Development of a novel instrument for assessing intentional non-adherence to official medical recommendations (iNAR-12): a sequential mixed-methods study in Serbia

Objectives
We aimed to (1) develop a novel instrument, suitable for the general population, capturing intentional non-adherence (iNAR), consisting of non-adherence to prescribed therapy, self-medication and avoidance of seeking medical treatment; (2) differentiate it from other forms of non-adherence, for example, smoking; and (3) relate iNAR to patient-related factors, such as sociodemographics, health status and endorsement of irrational beliefs (conspiratorial thinking and superstitions) and to healthcare-related beliefs and experiences ((mis)trust and negative experiences with the healthcare system, normalisation of patient passivity).

Design
To generate iNAR items, we employed a focus group with medical doctors, supplemented it with a literature search and invited a public health expert to refine it further. We examined the internal structure and predictors of iNAR in an observational study.

Setting
Data were collected online using snowball sampling and social networks.

Participants
After excluding those who failed one or more out of three attention checks, the final sample size was n=583 adult Serbian citizens, 74.4% female, mean age 39.01 years (SD=12.10).

Primary and secondary outcome measures
The primary, planned outcome is the iNAR Questionnaire, while smoking was used for comparison purposes.

Results
Factor analysis yielded a one-factor solution, and the final 12-item iNAR Questionnaire had satisfactory internal reliability (alpha=0.72). Health condition and healthcare-related variables accounted for 14% of the variance of iNAR behaviours, whereas sociodemographics and irrational beliefs did not additionally contribute.

Conclusions
We constructed a brief yet comprehensive measure of iNAR behaviours and related them to health and sociodemographic variables and irrational beliefs. The findings suggest that public health interventions should attempt to improve patients’ experiences with the system and build trust with their healthcare practitioners rather than aim at specific demographic groups or at correcting patients’ unfounded beliefs.

Study registration
The design and confirmatory analyses plan were preregistered (https://osf.io/pnugm).

Leggi
Giugno 2023

Rehabilitation cooperation and person-centred dialogue meeting for patients sick-listed for common mental disorders: 12 months follow-up of sick leave days, symptoms of depression, anxiety, stress and work ability – a pragmatic cluster randomised controlled trial from the CO-WORK-CARE project

Objectives
To study whether early and enhanced cooperation within the primary care centres (PCC) combined with workplace cooperation via a person-centred employer dialogue meeting can reduce days on sick leave compared with usual care manager contact for patients on sick leave because of common mental disorders (CMD). Secondary aim: to study lapse of CMD symptoms, perceived Work Ability Index (WAI) and quality of life (QoL) during 12 months.

Design
Pragmatic cluster randomised controlled trial, randomisation at PCC level.

Setting
28 PCCs in Region Västra Götaland, Sweden, with care manager organisation.

Participants
30 PCCs were invited, 28 (93%) accepted invitation (14 intervention, 14 control) and recruited 341 patients newly sick-listed because of CMD (n=185 at intervention, n=156 at control PCCs).

Intervention
Complex intervention consisting of (1) early cooperation among general practitioner (GP), care manager and a rehabilitation coordinator, plus (2) a person-centred dialogue meeting between patient and employer within 3 months. Control group: regular contact with care manager.

Main outcome measures
12 months net and gross number of sick leave days at group level. Secondary outcomes: 12 months depression, anxiety, stress symptoms, perceived WAI and QoL (EuroQoL-5 Dimensional, EQ-5D).

Results
No significant differences were found between intervention and control groups concerning days of sick leave (intervention net days of sick leave mean 102.48 (SE 13.76) vs control 96.29 (SE 12.38) p=0.73), return to work (HR 0.881, 95% CI 0.688 to 1.128), or CMD symptoms, WAI or EQ-5D after 12 months.

Conclusions
It is not possible to speed up CMD patients’ return to work or to reduce sick leave time by early and enhanced coordination among GP, care manager and a rehabilitation coordinator, combined with early workplace contact over and above what ‘usual’ care manager contact during 3 months provides.

Trial registration number
NCT03250026.

