Ductal carcinoma in situ and cause-specific mortality among younger and older postmenopausal women: the Women's Health Initiative.

BACKGROUND: Whether DCIS is associated with higher breast cancer-specific and all-cause mortality is unclear with few studies in older women. Therefore, we examined DCIS and breast cancer-specific, cardiovascular (CVD)-specific, and all-cause mortality among Women's Health Initiative (WHI) Clinical Trial participants overall and by age (< 70 versus ≥ 70 years). METHODS: Of 68,132 WHI participants, included were 781 postmenopausal women with incident DCIS and 781 matched controls. Serial screening mammography was mandated with high adherence. DCIS cases were confirmed by central medical record review. Adjusted multivariable Cox proportional hazard regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI). Kaplan Meier (KM) plots were used to assess 10-year and 20-year mortality rates. RESULTS: After 20.3 years total, and 13.2 years median post-diagnosis follow-up, compared to controls, DCIS was associated with higher breast cancer-specific mortality (HR 3.29; CI = 1.32-8.22, P = 0.01). The absolute difference in 20-year breast cancer mortality was 1.2% without DCIS and 3.4% after DCIS, log-rank P = 0.026. Findings were similar by age (< 70 versus ≥ 70 years) with no interaction (P interaction = 0.80). Incident DCIS was not associated with CVD-specific mortality (HR 0.77; CI-0.54-1.09, P = 0.14) or with all-cause mortality (HR 0.96; CI = 0.80-1.16, P = 0.68) with similar findings by age. CONCLUSIONS: In postmenopausal women, incident DCIS was associated with over three-fold higher breast cancer-specific mortality, with similar findings in younger and older postmenopausal women. These finding suggest caution in using age to adjust DCIS clinical management or research strategies.

Work-related quality of life in professionals involved in pediatric palliative care: a repeated cross-sectional comparative effectiveness study.

Background: Working in pediatric palliative care (PPC) impacts healthcare and allied professionals' work-related quality of life (QoL). Professionals who lack specific PPC training but who regularly provide services to the affected children have articulated their need for support from specialized PPC (SPPC) teams. Objectives: This study had two objectives: (1) to evaluate whether the availability of a SPPC team impacted the work-related QoL of professionals not specialized in PPC; and (2) to explore the work-related QoL of professionals working in PPC without specialized training. Design: Repeated cross-sectional comparative effectiveness design. Methods: One hospital with an established SPPC program and affiliated institutions provided the intervention group (IG). Three hospitals and affiliated institutions where generalist PPC was offered provided the comparison group (CG). Data were collected by paper-pencil questionnaire in 2021 and 2022. The Professional Quality of Life (ProQOL 5) questionnaire was used to assess work-related QoL, yielding separate scores for burnout (BO), secondary traumatic stress (STS) and compassion satisfaction (CS). A descriptive statistical analysis was performed and general estimation equations were modelled. To increase the comparability of the IG and CG, participants were matched by propensity scores. Results: The 301 participating non-PPC-specialized professionals had overall low to moderate levels of BO and STS and moderate to high levels of CS. However, none of these scores (BO: p = 0.36; STS: p = 0.20; CS: p = 0.65) correlated significantly with support from an SPPC team. Compared to nurses, physicians showed higher levels of BO (1.70; p = 0.02) and STS (2.69; p ⩽ 0.001). Conclusion: Although the study sample's overall work-related QoL was satisfactory, it showed a considerable proportion of moderate BO and STS, as well as moderate CS. To provide tailored support to professionals working in PPC, evidence regarding key SPPC support elements and their effectiveness is needed. Trial registration: ClinicalTrials.gov ID, NCT04236180.

Work-related quality of life in professionals involved in pediatric palliative care - Why was this study done? Caring for children suffering from life-limiting conditions and their families impacts professionals' work-related Quality of Life (QoL). Professionals without specific training often provide pediatric palliative care (PPC) to children and their families. - What did the researchers do? We aimed to determine whether the work-related the QoL of professionals without specialised PPC training would be positively influenced when they were supported by PPC specialists. We also wanted to explore what person-specific factors might correspond with higher or lower work-related QoL. Work-related QoL was analysed in relation to burnout (BO), secondary traumatic stress (STS), and compassion satisfaction (CS). These variables' levels were assessed with a questionnaire survey in 2021 and 2022. - What did the researchers find? The 301 participating professionals had overall low to moderate levels of BO and STS and moderate to high levels of CS. There was no substantial difference in work-related QoL in the professionals supported by PPC specialists compared to those who did not receive specialist support. Physicians showed higher levels of BO and STS than nurses. - What do the findings mean? Although the studied professionals' overall work-related QoL was satisfactory, there is a considerable proportion of moderate BO and STS scores in professionals working with children suffering from life-limiting conditions. Further research should explore the specific needs of professionals not specialised in PPC.

