Intervention Integrity in Mindfulness-Based Research

Assessing program or intervention fidelity/integrity is an important methodological consideration in clinical and educational research. These critical variables influence the degree to which outcomes can be attributed to the program and the success of the transition from research to practice and back again. Research in the Mindfulness-Based Program (MBP) field has been expanding rapidly over the last 20 years, but little attention has been given to how to assess intervention integrity within research and practice settings. The proliferation of different program forms, inconsistency in adhering to published curriculum guides, and variability of training levels and competency of trial teachers all pose grave risks to the sustainable development of the science of MBPs going forward. Three tools for assessing intervention integrity in the MBP field have been developed and researched to assess adherence and/or teaching competence: the Mindfulness-Based Cognitive Therapy-Adherence Scale (MBCT-AS), the Mindfulness-Based Relapse Prevention-Adherence and Competence Scale (MBRP-AC), and the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC). Further research is needed on these tools to better define their inter-rater reliability and their ability to measure elements of teaching competence that are important for participant outcomes. Research going forward needs to include systematic and consistent methods for demonstrating and verifying that the MBP was delivered as intended, both to ensure the rigor of individual studies and to enable different studies of the same MBP to be fairly and validly compared with each other. The critical variable of the teaching also needs direct investigation in future research. We recommend the use of the "Template for Intervention Description and Replication" (TIDieR) guidelines for addressing and reporting on intervention integrity during the various phases of the conduct of research and provide specific suggestions about how to implement these guidelines when reporting studies of mindfulness-based programs

Physicians' communication with patients about adherence to HIV medication in San Francisco and Copenhagen: a qualitative study using Grounded Theory

BACKGROUND: Poor adherence is the main barrier to the effectiveness of HIV medication. The objective of this study was to explore and conceptualize patterns and difficulties in physicians' work with patients' adherence to HIV medication. No previous studies on this subject have directly observed physicians' behavior. METHODS: This is a qualitative, cross-sectional study. We used a Grounded Theory approach to let the main issues in physicians' work with patients' adherence emerge without preconceiving the focus of the study. We included physicians from HIV clinics in San Francisco, U.S.A. as well as from Copenhagen, Denmark. Physicians were observed during their clinical work and subsequently interviewed with a semi-structured interview guide. Notes on observations and transcribed interviews were analyzed with NVivo software. RESULTS: We enrolled 16 physicians from San Francisco and 18 from Copenhagen. When we discovered that physicians and patients seldom discussed adherence issues in depth, we made adherence communication and its barriers the focus of the study. The main patterns in physicians' communication with patients about adherence were similar in both settings. An important barrier to in-depth adherence communication was that some physicians felt it was awkward to explore the possibility of non-adherence if there were no objective signs of treatment failure, because patients could feel "accused." To overcome this awkwardness, some physicians consciously tried to "de-shame" patients regarding non-adherence. However, a recurring theme was that physicians often suspected non-adherence even when patients did not admit to have missed any doses, and physicians had difficulties handling this low believability of patient statements. We here develop a simple four-step, three-factor model of physicians' adherence communication. The four steps are: deciding whether to ask about adherence or not, pre-questioning preparations, phrasing the question, and responding to the patient's answer. The three factors/determinants are: physicians' perceptions of adherence, awkwardness, and believability. CONCLUSION: Communication difficulties were a main barrier in physicians' work with patients' adherence to HIV medication. The proposed model of physicians' communication with patients about adherence – and the identification of awkwardness and believability as key issues – may aid thinking on the subject for use in clinical practice and future research

Cortisol patterns are associated with T cell activation in HIV.

ObjectiveThe level of T cell activation in untreated HIV disease is strongly and independently associated with risk of immunologic and clinical progression. The factors that influence the level of activation, however, are not fully defined. Since endogenous glucocorticoids are important in regulating inflammation, we sought to determine whether less optimal diurnal cortisol patterns are associated with greater T cell activation.MethodsWe studied 128 HIV-infected adults who were not on treatment and had a CD4(+) T cell count above 250 cells/µl. We assessed T cell activation by CD38 expression using flow cytometry, and diurnal cortisol was assessed with salivary measurements.ResultsLower waking cortisol levels correlated with greater T cell immune activation, measured by CD38 mean fluorescent intensity, on CD4(+) T cells (r = -0.26, p = 0.006). Participants with lower waking cortisol also showed a trend toward greater activation on CD8(+) T cells (r = -0.17, p = 0.08). A greater diurnal decline in cortisol, usually considered a healthy pattern, correlated with less CD4(+) (r = 0.24, p = 0.018) and CD8(+) (r = 0.24, p = 0.017) activation.ConclusionsThese data suggest that the hypothalamic-pituitary-adrenal (HPA) axis contributes to the regulation of T cell activation in HIV. This may represent an important pathway through which psychological states and the HPA axis influence progression of HIV

