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Purpose@#We evaluated the association between changes in social support after cancer treatment and recurrence-free survival (RFS) in such patients using a prospective cohort study. @*Materials and Methods@#Data were obtained from a prospective cohort study (NCT03131089) conducted at Samsung Medical Center (2013-2021). The primary outcome measure was RFS. Social support was measured using the social and family well-being (SFWB) domain of the Functional Assessment of Cancer Therapy-General. We calculated the changes in SFWB scores before and during treatment and the hazard ratio for RFS by comparing such changes. @*Results@#The mean±standard deviation (SD) age of the patients was 35±3.9 years, and 71.5% and 64.8% of the patients were married and had children, respectively. The mean±SD SFWB score at baseline was 20.5±5.0 out of 26. After cancer treatment, 35.9%, 10.3%, and 53.8% of the participants had increasing, unchanged, and decreasing SFWB scores, respectively. The decreasing SFWB score group had a higher risk of mortality or recurrence than the increasing group. Risk factors for the decreasing score were the presence of children during diagnosis. @*Conclusion@#In this cohort, changes in social support after treatment were associated with RFS in young patients with breast cancer. Health professionals should develop family interventions to help them receive proper social support.
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Background@#Currently, non-vitamin K-antagonist oral anticoagulant (NOAC) monotherapy has been suggested as the optimal antithrombotic therapy for atrial fibrillation (AF) beyond one year after coronary revascularization. The aim of this study was to compare the outcomes between NOAC monotherapy and NOAC plus antiplatelet combination therapy using realworld data. @*Methods@#Between 2015 and 2020, patients with AF who had received NOACs beyond one year after coronary revascularization were enrolled from Korean national insurance data. We emulated a pragmatic sequence of trials between the NOAC monotherapy and the antiplatelet combination therapy followed by propensity score matching. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCEs), a composite of all-cause death, myocardial infarction, and stroke. @*Results@#Among 206,407 person-trials from 4,465 individuals, we compared 3,275 pairs of the monotherapy and the matched combination therapy. During a median follow-up of 1.24 years, the incidence rate of MACCE was 19.4% and 20.0% per patient-year in the monotherapy group and the antiplatelet combination group, respectively (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.88–1.05; P = 0.422). Compared with the antiplatelet combination group, the monotherapy group had a significantly lower incidence rate of major bleeding, defined as intracranial bleeding or gastrointestinal bleeding requiring hospitalization (2.8% vs. 3.6% per patient-year; HR, 0.78; 95% CI, 0.62–0.97; P = 0.024). @*Conclusion@#As an antithrombotic therapy for AF beyond one year after coronary revascularization, NOAC monotherapy was associated with a similar risk of MACCE and a lower risk of major bleeding compared to NOAC plus antiplatelet combination therapy.
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Continuous renal replacement therapy (CRRT) has become the standard modality of renal replacement therapy (RRT) in critically ill patients. However, consensus is lacking regarding the criteria for discontinuing CRRT. Here we validated the usefulness of the prediction model for successful discontinuation of CRRT in a multicenter retrospective cohort. Methods: One temporal cohort and four external cohorts included 1,517 patients with acute kidney injury who underwent CRRT for >2 days from 2018 to 2020. The model was composed of four variables: urine output, blood urea nitrogen, serum potassium, and mean arterial pressure. Successful discontinuation of CRRT was defined as the absence of an RRT requirement for 7 days thereafter. Results: The area under the receiver operating characteristic curve (AUROC) was 0.74 (95% confidence interval, 0.71–0.76). The probabilities of successful discontinuation were approximately 17%, 35%, and 70% in the low-score, intermediate-score, and highscore groups, respectively. The model performance was good in four cohorts (AUROC, 0.73–0.75) but poor in one cohort (AUROC, 0.56). In one cohort with poor performance, attending physicians primarily controlled CRRT prescription and discontinuation, while in the other four cohorts, nephrologists determined all important steps in CRRT operation, including screening for CRRT discontinuation. Conclusion: The overall performance of our prediction model using four simple variables for successful discontinuation of CRRT was good, except for one cohort where nephrologists did not actively engage in CRRT operation. These results suggest the need for active engagement of nephrologists and protocolized management for CRRT discontinuation.
