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Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials

Por: Holzer · K. J. · Bartosiak · K. A. · Calfee · R. P. · Hammill · C. W. · Haroutounian · S. · Kozower · B. D. · Cordner · T. A. · Lenard · E. M. · Freedland · K. E. · Tellor Pennington · B. R. · Wolfe · R. C. · Miller · J. P. · Politi · M. C. · Zhang · Y. · Yingling · M. D. · Baumann
Introduction

Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Methods and analysis

Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.

Ethics and dissemination

The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.

Trial registration numbers

NCT05575128, NCT05685511, NCT05697835, pre-results.

Inter-facility transfers for emergency obstetrical and neonatal care in rural Madagascar: a cost-effectiveness analysis

Por: Franke · M. A. · Nordmann · K. · Frühauf · A. · Ranaivoson · R. M. · Rebaliha · M. · Rapanjato · Z. · Bärnighausen · T. · Muller · N. · Knauss · S. · Emmrich · J. V.
Context

There is a substantial lack of inter-facility referral systems for emergency obstetrical and neonatal care in rural areas of sub-Saharan Africa. Data on the costs and cost-effectiveness of such systems that reduce preventable maternal and neonatal deaths are scarce.

Setting

We aimed to determine the cost-effectiveness of a non-governmental organisation (NGO)-run inter-facility referral system for emergency obstetrical and neonatal care in rural Southern Madagascar by analysing the characteristics of cases referred through the intervention as well as its costs.

Design

We used secondary NGO data, drawn from an NGO’s monitoring and financial administration database, including medical and financial records.

Outcome measures

We performed a descriptive and a cost-effectiveness analysis, including a one-way deterministic sensitivity analysis.

Results

1172 cases were referred over a period of 4 years. The most common referral reasons were obstructed labour, ineffective labour and eclampsia. In total, 48 neonates were referred through the referral system over the study period. Estimated cost per referral was US$336 and the incremental cost-effectiveness ratio (ICER) was US$70 per additional life-year saved (undiscounted, discounted US$137). The sensitivity analysis showed that the intervention was cost-effective for all scenarios with the lowest ICER at US$99 and the highest ICER at US$205 per additional life-year saved. When extrapolated to the population living in the study area, the investment costs of the programme were US$0.13 per person and annual running costs US$0.06 per person.

Conclusions

In our study, the inter-facility referral system was a very cost-effective intervention. Our findings may inform policies, decision-making and implementation strategies for emergency obstetrical and neonatal care referral systems in similar resource-constrained settings.

Estimating the return on investment of the New York Tobacco Control Programme: a synthetic control study

Por: Nonnemaker · J. · Mann · N. · MacMonegle · A. J. · Gaber · J. · Fajobi · O.
Objective

To assess the return on investment (ROI) of the New York Tobacco Control Programme (NY TCP).

Setting

New York and other states of the USA.

Interventions

NY TCP.

Outcomes

Smoking prevalence, smoking-attributable healthcare expenditures (SAEs), smoking-attributable mortality, years of life lost (YLL), the dollar value of YLL and the ROI for healthcare expenditures and mortality.

Design and methods

We used a synthetic control method to estimate the effectiveness of NY TCP funding on smoking prevalence. The synthetic control method created a comparison group that best matched the adult smoking prevalence trend in New York state in the period prior to implementation of the NY TCP and compared smoking prevalence in the state to smoking prevalence in the synthetic control in the period after treatment (2001–2019). The synthetic control group represents what the trend in smoking prevalence in New York would have been had there been no tobacco control expenditures. The ROI was calculated as net savings for each outcome divided by net programme expenditures.

Results

Cumulative savings in SAE in New York from 2001 to 2019 amounted to US$13.2 billion. An estimated 41 771 smoking-attributable deaths (SADs) were averted in New York from 2001 to 2019, and an estimated 672 141 YLL averted as a result of NY TCP funding in the same period. From 2001 to 2019, the ROI for SAE in New York was approximately 14, the economic value ROI of the YLL due to SAD was nearly 145 and the combined ROI was almost 160.