Body Awareness: Construct and Self-Report Measures

OBJECTIVES:Heightened body awareness can be adaptive and maladaptive. Improving body awareness has been suggested as an approach for treating patients with conditions such as chronic pain, obesity and post-traumatic stress disorder. We assessed the psychometric quality of selected self-report measures and examined their items for underlying definitions of the construct. DATA SOURCES:PubMed, PsychINFO, HaPI, Embase, Digital Dissertations Database. REVIEW METHODS:Abstracts were screened; potentially relevant instruments were obtained and systematically reviewed. Instruments were excluded if they exclusively measured anxiety, covered emotions without related physical sensations, used observer ratings only, or were unobtainable. We restricted our study to the proprioceptive and interoceptive channels of body awareness. The psychometric properties of each scale were rated using a structured evaluation according to the method of McDowell. Following a working definition of the multi-dimensional construct, an inter-disciplinary team systematically examined the items of existing body awareness instruments, identified the dimensions queried and used an iterative qualitative process to refine the dimensions of the construct. RESULTS:From 1,825 abstracts, 39 instruments were screened. 12 were included for psychometric evaluation. Only two were rated as high standard for reliability, four for validity. Four domains of body awareness with 11 sub-domains emerged. Neither a single nor a compilation of several instruments covered all dimensions. Key domains that might potentially differentiate adaptive and maladaptive aspects of body awareness were missing in the reviewed instruments. CONCLUSION:Existing self-report instruments do not address important domains of the construct of body awareness, are unable to discern between adaptive and maladaptive aspects of body awareness, or exhibit other psychometric limitations. Restricting the construct to its proprio- and interoceptive channels, we explore the current understanding of the multi-dimensional construct and suggest next steps for further research

Acupressure to Reduce Treatment-Related Symptoms for Children With Cancer and Recipients of Hematopoietic Stem Cell Transplant: Protocol for a Randomized Controlled Trial.

BackgroundWe describe the study design and protocol of a pragmatic randomized controlled trial (RCT) Acupressure for Children in Treatment for a Childhood Cancer (ACT-CC).ObjectiveTo describe the feasibility and effectiveness of an acupressure intervention to decrease treatment-related symptoms in children in treatment for cancer or recipients of a chemotherapy-based hematopoietic stem cell transplant (HSCT).DesignTwo-armed RCTs with enrollment of 5 to 30 study days.SettingTwo pediatric teaching hospitals.PatientsEighty-five children receiving cancer treatment or a chemotherapy-based HSCT each with 1 parent or caregiver.InterventionPatients are randomized 1:1 to receive either usual care plus daily professional acupressure and caregiver delivered acupressure versus usual care alone for symptom management. Participants receive up to 20 professional treatments.Main outcomeA composite nausea/vomiting measure for the child.Secondary outcomesChild's nausea, vomiting, pain, fatigue, depression, anxiety, and positive affect.Parent outcomesDepression, anxiety, posttraumatic stress symptoms, caregiver self-efficacy, and positive affect. Feasibility of delivering the semistandardized intervention will be described. Linear mixed models will be used to compare outcomes between arms in children and parents, allowing for variability in diagnosis, treatment, and age.DiscussionTrial results could help childhood cancer and HSCT treatment centers decide about the regular inclusion of trained acupressure providers to support symptom management

Efficient Identification of HIV Serodiscordant Couples by Existing HIV Testing Programs in South Brazil.

ObjectiveTo examine the feasibility of identifying HIV negative at risk individuals in HIV serodiscordant couples, during voluntary HIV testing in South Brazil.MethodsWe surveyed HIV testers at 4 public testing sites in Rio Grande do Sul. We obtained information on risk behaviors and sexual partnerships. HIV testing and testing for recent infection were performed; HIV prevalence and risk behaviors were assessed among subjects who reported having a steady partner who was HIV positive (serodiscordant group) and compared with the general testing population.ResultsAmong 3100 patients, 490 (15.8%) reported being in a steady relationship with an HIV positive partner. New HIV infections were diagnosed in 23% of the serodiscordant group (vs. 13% in the general population, p = 0.01); among newly positive subjects, recent HIV infections were more frequent (23/86, 26.7%) among testers with positive partners than among the general testing group (52/334; 15.6%; p = 0.016). Less than half of the serodiscordant testers reported having used a condom during the last sexual intercourse with their HIV-positive partner. Participants with inconsistent condom use with steady partner were four times more likely to test positive for HIV compared to those who reported always using condoms with the steady partner (OR: 4.2; 95% CI: 2.3 to 7.5).ConclusionIt is highly feasible to identify large numbers of HIV susceptible individuals who are in HIV serodiscordant relationships in South Brazil testing sites. Condom use within HIV serodiscordant couples is low in this setting, suggesting urgent need for biomedical prevention strategies to reduce HIV transmission

Perturbed CD8+ T cell TIGIT/CD226/PVR axis despite early initiation of antiretroviral treatment in HIV infected individuals.

HIV-specific CD8+ T cells demonstrate an exhausted phenotype associated with increased expression of inhibitory receptors, decreased functional capacity, and a skewed transcriptional profile, which are only partially restored by antiretroviral treatment (ART). Expression levels of the inhibitory receptor, T cell immunoglobulin and ITIM domain (TIGIT), the co-stimulatory receptor CD226 and their ligand PVR are altered in viral infections and cancer. However, the extent to which the TIGIT/CD226/PVR-axis is affected by HIV-infection has not been characterized. Here, we report that TIGIT expression increased over time despite early initiation of ART. HIV-specific CD8+ T cells were almost exclusively TIGIT+, had an inverse expression of the transcription factors T-bet and Eomes and co-expressed PD-1, CD160 and 2B4. HIV-specific TIGIThi cells were negatively correlated with polyfunctionality and displayed a diminished expression of CD226. Furthermore, expression of PVR was increased on CD4+ T cells, especially T follicular helper (Tfh) cells, in HIV-infected lymph nodes. These results depict a skewing of the TIGIT/CD226 axis from CD226 co-stimulation towards TIGIT-mediated inhibition of CD8+ T cells, despite early ART. These findings highlight the importance of the TIGIT/CD226/PVR axis as an immune checkpoint barrier that could hinder future "cure" strategies requiring potent HIV-specific CD8+ T cells