Ramathibodi Medical Journal 2019-10-28T09:04:24+07:00 Assist. Prof. Dr. Chusak Okascharoen Open Journal Systems <p>Ramathibodi Medical Journal (RMJ) publishes article on clinical and laboratory medicine, health care policy and economics, medical education and ethics, and related topics. We welcome submissions from authors worldwide.</p> <p>ISSN 0125-3611 (Print)&nbsp;</p> <p>ISSN 2651-0561 (Online)</p> <p>Indexed in:&nbsp;&nbsp;<strong>&nbsp;&nbsp;<a title="ASEAN CITATION INDEX" href="" target="_blank" rel="noopener"><img src="/public/site/images/nuanphan_cha2/aci-logo-v41.png" width="100" height="40"></a>&nbsp; &nbsp;&nbsp;</strong><a title="ศูนย์ดัชนีการอ้างอิงวารสารไทย:Thai Citation Index (TCI) centre" href="" target="_blank" rel="noopener"><img title="tci" src="/public/site/images/tci_admin/tci.png" width="86" height="38" border="0"></a>&nbsp;&nbsp; &nbsp;<a title="Crossref" href=";container-title=Ramathibodi+Medical+Journal" target="_blank" rel="noopener"><img src="/public/site/images/nuanphan_cha2/images.png" width="77" height="50">&nbsp;</a>&nbsp; &nbsp;&nbsp;<a title="Google Scholar" href=";hl=th&amp;authuser=1" target="_blank" rel="noopener"><img src="/public/site/images/nuanphan_cha2/scholar_logo_64dp_(1).png" width="155" height="26"></a></p> Interpretation of Secondary Outcomes in Clinical Trials 2019-10-22T09:26:36+07:00 Chusak Okascharoen <p style="text-align: justify;">Recently, Fowler et al<sup>1</sup> report results of the CITRIS-ALI trial, a double-blind, placebo-controlled multicenter clinical trial in which 167 adults with sepsis and acute respiratory distress syndrome (ARDS) were randomized to receive high-dose intravenous vitamin C (50 mg/kg) or placebo every 6 hours for 96 hours. The trial was conducted among patients in the intensive care unit (ICU) with sepsis who were receiving mechanical ventilation and developed ARDS within 24 hours of ICU admission. The trial design was based on hypothesis that high-dose vitamin C administration may alleviate organ dysfunction, inflammation, and vascular injury from severe sepsis. The authors chose the primary outcomes as a change from baseline to 96 hours in the modified Sequential Organ Failure Assessment score (mSOFA) and changes from baseline to 168 hours in C-reactive protein and thrombomodulin. In addition, the authors also evaluated 43 secondary outcomes, including a variety of measures of inflammation and organ recovery.</p> <p style="text-align: justify;">Results of this trial shows that none of the primary outcomes was significantly different between treatment group and placebo group. However, 28-day all-cause mortality rates, 1 of 43 secondary outcomes, was statistically significant without adjusting for multiple comparisons (<em>P</em> = .01). The 28-day all-cause mortality rates were 29.8% in the treatment group and 46.3% in the placebo group, with a hazard ratio of 0.55 (95% CI, 0.33 - 0.90) which favoring the treatment group. This finding of significant secondary outcome raised the problem of interpretation of trial results. There are a lot of discussion in this matter in social media. Some clinicians may jump to the adoption of high-dose vitamin C and some clinicians still have question. Does administration of high-dose vitamin C in patients with sepsis with organ dysfunction confer benefit in reduction of 28-day all-cause mortality rates without significant change primary outcomes?</p> <p style="text-align: justify;">This issue is not new.<sup>2</sup> Impressive results for secondary outcomes always pose problems for clinicians trying to value the benefits observed in clinical trials. Large-scaled clinical trials consume lot of resources; man, money and time. Hence, it is typical that, in designing, investigators usually include several outcome measures to satisfy investigators and sponsors. Unrealized by most investigators, this raises the likelihood of finding a statistically significant result by chance alone increases with the number of tests undertaken.<sup>3</sup></p> <p style="text-align: justify;">The accuracy of results from secondary outcomes in clinical trials is influenced by other factors, such as the strength of the relationship between the treatment and secondary outcome, which may be very different from the strength of the relationship between the treatment and the primary outcome, as the underlying mechanisms may differ. As a result, it is common that statistical power for secondary outcomes is inadequate. In the analysis, effects or trends observed with respect to secondary outcomes should be confirmed through a properly designed, new clinical trial.<sup>4</sup></p> <p style="text-align: justify;">In summary, clinicians should not adopt a finding from significant secondary outcomes without a confirmatory study due to limitations of design and statistical analysis.