Conclusions

In this study, we found relatively large ROIs for the NY TCP, which suggests that the programme—which lowers SAE and saves lives—is an efficient use of public funds.

Depression and anxiety among nurses during the COVID‐19 pandemic: Longitudinal results over 2 years from the multicentre VOICE–EgePan study

Abstract

Aims

To examine symptoms of depression and generalised anxiety among nurses over 2 years during the pandemic and compare them to the general population.

Background

The COVID-19 pandemic has led to a significant increase in mental stress among the population worldwide. Nursing staff have been identified as being under remarkable strain.

Design

A multicentre prospective longitudinal study.

Methods

Symptoms of depression and generalised anxiety in 507 nurses were examined at four different time points (T1: April–July 2020, T2: November 2020–January 2021, T3: May–July 2021, T4: February–May 2022). Results were compared with values of the German general population, presence of gender-specific differences was analysed and frequencies of clinically relevant levels of depression and anxiety were determined.

Results

Throughout the study (T1–T4), a significant increase in depressive and anxiety symptoms was observed. At all four measurement time points, nurses showed significantly higher prevalence for depression and anxiety compared to the German general population. No significant gender differences were found. Frequencies for probable depression and generalised anxiety disorder among nurses were: 21.6% and 18.5% (T1), 31.4% and 29.2% (T2), 29.5% and 26.2% (T3), 33.7% and 26.4% (T4).

Conclusion

During the pandemic, symptoms of depression and generalised anxiety among nurses increased significantly and remained elevated. Their symptom levels were permanently higher than in the general population. These findings strongly suggest that the circumstances of the pandemic severely affected nurses´ mental health.

Relevance to Clinical Practice

The COVID-19 pandemic caused a great mental strain on caregivers. This study was able to demonstrate the significant increase in depression and anxiety among nurses during the pandemic. It highlights the urgent need for prevention, screening and support systems in hospitals.

Implications for the Profession

Supportive programmes and preventive services should be developed, not least to prevent the growing shortage of nurses in the health care systems.

Reporting Method

The study adhered to relevant EQUATOR guidelines. The STROBE checklist for cohort study was used as the reporting method.

Patient Contribution

Five hundred and seven nurses completed the questionnaire and provided data for analysis.

Trial and Protocol Registration

The study was registered with the German Clinical Trials Register (https://drks.de/search/en) under the following ID: DRKS00021268.

The prevalence of incivility in hospitals and the effects of incivility on patient safety culture and outcomes: A systematic review and meta‐analysis

Abstract

Aim

Workplace incivility is a barrier to safe and high-quality patient care in nursing workplaces and more broadly in tertiary hospitals. The present study aims to systematically review the existing evidence to provide a comprehensive understanding of the prevalence of co-worker incivility experienced and witnessed by nurses and other healthcare professionals, the effects of incivility on patient safety culture (PSC) and patient outcomes, and the factors which mediate the relationship between incivility and patient safety.

Methods

A systematic review with narrative synthesis and meta-analysis was undertaken to synthesize the data from 41 studies.

Data Sources

Databases searched included MEDLINE, PubMed, SCOPUS, CINAHL, PsycInfo, ProQuest, Emcare and Embase. Searches were conducted on 17 August 2021 and repeated on 15 March 2023.

Results

The pooled prevalence of experienced incivility was 25.0%. The pooled prevalence of witnessed incivility was 30.1%. Workplace incivility was negatively associated with the PSC domains of teamwork, reporting patient safety events, organization learning/improvement, management support for safety, leadership, communication openness and communication about error. The composite pooled effect size of incivility on these domains of PSC was OR = 0.590, 95% CI [0.515, 0.676]. Workplace incivility was associated with a range of patient safety outcomes (PSOs) including near misses, adverse events, reduced procedural and diagnostic performance, medical error and mortality. State depletion, profession, psychological responses to incivility, information sharing, help seeking, workload and satisfaction with organizational communication were found to mediate the relationship between incivility and patient safety.

