Multidisciplinary Advisory Board Research Articles

Areas of uncertainty on the diagnosis, treatment, and follow-up of hypophosphatemia in adults: an Italian Delphi consensus.

The study aimed to present the results of a Delphi consensus involving Italian experts focusing on the management of hypophosphatemia in adults. A multidisciplinary advisory board of nine physicians, experts in hypophosphatemia management, was established. Next, a literature search was performed to identify international guidelines, consensus, and clinical pathways, which were later presented to the advisory board. Collaboratively, the advisory board and authoring team selected key statements for the consensus process and focused on areas of uncertainty related to the management of hypophosphatemia. The advisory board also indicated the experts to be invited to participate in the consensus process. The Delphi method was employed to reach a consensus. The literature search yielded one guideline, five consensus documents, and one clinical pathway. While our search strategy aimed to identify documents on the management of all types of hypophosphatemia, most of the guidelines and consensus documents retrieved focused on X-linked hypophosphatemia. The consensus process focused on 11 key issues, achieving strong convergence (over 70% consensus) in the first Delphi round for 8 out of the 11 statements. Three statements proceeded to the second round, with strong agreement reached for two. Notably, consensus was not reached for the statement concerning the measurement of fibroblast growth factor 23 for diagnostic purposes. The study revealed that the community of clinical experts is well-informed and in agreement regarding hypophosphatemia management. It emphasized the importance of developing clear national guidance documents to support clinicians and multidisciplinary teams in patient management. These documents are crucial not only for healthcare professionals but also for those responsible for defining pathways and services, facilitating a more accurate management of hypophosphatemic patients.

The Role of Contrast-Enhanced Imaging Methods in Breast Cancer Early Diagnostics and Treatment Planning

Оn March 27, 2023, а multidisciplinary Advisory Board meeting was held in Moscow with the participation of Е.V. Artamonova, Е.А. Busko, V.V. Didenko, А.D. Zikiryakhodzhaev, М.S. Karpova, G.Е. Kvetenadze, P.V. Krivorot’ko, М.L. Mazo, А.V. Petrovsky, О.S. Puchkova, S.V. Serebryakova under the chairmanship of I.Е. Tyurin and N.I. Rozhkova. The participants discussed different issues of early diagnostics and treatment planning of breast cancer. We present the conclusion made by the Advisory Board.

It's time to address fear of cancer recurrence in family caregivers: usability study of an virtual version of the Family Caregiver-Fear Of Recurrence Therapy (FC-FORT).

Family caregivers of cancer survivors experience equal or greater levels of fear of cancer recurrence (FCR) than survivors themselves. Some interventions have demonstrated their ability to reduce FCR among cancer survivors and dyads (patient and caregivers). However, to date, no validated intervention exists to focus solely on family caregiver's FCR. This study aimed to (1) adapt the evidence-based in-person Fear Of Recurrence Therapy (FORT) for family caregivers (referred here in as FC-FORT) and to a virtual delivery format and (2) test its usability when offered virtually. The adaptation of FC-FORT was overseen by an advisory board and guided by the Information Systems Research Framework. Following this adaptation, female family caregivers and therapists were recruited for the usability study. Participants took part in 7 weekly virtual group therapy sessions, a semi-structured exit interview and completed session feedback questionnaires. Therapists were offered a virtual training and weekly supervision. Fidelity of treatment administration was assessed each session. Quantitative data were analyzed using descriptive statistics. Exit interviews were transcribed verbatim using NVivo Transcription and coded using conventional content analysis. Results were presented back to the advisory board to further refine FC-FORT. The advisory board (n = 16) met virtually on 7 occasions to adapt FC-FORT (i.e., patient manuals, virtual format) and discuss recruitment strategies. Minor (e.g., revised text, adapted materials to virtual format) and major adaptations (e.g., added and rearranged sessions) were made to FC-FORT and subsequently approved by the advisory board. Four family caregivers and three therapists took part in the first round of the usability testing. Six family caregivers and the same three therapists took part in the second round. Overall, participants were very satisfied with FC-FORT's usability. Qualitative analysis identified 4 key themes: usability of FC-FORT, satisfaction and engagement with content, group cohesion, and impact of FC-FORT. All participants indicated that they would recommend FC-FORT to others as is. Using a multidisciplinary advisory board, our team successfully adapted FC-FORT and tested its usability using videoconferencing. Results from this study indicate that the efficacy and acceptability of FC-FORT are now ready to be tested in a larger pilot study.

