Implementation of Molecular Autopsy for Sudden Cardiac Death in Japan　- Focus Group Study of Stakeholders.

BACKGROUND: We assessed the awareness of multidisciplinary healthcare professionals of the challenges related to implementation of molecular autopsy (MA) for sudden cardiac death (SCD) among children and young adults.Methods and Results: We conducted 11 focus groups with 31 multidisciplinary healthcare professionals, and categorized them into 2 themes: values, and challenges of MA implementation. The participants recognized 2 different values of MA: discovering the unknown cause of SCD, and SCD prevention among family members of victims. The coexistence of these values makes the MA process and role of professionals more complex. Participants were concerned about the psychological burden for bereaved family members and mentioned challenges in each process of the MA delivery system: obtaining consent, cause of death investigation, disclosing results, and preventive intervention. CONCLUSIONS: MA is a valuable procedure both in terms of forensic and preventive medicine. However, the dual meanings and complex characteristics of genetic information is a potential source of concern and confusion among healthcare professionals as well as bereaved family members. Increasing awareness among healthcare professionals of the MA process is essential for connecting all related areas of expertise.

Temporal Validation of an Assessment Tool that Predicts a Possibility of Home Discharge for Patients with Acute Stroke.

OBJECTIVES: Several prediction models have been developed to assess discharge destinations for patients with acute stroke; however, few studies have performed external validation. We aimed to perform a temporal external validation of a prediction tool to identify stroke patients with a high possibility of discharge to home. MATERIALS AND METHODS: From December 2017 to July 2019, consecutive patients with acute stroke were included. Clinical nurses and physical therapists applied the prediction model to assess the patients' possibility of home discharge. Whether or not the patient was discharged their own home was the outcome measured. We calculated the sensitivity and specificity of the model and evaluated the discrimination and calibration based on the area under the curve (AUC) and the calibration plot. RESULTS: Of the 1214 patients assessed, 618 (51%) were discharged home. Using the same cutoff values recommended in the study that first described the tool, we determined the sensitivity and specificity of 91% and 59%, respectively. The AUC to assess the model discrimination was 0.80 (95% confidence interval, 0.77-0.82) and the calibration plot showed acceptable agreement between the predicted and observed outcomes. CONCLUSIONS: The tool showed a high sensitivity, as expected, in the present study, which examined external validity during the different study periods.

Comprehensive genomic profiling for patients with chemotherapy-naïve advanced cancer.

Comprehensive genomic profiling (CGP) testing by next-generation sequencing has been introduced into clinical practice as part of precision cancer medicine to select effective targeted therapies. However, whether CGP testing at the time of first-line chemotherapy could be clinically useful is not clear. We conducted this single-center, prospective, observational study to investigate the feasibility of CGP testing for chemotherapy-naïve patients with stage III/IV gastrointestinal cancer, rare cancer, and cancer of unknown primary, using the FoundationOne® companion diagnostic (F1CDx) assay. The primary outcome was the detection rate of at least one actionable/druggable cancer genomic alteration. Actionable/druggable cancer genomic alterations were determined by the F1CDx report. An institutional molecular tumor board determined the molecular-based recommended therapies. A total of 197 patients were enrolled from October 2018 to June 2019. CGP success rate was 76.6% (151 of 197 patients), and median turnaround time was 19 days (range: 10-329 days). Actionable and druggable cancer genomic alterations were reported in 145 (73.6%) and 124 (62.9%) patients, respectively. The highest detection rate of druggable genomic alterations in gastrointestinal cancers was 80% in colorectal cancer (48 of 60 patients). Molecular-based recommended therapies were determined in 46 patients (23.4%). CGP testing would be a useful tool for the identification of a potentially effective first-line chemotherapy.

Longest survival by the combination of radiation-therapy and resection in patient with metastatic spinal paragangliomas from primary-neck lesion with succinate dehydrogenase subunit B (SDHB) mutation.

