Barriers and Facilitators to the Implementation of an Electronic Patient-Reported Outcome System at Cancer Hospitals in Japan.

Background and objective Implementing electronic patient-reported outcomes (ePROs) in oncology practice has shown substantial clinical benefits. However, it can be challenging in routine practice, warranting strategies to adapt to different clinical contexts. In light of this, this study aimed to describe the implementation process of the ePRO system and elucidate the provider-level implementation barriers and facilitators to a novel ePRO system at cancer hospitals in Japan. Methods We implemented an ePRO system linked to electronic medical records at three cancer hospitals. Fifteen patients with solid cancers at the outpatient oncology unit were asked to regularly complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) questionnaire and European Organization for Research and Treatment Core Quality of Life questionnaire (EORTC QLQ C30) by using the smartphone app between October 2021 and June 2022. Thirteen healthcare professionals were interviewed to identify implementation barriers and facilitators to the ePRO system by using the Consolidated Framework for Implementation Research framework. Results The healthcare professionals identified a lack of clinical resources and a culture and system that emphasizes treatment over care as the main barriers; however, the accumulation of successful cases, the leadership of managers, and the growing needs of patients can serve as facilitators to the implementation. Conclusions Our experience implementing an ePRO system in a few Japanese oncology practices revealed comprehensive barriers and facilitators. Further efforts are warranted to develop more successful implementation strategies.

How to select and understand guidelines for patient-reported outcomes: a scoping review of existing guidance.

BACKGROUND: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making. METHODS: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria. RESULTS: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the "place" and "purpose" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by "places" and "purposes". CONCLUSIONS: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it.

A Randomized Controlled Trial of Betamethasone on Fatigue in Patients With Advanced Cancer.

CONTEXT: Fatigue is one of the most uncomfortable physical symptoms seen in patients with advanced cancer. Previous studies have reported on the efficacy of corticosteroids from Western countries. OBJECTIVES: To assess the effectiveness of 4mg betamethasone improving fatigue among Japanese patients with advanced cancer. METHODS: A randomized, double-blind, placebo-controlled trial enrolled eligible patients with advanced cancer expected to survive 1-2 months, with an Eastern Cooperative Oncology Group Performance Status of 2-3, and experiencing fatigue according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15-palliative criteria. Participants received twice-daily oral administration of 2 mg betamethasone (4 mg/d) or placebo for seven days, with fatigue assessed using EORTC QLQ-C15-PAL subscale and numerical rating scale (NRS) score (at baseline and day seven). The trial was registered under the University Hospital Medical Information Network (UMIN)000011913. RESULTS: Among the 267 screened patients, 81 were eligible, of which 70 were evaluable (betamethasone, 33; placebo, 37). The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was -8.2 (95% CIs: -22.3, 0.0; P = 0.178) and in a NRS for fatigue was -1.2 (95% CIs: -2.5, -0.01; P = 0.048), respectively. Emotional function, appetite loss, and global-health were slightly better in the betamethasone group than in the placebo group. CONCLUSION: The impact of betamethasone 4 mg/d on alleviating fatigue in patients with advanced cancer in the last weeks of life did not reach statistical significance in the EORTC-QLQ-C15-PAL as the primary endpoint, however, it was significant in the NRS, the secondary endpoint.

Perceptions regarding the concept and definition of patient-reported outcomes among healthcare stakeholders in Japan with relation to quality of life: a cross-sectional study.

Patient-reported outcomes (PROs) are frequently used in a variety of settings, including clinical trials and clinical practice. The definition of PRO and quality of life (QOL) and their relationship have been concluded through discussions among experts that has been the premise of PRO guidelines are not clearly stated in the guidelines. Therefore, the definition of PRO, especially in relation to QOL, is sometimes explained simply, as "PRO includes QOL," but this complicated matters. This study investigated the perceptions of PRO among various stakeholders (including patients and their families, the industry, clinicians, regulatory or health technology assessment personnel, and academic researchers) in Japan to clarify its definitions and that of QOL, including their relationship.We conducted a two-step survey: a qualitative interview survey and a web-based survey to ensure the validity of the survey. During the interviews, eight stakeholders described their perceptions and thoughts on PRO and its relationship to QOL, and their experience of using PRO. Overall 253 clinicians, 249 company employees, and 494 patients participated in the web survey to confirm how the findings of the interview survey supported the results.In the interview survey, patient advocates described various perspectives of PRO and QOL, including unexpected dynamic relationships, while the most other stakeholders explained PRO and QOL with the language used in the guidelines, but their responses were split. The web-based survey revealed that all stakeholders had a lower awareness of PRO than QOL. The most common perception of PRO, especially in the relationship to QOL, was "they did not fully overlap." Although there were differences in perceptions of the relationship between PRO and QOL among clinicians, company employees, and patients, all perceived PRO as a tool to facilitate communication in clinical practice.The present results are inconsistent with the simplified explanation of PRO, but consistent with the original PRO guideline definitions, which also considered the role of PRO in clinical practice. To make PRO a more potent tool, all stakeholders using PRO should confirm its definition and how it differs from QOL, have a unified recognition in each PRO use, and avoid miscommunication.