Conclusion

Experienced and witnessed incivility is prevalent in tertiary hospitals and has a deleterious effect on PSC and PSOs. A better understanding of the mechanisms of this relationship will support the development of interventions aimed at reducing both incivility and patient harm.

Implications for the Profession and/or Patient Care Impact

This study quantifies the effect of incivility on PSC and outcomes. It provides support that interventions focusing on incivility are a valuable mechanism for improving patient care. It guides intervention design by highlighting which domains of PSC are most associated with incivility. It explores the profession-specific experiences of workplace incivility.

Reporting Method

This report adheres to PRISMA reporting guidelines.

Patient or Public Contribution

No patient or public contribution. The focus of this study is the nursing and healthcare workforce, therefore, patient or public involvement not required.

Trends in publication impact of evidence‐based healthcare terminology (2013–2022)

Abstract

Aims

This article explored the publication impact of evidence-based healthcare terminology to determine usage and discuss options for low usage terms.

Background

A plethora of terms describe the scholarship of evidence-based healthcare. Several terms are synonyms, creating redundancy and confusion. The abundance and overlap of terms may impede the discovery of evidence.

Design

This discursive article explored and discussed publication impact of evidence-based healthcare terms.

Methods

Evidence-based healthcare terms were identified, and their 10-year (2013–2022) publication impact was assessed in the CINAHL and Medline databases. A card sort method was also used to identify terms with low usage.

Results

A total of 18/32 terms were included in the review. The terms evidence-based practice, quality improvement, research and translational research were the most highly published terms. Publication data were presented yearly over a 10-year period. Most terms increased in publication use over time, except for three terms whose use decreased. Several terms related to translational research have multiple synonyms. It remains unknown whether these terms are interchangeable and possibly redundant, or if there are nuanced differences between terms.

Conclusion

We suggest a follow-up review in 3–5 years to identify publication trends to assess context and terms with continued low publication usage. Terms with persistent low usage should be considered for retirement in the reporting of scholarly activities. Additionally, terms with increasing publication trends should be treated as emerging terms that contribute to evidence-based healthcare terminology.

Implications for Nursing

Confusion about the use of appropriate terminology may hinder progress in the scholarship of evidence-based healthcare. We encourage scholars to be aware of publication impact as it relates to the use of specific terminology and be purposeful in the selection of terms used in scholarly projects and publications.

What impact has the Centre of Research Excellence in Digestive Health made in the field of gastrointestinal health in Australia and internationally? Study protocol for impact evaluation using the FAIT framework

Por: Koloski · N. · Duncanson · K. · Ramanathan · S. A. · Rao · M. · Holtmann · G. · Talley · N. J.
Introduction

The need for public research funding to be more accountable and demonstrate impact beyond typical academic outputs is increasing. This is particularly challenging and the science behind this form of research is in its infancy when applied to collaborative research funding such as that provided by the Australian National Health and Medical Research Council to the Centre for Research Excellence in Digestive Health (CRE-DH).

Methods and analysis

In this paper, we describe the protocol for applying the Framework to Assess the Impact from Translational health research to the CRE-DH. The study design involves a five-stage sequential mixed-method approach. In phase I, we developed an impact programme logic model to map the pathway to impact and establish key domains of benefit such as knowledge advancement, capacity building, clinical implementation, policy and legislation, community and economic impacts. In phase 2, we have identified and selected appropriate, measurable and timely impact indicators for each of these domains and established a data plan to capture the necessary data. Phase 3 will develop a model for cost–consequence analysis and identification of relevant data for microcosting and valuation of consequences. In phase 4, we will determine selected case studies to include in the narrative whereas phase 5 involves collation, data analysis and completion of the reporting of impact.