Independence at Home: After 10 years of evidence, it's time for a permanent Medicare program.

Dr. Kinosian is Treasurer for the American Academy of Home Care Medicine, and a participant in the Complete Care Academy Collaborative, a High-Need Accountable Care Organization Realizing Equity, Access, and Community Health (HN-ACO-REACH). Drs. Boling, and Kinosian are uncompensated board members, representing their practices, for the Complete Care Academy Collaborative. Dr. Leff serves as a clinical advisor to Medically Home, Dispatch Health, MedZed, Patina Health, and the Chartis Group. He serves as a volunteer member of the Humana Multidisciplinary Advisory Board. Drs. Deligiannidis, Boling, Kinosian, and Taler are salaried employees of their respective institutions, which currently (Deligiannidis) or previously (Boling, Kinosian, Taler) participated in IAH. Supplementary File S1. IAH Demonstration. Supplementary File S2. IAH Financial Incentive. Supplementary File S3. Compiled publicly reported data. Supplementary File S4. Practice level changes in savings. Supplementary File S5. Difference between difference and difference-in-differences. Supplementary File S6. Policy punch list. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Role of contrast enhancement at the early diagnosis and assessment of the lung cancer prevalence

An multidisciplinary advisory board meeting was held in Moscow on November 27, 2021 to discuss different issues of early diagnosis and assessment of lung cancer prevalence (staging) by country's leading specialists in the field of lung cancer diagnosis and treatment. We would like to present to your attention the Expert Panel's opinion.

Development of a core outcome set on Traditional Chinese Medicine and Western Medicine for rheumatic heart disease: a study protocol

IntroductionGlobally, rheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents. Clinical trials on RHD treatment with Traditional Chinese Medicine (TCM) or integrated medicine...

Developing Patient-Centered Real-World Evidence: Emerging Methods Recommendations From a Consensus Process

ObjectivesThe Joint ISPOR-ISPE Special Task Force on Real-World Evidence included patient/stakeholder engagement as a recommended good procedural practice when designing, conducting, and disseminating real-world evidence (RWE). However, there are no guidelines describing how patient experience data (PED) can be applied when designing real-world data (RWD) studies. This article describes development of consensus recommendations to guide researchers in applying PED to develop patient-centered RWE. MethodsA multidisciplinary advisory board, identified through recommendations of collaborators, was established to guide development of recommendations. Semistructured interviews were conducted to identify how experienced RWD researchers (n = 15) would apply PED when designing a hypothetical RWD study. Transcripts were analyzed and emerging themes developed into preliminary methods recommendations. An eDelphi survey (n = 26) was conducted to refine/develop consensus on the draft recommendations. ResultsWe identified 13 recommendations for incorporating PED throughout the design, conduct, and translation of RWE. The recommendations encompass themes related to the development of a patient-centered research question, designing a study, disseminating RWE, and general considerations. For example, consider how patient input can inform population/subgroups, comparators, and study period. Researchers can leverage existing information describing PED and may be able to apply those insights to studies relying ontraditional RWD sources and/or patient registries. ConclusionsApplying these emerging recommendations may improve the patient centricity of RWE through improved relevance of RWE to patient communities of interest and foster greater multidisciplinary participation and transparency in RWD research. As researchers gather experience by applying the methods recommendations, further refinement of these consensus recommendations may lead to “best practices.”

The prevention of pressure injuries in the positioning and mobilization of patients in the ICU: a good clinical practice document by the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)