Encouraging outpatients in an acute hospital for the relief of cancer-related pain: a qualitative study.

PURPOSE: To identify the processes of cancer-related pain relief and exacerbation faced by outpatients in an acute care hospital and to examine the support needed for outpatient pain control. METHODS: We conducted semi-structured, in-depth interviews with patients from the outpatient department of Showa University Northern Yokohama Hospital in Kanagawa Prefecture, Japan. Participants were recruited by purposive sampling. From the recorded data, verbatim transcripts were made and used as textual data for analysis by consistent comparative method. RESULTS: Between April 2018 and April 2022, interviews were conducted with 30 participants. Analysis of the verbatim transcripts generated 13 categories from 27 concepts. Category relationships were examined, and a conceptual framework was developed. Outpatients went from being in a state of hesitation towards consultation with medical professionals to receiving individual consistent follow-ups by medical professionals in the hospital and community pharmacies, which led to patient teleconsultations when their physical condition changed, leading to an improvement of pain. CONCLUSION: The process of relief and exacerbation of cancer-related pain experienced by outpatients in the acute care hospital reveals that the provision of consistent follow-up through remote or in-person interviews has an important role to play in pain management, as it helps to build relationships between patients and medical professionals. Alternatively, when outpatients exhibited endurance, their pain worsened, and they fell into a negative cycle of poor pain control.

Trends and future projections of cervical cancer-related outcomes in Japan: What happens if the HPV vaccine program is not implemented?

Contrary to other developed countries, in Japan, recent years have seen increases in cervical cancer incidence and mortality among young people. However, the human papillomavirus (HPV) vaccine program, a key measure for avoiding cervical cancer, has been virtually suspended. Temporal changes in cervical cancer profiles in this unique situation have not been fully investigated epidemiologically. Our study aimed to determine the current status and future trends of the incidence and mortality of cervical cancer and precancerous lesions in Japan. Mortality rates of cervical cancer during 1975 to 2016 and incidence rates of cervical cancer and cervical intraepithelial neoplasia (CIN) 3 during 1975 to 2013 were examined using vital statistics and population-based cancer registry data in Japan. Bayesian age-period-cohort analyses were performed to analyze temporal changes of the three cervical cancer-related outcomes. We also calculated projections to 2028 for the three outcomes, assuming that HPV vaccination coverage and screening rates in Japan would be maintained at the current level after the resumption of the national vaccination program. The risk of occurrence of the three outcomes showed similar changes by birth cohort, peaking in the mid-1890s to 1900s birth cohorts, declining sharply in the 1940s birth cohort, and persistently increasing in the 1950s and later birth cohorts. Projections to 2028 show increases in cervical cancer incidence and mortality in the 30 to 69 age group, with a particular increase in CIN3 incidence in the 25 to 49 age group, if HPV vaccine programs and screening are not effectively implemented. These findings revealed an increasing cervical disease burden among reproductive age females in Japan.

A qualitative research study in Japan investigating patients' experience with metastatic castration-resistant prostate cancer: from diagnosis to decision for Ra-223 treatment.

Aim: This qualitative study aimed to reveal symptoms and impacts among bone metastatic castration-resistant prostate cancer (or mCRPC) Japanese patients, prior to Radium-223 (Ra-223) treatment. Materials & Methods: Twenty-three mCRPC patients designated to receive Ra-223 and three treating physicians (Ra-223 prescribers) in Japan, were interviewed. All interview data were assessed for concept frequency, themes and saturation. Results: Forty-five percent of the patients (mean age: 75.8 years) were symptomatic at the time of enrollment. Interviews with all patients revealed 47 mCRPC symptoms, including back pain and bone-specific pain, and 45 life impacts, including worry about disease progression and the impact on daily, physical activities. Conclusion: The symptoms and impacts of living with mCRPC and the associated burden of bone metastasis and skeletal-related symptoms are varied and are important considerations for treatment.

