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.

The Impact of Subclinical Hypothyroidism on the Quality of Life During Pregnancy: Mapping 5-Level Version of EQ-5D and ThyPRO-39.

OBJECTIVES: To describe how subclinical hypothyroidism (SubHypo) influences the quality of life (QoL) during pregnancy. METHODS: In primary data collection (NCT04167423), thyroid stimulating hormone (TSH), free thyroxine (FT4), thyroid peroxidase antibodies, generic quality of life (QoL; 5-level version of EQ-5D [EQ-5D-5L]), and disease-specific QoL (ThyPRO-39) were measured among pregnant women. SubHypo during each trimester was defined according to the 2014 European Thyroid Association guidelines (TSH > 2.5, 3.0, and 3.5 IU/L, respectively; with normal FT4). Path analysis described relationships and tested mediation. Linear ordinary least squares, beta, tobit, and two-part regressions were used to map ThyPRO-39 and EQ-5D-5L. Alternative SubHypo definition was tested in sensitivity analysis. RESULTS: A total of 253 women at 14 sites (31 ± 5 years old, 15 ± 6 weeks pregnant) completed the questionnaires. Sixty-one (26%) had SubHypo and differed from 174 (74%) euthyroid women in smoking history (61% vs 41%), primiparity (62% vs 43%) and TSH level (4.1 ± 1.4 vs 1.5 ± 0.7 mIU/L, P < .001). EQ-5D-5L utility in SubHypo (0.89 ± 0.12) was lower than that in euthyroid (0.92 ± 0.11; P = .028) even after adjustment (difference -0.04, P = .033), whereas ocular (P = .001, ThyPRO-39), cognitive symptoms (P = .043), anxiety (P < .0001), and the composite score were higher. The impact of SubHypo on utility was mediated by anxiety. Results were confirmed by sensitivity analysis. Final mapping equation (ordinary least squares) includes goiter symptoms, anxiety, upset stomach, composite score (ThyPRO-39), FT4 levels, and week of pregnancy (determination coefficient 0.36). CONCLUSION: This is the first QoL mapping of SubHypo during pregnancy and the first evidence that SubHypo is associated with a negative impact on QoL. The effect is mediated by anxiety. EQ-5D-5L utilities can be generated based on ThyPRO-39 scores collected in pregnant euthyroid and patients with SubHypo.

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial.

BACKGROUND: While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders). METHODS: Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods). DISCUSSION: The SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021.

Health economic evaluation of a nurse-led care model from the nursing home perspective focusing on residents' hospitalisations.

BACKGROUND: Health economic evaluations of the implementation of evidence-based interventions (EBIs) into practice provide vital information but are rarely conducted. We evaluated the health economic impact associated with implementation and intervention of the INTERCARE model-an EBI to reduce hospitalisations of nursing home (NH) residents-compared to usual NH care. METHODS: The INTERCARE model was conducted in 11 NHs in Switzerland. It was implemented as a hybrid type 2 effectiveness-implementation study with a multi-centre non-randomised stepped-wedge design. To isolate the implementation strategies' costs, time and other resources from the NHs' perspective, we applied time-driven activity-based costing. To define its intervention costs, time and other resources, we considered intervention-relevant expenditures, particularly the work of the INTERCARE nurse-a core INTERCARE element. Further, the costs and revenues from the hotel and nursing services were analysed to calculate the NHs' losses and savings per resident hospitalisation. Finally, alongside our cost-effectiveness analysis (CEA), a sensitivity analysis focused on the intervention's effectiveness-i.e., regarding reduction of the hospitalisation rate-relative to the INTERCARE costs. All economic variables and CEA were assessed from the NHs' perspective. RESULTS: Implementation strategy costs and time consumption per bed averaged 685CHF and 9.35 h respectively, with possibilities to adjust material and human resources to each NH's needs. Average yearly intervention costs for the INTERCARE nurse salary per bed were 939CHF with an average of 1.4 INTERCARE nurses per 100 beds and an average employment rate of 76% of full-time equivalent per nurse. Resident hospitalisation represented a total average loss of 52% of NH revenues, but negligible cost savings. The incremental cost-effectiveness ratio of the INTERCARE model compared to usual care was 22'595CHF per avoided hospitalisation. As expected, the most influential sensitivity analysis variable regarding the CEA was the pre- to post-INTERCARE change in hospitalisation rate. CONCLUSIONS: As initial health-economic evidence, these results indicate that the INTERCARE model was more costly but also more effective compared to usual care in participating Swiss German NHs. Further implementation and evaluation of this model in randomised controlled studies are planned to build stronger evidential support for its clinical and economic effectiveness. TRIAL REGISTRATION: clinicaltrials.gov ( NCT03590470 ).

