Psychometric properties of two implementation measures: Normalization MeAsure Development questionnaire (NoMAD) and organizational readiness for implementing change (ORIC).

Background: Effective interventions need to be implemented successfully to achieve impact. Two theory-based measures exist for measuring the effectiveness of implementation strategies and monitor implementation progress. The Normalization MeAsure Development questionnaire (NoMAD) explores the four core concepts (Coherence, Cognitive Participation, Collective Action, Reflexive Monitoring) of the Normalization Process Theory. The Organizational Readiness for Implementing Change (ORIC) is based on the theory of Organizational Readiness for Change, measuring organization members' psychological and behavioral preparedness for implementing a change. We examined the measurement properties of the NoMAD and ORIC in a multi-national implementation effectiveness study. Method: Twelve mental health organizations in nine countries implemented Internet-based cognitive behavioral therapy (iCBT) for common mental disorders. Staff involved in iCBT service delivery (n = 318) participated in the study. Both measures were translated into eight languages using a standardized forward-backward translation procedure. Correlations between measures and subscales were estimated to examine convergent validity. The theoretical factor structures of the scales were tested using confirmatory factor analysis (CFA). Test-retest reliability was based on the correlation between scores at two time points 3 months apart. Internal consistency was assessed using Cronbach's alpha. Floor and ceiling effects were quantified using the proportion of zero and maximum scores. Results: NoMAD and ORIC measure related but distinct latent constructs. The CFA showed that the use of a total score for each measure is appropriate. The theoretical subscales of the NoMAD had adequate internal consistency. The total scale had high internal consistency. The total ORIC scale and subscales demonstrated high internal consistency. Test-retest reliability was suboptimal for both measures and floor and ceiling effects were absent. Conclusions: This study confirmed the psychometric properties of the NoMAD and ORIC in multi-national mental health care settings. While measuring on different but related aspects of implementation processes, the NoMAD and ORIC prove to be valid and reliable across different language settings.

Why was the study done?: Effective interventions need to be implemented successfully to achieve impact. Reliable measurement instruments are needed to determine if an implementation was successful or not. Two theory-based instruments exist for measuring the effectiveness of implementation strategies and monitor progress. The NoMAD measures aspects of normalization related to sense-making, willingness to implement, the work people do, and reflection. The Organizational Readiness for Implementing Change (ORIC) measures organization members' preparedness for implementing a change. What did we do?: This study examined whether the NoMAD and ORIC measure what they are supposed to measure. We translated the instruments from English to eight languages (Albanian, Danish, Dutch, French, German, Italian, and Spanish/Catalan) We applied various statistical methods to confirm the measurement properties, including correlations of scales, factor structures, test­retest reliability, consistency and floor and ceiling effects. 318 mental health professionals from nine countries participated in the study. What did we find?: For both instruments, total scores can be used as well as the subscale scores. Internal consistency for ORIC was high and for NoMAD adequate. Test­retest reliability was demonstrated, and floor and ceiling effects were rare. What does this mean?: NoMAD and ORIC are reliable instruments for measuring implementation processes and outcomes across mental health care settings in different countries and languages. They measure related but different aspects of implementation processes and outcomes. The measures are brief, and theory supported. However, more work is to be done on interpreting scores in relation to implementation success and regarding changes over time.

SARS-CoV-2 cellular and humoral responses in vaccine-naive individuals during the first two waves of COVID-19 infections in the southern region of The Netherlands: a cross-sectional population-based study.

With the emergence of highly transmissible variants of concern, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) still poses a global threat of coronavirus disease 2019 (COVID-19) resurgence. Cellular responses to novel variants are more robustly maintained than humoral responses, and therefore, cellular responses are of interest in assessing immune protection against severe disease in the population. We aimed to assess cellular responses to SARS-CoV-2 at the population level. IFNγ (interferon γ) responses to wild-type SARS-CoV-2 were analyzed using an ELISpot assay in vaccine-naive individuals with different humoral responses: Ig (IgM and/or IgG) seronegative (n = 90) and seropositive (n = 181) with low (<300 U/mL) or high (≥300 U/mL) humoral responses to the spike receptor binding domain (anti-S-RBD). Among the seropositive participants, 71.3% (129/181) were IFNγ ELISpot positive, compared to 15.6% (14/90) among the seronegative participants. Common COVID-19 symptoms such as fever and ageusia were associated with IFNγ ELISpot positivity in seropositive participants, whereas no participant characteristics were associated with IFNγ ELISpot positivity in seronegative participants. Fever and/or dyspnea and anti-S-RBD levels were associated with higher IFNγ responses. Symptoms of more severe disease and higher anti-S-RBD responses were associated with higher IFNγ responses. A significant proportion (15.6%) of seronegative participants had a positive IFNγ ELISpot. Assessment of cellular responses may improve estimates of the immune response to SARS-CoV-2 in the general population. IMPORTANCE: Data on adaptive cellular immunity are of interest to define immune protection against severe acute respiratory syndrome coronavirus 2 in a population, which is important for decision-making on booster-vaccination strategies. This study provides data on associations between participant characteristics and cellular immune responses in vaccine-naive individuals with different humoral responses.

