Conclusions: Overall, the available evidence of possible genetic risk factors for CRCI is limited. While some research suggests a role for the ε4 allele, the literature is generally inconsistent, and the currently available evidence does not allow clear-cut conclusions regarding the role of genetic factors in the development of CRCI. Larger genetic studies and studies investigating additional genetic variants are needed to uncover genetic risk factors for CRCI. [ABSTRACT FROM AUTHOR]

Background and purpose — Adequate staging of chondroid tumors at diagnosis is important as it determines both treatment and outcome. This systematic review provides an overview of MRI criteria used to differentiate between atypical cartilaginous tumors (ACT) and high-grade chondrosarcoma (HGCS). Patients and methods — For this systematic review PubMed and Embase were searched, from inception of the databases to July 12, 2018. All original articles describing MRI characteristics of pathologically proven primary central chondrosarcoma and ACT were included. A quality appraisal of the included papers was performed. Data on MRI characteristics and histological grade were extracted by 2 reviewers. Meta-analysis was performed if possible. The study is registered with PROSPERO, CRD42018067959. Results — Our search identified 2,132 unique records, of which 14 studies were included. 239 ACT and 140 HGCS were identified. The quality assessment showed great variability in consensus criteria used for both pathologic and radiologic diagnosis. Due to substantial heterogeneity we refrained from pooling the results in a meta-analysis and reported non-statistical syntheses. Loss of entrapped fatty marrow, cortical breakthrough, and extraosseous soft tissue expansion appeared to be present more often in HGCS compared with ACT. Interpretation — This systematic review provides an overview of MRI characteristics used to differentiate between ACT and HGCS. Future studies are needed to develop and assess more reliable imaging methods and/or features to differentiate ACT from HGCS. [ABSTRACT FROM AUTHOR]

Background: The treatment options for patients with therapy refractory metastatic colorectal cancer (mCRC) are sparse. TAS-102 (FTD/TPI) is a new oral anti-tumour agent composed of a nucleoside analogue, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil, indicated for patients with mCRC who are refractory to standard therapies. This study summarizes published and unpublished experience with FTD/TPI in clinical practice settings. Patients and methods: The Medline/PubMed, Embase and Cochrane Library databases were searched to identify observational studies on FTD/TPI monotherapy for mCRC. Papers describing use of FTD/TPI monotherapy outside clinical trials in series of patients evaluable for effectiveness were eligible. The outcomes of interest were median progression free survival (mPFS), median overall survival (mOS) as well as mean PFS time restricted to six months (PFS6m) and mean OS time restricted to one year (OS1y). Results of the pooled analyses of observational studies were compared to the results of the Japanese phase II trial and the two phase III trials, RECOURSE and TERRA. Results: Seven published and two unpublished studies with 1008 patients from 64 centres were included for analysis. The pooled mPFS was 2.2 months (95% CI 2.1 to 2.3 months), and the pooled mOS was 6.6 months (95% CI 6.1 to 7.1 months). PFS6m was 2.9 months (95% CI 2.6 to 3.1 months) and OS1y was 6.8 (95% CI 6.0 to 7.5) months. While these results all reflect RECOURSE, the pooled mOS is lower than in the phase II trial and the OS1y is inferior to both the phase II trial and TERRA. Conclusion: This systematic review and a meta-analysis indicates that in real life settings, the survival benefit of FTD/TPI monotherapy in patients with therapy refractory mCRC reflects the outcomes in RECOURSE but is inferior to outcomes in the two Asian efficacy trials. TAS 102 (Lonsurf) is an oral fixed dose combination of trifluridine (FTD) and tipiracil (TPI) indicated as salvage-line treatment in patients with therapy refractory metastatic colorectal cancer (mCRC). A Japanese phase II trial and two phase III trials, RECOURSE and TERRA, demonstrated that FTD/TPI prolonged overall survival. This systematic review and meta-analysis of real life data from 64 sites indicates that the effectiveness in daily clinical practice settings of FTD/TPI monotherapy in late stage mCRC reflects the outcomes in RECOURCE but is inferior to the outcomes in the Japanese phase II trial and TERRA. [ABSTRACT FROM AUTHOR]

