Research Spotlight

Serper, M., Parikh, N. D., Thiele, G., Ovchinsky, N., Mehta, S., Kuo, A., Ho, C., Kanwal, F., Volk, M., Asrani, S. K., Ghabril, M. S., Lake, J. R., Merriman, R. B., Morgan, T. R. and Tapper, E. B. (2022). “Patient-reported outcomes in HCC: A scoping review by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.” Hepatology.

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BACKGROUND AND AIMS: HCC is a leading cause of mortality in patients with advanced liver disease and is associated with significant morbidity. Despite multiple available curative and palliative treatments, there is a lack of systematic evaluation of patient-reported outcomes (PROs) in HCC. APPROACH AND RESULTS: The American Association for the Study of Liver Diseases Practice Metrics Committee conducted a scoping review of PROs in HCC from 1990 to 2021 to (1) synthesize the evidence on PROs in HCC and (2) provide recommendations on incorporating PROs into clinical practice and quality improvement efforts. A total of 63 studies met inclusion criteria investigating factors associated with PROs, the relationship between PROs and survival, and associations between HCC therapy and PROs. Studies recruited heterogeneous populations, and most were cross-sectional. Poor PROs were associated with worse prognosis after adjusting for clinical factors and with more advanced disease stage, although some studies showed better PROs in patients with HCC compared to those with cirrhosis. Locoregional and systemic therapies were generally associated with a high symptom burden; however, some studies showed lower symptom burden for transarterial radiotherapy and radiation therapy. Qualitative studies identified additional symptoms not routinely assessed with structured questionnaires. Gaps in the literature include lack of integration of PROs into clinical care to guide HCC treatment decisions, unknown impact of HCC on caregivers, and the effect of palliative or supportive care quality of life and health outcomes. CONCLUSION: Evidence supports assessment of PROs in HCC; however, clinical implementation and the impact of PRO measurement on quality of care and longitudinal outcomes need future investigation.

Blouin, A. G. and Askar, M. (2022). “Chimerism analysis for clinicians: a review of the literature and worldwide practices.” Bone Marrow Transplant.

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This review highlights literature pertinent to chimerism analysis in the context of hematopoietic cell transplantation (HCT). We also conducted a survey of testing practices of program members of CIBMTR worldwide. Questions included testing methods, time points, specimen type, cell lineage tested and testing indications. Recent literature suggests that detection of low level mixed chimerism has a clinical utility in predicting relapse. There is also increasing recognition of HLA loss relapse to potentially guide rescue decisions in cases of relapse. These developments coincide with wider access to high sensitivity next generation sequencing (NGS) in clinical laboratories. Our survey revealed a heterogeneity in practices as well as in findings and conclusions of published studies. Although the most commonly used method is STR, studies support more sensitive methods such as NGS, especially for predicting relapse. There is no conclusive evidence to support testing chimerism in BM over PB, particularly when using a high sensitivity testing method. Periodic monitoring of chimerism especially in diagnoses with a high risk of relapse is advantageous. Lineage specific chimerism is more sensitive than whole blood in predicting impending relapse. Further studies that critically assess how to utilize chimerism testing results will inform evidence based clinical management decisions.

Aggarwal, M., Ros, E., Allen, K., Sikand, G., Agarwala, A., Aspry, K., Kris-Etherton, P., Devries, S., Reddy, K., Singh, T., Litwin, S. E., Keefe, J. O., Miller, M., Andrus, B., Blankstein, R., Batiste, C., Belardo, D., Wenger, C., Batts, T., Barnard, N. D., White, B. A., Ornish, D., Williams, K. A., Ostfeld, R. J. and Freeman, A. M. (2022).
“Controversial Dietary Patterns: A High Yield Primer for Clinicians.” Am J Med.

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In cardiology clinic visits, the discussion of optimal dietary patterns for prevention and management of cardiovascular disease is usually very limited. Herein, we explore the benefits and risks of various dietary patterns including intermittent fasting (IF), low carbohydrate, Paleolithic, whole food plant based diet and Mediterranean dietary patterns within the context of cardiovascular disease to empower clinicians with the evidence and information they need to maximally benefit their patients.