COVID-19 pandemic response in the Meuse-Rhine Euroregion: methods, participation and recommendations of a longitudinal cross-border study.

BACKGROUND: Comparative data collection in transborder areas can contribute to informed decision making processes when dealing with borderless health threats such as pandemics, and thus help minimize the negative health effects for its citizens. To examine the pandemic response over time and the impact of infectious disease control in a cross-border setting, a prospective longitudinal study was conducted in the border area between Germany, Belgium and the Netherlands. In the spring of 2021, a random sample of 26,925 adult citizens selected from governmental registries was invited to collect a blood sample at home for SARS-CoV-2 antibody testing and to fill in an online questionnaire on attitudes and behaviour towards infection prevention measures, cross-border mobility, social network and support, COVID-19 self-reported infection(s) and symptoms, vaccination, general self-reported health and socio-demographics. In autumn 2021, participants were invited for a follow-up round. An online tool was developed to coordinate fieldwork procedures, real-time monitoring of participation and consultation of antibody test results. Furthermore, a helpdesk in all three languages for participants' support was set up. RESULTS: In the first round, 6,006 citizens in the Meuse-Rhine Euroregion participated. 15.3% of the invited citizens on the Belgian side of the border participated. In the Netherlands and Germany this was respectively 27% and 23.7%. In the follow-up round 4,286 (71.4%) citizens participated for the second time. The participation rate was highest in the age group 50-69 years and lowest in > 80 in all sub regions of the Meuse-Rhine Euroregion. More women participated than men. Overall, more blood samples were returned than completed questionnaires. In total, 3,344 citizens in the Meuse-Rhine Euroregion completed all components of participation in both rounds. CONCLUSIONS: The collection of comparative data can help better assess the pandemic response and the impact of infectious disease control in a cross-border area. Recommendations for a longitudinal cross-border study include a centralized online environment, mapping out potential challenges related to national regulations in the preparation phase and organizing regional coordination centres to create more familiarity and trust towards the involved organisations.

Antibodies against SARS-CoV-2 after natural infection in healthcare workers and clinical characteristics as putative antibody production prediction.

Introduction: There is a need for detailed data on early antibody responses against SARS-CoV-2 as this may contribute to the prediction of the clinical course of COVID-19 and the optimization of convalescent plasma treatment. This study aims to gain insight into developing antibodies to SARS-CoV-2 in health care workers (HCWs) infected in the first wave of the SARS-CoV-2 pandemic in the Netherlands. Materials and methods: In this retrospective analysis, sera from PCR-confirmed COVID-19 positive HCWs are included at the time of the initial PCR (T = 0, n = 95) and at least 21 days after the initial serum (T ≥ 21, n = 133). This study assesses correlations between qualitative total Ig, IgM, IgA, IgG, and quantitative anti-S-RBD antibody responses and participant characteristics. Results: Higher Ct values were associated with higher antibody positivity rates for total Ig (OR 1.261 (95% CI 1.095-1.452)), IgM (OR 1.373 (95% CI 1.125-1.675)), and IgA (OR 1.222 (95% CI 1.013-1.475)). Gender was predictive of IgM and IgA antibody positivity rates at T = 0 (OR 0.018 (95% CI 0.001-0.268)) and (OR 0.070 (95% CI 0.008-0.646)). At T ≥ 21, a substantial proportion of HCWs developed IgM (103/133; 77.4%) and total Ig (128/133; 96.2%) antibodies. IgA and IgG seroconversions were observed in only 51.1% (67/131) and 55.7% (73/131) of HCWs. Anti-S-RBD responses were higher when the interval between onset of symptoms and sampling was longer. Conclusion: The findings of this study give insight into early antibody responses and may have implications for the selection of convalescent plasma donors and the further development of monoclonal antibody treatment.

Is there a higher risk of a complicated course of hepatitis A in kidney transplant patients?

BACKGROUND: We describe a patient who was planned to receive a kidney transplant from his wife. Both were infected with Hepatitis A virus (HAV) two weeks prior to the planned transplantation. Due to prolonged shedding of HAV (up until 126 days) we decided to postpone the kidney transplant in order to prevent long term complications. OBJECTIVES: The main question in this case was is there a higher risk of a complicated course of HAV-infection after kidney transplantation? We discuss the need for upscale of preventative measures of HAV infections in solid organ transplant candidates. STUDY DESIGN: We performed a literature study on risks of a complicated course of HAV in solid organ transplant recipients and performed a seroprevalence study on anti-HAV in a cohort of 106 hemodialysis patients. RESULTS: Little is known whether HAV infection in solid organ transplant patients causes a more aggressive course of diseases. However, HAV infections in these populations are associated with increased risk of liver failure. CONCLUSIONS: This case highlights the need of scaling up preventative measures against HAV infections in solid organ transplant candidates.