Introdution: Variation in shape, position and treatment response of both tumor and organs at risk are major challenges for accurate dose delivery in radiotherapy. Adaptive radiotherapy (ART) has been proposed to customize the treatment to these motion/response patterns of the individual patients, but increases workload and thereby challenges clinical implementation. This paper reviews strategies and workflows for clinical and in silico implemented ART for prostate, bladder, gynecological (gyne) and ano-rectal cancers.Material and methods: Initial identification of papers was based on searches in PubMed. For each tumor site, the identified papers were screened independently by two researches for selection of studies describing all processes of an ART workflow: treatment monitoring and evaluation, decision and execution of adaptations. Both brachytherapy and external beam studies were eligible for review.Results: The review consisted of 43 clinical studies and 51 in silico studies. For prostate, 1219 patients were treated with offline re-planning, mainly to adapt prostate motion relative to bony anatomy. For gyne 1155 patients were treated with online brachytherapy re-planning while 25 ano-rectal cancer patients were treated with offline re-planning, all to account for tumor regression detected by magnetic resonance imaging (MRI)/computed tomography (CT). For bladder and gyne, 161 and 64 patients, respectively, were treated with library-based online plan selection to account for target volume and shape variations. The studies reported sparing of rectum (prostate and bladder cancer), bladder (ano-rectal cancer) and bowel cavity (gyne and bladder cancer) as compared to non-ART.Conclusion: Implementations of ART were dominated by offline re-planning and online brachytherapy re-planning strategies, although recently online plan selection workflows have increased with the availability of cone-beam CT. Advantageous dosimetric and outcome patterns using ART was documented by the studies of this review. Despite this, clinical implementations were scarce due to challenges in target/organ re-contouring and suboptimal patient selection in the ART workflows. [ABSTRACT FROM AUTHOR]

Background: Cancer and cancer treatments may impact the brain through several pathways leading to cognitive impairment. Neuroimaging evidence has begun to elucidate the neurobiological underpinnings of cancer-related cognitive impairment. The aim of this paper was to systematically review available literature on structural brain alterations following adult non-central nervous system (CNS) cancers and associated treatments. Methods: This review followed PRISMA guidelines and was registered in PROSPERO (ID#107387). Comprehensive searches were conducted in June 2018 using PubMed and Web of Science. Inclusion criteria were English peer-reviewed journal articles of formal, controlled studies that examined structural neuroimaging outcomes in adult non-CNS cancer patients and survivors. Selected articles were assessed for quality and risk of bias using the National Institutes of Health Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. Results: Thirty-six publications of prospective and cross-sectional studies met inclusion criteria and were included. Structural brain alterations following cancer and its treatment were reported in a majority of the publications as evidenced by reduced global and local gray matter volumes, impaired white matter microstructural integrity, and brain network alterations. Structural alterations were most often evident when cancer-treated groups were compared with healthy controls, and more subtle when compared with cancer controls. Regarding the existence of pretreatment impairments, the evidence was equivocal. There was significant between-study heterogeneity in imaging analytical approaches and use of statistical adjustments. Over half reported associations with cognitive outcomes, though regions and associated cognitive domains were heterogeneous. Conclusions: Structural brain alterations following cancer and cancer treatments were reported in a majority of the reviewed studies. However, the extent of observed alterations depended on the choice of comparison groups. Methodological issues exist that will need to be addressed systematically to ensure the validity of findings. Large-scale prospective studies with extended assessment points are warranted to replicate and build upon initial findings. [ABSTRACT FROM AUTHOR]

Background. Evidence for the safety and benefits of exercise training as a therapeutic and rehabilitative intervention for cancer survivors is accumulating. However, whereas the evidence for the efficacy of exercise training has been established in several meta-analyses, synthesis of qualitative research is lacking. In order to extend healthcare professionals' understanding of the meaningfulness of exercise in cancer survivorship care, this paper aims to identify, appraise and synthesize qualitative studies on cancer survivors' experience of participation in exercise-based rehabilitation. Material and methods. Five electronic databases (PubMed, PsychINFO, EMBASE, Cinahl and Scopus) were searched systematically for articles published up to May 2014 using keywords and MeSH terms. To be included, studies had to contain primary data pertaining to patient experiences from participation in supervised, structured moderate to vigorous-intensity exercise. Results. In total 2447 abstracts were screened and 37 papers were read in full. Of these, 19 studies (n = 390) were selected for inclusion and critically appraised. Synthesis of data extracted from eight studies including in total 174 patients (77% women, age 28-76 years) exclusively reporting experiences of participation in structured, supervised exercise training resulted in nine themes condensed into three categories: 1) emergence of continuity; 2) preservation of health; and 3) reclaiming the body reflecting the benefits of exercise-based rehabilitation according to cancer survivors. Accordingly, the potential of rebuilding structure in everyday life, creating a normal context and enabling the individual to re-establish confidentiality and trust in their own body and physical potential constitute substantial qualities fundamental to the understanding of the meaningfulness of exercise-based rehabilitation from the perspective of patients. Conclusions. In addition to the accumulating evidence for the efficacy of exercise training in cancer rehabilitation, it is incumbent upon clinicians and policy-makers to acknowledge and promote the meaningfulness of exercise for the individual, and to use this knowledge to provide new solutions to current problems related to recruitment of underserved populations, long-term adherence and implementation. [ABSTRACT FROM AUTHOR]