Breast cancer incidence and mortality by metabolic syndrome and obesity: The Women's Health Initiative.

BACKGROUND: In the Women's Health Initiative (WHI) randomized trial, dietary intervention significantly reduced breast cancer mortality, especially in women with more metabolic syndrome (MetS) components. Therefore, this study investigated the associations of MetS and obesity with postmenopausal breast cancer after long-term follow-up in the WHI clinical trials. METHODS: A total of 68,132 postmenopausal women, without prior breast cancer and with normal mammogram, were entered into WHI randomized clinical trials; 63,330 women with an entry MetS score comprised the study population. At entry, body mass index (BMI) was determined; MetS score (0, 1-2, and 3-4) included the following: (1) high waist circumference (≥88 cm), (2) high blood pressure (systolic ≥130 mm Hg and/or diastolic ≥85 mm Hg, or hypertension history), (3) high-cholesterol history, and (4) diabetes history. Study outcomes included breast cancer incidence, breast cancer mortality, deaths after breast cancer, and results by hormone receptor status. RESULTS: After a >20-year mortality follow-up, a higher MetS score (3-4), adjusted for BMI, was significantly associated with more poor prognosis, estrogen receptor (ER)-positive, progesterone receptor (PR)-negative cancers (p = .03), 53% more deaths after breast cancer (p < .001), and 44% higher breast cancer mortality (p = .03). Obesity status, adjusted for MetS score, was significantly associated with more good prognosis, ER-positive, PR-positive cancers (p < .001), more total breast cancers (p < .001), and more deaths after breast cancer (p < .001), with higher breast cancer mortality only in women with severe obesity (BMI, ≥35 kg/m2; p < .001). CONCLUSIONS: MetS and obesity status have independent, but differential, adverse associations with breast cancer receptor subtypes and breast cancer mortality risk. Both represent separate targets for breast cancer prediction and prevention strategies.

TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) Project: Protocol for an International Longitudinal Multicenter Study.

BACKGROUND: Nursing-sensitive events (NSEs) are common, accounting for up to 77% of adverse events in hospitalized patients (eg, fall-related harm, pressure ulcers, and health care-associated infections). NSEs lead to adverse patient outcomes and impose an economic burden on hospitals due to increased medical costs through a prolonged hospital stay and additional medical procedures. To reduce NSEs and ensure high-quality nursing care, appropriate nurse staffing levels are needed. Although the link between nurse staffing and NSEs has been described in many studies, appropriate nurse staffing levels are lacking. Existing studies describe constant staffing exposure at the unit or hospital level without assessing patient-level exposure to nurse staffing during the hospital stay. Few studies have assessed nurse staffing and patient outcomes using a single-center longitudinal design, with limited generalizability. There is a need for multicenter longitudinal studies with improved potential for generalizing the association between individual nurse staffing levels and NSEs. OBJECTIVE: This study aimed (1) to determine the prevalence, preventability, type, and severity of NSEs; (2) to describe individual patient-level nurse staffing exposure across hospitals; (3) to assess the effect of nurse staffing on NSEs in patients; and (4) to identify thresholds of safe nurse staffing levels and test them against NSEs in hospitalized patients. METHODS: This international multicenter study uses a longitudinal and observational research design; it involves 4 countries (Switzerland, Sweden, Germany, and Iran), with participation from 14 hospitals and 61 medical, surgery, and mixed units. The 16-week observation period will collect NSEs using systematic retrospective record reviews. A total of 3680 patient admissions will be reviewed, with 60 randomly selected admissions per unit. To be included, patients must have been hospitalized for at least 48 hours. Nurse staffing data (ie, the number of nurses and their education level) will be collected daily for each shift to assess the association between NSEs and individual nurse staffing levels. Additionally, hospital data (ie, type, teaching status, and ownership) and unit data (ie, service line and number of beds) will be collected. RESULTS: As of January 2024, the verification process for the plausibility and comprehensibility of patients' and nurse staffing data is underway across all 4 countries. Data analyses are planned to be completed by spring 2024, with the first results expected to be published in late 2024. CONCLUSIONS: This study will provide comprehensive information on NSEs, including their prevalence, preventability, type, and severity, across countries. Moreover, it seeks to enhance understanding of NSE mechanisms and the potential impact of nurse staffing on these events. We will evaluate within- and between-hospital variability to identify productive strategies to ensure safe nurse staffing levels, thereby reducing NSEs in hospitalized patients. The TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) study will focus on the optimization of scarce staffing resources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56262.

