Domains and outcomes of the core outcome set of congenital melanocytic naevi for clinical practice and research (the OCOMEN project): part 2.

BACKGROUND: Congenital melanocytic naevi (CMN) can have a great impact on patients' lives owing to perceived stigmatization, and the risk of melanoma development and neurological complications. Development of a core outcome set (COS) for care and research in CMN will allow standard reporting of outcomes. This will enable comparison of outcomes, allowing professionals to offer advice about the best management options. In previous research, stakeholders (patients, parents and professionals) reached consensus on the core domains of the COS. To select the appropriate measurement instruments, the domains should be specified by outcomes. OBJECTIVES: To reach consensus on the specific core outcomes describing the core domains pertaining to clinical care and research in CMN. METHODS: A list of provisional outcomes (obtained earlier) was critically reviewed by the Outcomes for COngenital MElanocytic Naevi (OCOMEN) research team and by relevant stakeholders through an online questionnaire, to refine this list and provide clear definitions for every outcome. When needed, discussion with individual participants was undertaken over the telephone or by email. During an online consensus meeting, stakeholders discussed the inclusion of potential outcomes. After the meeting, participants voted in two rounds for the inclusion of outcomes. RESULTS: Forty-four stakeholders from 19 countries participated. Nine core outcomes were included in the COS relative to clinical care and 10 core outcomes for research. CONCLUSIONS: These core outcomes will enable standard reporting in future care and research of CMN. This study facilitates the next step of COS development: selecting the appropriate measurement instruments for every outcome.

Development of an international core domain set for medium, large and giant congenital melanocytic naevi as a first step towards a core outcome set for clinical practice and research.

BACKGROUND: Medium, large and giant congenital melanocytic naevi (CMN) can impose a psychosocial burden on patients and families, and are associated with increased risk of developing melanoma or neurological symptoms. Lack of consensus on what outcomes to measure makes it difficult to advise patients and families about treatment and to set up best practice for CMN. OBJECTIVES: Fostering consensus among patient representatives and professionals, we aim to develop a core outcome set, defined as the minimum set of outcomes to measure and report in care and all clinical trials of a specific health condition. We focused on the 'what to measure' aspect, the so-called core domain set (CDS), following the COMET and CS-COUSIN guidelines. METHODS: We conducted a systematic review to identify outcomes reported in the literature. Focus groups with patient representatives identified patient-reported outcomes. All these outcomes were classified into domains. Through e-Delphi surveys, 144 stakeholders from 27 countries iteratively rated the importance of domains and outcomes. An online consensus meeting attended by seven patient representatives and seven professionals finalized the CDS. RESULTS: We reached consensus on six domains, four of which were applied to both care and research: 'quality of life', 'neoplasms', 'nervous system' and 'anatomy of skin'. 'Adverse events' was specific to care and 'pathology' to research. CONCLUSIONS: We have developed a CDS for medium-to-giant CMN. Its application in reporting care and research of CMN will facilitate treatment comparisons. The next step will be to reach consensus on the specific outcomes for each of the domains and what instruments should be used to measure these domains and outcomes.

Reentrant s-wave superconductivity in the periodic Anderson model with attractive conduction band Hubbard interaction.

Spin-flip scattering from magnetic impurities has a strong pair-breaking effect in s-wave superconductors where increasing the concentration of impurities rapidly destroys superconductivity. For small Kondo temperature T K the destruction of superconductivity is preceded by the reentrant superconductivity at finite temperature range T c2 < T < T c1, while the normal phase reappears at T < T c2 ∼ T K . Here we explore the superconducting phase in a periodic system modeled as the Anderson lattice with additional attractive on-site (Hubbard) interaction g acting on the conduction band electrons. We solve the equations using dynamical mean field theory which incorporates Kondo physics, while the pairing interaction is treated on the static mean-field level. For large coupling g we find reentrant superconductivity which resembles the case with diluted impurities. However, we find evidence that reentrant superconductivity is here not a consequence of many-body correlations leading to the Kondo effect, but it rather stems from a competition between the single-particle hybridization and superconducting pairing. An insight into the spectral functions with in-gap structures is obtained from an approximate noninteracting dual model whose solution interpolates between several exact limits.

Protocol for the development of core set of domains of the core outcome set for patients with congenital melanocytic naevi (OCOMEN project).