BackgroundThe aim of this document is to support clinical decision-making concerning positioning and mobilization of the critically ill patient in the early identification and resolution of risk factors (primary prevention) and in the early recognition of those most at risk (secondary prevention). The addresses of this document are physicians, nurses, physiotherapists, and other professionals involved in patient positioning in the intensive care unit (ICU).MethodsA consensus pathway was followed using the Nominal Focus Group and the Delphi Technique, integrating a phase of focused group discussion online and with a pre-coded guide to an individual phase. A multidisciplinary advisory board composed by nine experts on the topic contributed to both the phases of the process, to reach a consensus on four clinical questions positioning and mobilization of the critically ill patient.ResultsThe topics addressed by the clinical questions were the risks associated with obligatory positioning and therapeutic positions, the effective interventions in preventing pressure injuries, the appropriate instruments for screening for pressure injuries in the ICU, and the cost-effectiveness of preventive interventions relating to ICU positioning. A total of 27 statements addressing these clinical questions were produced by the panel. Among the statements, nine provided guidance on how to manage safely some specific patients’ positions, including the prone position; five suggested specific screening tools and patients’ factors to consider when assessing the individual risk of developing pressure injuries; five gave indications on mobilization and repositioning; and eight focused on the use of devices, such as positioners and preventive dressings.ConclusionsThe statements may represent a practical guidance for a broad public of healthcare professionals involved in the management of critically ill patients.

First Nationwide Molecular Screening Program in Spain for Patients With Advanced Breast Cancer: Results From the AGATA SOLTI-1301 Study.

BackgroundThe SOLTI-1301 AGATA study aimed to assess the feasibility of a multi-institutional molecular screening program to better characterize the genomic landscape of advanced breast cancer (ABC) and to facilitate patient access to matched-targeted therapies in Spain.MethodsDNA sequencing of 74 cancer-related genes was performed using FFPE tumor samples in three different laboratories with three different gene panels. A multidisciplinary advisory board prospectively recommended potential targeted treatments. The primary objective was to determine the success of matching somatic DNA alteration to an experimental drug/drug class.ResultsBetween September 2014 and July 2017, 305 patients with ABC from 10 institutions were enrolled. Tumor sequencing was successful in 260 (85.3%) patients. Median age was 54 (29-80); most tumors were hormone receptor-positive/HER2-negative (74%), followed by triple-negative (14.5%) and HER2-positive (11.5%). Ninety-seven (37%) tumor samples analyzed proceeded from metastatic sites. Somatic mutations were identified in 163 (62.7%) patients, mostly in PIK3CA (34%), TP53 (22%), AKT1 (5%), ESR1 (3%), and ERBB2 (3%) genes. Significant enrichment of AKT1 mutation was observed in metastatic versus primary samples (9% vs. 2%; p=0.01). Genome-driven cancer therapy was recommended in 45% (n=116) of successfully screened patients, 11% (n=13) of whom finally received it. Among these patients, 46.2% had a PFS of ≥6 months on matched therapy.ConclusionsAGATA is the first nationwide molecular screening program carried out in Spain and we proved that implementing molecular data in the management of ABC is feasible. Although these results are promising, only 11% of the patients with genome-driven cancer therapy received it.

Practical Considerations Relating to Routine Clinical Biomarker Testing for Non-small Cell Lung Cancer: Focus on Testing for RET Fusions.

For patients with advanced non–small cell lung cancer, genomic profiling of tumors to identify potentially targetable alterations and thereby inform treatment selection is now part of standard care. While molecular analyses are primarily focused on actionable biomarkers associated with regulatory agency-approved therapies, there are a number of emerging biomarkers linked to investigational agents in advanced stages of clinical development will become approved agents. A particularly timely example is the reported data and US Food and Drug Administration approval of highly specific small molecule inhibitors of the proto-oncogene tyrosine-protein kinase receptor RET indicate that testing for tumor RET gene fusions in patients with NSCLC has become clinically important. As the number of biomarkers to be tested in NSCLC grows, it becomes increasingly important to optimize and prioritize the use of biopsy tissue, in order to both continue to allow accurate histopathological diagnosis and also to support concurrent genomic profiling to identify perhaps relatively uncommon genetic events. In order to provide practical expert consensus guidance to optimize processes facilitating genomic testing in NSCLC and to overcome barriers to access and implementation, a multidisciplinary advisory board was held in New York, on January 30, 2019. The panel comprised physicians involved in sample procurement (interventional radiologists and a thoracic surgeon), surgical pathologists specializing in the lung, molecular pathologists, and thoracic oncologists. Particular consideration was given to the key barriers faced by these experts in establishing institutional genomic screening programs for NSCLC. Potential solutions have been devised in the form of consensus opinions that might be used to help resolve such issues.

