Acupuncture for hot flashes in hormone receptor-positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.

BACKGROUND: Hot flashes are a common side effect of endocrine therapy (ET) that contribute to poor quality of life and decreased treatment adherence. METHODS: Patients with breast cancer wo were receiving ET and experiencing hot flashes were enrolled through three parallel, randomized trials conducted in the United States, China, and South Korea. Participants were randomized to either immediate acupuncture (IA) or delayed acupuncture control (DAC). IA participants received 20 acupuncture sessions over 10 weeks, whereas DAC participants received usual care, then crossed over to acupuncture with a reduced intensity. The primary end point was a change in score on the endocrine symptom subscale of the Functional Assessment of Cancer Therapy (FACT)-Endocrine Symptoms between baseline and week 10. Secondary end points included the hot flash score and the FACT-Breast score. A planned pooled analysis of individual patient data was performed using longitudinal mixed models. RESULTS: In total, 158 women with stage 0-III breast cancer were randomized (United States, n = 78; China, n = 40; South Korea, n = 40). At week 10, IA participants reported statistically significant improvements in the endocrine symptom subscale score (mean change ± standard error: 5.1 ± 0.9 vs. 0.2 ± 1.0; p = .0003), the hot flash score (-5.3 ± 0.9 vs. -1.4 ± 0.9; p < .003), and the FACT-Breast total score (8.0 ± 1.6 vs. -0.01 ± 1.6; p = .0005) compared with DAC participants. The effect of the acupuncture intervention differed by site (p = .005). CONCLUSIONS: Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer-specific quality of life in women undergoing ET for breast cancer in the United States, China, and South Korea.

Patient-reported symptoms before adjuvant locoregional radiotherapy for breast cancer: triple-negative histology impacts the symptom burden.

BACKGROUND: Multimodal breast cancer treatment may cause side effects reflected in patient-reported outcomes and/or symptom scores at the time of treatment planning for adjuvant radiotherapy. In our department, all patients have been assessed with the Edmonton Symptom Assessment System (ESAS; a questionnaire addressing 11 major symptoms and wellbeing on a numeric scale of 0-10) at the time of treatment planning since 2016. In this study, we analyzed ESAS symptom severity before locoregional radiotherapy. PATIENTS AND METHODS: Retrospective review of 132 patients treated between 2016 and 2021 (all comers in breast-conserving or post-mastectomy settings, different radiotherapy fractionations) was performed. All ESAS items and the ESAS point sum were analyzed to identify subgroups with higher symptom burden and thus need for additional care measures. RESULTS: The biggest patient-reported issues were fatigue, pain, and sleep problems. Patients with triple negative breast cancer reported a higher symptom burden (mean 30 versus 20, p = 0.038). Patients assigned to adjuvant endocrine therapy had the lowest point sum (mean 18), followed by those on Her-2-targeting agents without chemotherapy (mean 19), those on chemotherapy with or without other drugs (mean 26), and those without systemic therapy (mean 41), p = 0.007. Those with pathologic complete response after neoadjuvant treatment had significantly lower anxiety scores (mean 0.7 versus 1.8, p = 0.03) and a trend towards lower depression scores, p = 0.09. CONCLUSION: Different surgical strategies, age, and body mass index did not impact on ESAS scores, while the type of adjuvant systemic therapy did. The effect of previous neoadjuvant treatment and unfavorable tumor biology (triple negative) emerged as important factors associated with symptom burden, albeit in different domains. ESAS data may facilitate identification of patients who should be considered for additional supportive measures to alleviate specific symptoms.

Assessing Substance Use Disorder Symptoms with a Checklist among Primary Care Patients with Opioid Use Disorder and/or Long-Term Opioid Treatment: An Observational Study.