Budhiraja, P., Kaplan, B., Kalot, M., Alayli, A. E., Dimassi, A., Chakkera, H. A., Heilman, R., Edwards, A. S. and Mustafa, R. A. (2022). “Current State of Evidence on Kidney Transplantation: How Fragile Are the Results?” Transplantation 106(2): 248-256.

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BACKGROUND: The study aims is to use the fragility index (FI) to examine the strength of evidence of randomized controlled trials (RCTs) published in the last decade on kidney transplantation. METHODS: We searched MEDLINE for studies on kidney transplantation. We included the RCTs that compared 2 groups with 1:1 randomization and reported significant P values (<0.05) for a dichotomous outcome and were published in the top 10 transplant journals. We calculated the FI; a calculation used to determine the minimum number of subjects needed to change from a nonevent to an event to make the study results nonsignificant (P ≥ 0.05). RESULTS: Fifty-seven RCTs met our inclusion criteria. The median sample size was 100 participants in each arm, the median number of events was 16 (interquartile range, 8-30) in the intervention group. Among the included trials, 79% were industry-funded, 93% involved medications, and the majority were open label. The median FI was 3 (interquartile range, 1-11). In 43% of the trials, the number of patients reported lost to follow-up was higher than or equal to the FI. Only 4% of the RCTs imputed a value for the missing dichotomous outcome. Furthermore, the median number of subjects who discontinued the trial because of adverse effects was 21, which was greater than the FI in 60% of the RCTs. CONCLUSIONS: The arbitrary classification of results into "significant" and "nonsignificant" based on P value <0.05 should perhaps be interpreted with the help of other statistical parameters and FI is one of them.

Yoon, Y.S., Whitaker, G. and Lee, Y.S. (2021). “Effects of the Configuration of Hearing Loss on Consonant Perception between Simulated Bimodal and Electric Acoustic Stimulation Hearing.” J Am Acad Audiol 32(8): 521-527.

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BACKGROUND:  Cochlear implant technology allows for acoustic and electric stimulations to be combined across ears (bimodal) and within the same ear (electric acoustic stimulation [EAS]). Mechanisms used to integrate speech acoustics may be different between the bimodal and EAS hearing, and the configurations of hearing loss might be an important factor for the integration. Thus, differentiating the effects of different configurations of hearing loss on bimodal or EAS benefit in speech perception (differences in performance with combined acoustic and electric stimulations from a better stimulation alone) is important. PURPOSE:  Using acoustic simulation, we determined how consonant recognition was affected by different configurations of hearing loss in bimodal and EAS hearing. RESEARCH DESIGN:  A mixed design was used with one between-subject variable (simulated bimodal group vs. simulated EAS group) and one within-subject variable (acoustic stimulation alone, electric stimulation alone, and combined acoustic and electric stimulations). STUDY SAMPLE:  Twenty adult subjects (10 for each group) with normal hearing were recruited. DATA COLLECTION AND ANALYSIS:  Consonant perception was unilaterally or bilaterally measured in quiet. For the acoustic stimulation, four different simulations of hearing loss were created by band-pass filtering consonants with a fixed lower cutoff frequency of 100 Hz and each of the four upper cutoff frequencies of 250, 500, 750, and 1,000 Hz. For the electric stimulation, an eight-channel noise vocoder was used to generate a typical spectral mismatch by using fixed input (200-7,000 Hz) and output (1,000-7,000 Hz) frequency ranges. The effects of simulated hearing loss on consonant recognition were compared between the two groups. RESULTS:  Significant bimodal and EAS benefits occurred regardless of the configurations of hearing loss and hearing technology (bimodal vs. EAS). Place information was better transmitted in EAS hearing than in bimodal hearing. CONCLUSION:  These results suggest that configurations of hearing loss are not a significant factor for integrating consonant information between acoustic and electric stimulations. The results also suggest that mechanisms used to integrate consonant information may be similar between bimodal and EAS hearing.