Objetivo principal: Evaluar la disfunción familiar desde una perspectiva holística en enfermos renales en terapia sustitutiva en un hospital de Monterrey, México. Metodología: Diseño mixto, analítico, transversal. Población conformada por 634 enfermos renales en terapias de sustitución de un hospital de segundo nivel en Monterrey. Se usó estadística descriptiva e inferencial para datos cuantitativos. Para la parte cualitativa se usó metodología fenomenológica conforme a la teoría fundamentada y análisis de dominios. Resultados principales: Alta prevalencia de disfuncionalidad familiar (70%). Según los enfermos renales en etapas avanzadas, el abandono por parte del cónyuge, la infidelidad marital, la exclusión familiar y los problemas económicos, son los principales factores que fracturan los lazos y la estruc-tura familiar. Conclusión principal: La enfermedad renal puede ser factor de disfuncionalidad familiar, hecho que compromete las relacio-nes entre los miembros familiares y afecta el apego a los tratamientos sustitutivos, al ser estos dependientes de un cuidador primario.
Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.
The Abilitator is a recently developed self-reported measurement tool for work ability and functioning of people in a weak labour market position. The aim of this study was to describe how self-reported information gathered with the Abilitator corresponds to information drawn from national registers.
Participants (n=669, mean age 44 years, 55% women) took part in the Work Ability Programme (2020–2023) that provided services for unemployed people with reduced work ability. They filled in the Abilitator questionnaire at the start of the service. Register-based data on participants’ health, income and received benefits was drawn from national registers. We evaluated how the different types of indicators concurred.
Statistically significant correlations (from weak to moderate) were found between different domains of the Abilitator and register-based data. Also, participants’ health status (information on mental health or musculoskeletal disorders) was displayed coherently in the results of the Abilitator. Overall, diagnosed mental health disorders distinguished participants’ Abilitator responses more strongly than diagnosed musculoskeletal disorders.
These findings provide further evidence on the applicability of the Abilitator as an instrument to evaluate work ability and functioning of people outside the work force.
Personal recovery is an important aspect for many individuals diagnosed with schizophrenia, as people can live rich, fulfilling lives despite ongoing symptoms. Prior reviews have found several factors to be associated with personal recovery, but a comprehensive overview of the psychosocial interventions aimed at improving personal recovery in schizophrenia is needed.
Key terms relating to personal recovery and psychosocial interventions to promote personal recovery will be searched for in the following databases: PubMed, EMBASE, PsycINFO, CINAHL, MEDLINE, Google Scholar, Web of Science Core Collection and Cochrane. Additionally, a simple search for grey literature will be conducted in The Networked Digital Library of Theses and Dissertations. Two reviewers will individually screen and extract the data, and the selection of sources will be documented in a Preferred Reporting Items for Systematic reviews and Meta-Analyses flow chart. A content analysis will be conducted on the data, and the findings will be presented in tables, and narratively synthesised. Lastly, research gaps will be identified, and recommendations for future research will be proposed.
Ethics approval was not required for the development or publishing of this protocol. Findings will be disseminated through conferences, meeting with patient organisations and consumers, and published in a peer-reviewed scientific journal.
The Finnish Retirement and Aging (FIREA) Study was set up to study changes in health behavioural and cardiometabolic risk factors across retirement transition, and to examine the long-term consequences of work and retirement on health and functioning with advancing age.
Public sector workers whose estimated statutory retirement date was in 2014–2019 were invited to participate by sending them a questionnaire 18 months prior to their estimated retirement date. In the first phase of the FIREA Study, participants were followed up with annual surveys, accelerometer and clinical measurements during retirement transition into post-retirement years. The FIREA survey cohort includes 6783 participants, of which 908 belong also to the activity substudy and 290 to the clinical substudy.
Collected data include survey measures about health, lifestyle factors, psychosocial distress, work-related factors as well as retirement intentions. Accelerometer and GPS devices are used to measure 24-hour movement behaviours. Clinical examination includes blood and hair sample, measurements of anthropometry, cardiovascular function, physical fitness, physical and cognitive function. Our results suggest that in general retirement transition seems to have beneficial influence on health behaviours as well as on physical and mental health, but there are large individual differences, and certain behaviours such as sedentariness tend to increase especially among those retiring from manual occupations.
The second phase of the FIREA Study will be conducted during 2023–2025, when participants are 70 years old. The FIREA Study welcomes research collaboration proposals that fall within the general aims of the project.
According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices.
This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace.
The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance.
Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19.
The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity.
Accurate, patient-centred evaluation of physical function in patients with cancer can provide important information on the functional impacts experienced by patients both from the disease and its treatment. Increasingly, digital health technology is facilitating and providing new ways to measure symptoms and function. There is a need to characterise the longitudinal measurement characteristics of physical function assessments, including clinician-reported outcome, patient-reported ported outcome (PRO), performance outcome tests and wearable data, to inform regulatory and clinical decision-making in cancer clinical trials and oncology practice.
In this prospective study, we are enrolling 200 English-speaking and/or Spanish-speaking patients with breast cancer or lymphoma seen at Mayo Clinic or Yale University who will receive intravenous cytotoxic chemotherapy. Physical function assessments will be obtained longitudinally using multiple assessment modalities. Participants will be followed for 9 months using a patient-centred health data aggregating platform that consolidates study questionnaires, electronic health record data, and activity and sleep data from a wearable sensor. Data analysis will focus on understanding variability, sensitivity and meaningful changes across the included physical function assessments and evaluating their relationship to key clinical outcomes. Additionally, the feasibility of multimodal physical function data collection in real-world patients with breast cancer or lymphoma will be assessed, as will patient impressions of the usability and acceptability of the wearable sensor, data aggregation platform and PROs.
This study has received approval from IRBs at Mayo Clinic, Yale University and the US Food and Drug Administration. Results will be made available to participants, funders, the research community and the public.
This article presents the study design of the qualitative part of the VersKiK study (Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence: study protocol of a large scale multi-methods non-interventional study) aiming to explore actual follow-up needs of childhood and adolescence cancer survivors and their informal caregivers, gaps in current follow-up care provision and trajectories of cancer survivors’ transition from paediatric to adult healthcare.
We will conduct up to 30 interviews with survivors of childhood and adolescence cancer and their informal caregivers with up to 20 participant observations of follow-up appointments. The results of these will be discussed in up to four focus groups with healthcare professionals and representatives of self-help groups. The study design aims to evaluate follow-up care after childhood cancer considering perspectives from survivors, their informal caregivers as well as healthcare providers. The combination of different data sources will allow us to get an in-depth understanding of the current state of follow-up care after paediatric cancer in Germany and to suggest recommendations for care improvement.
The VersKiK study was approved by the Ethics Committee Otto von Guericke University on 2 July 2021 (103/21), by the Ethics Committee of Johannes Gutenberg University Mainz on 16 June 2021 (2021-16035), by the Ethics Committee University of Lübeck on 10 November 2021 (21-451), by the Ethics Committee University of Hospital Bonn on 28 February 2022 (05/22). For each part of the qualitative study, a separate written informed consent is prepared and approved accordingly by the ethics committees named above.
Registered at German Clinical Trial Register, ID: DRKS00026092.
Japanese encephalitis virus (JEV) is a mosquito-borne flavivirus that causes encephalitis and other morbidity in Southeast Asia. Since February 2022, geographically dispersed JEV human, animal and vector detections occurred on the Australian mainland for the first time. This study will determine the prevalence of JEV-specific antibodies in human blood with a focus on populations at high risk of JEV exposure and determine risk factors associated with JEV seropositivity by location, age, occupation and other factors.
Samples are collected using two approaches: from routine blood donors (4153 samples), and active collections targeting high-risk populations (convenience sampling). Consent-based sampling for the latter includes a participant questionnaire on demographic, vaccination and exposure data. Samples are tested for JEV-specific total antibody using a defined epitope-blocking ELISA, and total antibody to Australian endemic flaviviruses Murray Valley encephalitis and Kunjin viruses.
Two analytic approaches will occur: descriptive estimates of seroprevalence and multivariable logistic regression using Bayesian hierarchical models. Descriptive analyses will include unadjusted analysis of raw data with exclusions for JEV-endemic country of birth, travel to JEV-endemic countries, prior JEV-vaccination, and sex-standardised and age-standardised analyses. Multivariable logistic regression will determine which risk factors are associated with JEV seropositivity likely due to recent transmission within Australia and the relative contribution of each factor when accounting for effects within the model.
National Mutual Acceptance ethical approval was obtained from the Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC). Local approvals were sought in each jurisdiction. Ethical approval was also obtained from the Australian Red Cross Lifeblood HREC.
Findings will be communicated to participants and their communities, and human and animal health stakeholders and policy-makers iteratively and after final analyses. Understanding human infection rates will inform procurement and targeted allocation of limited JEV vaccine, and public health strategies and communication campaigns, to at-risk populations.
