What the guide does not tell you: reflections on and lessons learned from applying the COM-B behavior model for designing real life interventions

Substantial inconsistency exists in the effectiveness of existing interventions to improve heart failure (HF) self-care, which can be partially explained by the fact that self-management interventions often lack theoretical models that underpin intervention development. The COM-B behavior model is a comprehensive theoretical framework that can be used to develop effective, theory-based interventions. The aim of this article is to highlight the challenges and practical solutions when applying the COM-B model to HF self-care, in order to provide useful support for researchers intending to use the model for designing behavior change interventions. “The Behaviour Change Wheel” handbook provides a step-by-step guide to understand and change behavior. When following the guide, some practical and methodological challenges were encountered. Lessons learnt to overcome these challenges are reported. Although the handbook is a comprehensive guide for designing behavior change interventions, a number of challenges arose. For example, the descriptions provided in the guide were not always sufficient to make solid judgments on how to categorize determinants; narrowing down intervention possibilities to a manageable number and prioritizing potential behavior change techniques over others involved a certain amount of subjectivity in an otherwise highly systematic and structured approach. For the encountered challenges, solutions are provided to illustrate how the model was applied practically to design theory-based behavior change interventions. This article provides a useful reference for researchers’ use of the COM-B behavior model, as it outlines challenges that may occur and potential solutions to overcome them

(η5-Cyclo­penta­dien­yl){[3-(2,2-dicyano­ethen­yl)bicyclo­[2.2.1]hepta-2,5-dien-2-yl]ethyn­yl}(triphenyl­phosphine)nickel(II)

The title compound, [Ni(C5H5)(C13H7N2)(C18H15P)] or (η5-C5H5)(PPh3)Ni—C C—C7H6—C(H)=C(CN)2, contains an unusual disubstituted norbornadienyl (NBD) ligand containing ethynyl (–C C–) and dicyano­vinyl [–C(H)=C(CN)2] groups. Disorder is present in the NBD group with site occupancies of 0.636 (10) and 0.364 (10) for two distinct orientations. There are no strong hydrogen bonds and the primary inter­actions are weak C—H⋯π(arene) inter­actions

Faciliating More Efficient Negotiations for Innovative Therapies: A Value-Based Negotiation Framework

OBJECTIVES: An increasing number of innovative therapies (e.g., gene- and cell-based treatments) have been developed in the past 20 years. Despite the significant clinical potential of these therapies, access delays may arise because of differing perspectives of manufacturers and payers regarding issues such as the value of the product, clinical and financial uncertainties, and sustainability.Managed entry agreements (MEAs) can enable access to treatments that would not be reimbursed by conventional methods because of such concerns. However, although MEA typologies exist, there is currently no structured process to come to agreements on MEAs, which can be difficult to decide upon and implement.To facilitate more structured MEA negotiations, we propose a conceptual "value-based negotiation framework" with corresponding application tools. METHODS: The framework was developed based on an iterative process of scientific literature review and expert input. RESULTS: The framework aims to (i) systematically identify and prioritize manufacturer and payer concerns about a new treatment, and (ii) select a mutually acceptable combination of MEA terms that can best address priority concerns, with the lowest possible implementation burden. CONCLUSIONS: The proposed framework will be tested in practice, and is a step toward supporting payers and manufacturers to engage in more structured, transparent negotiations to balance the needs of both sides, and enabling quicker, more transparent MEA negotiations and patient access to innovative products

‘Mapping’ health state utility values from non-preference-based measures : a systematic literature review in rare diseases