We expect this impact evaluation to comprehensively describe the contribution of the CRE-DH for intentional activity over the CRE-DH lifespan and beyond to improve outcomes for people suffering with chronic and debilitating digestive disorders.

Ethics and dissemination

This impact evaluation study has been registered with the Hunter New England Human Research Ethics Committee as project 2024/PID00336 and ethics application 2024/ETH00290. Results of this study will be disseminated via medical conferences, peer-reviewed publications, policy submissions, direct communication with relevant stakeholders, media and social media channels such as X (formely Twitter).

IMproving psYchosocial adjustment to Traumatic Brain Injury from acute to chronic injury through development and evaluation of the myTBI online psychoeducation platform: protocol for a mixed-methods study

Por: Troeung · L. · Sarunga Raja · T. L. · Mann · G. · Wagland · J. · MacLeod · C. · Martini · A.
Introduction

This protocol describes the myTBI study which aims to: (1) develop an online psychoeducation platform for people with traumatic brain injury (TBI), their family members/caregivers, and healthcare staff to improve psychosocial adjustment to TBI across different phases of injury (acute, postacute, and chronic), and (2) undertake an evaluation of efficacy, acceptability, and feasibility.

Methods and analysis

A three-stage mixed-methods research design will be used. The study will be undertaken across four postacute community-based neurorehabilitation and disability support services in Western Australia. Stage 1 (interviews and surveys) will use consumer-driven qualitative methodology to: (1) understand the recovery experiences and psychosocial challenges of people with TBI over key stages (acute, postacute, and chronic), and (2) identify required areas of psychosocial support to inform the psychoeducation platform development. Stage 2 (development) will use a Delphi expert consensus method to: (1) determine the final psychoeducation modules, and (2) perform acceptance testing of the myTBI platform. Finally, stage 3 (evaluation) will be a randomised stepped-wedge trial to evaluate efficacy, acceptability, and feasibility. Outcomes will be measured at baseline, postintervention, follow-up, and at final discharge from services. Change in outcomes will be analysed using multilevel mixed-effects modelling. Follow-up surveys will be conducted to evaluate acceptability and feasibility.

Ethics and dissemination

Ethics approval was granted by North Metropolitan Health Service Mental Health Research Ethics and Governance Office (RGS0000005877). Study findings will be relevant to clinicians, researchers, and organisations who are seeking a cost-effective solution to deliver ongoing psychoeducation and support to individuals with TBI across the recovery journey.

Trial registration number

ACTRN12623000990628.

Approaches for the treatment of perforated peptic ulcers: a network meta-analysis of randomised controlled trials - study protocol

Por: Wadewitz · E. · Friedrichs · J. · Grilli · M. · Vey · J. · Zimmermann · S. · Kleeff · J. · Ronellenfitsch · U. · Klose · J. · Rebelo · A.
Introduction

Perforated peptic ulcers are a life-threatening complication associated with high morbidity and mortality. Several treatment approaches are available. The aim of this network meta-analysis (NMA) is to compare surgical and alternative approaches for the treatment of perforated peptic ulcers regarding mortality and other patient-relevant outcomes.

Methods and analysis

A systematic literature search of PubMed/MEDLINE, Cochrane Library, Embase, CINAHL, ClinicalTrials.gov trial registry and ICTRP will be conducted with predefined search terms.

To address the question of the most effective treatment approach, an NMA will be performed for each of the outcomes mentioned above. A closed network of interventions is expected. The standardised mean difference with its 95% CI will be used as the effect measure for the continuous outcomes, and the ORs with 95% CI will be calculated for the binary outcomes.

Ethics and dissemination

In accordance with the nature of the data used in this meta-analysis, which involves aggregate information from previously published studies ethical approval is deemed unnecessary. Results will be disseminated directly to decision-makers (eg, surgeons, gastroenterologists) through publication in peer-reviewed journals and presentation at conferences.

PROSPERO registration number

CRD42023482932.

