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Objective@#The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial. @*Methods@#Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30–30.6 Gy in 15–17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50–50.4 Gy in 25–28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%. @*Results@#Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9–52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%–88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met. @*Conclusion@#The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.
ABSTRACT
OBJECTIVE: To assess actual rates of late vaginal stenosis and identify predisposing factors for complications among patients with previously untreated cervical cancer following high-dose-rate brachytherapy. METHODS: We performed longitudinal analyses of 57 patients using the modified Dische score at 6, 12, 18, 24, 36, and 60 months after treatment, which consisted of 15 interstitial brachytherapys and 42 conventional intracavitary brachytherapys, with a median follow-up time of 36 months (range, 6 to 144 months). RESULTS: More than half of the patients developed grade 1 (mild) vaginal stenosis within the first year of follow-up, and grade 2 (97.5%, moderate) to grade 3 (severe) stenosis gradually increased with time. Actual stenosis rates for grade 1, 2, and 3 were 97.5% (95% confidence interval [CI], 92.7 to 97.5), 60.7% (95% CI, 42.2 to 79.3), and 7.4% (95% CI, 0 to 18.4) at 3 years after treatment. Pallor reaction grade 2-3 at 6 months was only a statistically significant predisposing factor for grade 2-3 late vaginal stenosis 3 years or later with a hazard ratio of 3.48 (95% CI, 1.32 to 9.19; p=0.018) by a multivariate Cox proportional hazard model. Patients with grade 0-1 pallor reaction at 6 months showed a grade > or =2 vaginal stenosis rate of 53%, whereas the grade 2-3 pallor reaction group achieved a grade > or =2 vaginal stenosis rate at 3 years at 100% (p=0.001). CONCLUSION: High-dose-rate brachytherapy was associated with high incidence of late vaginal stenosis. Pallor reaction grade 2-3 at 6 months was predictive of late grade 2-3 vaginal stenosis at 3 years after treatment. These findings should prove helpful for patient counseling and preventive intervention.
Subject(s)
Adult , Aged , Aged, 80 and over , Female , Humans , Middle Aged , Brachytherapy/adverse effects , Constriction, Pathologic/etiology , Iridium Radioisotopes/therapeutic use , Pallor , Prognosis , Prospective Studies , Radiopharmaceuticals/therapeutic use , Retrospective Studies , Uterine Cervical Neoplasms/radiotherapy , Vaginal Diseases/etiologyABSTRACT
<b>BACKGROUND</b> : Electronic medical records (EMRs) were first introduced in the 1960s, and in Japan they are starting to become popular. Recognizing the need to adapt to a new clinical setting with EMRs, we aimed to explore which interviewing skills were associated with patient satisfaction in this era of EMR use.<br><b>METHODS</b> : A prospective observational study was conducted to evaluate interviewing skills among medical residents and to collate data on patients' satisfaction levels at an outpatient general medicine walk-in clinic at a teaching hospital in Japan. Five trained raters reviewed the video recordings of these interviews and assessed them based on a predetermined set of criteria for medical interview skills developed specifically for an outpatient EMR setting. The relationships between these assessment scores and patient satisfaction levels were analyzed.<br><b>RESULTS</b> : Significant skills that were associated with higher scores of patient satisfaction included : employed appropriate eye contact (P=0.021) ; and, invited patients directly without using a microphone (P=0.008). In addition, the degree of keyboard typing during interviews was not associated with patient satisfaction.<br><b>CONCLUSIONS</b> : In an outpatient setting with EMR, using good non-verbal communication skills to build trustful relationships with patients is more likely to influence patient satisfaction levels. Even when physicians are typing on a keyboard, if they keep appropriate eye contact during medical interviews, patient satisfaction can be improved.
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Appropriate clinical communication between patients and physicians requires better cooperation based on patientphysician rapport and consensus development through information sharing.Developing appropriate clinical communication is also important for safer and more reliable clinical care. The aim of the present study was to illustrate an effective politeness strategy for appropriate clinical communication.<BR>1) We conducted focus-group interviews and performed qualitative analysis on the basis of the results of interviews of both patients and physicians.We also performed an Internet survey and organized an Internet-based discussion ofthe politeness strategy and its effectiveness.<BR>2) Patients may consider physicians' overuse of honorifics as feigned politeness, Both patients and physicians recognize that such overuse may work against the development of rapport-based cooperation.<BR>3) Patients may expect physicians to use simpler honorifics, such as “-san.”However, by using honorifics physicians can show respect to patients and establish a more intimate relationship with patients through both positive and negative politeness strategies.<BR>4) When physicians can better understand and use local dialects, the effects of positive politeness may reduce the psychological distance between patients and physicians, have a relaxing effect on patients, and improve clinical information gathering.<BR>5) A positive politeness strategy, such as admiring and talking optimistically, may have different effects depending on the patient's condition or“face.”If successful, this strategy can contribute to the behavioral changes of patients.
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OBJECTIVE: To investigate Japanese physicians' use of dialects related to geographic areas and to elucidate how physicians respond to dialect-using patients.<BR>METHODS: We conducted a web-based open survey, to which 170 anonymous physicians reported. We examined the following 1) whether dialects are used during communication with patients; 2) how to communicate with patients using dialects; and, 3) reasons for having difficulty in communicating with patients who regularly use dialects. Geographical areas were divided into the following 8 areas Hokkaido-Tohoku, Kanto, Koshinetsu-Hokuriku, Tokai, Kinki, Chugoku, Shikoku and Kyushu-Okinawa.<BR>RESULTS: Of 170 physicians, 61.2% (95% CI: 53.4-68.5%) reported using dialects. These proportions differed by geographic area (F= 8.141; p<0.001) . Physicians practicing in Shikoku and Chugoku used dialects most frequently, while those practicing in Kanto and Hokkaido-Tohoku used dialects least frequently. Many dialect-using physicians thought that physicians should use the same dialect as dialect-using patients. In addition, dialect-using physicians were more likely to think that a physician-related factor was responsible for having difficulty in garnering clinical information.<BR>CONCLUSIONS: Use of dialects by Japanese physicians during communication with patients seems common and may differ by geographic areas. Physicians' use of dialects could be a useful tool for effective clinical communication.