Uptake of screening and risk-reducing recommendations among women with hereditary breast and ovarian cancer syndrome due to pathogenic BRCA1/2 variants evaluated at a large urban comprehensive cancer center.

PURPOSE: Carriers of pathogenic variants in BRCA1/2 have an elevated lifetime cancer risk warranting high-risk screening and risk-reducing procedures for early detection and prevention. We report on prevention practices among women with pathogenic BRCA variants in order to document follow through with NCCN recommendations and to identify barriers to guideline-recommended care. METHODS: Our cohort included women who had genetic testing through a cancer genetic clinic and completed a 54-item questionnaire to measure socio-demographics, medical history, rates of cancer screening and risk-reducing surgery, disclosure of test results, and cancer worry. Outcomes included rates of completion of risk-reducing salpingo-oophorectomy (RRSO), risk-reducing mastectomy (RRM), and NCCN risk-reducing and age-dependent screening guidelines (version 3.2019). Multivariable logistic regression analyses were used to evaluate potential predictors of these outcomes. RESULTS: Of 129 evaluable women with pathogenic BRCA1/2 variants, 95 (74%) underwent RRSO and 77 (60%) had RRM, respectively, and 107 (83%) were considered adherent to NCCN guidelines. Women with a history of breast or ovarian cancer were more likely to have RRM (OR = 4.38; 95% CI 1.80-11.51; p = 0.002). Increasing age was associated with an increased likelihood of RRSO (OR = 1.05; 95% CI 1.01-1.09; p = 0.019) and decreased likelihood for RRM (OR = 0.95; 95% CI 0.92-0.99; p = 0.013). Women who had RRM were 3 times more likely to undergo RRSO (OR = 2.81; 95% CI 1.10-7.44; p = 0.025). Women who had genetic testing after June 2013 were less likely to have RRM than those tested before June 2013 (OR = 0.42; 95% CI 0.18-0.95; p = 0.040. None of the other measured factors were associated with rates of RRSO, RRM or follow through with NCCN recommendations. There was near universal (127/129) reported disclosure of genetic test results to family members, resulting in the discovery of a median of 1 relative with a pathogenic variant (range = 0-8). CONCLUSION: An evaluation of follow up practice in a cohort of women with pathogenic variants in BRCA1/2 revealed high rates of reported completion of screening and surgical risk-reducing recommendations. Educational efforts should continue to reinforce the importance of follow-through with guideline recommended care among this high-risk group.

How external and agency characteristics are related to coordination in homecare - findings of the national multicenter, cross-sectional SPOTnat study.