BACKGROUND: Primary care (PC) offers an opportunity to treat opioid use disorders (OUD). The Substance Use Symptom Checklist ("Checklist") can assess DSM-5 substance use disorder (SUD) symptoms in PC. OBJECTIVE: To test the psychometric properties of the Checklist among PC patients with OUD or long-term opioid therapy (LTOT) in Kaiser Permanente Washington (KPWA). DESIGN: Observational study using item response theory (IRT) and differential item functioning (DIF) analyses of measurement consistency across age, sex, race and ethnicity, and receipt of treatment. PATIENTS: Electronic health records (EHR) data were extracted for all adult PC patients visiting KPWA 3/1/15-8/30/2020 who had ≥ 1 Checklist documented and indication of either (a) clinically-recognized OUD (i.e., documented OUD diagnosis and/or OUD medication treatment) or (b) LTOT in the year prior to the checklist. MAIN MEASURE: The Checklist includes 11 items reflecting DSM-5 criteria for SUD. We described the prevalence of 2 SUD symptoms reported on the Checklist (consistent with mild-severe DSM-5 SUD). Analyses were conducted in the overall sample and in two subsamples (clinically-recognized OUD and LTOT only). KEY RESULTS: Among 2007 eligible patients, 39.9% endorsed ≥ 2 SUD symptoms (74.3% in the clinically-recognized OUD subsample and 13.1% in LTOT subsample). IRT indicated that a unidimensional model for the 11 checklist items had excellent fit (comparative fit index = 0.998) with high item-level discrimination parameters for the overall sample and both subsamples. DIF across age, race and ethnicity, and treatment was observed for one item each, but had minimal impact on expected number of criteria (0-11) patients endorse. CONCLUSIONS: The Substance Use Symptom Checklist measured SUD symptoms consistent with DSM-5 conceptualization (scaled, unidimensional) in patients with clinically-recognized OUD and LTOT and had similar measurement properties across demographic subgroups. The Checklist may support symptom assessment in patients with OUD and diagnosis in patients with LTOT.

Acceptability and usefulness of the EORTC 'Write In three Symptoms/Problems' (WISP): a brief open-ended instrument for symptom assessment in cancer patients.

BACKGROUND: The use of open-ended questions supplementing static questionnaires with closed questions may facilitate the recognition of symptoms and toxicities. The open-ended 'Write In three Symptoms/Problems (WISP)' instrument permits patients to report additional symptoms/problems not covered by selected EORTC questionnaires. We evaluated the acceptability and usefulness of WISP with cancer patients receiving active and palliative care/treatment in Austria, Chile, France, Jordan, the Netherlands, Norway, Spain and the United Kingdom. METHODS: We conducted a literature search on validated instruments for cancer patients including open-ended questions and analyzing their responses. WISP was translated into eight languages and pilot tested. WISP translations were pre-tested together with EORTC QLQ-C30, QLQ-C15-PAL and relevant modules, followed by patient interviews to evaluate their understanding about WISP. Proportions were used to summarize patient responses obtained from interviews and WISP. RESULTS: From the seven instruments identified in the literature, only the free text collected from the PRO-CTAE has been analyzed previously. In our study, 161 cancer patients participated in the pre-testing and interviews (50% in active treatment). Qualitative interviews showed high acceptability of WISP. Among the 295 symptoms/problems reported using WISP, skin problems, sore mouth and bleeding were more prevalent in patients in active treatment, whereas numbness/tingling, dry mouth and existential problems were more prevalent in patients in palliative care/treatment. CONCLUSIONS: The EORTC WISP instrument was found to be acceptable and useful for symptom assessment in cancer patients. WISP improves the identification of symptoms/problems not assessed by cancer-generic questionnaires and therefore, we recommend its use alongside the EORTC questionnaires.

In symptomatic patients on as-needed inhaled corticosteroids-formoterol, VAS asthma is associated with small airways resistance.

OBJECTIVES: Impulse oscillometry (IOS) can demonstrate small airways disease even when spirometry values are normal. However, it is unknown if the absence of symptoms excludes increased small airways resistance in asthma patients. We aimed to correlate symptoms (assessed through visual analogue scales) with measures of small airways resistance in patients with asthma and to determine whether less symptomatic patients have increased small airways resistance. METHODS: We conducted a single center, prospective cohort study. We included controlled asthma patients on as-needed inhaled corticosteroids-formoterol. Patients were evaluated on their symptom VASs, Spirometry and IOS (with R5-R20% measuring small airways resistance) which were measured both in periods when they were less symptomatic and symptomatic. Symptoms were assessed using MASK-air®, an mHealth app that includes a daily monitoring questionnaire with validated VASs. We correlated MASK-air VASs with small airways resistance. RESULTS: We assessed 29 patients. There was a significant correlation between VAS asthma and R5-R20% in symptomatic periods (r = 0.43; 95% CI = 0.13;0.68, p = 0.019), but not in less symptomatic periods (0.04; 95% CI-0.40;0.46; p = 0.825). In less symptomatic periods, patients presenting with low VAS asthma (VAS < 30) displayed a lower median R5-R20% than the remainder (0.26 versus 0.35), as well as a lower R5% (0.13 versus 0.15) (p < 0.001). In 68.9% of less symptomatic patients, R5-R20 values remained higher than normal values. CONCLUSION: In symptomatic patients on as-needed inhaled corticosteroids-formoterol, VAS asthma was associated with small airways resistance. However, even if these patients are less symptomatic, small airways resistance may be higher than normal. Since SAD significantly affects asthma control, patients should be carefully followed-up, even in less symptomatic periods.