Advancing Social Mission in Nursing Education: Recommendations From an Expert Advisory Board

Social mission refers to a set of concepts and perspectives that promote health equity in health care delivery and within health professions. Little is known about social mission within the context of nursing education. This article clarifies the role of social mission in nursing education, offers current applications, and identifies future opportunities to maximize social mission within nursing to foster a more just culture of health. A multidisciplinary advisory board of experts in nursing education convened to review pertinent literature, current case exemplars, and craft a conceptual framework of social mission in nursing education. The resulting framework consisted of three action-oriented domains to implement social mission into nursing education: board accreditation, curriculum building and faculty training, and developing institutional culture. Successful implementation of social mission into nursing education, and subsequently the nursing workforce, offers the opportunity to further embed equity into health care. [J Nurs Educ. 2020;59(8):433-438.].

Complex clinical scenarios with the use of direct oral anticoagulants in patients with atrial fibrillation: amultidisciplinary expert advisory board.

The risk of developing atrial fibrillation (AF) and the risk of stroke both increase with advancing age. As such, many individuals have, or will develop, an indication for oral anticoagulation to reduce the risk of stroke. Currently, a large number of anticoagulants are available, including vitamin K antagonists, direct thrombin or factor Xa inhibitors (the last two also referred to as direct oral anticoagulants or DOACs), and different dosages are available. Of the DOACs, rivaroxaban can be obtained in the most different doses: 2.5 mg, 5 mg, 15 mg and 20 mg. Many patients develop co-morbidities and/or undergo procedures that may require the temporary combination of anticoagulation with antiplatelet therapy. In daily practice, clinicians encounter complex scenarios that are not always described in the treatment guidelines, and clear recommendations are lacking. Here, we report the outcomes of a multidisciplinary advisory board meeting, held in Utrecht (The Netherlands) on 3 June 2019, on decision making in complex clinical situations regarding the use of DOACs. The advisory board consisted of Dutch cardiovascular specialists: (interventional) cardiologist, internist, neurologist, vascular surgeon and general practitioners invited according to personal title and specific field of expertise.

The IN-DEEP project "INtegrating and Deriving Evidence, Experiences, Preferences": a web information model on magnetic resonance imaging for people with multiple sclerosis.

The IN-DEEP project aims to provide people with multiple sclerosis (PwMS) with evidence-based information on magnetic resonance imaging (MRI) in diagnosis and monitoring the disease through a website, and to collect their opinions on the clarity of the website's contents and its usefulness. A multidisciplinary advisory board committee was set up. We investigated the experience, attitude and information needs on MRI through three meetings with 24 PwMS, facilitated by an expert researcher and an observer. We developed the website on the basis of input from PwMS and systematic reviews and guidelines, assessed with AMSTAR and AGREE II. We sought feedback from nine PwMS who pilot-tested the beta-version of the website, during a meeting and through phone interviews and judged whether the contents were clear, understandable and useful, and the website was easily navigable. The website is in Italian. The website ( https://www.istituto-besta.it/in-deep-risonanza-magnetica2 ) provides two levels of information, different layouts and visualization of data covering MRI diagnostic accuracy, sensitivity and specificity, contents on how MRI can monitor PwMS over time to determine changes in the condition and evaluate treatment effects, practical information on how to prepare for the exam, educational tools and a glossary. The website was judged clear and useful by a sample of PwMS. The website is a tool to address PwMS information needs on the role of MRI. It could be used by neurologists to facilitate communication with PwMS.

Integra in Scalp Reconstruction After Tumor Excision: Recommendations From a Multidisciplinary Advisory Board.

Integra is a dermal regeneration template used in the reconstruction of burns, traumatic injuries, or excision lesions in patients who present particular risk factors for traditional surgical procedures. A multidisciplinary advisory board of expert dermatologists and plastic surgeons have discussed the use of Integra in the reconstruction of scalp defects after tumor excision, focusing on the evidence derived from literature and on their experience in the treatment of approximately 400 patients. In this position paper, the authors summarize the main evidence discussed during the board, and the common practice guidelines proposed by the experts. The use of Integra is recommended in elderly patients with multiple comorbidities who have a higher risk for potential complications in traditional surgery; these patients may in fact benefit from a lower anesthetic risk, a less complicated postsurgical care and limited morbidity at the donor site obtained with the dermal template. Integra should also be used in the reconstruction of large and complex wounds and in case of bone exposure, as it helps to overcome the challenges related to wound healing in difficult areas. Notably, Integra has proven to be effective in patients who have undergone previous surgical procedures or adjuvant radiation therapy, in which previous incisions, scarring and radiation damages may hamper the effectiveness of traditional procedures. Finally, Integra is recommended in patients with recurrent and aggressive tumors who need closer tumor surveillance, as it gives easy access to the tumor site for oncologic follow-up examination.