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## The Performances of Multiple Scoring Systems to Predict Patients Required Immediate Life-Saving Intervention in Emergency Department 2019-10-28T09:04:24+07:00 Panvilai Tangkulpanich Noraset Uppariputtanggoon Kasamon Aramvanitch <p style="text-align: justify;"><strong>Background:</strong> Crowding in emergency room is the major problem especially in the resuscitation room. Many patients require immediate life-saving interventions (LSI). Whereas, many different scoring systems such as national early warning score (NEWS), worthing physiological scoring system (WPS), modified early warning score (MEWS), and rapid emergency medicine score (REMS) have been developed for assessing patients at risk.</p> <p style="text-align: justify;"><strong>Objective:</strong> To evaluate the effectiveness of 4 scoring systems performance in predicting LSI use in emergency room and reenter to the resuscitation room within 48 hours.</p> <p style="text-align: justify;"><strong>Methods:</strong> Data were collected by a retrospective cross-sectional study of patients treated in the resuscitation room for 2 months period, at Ramathibodi Hospital. The number of patients who received LSI and reentry to resuscitation room were studied, compared by selected scoring systems.</p> <p style="text-align: justify;"><strong>Results:</strong> Total 839 patients entered resuscitation room, while 331 (39.45%) patients received LSI. The first three groups at risk were metabolic diseases, gastrointestinal systems, and infections, respectively. The most effective scoring system in predicting patients required LSI was MEWS, the discrimination of this system was significantly better than NEWS (AUC, 0.69 vs 0.65; 95% CI, 0.65 - 0.72; <em>P</em> = .01). Eighty-six patients (13.89%) from 619 patients reentered to the resuscitation room. Moreover, NEWS was the most effective in predicting patients who had a risk of reenter (AUC, 0.72; 95% CI, 0.66 - 0.78; <em>P </em>&lt; .001).</p> <p style="text-align: justify;"><strong>Conclusions:</strong> MEWS is the most effective scoring system for patient assessment of LSI utilization. However, NEWS is the one suitable for predicting reenter tendency.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## Clinical Outcomes of Antibiotic Prophylaxis in Vaginal Delivery Women at Ramathibodi Hospital 2019-10-04T13:51:09+07:00 Sophaphan Ploungbunmee Pornsri Disorntatiwat Sommart Bumrungphuet Nitaya Rotjananirankit <p style="text-align: justify;"><strong>Background:</strong> The rate of antibiotic use of vaginal delivery women in Ramathibodi Hospital is higher than expected standard criteria. The obstetrician team has developed clinical practice guidelines for rational drug use in antibiotic prophylaxis in vaginal delivery women.</p> <p style="text-align: justify;"><strong>Objectives:</strong> To examine the relationships among the percentage of using antibiotic prophylaxis, the prevalence of rational drug use and the prevalence of the episiotomy wound infection rate in vaginal delivery women before and after using the clinical practice guidelines for antibiotic prophylaxis.</p> <p style="text-align: justify;"><strong>Methods: </strong>The sample consisted of 983 vaginal delivery women who did not in the practice guidelines and 914 joined in practice guidelines groups. The rate of antibiotic use and episiotomy wound infection were collected before and after using the clinical practice guidelines for antibiotic prophylaxis. Data were analyzed by chi-square statistics.</p> <p style="text-align: justify;"><strong>Results:</strong> The rate of antibiotic use in vaginal delivery women is significantly related to the use of the practice guidelines (<em>P</em> &lt; .01), which is reduced from 25.43% to 9.85%. The prevalence of rational drug use increased from 12.40% to 34.44%. The prevalence of episiotomy wound infection of women vaginal birth before and after using the practice guidelines was not significantly different (<em>P</em> = .96). There was no episiotomy wound infection in both groups.</p> <p style="text-align: justify;"><strong>Conclusions:&nbsp;</strong>The clinical practice guidelines reduces antibiotic use in postpartum women without episiotomy wound infection and promotes rational drug use.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## Assessment of Hearing Aids Outcomes for Patients With Hearing Loss 2019-10-04T13:51:11+07:00 Rattinan Tiravanitchakul Wannipha Chuchai Pongsakorn Lorprasert Angkana Lertpoompunya <p style="text-align: justify;"><strong>Background:</strong> Age-related hearing loss is a vital problem that impacts daily living including communication, socialization, and wellbeing. To be fitted with appropriate hearing aids can certainly improve quality of life. Therefore, it is essential to develop a set of indicators that will be used to measure hearing aids outcomes.</p> <p style="text-align: justify;"><strong>Objectives: </strong>To determine the effectiveness of hearing-aid outcomes and to examine common hearing aid problems.