Quality indicators for integrating oncology and home palliative care in Japan: modified Delphi study.

CONTEXT: Home palliative care service increases the chance of dying at home, particularly for patients with advanced cancer, but late referrals to home palliative care services still exist. Indicators for evaluating programs that can facilitate the integration of oncology and home palliative care have not been defined. OBJECTIVES: This study developed quality indicators for the integration of oncology and home palliative care in Japan. METHODS: We conducted a systematic literature review (Databases included CENTRAL, MEDLINE, EMBASE, and Emcare) and a modified Delphi study to develop the quality indicators. Panelists rated a potential list of indicators using a 9-point scale over three rounds according to two criteria: appropriateness and feasibility. The criterion for the adoption of candidate indicators was set at a total mean score of 7 or more. Final quality indicators with no disagreement were included. RESULTS: Of the 973 publications in our initial search, 12 studies were included. The preliminary list of quality indicators by systematic literature review comprised 50 items. In total, 37 panelists participated in the modified Delphi study. Ultimately, 18 indicators were identified from the following domains: structure in cancer hospitals, structure in home palliative care services, the process of home palliative care service delivery, less aggressive end-of-life care, patient's psychological comfort, caregiver's psychological comfort, and patient's satisfaction with home palliative care service. CONCLUSION: Comprehensive quality indicators for the integration of oncology and home palliative care were identified. These indicators may facilitate interdisciplinary collaboration between professional healthcare providers in both cancer hospitals and home palliative care services.

Clinical practice guidelines for the care of psychologically distressed bereaved families who have lost members to physical illness including cancer.

The Japanese Psycho-Oncology Society and the Japanese Association of Supportive Care in Cancer developed evidence-based clinical practice guidelines for the care of psychologically distressed bereaved families who have lost members to physical illness including cancer. The guideline development group formulated two clinical questions. A systematic literature review was conducted. The level of evidence and the strength of the recommendations were graded and recommendation statements validated using the modified Delphi method. The recommendations were as follows: non-pharmacological interventions were indicated for serious psychological distress (depression and grief); antidepressants were indicated for depression; however, psychotropic medications including antidepressants were not recommended for 'complicated' grief. These guidelines will facilitate the provision of appropriate care to distressed bereaved family members and highlight areas where further research is needed.

Integrating home palliative care in oncology: a qualitative study to identify barriers and facilitators.

PURPOSE: Access to and close links with home palliative care services are essential to ensure seamless transitions between care settings in anticancer treatment. However, the timing of referrals to home palliative care services is often delayed. We explored barriers to and facilitators of improving the integration of home palliative care and medical oncology experienced by healthcare professionals in Japan. METHODS: This qualitative study involved semi-structured focus groups and individual interviews conducted via a web conferencing system. Participants were 27 healthcare professionals, including oncologists, palliative care physicians, home palliative care physicians, nurses from both cancer hospitals and home visit nursing agencies, and social workers from cancer hospitals. RESULTS: Barriers and facilitators were grouped into three themes: (1) perspectives and ideas on integrating oncology and home palliative care; (2) barriers; and (3) facilitators. Barriers included seven sub-themes: lack of referral criteria for home palliative care services; financial elements related to home palliative care services; patients' lack of understanding of the illness trajectory; collusion in doctor-patient communication about imminent death; frequent visits to cancer hospitals; variations in home palliative care services; and problems in providing treatment and care at home. Facilitators included two sub-themes: relationships between oncologists and home palliative care physicians, and cancer hospital staff experience/knowledge of home palliative care. CONCLUSION: This study identified barriers and facilitators to integrating home palliative care and oncology. Some barriers experienced by professionals were comparable with barriers to early integration of palliative care into oncology.

[Current Status and Improvement Strategies for Integrating Home Palliative Care in Oncology-A Qualitative Study].