Positive effect of the INTERCARE nurse-led model on reducing nursing home transfers: A nonrandomized stepped-wedge design.

BACKGROUND: Unplanned nursing home (NH) transfers are burdensome for residents and costly for health systems. Innovative nurse-led models of care focusing on improving in-house geriatric expertise are needed to decrease unplanned transfers. The aim was to test the clinical effectiveness of a comprehensive, contextually adapted geriatric nurse-led model of care (INTERCARE) in reducing unplanned transfers from NHs to hospitals. METHODS: A multicenter nonrandomized stepped-wedge design within a hybrid type-2 effectiveness-implementation study was implemented in 11 NHs in German-speaking Switzerland. The first NH enrolled in June 2018 and the last in November 2019. The study lasted 18 months, with a baseline period of 3 months for each NH. Inclusion criteria were 60 or more long-term care beds and 0.8 or more hospitalizations per 1'000 resident care days. Nine hundred and forty two long-term NH residents were included between June 2018 and January 2020 with informed consent. Short-term residents were excluded. The primary outcome was unplanned hospitalizations. A fully anonymized dataset of overall transfers of all NH residents served as validation. Analysis was performed with segmented mixed regression modeling. RESULTS: Three hundred and three unplanned and 64 planned hospitalizations occurred. During the baseline period, unplanned transfers increased over time (ß1  = 0.52), after which the trend significantly changed by a similar but opposite amount (ß2  = -0.52; p = 0.0001), resulting in a flattening of the average transfer rate throughout the postimplementation period (ß1  + ß2  ≈ 0). Controlling for age, gender, and cognitive performance did not affect these trends. The validation set showed a similar flattening trend. CONCLUSION: A complex intervention with six evidence-based components demonstrated effectiveness in significantly reducing unplanned transfers of NH residents to hospitals. INTERCARE's success was driven by registered nurses in expanded roles and the use of tools for clinical decision-making.

Health-related quality of life in women with autoimmune thyroid disease during pregnancy and postpartum: systematic review including 321,850 pregnancies.

BACKGROUND: Utilities of the general population or expert estimates have been used for all published cost-effectiveness analyses of screening for thyroid disorders in pregnancy. METHODS: A systematic review CRD42019120897 of studies with patient-reported outcomes (PRO) and laboratory evidence of thyroid function/autoimmunity was conducted using PubMed, Cochrane Central, EconLit, SocIndex, DARE, NHS EEDS, Annual Reviews, and CINAHL. Quality was assessed using Joanna Briggs Institute appraisal tool. RESULTS: Of 664 abstracts screened, we analyzed 97 full texts. All studies describing the impact of thyroid disease on the generic QoL excluded pregnant and postpartum women. 21 reports of acceptable quality (321,850 pregnancies) determined depression and anxiety with validated tools and/or reported subjective symptoms. During pregnancy, contradictory conclusions were published on the impact of thyroid disease on PRO. Postpartum, antithyroid antibodies coincide with alexithymia and depression, postpartum thyroiditis negatively impacts mood. No conclusion could be drawn on the impact of thyroid hormonal levels. CONCLUSIONS: The generic QoL in autoimmune thyroid disease during pregnancy has never been described, which represents an obstacle for the construction of economic models. We found contradictory information on the impact of thyroid disease on depression, anxiety, and specific symptoms.

Positive Antithyroid Antibodies and Nonsuppressed TSH Are Associated with Thyroid Cancer: A Retrospective Cross-Sectional Study.

The relationship between Hashimoto's thyroiditis (HT) and thyroid cancer (TC) is a controversial topic; it remains unclear if HT acts as a risk factor of TC. The aim of our study was to compare the presence of HT and thyroid function in patients with TC and benign nodules. We analyzed 2571 patients after fine needle aspiration biopsy of thyroid nodule. Totally, 91 patients with primary TC and 182 sex- and age-matched controls were included. Positive antithyroid peroxidase (anti-TPO) and antithyroglobulin (anti-Tg) antibodies were associated with TC (anti-TPO 44% in TC vs. 27% in controls, P = 0.005, anti-TG 35% in TC group vs. 21% in controls, P = 0.018), and the TC group had significantly higher TSH (median 1.88 mIU/l vs. 1.21 mIU/l, P < 0.001). Using multiple logistic regression, positive anti-TPO was identified as an independent risk factor (OR 2.21, P = 0.018), while spontaneously suppressed TSH < 0.5 mIU/l was a protective factor (OR 0.3, P = 0.01) against TC. In conclusion, nodules in subjects with positive antithyroid antibodies could be considered to have a higher risk of malignancy. However, based on our results, it is not possible to declare that TC is triggered by HT.

[Methods of economic analysis of screening programs. Situation in Czech Republic]. / Metody ekonomického hodnocení screeningových programu. Situace v Ceské republice.