</p> <p style="text-align: justify;"><strong>Methods:</strong> A retrospective analysis of medical records of 634 patients receiving hearing aids services at Ramathibodi Hospital from July 2015 to June 2016, was performed. Data were collected using a data collection form and were examined by conducting descriptive analysis and paired <em>t</em> tests. Common hearing aid problems were analyzed using qualitative content analysis.</p> <p style="text-align: justify;"><strong>Results: </strong>Of 634 patients receiving hearing aids services, the average hearing thresholds and speech recognition scores among with and without hearing aids, across a range of hearing loss, were statistically significant (<em>P</em> &lt; .01). Patients’ satisfaction on hospital services, and on hearing aids were 4.64 and 4.34, respectively. Common hearing aid problems were communication strategy, hearing aid manipulation, and routine maintenance of hearing aids and/or ear molds.</p> <p style="text-align: justify;"><strong>Conclusions: </strong>Patients receiving hearing aids services from Ramathibodi Hospital reported better speech sound hearing and communication. They were satisfied with hospital services and hearing aids on defined indicators.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## Predictors of Initial Acceptance of Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients After Intensive Educational-Behavioral Program 2019-10-28T09:03:45+07:00 Janejira Pengjam Visasiri Tantrakul Worakot Suwansathit <p style="text-align: justify;"><strong>Background:</strong>&nbsp;Continuous positive airway pressure (CPAP) device therapy is the standard treatment for obstructive sleep apnea (OSA) to date. However, acceptance and adherence rate remained low. Recent study showed that educational and behavioral modification program can improve the efficacy of CPAP use.</p> <p style="text-align: justify;"><strong>Objectives: </strong>To study rate of acceptance and its predictor factors of in patients with obstructive sleep apnea after participant in group modification behavior program.</p> <p style="text-align: justify;"><strong>Methods: </strong>This prospective cohort study was conducted in 247 obstructive sleep apnea patients at Ramathibodi Sleep Disorders Center, Ramathibodi Hospital from February to July 2015. There were indicated for CPAP. Participating states spanning included awareness, motivating, demonstration, and trials of CPAP evaluated every week for 3 weeks.</p> <p style="text-align: justify;"><strong>Results:</strong> Of 247 obstructive sleep apnea patients (62% male) were included with apnea-hypopnea index (AIH) (median [interquartile range], 41.5 [46.4]), and acceptance CPAP (85%). Factors influencing decision to use CPAP were&nbsp;severity of diseases (OR, 4.1; 95% CI, 1.2 - 13.9), triple trials (OR, 8.6; 95% CI, 2.1 - 35.4), and government reimbursement (OR, 8.1; 95% CI, 2.9 - 22.4).</p> <p style="text-align: justify;"><strong>Conclusions:</strong> After educational and behavioral intervention, the CPAP acceptance rate were high among Thai patients with obstructive sleep apnea. This program should be encouraged for more widespread clinical practice.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## The Accuracy of Postpartum Blood Loss Estimation Using Plastic Collector Bag and Visual Estimation at Ramathibodi Hospital 2019-10-04T13:51:14+07:00 Sirikanya Phaikaew Sophaphan Ploungbunmee <p style="text-align: justify;"><strong>Background:</strong> Postpartum hemorrhage is a common cause of maternal death. Accurate estimation of postpartum blood loss is important to help parturients before crisis.</p> <p style="text-align: justify;"><strong>Objectives:</strong>&nbsp;To compare estimation of postpartum blood loss and proportion of postpartum hemorrhage between plastic collector bag and visual estimation.</p> <p style="text-align: justify;"><strong>Methods:</strong> This study is quasi-experimental design. Participants were 20 singleton parturients, gestational age at 34 - 40 weeks and without complications during pregnancy who delivered at Ramathibodi Hospital. <em>T</em> test was used for comparing the difference of blood loss with Fisher exact test employed for calculating the proportion of parturients postpartum hemorrhage. The Bland-Altman method was used to determine the level of agreement between methods.</p> <p style="text-align: justify;"><strong>Results:</strong> Postpartum blood loss collected via a plastic collector bag was significantly more than the visual estimation (<em>P</em> &lt; .05). The mean difference of postpartum blood loss between 2 methods was 112.25 with 95% confidence limits of agreement between -212.15 and 436.66.</p> <p style="text-align: justify;"><strong>Conclusions:</strong>&nbsp;The plastic collector bag was more accurate in blood loss assessment than visual estimation. It can provide early care and prevention of complications that may occur with parturients.