This study aimed to investigate healthcare providers' experiences and examine potential strategies for integrating oncologic home palliative care(HPC). This qualitative study was conducted using semi-structured interviews via a web-conferencing system. The data underwent thematic analysis. The participants were 27 healthcare professionals, including oncologists, palliative care physicians, home palliative care physicians, nurses, and medical social workers. Two themes were identified; current status and improvement strategies. Current status encompassed 3 sub-themes: late HPC services involvement, few opportunities for early HPC services introduction, and early referral to HPC establishes rapport with patients. Improvement strategies included 6 sub-themes: interdisciplinary teams meeting to consider patients' hope, identification of outpatients that would benefit from HPC services, HPC service introduction via home visit nursing agencies and outpatient clinics, HPC services introduction via outpatient palliative care clinics, and booklet for patients and families. Numerous participants regarded the timing of HPC services referral as late and had experienced few cases of integrated oncologic HPC. Potential strategies existed in both hospital and home settings. The interdisciplinary collaboration between healthcare providers in both hospital and home settings may facilitate the integration of HPC in oncology.

Anesthesia for Cesarean Section and Postpartum Cardiovascular Events in Congenital Heart Disease: A Retrospective Cohort Study.

OBJECTIVE: To clarify the association between anesthetic technique and maternal and neonatal outcomes in parturients with congenital heart disease (CHD). DESIGN: Retrospective, observational cohort study. SETTING: An academic hospital. PARTICIPANTS: A total of 263 consecutive parturients with CHD who underwent cesarean section from 1994 to 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The authors compared postpartum cardiovascular events (composite of heart failure, pulmonary hypertension, arrhythmia, and thromboembolic complications) and neonatal outcomes (intubation and Apgar score <7 at one or five minutes) by anesthetic technique. Among 263 cesarean sections, general anesthesia was performed in 47 (17.9%) parturients and neuraxial anesthesia in 214 (81.3%) parturients. Cardiovascular events were more common in the general anesthesia group (n = 7; 14.9%) than in the neuraxial anesthesia group (n = 17; 7.9%). Generalized linear mixed models assuming a binomial distribution (ie, mixed-effects logistic regression), with a random intercept for each modified World Health Organization classification for maternal cardiovascular risk, revealed that general anesthesia was not significantly associated with cardiovascular events (odds ratio [OR], 1.00; 95% confidence interval [CI], 0.30-3.29). In addition, general anesthesia was associated with composite neonatal outcomes (Apgar score <7 at one or five minutes or need for neonatal intubation; OR, 13.3; 95% CI, 5.52-32.0). CONCLUSION: Anesthetic technique is not significantly associated with postpartum composite cardiovascular events. General anesthesia is significantly associated with increased need for neonatal intubation and lower Apgar scores.

Factors associated with suicidal ideation in patients with multiple myeloma.

Patients with multiple myeloma are at risk of suicide. The study objective was to investigate the clinical risk factors of suicidal ideation among multiple myeloma patients. Consecutive inpatients with a new primary diagnosis of multiple myeloma were recruited. Patients were asked to complete the Patient Health Questionnaire-9 to measure suicidal ideation and depression. Patient demographic and biomedical characteristics (age, gender, education, marital status, employment, performance status and cancer stage) and pain and depression scores were analyzed as potential factors associated with suicidal ideation. Of the 79 patients, 10 [12.6% (95% confidence interval: 7-22)] had suicidal ideation. The results of a logistic regression analysis showed that being unmarried, less advanced cancer stage and depression were significantly associated with the presence of suicidal ideation. These findings suggest that a non-negligible proportion of patients with multiple myeloma experience suicidal ideation and that several multidimensional factors are significantly associated.

Effectiveness of a brief psycho-oncology training program for general nurses: a preliminary study.

Many nurses are not confident in management of psychological distress in cancer patients. We developed a brief psycho-oncology training program for general nurses, and explored the usefulness of the program preliminary. Seventy-two nurses in 17 designated cancer hospitals received a 4-h program comprising an e-learning lecture on assessment and management of normal psychological responses to cancer and an onsite workshop, including a role-play exercise and group work. Primary outcomes were changes in self-reported confidence, knowledge and attitudes toward caring for patients with normal psychological response between pre-training and post-training. All outcomes, excepting several aspects of attitude, were significantly improved after training (P < 0.05). Intervention acceptability was good as no participants dropped out and all participants considered the program useful in clinical practice. Further consideration is required to clarify whether the cancer care provided by nurses who received psycho-oncology training is effective to ameliorate psychological distress in cancer patients.