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Purpose@#We developed a comprehensive return to work (RTW) intervention covering physical, psycho-social and practical issues for patients newly diagnosed and evaluated its efficacy in terms of RTW. @*Materials and Methods@#A multi-center randomized controlled trial was done to evaluate the efficacy of the intervention conducted at two university-based cancer centers in Korea. The intervention program comprised educational material at diagnosis, a face-to-face educational session at completion of active treatment, and three individualized telephone counseling sessions. The control group received other education at enrollment. @*Results@#At 1-month post-intervention (T2), the intervention group was more likely to be working compared to the control group after controlling working status at diagnosis (65.4% vs. 55.9%, p=0.037). Among patients who did not work at baseline, the intervention group was 1.99-times more likely to be working at T2. The mean of knowledge score was higher in the intervention group compared to the control group (7.4 vs. 6.8, p=0.029). At the 1-year follow-up, the intervention group was 65% (95% confidence interval, 0.78 to 3.48) more likely to have higher odds for having work. @*Conclusion@#The intervention improved work-related knowledge and was effective in facilitating cancer patients’ RTW.
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Purpose@#Cancer antigen 15-3 (CA15-3) is a serum tumor marker for breast cancer (BC) extensively used in clinical practice. CA15-3 is non-invasive, easily available, and a costeffective tumor marker for immediate diagnosis, monitoring and prediction of BC recurrence. We hypothesized that an elevation of CA15-3 may have prognostic impact in patients with early BC with normal serum CA15-3 level. @*Methods@#This was a retrospective cohort study, which included patients with BC who received curative surgery at a comprehensive single institution between 2000 and 2016.CA15-3 levels from 0 to 30 U/mL were considered normal, and patients who had CA15-3 > 30 U/mL, were excluded from the study. @*Results@#The mean age of study participants (n = 11,452) was 49.3 years. The proportion of participants with elevated CA15-3 ≥ 1 standard deviation (SD) compared with the previous examination during follow-up was 23.3% (n = 2,666). During the follow-up (median followup 5.8 years), 790 patients experienced recurrence. The fully-adjusted hazard ratio (HR) for recurrence comparing participants with stable CA15-3 level to subjects with elevated CA15-3 level was 1.76 (95% confidence interval [CI], 1.52–2.03). In addition, if the CA15-3was elevated ≥ 1 SD, the risk was much higher (HR, 6.87; 95% CI, 5.81–8.11) than in patients without elevated CA15-3 ≥ 1 SD. In sensitivity analysis, the recurrence risk was consistently higher in participants with elevated CA15-3 levels than in participants without elevated CA15-3 levels. The association between elevated CA15-3 levels and incidence of recurrence was observed in all subtypes and the association was stronger in patients with N+ than in patients with N0 stage (p-value for interaction < 0.01). @*Conclusion@#The results of the present study demonstrated that elevation of CA15-3 in patients with early BC and initial normal serum CA15-3 levels has a prognostic impact.
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Background@#s: Fimasartan is the most recently developed, potent, and long-acting angiotensin II receptor blocker (ARB). However, data are limited regarding treatment effects of fimasartan in patients with heart failure. @*Methods@#Between 2010 and 2016, patients who underwent coronary revascularization for myocardial infarction (MI) with heart failure and prescription of ARB at hospital discharge were enrolled from the Korean nationwide medical insurance data. Clinical outcomes were compared between patients receiving fimasartan and those receiving other ARBs (candesartan, valsartan, losartan, telmisartan, olmesartan, and irbesartan). The primary outcome was a composite of all-cause death, recurrent MI, hospitalization for heart failure, and stroke. @*Results@#Of 2,802 eligible patients, fimasartan was prescribed to 124 patients (4.4%). During a median follow-up of 2.2 years (interquartile range, 1.0–3.9), 613 events of the primary outcome occurred. There was no significant difference in the primary outcome between patients receiving fimasartan and those receiving other ARBs (adjusted hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.46–1.45). Compared with patients receiving other ARBs, those receiving fimasartan had comparable incidence of all-cause death (adjusted HR, 0.70; 95% CI, 0.30–1.63), recurrent MI (adjusted HR, 1.28; 95% CI, 0.49–3.34), hospitalization for heart failure (adjusted HR, 0.70; 95% CI, 0.27–1.84), and stroke (adjusted HR, 0.59; 95% CI, 0.18–1.96). @*Conclusion@#In this nationwide cohort, fimasartan, compared with other ARBs, had comparable treatment effects for a composite of all-cause death, recurrent MI, hospitalization for heart failure, and stroke in patients with heart failure after MI.