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## Factors Related to Foot Care Behaviors Among Patients With Type 2 Diabetes Mellitus in Da Nang, Vietnam 2019-10-04T13:51:15+07:00 Hoang Thi Ngoc Sen Poolsuk Janepanish Visudtibhan Apinya Siripitayakunkit <p style="text-align: justify;"><strong>Background: </strong>Foot ulceration and amputation have alarmingly increased among patients with type 2 diabetes mellitus in Vietnam. Poor foot care behavior is one of the crucial reasons which leads to diabetes related foot problems. Exploration factors related to foot care behaviors among people with diabetes becomes a necessary issue to limit this complication.</p> <p style="text-align: justify;"><strong>Objective:</strong> To determine factors related to foot care behaviors among patients with type 2 diabetes mellitus.</p> <p style="text-align: justify;"><strong>Methods: </strong>The descriptive correlation study was conducted in 140 participants by purposive sampling technique in the outpatient room of Da Nang Hospital, Da Nang, Vietnam from December 2017 to January 2018. Instrument used in the study included of the six cognitive impairment test, demographic form, the Nottingham assessment of functional foot care, foot care knowledge, foot care confidence scale, and foot care subscale in the social support scale for self-care in middle-aged patients with type 2 diabetes mellitus. Data were analyzed by chi-square test, Pearson product moment correlation coefficient, and Spearman rank correlation coefficient.</p> <p style="text-align: justify;"><strong>Results:</strong> Of 140 participants, 58.6% had poor foot care behaviors. Education level, foot care knowledge, foot care self-efficacy, and social support showed a statistically significant positive correlation with foot care behaviors. There was no significant correlation between age, gender, and foot care behaviors.</p> <p style="text-align: justify;"><strong>Conclusions: </strong>The study suggested that improving foot care knowledge, foot care behaviors and enhancing the role of nurses must be implemented for the improvement of foot care behaviors among patients with type 2 diabetes mellitus.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## Tobacco Use and Domestic Violence in Thailand: Matching Case-Control Study 2019-10-28T09:03:08+07:00 Araya Ha-upala Somporn Chotivitayataragorn Ronnachai Kongsakon <p style="text-align: justify;"><strong>Background:</strong> Tobacco dependence is not only a major health risk which can be prevented, but also is a starting point to use other substances and domestic violence.</p> <p style="text-align: justify;"><strong>Objective:</strong> To study the association between tobacco use and domestic violence in Thai families.</p> <p style="text-align: justify;"><strong>Methods:</strong> The study was designed as a matched case-control study in women aged 15 years and over, living in households across the country, both in urban and rural areas, in 9 provinces of Thailand. The total of 600 participants were included in this study which half of them are from domestic abused families while the other half are from nonabused families. The criteria of age, education, economic status, housing area and region were determined. Differences between groups were performed using chi-square test and <em>t</em> test.</p> <p style="text-align: justify;"><strong>Results:</strong> Domestic violence families (55.7%) used tobacco as compared to 42% of families without violence who hadn’t used tobacco. The tobacco used families were significantly having more domestic violence 1.63 times (95% CI 1.17 - 2.29) than non-tobacco used families.</p> <p style="text-align: justify;"><strong>Conclusions:</strong> This study showed that tobacco used in the families were more likely to have domestic violence than non-used families. This could raise awareness on tobacco used to create campaigns to reduce the rate of tobacco used which causes domestic violence.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement## Three Goals of Assessment in Medical Education 2019-10-04T13:51:08+07:00 Atipong Pathanasethpong <p style="text-align: justify;">Assessment is closely connected to learning since assessment allows a learner’s current competencies to be measured. The results of such a measurement can then be used to produce learning. There are three goals for assessment in medical education: assessment of learning, assessment for learning, and assessment as learning. These three goals serve different purposes and therefore differ in how they are carried out. They also require different approaches for the assessors. It is crucial that all three goals be balanced and attained lest the testing culture wax and the learning culture wane, resulting in a situation in which learners place too much emphasis on passing the tests and not enough emphasis on learning and growing. No single method of assessment can sufficiently achieve all three goals. One comprehensive approach to achieve as well as balance all three goals is to utilize programmatic assessment, in which various methods of assessment are employed based on their strengths and how they can cover each other’s limitations.</p> 2019-09-30T00:00:00+07:00 ##submission.copyrightStatement##