Objectives. Statistical methods play an important role in medical and dental research. In earlier studies it has been observed that current use of methods and reporting of statistics are responsible for some of the errors in the interpretation of results. The aim of this study was to investigate the quality of statistical reporting in dental research articles. Methods. A total of 200 articles published in 2010 were analysed covering five dental journals: Journal of Dental Research, Caries Research, Community Dentistry and Oral Epidemiology, Journal of Dentistry and Acta Odontologica Scandinavica. Each paper underwent careful scrutiny for the use of statistical methods and reporting. A paper with at least one poor reporting item has been classified as 'problems with reporting statistics' and a paper without any poor reporting item as 'acceptable'. Results. The investigation showed that 18 (9%) papers were acceptable and 182 (91%) papers contained at least one poor reporting item. Conclusions. The proportion of at least one poor reporting item in this survey was high (91%). The authors of dental journals should be encouraged to improve the statistical section of their research articles and to present the results in such a way that it is in line with the policy and presentation of the leading dental journals. [ABSTRACT FROM AUTHOR]

Background. Intraoperative radiotherapy (IORT) has been given for primary and locally recurrent rectal cancer for 30 years. Still, its effect is not clear. Material and methods. PubMed and EMBASE search for papers after 1989 on surgical treatment and external beam radiotherapy (EBRT) for primary advanced and locally recurrent rectal cancer, with and without IORT. From each center the most recent paper was generally selected. Survival and local recurrence at five years was tabulated for the total groups and separate R-stages. Also, the technique for IORT, use of EBRT and chemotherapy as well as surgical approach was registered. Results. In primary cancer 18 papers from 14 centers were tabulated, including one randomized and five internally comparing studies, as well as seven studies without IORT. In locally recurrent cancer 18 papers from 13 centers were tabulated, including four internally comparing studies and also five without IORT. Overall survival (OS) and local recurrence rate (LRR) were higher for primary cancer compared to recurrent cancer. Patients with R0 resections had better outcome than patients with R1 or R2 resections. For primary cancer OS and LR rate of the total groups and R0 stages was not influenced by IORT. An effect on R1/R2 stages cannot be excluded. The only randomized study (primary cancer) did not show any effect of IORT. Conclusion. IORT does not convincingly improve OS and LR rate for primary and locally recurrent rectal cancer. If there is an effect of IORT, it is small and cannot be shown outside randomized studies analyzing the separate R stages. [ABSTRACT FROM AUTHOR]

Background:The introduction of adjuvant chemotherapy following surgery for early breast cancer (BC) and its integration into routine clinical practice has consistently improved clinical outcomes. Since the addition of other agents to the contemporary standard of care containing an anthracycline, cyclophosphamide and a taxane has not lead to further prolongation of survival, subsequent efforts concentrated on escalating the administered doses and reducing the time interval between chemotherapy cycles. These strategies have been extensively evaluated in randomized trials and dose dense chemotherapy is now recommended by clinical practice guidelines. Method:Eligible trials were identified by searching the EMBASE, Pubmed, Scopus and Cochrane Library databases, as well as conference papers. The findings, shortcomings and impact of these studies are presented and critically discussed. Results:Although a large number of randomized trials has established the value of adjuvant chemotherapy, important questions remain unanswered. Ongoing research focuses on omitting treatment in good risk patients, identifying patients most likely to benefit from a dose dense approach and on administering personalized doses such as in tailored dose chemotherapy. Conclusions:Adjuvant chemotherapy for early BC is an evolving art. Further optimizations could potentially improve outcomes for a patient subset and spare others from unnecessary treatment-related toxicity. [ABSTRACT FROM PUBLISHER]