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Purpose@#To evaluate the reliability and validity of the Cataract-related Visual Function Questionnaire (CVFQ). @*Methods@#A prospective cross-sectional study of 141 cataract patients was conducted from March 2022 to June 2022. The questionnaire was created based on a literature review and advice from an expert panel. This study determined its construct validity, criterion validity, internal consistency, and test-retest reliability. @*Results@#The CVFQ consists of 15 items distributed among five categories: overall visual quality, overall visual function, distance vision, near vision, and glare. In the exploratory factor analysis of validity, the first three principal components explained 77.8% of the variance. The p-values in the Spearman correlation test comparing the pre- and postoperative total CVFQ score and best-corrected visual acuity (BCVA) were 0.006 and 0.004, respectively. In the reliability analysis, Cronbach’s alpha was > 0.9 for internal consistency and the p-values of each subcategory were all significant in the analysis of test-retest reliability. @*Conclusions@#Our results indicate that the CVFQ is useful for measuring the visual quality and visual function of cataract patients in Korea.
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Purpose@#The purpose of the study was to validate the Korean version of Cancer Survivors’ Unmet Needs (CaSUN) scale among non–small cell lung cancer survivors. @*Materials and Methods@#Participants were recruited from outpatient clinics at the Samsung Medical Center in Seoul, South Korea, from January to October 2020. Participants completed a survey questionnaire that included the CaSUN. Exploratory and confirmatory factor analysis and Pearson’s correlations were used to evaluate the reliability and validity of the Korean version of the CaSUN (CaSUN-K). We also tested known-group validity using an independent t test or ANOVA. @*Results@#In total, 949 provided informed consent and all of which completed the questionnaire. Among the 949 patients, 529 (55.7%) were male; the mean age and median time since the end of active treatment (standard deviation) was 63.4±8.8 years and the median was 18 months. Although the factor loadings were different from those for the original scale, the Cronbach’s alpha coefficients of the six domains in the CaSUN-K ranged from 0.68 to 0.95, indicating satisfactory internal consistency. In the CFA, the goodness-of-fit indices for the CaSUN-K were high. Moderate correlations demonstrated the convergent validity of CaSUN-K with the relevant questionnaire. More than 60% of the participants reported information-related unmet needs, and the CaSUN-K discriminated between the needs reported by the different subgroups that we analyzed. @*Conclusion@#The CaSUN-K is a reliable and valid measure for assessing the unmet needs in a cancer population, thus this tool help population to receive timely, targeted, and relevant care.
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Background/Aims@#There is increasing evidence that supplementation with pre- and probiotics appears to have positive effects on irritable bowel syndrome (IBS). The aim of this study was to determine the effects of a new synbiotic formulation on gastrointestinal symptoms in elderly patients with IBS. @*Methods@#Sixty-seven IBS patients aged ≥60 years were randomly assigned to either a placebogroup (n=34) or a synbiotic group (n=33). During a 4-week intervention, subjects used a placebo or a synbiotic containing Lactobacillus paracasei DKGF1 and extracts of Opuntia humifusa once a day. Patients were evaluated with the subject global assessment, visual analog scale, and Bristol stool chart. The primary outcome was the overall responder rate and the secondary outcome was the responder rates for abdominal symptom reduction at week 4. @*Results@#Overall, responder rates were significantly higher in the synbiotic group (51.5%) than in the placebo group (23.5%) (p=0.017). Abdominal pain (58.8% vs 81.8%) and psychological wellbeing (26.4% vs 60.6%) were noticeably improved in the synbiotic group (p=0.038 and p=0.004, respectively). However, there were no significant differences in gas and bloating symptoms (p=0.88 and p=0.88, respectively). In patients with constipation-dominant and diarrhea-dominant IBS (n=16), the synbiotic significantly improved abdominal pain and defecation symptoms (responder rates for the placebo vs the synbiotic: 22.2% vs 85.7%, p=0.04). There were no adverse events in either group. @*Conclusions@#The results indicate that this new synbiotic supplement can potentially relieve abdominal symptoms in elderly IBS patients.
