Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.
We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.
No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.
CRD42022347881.
People suffering from substance use disorders often live in social contexts with children or are parents themselves. Addicted parents show specific substance-related problems while raising their children, which often leads to various lifelong consequences for the children. The German rehabilitative treatment system allows bringing children to inpatient treatment centres. This mixed-methods study evaluates a newly developed intervention, called ‘KontextSucht’ or ‘AddictionContext’, for parents in rehabilitation treatment centres concerning the effectiveness of the intervention in parenting and abstinence outcome.
The study uses a two-stage parallel mixed-methods design. A feasibility study (stage 1) and a benefit assessment (stage 2) will be conducted to evaluate the intervention. Both parts of the study will be carried out with qualitative and quantitative work packages. German-speaking parents of children 0–14 years will be included in this study. Qualitative data will be analysed using qualitative content analyses, whereas quantitative data will be analysed descriptively using regression analysis as well as linear mixed models.
All participants will receive detailed information on the study and sign informed consent before data collection. The research team has obtained the approval of the Ethical Review Committee at the Technical University of Munich in Germany and will follow all legislation rules regarding data protection. The study results will be published in peer-reviewed national and international journals. Furthermore, the study results will be included in an intervention manual distributed to treatment centres.
DRKS00030950.
Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.
Eligible paediatric patients (N=750–1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24–36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.
Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.
Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.
Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes.
We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’.
Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations.
The findings of this scoping review will give insight into the nature and effectiveness of elements of integrated care and will generate hypotheses for further research.
In many countries, before COVID-19 vaccines became available, reluctance to get vaccinated was particularly prevalent among women, the most disadvantaged social groups and ethnoracial minorities, known to be at higher risk for the virus. Using a longitudinal perspective, we analyse the social determinants that are associated with the transition from attitudes towards vaccination to actual vaccination practices.
Representative population-based prospective cohort.
From November 2020 to July 2021.
Adults included in the Epidemiology and Living Conditions (EpiCoV) cohort (n=86 701).
Attitudes towards vaccination in November 2020 before COVID-19 vaccines were available in France (in January 2021) and vaccination practices in July 2021.
Among those who were initially reluctant in November 2020, the youngest, the poorest 10% (OR=0.68, 0.59–0.77), non-European immigrants (OR=0.72, 0.59–0.88) and descendants of non-European immigrants (OR=0.72, 0.61–0.86) were less likely to be vaccinated in July 2021, irrespective of trust in government and scientists. The same social factors were associated with non-vaccination among those who initially were undecided or who favoured vaccination.
Despite the fact that COVID-19 vaccines were relatively available and free of charge in France in July 2021, social inequalities in vaccination against the virus remained the same than those observed in vaccination reluctance in November 2020, before vaccines were available. While adjusting for trust, migration background, younger age and lower income were associated with lower vaccination uptake irrespective of initial intention. By neglecting to genuinely target specific groups that were initially reluctant to be vaccinated, vaccination policies contributed to strengthening pre-existing social inequalities around COVID-19 burden.
by Ana Castro-Avila, Catalina Merino-Osorio, Felipe González-Seguel, Agustín Camus-Molina, Felipe Muñoz-Muñoz, Jaime Leppe, on behalf of the IMPACCT COVID-19 study group
IntroductionThe COVID-19 pandemic can be seen as a natural experiment to test how bed occupancy affects post-intensive care unit (ICU) patient’s functional outcomes. To compare by bed occupancy the frequency of mental, physical, and cognitive impairments in patients admitted to ICU during the COVID-19 pandemic.
MethodsProspective cohort of adults mechanically ventilated >48 hours in 19 ICUs from seven Chilean public and private hospitals. Ninety percent of nationwide beds occupied was the cut-off for low versus high bed occupancy. At ICU discharge, 3- and 6-month follow-up, we assessed disability using the World Health Organization Disability Assessment Schedule 2.0. Quality of life, mental, physical, and cognitive outcomes were also evaluated following the core outcome set for acute respiratory failure.
ResultsWe enrolled 252 participants, 103 (41%) during low and 149 (59%) during high bed occupancy. Patients treated during high occupancy were younger (P50 [P25-P75]: 55 [44–63] vs 61 [51–71]; p Conclusions
There were no differences in post-ICU outcomes between high and low bed occupancy. Most patients (>90%) had at least one mental, physical or cognitive impairment at ICU discharge, which remained high at 6-month follow-up (57%).
Clinical trial registrationNCT04979897 (clinicaltrials.gov).
by Ana Šemrov, Valerija Tadić, Mario Cortina-Borja, Jugnoo Sangeeta Rahi, on behalf of The Resilience and Childhood Visual Impairment Study Group
Childhood visual impairment can have a significant impact on an individual’s development. To improve clinical care and develop appropriate psychosocial interventions of these patients, it is necessary to understand the contributing and modifiable factors that both identify individuals in greater need and could be targeted in interventions. Here we investigate the broader individual, family, and environmental factors associated with vision-related quality of life (VQoL) of children and young people with visual impairment (CYP-VI). Data for this cross-sectional study were collected from September 2014 to May 2017 to develop and validate two vision-specific patient-reported outcome measures (PROMs) for CYP-VI. Patients were recruited from 22 hospitals in the United Kingdom and were aged 7–18 years with visual impairment as per WHO criteria. Participants self-completed the two PROMs, VQoL and Functional Vision Questionnaires. Clinical characteristics were extracted from medical records. Their carers provided information on family sociodemographic backgrounds. Associations between the VQoL scores and other factors were examined using Spearman’s correlation, Kruskal-Wallis, Wilcoxon rank-sum tests, and quantile regression models. The sample consisted of 152 CYP-VI (67 females). Better VQoL was significantly associated with better functional vision overall (rSpearman = –0.52), parent-reported absence of additional chronic conditions (dCohen = 0.46), attending mainstream (versus other) school (dCohen = 0.44), higher socio-economic status (rSpearman = 0.17) and higher parental education level (rSpearman = 0.20). No other investigated factors were significantly associated with VQoL. The final quantile regression model included functional vision scores and the presence of additional health condition. Variation in self-reported VQoL in CYP-VI can be partly accounted for by factors relating to the clinical status of the affected child and, more importantly, by non-health-related factors. This needs to be considered in clinical practice when assessing vision-specific outcomes and providing support to CYP-VI, as well as in the development of future interventions.