Background: In rare disease (RD) studies, generic preference-based patient-reported outcome measures (PROMs) that yield health state utility values (HSUVs) are seldom collected, as they are considered not sensitive enough for these small and heterogeneous patient populations. In such cases, a HSUV can also be obtained by ‘mapping’ a more sensitive ‘source’ (e.g., disease-specific PROM) to a ‘target' preference-based measure (e.g., EuroQol-5 Dimension (EQ-5D)) through a statistical relationship. Objective: This study aimed to systematically review all published studies using ‘mapping’ to derive HSUVs from non-preference-based measures in RDs (i.e. affecting fewer than 1 in 2,000 people), and identify any critical issue related to the main features of RDs. Methods: The following databases were searched during the first half of 2019 without time, study design or language restrictions: MEDLINE (via PubMed), the School of Health and Related Research Health Utility Database (ScHARRHUD) and the Health Economics Research Centre (HERC) database of mapping studies (version 7.0). The keywords combined terms related to ‘mapping’ with ORPHANET’s list of RD indications (e.g., ‘acromegaly’), in additional to ‘rare’ and ‘orphan’. ‘Very rare’ diseases (i.e. with less than 1000 cases or families documented in the medical literature) were excluded from the searches. A predefined, pilot-tested extraction template (in Excel®) was used to collect structured information from the studies. Results: Two groups of studies were identified in the review. The first group (n=19) developed novel mapping algorithms in thirteen different RDs. As a target measure, the majority used EQ-5D, and the others the Short-Form Six-Dimension (SF-6D) and 15D; most studies adopted Ordinary Least Squares (OLS) regression. The second group of studies (n=9) applied previously existing algorithms in non-RDs to comparable RDs, mainly in the field of cancer. The critical issues relating to ‘mapping’ in RDs included the availability of very few studies, the relatively high number of cancer studies, and the absence of research in paediatric RDs. Moreover, the reviewed studies recruited small samples, hindering the cross-validation of algorithms and application of more complex regression models, showed a limited overlap between RD-specific and generic PROMs, and highlighted the presence of cultural and linguistic factors influencing results in multi-country studies. Additionally, few studies explicitly referred to published recommendations for mapping. Lastly, the application of existing algorithms in non-RDs was likely to produce inaccuracies at the bottom of the EQ-5D scale, due to the greater severity of RDs. Conclusions: More research is encouraged to develop algorithms for a broader spectrum of RDs (including those affecting young children), improve mapping study quality, test the generalizability of algorithms developed in non-RDs (e.g., HIV) to rare variants or evolutions of the same condition (e.g., AIDS wasting syndrome), and verify the robustness of results when mapped HSUVs are used in cost-utility models

Treatment of Monozygotic Twins With Obsessive Compulsive Disorder Using Cognitive Therapy and Exposure With Ritual Prevention

BACKGROUND: Assessment and treatment of cohabiting monozygotic (MZ) twins with obsessive compulsive disorder (OCD) is a possible challenge for clinical psychologists. AIMS: This study aims to present a detailed history of two sets of cohabiting MZ twins with OCD, and describe the adaption of cognitive behavior therapy in their treatments. METHOD: Two sets of cohabiting MZ twins completed a structured intake and the Yale Brown Obsessive Compulsive Scale as well as measures of depression, anxiety, a measure of obsessive beliefs, and thought action fusion. One set received cognitive behavior therapy and exposure with ritual prevention (ERP) simultaneously and the other received ERP separately. Pre-, post-treatment and follow-up assessments occurred for both sets of twins. RESULTS: All four individuals showed notable decreases in OCD, and results were maintained for three of the four participants at follow-up points. CONCLUSIONS: This study highlights the developmental course of OCD that can occur in cohabiting twins, and the clinical adaption that may be necessary

Electrospray mass spectrometry of NeuAc oligomers associated with the C fragment of the tetanus toxin

The Clostridial neurotoxins, botulinum and tetanus, gain entry into neuronal cells by protein recognition involving cell specific binding sites. The sialic or N-acetylneuraminic acid (NeuAc) residues of gangliosides attached to the surface of motor neurons are the suspected recognition and interaction points with Clostridial neurotoxins, although not necessarily the only ones. We have used electrospray ionization mass spectrometry (ESIMS) to examine formation of complexes between the tetanus toxin C fragment, or targeting domain, and carbohydrates containing NeuAc groups to determine how NeuAc residues contribute to ganglioside binding. ESI-MS was used to rapidly and efficiently measure dissociation constants for a number of related NeuAc-containing carbohydrates and NeuAc oligomers, information that has helped identify the structural features of gangliosides that determine their binding to tetanus toxin. The strength of the interactions between the C fragment and (NeuAc){sub n}, are consistent with the topography of the targeting domain of tetanus toxin and the nature of its carbohydrate binding sites. The results suggest that the targeting domain of tetanus toxin contains two binding sites that can accommodate NeuAc (or a dimer). This study also shows that NeuAc must play an important role in ganglioside binding and molecular recognition, a process critical for normal cell function and one frequently exploited by toxins, bacteria and viruses to facilitate their entrance into cells