Identifying the top 10 research priorities for the school food system in the UK: a priority setting exercise

Por: Schliemann · D. · Spence · S. · OKane · N. · Chiang · C. C. · Olgacher · D. · McKinley · M. C. · Woodside · J. V. · on behalf of the GENIUS network · Schliemann · Spence · OKane · Chiang · Olgacher · McKinley · Woodside
Introduction

The school food system varies widely between schools and across the UK. There is a need to understand evidence gaps in school food research to allow the development, implementation and evaluation of policies and interventions to support children’s healthy eating at school. This study aimed to conduct a priority setting exercise to co-produce research priorities in relation to the UK school food system.

Methods

The James Lind Alliance process informed this priority setting exercise; all key steps engaged a wide range of UK school food stakeholders (including teachers, parents, principals, school governors, policymakers, caterers). An initial online stakeholder survey identified perceived research priorities. In a second survey, stakeholders were asked to rank these priorities. Lastly, an online priority setting workshop with stakeholders elicited the most important research priorities.

Results

In 2021, school food stakeholders (n=1280) completed the first survey, from which 136 research priorities were identified. In the second survey, participants (n=107) ranked these research priorities regarding their importance. Lastly, 30 workshop participants discussed and reached consensus on the research priorities. After final refinement by the research team, 18 priorities resulted, with the top 10 being related to the provision of free school meals (effectiveness of cost-effectiveness of different levels of eligibility, including universal provision), implementation of policy (including improving uptake) and food standards, issues around procurement, leadership, inequalities, social norms, the eating environment, food culture throughout the school setting and healthy eating.

Conclusion

The top 10 research priorities were elicited through a rigorous approach, including a wide range of stakeholders across the UK. These should be considered by policymakers, researchers and others to inform research, evidence-based policy development and, ultimately, improve the UK school food system.

Evaluating a rehabilitative intervention for substance-dependent patients with and without their accompanying children in Germany (KontextSucht): study protocol for a non-randomised trial

Por: Stullich · A. · Hoffmann · L. · Stephan · J. · Gehrmann · J. · Richter · M. · for the KontextSucht study group
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

DRKS00030950.

Low-value MRI of the knee in Norway: a register-based study to identify the proportion of potentially low-value MRIs and estimate the related costs

Por: Hofmann · B. · Havik · V. · Andersen · E. R. · Brandsaeter · I. O. · Kjelle · E.
Objectives

The objective of this study is to investigate the proportion of potentially low-value knee MRI in Norway and to provide an estimate of the related costs.

Design

Register study based on conditional data extraction and analysis of data from Control and Reimbursement of Healthcare Claims registry in Norway.

Setting

MRI in public specialist healthcare with universal health coverage (Norway).

Participants

48 212 MRIs for 41 456 unique patients and 45 946 reimbursement claims.

Outcome measures

Proportion of MRIs of the knee that (1) did not have a relevant tentative diagnosis prior to the knee MRI, (2) did not have a relevant alternative image of the knee before the MRI or (3) did not have a relevant code from the specialist care within 6 months after the MRI, and those that had combinations of 1, 2 and 3. Estimated costs for those that had combinations of 1, 2 and 3.

Results

Very few patients (6.4%) had a relevant diagnosis code or prior imaging examination when having the MRI and only 14.6% got a knee-related diagnosis code from the specialist care within 6 months after the MRI. 21.8% of the patients had knee X-ray, CT or ultrasound within 6 months before the MRI. Between 58% and 85% of patients having knee MRIs in Norway have no relevant examinations or diagnoses six months prior to or after the MRI examination. These examinations are unlikely to benefit patients and they correspond to between 24 108 and 35 416 MRIs at a cost of 6.7–9.8 million per year.

Conclusion

A substantial proportion of MRIs of the knee in Norway have no relevant examinations or diagnoses before or after the MRI and are potentially of low value. Reducing low-value MRIs could free resources for high-value imaging, reduce waiting times, improve the quality of care and increase patient safety and professional integrity.