The effectiveness of reminiscence therapy on the symptom management, the life satisfaction, and the self-transcendence in palliative care patients: a randomized controlled trial.

PURPOSE: To examine the effect of individualized reminiscence therapy on the management of global distress and physical and psychological symptoms, life satisfaction and self-transcendence levels of palliative care patients. METHODS: In a single-center palliative care service in western Turkey, 48 patients without cognitive impairment and able to communicate were included in the study. However, 44 patients completed the study. Patients who met the inclusion criteria were randomly assigned to the reminiscence therapy (intervention), unstructured social interviewing (placebo), and control groups (16 people for each group) before the start of the study. The sessions for the interview and placebo groups were conducted face-to-face in the patient's room (while the patient was sitting or lying down) for 15 days (2 weeks), every other day, for a total of eight sessions (each session was approximately 30 min). Data collection instruments-the Memorial Symptom Assessment Scale, the Contentment with Life Assessment Scale, and the Self-Transcendence Scale-were collected at baseline (first day) and after the intervention (day 15th). Statistical significance level was accepted as p < 0.05. RESULTS: There was no decrease in physical and total symptom burden (p > 0.05). There were significant reductions in general distress and psychological symptoms in the intervention and placebo groups within the group (p < 0.05), but there were no significant differences between the control group and all groups when compared (p > 0.05). Group × time interactions were statistically significant for life satisfaction and self-transcendence (p < 0.001), and there was a substantial increase in the intervention group compared to the other groups. CONCLUSION: It may be recommended that reminiscence therapy intervention be included in routine nursing care as it may contribute positively to the psychological recovery of palliative care patients approaching the end of life. TRIAL REGISTRATION: ClinicalTrails.gov (Registration number: NCT05242016). Prospectively registered on 1 February 2022.

Validation of the Skin Symptom Assessment (SSA) questionnaire for the evaluation of radiation dermatitis in breast cancer patients.

PURPOSE: Radiation dermatitis (RD) is a painful side effect of radiation therapy (RT). The objective of this analysis was to investigate the validity and reliability of the Skin Symptom Assessment (SSA) questionnaire in evaluating the severity of patient- and clinician-reported outcomes for RD in breast cancer patients by comparing it to a validated assessment tool, the Radiation-Induced Skin Reaction Assessment Scale (RISRAS) questionnaire. METHODS: This study compared patient and clinician-reported outcomes for RD from previous clinical trials conducted in a Canadian cancer centre. The analysis included 376 and 38 patients in the two trials using Mepitel Film (doi.org/10.1200) and StrataXRT (clinicaltrials.gov identifier: NCT05594498), respectively. Patients in both studies completed the SSA and RISRAS questionnaires at baseline, 2-weeks post-RT, and 3 months after completion of RT. Clinician SSA and RISRAS assessments were collected at baseline and 2-weeks post-RT. These time points were analyzed longitudinally to investigate the SSA's validity in RD symptom assessment. RESULTS: The majority of patient-reported items on the SSA and RISRAS assessments demonstrated positive significant associations between symptoms of itchiness, between pain/soreness and pain/discomfort, and between blistering or erythema with burning sensation items. All items in the clinician-reported SSA and clinician component of RISRAS showed positive statistical significance between items measuring erythema, pigmentation or edema with dry desquamation, and blistering/peeling with moist desquamation. CONCLUSIONS: The SSA has been validated for assessing patient- and clinician-reported symptoms of RD accurately as outcomes correlate well with the previously validated RISRAS assessment.

Differences in palliative care needs between cancer patients and non-cancer patients at the start of specialized palliative care: A nationwide register-based study.