Background. Radical prostatectomy (RP) is worldwide probably the most common procedure to treat localized prostate cancer (PC). Due to a more widespread use of Prostate-Specific Antigen (PSA) testing, patients operated today are often younger and have organ confined disease justifying a more preservative surgery. At the same time, surgical technique has improved resulting in lower risk of permanent side-effects. This paper aims to give an overview of results from modern surgery regarding cancer control and side-effects. A brief overview of the history is given. Material and Methods. A literature research identified recently published papers focusing on outcome and side-effects after RP. Results. One large randomized study (SPCG-4) compared RP and watchful waiting (WW). The study showed that RP was superior to WW in preventing local progression (RR 0.36), distant metastasis (RR 0.65) and death from PC (RR 0.65). Observational studies also show a better outcome for men treated with RP compared to WW. Peri-operative mortality after RP is low in most material around 0.1%. The risk of stricture of the vesico-urethral anastomosis has decreased with improved technique from historically 10-20% to a low incidence of around 2-9% today. Also the risk of incontinence has declined with improved technique. However, while the rates of severe incontinence is usually very low, as many as 30% still report light incontinence after long-term follow-up. Erectile dysfunction (ED) is still a frequent side-effect after RP. This risk is dependent on age, pre-operative sexual function, surgical technique and other risk factors for ED such as smoking, diabetes, etc. In selected subgroups the risk of ED is low. Inguinal hernia is a more recently described complication after open retropubic RP with a post-operative incidence of 15-20% within three years of surgery. Conclusion. RP is an effective method to achieve cancer control in selected patients. With modern technique it is a safe procedure with a low risk of permanent side-effects except for ED. [ABSTRACT FROM AUTHOR]

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]

In the 1990s, 5-flourouracil (5-FU) was introduced as a treatment for keloids; however, there is still no consensus on its use. In order to guide clinical practice, a systematic review of the clinical evidence on the effectiveness of 5-FU in keloid treatment was carried out. Eight databases were searched on 10 September 2014 using the terms "keloid" and "5-FU", together with all synonyms of these terms. Two reviewers selected original research reports using 5-FU alone or combined with a maximum of 2 other therapies. Eighteen papers were found that reported either on intralesional 5-FU alone, or on 5-FU combined with triamcinolone acetonide (TAC:5-FU) or excision, including 482 patients. 5-FU treatment was effective in 45–96% of patients, but only TAC:5-FU may perform better than TAC alone. Due to a poor level of evidence, further research should establish the superiority of repeated intralesional TAC:5-FU injections over TAC alone with several doses and injection schedules. [ABSTRACT FROM AUTHOR]

Objectives. Doses induced by individual dental examinations are low. However, dental radiography accounts for nearly one third of the total number of radiological examinations in the European Union. Therefore, special attention is needed with regard to radiation protection. In order to lower patient doses, the staff performing dental examinations must have competence in imaging as well as in radiation protection issues. This paper presents a systematic review about the core competencies needed by the healthcare staff in performing digital dental radiological imaging quality assurance. Materials and methods. The following databases were searched: Pubmed, Cinahl, Pro Quest and IEEXplore digital library. Also volumes of some dental imaging journals and doctoral theses of the Finnish universities educating dentists were searched. The search was performed using both MeSH terms and keywords using the option 'search all text'. The original keywords were: dental imaging, digital, x-ray, panoramic, quality, assurance, competence, competency, skills, knowledge, radiographer, radiologist technician, dentist, oral hygienist, radiation protection and their Finnish synonyms. Results. Core competencies needed by the healthcare staff performing digital dental radiological imaging quality assurance described in the selected studies were: management of dental imaging equipment, competence in image quality and factors associated with it, dose optimization and quality assurance. Conclusions. In the future there will be higher doses in dental imaging due to increasing use of CBCT and digital imaging. The staff performing dental imaging must have competence in dental imaging quality assurance issues found in this review. They also have to practice ethical radiation safety culture in clinical practice. [ABSTRACT FROM AUTHOR]

Objective. To assess the ability of multivariate models and single factors to correctly identify future caries development in pre-school children and schoolchildren/adolescents. Study design. A systematic literature search for relevant papers was conducted with pre-determined inclusion criteria. Abstracts and full-text articles were assessed independently by two reviewers. The quality of studies was graded according to the QUADAS tool. The quality of evidence of models and single predictors was assessed using the GRADE approach. Results. Ninety original articles fulfilled the inclusion criteria. Seven studies had high quality, 35 moderate and the rest poor quality. The accuracy of multivariate models was higher for pre-school children than for schoolchildren/adolescents. However, the models had seldom been validated in independent populations, making their accuracy uncertain. Of the single predictors, baseline caries experience had moderate/good accuracy in pre-school children and limited accuracy in schoolchildren/adolescents. The period of highest risk for caries incidence in permanent teeth was the first few years after tooth eruption. In general, the quality of evidence was limited. Conclusions. Multivariate models and baseline caries prevalence performed better in pre-school children than in schoolchildren/adolescents. Baseline caries prevalence was the most accurate single predictor in all age groups. The heterogeneity of populations, models, outcome criteria, measures and reporting hampered the synthesis of results. There is a great need to standardize study design, outcome measures and reporting of data in studies on caries risk assessment. The accuracy of prediction models should be validated in at least one independent population. [ABSTRACT FROM AUTHOR]