Spallation Neutron Production by 0.8, 1.2 and 1.6 GeV Protons on various Targets

Spallation neutron production in proton induced reactions on Al, Fe, Zr, W, Pb and Th targets at 1.2 GeV and on Fe and Pb at 0.8, and 1.6 GeV measured at the SATURNE accelerator in Saclay is reported. The experimental double-differential cross-sections are compared with calculations performed with different intra-nuclear cascade models implemented in high energy transport codes. The broad angular coverage also allowed the determination of average neutron multiplicities above 2 MeV. Deficiencies in some of the models commonly used for applications are pointed out.Comment: 20 pages, 32 figures, revised version, accepted fpr publication in Phys. Rev.

Efficacy of exposure versus cognitive therapy in anxiety disorders: systematic review and meta-analysis

<p>Abstract</p> <p>Background</p> <p>There is growing evidence of the effectiveness of Cognitive Behavioural Therapy (CBT) for a wide range of psychological disorders. There is a continued controversy about whether challenging maladaptive thoughts rather than use of behavioural interventions alone is associated with the greatest efficacy. However little is known about the relative efficacy of various components of CBT. This review aims to compare the relative efficacy of Cognitive Therapy (CT) versus Exposure (E) for a range of anxiety disorders using the most clinically relevant outcome measures and estimating the summary relative efficacy by combining the studies in a meta-analysis.</p> <p>Methods</p> <p>Psych INFO, MEDLINE and EMBASE were searched from the first available year to May 2010. All randomised controlled studies comparing the efficacy of exposure with cognitive therapy were included. Odds ratios (OR) or standardised means' differences (Hedges' g) for the most clinically relevant primary outcomes were calculated. Outcomes of the studies were grouped according to specific disorders and were combined in meta-analyses exploring short-term and long-term outcomes.</p> <p>Results</p> <p>20 Randomised Controlled Trials with (n = 1,308) directly comparing the efficacy of CT and E in anxiety disorders were included in the meta-analysis. No statistically significant difference in the relative efficacy of CT and E was revealed in Post Traumatic Stress Disorder (PTSD), in Obsessive Compulsive Disorder (OCD) and in Panic Disorder (PD). There was a statistically significant difference favouring CT versus E in Social Phobia both in the short-term (Z = 3.72, p = 0.0002) and the long-term (Z = 3.28, p = 0.001) outcomes.</p> <p>Conclusions</p> <p>On the basis of extant literature, there appears to be no evidence of differential efficacy between cognitive therapy and exposure in PD, PTSD and OCD and strong evidence of superior efficacy of cognitive therapy in social phobia</p

When it's at: An examination of when cognitive change occurs during cognitive therapy for compulsive checking in obsessive-compulsive disorder

Abstract Background and objectives The cognitive theory of compulsive checking in OCD proposes that checking behaviour is maintained by maladaptive beliefs, including those related to inflated responsibility and those related to reduced memory confidence. This study examined whether and when specific interventions (as part of a new cognitive therapy for compulsive checking) addressing these cognitive targets changed feelings of responsibility and memory confidence. Methods Participants were nine adults with a primary or secondary diagnosis of OCD who reported significant checking symptoms (at least one hour per day) on the Yale-Brown Obsessive-Compulsive Scale. A single-case multiple baseline design was used, after which participants received 12 sessions of cognitive therapy. From the start of the baseline period through to the 1 month post-treatment follow-up assessment session, participants completed daily monitoring of feelings of responsibility, memory confidence, and their time spent engaging in compulsive checking. Results Results revealed that feelings of responsibility significantly reduced and memory confidence significantly increased from baseline to immediately post-treatment, with very high effect sizes. Multilevel modelling revealed significant linear changes in feelings of responsibility (i.e., reductions over time) and memory confidence (i.e., increases over time) occurred following the sessions when these were addressed. Finally, we found that improvements in these over the course of the treatment significantly predicted reduced time spent checking. Limitations The small sample size limits our ability to generalize our results. Conclusions Results are discussed in terms of a focus on the timing of change in cognitive therapy