BACKGROUND: Patients with non-cancer disease are less likely to receive specialized palliative care than cancer patients. To be able to provide the best specialized palliative care, it is important to understand palliative care needs of non-cancer patients and whether the type and level of needs differ from those of cancer patients. Large studies including both cancer and non-cancer patients, using validated needs-assessment-tools, are needed to understand differences in palliative care needs at admittance to specialized palliative care. AIMS: To compare palliative care needs at the start of palliative care for cancer and non-cancer disease. DESIGN: Six-year nationwide register-based study. SETTING/PARTICIPANTS: This study included patients from all Danish specialized palliative care services (hospice care, hospital-based palliative care, home-based palliative care, or consultation) who completed a need-assessment-questionnaire. Ordinal logistic regression was performed to study the association between diagnosis and needs. RESULTS: Cancer patients had a higher probability of receiving specialized palliative care. Of the 44,315 palliative care admissions included in this study, 93.3% were on cancer patients. Independent of diagnosis patients experienced on average six needs and high levels of fatigue and impaired physical functioning. Non-cancer patients had significantly higher odds of insomnia, fatigue and impaired emotional functioning, physical functioning, and quality of life whereas cancer patients had higher odds of pain (except for patients with neurological disease). CONCLUSIONS: The higher levels of several symptoms/problems among non-cancer patients compared to cancer patients suggests that referral to specialized palliative care should be improved for non-cancer patients perhaps by improving identification of palliative needs.

Menopause and Traumatic Brain Injury: A NIDILRR Collaborative Traumatic Brain Injury Model Systems Study.

OBJECTIVE: To examine the experience of menopause symptoms in women with traumatic brain injury (TBI). DESIGN: Cross-sectional descriptive study. SETTING: Five sites of the TBI Model Systems (TBIMS) program. PARTICIPANTS: Participants were 210 women, aged 40-60 years, who were not taking systemic hormones and did not have both ovaries removed: 61 participants were enrolled in the TBIMS, who were at least 2 years post-TBI and living in the community. One hundred forty-nine participants without TBI were recruited from a research registry and the metropolitan Detroit community. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A checklist comprised of 21 menopause symptoms assessing 4 symptom clusters (vasomotor, somatic, psychological, and cognitive). RESULTS: TBI and non-TBI groups did not significantly differ and showed small effect sizes on vasomotor symptoms. On the remaining symptom clusters, women with TBI showed greater presence and severity of symptoms than women without TBI, as well as fewer differences between premenopausal and postmenopausal women on those symptoms. A profile indicating an additive or potentiating effect of TBI on menopause symptoms was not observed. CONCLUSIONS: Findings support a conceptual model of menopause and TBI indicating that symptoms most closely associated with estrogen decline are similar for women with and without TBI, whereas symptoms that overlap with common TBI sequelae are generally more frequent and severe among these women. Likely because of lower baseline of symptoms premenopause, postmenopausal women without TBI reported more numerous and severe symptoms relative to their premenopausal counterparts without TBI. Overall, it may be that women without TBI experience menopause as more of a "change" of life, whereas women with TBI chronically face significantly more of these symptoms than women without TBI.

Enhanced clinical decisions for management of benign prostatic hyperplasia using patient-reported outcomes: protocol for a prospective observational study.

BACKGROUND: Lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) significantly impact quality of life among older men. Despite the prevalent use of the American Urological Association Symptom Index (AUA-SI) for BPH, this measure overlooks key symptoms such as pain and incontinence, underscoring the need for more comprehensive patient-reported outcome (PRO) tools. This study aims to integrate enhanced PROs into routine clinical practice to better capture the spectrum of LUTS, thereby improving clinical outcomes and patient care. METHODS: This prospective observational study will recruit men with LUTS secondary to BPH aged ≥ 50 years from urology clinics. Participants will be stratified into medical and surgical management groups, with PRO assessments scheduled at regular intervals to monitor LUTS and other health outcomes. The study will employ the LURN Symptom Index (SI)-29 alongside the traditional AUA-SI and other non-urologic PROs to evaluate a broad range of symptoms. Data on comorbidities, symptom severity, and treatment efficacy will be collected through a combination of electronic health records and PROs. Analyses will focus on the predictive power of these tools in relation to symptom trajectories and treatment responses. Aims are to: (1) integrate routine clinical tests with PRO assessment to enhance screening, diagnosis, and management of patients with BPH; (2) examine psychometric properties of the LURN SIs, including test-retest reliability and establishment of clinically meaningful differences; and (3) create care-coordination recommendations to facilitate management of persistent symptoms and common comorbidities measured by PROs. DISCUSSION: By employing comprehensive PRO measures, this study expects to refine symptom assessment and enhance treatment monitoring, potentially leading to improved personalized care strategies. The integration of these tools into clinical settings could revolutionize the management of LUTS/BPH by providing more nuanced insights into patient experiences and outcomes. The findings could have significant implications for clinical practices, potentially leading to updates in clinical guidelines and better health management strategies for men with LUTS/BPH. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov (NCT05898932).

Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation.

BACKGROUND: To compare and evaluate objective and subjective clinical parameters between 0.05% cyclosporine nanoemulsion (CsN) and 0.15% hyaluronic acid (HA) administration in patients with mild-to-moderate dry eyes. METHODS: In this prospective, randomized, double-masked, single-center, and placebo-controlled parallel study, patients with mild-to-moderate dry eyes were randomly allocated to be treated with 0.05% CsN or 0.15% HA twice daily. Patients were followed-up at 4, 8, and 12 weeks. Objective and subjective parameters were evaluated during each visit. RESULTS: A total of 35 patients were enrolled in this study. Compared with baseline, tear film break-up time and fluorescein staining scores at 4, 8, and 12 weeks significantly improved in the CsN group. However, the Schirmer I test showed no statistically significant change until week 12. Using the Symptom Assessment in Dry Eye (SANDE) score, both groups gradually showed significant improvement compared with baseline values. However, the Dry Eye-Related Quality-of-life Score Questionnaire (DEQS) showed no statistically significant change during the treatment period. CONCLUSIONS: Both 0.05% CsN and 0.15% HA administration twice a day effectively improved the objective signs and subjective symptoms of patients with mild-to-moderate dry eyes. However, patients treated with 0.05% CsN experienced greater and faster improvement.

Pilot study evaluating feasibility and utility of pharmacist-driven oral antineoplastic agent monitoring program.

INTRODUCTION: Oncologists are increasingly prescribing oral antineoplastic agents which have benefits and challenges impacting patient outcomes. Practice guidelines recommend monitoring symptoms and adherence without outlining any specific tools or methods for monitoring. Pharmacists are successful in monitoring patients on therapy and improving outcomes. We aimed to assess the feasibility and utility of a pharmacist-delivered and medical record-integrated adherence and symptom monitoring program for patients on oral antineoplastic agents. METHODS: This single-center, prospective, interventional study designed and implemented an adherence and monitoring program. A pharmacist contacted patients twice between clinic visits for three months. During telephone encounters, patients were verbally screened for medication adherence and assessed for new or changing symptoms using the Edmonton Symptom Assessment System as a signal of possible adverse events. We measured feasibility via patient enrollment, completed proportion of scheduled contacts, and pharmacist time. Utility was assessed through patient adherence, satisfaction surveys, healthcare resource utilization, and pharmacist interventions (i.e., patient education, adherence assistance, and symptom management). RESULTS: Fifty-one patients participated. Ninety-one percent of scheduled patient contacts were completed. Edmonton Symptom Assessment System was administered by pharmacy personnel 102 times. Patient-reported adherence was 100%. Overall satisfaction was 85% and 100%, for patients and physicians, respectively. Fifty-one (98%) pharmacist recommendations were accepted. There were 14 total utilizations of healthcare resources-5.2 per 1000 patient days. CONCLUSIONS: This study suggests a pharmacist monitoring program for patients taking oral antineoplastic agents is feasible and provides utility. Further research is needed to evaluate whether this program improves safety, adherence, and outcomes in patients using oral antineoplastic agents.

New categorization of chest pain: noncardiac is in, atypical is out!

Chest pain poses a diagnostic challenge in the emergency department and requires a thorough clinical assessment. The traditional distinction between "atypical" and "typical" chest pain carries the risk of not addressing nonischemic clinical pictures. The newly conceived subdivision into cardiac, possibly cardiac, and (probably) noncardiac causes of the presenting symptom complex addresses a much more interdisciplinary approach to a symptom-oriented diagnostic algorithm. The diagnostic structures of the chest pain units in Germany do not currently reflect this. An adaptation should therefore be considered.

