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Parents' Trigger Tool for Children with Medical Complexity – PAT‐CMC: Development of a recognition tool for clinical deterioration at home

Abstract

Aim

To develop a trigger tool for parents and lay caregivers of children with medical complexity (CMC) at home and to validate its content.

Design

This was a multi-method study, using qualitative data, a Delphi method and a concept mapping approach.

Methods

A three-round electronic Delphi was performed from December 2021 to April 2022 with a panel of 23 expert parents and 30 healthcare providers, supplemented by a preliminary qualitative exploration of children's signs of deterioration and three consensus meetings to develop the PArents' Trigger Tool for Children with Medical Complexity (PAT-CMC). Cognitive interviews with parents were performed to assess the comprehensiveness and comprehensibility of the tool. The COREQ checklist, the COSMIN guidelines and the CREDES guidelines guided the reporting respectively of the qualitative study, the development and content validity of the trigger tool and the Delphi study.

Results

The PAT-CMC was developed and its content validated to recognize clinical deterioration at home. The tool consists of 7 main clusters of items: Breathing, Heart, Devices, Behaviour, Neuro-Muscular, Nutrition/Hydration and Other Concerns. A total of 23 triggers of deterioration were included and related to two recommendations for escalation of care, using a traffic light coding system.

Conclusion

Priority indicators of clinical deterioration of CMC were identified and integrated into a validated trigger tool designed for parents or other lay caregivers at home, to recognize signs of acute severe illness and initiate healthcare interventions.

Impact

The PAT-CMC was developed to guide families in recognizing signs of deterioration in CMC and has potential for initiating an early escalation of care. This tool may also be useful to support education provided by healthcare providers to families before hospital discharge.

Patient or Public Contribution

Parents of CMC were directly involved in the selection of relevant indicators of children's clinical deterioration and the development of the trigger tool. They were not involved in the design, conducting, reporting or dissemination plans of this research.

Entangled in complexity: An ethnographic study of organizational adaptability and safe care transitions for patients with complex care needs

Abstract

Aim

The aim of this study was to visualize vulnerabilities and explore the dynamics of inter-professional collaboration and organizational adaptability in the context of care transitions for patients with complex care needs.

Design

An ethnographic design using multiple convergent data collection techniques.

Methods

Data collection involved document review, participant observations and interviews with healthcare and social care professionals (HSCPs). Narrative analysis was employed to construct two illustrative patient scenarios, which were then examined using the Functional Resonance Analysis Method (FRAM). Thematic analysis was subsequently applied to synthesize the findings.

Results

Inconsistencies in timing and precision during care transitions pose risks for patients with complex care needs as they force healthcare systems to prioritize structural constraints over individualized care, especially during unforeseen events outside regular hours. Such systemic inflexibility can compromise patient safety, increase the workload for HSCPs and strain resources. Organizational adaptability is crucial to managing the inherent variability of patient needs. Our proposed ‘safe care transition pathway’ addresses these issues, providing proactive strategies such as sharing knowledge and increasing patient participation, and strengthening the capacity of professionals to meet dynamic care needs, promoting safer care transitions.

Conclusion

To promote patient safety in care transitions, strategies must go beyond inter-professional collaboration, incorporating adaptability and flexible resource planning. The implementation of standardized safe care transition pathways, coupled with the active participation of patients and families, is crucial. These measures aim to create a resilient, person-centred approach that may effectively manage the complexities in care transitions.

Implications

The recommendations of this study span the spectrum from policy-level changes aimed at strategic resource allocation and fostering inter-professional collaboration to practical measures like effective communication, information technology integration, patient participation and family involvement. Together, the recommendations offer a holistic approach to enhance care transitions and, ultimately, patient outcomes.

Reporting Method

Findings are reported per the Consolidated Criteria for Reporting Qualitative research (COREQ).

Patient or Public Contribution

No patient or public contribution.

Protective and risk factors of workplace violence against nurses: A cross‐sectional study

Abstract

Aims

To describe how workplace violence (WPV) is experienced by nurses in hospitals and community services and identify protective and risk factors.

Methods

An online cross-sectional national study was conducted from January to April 2021 in Italy. Hospitals and community services were involved in the study. The survey combined the adapted and validated Italian version of the Violence in Emergency Nursing and Triage (VENT) questionnaire, which explores the episodes of WPV experienced during the previous 12 months, the Practice Environment Scale of the Nursing Work Index (PES-NWI) and some additional questions about staffing levels extracted from a previous RN4CAST study. Nurses working in all clinical settings and community services were invited to participate in the survey. Descriptive and inferential statistics were used for data analysis. We adhered to the STROBE reporting guidelines.