Leggi
Giugno 2023

Effect of a 12-week high-intensity exercise intervention: a comparison of cardiac exercise adaptations during biological disease-modifying antirheumatic drug treatment (TNF inhibitors vs IL-6 signalling inhibitors) in patients with rheumatoid arthritis – study protocol for a randomised controlled trial

Introduction
The chronic inflammatory state in rheumatoid arthritis (RA) augments the risk of cardiovascular disease (CVD), with pro-inflammatory cytokines tumour necrosis factor (TNF) and interleukin 6 (IL-6) playing a vital role. Consequently, biological disease-modifying antirheumatic drugs (bDMARDs) may attenuate that risk. IL-6 is also a myokine, secreted from exercising skeletal muscles, where IL-6 exhibits anti-inflammatory effects that may ameliorate the risk of CVD. In healthy humans treated with IL-6 signalling inhibitors (IL-6i), exercise induced loss of visceral fat mass and cardiac adaptations were abolished. We hypothesise that IL-6 signalling inhibition will impair the cardiac and metabolic adaptions to exercise training compared with TNF inhibition in RA patients.

Methods and analysis
80 RA patients treated with IL-6i (n=40) or TNF inhibitors (n=40) are included in a 12-week randomised investigator-blinded 4×4 min high-intensity interval training (HIIT) study. Patients are stratified for medical treatment and sex and allocated 1:1 to an exercise or a no exercise control group (four groups). The supervised exercise intervention comprises 3 weekly HIIT sessions on an ergometer bicycle. The primary outcome is the change in left ventricular mass (LVM), and key secondary outcome is change in visceral fat mass. Both outcomes are measured by MRI. Primary statistical analysis will evaluate LVM at follow-up in a regression model. Intention-to-treat and per protocol analyses will be conducted. The latter necessitates a minimum attendance rate of 80%, adherence to bDMARDs treatment of ≥80% and minimum 8 min (50%) of maximal heart rate above 85% per session.

Ethics and dissemination
The study has been approved by the Capital Region Ethics Committee (H-21010559 amendments 86424, 87463 and 88044) and the Danish Medicines Agency (2021-b005287-21). The trial will follow ICH-GCP guidelines. Regardless of outcome, results will be published in relevant peer-reviewed journals.

Trial registration numbers
Eudra-CT: 2021-b005287-21 and NCT05215509.

Leggi
Maggio 2023

Long-term psychosocial consequences of false-positive screening mammography: a cohort study with follow-up of 12-14 years in Denmark

Objective
To compare the long-term psychosocial consequences of mammography screening among women with breast cancer, normal results and false-positive results.

Design
A matched cohort study with follow-up of 12–14 years.

Setting
Denmark from 2004 to 2019.

Participants
1170 women who participated in the Danish mammography screening programme in 2004–2005.

Intervention
Mammography screening for women aged 50–69 years.

Outcome measures
We assessed the psychosocial consequences with the Consequences Of Screening–Breast Cancer, a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions.

Results
Across all 14 psychosocial outcomes, women with false-positive results averagely reported higher psychosocial consequences compared with women with normal findings. Mean differences were statistically insignificant except for the existential values scale: 0.61 (95% CI (0.15 to 1.06), p=0.009). Additionally, women with false-positive results and women diagnosed with breast cancer were affected in a dose–response manner, where women diagnosed with breast cancer were more affected than women with false-positive results.

Conclusion
Our study suggests that a false-positive mammogram is associated with increased psychosocial consequences 12–14 years after the screening. This study adds to the harms of mammography screening. The findings should be used to inform decision-making among the invited women and political and governmental decisions about mammography screening programmes.

Leggi
Aprile 2023

A predictive modelling approach to illustrate factors correlating with stunting among children aged 12-23 months: a cluster randomised pre-post study

Objective
The aim of this study was to construct a predictive model in order to develop an intervention study to reduce the prevalence of stunting among children aged 12–23 months.

Design
The study followed a cluster randomised pre-post design and measured the impacts on various indicators of livelihood, health and nutrition. The study was based on a large dataset collected from two cross-sectional studies (baseline and endline).

Setting
The study was conducted in the north-eastern region of Bangladesh under the Sylhet division, which is vulnerable to both natural disasters and poverty. The study specifically targeted children between the ages of 12 and 23 months.

Main outcome measures
Childhood stunting, defined as a length-for-age z-score

Leggi
Aprile 2023