Cognitive dysfunction among newly diagnosed older patients with hematological malignancy: frequency, clinical indicators and predictors.

BACKGROUND: Medical staff often overlook or underestimate the presence or severity of cognitive dysfunction. The purpose of this study was to clarify the frequency, clinical indicators and predictors of cognitive dysfunction among newly diagnosed older patients with hematologic malignancy receiving first-line chemotherapy. METHODS: Patients aged 65 years or over with a primary diagnosis of malignant lymphoma or multiple myeloma were consecutively recruited. Cognitive dysfunction was evaluated using the Mini-Mental State Examination (MMSE) twice: before starting chemotherapy (T1) and 1 month later (T2). Participants also underwent a comprehensive geriatric assessment at T1. Potential clinical indicators that were associated with cognitive dysfunction were explored via cross-sectional analysis at T1. Predictors of cognitive dysfunction at T2 were also investigated among patients without cognitive dysfunction at T1. RESULTS: A total of 145 participants participated in the study; cognitive dysfunction at T1 was present in 20%. Multivariate analysis demonstrated that lower educational attainment and poorer instrumental activities of daily living were significant clinical indicators of cognitive dysfunction. Among 99 patients who did not have cognitive dysfunction at T1 and underwent cognitive assessment at T2, 7% developed dysfunction. Subjective perception of difficulty remembering at T1 was the only factor which significantly predicted new-onset cognitive dysfunction at T2. CONCLUSIONS: The prevalence rate of cognitive dysfunction was non-negligible among older patients with hematologic malignancy before and immediately after initial chemotherapy. Attention to the clinical indicators and predictors found in this study may provide facilitate the identification of cognitive dysfunction in patients with cancer.

Brief multifamily Psychoeducation for family members of patients with chronic major depression: a randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is a common and often chronic problem. Patients with chronic MDD often have negative impacts on the health of their families. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder, and has been shown to reduce the rate of relapse in individuals with schizophrenia and to reduce the burden on their caregivers. Thus, we predict that family psychoeducation has the potential to reduce the burden on the caregivers of patients with chronic MDD. In the present study, we aimed to investigate the effects of brief multifamily psychoeducation (BMP) on the mental health status of family members of patients with chronic MDD. METHODS: We conducted a clinical trial consisting of 49 chronic MDD patients and their families. Each family was randomly assigned to either the BMP intervention group or the control group. The intervention group received four BMP sessions, once every two weeks for eight weeks. The control group received one counseling session administered by a nurse. All patients received standard treatment administered by physicians. The primary outcome measurement was the Kessler Screening Scale for Psychological Distress (K6) score of family members at 16- weeks after the first BMP session. Secondary outcomes were depressive symptoms of both family members and patients at multiple time points, as well as family functioning as evaluated by the patients. Intention-to-treat analyses were conducted. RESULTS: There was no statistically significant effect of BMP on K6 scores at 16- weeks (mean difference 1.17, 95% confidence interval: - 0.63 to 2.98, P = 0.19). Exploratory analyses revealed that BMP reduced depressive symptoms in family members at 8- weeks (difference = - 3.37, 95%CI -6.32 to - 0.43, P = 0.02) and improved family functioning at multiple time points (Role; 8 W, difference = - 0.13, 95%CI -0.26 to - 0.00, P = 0.04, Affective Responsiveness; 8 W, difference = - 0.24, 95%CI -0.43 to - 0.05, P = 0.01, 32 W, difference = - 0.22, 95%CI -0.41 to - 0.03, P = 0.02, Behavior Control; 16 W, difference = - 0.17, 95%CI -0.34 to - 0.00, P = 0.04). CONCLUSIONS: Four BMP sessions did not significantly reduce the psychological distress of family members of patients with chronic MDD. TRIAL REGISTRATION: Clinical Trials. gov NCT01734291 , retrospectively registered (Registration date: November 21, 2012).