BACKGROUND: Homecare client services are often distributed across several interdependent healthcare providers, making proper care coordination essential. However, as studies exploring care coordination in the homecare setting are scarce, serious knowledge gaps exist regarding how various factors influence coordination in this care sector. To fill such gaps, this study's central aim was to explore how external factors (i.e., financial and regulatory mechanisms) and homecare agency characteristics (i.e., work environment, workforce, and client characteristics) are related to care coordination in homecare. METHODS: This analysis was part of a national multicentre, cross-sectional study in the Swiss homecare setting that included a stratified random sample of 88 Swiss homecare agencies. Data were collected between January and September 2021 through agency and employee questionnaires. Using our newly developed care coordination framework, COORA, we modelled our variables to assess the relevant components of care coordination on the structural, process, and outcome levels. We conducted both descriptive and multilevel regression analyses-with the latter adjusting for dependencies within agencies-to explore which key factors are associated with coordination. RESULTS: The final sample size consisted of 1450 employees of 71 homecare agencies. We found that one explicit coordination mechanism ("communication and information exchange" (beta = 0.10, p <.001)) and four implicit coordination mechanisms-"knowledge of the health system" (beta = -0.07, p <.01), "role clarity" (beta = 0.07, p <.001), "mutual respect and trust" (beta = 0.07, p <.001), and "accountability, predictability, common perspective" (beta = 0.19, p <.001)-were significantly positively associated with employee-perceived coordination. We also found that the effects of agency characteristics and external factors were mediated through coordination processes. CONCLUSION: Implicit coordination mechanisms, which enable and enhance team communication, require closer examination. While developing strategies to strengthen implicit mechanisms, the involvement of the entire care team is vital to create structures (i.e., explicit mechanisms) that enable communication and information exchange. Appropriate coordination processes seem to mitigate the association between staffing and coordination. This suggests that they support coordination even when workload and overtime are higher.

Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation.

OBJECTIVES: Linaclotide, a guanylate cyclase-C agonist, was recently approved in the United States for the treatment of children 6-17 years old with functional constipation. This study evaluated the safety and efficacy of various linaclotide doses in children 7-17 years old with irritable bowel syndrome with constipation (IBS-C). METHODS: In this 4-week, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study, children with IBS-C were randomized to once-daily placebo or linaclotide (Dose A: 18 or 36 µg, B: 36 or 72 µg, and C: 72 µg or 145 µg, or 290 µg); those aged 7-11 years in a 1:1:1:1 allocation based on weight (18 to <35 kg:18 µg, 36 µg, or 72 µg; or ≥35 kg: 36 µg, 72 µg, or 145 µg), and those aged 12-17 years in a 1:1:1:1:1 allocation (the higher option of Doses A-C or 290 µg). The primary efficacy endpoint was a change from baseline in 4-week overall spontaneous bowel movement (SBM) frequency rate over the treatment period. Adverse events and clinical laboratory measures were also assessed. RESULTS: Efficacy, safety, and tolerability were assessed in 101 patients. In the intent-to-treat population, numerical improvement was observed in overall SBM frequency rate with increasing linaclotide doses (A: 1.62, B: 1.52, and C: 2.30, 290 µg: 3.26) compared with placebo. The most reported treatment-emergent adverse events were diarrhea and pain, with most cases being mild and none being severe. CONCLUSIONS: Linaclotide was tolerated well in this pediatric population, showing numerical improvement in SBM frequency compared with placebo.

HYADES - A Global Archive of Annual Maxima Daily Precipitation.

Time series of annual maxima daily precipitation are crucial for understanding extreme precipitation behavior and its shifts toward nonstationarity with global warming. Extreme precipitation insight assists hydraulic infrastructure design, water resource management, natural hazard prevention, and climate change adaptation. However, not even a third of the records are of sufficient length, and the number of active stations keeps decreasing. Herein, we present HYADES: archive of yearly maxima of daily precipitation records, a global dataset derived from the Global Historical Climatology Network database of daily records (GHCN-Daily). The HYADES dataset contains records from 39 206 stations (heterogeneously distributed worldwide) with record lengths varying from 16 to 200 years between 1805 and 2023. HYADES was extracted through a methodology designed to accurately capture the true maxima even in the presence of missing values within the records. The method's thresholds were determined and evaluated through Monte Carlo simulations. Our approach demonstrates a 96.73% success rate in detecting the true maxima while preserving time series statistical properties of interest (L-moments and temporal monotonic trend).

Low physical function Post-Cancer diagnosis is associated with higher mortality risk in postmenopausal women.