Abstract P6-18-02: Primary and secondary results of the first nationwide molecular screening program in Spain for patients with advanced breast cancer (AGATA SOLTI-1301 study)

Abstract Background: Metastatic breast cancer is the second leading cause of death among women globally. A better understanding of tumor biology, and the availability of high-throughput technologies, have enabled the emergence of precision medicine bringing new expectations and giving rise to molecular screening programs (MSP). SOLTI, as a collaborative Spanish network, designed AGATA, the first multi-institutional MSP ever implemented in this country. Here, we report both the primary and some of the secondary results of the pilot study. Methods: A total of 10 sites within SOLTI network in Spain participated. DNA-sequencing of 56 cancer related genes was performed using FFPE tumor samples (primary or metastatic). Each clinical case was reviewed by a multidisciplinary advisory board (MAB), which recommended, in a prospective manner, potential experimental treatments, mainly in the context of clinical trials. The primary objective was to determine the success rate of matching a DNA alteration to an experimental drug or drug class. Secondary objectives included a comprehensive molecular characterization of tumor samples by PAM50 subtyping and quantification of protein expression levels by MASS-SPEC (70 proteins panel). Results: 305 patients (pts) were screened from September 2014 to July 2017 and 260 (85.3%) were finally evaluated by the MAB. Pts characteristics were: mean age 54 years (29-80), ER+/HER2- (n=192; 74%), HER2+ (n=30; 11.5%) and TNBC (n=38; 14.5%). 163 primary tumors and 97 metastatic samples were profiled. Regarding the primary objective, 116 pts (45%) presented at least one mutation (range 1-6) that could be matched to a drug or drug class. Of these, 13 pts (11.2%) received therapy matched to their molecular profile according to the MAB recommendation and their follow-up is still on-going. No mutation was detected in 97 (37%) pts (WT), and 47 patients (18.1%) presented a mutation but no match was possible. The most common mutations were PIK3CA (34%), TP53 (22%), AKT1 (5%), ESR1 (3%) and ERBB2 (3%). Intrinsic subtype distribution in 177 samples was as follows: 34% Luminal A (n=60); 21% Luminal B (n=36); 13% HER2E (n=22); 19% Basal-like (n=34) and 13% Normal-like (n=23). Compared to primary tumors (n=110), the proportion of HER2-enriched disease in metastatic tumors (n=63) was significantly higher (6% vs 20%; p=0.005). Protein expression analysis was performed in 146 samples (94 primary and 57 metastasis). In 19 cases (13%), the outlier expression of some targetable proteins (FGFR1 [n=4, 2.7%], IGF1R [n=4, 2.7%], EGFR [n=1, 0.7%], CEACAM5 [n=6, 4.1%], IDO1 [n=2, 1.37%], TROP2 [n=2, 1.37%]) were identified. Of note, HER2 overexpression (>740 amol/μg) was observed in 4 HER2- cases. Finally, among WT tumors, 21% presented a potential drug-matched protein target. Conclusions: Nationwide molecular screening in Spain is feasible. Nearly half of patients had tumors with mutation(s), mostly PIK3CA, that could be matched to a potential drug or drug class. PAM50 profile might be helpful to navigate towards a therapeutic decision making, although the MAB could not make any targeted-driven recommendation yet with this data. More clinical evidence is needed to use MASS-SPEC as a diagnostic tool. Citation Format: Pernas S, Villagrasa P, Nuciforo PG, Vivancos A, Scaltriti M, Rodón J, Burgués O, Canes J, Dueñas M, Cecchi F, Vidal M, Lluch A, Perelló A, Llombart A, Dorca J, Montaño A, Oliveira M, Ribas G, Rapado I, Paré L, Prat A, Ciruelos E. Primary and secondary results of the first nationwide molecular screening program in Spain for patients with advanced breast cancer (AGATA SOLTI-1301 study) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-18-02.