Metastatic paraganglioma (MPG) of the spine is a rare condition, with no established management. Herein, we report the longest survival case of a primary neck tumor that caused spinal MPG with a succinate dehydrogenase subunit B (SDHB) mutation (c.470delT, p.L157X) which could have promoted its malignancy. This male patient initially presented with a left neck PG which was diagnosed by a biopsy when he was 54 years-old. Simultaneously performed additional examinations revealed the spinal metastatic tumors on the T5-7 vertebrae and L3 vertebra-sacrum. These primary neck and metastatic spinal tumors' growths were once suppressed under the radiation therapy. Nineteen years later, he developed acute progressive paraparesis due to a mass located at the T2-3 level, tightly compressing the spinal cord, and protruding into the left thoracic cavity. We resected the maximum possible area of tumor in the spinal canal, confirmed MPG by histological examination, and then, we administered radiation therapy of 40 Gy in 20 fractions. Eventually, the patient was able to walk unaided with no evidential tumor recurrence for 3 years after treatment. Generally, clinical feature of MPG with SDHB mutation from abdominal lesion is thought to be poor prognosis. However, our case suggests the possibility of long-term control of spinal MPG with the adequate combination of radiation therapy and resection if metastatic lesions from primary-neck lesion with an SDHB mutation are remained to spine.

Clinical significance of TP53 variants as possible secondary findings in tumor-only next-generation sequencing.

In tumor-only next-generation sequencing (NGS), identified variants have the potential to be secondary findings (SFs), but they require verification through additional germline testing. In the present study, 194 patients with advanced cancer who underwent tumor-only NGS between April 2015 and March 2018 were enrolled, and the incidences of possible and true SFs were evaluated. Among them, 120 patients (61.9%) harbored at least one possible SF. TP53 was the most frequent gene in which 97 variants were found in 91 patients (49.5%). Nine patients provided informed consent to undergo additional germline testing, and a total of 14 variants (BRCA1, n = 1; BRCA2, n = 2; PTEN, n = 2; RB1, n = 1; SMAD4, n = 1; STK11, n = 1; TP53, n = 6) were analyzed. Three variants (BRCA1, n = 1; BRCA2, n = 2) were confirmed to be SFs, whereas TP53 variants were confirmed to be somatic variants. To confirm the low prevalence of SFs in TP53, we analyzed 24 patients with TP53 variants who underwent a paired tumor-normal NGS assay. As expected, all TP53 variants were confirmed to be somatic variants. A total of 30 patients were tested for germline variants in TP53, but none of them resulted in true SFs, suggesting the low prevalence of SFs in this gene. Therefore, the significance of additional germline testing for TP53 variants appears to be relatively low in daily clinical practice using a tumor-only NGS assay, unless patients have any relevant medical or family history.

Salvage gamma knife radiosurgery for active brain metastases from small-cell lung cancer after whole-brain radiation therapy: a retrospective multi-institutional study (JLGK1701).

PURPOSE: To evaluate the efficacy of gamma knife radiosurgery (GKS) for brain metastases (BMs) from small-cell lung cancer after whole-brain radiotherapy (WBRT). METHODS: We retrospectively analyzed the usefulness and safety of GKS in 163 patients from 15 institutions with 1-10 active BMs after WBRT. The usefulness and safety of GKS were evaluated using statistical methods. RESULTS: The median age was 66 years, and 79.1% of patients were men. The median number and largest diameter of BM were 2.0 and 1.4 cm, respectively. WBRT was administered prophylactically in 46.6% of patients. The median overall survival (OS) was 9.3 months, and the neurologic mortality was 20.0%. Crude incidences of local control failure and new lesion appearance were 36.6% and 64.9%, respectively. A BM diameter ≥ 1.0 cm was a significant risk factor for local progression (hazard ratio [HR] 2.556, P = 0.039) and neurologic death (HR 4.940, P = 0.031). Leukoencephalopathy at the final follow-up was more prevalent in the therapeutic WBRT group than in the prophylactic group (P = 0.019). The symptom improvement rate was 61.3%, and neurological function was preserved for a median of 7.6 months. Therapeutic WBRT was not a significant risk factor for OS, neurological death, local control, or functional deterioration (P = 0.273, 0.490, 0.779, and 0.560, respectively). Symptomatic radiation-related adverse effects occurred in 7.4% of patients. CONCLUSIONS: GKS can safely preserve neurological function and prevent neurologic death in patients with 1-10 small, active BMs after prophylactic and therapeutic WBRT.