Results

A total of 6079 nurses completed the survey, 32.4% (n = 1969) had experienced WPV in the previous 12 months, and 46% (n = 920) reported WPV only in the previous week. The most significant protective factors were nurses' age, patients' use of illegal substances, attitude of individual nurses and considering effective the organization's procedures for preventing and managing episodes of violence. The most significant risk factors included workload, recognizing violence as an inevitable part of the job, patients' cultural aspects and patients' agitated behaviour. The frequency of WPV was significantly higher in certain areas, such as the emergency department and in mental health wards.

Conclusion

Workplace violence (WPV) against nurses is a very frequent and concerning issue, especially in hospitals and community services. Based on our findings, integrated and multimodal programmes for prevention and management of WPV are recommended. More attention and resources need to be allocated to reduce WPV by improving the quality of nurses' workplace environment and implementing violence-free policies for hospitals.

Implications for the Profession and/or Patient Care

Impact

Workplace verbal and physical violence is a widespread phenomenon, both in hospital and community settings, and even during COVID-19 pandemic. This problem is exacerbated by the lack of effective reporting systems, fear of retaliation and the tendency to consider violence as an inevitable part of the job. The characteristics of professionals, patients, work environment and organizational factors are involved in the spread of workplace violence, determining its multifactorial nature. Integrated and multimodal programmes to prevent and manage of workplace violence are probably the only way to effectively counteract workplace violence against nurses. Healthcare policymakers, managers of hospital and community services need to proactively prevent and effectively manage and monitor episodes of violence. Nurses need to feel protected and safeguarded against any form of verbal or physical violence, to provide high-quality care in a totally safe environment.

Patient or Public Contribution

No patient or public contribution.

Multiparameter immunoprofiling for the diagnosis and differentiation of progressive versus nonprogressive nontuberculous mycobacterial lung disease–A pilot study

by Paige K. Marty, Balaji Pathakumari, Thomas M. Cox, Virginia P. Van Keulen, Courtney L. Erskine, Maleeha Shah, Mounika Vadiyala, Pedro Arias-Sanchez, Snigdha Karnakoti, Kelly M. Pennington, Elitza S. Theel, Cecilia S. Lindestam Arlehamn, Tobias Peikert, Patricio Escalante

Clinical prediction of nontuberculous mycobacteria lung disease (NTM-LD) progression remains challenging. We aimed to evaluate antigen-specific immunoprofiling utilizing flow cytometry (FC) of activation-induced markers (AIM) and IFN-γ enzyme-linked immune absorbent spot assay (ELISpot) accurately identifies patients with NTM-LD, and differentiate those with progressive from nonprogressive NTM-LD. A Prospective, single-center, and laboratory technician-blinded pilot study was conducted to evaluate the FC and ELISpot based immunoprofiling in patients with NTM-LD (n = 18) and controls (n = 22). Among 18 NTM-LD patients, 10 NTM-LD patients were classified into nonprogressive, and 8 as progressive NTM-LD based on clinical and radiological features. Peripheral blood mononuclear cells were collected from patients with NTM-LD and control subjects with negative QuantiFERON results. After stimulation with purified protein derivative (PPD), mycobacteria-specific peptide pools (MTB300, RD1-peptides), and control antigens, we performed IFN-γ ELISpot and FC AIM assays to access their diagnostic accuracies by receiver operating curve (ROC) analysis across study groups. Patients with NTM-LD had significantly higher percentage of CD4+/CD8+ T-cells co-expressing CD25+CD134+ in response to PPD stimulation, differentiating between NTM-LD and controls. Among patients with NTM-LD, there was a significant difference in CD25+CD134+ co-expression in MTB300-stimulated CD8+ T-cells (p

Knowledge, attitudes, and practices about HIV and other sexually transmitted infections among High School students in Southern Italy: A cross-sectional survey

by Francesco Di Gennaro, Francesco Vladimiro Segala, Giacomo Guido, Mariacristina Poliseno, Laura De Santis, Alessandra Belati, Carmen Rita Santoro, Irene Francesca Bottalico, Carmen Pellegrino, Roberta Novara, Luisa Frallonardo, Mariangela Cormio, Michele Camporeale, Sergio Cotugno, Vincenzo Giliberti, Stefano Di Gregorio, Valentina Totaro, Nicola Catucci, Anna De Giosa, Roberta Giusto, Ilaria Viviana Lanera, Gioacchino Angarano, Sergio Lo Caputo, Annalisa Saracino