In the process of reducing health budget the question of the effectiveness of investment in population-based screening programs is very actual. Because of the scope, screening is becoming very expensive and burdens healthy people. An essential part of any screening program is careful consideration, registration and monitoring of the results. Here economic analysis are irreplaceable. They enable an objective assessment of the effectiveness of the use of resources and thus become an important basis for decision-making about the allocation of scarce resources for improving the health status of the population. The present text deals with the basic types of economic analysis, including their significance and possibilities when making decisions about recommended screening procedures in the Czech Republic.

Mild iodine deficiency in women after spontaneous abortions living in an iodine-sufficient area of Czech Republic: prevalence and impact on reproductive health.

OBJECTIVE: Iodine deficiency is associated with thyroid dysfunction and adverse pregnancy outcomes. The aim of our study was to investigate the status of iodine saturation in women after spontaneous abortion (SpA) residing in an iodine-sufficient area and to evaluate their subsequent reproductive health. DESIGN: Nonrandomized prospective follow-up study. PATIENTS AND METHODS: We compared urinary iodine concentration (UIC) in 171 women 2-8 weeks (median 4) after an early SpA with age-matched controls. Women with known thyroid diseases were excluded. We also analysed a relationship of UIC to serum thyroid-stimulating hormone, free thyroxine, antibodies against thyroid peroxidase and thyroid ultrasound. Afterwards, we followed the women for a median of 38 months (range 12-47). We used a multivariate regression analysis to assess the influence of iodine status and other thyroid biochemical and ultrasound parameters on their subsequent reproductive health. RESULTS: Women after SpA were almost twice as likely to suffer from mild iodine deficiency and had lower median UIC as compared to age-matched controls [rate 105/181 (58·0%) vs 57/181 (31·5%), P < 0·001, medians UIC 92·00 vs 117·80 mcg/l, P < 0·001]. UIC was not influenced by the use of iodine supplements in the previous pregnancy. We did not find any association neither between UIC and thyroid dysfunction and/or thyroid antibodies, nor between UIC and rates of subsequent successful pregnancies or obstetric complications. CONCLUSIONS: More than half of women after SpA residing in an iodine-sufficient area are suffering from mild iodine deficiency. However, it does not seem to have a negative impact on their subsequent reproductive health.

Association between low levels of Mannan-binding lectin and markers of autoimmune thyroid disease in pregnancy.

Functional deficiency of mannan-binding lectin (MBL) has been associated with adverse pregnancy outcome. Adverse events during pregnancy have also been described in women with autoimmune thyroid diseases (AITD), and thyroid hormones have been shown to influence serum levels of MBL. Therefore, the aim of this study was to analyse the impact of MBL-deficiency on the outcome of pregnancy in relation to the presence of AITD. Almost one year after delivery, we assessed serum MBL levels and MBL2-genotypes in 212 women positively screened for AITD in pregnancy. In 103 of these women, we could also measure MBL levels in frozen serum samples from the 9-12(th) gestational week, obtaining 96 pairs of MBL values (pregnancy vs. follow-up). As controls, 80 sera of pregnant women screened negatively for AITD were used. MBL2-genotyping was performed using multiplex PCR. Women with thyroid dysfunction and/or thyroid peroxidase antibodies (TPOAb) had lower MBL levels during pregnancy than controls, (3275 vs. 5000 ng/ml, p<0.05). The lowest levels were found in women with elevated thyroid-stimulating hormone (TSH) levels in the absence of TPOAb (2207 ng/ml; p<0.01 as compared to controls). MBL2 genotype distribution did not differ between subgroups. At a median follow-up period of 17 months (range: 3-78 months) after delivery, median MBL level had decreased further to 1923 ng/ml (p<0.0001) without significant changes in TSH. In an explorative survey, functional MBL-deficiency was neither linked to a history of spontaneous abortion, nor other obstetric complications, severe infections throughout life/pregnancy or antibiotics use in pregnancy. In conclusion, hypothyroidism during pregnancy is associated with decreased MBL levels, and the levels decreased further after delivery.

Screening for autoimmune thyroid disorders after spontaneous abortion is cost-saving and it improves the subsequent pregnancy rate.