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Purpose@#The purpose of the study was to validate the Korean version of Patient-Reported Outcomes Measurement Information System 29 Profile v2.1 (K-PROMIS-29 V2.1) among cancer survivors. @*Materials and Methods@#Participants were recruited from outpatient clinics of the Comprehensive Cancer Center at the Samsung Medical Center in Seoul, South Korea, from September to October 2018. Participants completed a survey questionnaire that included the K-PROMIS-29 V2.1 and the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). Principal component analysis and confirmatory factor analysis (CFA) and Pearson’s correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. @*Results@#The mean age of the study participants was 54.4 years, the mean time since diagnosis was 1.2 (±2.4) years, and 349 (87.3%) completed the entire questionnaire. The Cronbach’s alpha coefficients of the seven domains in the K-PROMIS-29 V2.1 ranged from 0.81 to 0.96, indicating satisfactory internal consistency. In the CFA, the goodness-of-fit indices for the K-PROMIS-29 V2.1 were high (comparative fit index, 0.91 and standardized root-mean-squared residual, 0.06). High to moderate correlations were found between comparable subscales of the K-PROMIS-29 V2.1 and subscales of the EORTC QLQ-C30 (r=0.52-0.73). @*Conclusion@#The K-PROMIS-29 V2.1 is a reliable and valid measure for assessing the health-related quality of life domains in a cancer population, thus supporting their use in studies and oncology trials.
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Objective@#There is a growing movement to introduce Patient-Reported Outcome (PRO) to clinical settings. This study aimed to investigate the routine use of PRO in tertiary hospital clinical settings. @*Methods@#From January 2016 to December 2018, the usage status of Patient-Reported Outcome Measures (PROMs) submitted to the electronic medical record of a tertiary hospital clinical setting was investigated. Descriptive analysis was conducted to investigate the usage status of PROMs by 42 departments. Also, the most frequently used PROMs by departments, the purpose of measurement, the use rate of verified PROMs were investigated. @*Results@#The PROMs accounted for 66% (98) of the 148 Instruments. Of the 98 PROMs, 64% (63) were using a validation Korean version of PROMs. Only about 1% of total outpatient visits applied PROMs, and among them, it was frequently used in urology (13%), orthopedics (8%), and otolaryngology (5%). The use rate of the validated PROMs was found to be 64%. Conclusions: The use of PROMs in domestic clinical settings was found to be very limited and frequently used only in specific departments. It is essential to use a PROMs that has been validated according to guidelines, as the use of validated PROMs will provide beneficial information to health professionals and also for the patient health improvement by objectively measuring the patient's health status.
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This study was conducted as a pilot project to evaluate the feasibility of building an integrate dementia platform converging preexisting dementia cohorts from several variable levels. The following four cohorts were used to develop this pilot platform: 1) Clinical Research Center for Dementia of South Korea (CREDOS), 2) Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer’s disease (K-BASE), 3) Environmental Pollution-induced Neurological Effects (EPINEF) study, and 4) a prospective registry in Dementia Platform Korea project (DPKR). A total of 29916 patients were included in the platform with 348 integrated variables. Among participants, 13.9%, 31.5%, and 44.2% of patients had normal cognition, mild cognitive impairment, and dementia, respectively. The mean age was 72.4 years. Females accounted for 65.7% of all patients. Those with college or higher education and those without problems in reading or writing accounted for 12.3% and 46.8%, respectively. Marital status, cohabitation, family history of Parkinson’s disease, smoking and drinking status, physical activity, sleep status, and nutrition status had rates of missing information of 50% or more. Although individual cohorts were of the same domain and of high quality, we found there were several barriers to integrating individual cohorts, including variability in study variables and measurements. Although many researchers are trying to combine pre-existing cohorts, the process of integrating past data has not been easy. Therefore, it is necessary to establish a protocol with considerations for data integration at the cohort establishment stage.
