Accentuating patient values in shared decision-making:A mixed methods development of an online value clarification tool and communication training in the context of early phase clinical cancer trials

Objective: In the shared decision-making (SDM) process for potential early phase clinical cancer trial participation, value clarification is highly recommended. However, exploration and discussion of patient values between patients and oncologists remains limited. This study aims to develop an SDM-supportive intervention, consisting of a preparatory online value clarification tool (OnVaCT) and a communication training. Methods: The OnVaCT intervention was developed and pilot-tested by combining theoretical notions on value clarification, with interview studies with patients and oncologists, focus groups with patient representatives and oncologists, and think aloud sessions with patients, following the Medical Research Council (MRC) framework for complex interventions. These human-centered methodologies enabled a user-centered approach at every step of the development process of the intervention. Results: This study shows relevant patient values and oncologists’ perspectives on value exploration and discussion in daily practice. This has been combined with theoretical considerations into the creation of characters based on real-life experiences of patients in the OnVaCT, and how the tool is combined with a communication training for oncologists to improve SDM.</p

Core values of patients with advanced cancer considering participation in an early-phase clinical trial: a qualitative study

Objective: This article identifies the core values that play a role in patients’ decision-making process about participation in early-phase clinical cancer trials. Methods: Face-to-face, semi-structured serial interviews (n = 22) were performed with thirteen patients with advanced cancer recruited in two Dutch specialized cancer centers. In a cyclic qualitative analysis process, open and axial coding of the interviews finally led to an overview of the values that are woven into patients’ common language about cancer and clinical trials. Results: Six core values were described, namely, acceptance creates room for reconsideration of values, reconciliation with one’s fate, hope, autonomy, body preservation, and altruism. Previously found values in advanced cancer, such as acceptance, hope, autonomy, and altruism, were further qualified. Reconciliation with one’s fate and body preservation were highlighted as new insights for early-phase clinical cancer trial literature. Conclusions: This article furthers the understanding of core values that play a role in the lives and decision-making of patients with advanced cancer who explore participation in early-phase clinical cancer trials. These values do not necessarily have to be compatible with one another, making tragic choices necessary. Understanding the role of core values can contribute to professional sensitivity regarding what motivates patients’ emotions, thoughts, and decisions and help patients reflect on and give words to their values and preferences. It supports mutual understanding and dialog from which patients can make decisions according to their perspectives on a good life for themselves and their fellows in the context of participation in an early-phase clinical cancer trial

The MARCH6-SQLE Axis Controls Endothelial Cholesterol Homeostasis and Angiogenic Sprouting

Tan et al. identify the E3-ligase MARCH6 as an important regulator of endothelial sprouting angiogenesis, owing to its ability to degrade the cholesterol biosynthetic enzyme SQLE. The study highlights that adequate SQLE levels are a critical determinant of maintaining endothelial junctions and proper sprouting angiogenesis

Relation between cytokine production and disease severity.

<p>Values are presented as medians (pg/ml) with the interquartile range. For the number of bowel resections and treatment exposure patients were dichotomized in a low and high group according to the number of resections or the percentage of years in which they were treated with steroids, thiopurines, biologicals, methotrexate or cyclosporine, corrected for disease duration. Two patients were excluded for the analysis for treatment exposure, because no complete drug history was available. TNF-α, Tumor necrosis factor alpha; IL, Interleukin; L1, ileal disease; L3, ileocolonic disease; P-, no fistulas; P+, fistulating disease.</p

Baseline characteristics of the included patients with CD and HC.

<p>CD, Crohn’s disease; HC, healthy controls; SD, standard deviation; 5-ASA, 5-aminosalicylic acid.</p><p>Baseline characteristics of the included patients with CD and HC.</p

cytokine production in healthy controls versus patients with quiescent CD.

<p>Cytokine levels (pg/ml) are presented as medians with the interquartile range [IQR]. TNF-α, Tumor necrosis factor alpha; IL, Interleukin; IQR, interquartile range; CD, Crohn's disease.</p><p>cytokine production in healthy controls versus patients with quiescent CD.</p

Primer sequences and conditions for the TNF-α promoter gene.

<p>Mg_: Magnesium concentration.</p><p>Primer sequences and conditions for the TNF-α promoter gene.</p

Cytokine production and disease characteristics.

<p>Cytokine levels (pg/ml) are presented as medians with the interquartile range [IQR]. HC, Healthy control; TNF-α, Tumor necrosis factor alpha; IL, Interleukin; L1, ileal disease; L2, colonic disease; L3, ileocolonic disease; P-, no peri-anal disease; P+, peri-anal disease; IQR, interquartile range.</p><p>Cytokine production and disease characteristics.</p