High School students, recognized as a high-risk group for sexually transmitted infections (STIs), were the focal point of an educational campaign in Southern Italy to share information and good practices about STIs and HIV/AIDS. A baseline survey comprising 76 items was conducted via the REDCap platform to assess students’ initial knowledge, attitudes, and practices (KAP) related to STIs and HIV/AIDS. Sociodemographic variables were also investigated. The association between variables and KAP score was assessed by Kruskal-Wallis’ or Spearman’s test, as appropriate. An ordinal regression model was built to estimate the effect size, reported as odds ratio (OR) with a 95% confidence interval (CI), for achieving higher KAP scores among students features. On a scale of 0 to 29, 1702 participants achieved a median KAP score of 14 points. Higher scores were predominantly reported by students from classical High Schools (OR 3.19, 95% C.I. 1.60–6.33, p

Effects of (2<i>R</i>,6<i>R</i>)-hydroxynorketamine in assays of acute pain-stimulated and pain-depressed behaviors in mice

by Todd M. Hillhouse, Kaitlyn J. Partridge, Patrick I. Garrett, Sarah C. Honeycutt, Joseph H. Porter

Ketamine has been shown to produce analgesia in various acute and chronic pain states; however, abuse liability concerns have limited its utility. The ketamine metabolite (2R,6R)-hydroxynorketamine (HNK) has been shown to produce antidepressant-like effects similar to ketamine without abuse liability concerns. (2R,6R)-HNK produces sustained analgesia in models of chronic pain, but has yet to be evaluated in models of acute pain. The present study evaluated the efficacy of acute (2R,6R)-HNK administration (one injection) in assays of pain-stimulated (52- and 56-degree hot plate test and acetic acid writhing) and pain-depressed behavior (locomotor activity and rearing) in male and female C57BL/6 mice. In assays of pain-stimulated behaviors, (2R,6R)-HNK (1–32 mg/kg) failed to produce antinociception in the 52- and 56-degree hot plate and acetic acid writhing assays. In assays of pain-depressed behaviors, 0.56% acetic acid produced a robust depression of locomotor activity and rearing that was not blocked by pretreatment of (2R,6R)-HNK (3.2–32 mg/kg). The positive controls morphine (hot plate test) and ketoprofen (acetic acid writhing, locomotor activity, and rearing) blocked pain-stimulated and pain-depressed behaviors. Finally, the effects of intermittent (2R,6R)-HNK administration were evaluated in 52-degree hot plate and pain-depressed locomotor activity and rearing. Intermittent administration of (2R,6R)-HNK also did not produce antinociceptive effects in the hot plate or pain-depressed locomotor activity assays. These results suggest that (2R,6R)-HNK is unlikely to have efficacy in treating acute pain; however, the efficacy of (2R,6R)-HNK in chronic pain states should continue to be evaluated.

Self-administration medication errors at home and its predictors among illiterate and low-literate community-dwelling older adults with polypharmacy: A negative binomial hierarchical regression

by Nafiseh Ghassab-Abdollahi, Haidar Nadrian, Elnaz Shaseb, Narges Kheirollahi, Mina Hashemiparast

Background

Older adults with polypharmacy are more prone to medication errors. People with low educational attainment have more difficulties in taking their medications.

Objectives

This study aimed to identify the extent of medication self-administration errors (MSEs) and the contributing factors among illiterate and low-literate community-dwelling older adults with polypharmacy.

Method

The present cross-sectional study was conducted among people aged 60 and above. The data were collected using the sociodemographic, clinical, and Belief about Medicines Questionnaires (BMQ). To determine the extent of MSE, a medication error checklist was used. The negative binomial hierarchical regression model in the five blocks was performed.