Psychiatric characteristics of older persons with medically unexplained symptoms: A comparison with older patients suffering from medically explained symptoms.

BACKGROUND: Empirical studies on the clinical characteristics of older persons with medically unexplained symptoms are limited to uncontrolled pilot studies. Therefore, we aim to examine the psychiatric characteristics of older patients with medically unexplained symptoms (MUS) compared to older patients with medically explained symptoms (MES), also across healthcare settings. METHODS: A case-control study including 118 older patients with MUS and 154 older patients with MES. To include patients with various developmental and severity stages, patients with MUS were recruited in the community (n = 12), primary care (n = 77), and specialized healthcare (n = 29). Psychopathology was assessed according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (Mini-International Neuropsychiatric Interview) and by dimensional measures (e.g., psychological distress, hypochondriasis, and depressive symptoms). RESULTS: A total of 69/118 (58.5%) patients with MUS met the criteria for a somatoform disorder according to DSM-IV-TR criteria, with the highest proportion among patients recruited in specialized healthcare settings (p = 0.008). Patients with MUS had a higher level of psychological distress and hypochondriasis compared to patients with MES. Although psychiatric disorders (beyond somatoform disorders) were more frequently found among patients with MUS compared to patients with MES (42.4 vs. 24.8%, p = 0.008), this difference disappeared when adjusted for age, sex, and level of education (odds ratio = 1.7 [95% confidence interval: 1.0-3.0], p = 0.070). CONCLUSIONS: Although psychological distress is significantly higher among older patients with MUS compared to those with MES, psychiatric comorbidity rates hardly differ between both patient groups. Therefore, treatment of MUS in later life should primarily focus on reducing psychological distress, irrespective of the healthcare setting patients are treated in.

Notification data and criteria during a large Q-fever epidemic reassessed.

From 2007 to 2010, the largest reported Q-fever epidemic occurred in the Netherlands with 4026 notified laboratory-confirmed cases. During the course of the epidemic, health-seeking behaviour changed and awareness among health professionals increased. Changes in laboratory workflows were implemented. The aim of this study was to analyse how these changes instigated adjustments of notification criteria and how these adjustments affected the monitoring and interpretation of the epidemic. We used the articles on laboratory procedures related to the epidemic and a description of the changes that were made to the notification criteria. We compared the output of a regional laboratory with notifications to the regional Public Health Service and the national register of infectious diseases. We compared the international notification criteria for acute Q-fever. Screening with ELISA IgM phase II and PCR was added to the diagnostic workflow. In the course of the epidemic, serology often revealed a positive IgG/IgM result although cases were not infected recently. With increasing background seroprevalence, the presence of IgM antibodies can only be suggestive for acute Q-fever and has to be confirmed either by seroconversion of IgG or a positive PCR result. Differences in sero-epidemiology make it unlikely that full harmonisation of notification criteria between countries is feasible.

Prognostic significance of social network, social support and loneliness for course of major depressive disorder in adulthood and old age.

AIMS: Poor recovery from depressive disorder has been shown to be related to low perceived social support and loneliness, but not to social network size or frequency of social interactions. Some studies suggest that the significance of social relationships for depression course may be greater in younger than in older patients, and may differ between men and women. None of the studies examined to what extent the different aspects of social relationships have unique or overlapping predictive values for depression course. It is the aim of the present study to examine the differential predictive values of social network characteristics, social support and loneliness for the course of depressive disorder, and to test whether these predictive associations are modified by gender or age. METHODS: Two naturalistic cohort studies with the same design and overlapping instruments were combined to obtain a study sample of 1474 patients with a major depressive disorder, of whom 1181 (80.1%) could be studied over a 2-year period. Social relational variables were assessed at baseline. Two aspects of depression course were studied: remission at 2-year follow-up and change in depression severity over the follow-up period. By means of logistic regression and random coefficient analysis, the individual and combined predictive values of the different social relational variables for depression course were studied, controlling for potential confounders and checking for effect modification by age (below 60 v. 60 years or older) and gender. RESULTS: Multiple aspects of the social network, social support and loneliness were related to depression course, independent of potential confounders - including depression severity - but when combined, their predictive values were found to overlap to a large extent. Only the social network characteristic of living in a larger household, the social support characteristic of few negative experiences with the support from a partner or close friend, and limited feelings of loneliness proved to have unique predictive value for a favourable course of depression. Little evidence was found for effect modification by gender or age. CONCLUSIONS: If depressed persons experience difficulties in their social relationships, this may impede their recovery. Special attention for interpersonal problems, social isolation and feelings of loneliness seems warranted in depression treatment and relapse prevention. It will be of great interest to test whether social relational interventions can contribute to better recovery and relapse prevention of depressive disorder.