Evaluation of new lesions and symptoms after gamma knife radiosurgery for brain metastases: a retrospective cohort study.

BACKGROUND: Symptomatic new lesions that appear after gamma knife radiosurgery (GKRS) for brain metastases have not been thoroughly described. METHODS: Among 238 patients who underwent a single session of GKRS without whole-brain radiotherapy or surgery for brain metastases between 2009 and 2014, a total of 165 (69.3%) patients underwent follow-up magnetic resonance imaging (MRI). Their electrical health records were reviewed retrospectively. The median age was 68 years, and 62.4% patients were men. The median number of brain metastases was 2. The most frequent primary organ site was the lung (71.5%). Then, we evaluated predictors for the symptoms of new lesions. RESULTS: New lesions and leptomeningeal dissemination were observed in 101 (61.2%) and 23 (14.2%) patients, respectively. The median number of new lesions was 2; moreover, 20 of 101 patients (19.8%) with new lesions had tumours with the largest diameters of > 1 cm. Among 101 patients with new lesions, 13 were symptomatic (12.9%). Patients with larger new lesions (> 1 cm of the largest diameter) experienced symptoms more frequently (odds ratio 7.6, P < 0.01). Symptoms resolved after salvage GKRS in seven of 11 patients who abided by the recommended follow-up MRI schedule. No significant risk factors were found for symptoms of new lesions. CONCLUSIONS: The incidence of symptomatic new lesions that appeared after GKRS was low, and more than half of the patients showed improvements in their symptoms after salvage GKRS. However, careful MRI-based assessments and salvage GKRS are critical for the quality of life.

Assessment Model to Identify Patients With Stroke With a High Possibility of Discharge to Home: A Retrospective Cohort Study.

BACKGROUND AND PURPOSE: Discharge planning for inpatients with acute stroke can enhance reasonable use of healthcare resources, as well as improve clinical outcomes and decrease financial burden of patients. Especially, prediction for discharge destination is crucial for discharge planning. This study aimed to develop an assessment model to identify patients with a high possibility of discharge to home after an acute stroke. METHODS: We reviewed the electronic medical records of 3200 patients with acute stroke who were admitted to a stroke center in Japan between January 1, 2011, and December 31, 2015. The outcome variable was the discharge destination of postacute stroke patients. The predictive variables were identified through logistic regression analysis. Data were divided into 2 data sets: the learning data set (n=2240) for developing the instrument and the test data set (n=960) for evaluating the predictive capability of the model. RESULTS: In all, 1548 (48%) patients were discharged to their homes. Multiple logistic regression analysis identified 5 predictive variables for discharge to home: living situation, type of stroke, functional independence measure motor score on admission, functional independence measure cognitive score on admission, and paresis. The assessment model showed a sensitivity of 85.0% and a specificity of 75.3% with an area under the curve equal to 0.88 (95% confidence interval, 0.86-0.89) when the cutoff point was 10. On evaluating the predictive capabilities, the model showed a sensitivity of 88.0% and a specificity of 68.7% with an area under the curve equal to 0.87 (95% confidence interval, 0.85-0.89). CONCLUSIONS: We have developed an assessment model for identifying patients with a high possibility of being discharged to their homes after an acute stroke. This model would be useful for health professionals to adequately plan patients' discharge soon after their admission.

Serum 1,5-Anhydroglucitol: Risk Factor of Acute Ischemic Stroke and Transient Ischemic Attack in Well-Controlled Diabetes.