ABSTRACT
Nonpharmaceutical interventions (e.g., social distancing) are recommended to prevent the spread of respiratory viruses. However, few epidemiological studies have assessed whether social distancing in actual settings reduces the disease burden of severe acute respiratory infections (SARIs) in the general population. Accordingly, we aimed to assess associations between nationwide social distancing for coronavirus disease 2019 (COVID-19) and non-COVID-19 SARIs. We collected data on SARI epidemiologic characteristics recorded from January 2018 through December 2020 from the nationwide sentinel SARI surveillance data maintained by the Korea Disease Control and Prevention Agency. The number of SARIs per 1000 hospitalized patients decreased significantly to 18.61, 18.15, and 6.25 in 2018, 2019, and 2020 (p<0.001), respectively, during the surveillance period of 3 years. The number of intensive care unit admissions associated with SARIs per 1000 hospitalized patients was 0.83, 0.69, and 0.54 in 2018, 2019, and 2020 (p< 0.001), respectively, and the number of SARI-associated mortalities per 1000 patients was 0.42, 0.29, and 0.27 in 2018, 2019, and 2020 (p<0.001), respectively. Moreover, SARIs had two peak seasons in 2 years of the surveillance period (2018 and 2019). However, seasonality was not observed since social distancing was initiated. Our sentinel surveillance data demonstrated a remarkable reduction in SARI disease burden and a change in seasonality following the implementation of nationwide social distancing. Accordingly, we suggest that social distancing could be effective in forthcoming seasonal epidemics of non-COVID-19 origin, although the impact thereof on other aspects of society needs to be carefully considered.
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Purpose@#In this study, we examined the impact of reconstruction using tissue expander insertion (TEI) on the risk of radiation dermatitis in patients undergoing postmastectomy radiotherapy (PMRT). @*Methods@#Between August 2015 and March 2019, patients with breast cancer who had received systemic chemotherapy and PMRT were prospectively included. Skin parameters, including melanin, erythema, hydration, sebum, and elasticity, were measured using a multiprobe instrument at 6 time points: before the initiation of radiotherapy (pre-RT), at weeks 1, 3, and 5 during radiotherapy (weeks 1–5), and 1 and 3-month after radiotherapy (post-RT-1m and post-RT-3m). Patient-reported outcomes (PROs) were assessed at each time point.Changes in biophysical parameters and PRO were compared between patients with and without TEI (TEI+ vs. TEI−). @*Results@#Thirty-eight patients, including 18 with TEI+ and 20 with TEI-, were analyzed. The pattern of time-course changes in biophysical parameters and PRO did not differ between TEI+ and TEI− patients. The melanin index was highest at post-RT-1m, while the erythema index was highest at week 5. At post-RT-3m, TEI+ patients presented higher melanin values than TEI- patients, with no statistical significance (coefficient, 47.9 vs. 14.2%; p = 0.07). In all patients, water content decreased throughout the measurement period. At post-RT-3m, TEI+ patients demonstrated a further decrease in water content, while the TEI- group nearly recovered the water content to pre-RT status (coefficient, −17.1, −2.5; p = 0.11). The sebum and elasticity levels were not altered by TEI. @*Conclusion@#In patients undergoing PMRT, TEI did not significantly affect the changing patterns of skin biophysical parameters and PRO during radiotherapy.