Lay abstract Aim: This study looked at symptoms and impacts among patients with a type of prostate cancer called metastatic castration-resistant prostate cancer. This cancer has spread to other parts of the body including patients' bones. Patients' prostate-specific antigen levels continue to rise despite surgical or medical treatment and their doctors decided the next best treatment is Radium-223 (Ra-223), a radiopharmaceutical therapy. Materials & methods: Twenty-three metastatic castration-resistant prostate cancer patients designated to receive Ra-223 and three treating physicians (Ra-223 prescribers) in Japan, were interviewed. All interview data were assessed for the number of times some words or themes are mentioned by the patients. Results: Ten of the 23 patients (average age of 76 years) had symptoms when the study started. Interviewed patients talked about symptoms including back pain and pain in their bones, and how their cancer caused them to worry about their physical activities and disease progression. Conclusion: The symptoms impact on patients' daily living and the burden of bone metastasis and bone-related symptoms are varied and are important considerations for treatment.

Translation and validation of the Japanese version of the measure of moral distress for healthcare professionals.

OBJECTIVES: Moral distress occurs when professionals cannot carry out what they believe to be ethically appropriate actions because of constraints or barriers. We aimed to assess the validity and reliability of the Japanese translation of the Measure of Moral Distress for Healthcare Professionals (MMD-HP). METHODS: We translated the questionnaire into Japanese according to the instructions of EORTC Quality of Life group translation manual. All physicians and nurses who were directly involved in patient care at nine departments of four tertiary hospitals in Japan were invited to a survey to assess the construct validity, reliability and factor structure. Construct validity was assessed with the relation to the intention to leave the clinical position, and internal consistency was assessed with Cronbach's alpha. Confirmatory factor analysis was conducted. RESULTS: 308 responses were eligible for the analysis. The mean total score of MMD-HP (range, 0-432) was 98.2 (SD, 59.9). The score was higher in those who have or had the intention to leave their clinical role due to moral distress than in those who do not or did not have the intention of leaving (mean 113.7 [SD, 61.3] vs. 86.1 [56.6], t-test p < 0.001). The confirmatory factor analysis and Cronbach's alpha confirmed the validity (chi-square, 661.9; CMIN/df, 2.14; GFI, 0.86; CFI, 0.88; CFI/TLI, 1.02; RMSEA, 0.061 [90%CI, 0.055-0.067]) and reliability (0.91 [95%CI, 0.89-0.92]) of the instrument. CONCLUSIONS: The translated Japanese version of the MMD-HP is a reliable and valid instrument to assess moral distress among physicians and nurses.

Inability to control gestational weight gain: an interpretive content analysis of pregnant Chinese women.

OBJECTIVE: This study aims to explore barriers to controlling gestational weight gain in pregnant Chinese women. DESIGN: Data were collected through semistructured interviews with pregnant women experiencing excessive gestational weight gain who struggled with weight management, and the data were examined using an interpretive content analysis. SETTINGS AND PARTICIPANTS: Fifty participants (≥18 years, with excessive gestational weight gain) were recruited when they visited the hospital for antenatal health checkups in Wuhan city (n=36) and Jinan city (n=14) between September and October 2018. RESULTS: Interpretive content analysis identified 75 barriers after examining diet, physical activity levels and general issues stemming from knowledge and beliefs, and physical, social, logistical, emotional and structural characteristics. Compared with reported deductive codes, this study inductively extracted 15 new codes. The most frequent codes showed that expectant grandparents greatly influenced pregnant women's lifestyles, through overprotection, traditional and conservative ideas and practices, and a lack of reliable knowledge or acceptable guidance on gestational weight control. CONCLUSIONS: This study provides a better understanding of the most important obstacles faced during decision making about gestational weight control in Chinese settings, especially the influence of traditional ideas/practices and expectant grandparents. Identifying the specific barriers to weight control should facilitate potential tailored supportive interventions. More efforts on health education for the whole family and a better use of maternal handbooks would be particularly beneficial.

Mindset modification of community pharmacists in a collaborative relationship between a major hospital and neighboring community pharmacies: a qualitative study.

