American Journal of Kidney Diseases最新文献

Rationale & objective: Valid measures of side effects are important to inform clinical use of calcineurin inhibitors (CNIs). This study sought to develop and establish the content validity of a PRO measure to capture side effects among kidney transplant recipients taking CNIs.

Study design: Qualitative interviews for concept elicitation and cognitive debriefing.

Setting & participants: Participants enrolled in the qualitative study were adults who received a kidney transplant ≤5 years earlier and were currently taking a CNI for immunosuppression.

Analytical approach: Concept elicitation interview data were analyzed by developing a codebook from a list of symptoms described by participants that they attributed to CNIs or their immunosuppression regimen and by applying the constant comparative approach separately by two coders. The most bothersome and important side effects reported by participants were used to select existing PRO items. Cognitive debriefing examined item comprehensibility, comprehensiveness, and relevance.

Results: Among 24 participating patients, 12 underwent concept elicitation interviews. Most (n=10) participants reported neurological or cognitive CNI side effects and a majority of those (n=6) reported that neurological and cognitive side effects were the most bothersome adverse consequences of therapy. Based on these findings, 16 items were either selected from the Functional Assessment for Chronic Illness Therapy (FACIT) PRO item library or were newly written. These items were refined and reduced to 13 for cognitive debriefing that was completed by 18 participants. These items were organized into two scales: Tremors and Cognitive Side Effects.

Limitations: Though a diverse set of patients participated, they were not representative of all recipients of kidney transplants. The PRO's reliability, convergent and known-groups validity, and responsiveness to change were not evaluated. Symptoms could not be definitively attributed to CNIs.

Conclusions: A newly developed PRO measure, the Functional Assessment of Chronic Illness Therapy-Calcineurin Inhibitor-Neurotoxicity (FACIT-CNI-Ntx), captures important side effects among patients receiving CNIs.

Rationale & objective: Sharing Patient's Illness Representations to Increase Trust (SPIRIT) is an evidence-based advance care planning intervention targeting dialysis patients and their surrogate decision-makers. To address SPIRIT's implementation potential, we report on a process evaluation in our recently completed five-state cluster-randomized trial.

Study design: A descriptive study of implementation within a randomized clinical trial.

Setting & participants: 231 patient-surrogate dyads and 60 dialysis care providers in the 22 active intervention clinics.

Exposure: Status as a patient/surrogate, care provider, or care provider "champion" who all were randomized to clinics implementing the SPIRIT implementation. OUTCOME(S): (1) Intervention reach (e.g., number of dyads who received SPIRIT relative to each clinic's census); (2) fidelity (e.g., champions' self-evaluation checklists, patient and surrogate surveys); (3) sustainability (patient, surrogate and dialysis care provider acceptability surveys); and (4) context (e.g., clinic characteristics).

Results: 191 (82.7%) completed SPIRIT session 1 and 146 (76.4% of 191) completed the optional session 2. Of the 40 champions, 34 completed at least one SPIRIT session 1. Champions reported that all six intervention steps were completed in 98% to 100% of their sessions. The median duration of session 1 and session 2 were 60 minutes and 15 minutes, respectively. The acceptability surveys suggested a high-level of acceptance by patients, surrogates, and providers. Champions reported the main benefits of SPIRIT to be enhanced learning; communication; and improved relationships for patients, surrogates, and providers. The challenges champions reported were scheduling a time that worked for the patient, surrogate, and champion; feeling torn between SPIRIT and other clinical demands; and the emotional burden on the champions themselves.

Limitations: The lack of data on actual continued use of SPIRIT and low provider participation in acceptability survey.

Conclusions: This study suggests that SPIRIT was delivered with high fidelity and was experienced positively by stakeholders. However, challenges such as staffing and emotional burden required clinic-level support and warrant future studies testing implementation strategies to address these barriers.