To investigate if the Jenkins Sleep Scale (JSS) demonstrates sex-related differential item functioning (DIF).
Cross-sectional study.
Survey data from the Finnish Public Sector study (2015–2017).
77 967 employees in the Finnish public sector, with a mean age of 51.9 (SD 13.1) years and 82% women.
Item response theory estimates: difficulty and discrimination parameters of the JSS and differences in these parameters between men and women.
The mean JSS total score was 6.4 (4.8) points. For all four items of the JSS, the difficulty parameter demonstrated a slight shift towards underestimation of the severity of sleep difficulties. The discrimination ability of all four items was moderate to high. For the JSS composite score, overall discrimination ability was moderate (0.98, 95% CI 0.97 to 0.99). Mild uniform DIF (p
The JSS showed overall good psychometric properties among this healthy population of employees in the Finnish public sector. The JSS was able to discriminate people with different severities of sleep disturbances. However, when using the JSS, the respondents might slightly underestimate the severity of these disturbances. While the JSS may produce slightly different results when answered by men and women, these sex-related differences are probably negligible when applied to clinical situations.
Quantify disparities and identify correlates and predictors of ‘wellness’ supplement use among nurses during the first year of the pandemic.
Longitudinal secondary analysis of Nurses' Health Studies 2 and 3 and Growing Up Today Study data.
Sample included 36,518 total participants, 12,044 of which were nurses, who completed surveys during the first year of the COVID-19 pandemic (April 2020 to April 2021). Analyses were conducted in March 2023. Modified Poisson models were used to estimate disparities in ‘wellness’ supplement use between nurses and non-healthcare workers and, among nurses only, to quantify associations with workplace-related predictors (occupational discrimination, PPE access, workplace setting) and psychosocial predictors (depression/anxiety, county-level COVID-19 mortality). Models included race/ethnicity, gender identity, age and cohort as covariates.
Nurses were significantly more likely to use all types of supplements than non-healthcare workers. Lacking personal protective equipment and experiencing occupational discrimination were significantly associated with new immune supplement use. Depression increased the risk of using weight loss, energy and immune supplements.
Nurses' disproportionate use of ‘wellness’ supplements during the COVID-19 pandemic may be related to workplace and psychosocial stressors. Given well-documented risks of harm from the use of ‘wellness’ supplements, the use of these products by nurses is of concern.
‘Wellness’ supplements promoting weight loss, increased energy, boosted immunity and cleansing of organs are omnipresent in today's health-focused culture, though their use has been associated with harm. This is of added concern among nurses given their risk of COVID-19 infection at work. Our study highlighted the risk factors associated with use of these products (lacking PPE and experiencing occupational discrimination). Findings support prior research suggesting a need for greater public health policy and education around the use of ‘wellness’ supplements.
STROBE guidelines were followed throughout manuscript.
No patient or public contribution was involved.
Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.
This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.
The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.
Decisions about nurse staffing models are a concern for health systems globally due to workforce retention and well-being challenges. Nurse staffing models range from all Registered Nurse workforce to a mix of differentially educated nurses and aides (regulated and unregulated), such as Licensed Practical or Vocational Nurses and Health Care Aides. Systematic reviews have examined relationships between specific nurse staffing models and client, staff and health system outcomes (eg, mortality, adverse events, retention, healthcare costs), with inconclusive or contradictory results. No evidence has been synthesised and consolidated on how, why and under what contexts certain staffing models produce different outcomes. We aim to describe how we will (1) conduct a realist review to determine how nurse staffing models produce different client, staff and health system outcomes, in which contexts and through what mechanisms and (2) coproduce recommendations with decision-makers to guide future research and implementation of nurse staffing models.
Using an integrated knowledge translation approach with researchers and decision-makers as partners, we are conducting a three-phase realist review. In this protocol, we report on the final two phases of this realist review. We will use Citation tracking, tracing Lead authors, identifying Unpublished materials, Google Scholar searching, Theory tracking, ancestry searching for Early examples, and follow-up of Related projects (CLUSTER) searching, specifically designed for realist searches as the review progresses. We will search empirical evidence to test identified programme theories and engage stakeholders to contextualise findings, finalise programme theories document our search processes as per established realist review methods.
Ethical approval for this study was provided by the Health Research Ethics Board of the University of Alberta (Study ID Pro00100425). We will disseminate the findings through peer-reviewed publications, national and international conference presentations, regional briefing sessions, webinars and lay summary.