Supportive care needs and psychological distress and/or quality of life in ambulatory advanced colorectal cancer patients receiving chemotherapy: a cross-sectional study.

BACKGROUND: Although currently many advanced colorectal cancer patients continuously receive chemotherapy, there are very few findings with regard to the supportive care needs of such patients. METHODS: The purposes of this study were to investigate the patients' perceived needs and the association with psychological distress and/or quality of life, and to clarify the characteristics of patients with a high degree of unmet needs. Ambulatory colorectal cancer patients who were receiving chemotherapy were asked to complete the Short-Form Supportive Care Needs Survey questionnaire, which covers five domains of need (health system and information, psychological, physical, care and support, and sexuality needs), the Hospital Anxiety and Depression Scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. RESULTS: Complete data were available for 100 patients. Almost all of the top 10 most common unmet needs belonged to the psychological domain. The patients' total needs were significantly associated with both psychological distress (r = 0.65, P < 0.001) and quality of life (r = -0.38, P < 0.001). A multiple regression analysis revealed that the female gender was significantly associated with higher total needs. CONCLUSIONS: The moderate to strong associations that exist between patients' needs and psychological distress and/or quality of life suggest that interventions that respond to patients' needs may be one possible strategy for ameliorating psychological distress and enhancing quality of life. Female patients' needs should be evaluated more carefully.

Effect of posture and extracranial contamination on results of cerebral oximetry by near-infrared spectroscopy.

BACKGROUND: Near-infrared spectroscopy (NIRS)-based cerebral oximetry is a noninvasive technology used to estimate regional cerebral oxygen saturation (rSO2). Extracranial blood flow is known to substantially affect rSO2 values measured by most clinically available devices. Several studies have also reported that the Trendelenburg position and upright position have a larger effect on rSO2 measurements than the supine position. Therefore, we investigated the effect of these two positions (the Trendelenburg position versus the upright position) and extracranial contamination on rSO2 measurements obtained using two commercially available devices and one prototype device. METHODS: Twelve healthy volunteers were enrolled in the study. They each had three cerebral oximetry devices applied to their forehead (FORE-SIGHT ELITE™, CAS Medical Systems Inc., Branford, CT, USA; INVOS 5100c™, Medtronic, Minneapolis, MN, USA; and NIRO-TRS, Hamamatsu Photonics, Hamamatsu, Japan). A circumferential pneumatic head cuff was positioned proximal to the NIRS cerebral oximetry sensors. We measured rSO2, heart rate (HR), and blood pressure (BP) in six conditions (supine, Trendelenburg and upright positions, with and without scalp ischemia induced by head cuff inflation) every 5 min with each oximetry device. Total hemoglobin (tHb), which is associated with cerebral blood volume (CBV) as measured by positron emission tomography, was measured using the NIRO-TRS device to determine extracranial blood volume in each position. RESULTS: Measurements of rSO2 with all the devices were affected by extracranial contamination. The percentage of extracranial contamination was highest with INVOS 5100c™ in the upright position (INVOS, 21.3%; FORE-SIGHT, 14.3%; NIRO-TRS, 3.6%). Measurements of rSO2 obtained in the upright position were significantly lower than those obtained in the supine position, using INVOS-5100c™ and FORE-SIGHT ELITE™ (71 vs. 74% and 67 vs. 72%, respectively), but not using NIRO-TRS (62 vs. 64%). A significant decrease in tHb was observed after head cuff inflation in the supine and Trendelenburg positions (supine, 0.132-0.123 µmol/l; Trendelenburg, 0.133-0.125 µmol/l). CONCLUSIONS: Except when using NIRO-TRS, measurements of rSO2 in the forehead are significantly lower when measured in the upright position than in the supine position. All devices in this study were affected by extracranial contamination.

Effectiveness of a psycho-oncology training program for oncology nurses: a randomized controlled trial.