Cohort profile: BioMD-Y (biopsychosocial factors of major depression in youth) - a biobank study on the molecular genetics and environmental factors of depression in children and adolescents in Munich

Por: Scherff · A. D. · Feldmann · L. · Piechaczek · C. · Pehl · V. · Wagenbüchler · P. · Wermuth · I. · Ghotbi · N. · Allgaier · A.-K. · Freisleder · F. J. · Beins · E. C. · Forstner · A. J. · Nöthen · M. M. · Czamara · D. · Rex-Haffner · M. · Ising · M. · Binder · E. · Greimel · E. · Sch
Purpose

BioMD-Y is a comprehensive biobank study of children and adolescents with major depression (MD) and their healthy peers in Germany, collecting a host of both biological and psychosocial information from the participants and their parents with the aim of exploring genetic and environmental risk and protective factors for MD in children and adolescents.

Participants

Children and adolescents aged 8–18 years are recruited to either the clinical case group (MD, diagnosis of MD disorder) or the typically developing control group (absence of any psychiatric condition).

Findings to date

To date, four publications on both genetic and environmental risk and resilience factors (including FKBP5, glucocorticoid receptor activation, polygenic risk scores, psychosocial and sociodemographic risk and resilience factors) have been published based on the BioMD-Y sample.

Future plans

Data collection is currently scheduled to continue into 2026. Research questions will be further addressed using available measures.

Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA

Por: Gilbert · B. T. P. · Mongin · D. · Aymon · R. · Lauper · K. · Laedermann · C. · Perrier · C. · Mueller · R. · Courvoisier · D. S. · Finckh · A.
Objectives

This observational study compares the effectiveness of baricitinib (BARI), a targeted synthetic disease-modifying antirheumatic drug (tsDMARD), with alternative biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA), from a prospective, longitudinal cohort.

Methods

We compared patients initiating a treatment course (TC) of BARI, tumour necrosis factor inhibitors (TNFi) or bDMARDs with other modes of action (OMA), during a period when all these DMARDs were available in Switzerland. The primary outcome was drug maintenance; secondary outcomes included discontinuation rates related specifically to ineffectiveness and adverse events. We further analysed rates of low disease activity (LDA) and remission (REM) at 12 months and drug maintenance in bDMARD-naïve and tsDMARD-naïve population.

Results

A total of 1053 TCs were included: 273 on BARI, 473 on TNFi and 307 on OMA. BARI was prescribed to older patients with longer disease duration and more previous treatment failures than TNFi. Compared with BARI, the adjusted drug maintenance was significantly shorter for TNFi (HR for discontinuation: 1.76; 95% CI, 1.32 to 2.35) but not compared with OMA (HR 1.27; 95% CI, 0.93 to 1.72). These results were similar in the b/tsDMARD-naïve population. The higher discontinuation of TNFi was mostly due to increased discontinuation for ineffectiveness (HR 1.49; 95% CI, 1.03 to 2.15), with no significant differences in drug discontinuation for adverse events (HR 1.46; 95% CI, 0.83 to 2.57). The LDA and REM rates at 12 months did not differ significantly between the three groups.

Conclusions

BARI demonstrated a significantly higher drug maintenance compared with TNFi, mainly due to lower drug discontinuations for ineffectiveness. We found no difference in drug maintenance between BARI and OMA. Clinical outcomes did not differ between the three groups. Our results suggest that BARI is an appropriate therapeutic alternative to bDMARDs in the management of RA.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Por: Wilkinson · J. · Heal · C. · Antoniou · G. A. · Flemyng · E. · Alfirevic · Z. · Avenell · A. · Barbour · G. · Brown · N. J. L. · Carlisle · J. · Clarke · M. · Dicker · P. · Dumville · J. C. · Grey · A. · Grohmann · S. · Gurrin · L. · Hayden · J. A. · Heathers · J. · Hunter · K. E. · Lasser
Introduction

Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.