BACKGROUND: Serum 1,5-anhydroglucitol (1,5-AG) levels are a measure that provides information on daily glycemic variations. We evaluated whether 1,5-AG could be a possible marker of acute ischemic stroke (AIS) or transient ischemic attacks (TIA) in patients with diabetes mellitus (DM). METHODS: We retrospectively reviewed electronic medical records of 5,294 AIS/TIA patients. Of the 5,294, 1,898 had diabetes and in 1,246, serum 1,5-AG levels were measured (group S). Group S was divided into 2 subgroups: hemoglobin A1c (HbA1c) <7% (S-low) and >7% (S-high). As controls, 394 outpatients with diabetes (group C) without AIS/TIA were likewise divided into subgroups, C-low and C-high according to HbA1c level. In each HbA1c subgroup, the association between serum 1,5-AG (≥14 vs. <14 µg/mL) and stroke was examined using multivariable logistic regression (MLR) with stepwise variable selection. In model 1, the OR and 95% CI was examined adjusted for age and gender. Known risk factors for stroke; hypertension, dyslipidemia, alcohol consumption, smoking, and estimated glomerular filtration rate were included in model 2. RESULTS: Overall, serum 1,5-AG levels were lower in group S than in group C. Serum 1,5-AG levels were low in subgroups S-high and C-high, showing no differences in mean values. However, mean serum 1,5-AG levels in S-low was statistically lower than that in C-low. MLR analysis showed that the OR for low (<14 µg/mL) 1,5-AG for stroke was statistically significant only in well-controlled diabetes (OR [95% CI] 2.19 [1.54-3.10]) in model 1 and (2.26 [1.56-3.28]) model 2. CONCLUSIONS: Low serum 1,5-AG levels could be a possible marker for AIS/TIA risk in patients with well-controlled DM.

Issues in Developing and Evaluating a Culturally Tailored Internet Cancer Support Group.

The purpose of this article is to explore practical issues in developing and implementing a culturally tailored Internet Cancer Support Group for a group of ethnic minority patients with cancer-Asian Americans. Throughout the research process of the original study testing the Internet cancer support group, the research team made written records of practical issues and plausible rationales for the issues. Weekly group discussion among research team members was conducted, and the discussion records were evaluated and analyzed using a content analysis (with individual words as the unit of analysis). The codes from the analysis process were categorized into idea themes, through which the issues were extracted. The issues included those in (1) difficulties in using multiple languages, (2) collaboration with the information technology department and technical challenges, (3) difficulties in recruitment, (4) difficulties in retention, (5) optimal timing, and (6) characteristics of the users. Based on the findings, we suggest that researchers plan a workable translation process, check technical needs in advance, use multiple strategies to recruit and retain research participants, plan the right time for data collection, and consider characteristics of the users in the study design.

A screening instrument to identify ulcerative colitis patients with the high possibility of current non-adherence to aminosalicylate medication based on the Health Belief Model: a cross-sectional study.

BACKGROUND: Non-adherence to aminosalicylates is observed among 30% to 45% of patients with ulcerative colitis and increases the risk of relapse. The Health Belief Model is a theoretical model that could offer a broader perspective to improve patients' self-medication adherence. This study aimed to develop a screening instrument based on the Health Belief Model to screen patients with ulcerative colitis who had a high possibility of current non-adherence to aminosalicylates. The study was also designed to allow examination of factors of non-adherence. METHODS: A multicenter, cross-sectional study was conducted in outpatients diagnosed with ulcerative colitis and prescribed aminosalicylates. Non-adherence was defined as taking less than 80% of the prescribed dose. We hypothesized that there was a significant relationship between current aminosalicylate non-adherence and five components of the HBM: beliefs about taking aminosalicylates, disease characteristics, medication characteristics, abdominal symptoms, and sociodemographic characteristics. A logistic regression model was applied and the coefficients converted to a numeric scores in order to develop a screening instrument which could reliably discriminate non-adherent and adherent subjects. RESULTS: Non-adherence was observed in 127 (29.6%) of the 429 enrolled subjects. Lower perceptions of belief in taking aminosalicylates, absence of visible bleeding, eight daily tablets or less taken, and no concomitant use of thiopurines were related to non-adherence. We then developed a screening instrument comprising 22 items. When the cut-off point was set at 60, the instrument showed 85.0% sensitivity and 69.2% specificity with an area under the curve of 0.84 (95% confidence interval = 0.79-0.91). CONCLUSIONS: The instrument appeared to be reliable for identifying patients with a high possibility of current non-adherence to aminosalicylates. Further, the instrument may provide useful information for detecting patients with a high possibility of current non-adherence and for assessing factors of non-adherence. On the other hand, we need to evaluate disease activity more strictly and examine whether it is included in the screening instrument in the future.

