Defining Criteria for Guiding Cancer Patients to Find a Reputable Complementary Medicine Provider: Results of a Literature Review and a Consensus Procedure

Purpose: Even in cases of positive evidence for complementary medicine (CM) therapies, it is still difficult for cancer patients to identify reputable providers. The aim of this study was to develop and evaluate a criteria list to provide guidance to cancer patients seeking a reputable CM provider. Methods: The design combined a literature review, an expert consensus procedure (n=15) and an assessment from three stakeholder perspectives (patients (n=18), CM providers (n=26) and oncology physicians (n=20)). Results: A total of 30 existing CM criteria were extracted from the literature, and 12 more were added by the experts. The main challenge was to define criteria that could easily be applied by the patients. A final comprehensive list of 8 criteria guiding cancer patients to find a reputable CM provider was developed. Conclusion: Health professionals and cancer information services might find the criteria list helpful when aiming to strengthen patients' awareness of quality-related factors associated with CM providers. The criteria developed might be helpful when standards are established for quality assurance in CM in oncology

Fat Mass and Obesity-Associated Gene (FTO) in Eating Disorders: Evidence for Association of the rs9939609 Obesity Risk Allele with Bulimia nervosa and Anorexia nervosa

Objective: The common single nucleotide polymorphism (SNP) rs9939609 in the fat mass and obesity-associated gene (FTO) is associated with obesity. As genetic variants associated with weight regulation might also be implicated in the etiology of eating disorders, we evaluated whether SNP rs9939609 is associated with bulimia nervosa (BN) and anorexia nervosa (AN). Methods: Association of rs9939609 with BN and AN was assessed in 689 patients with AN, 477 patients with BN, 984 healthy non-population-based controls, and 3,951 population-based controls (KORA-S4). Based on the familial and premorbid occurrence of obesity in patients with BN, we hypothesized an association of the obesity risk A-allele with BN. Results: In accordance with our hypothesis, we observed evidence for association of the rs9939609 A-allele with BN when compared to the non-population-based controls (unadjusted odds ratio (OR) = 1.142, one-sided 95% confidence interval (CI) 1.001-infinity; one-sided p = 0.049) and a trend in the population-based controls (OR = 1.124, one-sided 95% CI 0.932-infinity; one-sided p = 0.056). Interestingly, compared to both control groups, we further detected a nominal association of the rs9939609 A-allele to AN (OR = 1.181, 95% CI 1.027-1.359, two-sided p = 0.020 or OR = 1.673, 95% CI 1.101-2.541, two-sided p = 0.015,). Conclusion: Our data suggest that the obesity-predisposing FTO allele might be relevant in both AN and BN. Copyright (C) 2012 S. Karger GmbH, Freibur

Improved upper limb function in non-ambulant children with SMA type 2 and 3 during nusinersen treatment: a prospective 3-years SMArtCARE registry study

Background The development and approval of disease modifying treatments have dramatically changed disease progression in patients with spinal muscular atrophy (SMA). Nusinersen was approved in Europe in 2017 for the treatment of SMA patients irrespective of age and disease severity. Most data on therapeutic efficacy are available for the infantile-onset SMA. For patients with SMA type 2 and type 3, there is still a lack of sufficient evidence and long-term experience for nusinersen treatment. Here, we report data from the SMArtCARE registry of non-ambulant children with SMA type 2 and typen 3 under nusinersen treatment with a follow-up period of up to 38 months. Methods SMArtCARE is a disease-specific registry with data on patients with SMA irrespective of age, treatment regime or disease severity. Data are collected during routine patient visits as real-world outcome data. This analysis included all non-ambulant patients with SMA type 2 or 3 below 18 years of age before initiation of treatment. Primary outcomes were changes in motor function evaluated with the Hammersmith Functional Motor Scale Expanded (HFMSE) and the Revised Upper Limb Module (RULM). Results Data from 256 non-ambulant, pediatric patients with SMA were included in the data analysis. Improvements in motor function were more prominent in upper limb: 32.4% of patients experienced clinically meaningful improvements in RULM and 24.6% in HFMSE. 8.6% of patients gained a new motor milestone, whereas no motor milestones were lost. Only 4.3% of patients showed a clinically meaningful worsening in HFMSE and 1.2% in RULM score. Conclusion Our results demonstrate clinically meaningful improvements or stabilization of disease progression in non-ambulant, pediatric patients with SMA under nusinersen treatment. Changes were most evident in upper limb function and were observed continuously over the follow-up period. Our data confirm clinical trial data, while providing longer follow-up, an increased number of treated patients, and a wider range of age and disease severity