Objective. Screening for distress is controversial with many advocates and detractors. Previously it was reasonable to assert that there was a lack of evidence but this position is no longer tenable. The question is now: what does the evidence show and, in particular, when is screening successful and when is screening unsuccessful? The aim of this paper is to review the most up-to-date recent findings from randomized and non-randomized trials regarding the merits of screening for distress in cancer settings. Methods. A search was made of the Embase/Medline and Web of knowledge abstract databases from inception to December 2012. Online theses and experts were contacted. Inclusion criteria were interventional (randomized and non-randomized) trials concerning screening for psychological distress and related disorders. Studies screening for quality of life were included. Results. Twenty-four valid interventional studies of distress/QoL screening were identified, 14 being randomized controlled trials (RCTs). Six of 14 screening RCTs reported benefits on patient well-being and an additional three showed benefits on secondary outcomes such as communication between clinicians and patients. Five randomized screening trials failed to show any benefits. Only two of 10 non-randomized sequential cohort screening studies reported benefits on patient well-being but an additional six showed secondary benefits on quality of care (such as receipt of psychosocial referral). Two non-randomized screening trials failed to show benefits. Of 24 studies, there were 17 that reported some significant benefits of screening on primary or secondary outcomes, six that reported no effect and one that reported a non-significantly deleterious effect upon communication. Across all studies, barriers to screening success were significant. The most significant barrier was receipt of appropriate aftercare. The proportion of cancer patients who received psychosocial care after a positive distress screen was only one in three. Screening was more effective when it was linked with mandatory intervention or referral. Conclusions. Screening for distress/QoL is likely to benefit communication and referral for psychosocial help. Screening for distress has the potential to influence patient well-being but only if barriers are addressed. Quality of care barriers often act as a rate limiting step. Key barriers are lack of training and support, low acceptability and failure to link treatment to the screening results. [ABSTRACT FROM AUTHOR]

Background. Determining the non-inferiority margin is an essential step in the design and interpretation of non-inferiority trials, and this margin should be preferably justified on clinical and statistical grounds. Methods. After a PubMed search for phase III trials in advanced breast cancer (BC) or non-small cell lung cancer (NSCLC) published between January 1998 and December 2009 in 11 leading journals, non-inferiority trials were selected by manual search of the full papers. Results. Twenty-four of 195 trials had a primary non-inferiority hypothesis. When the two six-year study periods were compared, there were time trends within BC and NSCLC, with most non-inferiority trials in BC reported in the first six-year period, and vice-versa for NSCLC. The median sample size was larger for non-inferiority than superiority trials (p < 0.01). The choice of a non-inferiority margin was reportedly justified in only five cases. Non-inferiority trials were more likely than superiority trials to yield positive results (p < 0.001), as were trials in breast cancer (p = 0.02). Conclusions. Non-inferiority margins for cancer trials appear to be chosen mostly on historical grounds. Since nearly three-quarters of non-inferiority trials achieve their primary objective, the extent to which the choice of margins has influence on trial results remains to be determined. [ABSTRACT FROM AUTHOR]

Objective. Amelogenesis imperfecta (AI) is a disease primarily affecting amelogenesis, but other aberrations have been reported. The purposes of this review were: (1) to identify other anomalies associated with AI, and (2) to describe the impact of the disease and its associated conditions on the oral health-related quality of life of patients, and the economic consequences. Material and methods. A literature search was conducted in the following databases: PubMed, EMBASE, Bibliotek.dk, The Cochrane Library, Web of Science, and OMIM, supplemented by a search for selected authors. Based on titles and abstracts, 137 papers were identified. Results. Most articles were case reports or case series with few cases. Aberrations were reported in the eruption process, in the morphology of the crown, in the pulp-dentine organ, and in the number of teeth. Gingival conditions and oral hygiene were usually reported to be poor, and calculus was a common finding. Open bite was the most commonly reported malocclusion. A negative impact on patients' oral health-related quality of life was described, but information was scarce. No information was found on the economic impact. Conclusions. A number of aberrations associated with AI have been reported, but not sufficiently systematic to allow for a secondary analysis and synthesis of the findings. The impact on patients in terms of reduced quality of life and economic burden needs to be studied. [ABSTRACT FROM AUTHOR]