• Title/Summary/Keyword: Non-clinical outcomes

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Improving Tuberculosis Medication Adherence: The Potential of Integrating Digital Technology and Health Belief Model

  • Mohd Fazeli Sazali;Syed Sharizman Syed Abdul Rahim;Ahmad Hazim Mohammad;Fairrul Kadir;Alvin Oliver Payus;Richard Avoi;Mohammad Saffree Jeffree;Azizan Omar;Mohd Yusof Ibrahim;Azman Atil;Nooralisa Mohd Tuah;Rahmat Dapari;Meryl Grace Lansing;Ahmad Asyraf Abdul Rahim;Zahir Izuan Azhar
    • Tuberculosis and Respiratory Diseases
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    • v.86 no.2
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    • pp.82-93
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    • 2023
  • Tuberculosis (TB) is a significant public health concern. Globally, TB is among the top 10 and the leading cause of death due to a single infectious agent. Providing standard anti-TB therapy for at least 6 months is recommended as one of the crucial strategies to control the TB epidemic. However, the long duration of TB treatment raised the issue of non-adherence. Non-adherence to TB therapy could negatively affect clinical and public health outcomes. Thus, directly observed therapy (DOT) has been introduced as a standard strategy to improve anti-TB medication adherence. Nonetheless, the DOT approach has been criticized due to inconvenience, stigma, reduced economic productivity, and reduced quality of life, which ultimately could complicate adherence issues. Apart from that, its effectiveness in improving anti-TB adherence is debatable. Therefore, digital technology could be an essential tool to enhance the implementation of DOT. Incorporating the health belief model (HBM) into digital technology can further increase its effectiveness in changing behavior and improving medication adherence. This article aimed to review the latest evidence regarding TB medication non-adherence, its associated factors, DOT's efficacy and its alternatives, and the use of digital technology and HBM in improving medication adherence. This paper used the narrative review methodology to analyze related articles to address the study objectives. Conventional DOT has several disadvantages in TB management. Integrating HBM in digital technology development is potentially effective in improving medication adherence. Digital technology provides an opportunity to improve medication adherence to overcome various issues related to DOT implementation.

Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI

  • You-Jeong Ki;Bong Ki Lee;Kyung Woo Park;Jang-Whan Bae;Doyeon Hwang;Jeehoon Kang;Jung-Kyu Han;Han-Mo Yang;Hyun-Jae Kang;Bon-Kwon Koo;Dong-Bin Kim;In-Ho Chae;Keon-Woong Moon;Hyun Woong Park;Ki-Bum Won;Dong Woon Jeon;Kyoo-Rok Han;Si Wan Choi;Jae Kean Ryu;Myung Ho Jeong;Kwang Soo Cha;Hyo-Soo Kim;HOST-RP-ACS investigators
    • Korean Circulation Journal
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    • v.52 no.4
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    • pp.304-319
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    • 2022
  • Background and Objectives: De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-ST-segment elevation ACS (NSTE-ACS). Methods: This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year. Results: Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48-0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48-2.26; p=0.915; p for interaction=0.271). Conclusions: Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results

  • Aghili, Mahdi;Sotoudeh, Sarvazad;Ghalehtaki, Reza;Babaei, Mohammad;Farazmand, Borna;Fazeli, Mohammad-Sadegh;Keshvari, Amir;Haddad, Peiman;Farhan, Farshid
    • Radiation Oncology Journal
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    • v.36 no.1
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    • pp.17-24
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    • 2018
  • Purpose: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. Materials and Methods: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. Results: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. Conclusion: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.

Influence of Maternal Environmental Tobacco Smoke Exposure Assessed by Hair Nicotine Levels on Birth Weight