BACKGROUND: Patient information sharing between hospitals and community pharmacies is generally insufficient. Since August 2013, the pharmacy department of Kyoto University Hospital has initiated and mediated a collaborative relationship between physicians and neighboring community pharmacies (e.g., sharing outpatient blood test results, holding regular meetings among professionals, delivery of tracing reports from community pharmacists to physicians about outpatients). METHODS: This study describes how community pharmacists have developed as a result of this professional collaboration (known as the "Kyoto University Hospital model") and attempts to grasp its current situation through interviews with pharmacists. The authors conducted semi-structured individual interviews with community pharmacists between June and December 2014. The interview data were analyzed using the constant comparative method. RESULTS: Twenty-one pharmacists working for 11 neighboring community pharmacies were interviewed, at which point theoretical saturation was achieved. The mean interview time was about 50 min. Among the participants, there were 15 women and 6 men; 10 were pharmacist managers and 11 were staff pharmacists. Through the analysis of the interview data, 13 categories were generated from 32 concepts. The results indicated that, through the Kyoto University Hospital model, community pharmacists shifted from a "Mindset of being the hospital's subcontractor" to "Being motivated to participate in team care." Specifically, their professional attitude shifted in a positive direction to "Being motivated to participate in team care", which was a departure from their previous feelings of inadequacy, related to their "Mindset of being the hospital's subcontractor" and how "Barrier to medicine counseling". CONCLUSIONS: Under the Kyoto University Hospital Model, hospital pharmacists encouraged active collaboration between physicians, hospital pharmacies, and community pharmacists by cultivating face-to-face relationships. This in turn helped community pharmacists become more conscious of their expert status, and thereby participate actively in patients' treatment.

Trends in descriptions of palliative care in the cancer clinical practice guidelines before and after enactment of the Cancer Control Act (2007): content analysis.

BACKGROUND: Palliative care was a priority issue in the Cancer Control Act enacted in 2007 in Japan, and this has resulted in efforts being made toward educational goals in clinical settings. An investigation of how descriptions of palliative care for the treatment of cancer have changed in clinical practice guidelines (CPGs) could be expected to provide a better understanding of palliative care-related decision-making. This study aimed to identify trends in descriptions of palliative care in cancer CPGs in Japan before and after enactment of the Cancer Control Act. METHODS: Content analysis was used to count the lines in all relevant CPGs. We then compared the number of lines and the proportion of descriptions mentioning palliative care at two time points: the first survey (selection period: February to June 2007) and the second survey (selection period: February to December 2015). Descriptions from the CPGs were independently selected from the Toho University Medical Media Center and Medical Information Network Distribution Service databases, and subsequently reviewed, by two investigators. RESULTS: Descriptions were analyzed for 10 types of cancer. The proportion of descriptions in the first survey (4.4%; 933/21,344 lines) was similar to that in the second survey (4.5%; 1325/29,269 lines). CONCLUSIONS: After the enactment of the Cancer Control Act, an increase was observed in the number, but not in the proportion, of palliative care descriptions in Japanese cancer CPGs. In the future, CPGs can be expected to play a major role in helping cancer patients to incorporate palliative care more smoothly.

A qualitative study on coping behaviors and influencing factors among mothers in Japan raising children under three years old while experiencing physical and mental subjective symptoms.

BACKGROUND: No studies illustrating the coping behaviors of mothers experiencing physical and mental subjective symptoms, or the factors that contribute to these behaviors, have been investigated. Therefore, the present study sought to develop a conceptual framework on the coping behaviors and contributing factors of mothers experiencing physical and mental subjective symptoms. METHODS: This qualitative study involved theoretical sampling and semi-structured interviews of mothers who were raising children under 3 years of age in Japan and had experienced physical and mental subjective symptoms since giving birth. Women who were pregnant, required regular medical exams, or had difficulty communicating in Japanese were excluded. All mothers were recruited via personal contacts, snowball sampling, and posters at a community center and nursery schools. Analysis was conducted using the constant comparative method. The interview data were extracted in contextual units based on analytical themes, and concepts were generated. Relationships between concepts were investigated and categorized. To confirm theoretical saturation and ensure the validity of the data, a study supervisor was appointed, four qualitative researchers examined the results, and the interview respondents underwent member checking. RESULTS: There were a total of 21 participants. Thirteen categories were created from 29 concepts identified from the analytical theme "What do mothers do when raising children under 3 years of age while experiencing physical and mental subjective symptoms?" While experiencing subjective symptoms, mothers raising children under 3 years of age tended to lead a child-centric lifestyle and were hesitant to visit the doctor, not only because of typical reasons such as time and costs, but also because of factors related to their child. Some circumstances occurring while experiencing physical and mental subjective symptoms led mothers to put their own needs first and attempt to cope on their own as much as possible. As a result, most mothers would only visit a doctor after becoming seriously ill. CONCLUSION: Mothers raising children under 3 years of age in Japan tend to put their own needs on hold when experiencing subjective symptoms. As a result, they attempt to cope on their own and, at times, only visit a doctor after becoming seriously ill.

