Third Report of the Japan Diabetes Society/Japanese Cancer Association Joint Committee on Diabetes and Cancer: Summary of the results of a questionnaire survey of oncologists and diabetologists-Secondary publication.

The Japan Diabetes Society and the Japan Cancer Association launched a joint committee and published their "First Joint Committee Report on Diabetes and Cancer" in 2013, compiling recommendations for physicians and health-care providers as well as for the general population. In 2016, the "Second Joint Committee Report on Diabetes and Cancer" summarized the current evidence on glycemic control and cancer risk in patients with diabetes. The current "Third Joint Committee Report on Diabetes and Cancer", for which the joint committee also enlisted the assistance of the Japanese Society of Clinical Oncology and the Japanese Society of Medical Oncology, reports on the results from the questionnaire survey, "Diabetes Management in Patients Receiving Cancer Therapy," which targeted oncologists responsible for cancer management and diabetologists in charge of glycemic control in cancer patients. The results of the current survey indicated that there is a general consensus among oncologists and diabetologists with regard to the need for guidelines on glycemic control goals, the relevance of glycemic control, and glycemic control during cancer therapy in cancer patients.

Validity and Reproducibility of a Semiquantitative Food Frequency Questionnaire for Measuring Intakes of Foods and Food Groups.

We evaluated the validity and reproducibility of a semiquantitative food frequency questionnaire (FFQ) for measuring intakes of 149 foods and 25 food groups among 736 participants of the Women's Lifestyle Validation Study (WLVS, 2010-2012) and 649 participants of the Men's Lifestyle Validation Study (MLVS, 2011-2013). Validity of the FFQ compared with two 7-day dietary records measured 6 months apart and the reproducibility between 2 FFQs administered 1 year apart (FFQ1 and FFQ2) were assessed using Spearman correlations and intraclass correlation coefficients. The average 1-year reproducibility of FFQ-measured foods was 0.64 in both the WLVS and MLVS. Reproducibility of the food groups (mean = 0.71 among women and 0.72 among men) was generally higher than that for individual foods. Among women, the average validity correlation for individual foods was 0.59 when comparing FFQ2 with the 7-day dietary records. Among men, the corresponding average validity correlation was 0.61. Compared with individual foods, food groups had slightly higher validity correlations in both women (range, 0.45-0.92; mean = 0.61) and men (range, 0.46-0.88; mean = 0.65). This study reaffirms that the FFQ performs well in measuring most foods and food groups and provides data to adjust for measurement errors in epidemiologic studies of foods and food groups.

Translation and validation of a lifestyle questionnaire related to prostate cancer.

BACKGROUND: Valid and reliable instruments are needed to measure prostate cancer-related lifestyle changes, plan evidence-based interventions to modify lifestyle, and improve treatment outcomes. Due to the lack of appropriate instruments, this study was conducted to translate the Effects of Prostate Cancer upon Lifestyle Questionnaire (EPCLQ) into Persian and examine its psychometric properties in a sample of Iranian older adults with prostate cancer. METHODS: This methodological study was carried out between 2021 and 2022. Initially, the EPCLQ, comprising 36 items, was translated into Persian through a meticulous translation and back-translation procedure. Subsequent steps involved the assessment of face validity, qualitative content validity, content validity index, content validity ratio, construct validity via confirmatory factor analysis, and reliability testing of the Persian version of the EPCLQ. RESULTS: The psychometric evaluation led to the exclusion of 4 items from the EPCLQ. The refined model demonstrated satisfactory fit indices (PCFI = 0.732, PNFI = 0.696, CMIN/DF = 2.29, RMSEA = 0.072, IFI = 0.920, CFI = 0.919, and GFI = 0.971), indicating an appropriate fit of the final model. The internal consistency, as measured by Cronbach's alpha, was 0.67, and the intraclass correlation coefficient for the questionnaire was 0.938, reflecting high reliability. CONCLUSIONS: The Persian version of the EPCLQ, now consisting of 32 items, has been validated and is reliable for assessing the impact of prostate cancer on lifestyle among older adults. Its simplicity and the clarity of the items make it suitable for use in clinical settings or during home visits for follow-up assessments.