  • Lee, Jungun;Lee, Dong-Ryul;Lee, Do-Hoon;Paek, Yu-Jin;Lee, Won-Chul
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.7
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    • pp.3029-3034
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    • 2015
  • Background: While the perinatal outcomes of active maternal smoking are well documented, results of the effects of environmental tobacco smoke (ETS) exposure during pregnancy are inconsistent. We aimed to examine the effect of ETS exposure, assessed by maternal hair nicotine levels at $35^{th}$ week of gestation, on birth weight and the risk of small for gestational age (SGA) and low birth weight (LBW). Materials and Methods: A total of 871 non-smoking healthy pregnant women were recruited by one Korean hospital between 1 October 2006 and 31 July 2007. Hair samples were collected and anthropometric questionnaires administered at $35^{th}$ week of gestation. The primary outcome was birth weight and secondary outcomes were the risk of babies being SGA and LBW. Results: Log-transformed hair nicotine concentrations were inversely related with birth weight after adjusting for confounding variables (${\beta}=-0.077$, p=0.037). After stratifying hair nicotine levels by tertiles (T1, low [0.0-0.28 ng/mg]; T2, medium [0.29-0.62 ng/mg]; and T3, high [0.63-5.99 ng/mg]), the mean birth weight in each groups were 3,342g (T1) 3,296g (T2) and 3,290 g (T3), respectively. However the difference between groups was not statistically significant by analysis of co-variance (ANCOVA) adjusting for covariates (p=0.062). In logistic regression analysis, the risk of SGA was higher in the T3 (OR=1.59, 95%CI 1.05-2.42) than in the reference group (T1), after controlling for confounding variables. The risk of low birth weight (<2,500g, LBW) was not significantly higher (OR=1.44, 95%CI 0.95-2.19), but the risk of babies being below 3,000g birth weight was increased in the T3 group (OR=1.53, 95%CI 1.00-2.36) compared with that in the T1 group. Conclusions: Maternal ETS exposure during pregnancy was inversely related with birth weight. The risk of SGA increased in the highest ETS exposure group compared with in the low exposure group. To prevent ETS exposure during pregnancy, more comprehensive tobacco control policies are needed.

A Randomized Comparative Study of Blind versus Ultrasound Guided Glenohumeral Joint Injection of Corticosteroids for Treatment of Shoulder Stiffness

  • Lee, Hyo-Jin;Ok, Ji-Hoon;Park, In;Bae, Sung-Ho;Kim, Sung-Eun;Shin, Dong-Jin;Kim, Yang-Soo
    • Clinics in Shoulder and Elbow
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    • v.18 no.3
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    • pp.120-127
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    • 2015
  • Background: We prospectively compared the response to blind and ultrasound-guided glenohumeral injection of corticosteroids for treatment of shoulder stiffness. Methods: A total of 77 patients with shoulder stiffness between April 2008 and March 2012 were recruited. Patients were randomized to receive either a blind (group 1, n=39) or ultrasound-guided (group 2, n=38) glenohumeral injection of 40 mg triamcinolone. The clinical outcomes and shoulder range of motion (ROM) before injection, at 3, 6, and 12 months after injection and at the last follow-up were assessed. The same rehabilitation program was applied in both groups during the follow-up period. Results: There was no significant difference in demographic data on age, sex, ROM, and symptom duration before injection between groups (p>0.05). There were no significant differences in ROM including forward flexion, external rotation at the side, external rotation at $90^{\circ}$ abduction, and internal rotation, visual analogue scale for pain and functional outcomes including American Shoulder and Elbow Surgeons score, Simple Shoulder test between the two groups at any time point (p>0.05). Conclusions: Based on the current data, the result of ultrasound-guided glenohumeral injection was not superior to that of blind injection in the treatment of shoulder stiffness. We suggest that ultrasound-guided glenohumeral injection could be performed according to the patient's compliance and the surgeon's preference. Once familiar with the non-imaging-guided glenohumeral injection, it is an efficient and reliable method for the experienced surgeon. Ultrasound could be performed according to the surgeon's preference.

Clinical outcome of conservative treatment of injured inferior alveolar nerve during dental implant placement

  • Kim, Yoon-Tae;Pang, Kang-Mi;Jung, Hun-Jong;Kim, Soung-Min;Kim, Myung-Jin;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.39 no.3
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    • pp.127-133
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    • 2013
  • Objectives: Infererior alveolar nerve (IAN) damage may be one of the distressing complications occurring during implant placement. Because of nature of closed injury, a large proportion is approached non-invasively. The purpose of this study was to analyze the outcomes of conservative management of the injured nerve during dental implant procedure. Materials and Methods: Sixty-four patients of implant related IAN injury, who were managed by medication or observation from January 1997 to March 2007 at the Department of Oral and Maxillofacial Surgery, Seoul National University Dental Hospital, were retrospectively investigated. The objective tests and subjective evaluations were performed to evaluate the degree of damage and duration of sensory disturbance recovery. Tests were performed on the day of the first visit and every two months afterward. Patient's initial symptoms, proximity of the implant to the IAN, time interval between implant surgery and the first visit to our clinic, and treatment after implant surgery were analyzed to determine whether these factors affected the final outcomes. Results: Among the 64 patients, 23 had a chief complaint of sensory disturbance and others with dysesthesia. The mean time until first visit to our hospital after the injury was 10.9 months.One year after nerve injury, the sensation was improved in 9 patients, whereas not improved in 38 patients, even 4 patients experienced deterioration. Better prognosis was observed in the group of patients with early visits and with implants placed or managed not too close to the IAN. Conclusion: Nearly 70% of patients with IAN injury during implant placement showed no improvement in sensation or dysesthesia with the conservative management. Earlier decision for active treatment needs to be considered because of possibility of deterioration of symptoms and unsatisfactory recovery.