Methods and analysis

The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.

Ethics and dissemination

The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Living with schizophrenia and type 2 diabetes and the implication for diabetes self‐care: A qualitative study

Abstract

Aim

To achieve an in-depth understanding of the challenges associated with diabetes management when having both schizophrenia and type 2 diabetes, while also identifying the needs for improved diabetes self-care.

Design

The study employed a qualitative explorative design utilizing a phenomenological-hermeneutic inspired approach, involving field observations and individual semistructured interviews.

Methods

Data were collected during 2020–2021 through 17 field observations of outpatient consultations and 13 individual semistructured interviews. Data, including field notes and verbatim transcribed interviews, underwent analysis following Ricoeur's interpretive philosophy, encompassing three levels: naïve reading, structural analysis and critical interpretation and discussion. This study adheres to the COREQ guidelines for qualitative research.

Results

Three key themes emerged: ‘Diabetes when life is noisy’, ‘Sacrifices and compromises in life’ and ‘The double silence’. Everyday life is significantly affected when having both schizophrenia and T2D. The mental health state dominates in relation to diabetes self-care and individuals experience challenges balancing between the two conditions. However, there exists a general acknowledgement for diabetes and its long-term complications as a serious medical condition demanding careful attention and treatment.

Conclusion

Self-managing two such complex conditions can be overwhelming and make it difficult for the individual to differentiate symptoms and prioritize diabetes care. Moreover, the existing fragmentation within healthcare systems poses communication challenges, resulting in disjointed patient pathways.

Implications for patient care

The study emphasizes the need for a holistic re that addresses the physical, emotional and social challenges. There is also a need for increased awareness and education among informal caregivers and healthcare professionals to foster better understanding and support.

Good while it lasted? Estimating the long-term and withdrawal effects of results-based financing in Malawi on maternal care utilisation using routine data

Por: Dasgupta · T. · De Allegri · M. · Brenner · S. · Kaminjolo-Kambala · C. · Lohmann · J.
Objectives

This study aimed to evaluate the effect of introduction and subsequent withdrawal of the Results-based Financing for Maternal and Newborn Health Initiative (RBF4MNH) in Malawi on utilisation of facility-based childbirths, antenatal care (ANC) and postnatal care (PNC).

Design

A controlled interrupted time series design was used with secondary data from the Malawian Health Management Information System.

Setting

Healthcare facilities at all levels identified as providing maternity services in four intervention districts and 20 non-intervention districts in Malawi.

Participants

Routinely collected, secondary data of total monthly service utilisation of facility-based childbirths, ANC and PNC services.

Interventions

The intervention is the RBF4MNH initiative, introduced by the Malawian government in 2013 to improve maternal and infant health outcomes and withdrawn in 2018 after ceasing of donor funding.

Outcome measures

Differences in total volume and trends of utilisation of facility-based childbirths, ANC and PNC services, compared between intervention versus non-intervention districts, for the study period of 90 consecutive months.

Results

No significant effect was observed, on utilisation trends for any of the three services during the first 2.5 years of intervention. In the following 2.5 years after full implementation, we observed a small positive increase for facility-based childbirths (+0.62 childbirths/month/facility) and decrease for PNC (–0.55 consultations/month/facility) trends of utilisation respectively. After withdrawal, facility-based childbirths and ANC consultations dropped both in immediate volume after removal (–10.84 childbirths/facility and –20.66 consultations/facility, respectively), and in trends of utilisation over time (–0.27 childbirths/month/facility and -1.38 consultations/month/facility, respectively). PNC utilisation levels seemed unaffected in intervention districts against a decline in the rest of the country.

Conclusions

Concurrent with wider literature, our results suggest that effects of complex health financing interventions, such as RBF4MNH, can take a long time to be seen. They might not be sustained beyond the implementation period if measures are not adopted to reform existing health financing structures.