HIV priorities by Italian AIDS advocacy groups: information on prevention (still) comes first. An on-line survey.

to define a list of priorities for activities and research projects based on the consultation of Italian AIDS advocacy groups through an online survey. a multidisciplinary advisory board was set up to define the survey and discuss the findings. Five areas - and related items - were listed: prevention, continuity of care, discrimination, research, key populations. Fifty-eight AIDS advocacy groups were identified and invited through e-mail to the survey, which lasted two months. Responders were asked to select a priority area and vote two items. Then, as second choice, they had to choose up to three items across the other areas. The final step of the prioritization process was the discussion of the survey findings with the advisory board. Italian HIV advocacy groups. thirty-seven groups responded (64%). The priority selected by most was prevention (around 80%), particularly preventive information addressed to teenagers and the general population. For the second choice, the most chosen items referred to discrimination and the continuity of care. The advisory board members underlined the need for a planned, organized, monitored, and evidence-based approach for HIV prevention information in different settings. different strategies to provide HIV prevention information should be proposed and monitored according to different targets, following an evidence-based approach. The stigma and discrimination against people with HIV and AIDS must be cleaned up to foster safe sex behaviours, providing education interventions at school. Wider structural issues have to be addressed, such as the availability and affordability of health services, contraceptive choices and condoms, poverty, and cultural gender norms.

Developing religiously-tailored health messages for behavioral change: Introducing the reframe, reprioritize, and reform (“3R”) model

RationaleAs community health interventions advance from being faith-placed to authentically faith-based, greater discussion is needed about the theory, practice, and ethics of delivering health messages embedded within a religious worldview. While there is much potential to leverage religion to promote health behaviors and improve health outcomes, there is also a risk of co-opting religious teachings for strictly biomedical ends. ObjectiveTo describe the development, implementation, and ethical dimensions of a conceptual model for religiously-tailoring health messages. MethodWe used data from 6 focus groups and 19 interviews with women aged 40 and older sampled from diverse Muslim community organizations to map out how religious beliefs and values impact mammography-related behavioral, normative and control beliefs. These beliefs were further grouped into those that enhance mammography intention (facilitators) and those that impede intention (barriers). In concert with a multi-disciplinary advisory board, and by drawing upon leading theories of health behavior change, we developed the “3R” model for crafting religiously-tailored health messages. ResultsThe 3R model addresses barrier beliefs, which are beliefs that negatively impact adopting a health behavior, by (i) reframing the belief within a relevant religious worldview, (ii) reprioritizing the belief by introducing another religious belief that has greater resonance with participants, and (iii) reforming the belief by uncovering logical flaws and/or theological misinterpretations. These approaches were used to create messages for a peer-led, mosque-based, educational intervention designed to improve mammography intention among Muslim women. ConclusionsThere are benefits and potential ethical challenges to using religiously tailored messages to promote health behaviors. Our theoretically driven 3R model aids interventionists in crafting messages that address beliefs that hinder healthy behaviors. It is particularly useful in the context of faith-based interventions for it highlights the ethical choices that must be made when incorporating religious values and beliefs in tailored messages.

315TiP - AGATA molecular screening program: Implementing precision medicine in patients with advanced breast cancer in Spain