OBJECTIVE: Oncology nurses are expected to play an important role in psychosocial care for cancer patients. The aim of this study was to examine whether a novel training program aimed at enhancing oncology nurses' ability to assess and manage common psychological problems in cancer patients would improve participants' self-reported confidence, knowledge, and attitudes regarding care of patients with common psychological problems (trial register: UMIN000008559). METHODS: Oncology nurses were assigned randomly to either the intervention group (N = 50) or the waiting list control group (N = 46). The intervention group received a 16-h program, the content of which focused on four psychological issues: normal reactions, clinically significant distress, suicidal thoughts, and delirium. Each session included a role-play exercise, group work, and didactic lecture regarding assessment and management of each problem. Primary outcomes were changes in self-reported confidence, knowledge, and attitudes toward the common psychological problems between pre-intervention and 3 months post-intervention. Secondary outcomes were job-related stress and burnout. Intervention acceptability to participants was also assessed. RESULTS: In the intervention group, confidence and knowledge but not attitudes were significantly improved relative to the control group. No significant intervention effects were found for job- related stress and burnout. A high percentage (98%) of participants considered the program useful in clinical practice. CONCLUSIONS: This psycho-oncology training program improved oncology nurses' confidence and knowledge regarding care for patients with psychological problems. Copyright © 2015 John Wiley & Sons, Ltd.

Aquaphotomics: Near Infrared Spectroscopy and Water States in Biological Systems.

Aquaphotomics is a new discipline that provides a framework for understanding changes in water molecular system presented as a water spectral pattern, to mirror the rest of the solution and to give a holistic description related to system functionality. One of its main purposes is to identify water bands as main coordinates of future absorbance patterns to be used as a system biomarker. This chapter presents the Aquaphotomics methodology and illustrates a way to identify specific water bands using temperature change and addition of solutions of different ionic strength as perturbations. Rapid and precise measurement of low concentration solutes has been given as a strong evidence of the vast information that "the water spectral pattern as molecular mirror" approach provides. Few applications using near infrared spectroscopy and multivariate analysis as main tools of Aquaphotomics have been presented.

Cardiac Resynchronization Therapy-Induced Cardiac Index Increase Measured by Three-Dimensional Echocardiography Can Predict Decreases in Brain Natriuretic Peptide.

OBJECTIVES: First, to examine the perioperative association between increased cardiac index (CI) measured using three-dimensional echocardiography (CI3D), two-dimensional echocardiography (CI2D), and FloTrac/Vigileo (CIFT) (Edwards Lifesciences, Irvine, CA) after cardiac resynchronization therapy (CRT) and decreased brain natriuretic peptide (BNP) 6 months after CRT. Second, to evaluate the accuracy and tracking ability of CI2D and CIFT. DESIGN: A prospective clinical study. SETTING: A cardiac surgery operating room in a single cardiovascular center. PARTICIPANTS: Forty-five patients undergoing elective CRT lead implantation. INTERVENTIONS: CIFT and CI2D were determined simultaneously before and after CRT using CI3D as the reference method. MEASUREMENTS AND MAIN RESULTS: BNP was measured before CRT and 6 months after CRT. Areas under the receiver operator characteristic curves (AUCs) were calculated for each method of measurement to predict BNP decrease. AUC was largest for CI3D (AUC = 0.735, p = 0.017). Bland-Altman analysis revealed that the percentage error was 58% for CIFT and 28% for CI2D. A polar plot analysis showed that the mean angular bias was -7.26° and 0.64°, the radial limits of agreement were 70° and 29.4°, and the concordance rate was 67.7% and 93.8% for CIFT and CI2D, respectively. CONCLUSIONS: CI significantly increased after CRT in patients whose BNP level decreased 6 months after CRT. However, only CI3D could predict decreases in BNP 6 months after CRT. Although CI2D was acceptable compared with CI3D, the tracking ability of CI changes was just below acceptable. CIFT has a wide limit of agreement with CI3D, with a poor tracking ability.

Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a ß3-adrenoceptor agonist, in patients with overactive bladder in Asia.

AIMS: To assess the efficacy and safety of mirabegron 50 mg once daily compared with placebo and the active control, tolterodine extended-release (ER) 4 mg once daily, in patients with symptoms of overactive bladder (OAB) in Taiwan, Korea, China, and India. METHODS: A 12-week multinational, randomized, double-blind, parallel-group placebo- and active-controlled trial. The primary efficacy endpoint was change from baseline to final visit in mean number of micturitions/24 hr. Secondary endpoints were: mean number of urgency episodes, incontinence episodes and urge incontinence episodes/24 hr, mean number of nocturia episodes per night, mean volume voided per micturition, and quality-of-life (QoL) scores as assessed by the King's Health Questionnaire (KHQ). RESULTS: Of 1,126 patients who were randomized to receive double-blind study drug, 921 patients (300, 311, and 310 in the placebo, mirabegron 50 mg, and tolterodine ER 4 mg groups, respectively) completed the treatment period. Demographic characteristics were similar across treatment groups. A statistically significant improvement versus placebo in mean number of micturitions/24 hr was seen with mirabegron 50 mg at all timepoints (P < 0.05) as well as final visit (-0.57 with 95% confidence intervals [CIs] of [-1.04, -0.09], P = 0.019). There was no significant difference between treatment groups in improvement from baseline to final visit in any of the secondary outcome measures except volume voided per micturition. The overall incidence of drug-related adverse events was 17.2%, 15.8%, and 21.3%, in the placebo, mirabegron 50 mg, and tolterodine ER 4 mg groups, respectively. CONCLUSIONS: Mirabegron 50 mg once daily for 12 weeks was superior to placebo in reducing the frequency of micturitions in patients with symptoms of OAB in Taiwan, Korea, China, and India.

Good death for children with cancer: a qualitative study.

OBJECTIVE: This study aims to explore the characteristics of a good death for children with cancer. METHODS: A total of 10 pediatric cancer survivors, 10 bereaved family members and 20 medical professionals participated in in-depth interviews. Qualitative content analysis was performed on the transcribed data obtained from semi-structured interviews. RESULTS: Thirteen characteristics including unique and specific for children of a good death were identified: (i) sufficient opportunities to play freely, (ii) peer supporters, (iii) continued access to the patient's usual activities and relationships, (iv) assurance of privacy, (v) respect for the patient's decisions and preferences, (vi) a sense that others acknowledge and respect the patient's childhood, (vii) comfort care to minimize distressing symptoms, (viii) hope, (ix) not aware of the patient's own impending death, (x) constant dignity, (xi) strong family relationships, (xii) no sense of being a burden to family members and (xiii) good relationships with medical staffs. CONCLUSIONS: This study identifies important characteristics of a good death for children with cancer. These findings may help medical staffs provide optimal care for children with cancer and their families, enabling them to achieve a good death.

Preoperative brain magnetic resonance imaging and postoperative delirium after off-pump coronary artery bypass grafting: a prospective cohort study.

BACKGROUND: Delirium after cardiac surgery is a serious complication, increasing morbidity and mortality. Despite its high expectations, off-pump coronary artery bypass grafting (OPCAB) has largely failed to reduce the incidence of postoperative neurological complications. To further investigate the reasons for this failure, we used perioperative brain magnetic resonance imaging (MRI) to determine the relation between MRI findings and postoperative delirium. METHODS: Altogether, 98 patients undergoing elective OPCAB were enrolled in this prospective observational study. Patients underwent brain MRI and magnetic resonance angiography (MRA) before and after surgery to identify cerebral infarction, white matter lesions, and intracranial artery stenosis. Postoperative delirium in the intensive care unit was measured using the delirium rating scale. The relation between postoperative delirium and MRI findings was examined using logistic regression. RESULTS: Magnetic resonance imaging and MRA was completed in 88 (90%) of the patients. New ischemic lesions were present in seven (7.9%) patients. Delirium rating scale scores of 0, 1-7, and ≥ 8 were found in 25 (31%), 48 (60%), and seven (9%) patients, respectively. Multivariate logistic regression analysis revealed that new ischemic lesions (odds ratio [OR] 11.07, 95% confidence interval [CI]: 1.53 to 80.03; P = 0.017), carotid artery stenosis (OR 7.06, 95% CI: 1.59 to 31.13; P = 0.010), history of myocardial infarction (OR 3.78, 95% CI: 1.05 to 13.65; P = 0.043), and deep subcortical white matter hyperintensity (OR 3.04, 95% CI: 1.14 to 8.12; P = 0.027) were significantly associated with postoperative delirium. CONCLUSIONS: Magnetic resonance imaging findings of new cerebral ischemic lesions, carotid stenosis, and deep subcortical white matter hyperintensity correlated significantly with postoperative delirium in patients who had undergone OPCAB surgery.