Changes in Toxicological Characteristics after Sales of Nonprescription Drugs in Convenience Stores (안전상비의약품 판매 이후 중독환자 특성 변화)

  • Kim, Chang Yeong;Lee, Eui Jung;Lee, Sung Woo;Kim, Su Jin;Han, Kap Su
    • Journal of The Korean Society of Clinical Toxicology
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    • v.16 no.1
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    • pp.42-48
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    • 2018
  • Purpose: On November 15, 2012, sales of OTC (Over-The-Counter) drugs began at convenience stores, which changed the accessibility of some drugs. As a result, the exposure and access patterns of these drugs could have changed. In this study, we reviewed the changes in the characteristics of drug poisoning patients because of the reposition of nonprescription drugs according to the revised Pharmaceutical Affairs Act. Methods: A retrospective study was conducted to evaluate changes in characteristics of drug poisoning patients between 2008 and 2016. A registry was developed by an emergency medical center in a local tertiary teaching hospital, and patients who visited the center were enrolled in this registry. We compared two periods, from 2008 to 2012 (Pre OTC) and from 2013 to 2016 (Post OTC), for type of intoxicant, time from poisoning to visiting the emergency center, intention, psychiatric history, previous suicidal attempt, alcohol status, and emergency room outcomes. The primary outcome was the number of patients who took acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Secondary outcomes were ICU admission rate, mortality rate, and number of patients who visited the ER when the pharmacy was closed after taking acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Results: Among 1,564 patients, 945 and 619 patients visited the emergency room during pre and post OTC periods. The number of patients with acetaminophen and NSAIDs poisoning decreased from 9.2% to 6.1% (p=0.016). The ICU admission rate and mortality rate in the emergency room did not show significant results in the relevant patient groups, and so was the number of patients visiting ER when the pharmacy was closed taking acetaminophen and NSAIDs. Conclusion: Despite the sales of nonprescription drugs at convenience stores, the number of acetaminophen and NSAIDs poisoning patients decreased.

Risk Factors for Preterm Birth and Low Birth Weight Among Pregnant Indian Women: A Hospital-based Prospective Study

  • Tellapragada, Chaitanya;Eshwara, Vandana Kalwaje;Bhat, Parvati;Acharya, Shashidhar;Kamath, Asha;Bhat, Shashikala;Rao, Chythra;Nayak, Sathisha;Mukhopadhyay, Chiranjay
    • Journal of Preventive Medicine and Public Health
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    • v.49 no.3
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    • pp.165-175
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    • 2016
  • Objectives: The present study was undertaken to study the maternal risk factors for preterm birth (PTB) and low birth weight (LBW) with a special emphasis on assessing the proportions of maternal genitourinary and periodontal infections among Indian women and their association with adverse pregnancy outcomes. Methods: A hospital-based prospective study comprising 790 pregnant women visiting the obstetrics clinic for a routine antenatal check-up was undertaken. Once recruited, all study participants underwent clinical and microbiological investigations for genitourinary infections followed by a dental check-up for the presence of periodontitis. The study participants were followed up until their delivery to record the pregnancy outcomes. Infectious and non-infectious risk factors for PTB and LBW were assessed using univariate and multivariate Cox regression analysis. Independent risk factors for PTB and LBW were reported in terms of adjusted relative risk (ARR) with the 95% confidence interval (CI). Results: Rates of PTB and LBW in the study population were 7.6% and 11.4%, respectively. Previous preterm delivery (ARR, 5.37; 95% CI, 1.5 to 19.1), periodontitis (ARR, 2.39; 95% CI, 1.1 to 4.9), Oligohydramnios (ARR, 5.23; 95% CI, 2.4 to 11.5), presence of Nugent's intermediate vaginal flora (ARR, 2.75; 95% CI, 1.4 to 5.1), gestational diabetes mellitus (ARR, 2.91; 95% CI, 1.0 to 8.3), and maternal height <1.50 m (ARR, 2.21; 95% CI, 1.1 to 4.1) were risk factors for PTB, while periodontitis (ARR, 3.38; 95% CI, 1.6 to 6.9), gestational hypertension (ARR, 3.70; 95% CI, 1.3 to 10.8), maternal height <1.50 m (ARR, 2.66; 95% CI, 1.3 to 5.1) and genital infection during later stages of pregnancy (ARR, 2.79; 95% CI, 1.2 to 6.1) were independent risk factors for LBW. Conclusions: Our study findings underscore the need to consider screening for potential genitourinary and periodontal infections during routine antenatal care in developing countries.