BACKGROUND: Postmenopausal women with cancer experience an accelerated physical dysfunction beyond that expected through aging alone due to cancer and its treatments. The aim of this study is to determine whether declines in physical function after cancer diagnosis are associated with all-cause mortality and cancer-specific mortality. METHODS: This prospective cohort study included 8,068 postmenopausal women enrolled in the Women's Health Initiative (WHI) who were diagnosed with cancer and had physical function assessed within 1-year of cancer diagnosis. Self-reported physical function was measured using the 10-item physical function subscale of the RAND 36-Item Health Survey. Cause of death was determined by medical record review with central adjudication and linkage to the National Death Index. Death was adjudicated through February 2022. RESULTS: Over a median follow-up of 7.7 years from cancer diagnosis 3,316 (41.1%) women died. Our results showed that for every 10% decline in the physical function score after cancer diagnosis, all-cause mortality and cancer-specific mortality were significantly reduced by 12% (HR, 0.88; 95% CI, 0.87 to 0.89) and (HR, 0.88; 95%CI, 0.86 to 0.91), respectively. Further categorical analyses showed a significant dose-response relationship between post-diagnosis physical function categories and mortality outcomes (trend test P < .001), where the median survival time for women in the lowest physical function quartile was 9.1 (8.6, 10.6) years compared to 18.4 (15.8, 22.0) years for women in the highest physical function quartile. CONCLUSION: Postmenopausal women with low physical function after cancer diagnosis may be at higher risk of mortality from all causes and cancer-related mortality.

The History of Academic Leadership Education in Orthopaedic Surgery.

Background: The growth of the American academic orthopaedic community over the last 53 years has been accompanied by an expanding need for academic leadership education. Methods: The transition of the Association of Orthopaedic Chairmen, to the Academic Orthopaedic Society, to the American Orthopaedic Association through its Academic Leadership Committee and American Orthopaedic Association Council of Residency Directors is reviewed. Results: Academic orthopaedic community members recognized that the evolving leadership needs of the academic community could be better addressed by transitioning to a new organization, the Academic Orthopaedic Society and eventually by creating a new structure within a well aligned and well-resourced existing organization, the American Orthopaedic Association. Conclusion: Organizational and leadership flexibility has been vital to serving the evolving need of the American academic orthopaedic community for leadership education.

Randomized controlled trial of linaclotide in children aged 6-17 years with functional constipation.

OBJECTIVES: Linaclotide, a guanylate cyclase-C agonist, was recently approved in the United States for treatment of children 6-17 years old with functional constipation (FC). This study evaluated the safety and efficacy of several linaclotide doses in children 6-17 years old with FC. METHODS: In this multicenter, randomized, double-blind, placebo-controlled phase 2 study, 173 children with FC (based on Rome III criteria) were randomized to once-daily linaclotide (A: 9 or 18 µg, B: 18 or 36 µg, or C: 36 or 72 µg) or placebo in a 1:1:1:1 ratio for 6- to 11-year-olds (dosage determined by weight: 18 to <35 or ≥35 kg) and linaclotide (18, 36, 72, or 145 µg) or placebo in a 1:1:1:1:1 ratio for 12- to 17-year-olds. The primary efficacy endpoint was change from baseline in weekly spontaneous bowel movement (SBM) frequency throughout the 4-week treatment period. Adverse events (AE), clinical laboratory values, and electrocardiograms were monitored. RESULTS: Efficacy and safety were assessed in 173 patients (52.0% aged 6-11 years; 48.0% aged 12-17 years); 162 (93.6%) completed the treatment period. A numerical improvement in mean SBM frequency was observed with increasing linaclotide doses (1.90 in 6- to 11-year-olds [36 or 72 µg] and 2.86 in 12- to 17-year-olds [72 µg]). The most reported treatment-emergent AE was diarrhea, with most cases being mild; none were severe. CONCLUSIONS: Linaclotide was well tolerated in this pediatric population, with a trend toward efficacy in the higher doses, warranting further evaluation.

Eight weeks of exercise intervention improves visuomotor and functional capacity, performance, and physiological profile in a patient with choroidal melanoma.