Defining criteria for guiding cancer patients to find a reputable complementary medicine provider: Results of a literature review and a consensus procedure

Purpose: Even in cases of positive evidence for complementary medicine (CM) therapies, it is still difficult for cancer patients to identify reputable providers. The aim of this study was to develop and evaluate a criteria list to provide guidance to cancer patients seeking a reputable CM provider. Methods: The design combined a literature review, an expert consensus procedure (n=15) and an assessment from three stakeholder perspectives (patients (n=18), CM providers (n=26) and oncology physicians (n=20)). Results: A total of 30 existing CM criteria were extracted from the literature, and 12 more were added by the experts. The main challenge was to define criteria that could easily be applied by the patients. A final comprehensive list of 8 criteria guiding cancer patients to find a reputable CM provider was developed. Conclusion: Health professionals and cancer information services might find the criteria list helpful when aiming to strengthen patients’ awareness of quality-related factors associated with CM providers. The criteria developed might be helpful when standards are established for quality assurance in CM in oncology

German-language translation of the PANELVIEW instrument to evaluate the guideline development process from the perspective of the guideline group

Introduction: The development process for clinical guidelines is influenced by factors that are relevant to the validity of a guideline but often are not captured sufficiently in the final guideline documents. PANELVIEW is an English-language tool that can be used to explore the guideline development process from the perspective of guideline group members. Our aim was to translate the PANELVIEW tool into German, taking into account national contexts and linguistic differences.Methods: The PANELVIEW tool was initially translated by a core team, then refined and approved by a group of experts in a consensus-based Delphi process. The experts were selected on the basis of their experience in guideline development covering different fields (clinical, methodological, organisational, health professional, patient perspective) and geographical regions (Germany, Austria, Switzerland). A representative of the original PANELVIEW team was also involved. The Delphi steps included an online survey, an online consensus conference and final approval by circulating the results via email. Individual items were seen as generally agreed upon if the level of agreement in the respective steps was 75 % or more.Results: The expert group consisted of 12 persons. Of these, 11 (92 %) participated in the online survey and 10 (83 %) in the subsequent consensus conference. After the first Delphi step, sufficient agreement was achieved for 19 of 34 items (56 %). The remaining 15 items were discussed in the consensus conference and finally obtained 100 % agreement. The discussion focused on clarifying and adapting terms whose meaning was ambiguous or inadequate in the German context, which led to a deviation from the original wording in some instances.Discussion: The PANELVIEW tool was translated into German by means of a Delphi process. PANELVIEW complements existing instruments for assessing the methodological quality of guidelines by capturing the perspective of the guideline group. This will enable guideline developers and organisations to identify problems in the drafting process and avoid them in future projects. User testing and validation of the German-language PANELVIEW tool are planned for the future.Conclusion: The German-language translation of PANELVIEW will enable guideline developers in German-speaking countries to continuously evaluate and, where necessary, improve the process and methods of guideline development

Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) - an international randomized phase III trial

San Antonio Breast Cancer Symposium, San Antonio, TX, DEC 05-09, 201

Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) - an international randomized phase III trial

San Antonio Breast Cancer Symposium, San Antonio, TX, DEC 05-09, 201

The Hyperactivity/Inattention Subscale of the Strengths and Difficulties Questionnaire Predicts Short- and Long-Term Weight Loss in Overweight Children and Adolescents Treated as Outpatients

Objective: The success of treatment for pediatric obesity is variable and often unsatisfactory. This study elucidates the influence of inattention and hyperactivity/impulsivity on short- and long-term weight loss and maintenance after outpatient treatment. Methods: We included 8- to 16-year-old overweight and obese participants treated in 17 multidisciplinary outpatient treatment centers in a nationwide observational study. All treatment centers that reported long-term (1-year) follow-up weight data of at least 60% of the participants were included. At the beginning and end of treatment and at 1 year follow-up weight and height were measured at the center. Inattention and hyperactivity/impulsivity were assessed with the hyperactivity/inattention subscale (HI) of the parent-rated Strengths and Difficulty Questionnaire (SDQ). General linear models were used with the standard deviation scores of the BMI (BMI-SDS) as dependent variable and HI scores as main independent variable adjusting for age, sex, baseline BMI-SDS, and center. Results: 394 participants were included (57% female, age: 11.7± 2.0 years, baseline BMI-SDS 2.32 ±.46 kg/m2). HI scores were significantly associated with short- and long-term BMI-SDS (p < 0.0005), with higher baseline HI scores predicting less weight loss. Conclusions: Our results indicate that inattention and hyperactivity/impulsivity are linearly associated with reduced short- and long-term weight loss. Implications for treatment are discussed