BACKGROUND: Having large congenital melanocytic naevi (CMN) is associated with a psychosocial burden on patients and their parents because of its remarkable appearance and the extra care it may require. Large CMN also pose an increased risk of malignant melanoma or neurocutaneous melanosis. There is a lack of international consensus on what important outcome domains to measure in relation to treatment. This makes it difficult to compare options, to properly inform patients and their parents, and to set up treatment policy for CMN. Therefore, we aim to develop a core outcome set (COS), i.e. the minimum set of outcomes that are recommended to be measured and reported in all clinical trials of a specific health condition. This COS can be used in the follow-up of CMN patients with or without treatment, in clinical research and practice. METHODS: In the Outcomes for Congenital Melanocytic Nevi (OCOMEN) projects, we follow the recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Core Outcomes Set Initiative (CS-COUSIN). This project entails the following: (i) a systematic review to identify the previous reported outcomes in literature; (ii) focus groups with national and international patients and parents to identify patient-important outcomes; (iii) classification of outcomes into outcome domains; (iv) e-Delphi surveys in which stakeholders (patients/parents and professionals) can rate the importance of domains and outcomes; and (v) an online consensus meeting to finalize the core outcome domains of the COS. RESULTS: The results will be disseminated by means of publication in a leading journal and presentations in international meetings or conferences. We engage international experts in CMN, both patients and professionals, to ensure the international utility and applicability of the COS.

Insight into "Calculated Risk": An Application to the Prioritization of Emerging Infectious Diseases for Blood Transfusion Safety.

Increasing identification of transmissions of emerging infectious diseases (EIDs) by blood transfusion raised the question which of these EIDs poses the highest risk to blood safety. For a number of the EIDs that are perceived to be a threat to blood safety, evidence on actual disease or transmission characteristics is lacking, which might render measures against such EIDs disputable. On the other hand, the fact that we call them "emerging" implies almost by definition that we are uncertain about at least some of their characteristics. So what is the relative importance of various disease and transmission characteristics, and how are these influenced by the degree of uncertainty associated with their actual values? We identified the likelihood of transmission by blood transfusion, the presence of an asymptomatic phase of infection, prevalence of infection, and the disease impact as the main characteristics of the perceived risk of disease transmission by blood transfusion. A group of experts in the field of infectious diseases and blood transfusion ranked sets of (hypothetical) diseases with varying degrees of uncertainty associated with their disease characteristics, and used probabilistic inversion to obtain probability distributions for the weight of each of these risk characteristics. These distribution weights can be used to rank both existing and newly emerging infectious diseases with (partially) known characteristics. Analyses show that in case there is a lack of data concerning disease characteristics, it is the uncertainty concerning the asymptomatic phase and the disease impact that are the most important drivers of the perceived risk. On the other hand, if disease characteristics are well established, it is the prevalence of infection and the transmissibility of the disease by blood transfusion that will drive the perceived risk. The risk prioritization model derived provides an easy to obtain and rational expert assessment of the relative importance of an (emerging) infectious disease, requiring only a limited amount of information. Such a model might be used to justify a rational and proportional response to an emerging infectious disease, especially in situations where little or no specific information is available.

Estimating the risk of dengue transmission from Dutch blood donors travelling to Suriname and the Dutch Caribbean.

BACKGROUND: The risk of dengue transmitted by travellers is known. Methods to estimate the transmission by transfusion (TT) risk from blood donors travelling to risk areas are available, for instance, the European Up-Front Risk Assessment Tool (EUFRAT). This study aimed to validate the estimated risk from travelling donors obtained from EUFRAT. METHODS: Surveillance data on notified dengue cases in Suriname and the Dutch Caribbean islands (Aruba, Curaçao, St. Maarten, Bonaire, St. Eustatius and Saba) in 2001-2011 was used to calculate local incidence rates. Information on travel and donation behaviour of Dutch donors was collected. With the EUFRAT model, the TT risks from Dutch travelling donors were calculated. Model estimates were compared with the number of infections in Dutch travellers found by laboratory tests in the Netherlands. RESULTS: The expected cumulative number of donors becoming infected during travels to Suriname and the Dutch Caribbean from 2001 to 2011 was estimated at 5 (95% CI, 2-11) and 86 (45-179), respectively. The infection risk inferred from the laboratory-based study was 19 (9-61) and 28 (14-92). Given the independence of the data sources, these estimates are remarkably close. The model estimated that 0·02 (0·001-0·06) and 0·40 (0·01-1·4) recipients would have been infected by these travelling donors. CONCLUSIONS: The EUFRAT model provided an estimate close to actual observed number of dengue infections. The dengue TT risk among Dutch travelling donors can be estimated using basic transmission, travel and donation information. The TT risk from Dutch donors travelling to Suriname and the Dutch Caribbean is small.