Symptomology following COVID-19 among adults in Alberta, Canada: an observational survey study

Por: Chen · X. · Norris · C. · Whitten · T. · Ho · C. · Mann · B. · Bakal · J.
Objective

Fatigue, headache, problems sleeping and numerous other symptoms have been reported to be associated with long COVID. However, many of these symptoms coincide with symptoms reported by the general population, possibly exacerbated by restrictions/precautions experienced during the COVID-19 pandemic. This study examines the symptoms reported by individuals who tested positive for COVID-19 compared with those who tested negative.

Design

Observational study.

Setting

The study was conducted on adult residents in Alberta, Canada, from October 2021 to February 2023.

Participants

We evaluated self-reported symptoms in 7623 adults with positive COVID-19 tests and 1520 adults who tested negative, using surveys adapted from the internationally standardised International Severe Acute Respiratory and emerging Infection Consortium (ISARIC)-developed COVID-19 long-term follow-up tools. These individuals had an index COVID-19 test date between 1 March 2020 and 31 December 2022 and were over 28 days post-COVID-19 testing.

Primary outcome measures

The primary outcomes were to identify the symptoms associated with COVID-19 positivity and risk factors for reporting symptoms.

Results

Fatigue was the top reported symptom (42%) among COVID-19-positive respondents, while headache was the top reported symptom (32%) in respondents who tested negative. Compared with those who tested negative, COVID-19-positive individuals reported 1.5 times more symptoms and had higher odds of experiencing 31 out of the 40 listed symptoms during the postinfectious period. These symptoms included olfactory dysfunction, menstruation changes, cardiopulmonary and neurological symptoms. Female sex, middle age (41–55 years), Indigeneity, unemployment, hospital/intensive care unit (ICU) admission at the time of testing and pre-existing health conditions independently predicted a greater number and variety of symptoms.

Conclusions

Our results provide evidence that COVID-19 survivors continue to experience a significant number and variety of symptoms. These findings can help inform targeted strategies for the unequally affected population. It is important to offer appropriate management for symptom relief to those who have survived the acute COVID-19 illness.

Sex-specific Impact of the first COVID-19 Lockdown on Age Structure and Case Acuity at Admission in a Patient Population in southwestern Germany: a retrospective comparative Study in Neuroradiology

Por: Reder · S. R. · Herrlich · N. · Grauhan · N. F. · Othman · A. E. · Müller-Eschner · M. · Brockmann · C. · Brockmann · M. A.
Objectives

A hard lockdown was presumed to lead to delayed diagnosis and treatment of serious diseases, resulting in higher acuity at admission. This should be elaborated based on the estimated acuity of the cases, changes in findings during hospitalisation, age structure and biological sex.

Design

Retrospective monocentric cross-sectional study.

Setting

German Neuroradiology Department at a .

Participants

In 2019, n=1158 patients were admitted in contrast to n=884 during the first hard lockdown in 2020 (11th–13th week).

Main outcome measures

Three radiologists evaluated the initial case acuity, classified them into three groups (not acute, subacute and acute), and evaluated if there was a relevant clinical deterioration. The data analysis was conducted using non-parametric methods and multivariate regression analysis.

Results

A 24% decrease in the number of examinations from 2019 to 2020 (p=0.025) was revealed. In women, the case acuity increased by 21% during the lockdown period (p=0.002). A 30% decrease in acute cases in men was observable (in women 5% decrease). Not acute cases decreased in both women and men (47%; 24%), while the subacute cases remained stable in men (0%) and decreased in women (28%). Regression analysis revealed the higher the age, the higher the acuity (p

Conclusion

The lockdown led to a decrease in neuroradiological consultations, with delays in seeking medical care. In women, the number of most severe cases remained stable, whereas the mean case acuity and age increased. This could be due to greater pandemic-related anxiety among women, however, with severe symptoms they were seeking for medical help. In contrast in men, the absolute number of most severe cases decreased, whereas the mean acuity and age remained nearly unaffected. This could be attributable to a reduced willingness to seek for medical consultation.

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