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Background@#The purpose of the study was to translate and linguistically validate a Korean language version of the PROMIS (K-PROMIS) for the six profile adult domains: Fatigue, Pain Intensity, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. @*Methods@#A total of 268 items were translated into Korean according to the Functional Assessment of Chronic Illness Therapy multilingual translation methodology. Participants first completed approximately 27 to 35 items and were then interviewed to evaluate the conceptual equivalence of the translation to the original English language source.The K-PROMIS items that met the a priori threshold of ≥ 20% of respondents with comprehension difficulties in the cognitive interview. @*Results@#54 of the 268 items were identified as difficult items to comprehend for at least 20% of respondents in Round 1. The most frequently identified K-PROMIS domain on difficult items to comprehend was the Physical function (24.5%). Most items with linguistic difficulties were Fatigue and Physical function. Cultural difficulties were only included the Physical function and Ability to Participate in Social Roles and Activities domains. 25 of 54 items were slightly revised, and then these revised items were tested with additional six participants in Round 2, and most participants had no problems to understand modified items. @*Conclusion@#The six profile adult domains of K-PROMIS have been linguistically validated.Further psychometric validation of the K-PROMIS items will provide additional information of meaningful outcomes for chronic disease and clinical setting.
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Background/Aims@#Proton pump inhibitors (PPIs) increase gastric pH and alter the gut microbiome. An increased risk for infectious diseases has been reported in PPI users. However, little is known about the association of PPI use with pyogenic liver abscess (PLA) incidence risk. @*Methods@#We conducted a population-based cohort study using data from a nationwide representative sample of the Korean general population followed up for 10 years (January 1, 2003 to December 31, 2013). We identified PPI prescriptions and considered PPI as a timevarying variable. Proportional hazards regression model was used for incident PLA comparing PPI use versus non-use. Propensity score matching was also conducted. @*Results@#During the 4 209 229 person-years of follow-up, 58 595 participants had at least 1 PPI prescription and 541 patients developed liver abscess. The age-, sex-, residential area-, and income-adjusted hazard ratio for PLA incidence with PPI use was 4.19 (95% CI, 2.54-6.92). The association was observed in fully adjusted models (hazard ratio 3.88; 95% CI, 2.33-6.44). The positive association between PPI use and PLA was consistent in all subgroups analyzed and in propensity score matching group. @*Conclusion@#The present data indicate that PPI use is associated with an increased PLA risk. Therefore, it is necessary to prescribe PPIs with clear indication and to avoid improper use of PPIs.
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This study was conducted as a pilot project to evaluate the feasibility of building an integrate dementia platform converging preexisting dementia cohorts from several variable levels. The following four cohorts were used to develop this pilot platform: 1) Clinical Research Center for Dementia of South Korea (CREDOS), 2) Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer’s disease (K-BASE), 3) Environmental Pollution-induced Neurological Effects (EPINEF) study, and 4) a prospective registry in Dementia Platform Korea project (DPKR). A total of 29916 patients were included in the platform with 348 integrated variables. Among participants, 13.9%, 31.5%, and 44.2% of patients had normal cognition, mild cognitive impairment, and dementia, respectively. The mean age was 72.4 years. Females accounted for 65.7% of all patients. Those with college or higher education and those without problems in reading or writing accounted for 12.3% and 46.8%, respectively. Marital status, cohabitation, family history of Parkinson’s disease, smoking and drinking status, physical activity, sleep status, and nutrition status had rates of missing information of 50% or more. Although individual cohorts were of the same domain and of high quality, we found there were several barriers to integrating individual cohorts, including variability in study variables and measurements. Although many researchers are trying to combine pre-existing cohorts, the process of integrating past data has not been easy. Therefore, it is necessary to establish a protocol with considerations for data integration at the cohort establishment stage.