Effects of aromatherapy massage on face-down posture-related pain after vitrectomy: a randomized controlled trial.

Postoperative face-down posturing (FDP) is recommended to optimize the effects of intraocular gas tamponade after vitrectomy. However, patients undergoing FDP usually experience physical and psychological burdens. This 3-armed, randomized, single-center trial investigated the effects of aromatherapy on FDP-related physical pain. Sixty-three patients under FDP were randomly allocated to one of three treatment groups: aromatherapy massage with essential oil (AT), oil massage without essential oil (OT), and a control group. The AT and OT groups received 10 minutes of massage by ward nurses trained by an aromatherapist, while the control group received usual care. Outcomes were assessed as short-term (pre- to post-intervention) and long-term (first to third postoperative day) changes in physical pain in five body regions using face-scale. The AT and OT groups both revealed similar short-term pain reductions after intervention, compared with the control group. Regarding long-term effects, neither group experienced significant effects until the second day. Significantly more pain reduction compared with usual care occurred on the third day, mainly in the AT group, though there were few significant differences between the AT and OT groups. In conclusion, this study suggests that simple oil massage is an effective strategy for immediate pain reduction in patients undergoing FDP, while aromatherapy may have a long-term effect on pain reduction.

Care managers' confidence in managing home-based end-of-life care: a cross-sectional study.

BACKGROUND: There are increasing occasions for care managers (CMs) to manage end-of-life (EOL) situations for older persons at home, in Japan. However, many CMs report anxiety, difficulties and low confidence in managing such care, although confidence is considered a significant determinant of professional performance. This study examined the confidence of CMs at managing home-based EOL situations and its factors. METHODS: Participants of this cross-sectional study were CMs from 1,200 homecare agencies in Japan, which were systematically sampled from a national database. Participants were asked about their overall confidence in managing home-based EOL situations, as well as their demographic, professional and agency characteristics. Multiple logistic regression analysis was conducted to examine the factors associated with CM confidence levels. RESULTS: Valid responses were obtained from 458 participants (response rate, 39.4%). Among the respondents, 81.0% (n = 371) were female; mean age 49.2 years old (standard deviation = 8.8). Their professional backgrounds included nurses (28.2%), care workers (49.8%), social workers (10.9%), and home attendants (6.1%). Approximately 70% of CMs expressed some level of confidence in managing home-based EOL situations. Multiple logistic regression analysis showed that being confident was significantly associated with having a nursing license (OR: 2.71, 95% CI: 1.26-6.19) and having an additional work responsibility other than being a CM, such as working as a homecare nurse or a home attendant (OR: 2.78, 95% CI: 1.06-4.74). Higher confidence levels were more frequently reported among those who had multiple experiences with EOL situations, compared with those who had none, or only one experience: OR=2.60 (95% CI 1.26-5.50) for those with 2-3 cases; OR=7.12 (3.21-16.56) for those with 4-10 cases; OR = 33.67 (8.14-235.19) for those with 11 cases and over. CONCLUSIONS: These results suggest that CMs with direct, hands-on experience with EOL care, or who have managed multiple EOL cases, tended to be confident at managing home-based EOL situations. Given that the number of nurses working as CMs is decreasing, further research is needed to explore what support CMs need to increase their confidence, especially when the CMs do not have nursing licenses and/or experience with EOL situations.

Reproductive decision-making following the diagnosis of an inherited metabolic disorder via newborn screening in Japan: a qualitative study.

Introduction: The aim of the study was to describe the factors influencing the reproductive decision-making of carrier parents after the diagnosis of an inherited metabolic disorder in newborn screening in Japan. Methods: We conducted a semi-structured interview with 12 parents and analyzed data based on content analysis methodology. Results: We identified 11 factors, including personal evaluation of recurrence risk, understanding of hereditary phenomena, concerns and desires for future planned children, concerns for older siblings, perceptions of diseases, degree of acceptance and denial of diseases, the opinions of others on having another child, optimism/faith in positive outcomes, self-evaluation of parental capability, factors unrelated to the disease, and the "right" time to expand the family. Discussion: Perceptions and acceptance of disease are both important factors in reproductive decision-making, though these factors fluctuate continuously during the childbearing period. Therefore, effective reproductive genetic counseling will be considerate of the parents' fluctuating perceptions on reproduction. To ensure that the decision-making process is for the benefit of the parents and future children, long-term involvement of health care professionals is needed to assess the client's acceptance of the disease and their understanding of genetic phenomena and recurrence rates.