The cumulative burden of self-reported, clinically relevant outcomes in long-term childhood cancer survivors and implications for survivorship care: A DCCSS LATER study.

BACKGROUND: The aim of this study is to evaluate how cumulative burden of clinically relevant, self-reported outcomes in childhood cancer survivors (CCSs) compares to a sibling control group and to explore how the burden corresponds to levels of care proposed by existing risk stratifications. METHODS: The authors invited 5925 5-year survivors from the Dutch Childhood Cancer Survivor Study (DCCSS LATER) cohort and their 1066 siblings to complete a questionnaire on health outcomes. Health outcomes were validated by self-reported medication use or medical record review. Missing data on clinically relevant outcomes in CCSs for whom no questionnaire data were available were imputed with predictive mean matching. We calculated the mean cumulative count (MCC) for clinically relevant outcomes. Furthermore, we calculated 30-year MCC for groups of CCSs based on primary cancer diagnosis and treatment, ranked 30-year MCC, and compared the ranking to levels of care according to existing risk stratifications. RESULTS: At median 18.5 years after 5-year survival, 46% of CCSs had at least one clinically relevant outcome. CCSs experienced 2.8 times more health conditions than siblings (30-year MCC = 0.79; 95% confidence interval [CI], 0.74-0.85 vs. 30-year MCC = 0.29; 95% CI, 0.25-0.34). CCSs' burden of clinically relevant outcomes consisted mainly of endocrine and vascular conditions and varied by primary cancer type. The ranking of the 30-year MCC often did not correspond with levels of care in existing risk stratifications. CONCLUSIONS: CCSs experience a high cumulative burden of clinically relevant outcomes that was not completely reflected by current risk stratifications. Choices for survivorship care should extend beyond primary tumor and treatment parameters, and should consider also including CCSs' current morbidity.

A systematic review on the application of machine learning models in psychometric questionnaires for the diagnosis of attention deficit hyperactivity disorder.

Attention deficit hyperactivity disorder is one of the most prevalent neurodevelopmental disorders worldwide. Recent studies show that machine learning has great potential for the diagnosis of attention deficit hyperactivity disorder. The aim of the present article is to systematically review the scientific literature on machine learning studies for the diagnosis of attention deficit hyperactivity disorder, focusing on psychometric questionnaire tools. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were adopted. The review protocol was registered in the PROSPERO database. A search was conducted in three databases-Web of Science Core Collection, Scopus and Pubmed-with the aim of identifying studies that apply ML techniques to support the diagnosis of attention deficit hyperactivity disorder. A total of 17 empirical studies were found that met the established inclusion criteria. The results showed that machine learning can be used to increase the accuracy of attention deficit hyperactivity disorder diagnosis. Machine learning techniques are useful and effective strategies that can complement traditional diagnostics in patients with attention deficit hyperactivity disorder.

Patient-reported outcomes in chronic hepatitis delta: An exploratory analysis of the Phase III MYR301 trial of bulevirtide.

BACKGROUND & AIMS: Once-daily treatment of chronic hepatitis delta (CHD) with bulevirtide is well tolerated and associated with significant reductions in HDV RNA in the blood and in biochemical liver disease activity. This study explored the effects of 48-week bulevirtide treatment on health-related quality of life (HRQoL) in patients with CHD. METHODS: In an open-label, randomised, Phase 3 trial, 150 patients with CHD and compensated liver disease were stratified by liver cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks. HRQoL was evaluated by the following patient-reported outcome (PRO) instruments at baseline, 24 weeks, and 48 weeks: EQ-5D-3L, Hepatitis Quality of Life Questionnaire (HQLQ), and Fatigue Severity Scale (FSS). RESULTS: Patient characteristics and HRQoL scores were balanced at baseline between the treatment (2 mg, n = 49; 10 mg, n = 50) and control (n = 51) groups. Patients receiving 2-mg bulevirtide reported significant improvements compared with controls on the HQLQ domains of role physical, hepatitis-specific limitations, and hepatitis-specific health distress. Numerically higher scores for general health, hepatitis-specific limitations, and hepatitis-specific health distress domains were reported by patients with cirrhosis who received bulevirtide vs control. FSS scores remained stable across treatment groups throughout. At week 48, patients in the 2-mg group showed greater mean improvement from baseline in health status compared with controls on the EQ-5D-3L visual analogue scale. CONCLUSION: PROs indicate that 48-week treatment with bulevirtide monotherapy may improve aspects of HRQoL in patients with CHD. IMPACT AND IMPLICATIONS: Bulevirtide 2 mg is the only approved treatment for patients with chronic hepatitis delta (CHD) in the EU. Patients with CHD have worse quality of life scores than those with chronic hepatitis B. Bulevirtide treatment for 48 weeks reduced HDV RNA and alanine aminotransferase levels and was well tolerated among patients with CHD. For the first time, this study shows that patients who received bulevirtide therapy for 48 weeks reported improvements in physical and hepatitis-related quality of life domains compared to those who did not receive therapy (control group). CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT03852719.

Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies - impact of drug packaging and administration method on patient reported outcomes.

BACKGROUND: Here, the perspective of patients with primary and secondary immunodeficiency receiving subcutaneous immunoglobulin (SCIg) via introductory smaller size pre-filled syringes (PFS) or vials were compared. METHODS: An online survey was conducted in Canada by the Association des Patients Immunodéficients du Québec (APIQ) (10/2020-03/2021). Survey questions included: reasons for choosing SCIg packaging and administration methods, training experiences, infusion characteristics, and switching methods. The survey captured structured patient-reported outcomes: treatment satisfaction and its sub-domains, symptom state, general health perception, and physical and mental function. Respondents using PFS were compared with vial users, overall and stratified by their administration method (pump or manual push). RESULTS: Of the 132 total respondents, 66 respondents used vials, with 38 using a pump and 28 using manual push. PFS (5 and 10 mL sizes) were being used by 120 respondents, with 38 using a pump and 82 using manual push. PFS users were associated with a 17% lower median (interquartile range) SCIg dose (10 [8, 12] vs. 12 [9, 16] g/week, respectively), a significantly shorter infusion preparation time (15 [10, 20] vs. 15 [10, 30] mins, respectively), and a trend for shorter length of infusion (60 [35, 90] vs. 70 [48, 90] mins, respectively) compared with those on vials. Patient-reported treatment satisfaction scores were overall similar between vial and PFS users (including on the domains of effectiveness and convenience), except for a higher score for vials over PFS on the domain of global satisfaction (p=0.02). CONCLUSIONS: Consistent with prescribing that reflects a recognition of less wastage, PFS users were associated with a significantly lower SCIg dose compared with vial users. PFS users were also associated with shorter pre-infusion times, reflecting simpler administration mechanics compared with vial users. Higher global satisfaction with treatment among vial users compared with PFS users was consistent with users being limited to smaller PFS size options in Canada during the study period. Patient experience on PFS is expected to improve with the introduction of larger PFS sizes. Overall, treatment satisfaction for SCIg remains consistently high with the introduction of PFS packaging compared with vials.

Researchers support preprints and open access publishing, but with reservations: A questionnaire survey of MBSJ members.

Since the 1990s, journals have become increasingly online and open access. In fact, about 50% of articles published in 2021 were open access. The use of preprints (i.e., non-peer-reviewed articles) has also increased. However, there is limited awareness of these concepts among academics. Therefore, we conducted a questionnaire-based survey among members of the Molecular Biology Society of Japan. The survey was conducted between September 2022 and October 2022, with 633 respondents, 500 of whom (79.0%) were faculty members. In total, 478 (76.6%) respondents had published articles as open access, and 571 (91.5%) wanted to publish their articles in open access. Although 540 (86.5%) respondents knew about preprints, only 183 (33.9%) had posted preprints before. In the open-ended section of the questionnaire survey, several comments were made about the cost burdens associated with open access and the difficulty of how academic preprints are handled. Although open access is widespread, and recognition of preprints is increasing, some issues remain that need to be addressed. Academic and institutional support, and transformative agreement may help reduce the cost burden. Guidelines for handling preprints in academia are also important for responding to changes in the research environment.