The aim of this case study was to investigate the effects of an 8-wk combined exercise intervention, consisting of visual-coordinative and high-intensity interval training (HIIT), on the physical and visuomotor-functional capacity, performance, and physiological profile of a moderately active 29-yr-old man diagnosed with choroidal melanoma of the left eye. Data were collected on three occasions: at the initial diagnosis (T0), after hospitalization and radiotherapy treatment (T1), and following the recovery through the exercise intervention (T2), spanning a total of 17 wk. The primary outcome variables consisted of visuomotor and functional tests (VFTs), cardiorespiratory fitness (CRF), and microvascular circulation measured via flicker light-induced dilation (FiD). For visuomotor tests in general, a significant decline was observed between baseline T0 and T1 (by 6%-22%), followed by significant improvements at T2 (by 11%-36%), surpassing the initially observed T0 values. The cardiopulmonary exercise testing (CPET)-derived parameters exhibited a similar pattern, declining from T0 to T1 [by 8%-12% for peak V̇o2, peak power output (PO), and CPET duration, respectively], with a subsequent recovery observed in response to 8 wk of exercise training (T2), resulting in increases of 11%-25% for V̇o2, peak PO, and CPET duration. Interestingly, the dilation of both arteries and veins in response to the FiD stimulus exhibited a twofold increase compared with baseline levels. Our results suggest that the 8-wk exercise intervention improved patients' VFT and CRF profiles and exceeded baseline values. Additional investigation, particularly through randomized controlled trials, is needed to comprehensively explain changes in FiD.NEW & NOTEWORTHY Results presented here suggest that combined visual-coordinative and HIIT training improves the visual-functional capacity, performance, and physiological profile of choroidal melanoma patients during treatment recovery. This case study lays the groundwork for further research concerning exercise therapy in this unique patient population. In addition, further investigation is required to fully comprehend the combined effects of exercise and radiation therapy on vasculature and oxygenation in patients with choroidal melanoma.

Comparison of In Vivo Stiffness of Tendons Commonly Used for Anterior Cruciate Ligament Reconstruction - A Shear Wave Elastography Study.

RATIONALE AND OBJECTIVES: There are currently no studies investigating the in vivo stiffness of the most commonly used autografts for anterior cruciate ligament reconstruction (ACLR) using Shear wave elastography (SWE). We hypothesize that there are differences regarding the elastic properties between the three tendons commonly used for ACLR and that they are influenced by patient-related factors. MATERIALS AND METHODS: 80 healthy subjects (25 females, 55 males, age: 25.33 ± 4.76 years, BMI: 23.76 ± 3.14 kg/m2, 40 semiprofessional athletes, athlete group [AG], age: 25.51 [19-29]; 40 healthy controls, control group [CG], age: 25.50 [20-29]) were recruited as participants. In addition to patient reported outcome scores, every participant underwent a standardized multimodal ultrasound protocol consisting of B-mode-ultrasound (B-US), Color Doppler-ultrasound (CD-US) and a SWE examination of the bilateral quadriceps tendon (QT), patellar tendon (PT) and semitendinosus tendon (ST). RESULTS: The highest shear wave velocity (SWV) were observed in ST (4.88 (4.35-5.52) m/s, ST vs QT, p = 0.005; ST vs PT, p < 0.001) followed by QT (4.61 (4.13-5.26) m/s, QT vs PT, p < 0.001) and PT (3.73 (3.30-4.68) m/s). Median QT, PT and ST stiffness was significantly higher in AG compared to CG. Male subjects tend to have stiffer QT and PT than female subjects. Positive correlation with SWV was obtained for age and activity level. CONCLUSION: There are significant differences regarding in vivo tendon stiffness between the most frequently used autograft tendon options for ACLR. The quantitative information obtained by SWE could be of particular interest for graft choice for ACLR.

Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.