A comparison of the prevalence of dry mouth and other symptoms using two different versions of the Edmonton Symptom Assessment System on an inpatient palliative care unit.

BACKGROUND: Symptom assessment is key to effective symptom management and palliative care for patients with advanced cancer. Symptom prevalence and severity estimates vary widely, possibly dependent on the assessment tool used. Are symptoms specifically asked about or must the patients add them as additional symptoms? This study compared the prevalence and severity of patient-reported symptoms in two different versions of a multi-symptom assessment tool. In one version, three symptoms dry mouth, constipation, sleep problems were among those systematically assessed, while in the other, these symptoms had to be added as an "Other problem". METHODS: This retrospective cross-sectional study included adult patients with advanced cancer at an inpatient palliative care unit. Data were collected from two versions of the Edmonton Symptom Assessment System (ESAS): modified (ESAS-m) listed 11 symptoms and revised (ESAS-r) listed 9 and allowed patients to add one "Other problem". Seven similar symptoms were listed in both versions. RESULTS: In 2013, 184 patients completed ESAS-m, and in 2017, 156 completed ESAS-r. Prevalence and severity of symptoms listed in both versions did not differ. In ESAS-m, 83% reported dry mouth, 73% constipation, and 71% sleep problems, but on ESAS-r, these symptoms were reported by only 3%, 15% and < 1%, respectively. Although ESAS-r severity scores for these three symptoms were higher than on ESAS-m, differences did not reach statistical significance. CONCLUSION: We identified significant differences in patient symptom reporting based on whether symptoms like dry mouth, obstipation and sleep problems were specifically assessed or had to be added by patients as an "Other problem".

Inter-reporter differences in symptom burdens in Japanese children with cancer.

BACKGROUND: Recent studies about inter-reporter differences and patient-reported outcomes (PROs) in childhood cancer from Western countries showed that caregiver proxy reports tend to overestimate symptom burdens in comparison with children's self-reports. However, the results from Western countries may not be generalizable to Asian countries. METHODS: This paper is a secondary analysis of a validation study of the Japanese pediatric version of the Memorial Symptom Assessment Scale including 88 dyads of children aged 7-12 years and 74 dyads of children aged 13-18 years and their caregivers. The study assessed the inter-reporter differences of eight and 31 symptom burdens calculated as symptom scores in children aged 7-12 years and 13-18 years, respectively, and the association between inter-reporter differences and the characteristics of children and caregivers. RESULTS: The majority of children and caregivers scored equally at the dyadic level for almost all symptoms. However, 37.5% of symptoms in children aged 7-12 years and 10.0% of symptoms in children aged 13-18 years showed significant inter-reporter differences, suggesting a general tendency of caregivers to underestimate their children's symptom burden. The caregiver's age was the characteristic most frequently associated with magnitude of inter-reporter differences. CONCLUSIONS: Caregiver proxy reports may be a reliable source of PROs in Japanese children with cancer, as self-reported and caregiver proxy-reported symptom burdens were generally concordant. However, as some significant inter-reporter differences were observed, an effort should be made within the medical community to evaluate the parent-child relationship to minimize inter-reporter differences and achieve better symptom management.

Cross-cultural adaptation and psychometric validation of point-of-care outcome assessment tools in Chinese palliative care clinical practice.

BACKGROUND: A standardized national approach to routinely assessing palliative care patients helps improve patient outcomes. However, a quality improvement program-based on person centered outcomes within palliative care is lacking in Mainland China. The well-established Australian Palliative Care Outcome Collaboration (PCOC) national model improves palliative care quality. This study aimed to culturally adapt and validate three measures that form part of the PCOC program for palliative care clinical practice in China: The PCOC Symptom Assessment Scale (PCOC SAS), Palliative Care Problem Severity Scale (PCPSS), Palliative Care Phase. METHODS: A study was conducted on cross-cultural adaptation and validation of PCOC SAS, PCPSS and Palliative Care Phase, involving translation methods, cognitive interviewing, and psychometric testing through paired assessments. RESULTS: Cross-cultural adaptation highlighted the need to strengthen the link between the patient's care plan and the outcome measures to improve outcomes, and the concept of distress in PCOC SAS. Analysis of 368 paired assessments (n = 135 inpatients, 22 clinicians) demonstrated that the PCOC SAS and PCPSS had good and acceptable coherence (Cronbach's a = 0.85, 0.75 respectively). Palliative Care Phase detected patients' urgent needs. PCOC SAS and PCPSS showed fair discriminant and concurrent validity. Inter-rater reliability was fair for Palliative Care Phase (k = 0.31) and PCPSS (k = 0.23-0.30), except for PCPSS-pain, which was moderate (k = 0.53). CONCLUSIONS: The Chinese version of PCOC SAS, PCPSS, and Palliative Care Phase can be used to assess outcomes as part of routine clinical practice in Mainland China. Comprehensive clinical education regarding the assessment tools is necessary to help improve the inter-rater reliability.