Erratum to: Preoperative brain magnetic resonance imaging and postoperative delirium after off-pump coronary artery bypass grafting: a prospective cohort study.

Erratum to: Can J Anesth/J Can Anesth DOI 10.1007/s12630-015-0327-x. In the published version, the first name of the third author is incorrect and should read Naoaki Yamada as given in this erratum. The publisher apologizes most sincerely for this error.

Assessing medical decision making capacity among cancer patients: Preliminary clinical experience of using a competency assessment instrument.

OBJECT: This study investigates the usefulness of the Structured Interview for Competency and Incompetency Assessment Testing and Ranking Inventory (SICIATRI) for cancer patients, which is a structured interview that assesses a patient's competency in clinical practice. METHODS: The SICIATRI, originally developed to measure patients' competency to give informed consent, were administered referred cancer patients who needed for assessing medical decision making capacity. The usefulness of the SICIATRI was investigated retrospectively. Recommendation for modification of the SICIATRI for cancer patients if applicable were made by the research team. RESULTS: Among the 433 cancer patients referred for psychiatric consultation, 12 were administered the SICIATRI and all of the administration were conducted without big problems. All patients were 60 years or older. The most common purpose for competency evaluation was to analyze patients' understanding of the anti-cancer treatment proposed by oncologists, followed by their refusal of the treatment. Half of the patients (n = 6) were diagnosed with delirium and three among them were judged as having the most impaired status of a patient's competency. Two patients (17%) were diagnosed with major depression and another two (17%) were mental retardation and each one patient was diagnosed with dementia and past history of alcohol dependence. Among 6 patients without delirium 5 subjects including a dementia patient were judged as fully competent. Total of 5 small potential modifications of the SICIATRI for its use with Japanese cancer patients were recommended. SIGNIFICANCE OF RESULTS: Our experience suggests that the SICIATRI is a useful instrument for psycho-oncology clinical practice.

Randomized controlled trial data for successful new drug application for rare diseases in the United States.

BACKGROUND: Randomized controlled trial (RCT) data have important implications in drug development. However, the feasibility and cost of conducting RCTs lower the motivation for drug development, especially for rare diseases. We investigated the potential factors associated with the need for RCTs in the clinical data package for new drug applications for rare diseases in the United States (US). This study focused on 233 drugs with orphan drug designations approved in the US between April 2001 and March 2021. Univariable and multivariable logistic regression analyses were conducted to investigate the association between the presence or absence of RCTs in the clinical data package for new drug applications. RESULTS: Multivariable logistic regression analysis showed that the severity of the disease outcome (odds ratio [OR] 5.63, 95% confidence interval [CI] 2.64-12.00), type of drug usage (odds ratio [OR] 2.95, 95% confidence interval [CI] 1.80-18.57), and type of primary endpoint (OR 5.57, 95% CI 2.57-12.06) were associated with the presence or absence of RCTs. CONCLUSIONS: Our results indicated that the presence or absence of RCT data in the clinical data package for successful new drug application in the US was associated with three factors: severity of disease outcome, type of drug usage, and type of primary endpoint. These results highlight the importance of selecting target diseases and potential efficacy variables to optimize orphan drug development.