BACKGROUND: Linaclotide, a guanylate cyclase C agonist, has been approved in the USA for the treatment of chronic idiopathic constipation and irritable bowel syndrome with predominant constipation in adults. We aimed to assess the efficacy and safety of linaclotide in paediatric patients aged 6-17 years with functional constipation. METHODS: This randomised, double-blind, placebo-controlled, multicentre, phase 3 study was done at 64 clinic or hospital sites in seven countries (USA, Canada, Israel, Italy, the Netherlands, Ukraine, and Estonia). Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 µg or placebo once daily for 12 weeks. Participants, investigators, and data assessors were masked to assignment. The primary efficacy endpoint was change from baseline (CFB) in the 12-week frequency rate of spontaneous bowel movements (SBMs; occurring in the absence of rescue medication on the calendar day of or before the bowel movement) per week and the secondary efficacy endpoint was CFB in stool consistency over the 12-week treatment period; efficacy and safety were analysed in all patients in the randomised population who received at least one dose of study intervention (modified intention-to-treat population and safety population, respectively). The study is registered with ClinicalTrials.gov, NCT04026113, and the functional constipation part of the study is complete. FINDINGS: Between Oct 1, 2019, and March 21, 2022, 330 patients were enrolled and randomly assigned to linaclotide (n=166) or placebo (n=164). Two patients in the linaclotide group did not receive any treatment; thus, efficacy and safety endpoints were assessed in 328 patients (164 patients in each group). 293 (89%) patients completed the 12-week treatment period (148 in the linaclotide group and 145 in the placebo group). 181 (55%) of 328 patients were female and 147 (45%) were male. At baseline, the mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) for placebo and 1·16 SBMs per week (0·83) for linaclotide, increasing to 2·29 SBMs per week (1·99) for placebo and 3·41 SBMs per week (2·76) for linaclotide during intervention. Compared with placebo (least-squares mean [LSM] CFB 1·05 SBMs per week [SE 0·19]), patients treated with linaclotide showed significant improvement in SBM frequency (LSM CFB 2·22 SBMs per week [0·19]; LSM CFB difference 1·17 SBMs per week [95% CI 0·65-1·69]; p<0·0001). Linaclotide also significantly improved stool consistency over placebo (LSM CFB 1·11 [SE 0·08] vs 0·69 [0·08]; LSM CFB difference 0·42 [95% CI 0·21-0·64]; p=0·0001). The most reported treatment-emergent adverse event (TEAE) by patients treated with linaclotide was diarrhoea (seven [4%] of 164 vs three [2%] of 164 patients in the placebo group) and by patients treated with placebo was COVID-19 (five [3%] vs four [2%] in the linaclotide group). The most frequent treatment-related TEAE was diarrhoea (linaclotide: six [4%] patients; placebo: two [1%] patients). One serious adverse event of special interest (treatment-related severe diarrhoea resulting in dehydration and hospitalisation) occurred in a female patient aged 17 years in the linaclotide group; this case resolved without sequelae after administration of intravenous fluids. No deaths occurred during the study. INTERPRETATION: Linaclotide is an efficacious and well tolerated treatment for functional constipation in paediatric patients and has subsequently been approved by the US Food and Drug Administration for this indication. FUNDING: AbbVie and Ironwood Pharmaceuticals.

Setting new priorities for nursing research: The updated Swiss Nursing Research Agenda-a systematic, participative approach.

AIM: To identify current key areas for nursing research in Switzerland, we revised the Swiss Research Agenda for Nursing (SRAN) initially published in 2008. BACKGROUND: By developing a research agenda, nursing researchers internationally prioritize and cluster relevant topics within the research community. The process should be collaborative and systematic to provide credible information for decisionmakers in health care research, policy, and practice. SOURCES OF EVIDENCE: After a participative, systematic, and critical evaluation within and outside of the Swiss Association for Nursing Science, the updated SRAN 2019-2029 defines four research priorities (new models of care, nursing care interventions, work and care environment, and quality of care and patient safety) and four transversal themes (organization of research, research methodologies, research in health care policy and public health perspectives). CONCLUSION: Adding to other national nursing research agendas, the categories are organized in a framework of key research priorities and transversal themes. They relate to the importance of global and local foci of research as well as challenges in health care services and policy systems. The agenda is an important prerequisite for enhancing the influence of nursing research in Switzerland and provides guidance for the next decade. IMPLICATIONS FOR NURSING PRACTICE: The revised agenda ensures that research projects target key knowledge gaps and the discipline's core questions in respective countries. IMPLICATIONS FOR HEALTH POLICY: Nursing research should inform and influence health policy on all institutional and political levels. Therefore, the integration of public health perspectives in research is one of the most important new aspects of SRAN 2019-2029.

Nursing care left undone in psychiatric hospitals and its association with nurse staffing: A cross-sectional multi-centre study in Switzerland.