How Evacuees Obtained Health Care Information After the Great East Japan Earthquake: A Qualitative Interview Study.

OBJECTIVE: To explore how evacuees obtained health care information at their evacuation destinations after the Great East Japan Earthquake. METHODS: We conducted semi-structured interviews of 11 evacuees who moved to City A in Kyoto Prefecture following the Great East Japan Earthquake. The interviews explored how the evacuees obtained health care information, including the main factors of influence. The interviews were transcribed and analyzed to identify trends by using the constant comparative method. RESULTS: Four categories emerged from 6 concepts. Mother-children evacuees and family evacuees tended to obtain health care information in different ways. Family evacuees had moved as a family unit and had obtained their health care information from local neighbors. Mother-children evacuees were mothers who had moved with their children, leaving behind other family members. These evacuees tended to obtain information from other mother-children evacuees. At the time of evacuation, we found 2 factors, emotions and systems, influencing how mother-children evacuees obtained health care information. CONCLUSIONS: We found 2 different ways of obtaining health care information among mother-children evacuees and other evacuees. At the time of evacuation, 2 factors, emotions and systems, influenced how mother-children evacuees obtained health care information. Community-building support should be a priority from an early stage after a disaster for health care management. (Disaster Med Public Health Preparedness. 2017;11:729-734).

Superiority of laparoscopic proximal gastrectomy with hand-sewn esophagogastrostomy over total gastrectomy in improving postoperative body weight loss and quality of life.

BACKGROUND: Proximal gastrectomy is not widely performed because the procedure is complicated, particularly under laparoscopy. We developed a simple laparoscopic technique of hand-sewn esophagogastrostomy with an anti-reflux mechanism. This study aimed to evaluate and compare the postoperative body weight loss (BWL) and quality of life (QOL) following laparoscopic proximal gastrectomy (LPG) and laparoscopic total gastrectomy (LTG) in patients with upper gastric cancer. METHODS: We retrospectively analyzed patients with stage I upper gastric cancer undergoing LPG or LTG at Kyoto University Hospital between March 2006 and June 2014. The main outcome measures were the % BWL 1 year after gastrectomy, postoperative anastomotic stricture, and reflux esophagitis. Additionally, patient-reported outcomes were evaluated using the Post-Gastrectomy Syndrome Assessment Scale (PGSAS)-45 in patients presenting at the outpatient clinic and exhibiting no recurrence. RESULTS: A total of 62 patients were included in this study (LTG, n = 42 vs. LPG, n = 20). The % BWL at 12 months in the LPG group was less than that in the LTG group (-16.3 vs. -10.7%). Multivariate analysis revealed that LPG was associated with less BWL (P = 0.003). Anastomotic stricture occurred more frequently in the LPG group than in the LTG group (0 vs. 25%). One patient in each group exhibited grade B severity of reflux esophagitis (based on the Los Angeles classification). In the questionnaire survey, LPG was better than LTG in terms of diarrhea and dissatisfaction with symptoms. In terms of reflux symptoms, patients in the LPG group experienced less acid and bile regurgitation symptoms compared with those in the LTG group. CONCLUSIONS: LPG with hand-sewn esophagogastrostomy results in less postoperative BWL and better QOL than LTG despite higher rates of anastomotic stricture.

Predicting failure to follow-up screened high blood pressure in Japan: a cohort study.

BACKGROUND: This study aimed to determine the prevalence and predictors of working-age individuals who did not follow-up for possible hypertension that was detected in the population-based screening. METHODS: We conducted a retrospective cohort study, using the database of health insurance claims and health checkups from several health insurance societies for employees in Japan. Screened participants aged ≥20 years, with possible hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) and without known antihypertensive treatment, were included. The outcome was lack of clinical follow-up for possible hypertension within 6 months of the latest screening. Multivariate logistic regression analysis was performed to identify predictors. RESULTS: Among 17,173 participants (15,793 males and 1380 females) who were identified as possible hypertensives, 89.7 and 82.3% of them, respectively, did not consult physicians for screened possible hypertension. Predictors of no clinical follow-up for males included younger age, lower body mass index (BMI), lower hemoglobin A1c and milder hypertension. Predictors for females included younger age, lower BMI and being insured. CONCLUSIONS: Approximately 80% of participants failed to consult physicians even with positive screening results. Younger individuals with lower BMI are at high risk of no clinical follow-up.