The Fragility of Statistically Significant Results in Randomized Clinical Trials for COVID-19.

Importance: Interpreting results from randomized clinical trials (RCTs) for COVID-19, which have been published rapidly and in vast numbers, is challenging during a pandemic. Objective: To evaluate the robustness of statistically significant findings from RCTs for COVID-19 using the fragility index. Design, Setting, and Participants: This cross-sectional study included COVID-19 trial articles that randomly assigned patients 1:1 into 2 parallel groups and reported at least 1 binary outcome as significant in the abstract. A systematic search was conducted using PubMed to identify RCTs on COVID-19 published until August 7, 2021. Exposures: Trial characteristics, such as type of intervention (treatment drug, vaccine, or others), number of outcome events, and sample size. Main Outcomes and Measures: Fragility index. Results: Of the 47 RCTs for COVID-19 included, 36 (77%) were studies of the effects of treatment drugs, 5 (11%) were studies of vaccines, and 6 (13%) were of other interventions. A total of 138 235 participants were included in these trials. The median (IQR) fragility index of the included trials was 4 (1-11). The medians (IQRs) of the fragility indexes of RCTs of treatment drugs, vaccines, and other interventions were 2.5 (1-6), 119 (61-139), and 4.5 (1-18), respectively. The fragility index among more than half of the studies was less than 1% of each sample size, although the fragility index as a proportion of events needing to change would be much higher. Conclusions and Relevance: This cross-sectional study found a relatively small number of events (a median of 4) would be required to change the results of COVID-19 RCTs from statistically significant to not significant. These findings suggest that health care professionals and policy makers should not rely heavily on individual results of RCTs for COVID-19.

Evaluation of radiological recurrence patterns following gamma knife radiosurgery for solitary meningioma previously treated via cranial surgery.

The use of gamma knife radiosurgery (GKS) for meningiomas after cranial surgery has been extensively evaluated; however, studies on tumor progression, including recurrence out of the margin dose line, are scarce. Hence, we aimed to evaluate the meningioma recurrence after GKS within and out of the margin dose. We included 37 consecutive patients with World Health Organization (WHO) grade 1 meningiomas who were treated with GKS following cranial surgery. Radiologically indicated recurrences were classified into three patterns by their relationship to the margin dose and tumor. The median follow-up was 58.9 months; 2 (5.4%) patients died. Only 2 (5.4%) patients did not keep active daily lives because of tumor progression. Cumulative local control at 5 years was 85.2%. Local recurrence and recurrence out of the margin dose occurred in 5 (13.5%) and 13 (35.1%) patients, respectively. A larger preoperative maximum diameter was a risk factor for local recurrence (hazard ratio [HR]: 2.118; P = 0.033), adjacent progression (HR: 1.633; P = 0.015), and remote progression (HR: 2.016; P = 0.003). Symptomatic adverse radiation effects occurred in 1 patient. Salvage GKS and cranial surgery were performed in 9 (24.3%) and 8 (21.6%) patients, respectively. Progression to WHO grade 2-3 occurred in 5 (13.5%) patients. A larger preoperative maximum diameter was a risk factor for progression of WHO grade (HR: 2.016, P = 0.033). Progression out of the margin dose was associated with a larger preoperative tumor size.

Self-management behavior concerning physical activity of Japanese type 2 diabetes patients, characterized by sex, daily energy intake and body mass index.