Diagnostic Accuracy of a Mobile AI-Based Symptom Checker and a Web-Based Self-Referral Tool in Rheumatology: Multicenter Randomized Controlled Trial.

BACKGROUND: The diagnosis of inflammatory rheumatic diseases (IRDs) is often delayed due to unspecific symptoms and a shortage of rheumatologists. Digital diagnostic decision support systems (DDSSs) have the potential to expedite diagnosis and help patients navigate the health care system more efficiently. OBJECTIVE: The aim of this study was to assess the diagnostic accuracy of a mobile artificial intelligence (AI)-based symptom checker (Ada) and a web-based self-referral tool (Rheport) regarding IRDs. METHODS: A prospective, multicenter, open-label, crossover randomized controlled trial was conducted with patients newly presenting to 3 rheumatology centers. Participants were randomly assigned to complete a symptom assessment using either Ada or Rheport. The primary outcome was the correct identification of IRDs by the DDSSs, defined as the presence of any IRD in the list of suggested diagnoses by Ada or achieving a prespecified threshold score with Rheport. The gold standard was the diagnosis made by rheumatologists. RESULTS: A total of 600 patients were included, among whom 214 (35.7%) were diagnosed with an IRD. Most frequent IRD was rheumatoid arthritis with 69 (11.5%) patients. Rheport's disease suggestion and Ada's top 1 (D1) and top 5 (D5) disease suggestions demonstrated overall diagnostic accuracies of 52%, 63%, and 58%, respectively, for IRDs. Rheport showed a sensitivity of 62% and a specificity of 47% for IRDs. Ada's D1 and D5 disease suggestions showed a sensitivity of 52% and 66%, respectively, and a specificity of 68% and 54%, respectively, concerning IRDs. Ada's diagnostic accuracy regarding individual diagnoses was heterogenous, and Ada performed considerably better in identifying rheumatoid arthritis in comparison to other diagnoses (D1: 42%; D5: 64%). The Cohen κ statistic of Rheport for agreement on any rheumatic disease diagnosis with Ada D1 was 0.15 (95% CI 0.08-0.18) and with Ada D5 was 0.08 (95% CI 0.00-0.16), indicating poor agreement for the presence of any rheumatic disease between the 2 DDSSs. CONCLUSIONS: To our knowledge, this is the largest comparative DDSS trial with actual use of DDSSs by patients. The diagnostic accuracies of both DDSSs for IRDs were not promising in this high-prevalence patient population. DDSSs may lead to a misuse of scarce health care resources. Our results underscore the need for stringent regulation and drastic improvements to ensure the safety and efficacy of DDSSs. TRIAL REGISTRATION: German Register of Clinical Trials DRKS00017642; https://drks.de/search/en/trial/DRKS00017642.

Agreement between patient-reported and clinically documented symptoms of acute myeloid leukemia: Study protocol.

AIM: To describe our methods to compare patient-reported symptoms of acute myeloid leukemia and the corresponding documentation by healthcare providers in the electronic health record. BACKGROUND: Patients with acute myeloid leukemia experience many distressing symptoms, particularly related to chemotherapy. The timely recognition and provision of evidence-based interventions to manage these symptoms can improve outcomes. However, lack of standardized formatting for symptom documentation within electronic health records leads to challenges for clinicians when accessing and comprehending patients' symptom information, as it primarily exists in narrative forms in various parts of the electronic health record. This variability raises concerns about over- or under-reporting of symptoms. Consistency between patient-reported symptoms and clinician's symptom documentation is important for patient-centered symptom management, but little is known about the degree of agreement between patient reports and their documentation. This is a detailed description of the study's methodology, procedures and design to determine how patient-reported symptoms are similar or different from symptoms documented in electronic health records by clinicians. DESIGN: Exploratory, descriptive study. METHODS: Forty symptoms will be assessed as patient-reported outcomes using the modified version of the Memorial Symptom Assessment Scale. The research team will annotate symptoms from the electronic health record (clinical notes and flowsheets) corresponding to the 40 symptoms. The degree of agreement between patient reports and electronic health record documentation will be analyzed using positive and negative agreement, kappa statistics and McNemar's test. CONCLUSION: We present innovative methods to comprehensively compare the symptoms reported by acute myeloid leukemia patients with all available electronic health record documentation, including clinical notes and flowsheets, providing insights into symptom reporting in clinical practice. IMPACT: Findings from this study will provide foundational understanding and compelling evidence, suggesting the need for more thorough efforts to assess patients' symptoms. Methods presented in this paper are applicable to other symptom-intensive diseases.