BACKGROUND: Hypothyroidism and/or autoimmune thyroid disorders (AITD) may contribute to spontaneous abortions (SpA). Cost-effectiveness analyses of thyroid screening in women after SpA are lacking. Our aim was to evaluate the cost-effectiveness of screening for AITD and/or hypothyroidism and their treatment in women after SpA with regard to their reproductive health. METHODS: We performed a cross-sectional non-randomized study with follow-up in 2008-2011 in the settings of Departments of Endocrinology and Obstetrics/Gynecology of a university hospital. We enrolled 258 women after SpA before the 12th gestational week and followed them for a median of 3 years. At enrollment, serum concentrations of thyroid stimulatory hormone (TSH), antibodies to thyroid peroxidase (TPOAb) and free thyroxine (FT4) were measured and thyroid ultrasound performed. Women with overt hypothyroidism were treated with levothyroxine (n = 45; 61.6%) and women with subclinical hypothyroidism or euthyroid AITD were treated (n = 28; 38.4%) or left untreated (n = 38; 14.7%). Euthyroid women without signs of AITD served as controls (n = 147; 57.0%). RESULTS: Of the 38 untreated women with AITD and/or subclinical hypothyroidism, 8 (21.1%) reported secondary infertility as compared to 16/147 (10.9%) controls and 3/73 (4.1%) treated women (p = 0.021). Treatment was associated with an increased rate of successfully completed subsequent pregnancies (increment of 6 newborns/100 women) and a savings of €19,539/100 women. Total costs per successfully completed pregnancy were €1,189 in controls, €1,564 in the treated, and €2,488 in the untreated women. CONCLUSIONS: Screening for thyroid disorders in women after SpA and treatment with levothyroxine is cost-saving and it improves the subsequent pregnancy rate.

Is age a risk factor for hypothyroidism in pregnancy? An analysis of 5223 pregnant women.

CONTEXT: The guidelines of American Thyroid Association from 2011 include age over 30 as one of the risk factors for hypothyroidism in pregnancy. OBJECTIVE: Our objective was to verify whether age increases the risk of autoimmune thyroid disease in pregnancy. DESIGN: We performed a cross-sectional study in 2006-2008 with laboratory assessment in a single center using primary care gynecological ambulances in cooperation with a referral center. PATIENTS: The study included 5223 consecutive pregnant women in gestational wk 9-12. MAIN OUTCOME MEASURE: We assessed the occurrence of pathological serum concentrations of TSH and/or antibodies against thyroperoxidase (TPOAb) with regard to age. Reference interval for TSH was 0.06-3.67 mU/liter; the upper cutoff value for TPOAb was 143 kU/liter. RESULTS: Overall, 857 women (16.4%) were positively screened. Of these, 294 (5.63%) had TSH elevation, 146 (2.79%) had TSH suppression, 561 (10.74%) were TPOAb positive, and 417 (7.98%) were euthyroid and TPOAb positive. The average age of women was 31.1 yr. The prevalence of hypothyroidism was 5.5 and 5.8% in women aged 30 or older and those under 30 yr, respectively (P value nonsignificant). Using a logistic regression model, we didn't find any significant association between age and serum TSH suppression, TSH elevation, or TPOAb positivity (P = 0.553, P = 0.680, and P = 0.056, respectively) or between age and TSH elevation with TPOAb positivity (P = 0.967). In a subgroup analysis of risk factors for hypothyroidism in 132 hypothyroid women, addition of age 30 or older increased the proportion of women identified in a case-finding screening strategy from 55.3 to 85.6%. CONCLUSIONS: Prevalence of autoimmune thyroid disease does not increase with age in pregnant women; however, addition of age 30 or over to the case-finding screening strategy may substantially improve its efficiency due to a larger number of women screened.

Low concordance between positive antibodies to thyroperoxidase and thyroid ultrasound autoimmune pattern in pregnant women.

The diagnostic and prognostic role of thyroid ultrasound (TUS) in pregnant women positive for antibodies to thyroperoxidase (TPOAb) is unclear. The aim of our study was to compare the relation of ultrasound thyroid texture to the thyroid laboratory tests in pregnant women and controls. Using a semi-quantitative assessment we compared TUS in two groups of women with positive TPOAb and/or with thyroid dysfunction (TSH out of 0.06-3.67 mIU/L): 186 women in 1(st) trimester of pregnancy recruited from universal screening and 67 asymptomatic age-comparable non-pregnant non-postpartum women recruited from screening of general population (controls). Women with previous history of thyroid diseases were excluded. Only 64/131 (48.9 %) of TPOAb-positive pregnant women were TUS-positive (TUS with autoimmune pattern) in comparison with 35/49 (71.4 %) TPOAb-positive controls (p <0.011). Pregnant women had more often TSH >10.0 mIU/L if they were TPOAb-positive/TUS-positive as compared to those TPOAb-positive/TUS-negative (8/64 (12.5 %) vs. 0/67 (0 %), p = 0.009). The prevalence of preterm deliveries among TPOAb-positive women was significantly lower if TPOAb-positivity was not accompanied by TUS-positivity (2/67 (3.0 %) vs. 10/64 (15.6 %) in TPOAb-positive/TUS-positive women, p = 0.028). In conclusion, nearly half of the TPOAb-positive pregnant women did not have an autoimmune pattern in TUS. Normal TUS image in TPOAb-positive pregnant women might be a protective factor for preterm delivery.