Background: Metastatic breast cancer continues to be a major cause of cancer death among women globally. In recent years, a better understanding of tumor biology, and the availability of high-throughput technologies has enabled the emergence of precision medicine bringing new expectations and giving rise to molecular screening programs worldwide. Recently, the MOSCATO trial has shown for the very first time that prospectively sequencing a large panel of genes and utilizing this information to guide treatment choices may improve the outcome of a subset of patients. Some institutions are implementing such strategy as part of the routine treatment decision-making process. However, SOLTI, as a collaborative Spanish network, runs AGATA, the first multi-institutional molecular screening program ever implemented in this country. Patient recruitment started in October 2014 and is expected to conclude in June 2017. Trial design: Up to 260 patients with metastatic breast cancer will be recruited in 10 participating sites in Spain. Mutation testing is performed prospectively in the genomic laboratories of Vall d´Hebron Institute of Oncology in Barcelona, 12 de Octubre University Hospital in Madrid, and the University Clinical Hospital of Valencia. Upon molecular characterization and collection of key clinical data, each case is reviewed by a multidisciplinary advisory board, which recommends potential experimental treatments, mainly in the context of clinical trials. During this pilot stage, our primary objective is to determine the success rate in including patients in trials based on their molecular profile. Additional aims are to identify technical and logistical barriers to the implementation of a nationwide program, describe the genomic profiles of the tumors, and assess patient outcomes. Retrospective gene expression (PAM50 + 110 genes and 20 miRNAs) and proteomic analysis (40 markers) will be performed to provide a more comprehensive molecular profile of the tumors that may help explain sensitivity or resistance to administered therapies. Data collected within this program is expected to generate hypotheses for further investigations directed to improve precision medicine. Clinical trial identification: NCT02445482 Legal entity responsible for the study: SOLTI Breast Cancer Research Group Funding: Novartis, Mutua Madrileña, Instituto de Salud Carlos III Disclosure: All authors have declared no conflicts of interest.

Management of veno-occlusive disease: the multidisciplinary approach to care.

Although it is considered a relatively rare disorder, veno-occlusive disease (VOD) is one of the main causes of overall, non-relapse mortality associated with haematopoietic stem cell transplantation (HSCT). This article, based on the consensus opinion of haemato-oncology nurses, haemato-oncologists and pharmacists from both adult and paediatric services at the VOD International Multi-Disciplinary Advisory Board at the European Society for Blood and Marrow Transplantation (EBMT) meeting, Istanbul, 2015, aims to explore the multidisciplinary approach to care for the management of VOD, with an emphasis on current challenges in this area. The careful monitoring of HSCT patients allows early detection of the symptoms associated with VOD and timely treatment, ultimately improving patient outcomes. As part of a multidisciplinary team, nurses have an essential role to play, from pretransplant assessment to medical management and overall care of the patient. Physicians and pharmacists have a responsibility to facilitate education and training so that nurses can work effectively within that team.

Identifying effective behavioural components of Intervention and Comparison group support provided in SMOKing cEssation (IC-SMOKE) interventions: a systematic review protocol.

BackgroundSystematic reviews of behaviour change interventions for smoking cessation vary in scope, quality, and applicability. The current review aims to generate more accurate and useful findings by (1) a detailed analysis of intervention elements that change behaviour (i.e. behaviour change techniques (BCTs)) and potential moderators of behaviour change (i.e. other intervention and sample characteristics) and (2) assessing and controlling for variability in support provided to comparison groups in smoking cessation trials.MethodsA systematic review will be conducted of randomized controlled trials of behaviour change interventions for smoking cessation in adults (with or without pharmacological support), with a minimum follow-up of 6 months, published after 1995. Eligible articles will be identified through the Cochrane Tobacco Addiction Group Specialized Register. Study authors will be asked for detailed descriptions of smoking cessation support provided to intervention and comparison groups. All data will be independently coded by two researchers. The BCT taxonomy v1 (tailored to smoking cessation interventions) and template for intervention description and replication criteria will be used to code intervention characteristics. Data collection will further include sample and trial characteristics and outcome data (smoking cessation rates). Multilevel mixed-effects meta-regression models will be used to examine which BCTs and/or BCT clusters delivered to intervention and comparison groups explain smoking cessation rates in treatment arms (and effect sizes) and what key moderators of behaviour change are. Predicted effect sizes of each intervention will be computed assuming all interventions are compared against comparison groups receiving the same levels of behavioural support (i.e. low, medium, and high levels). Multi-disciplinary advisory board members (policymakers, health care providers, and (ex-)smokers) will provide strategic input throughout the project to ensure the review’s applicability to policy and practice.DiscussionBy capturing BCTs in intervention and comparison groups, this systematic review will provide more accurate estimates of the effectiveness of smoking cessation interventions, the most promising BCTs and/or BCT clusters associated with smoking cessation rates in intervention and comparison arms, and important moderators of behaviour change. The results could set new standards for conducting meta-analyses of behaviour change interventions and improve research, service delivery, and training in the area of smoking cessation.Systematic review registrationPROSPERO CRD42015025251Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0253-1) contains supplementary material, which is available to authorized users.