Assessment of Somatization and Medically Unexplained Symptoms in Later Life.

The assessment of medically unexplained symptoms and "somatic symptom disorders" in older adults is challenging due to somatic multimorbidity, which threatens the validity of somatization questionnaires. In a systematic review study, the Patient Health Questionnaire-15 (PHQ-15) and the somatization subscale of the Symptom Checklist 90-item version (SCL-90 SOM) are recommended out of 40 questionnaires for usage in large-scale studies. While both scales measure physical symptoms which in younger persons often refer to unexplained symptoms, in older persons, these symptoms may originate from somatic diseases. Using empirical data, we show that PHQ-15 and SCL-90 SOM among older patients correlate with proxies of somatization as with somatic disease burden. Updating the previous systematic review, revealed six additional questionnaires. Cross-validation studies are needed as none of 46 identified scales met the criteria of suitability for an older population. Nonetheless, specific recommendations can be made for studying older persons, namely the SCL-90 SOM and PHQ-15 for population-based studies, the Freiburg Complaint List and somatization subscale of the Brief Symptom Inventory 53-item version for studies in primary care, and finally the Schedule for Evaluating Persistent Symptoms and Somatic Symptom Experiences Questionnaire for monitoring treatment studies.

[The prognosis of medically unexplained symptoms]. / De prognose van somatisch onvoldoende verklaarde lichamelijke klachten.

- The condition where someone has physical symptoms for a number of weeks for which no clear somatic cause can be found, is known as medically unexplained symptoms (MUS).- In this article we give an overview of current insights into the prognosis of MUS.- Extensive somatic testing in patients diagnosed with MUS by a physician, rarely results in a somatic diagnosis.- In approximately half of these patients, MUS disappear spontaneously within one year.- Symptom-related characteristics - such as experiencing multiple physical symptoms simultaneously-, and psychological characteristics - such as unhelpful thoughts - are predictors of an unfavourable prognosis for MUS.- Close monitoring of patients with MUS enables timely interventions, and may help to prevent MUS following an unfavourable course. Existing guidelines may help in choosing treatment and tailoring it to the individual patient.

Big Five personality traits and medically unexplained symptoms in later life.

BACKGROUND: Personality dysfunction has been postulated as the most clinically salient problem of persons suffering from medically unexplained symptoms (MUS) but empirical studies are scarce. This study aims to compare the personality profile of older patients suffering from MUS with two comparison groups and a control group. METHODS: Ninety-six older patients with MUS were compared with 153 frequent attenders in primary care suffering from medically explained symptoms (MES), 255 patients with a past-month depressive disorder (DSM-IV-TR), and a control group of 125 older persons. The Big Five personality domains (NEO-Five-Factor Inventory) were compared between groups by multiple ANCOVAs adjusted for age, sex, education, partner status and cognitive functioning. Linear regression analyses were applied to examine the association between health anxiety (Whitley Index) and somatization (Brief Symptom Inventory). RESULTS: The four groups differed with respect to neuroticism (P<0.001), extraversion (P<0.001), and agreeableness (P=0.045). Post hoc analyses, showed that MUS patients compared to controls scored higher on neuroticism and agreeableness, and compared to depressed patients lower on neuroticism and higher on extraversion as well agreeableness. Interestingly, MUS and MES patients had a similar personality profile. Health anxiety and somatization were associated with a higher level of neuroticism and a lower level of extraversion and conscientiousness, irrespective whether the physical symptom was explained or not. CONCLUSIONS: Older patients with MUS have a specific personality profile, comparable to MES patients. Health anxiety and somatization may be better indicators of psychopathology than whether a physical symptom is medically explained or not.

Effect of milk and lactose on zinc absorption in lactose-intolerant postmenopausal women.

We evaluated the effect of lactose intolerance on intestinal zinc absorption under various test conditions in a group of postmenopausal women. Fractional zinc absorption was studied with a dual-isotope technique using 65Zn and 51Cr (as nonabsorbable fecal markers). We performed four absorption tests on sixteen subjects with water (control), whole cow milk, lactose-free cow milk and lactose alone. Mean (+/- SEM) fractional zinc absorption was 0.558 +/- 0.032 with water, 0.276 +/- 0.031 with milk, 0.246 +/- 0.028 with lactose-free milk and 0.564 +/- 0.051 with lactose. No significant differences in zinc absorption were found under any of the test conditions between lactose-tolerant and lactose-intolerant subjects. Milk and lactose-free milk significantly reduced zinc absorption in both groups.