Development of a signs and symptoms outcome measure for caregivers of patients with methylmalonic acidemia and propionic acidemia (MMAPAQ).

BACKGROUND AND OBJECTIVE: Methylmalonic acidemia (MMA) and propionic acidemia (PA) are rare inborn errors of metabolism with shared signs and symptoms that are associated with significant morbidity and mortality. No disease-specific clinical outcomes assessment instruments for MMA and/or PA currently exist to capture the patient perspective in clinical trials. Because patients with these conditions are generally young and have cognitive impairments, an observer-reported outcome (ObsRO) instrument is crucial. We report results from qualitative research supporting development of the Methylmalonic Acidemia and Propionic Acidemia Questionnaire (MMAPAQ), a signs and symptoms ObsRO measure for caregivers of patients with MMA and/or PA. METHODS: Concept elicitation (CE) interviews were conducted with 35 participants across 2 studies who were aged ≥18 years and caregivers of patients with a confirmed diagnosis of MMA or PA, and an additional 5 patients aged ≥6 years with MMA or PA in Study 1, to identify core signs/symptoms for inclusion in the MMAPAQ. All interviews were conducted in English. Study 2 included cognitive interviews (CI) with caregivers and clinical experts to further assess content validity. CE and a conceptual framework review were also conducted with clinical experts to further support findings. RESULTS: A consistent set of signs/symptoms of MMA and PA were reported by eligible caregivers interviewed in study 1 (n = 21) and study 2 (n = 14), representing 11 patients with MMA and 20 with PA. Based on concepts reported in study 1, a draft instrument was constructed and compared with the Pediatric Quality of Life Inventory™ (PedsQL™) and Family Impact module, demonstrating face validity for measuring key signs/symptoms important to patients and caregivers. The PedsQL™ and Family Impact modules were preferred to assess patient and caregiver impacts. Two waves of CE and CIs were conducted in study 2, with wave 1 resulting in removal of 7 items and other revisions to improve clarity, and wave 2 resulting in modification of examples used for 2 items. The final instrument consisted of the following 7 items assessed over the past 7 days using a Likert-type response scale ranging from "never" to "very often": uncontrollable or involuntary movements, dehydration, rapid breathing at rest, appearing lethargic, appearing disinterested in eating, refusing to eat, and vomiting. CONCLUSIONS: This study establishes the content validity of the MMAPAQ as the first ObsRO questionnaire for measuring core signs and symptoms of MMA and PA in clinical trials and community research. Scoring and psychometric measurement properties of the MMAPAQ will be established in future studies. The PedsQL™ was found to have face validity in measuring concepts that affect the MMA and PA patient populations and should also be considered for use in clinical trials in MMA and PA.

The prevalence, determinants, and consequences of post-COVID in healthcare workers: A cross-sectional survey.

Data on post-coronavirus disease (COVID) in healthcare workers (HCWs) are scarce. We aimed to assess prevalence, determinants, and consequences of post-COVID in HCWs. In fall 2022, we performed a cross-sectional survey in a tertiary care hospital with a web-based questionnaire sent to HCWs. Post-COVID was defined as persistent/new symptoms 3 months after acute COVID. Propensity score weighting was performed to assess the impact of post-COVID on return-to-work. 1062 HCWs completed the questionnaire, 713 (68%) reported at least one COVID, and 109 (10%) met the definition for post-COVID, with workplace contamination reported in 51 (47%). On multivariable analysis, risk factors for post-COVID were female gender (p = 0.047), ≥50 years (p = 0.007), immunosuppression (p = 0.004), ≥2 COVID episodes (p = 0.003), and ≥5 symptoms during acute COVID (p = 0.005). Initial sick leave was prescribed for 94 HCWs (86% post-COVID), for a median duration of 7 [7-9] days, and extended for 23. On return-to-work, 91 (84%) had residual symptoms, primarily asthenia/fatigue (72%) and cognitive impairment (25%). Cognitive impairment at return-to-work was associated with post-COVID. Ten HCWs (9%) received a medical diagnosis of post-COVID, 8 consulted the occupational physician, and four required work adaptation. Post-COVID affected 10% of HCWs. Long-term consequences included repeated sick leaves and residual symptoms on return-to-work.