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

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).; 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).; 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.; ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021

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

Utilities of the general population or expert estimates have been used for all published cost-effectiveness analyses of screening for thyroid disorders in pregnancy. 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. 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. 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.</p

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

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

Clinical characteristics of the study group.

<p> AITD: autoimmune thyroid disorders. TPOAb: antibodies against thyroperoxidase. The data were obtained from questionnaires filled by the participating women.</p

MBL levels in pregnant women with and without autoimmune thyroid disorders.

<p>Overall, 103 women tested positively in a screening for AITD performed between the 9^th and 12^th gestational weeks (grouped together in the left column). They were found to be positive for TPOAb in 86 cases (of these, 12 had TSH elevation, 6 had TSH suppression; the rest was euthyroid). Of the 17 TPOAb-negative ones, 10 had TSH elevation and 7 had TSH suppression. Eighty women were negative for both parameters (right column). Horizontal bars represent median values of serum MBL.</p

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

Serum MBL levels in pregnant women screened for AITD.

<p>–1000 ng/ml and high: >1000 ng/ml. Low serum MBL levels: <100 ng/ml; intermediate: 100</p

Serum levels of MBL and thyroid parameters in pregnant women screened for autoimmune thyroid disorders in the 9-12^th gestational wks.

<p>^*(p<0.05), ^**(p<0.01), ^***(p<0.001) (Mann Whitney test). Positivity in screening: TSH<0.06 or >3.67 mIU/l and/or TPOAb>143 kU/l. TSH: thyroid stimulating hormone; FT4: free thyroxine; TPOAb: antibodies against thyroperoxidase. All 212 women included provided a blood sample for MBL analysis after delivery. In 103women, MBL could also be measured in a sample frozen at screening in pregnancy, which summed up to 96 pairs (pregnancy vs. follow-up). Statistical significances of comparison between values in positively vs. negatively screened women are marked by </p