Predictors of hyperglycaemic individuals who do not follow up with physicians after screening in Japan: a cohort study.

AIMS: Although people screened as being hyperglycaemic often fail to follow up with physicians for clinical assessment, epidemiologic findings on the frequency and predictors of not following up (hereafter, "no follow-up") are lacking. The purpose of this study was to examine the no follow-up rate with physicians after screening for diabetes and predictors of no follow-up. METHODS: We assessed cases of no follow-up with physicians within six months after screening based on medical claims data from employee-based social health insurance programs in Japan, for people aged 20 to 68 years from 2005 to 2010. RESULTS: Among 3878 screened participants with hyperglycaemia, 2527 (65%) did not follow up with their physicians within six months after screening. Multiple logistic regression analysis revealed that younger age and lower blood glucose level predicted no follow-up among both men and women, while lower body mass index and negative proteinuria also predicted no follow-up among men. Treatment for dyslipidaemia facilitated follow-up among both genders, and treatment for hypertension or depression facilitated follow-up among men. CONCLUSIONS: Approximately two thirds of individuals screened as having hyperglycaemia did not follow up with their physicians within six months after screening. Predictors of no follow-up were younger age and milder hyperglycaemia. Being on treatment for co-morbidities tended to facilitate follow-up.

Birth environment facilitation by midwives assisting in non-hospital births: a qualitative interview study.

OBJECTIVE: midwifery homes (similar to birth centres) are rich in midwifery wisdom and skills that differ from those in hospital obstetrical departments, and a certain percentage of pregnant women prefer birth in these settings. This study aimed to understand the organisation of the perinatal environment considered important by independent midwives in non-hospital settings and to clarify the processes involved. DESIGN: semi-structured qualitative interview study and constant comparative analysis. PARTICIPANTS: 14 independent midwives assisting at births in midwifery homes in Japan, and six independent midwives assisting at home births. SETTING: Osaka, Kyoto, Nara, and Shiga, Japan. FINDINGS: midwives assisting at non-hospital births organised the birth environment based on the following four categories: 'an environment where the mother and family are autonomous'; 'a physical environment that facilitates birth'; 'an environment that facilitates the movement of the mother for birth'; and 'scrupulous safety preparation'. These, along with their sub-categories, are presented in this paper. KEY CONCLUSIONS: independent midwives considered it important to create a candid relationship between the midwife and the woman/family from the period of pregnancy to facilitate birth in which the woman and her family were autonomous. They also organised a distinctive environment for non-hospital birth, with preparations to guarantee safety. Experiential knowledge and skills played a major part in creating an environment to facilitate birth, and the effectiveness of this needs to be investigated objectively in future research.

Verification of the psychometric properties of the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 palliative (EORTCQLQ-C15-PAL).

PURPOSE: We compared Japanese versions of the EORTC QLQ-C15-PAL and QLQ-C30 to assess the utility of the former survey for terminal-phase cancer patients. METHODS: We used QLQ-C30 scores from the survey prior to each patient's death and extracted QLQ-C15-PAL data. We determined intraclass correlation coefficients (ICCs) of the five QLQ-C15-PAL subscales: physical functioning, emotional functioning, fatigue, nausea and vomiting, and global health status/quality of life (QOL) and assessed equivalent-form reliability. Regression analysis was used to determine the extent to which QLQ-C15-PAL items explained the QLQ-C30 score. RESULTS: Our study included 32 of 91 cancer patients receiving palliative care who could self-administer the questionnaire. The ICC between the QLQ-C15-PAL and QLQ-C30 scores was 0.93 or higher. The proportion of variance (R-squared) for each subscale was 0.87 or higher. CONCLUSION: We examined the validity and reliability of the Japanese version of the QLQ-C15-PAL. We found an 87% or higher chance that the QLQ-C15-PAL could explain the original QLQ-C30 score. Therefore, QLQ-C15-PAL appears to be useful for assessing the QOL of terminal-phase cancer patients.