ABSTRACT
Nonpharmaceutical interventions (e.g., social distancing) are recommended to prevent the spread of respiratory viruses. However, few epidemiological studies have assessed whether social distancing in actual settings reduces the disease burden of severe acute respiratory infections (SARIs) in the general population. Accordingly, we aimed to assess associations between nationwide social distancing for coronavirus disease 2019 (COVID-19) and non-COVID-19 SARIs. We collected data on SARI epidemiologic characteristics recorded from January 2018 through December 2020 from the nationwide sentinel SARI surveillance data maintained by the Korea Disease Control and Prevention Agency. The number of SARIs per 1000 hospitalized patients decreased significantly to 18.61, 18.15, and 6.25 in 2018, 2019, and 2020 (p<0.001), respectively, during the surveillance period of 3 years. The number of intensive care unit admissions associated with SARIs per 1000 hospitalized patients was 0.83, 0.69, and 0.54 in 2018, 2019, and 2020 (p< 0.001), respectively, and the number of SARI-associated mortalities per 1000 patients was 0.42, 0.29, and 0.27 in 2018, 2019, and 2020 (p<0.001), respectively. Moreover, SARIs had two peak seasons in 2 years of the surveillance period (2018 and 2019). However, seasonality was not observed since social distancing was initiated. Our sentinel surveillance data demonstrated a remarkable reduction in SARI disease burden and a change in seasonality following the implementation of nationwide social distancing. Accordingly, we suggest that social distancing could be effective in forthcoming seasonal epidemics of non-COVID-19 origin, although the impact thereof on other aspects of society needs to be carefully considered.
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Purpose@#In this study, we examined the impact of reconstruction using tissue expander insertion (TEI) on the risk of radiation dermatitis in patients undergoing postmastectomy radiotherapy (PMRT). @*Methods@#Between August 2015 and March 2019, patients with breast cancer who had received systemic chemotherapy and PMRT were prospectively included. Skin parameters, including melanin, erythema, hydration, sebum, and elasticity, were measured using a multiprobe instrument at 6 time points: before the initiation of radiotherapy (pre-RT), at weeks 1, 3, and 5 during radiotherapy (weeks 1–5), and 1 and 3-month after radiotherapy (post-RT-1m and post-RT-3m). Patient-reported outcomes (PROs) were assessed at each time point.Changes in biophysical parameters and PRO were compared between patients with and without TEI (TEI+ vs. TEI−). @*Results@#Thirty-eight patients, including 18 with TEI+ and 20 with TEI-, were analyzed. The pattern of time-course changes in biophysical parameters and PRO did not differ between TEI+ and TEI− patients. The melanin index was highest at post-RT-1m, while the erythema index was highest at week 5. At post-RT-3m, TEI+ patients presented higher melanin values than TEI- patients, with no statistical significance (coefficient, 47.9 vs. 14.2%; p = 0.07). In all patients, water content decreased throughout the measurement period. At post-RT-3m, TEI+ patients demonstrated a further decrease in water content, while the TEI- group nearly recovered the water content to pre-RT status (coefficient, −17.1, −2.5; p = 0.11). The sebum and elasticity levels were not altered by TEI. @*Conclusion@#In patients undergoing PMRT, TEI did not significantly affect the changing patterns of skin biophysical parameters and PRO during radiotherapy.
ABSTRACT
Background@#The purpose of the study was to translate and linguistically validate a Korean language version of the PROMIS (K-PROMIS) for the six profile adult domains: Fatigue, Pain Intensity, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. @*Methods@#A total of 268 items were translated into Korean according to the Functional Assessment of Chronic Illness Therapy multilingual translation methodology. Participants first completed approximately 27 to 35 items and were then interviewed to evaluate the conceptual equivalence of the translation to the original English language source.The K-PROMIS items that met the a priori threshold of ≥ 20% of respondents with comprehension difficulties in the cognitive interview. @*Results@#54 of the 268 items were identified as difficult items to comprehend for at least 20% of respondents in Round 1. The most frequently identified K-PROMIS domain on difficult items to comprehend was the Physical function (24.5%). Most items with linguistic difficulties were Fatigue and Physical function. Cultural difficulties were only included the Physical function and Ability to Participate in Social Roles and Activities domains. 25 of 54 items were slightly revised, and then these revised items were tested with additional six participants in Round 2, and most participants had no problems to understand modified items. @*Conclusion@#The six profile adult domains of K-PROMIS have been linguistically validated.Further psychometric validation of the K-PROMIS items will provide additional information of meaningful outcomes for chronic disease and clinical setting.