OBJECTIVES: We assess differences in physical activity self-management behavior in association with dietary intake and BMI between the sexes in patients with type 2 diabetes. METHODS: Patients with type 2 diabetes (n = 145) completed a self-administrated questionnaire. Patients were classified into four groups by BMI and dietary intake: non-obesity and non-overeating (NO/NOE); non-obesity and overeating (NO/OE); obesity and non-overeating (O/NOE); obesity and overeating (O/OE). Differences in physical activity self-management behavior between the four groups were determined by the analysis of variance using a Tukey-Kramer post hoc test. RESULTS: Male O/OE group showed higher HbA1c (p = 0.001) than the other groups. Male NO/OE group had higher steps/day than O/NOE (p = 0.036) and score of "Exercising to stimulate the enjoyment of eating" was higher than O/OE (p = 0.031). Female NO/OE group showed higher HbA1c (p = 0.001) than NO/NOE and O/NOE. CONCLUSIONS: BMI and dietary intake were associated with frequencies of physical activity self-management strategies in men. Self-management behavior peculiar to male NO/OE group is "Exercising to stimulate the enjoyment of eating". Health professionals should assess sex, BMI, and dietary intake of patients and endeavor to improve individuals' ability to regulate their caloric balance based on physical activity level.

Process and contents of telephone consultations between registered nurses and clients with HIV/AIDS in Japan.

Antiviral therapy is essential for HIV/AIDS patients, but many variables impede patients' adherence to therapy. To facilitate adherence, trained registered nurses in Japan provided consultation by phone at the AIDS Clinical Center. This study describes the process and content of this intervention and explores the predictors for length of time of phone consultations. The study was completed over 1 month using a time study, checklist, and medical record inquiry. A total of 175 consultations were described. Mean time was 4.8 +/- 3.8 min, and longer for patients with complications or comorbidity. Although the contents of conversations differed according to the phase of highly active antiretroviral therapy, major identified themes included need for medical consultation, symptom control, provision of information, and active listening. The results are useful for those trying to find ways to use telephone consultation effectively to reinforce adherence.

Reliability and validity of revised and short form versions of diabetes diet-related quality of life scale.

OBJECTIVE: To develop both a revised version of the Diabetes Diet-Related Quality of Life (DDRQOL-R) scale that can be applied to patients with nephropathy and a short form of the DDRQOL-R. METHOD: A total of 184 outpatients with type 2 diabetes were asked to complete the self-administered DDRQOL-R scale to confirm its psychometric properties. A short-form version was developed, based on two methods: the result of the developed DDRQOL-R scale and consensus using the Delphi method among medical experts. RESULTS: Correlations were generally strong between the DDRQOL-R factors extracted by factor analysis and each SF-36 subscale. Cronbach's α coefficients were at least 0.7, and intraclass correlation coefficients were between 0.59 and 0.78. The nine items that showed high factor loadings were also assessed as important by the medical experts and were selected for the short form of the scale. The reliability and validity of the short form were found to be similar to those of the DDRQOL-R scale. DISCUSSION: Our findings indicate that the DDRQOL-R scale and its short form have acceptable reliability and validity. The revised version is highly versatile, and the short form can be conveniently administered.

A culturally tailored Internet cancer support group for Asian American breast cancer survivors: A randomized controlled pilot intervention study.

Introduction The necessity of culturally competent Internet Cancer Support Groups (ICSGs) for ethnic minorities has recently been highlighted in order to increase its attractiveness and usage. The purpose of this study was to determine the preliminary efficacy of a culturally tailored registered-nurse-moderated ICSG for Asian American breast cancer survivors in enhancing the women's breast cancer survivorship experience. Methods The study included two phases: (a) a usability test and an expert review; and (b) a randomized controlled pilot intervention study. The usability test was conducted among five Asian American breast cancer survivors using a one-month online forum, and the expert review was conducted among five experts using the Cognitive Walkthrough method. The randomized controlled pilot intervention study (a pre-test and post-test design) was conducted among 65 Asian American breast cancer survivors. The data were analysed using content analysis and descriptive and inferential statistics including the repeated ANOVA. Results All users and experts positively evaluated the program and provided their suggestions for the display, educational contents, and user-friendly structure. There were significant positive changes in the support care needs and physical and psychological symptoms ( p < 0.05) of the control group. There were significant negative changes in the uncertainty level of the intervention group ( p < 0.10). Controlling for background and disease factors, the intervention group showed significantly greater improvements than the control group in physical and psychological symptoms and quality of life ( p < 0.10). Discussion The findings supported the positive effects of ICSGs on support care needs, psychological and physical symptoms, and quality of life.