Satisfaction with maternity triage following implementation of the Birmingham Symptom-Specific Obstetric Triage System (BSOTS): Perspectives of women and staff.

AIM: To explore the satisfaction and experiences of women and staff with the BSOTS in an Australian hospital. DESIGN: Cross-sectional descriptive survey. METHODS: Surveys were distributed to women and staff between February and May 2022. Survey questions reflected satisfaction with triage and provision of care under the BSOTS system (for women) and confidence in using the BSOTS system and its impact on triage-related care (for staff). Survey data were summarized using descriptive statistics, and qualitative responses were analysed using content analysis. RESULTS: There were 50 women and 40 staff (midwives and doctors) survey respondents. Most women were satisfied with triage wait times, the verbal information they received and the time it took for them to receive care. Nearly all midwife participants indicated they had high knowledge and confidence in using the BSOTS. Most staff indicated that the BSOTS supported the accurate assessment of women and had benefits for women, staff and the hospital. CONCLUSION: The findings showed that women and staff were satisfied with receiving and providing care in a maternity triage setting under the BSOTS system. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Implementing standardized maternity triage approaches such as the BSOTS in health settings delivering care to pregnant women is recommended for improving flow of care and perceptions of care quality by women. IMPACT: Quality of maternity triage processes is likely to impact the satisfaction of women attending services and the staff providing care. The BSOTS was shown to improve maternity triage processes and was associated with satisfaction of women and staff. Maternity settings can benefit from implementing triage approaches such as the BSOTS as it standardizes and justifies the care provided to women. This is likely to result in satisfaction of women and staff engaged in maternity triage and improve the birth outcomes of women and babies. REPORTING METHOD: The reporting of this paper has followed SQUIRE guidelines. PATIENT OR PUBLIC CONTRIBUTION: Women engaged with maternity services were participants in the study but did not contribute to the design, conduct or publication of the study.

Construction of a nursing assessment framework for patients in anaesthesia recovery period: A modified Delphi study.

AIM: To construct a nursing assessment framework for patients in anaesthesia recovery period. DESIGN: A three-round modified Delphi method was employed to capture the consensus of 22 panellists. METHODS: The initial items in the nursing assessment framework for patients in anaesthesia recovery period were developed based on the mini-clinical evaluation exercise (mini-CEX). A panel of 22 experts participated in this study. The panellists have more than 10 years of experience in either clinical anaesthesia, or post-anesthesia nursing, or operating room nursing, or surgical intensive nursing. Between March and April 2023, the panellists evaluated and recommended revisions to the initial framework. RESULTS: This study resulted in the development of a nursing assessment framework for patients in anaesthesia recovery period. The initial version of the framework consisted of six dimensions with 27 items. Six items were modified after the first round of consultation. After the second round, five modifications and four deletions were made based on expert opinion. The third round resulted in a convergence of expert opinion. The framework, which consists of 24 items across five dimensions, was refined. The five dimensions are as follows: History-taking, Physical assessment, Clinical judgement, Organizational efficiency and Humanistic concern. CONCLUSION: The nursing assessment framework for patients in anaesthesia recovery period was reached consensus between the 22 experts' opinions. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: The assessment framework constructed in this study could be used for the process evaluation of post-anesthesia nursing. The framework may guide perianesthesia nurses in the timely and effective assessment of patients during this critical phase of care. It may be used for perianesthesia nursing education or to evaluate nurses' assessment skills. REPORTING METHOD: The study is reported in accordance with the Guidance on Conducting and Reporting DElphi Studies (CREDES) recommendations. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.