Late Outcomes of Pediatric and Congenital Heart Disease Patients Following Cardiac Resynchronization Therapy

  • Jeong Eun Ahn;Susan Taejung Kim;Hye Won Kwon;Sang Yun Lee;Gi Beom Kim;Jae Gun Kwak;Woong Han Kim;Mi Kyoung Song;Eun Jung Bae
    • Korean Circulation Journal
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    • v.52 no.12
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    • pp.865-875
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    • 2022
  • Background and Objectives: Cardiac resynchronization therapy (CRT) is an effective treatment for heart failure. However, in pediatric and congenital heart disease (CHD) patients, current adult indications cannot be directly applied because of heterogeneity in anatomy and diagnosis. Therefore, CRT responses and clinical outcomes in these patients were investigated to derive possible candidates for CRT. Methods: This study retrospectively analyzed 16 pediatric and CHD patients who underwent CRT implantation at a single center in early (0.7±0.2 year) and late (4.7±0.3 years) follow-up period after CRT. Results: The median age at CRT implantation was 2.5 (0.3-37.2) years, and median follow-up duration was 6.3 (0.1-13.6) years. Thirteen had non-transvenous CRT. Two had congenital complete atrioventricular (AV) block with previous right ventricular pacing, 5 had dilated cardiomyopathy (DCM) with left bundle branch block, and 9 had CHD. The mean ejection fraction of the systemic ventricle increased from 28.1±10.0% to 44.3±21.0% (p=0.003) in early and 51.8±16.3% (p=0.012) in late outcome. The mean functional class improved from 3.1±0.9 to 1.8±1.1 after CRT (p=0.003). Twelve patients (75%) showed improvement in ventricular function or functional class after CRT. Proportion of responders differed between patients without CHD (2/2 patients with complete AV block and 5/5 with DCM, 100%) and those with CHD (5/9, 56%), although statistical significance was not reached (p=0.088). Conclusions: CRT improved ventricular function and functional status according to the underlying condition in pediatric and CHD patients. However, further large and longer-term studies are needed to establish the guideline for the patient selection of CRT in these patients.

Comparison of early wound healing using modified papilla preservation technique between enamel matrix derivative and recombinant human fibroblast growth factor

  • Yohei Nakayama;Shinichi Tabe;Kazuma Igarashi;Satoshi Moriya;Tsuyoshi Katsumata;Ryo Kobayashi;Shuta Nakagawa;Tomoko Nishino;Namiko Fukuoka;Kota Hosono;Mai Yamasaki;Yosuke Yamazaki;Moe Ogihara-Takeda;Shoichi Ito;Yumi Saito;Arisa Yamaguchi;Yuto Tsuruya;Mizuho Yamazaki-Takai;Shoichi Yoshino;Hideki Takai;Yorimasa Ogata
    • Journal of Periodontal and Implant Science
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    • v.54 no.4
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    • pp.236-252
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    • 2024
  • Purpose: Enamel matrix derivative (EMD) has demonstrated beneficial effects on wound healing following surgery. However, the effects of recombinant human fibroblast growth factor 2 (rhFGF-2) in periodontal regeneration therapy have not been extensively studied. This retrospective study was conducted to compare the wound healing outcomes of the modified papilla preservation technique (mPPT) between EMD and rhFGF-2 therapies. Methods: A total of 79 sites were evaluated for early wound healing using the modified early wound healing index (mEHI), which included 6 items: incision, fibrin clotting, step, redness, swelling, and dehiscence. A numeric analog scale, along with postoperative images of the 6 mEHI items, was established and used for the evaluations. The inter-rater reliability of the mEHI was assessed via intraclass correlation coefficients (ICCs). After adjusting for factors influencing the mPPT, the differences in mEHI scores between the EMD and rhFGF-2 groups were statistically analyzed. Additionally, radiographic bone fill (RBF) was evaluated 6 months after surgery. Results: The ICC of the mEHI was 0.575. The mEHI, redness score, and dehiscence scores were significantly higher in the rhFGF-2 group (n=33) than in the EMD group (n=46). Similar results were observed in the subgroup of patients aged 50 years or older, but not in those younger than 50 years. In the subgroup with non-contained bone defects, related results were noted, but not in the subgroup with contained bone defects. However, early wound healing did not correlate with RBF at 6 months after surgery. Conclusions: Within the limitations of this study, the findings suggest that early wound healing following the use of mPPT with rhFGF-2 is somewhat superior to that observed after mPPT with EMD. However, mEHI should be improved for use as a predictive tool for early wound healing and to reflect clinical outcomes after surgery.