INTRODUCTION: Nursing care left undone occurs when nurses omit activities because of resource shortfalls. Higher levels of nursing care left undone are associated with worse nurse staffing and organizational factors. Plentiful evidence from acute, long-term and community care supports such associations; however, mental healthcare settings are under-studied. AIM: The aim of the study was to describe nursing care left undone's frequency in mental health inpatient settings and explore its association with nurse staffing levels. METHOD: As part of the multi-centre cross-sectional MatchRN Psychiatry study, data were collected by questionnaire from 114 units in 13 Swiss psychiatric hospitals. Nursing care left undone was analysed describing frequencies descriptively and used linear mixed models to assess its association with staffing. RESULTS: Data from 994 nurses were analysed. The most commonly omitted activities were evaluating nursing processes (30.5%), formulating nursing diagnoses (27.4%) and defining care objectives (22.7%). Nursing care left undone was higher in units with low staffing levels. DISCUSSION: As in somatic care settings, in psychiatric hospitals, 'indirect' care activities are most commonly omitted. IMPLICATIONS FOR PRACTICE: This study highlights factors affecting the frequency of nursing care left undone, including staffing levels and perceived leadership. The findings emphasize the importance of nurse managers taking action to improve work environment factors.

How regulatory frameworks drive differences in home-care agencies: Results from a national multicenter cross-sectional study in Switzerland.

INTRODUCTION: The sustainability and rising costs of the health-care system are of concern. Although health-care reforms impact various areas of care, there is only limited evidence on how regulations affect home-care agencies and health-care delivery. OBJECTIVES: The primary aim was to explore different financial and regulatory mechanisms and how they drive differences in the organizational structures, processes, and work environment of home-care agencies. DESIGN AND METHODS: We used data from a national multicenter cross-sectional study of Swiss home care that included a random sample of 88 home-care agencies with a total of 3223 employees. Data was collected in 2021 through agency and personnel questionnaires including geographic characteristics, financial and regulatory mechanisms, service provision, financing, work environment, resources and time allocation, and personnel recruitment. We first conducted a cluster analysis to build agency groups with similar financial and regulatory mechanisms. We then performed Fisher's exact, ANOVA, and Kruskal-Wallis tests to determine group differences in organizational structures, processes, and work environments. Finally, we performed a lasso regression to determine which variables were predictive for the groups. RESULTS: Four agency groups were built, differing in view of financial and regulatory mechanisms and we found differences in the range and amount of services provided, with regard to employment conditions and cost structures. DISCUSSION: The most prominent differences were found between agency groups with versus agency groups without a service obligation. Financial incentives must be well aligned with the goal of achieving and maintaining financially sustainable, accessible, and high-quality home care.

The relationship between nursing home staffing and resident safety outcomes: A systematic review of reviews.

BACKGROUND: Resident safety is an important topic for nursing home practice with up to 33 % of residents subjected to an adverse event. In spite of a large evidence base examining the relationship between nursing home staffing and resident outcomes, the findings of several systematic reviews remain inconclusive and contradicting, possibly due to methodological shortcomings. OBJECTIVE: The main aim of this review was to provide a comprehensive overview of the literature on nursing home staffing and its relationship with resident safety outcomes. DESIGN: We undertook a systematic review of reviews. We searched Medline, CINAHL and Embase by the end of November 2022. Reviews were included if they assessed the relationship between nursing home staffing and resident safety outcomes using objective measures and data at resident level. Quality appraisal was conducted using the SIGN-checklist, but we did not exclude any reviews based on quality assessment. We used a narrative approach, tables and figures to summarize the findings. RESULTS: We included 13 systematic reviews published between 2006 and 2022 building on primary evidence from 1977 to 2022. Twelve reviews investigated the relationship between nurse staffing and resident safety outcomes (187 unique primary studies), and one review focused on allied health professionals (28 primary studies). Five reviews originated as work to inform governmental recommendations on staffing. We found diverse approaches used to investigate the staffing-outcome relationship with regard to design, timeframe, operationalization, data-source and theoretical rationales guiding the studies. The most prominently reported resident safety outcomes were pressure ulcers and urinary tract infections. Commonly reported staffing measures included number and level of education of nursing home staff. Based on narrative summaries, staffing seems to have a favorable relationship with resident safety outcomes, but logic models explaining the mechanisms of this relationship were sparsely reported. CONCLUSIONS: The existing literature shows methodological limitations that demand a change in research on the staffing-outcome relationship in the nursing home setting. Our work highlights the need for carefully designed primary studies that address the pertinent shortcomings by design, timeframe, operationalization, data-source and theoretical rationales. These future studies will allow to carefully examine the causal relationship between selected staffing measures and resident safety outcomes in further detail and serve as legitimate evidence bases to inform action plans for clinical practice and to evaluate staffing policies.