Results

The final sample size was 276 people. The frequency of MSEs in the last 6 months was 69.2%. Sixteen percent of participants had made four or more mistakes. The most common MSEs were forgetting, improper taking of medications with food, improper timing, incorrect dosage (lower dose), and forgetting the doctor’s instructions. Near 18% of participants reported adverse events following their mistakes. The significant predictors of MSEs were being completely illiterate (p = 0.021), the higher number of doctor visits per year (p = 0.014), irregularly seeing doctors (p Conclusion

Despite the high prevalence of MSEs among older patients, practical strategies to deal with them at their homes have not been established among health systems. MSE as a multifactorial event can be caused by a collection of internal and external factors. Further studies to identify the role of patients, clinicians, procedures, and systems in developing MSEs as interconnected components are needed.

Evaluation of nurse‐reported missed care in a post‐anesthesia care unit: A mixed‐methods study

Abstract

Background

Nurse-reported missed care (NRMC) is considered as any significant delay or omission in provision of nursing care.

Aim

(i) Evaluate the frequency, types, and reasons for NRMC in the Post-anesthesia Care Unit (PACU). (ii) Evaluate associations between nurse demographic and workload factors with NRMC. (iii) Explore nurses' perception of NRMC in the PACU.

Methods

A cross-sectional study was conducted in the PACU in a tertiary acute care hospital over 3 months. Full-time PACU nurses were conveniently sampled to complete an anonymous survey after their daily shift over different shifts. It contained three sections: (i) nurse demographics; (ii) elements of NRMC; and (iii) reasons for NRMC. Qualitative interviews employed a semi-structured guide to explore perceptions and experiences of NRMC. Descriptive, inferential statistics, and thematic analyses were applied.

Results

Sixty-six survey responses were collected. 48.5% of respondents indicated at least one NRMC activity. Activities more clinically sensitive were less missed. Eight nurses were interviewed. Four main themes were identified: (i) communication with patients; (ii) communication and teamwork with colleagues; (iii) dual role of documentation; and (iv) staffing inadequacy. Language barriers made communication challenging. Staff shortage exacerbates workload but effective teamwork and documentation facilitates nursing care.

Conclusion

Communication and staffing concerns aggravate NRMC. Teamwork and personal contentment were satisfactory. Nurses' turnover intention may worsen staffing.

Clinical Relevance

Timeliness and quality of nursing care is impacted by elements such as manpower, allocation of resources, work processes, and workplace environmental or interpersonal factors such as culture and language fit. Re-evaluation of nursing resources and work processes may assist post-anesthesia care unit nurses in fulfilling their role, decreasing the prevalence of nurse-reported missed care.

Defining predictors of responsiveness to advanced therapies in Crohns disease and ulcerative colitis: protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine

Por: Wyatt · N. J. · Watson · H. · Anderson · C. A. · Kennedy · N. A. · Raine · T. · Ahmad · T. · Allerton · D. · Bardgett · M. · Clark · E. · Clewes · D. · Cotobal Martin · C. · Doona · M. · Doyle · J. A. · Frith · K. · Hancock · H. C. · Hart · A. L. · Hildreth · V. · Irving · P. M. · Iqbal · S
Introduction

Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient’s quality of life. Therapeutic developments in the last 20 years have revolutionised treatment. However, clinical trials and real-world data show primary non-response rates up to 40%. A significant challenge is an inability to predict which treatment will benefit individual patients.

Current understanding of IBD pathogenesis implicates complex interactions between host genetics and the gut microbiome. Most cohorts studying the gut microbiota to date have been underpowered, examined single treatments and produced heterogeneous results. Lack of cross-treatment comparisons and well-powered independent replication cohorts hampers the ability to infer real-world utility of predictive signatures.

IBD-RESPONSE will use multi-omic data to create a predictive tool for treatment response. Future patient benefit may include development of biomarker-based treatment stratification or manipulation of intestinal microbial targets. IBD-RESPONSE and downstream studies have the potential to improve quality of life, reduce patient risk and reduce expenditure on ineffective treatments.

Methods and analysis

This prospective, multicentre, observational study will identify and validate a predictive model for response to advanced IBD therapies, incorporating gut microbiome, metabolome, single-cell transcriptome, human genome, dietary and clinical data. 1325 participants commencing advanced therapies will be recruited from ~40 UK sites. Data will be collected at baseline, week 14 and week 54. The primary outcome is week 14 clinical response. Secondary outcomes include clinical remission, loss of response in week 14 responders, corticosteroid-free response/remission, time to treatment escalation and change in patient-reported outcome measures.

Ethics and dissemination

Ethical approval was obtained from the Wales Research Ethics Committee 5 (ref: 21/WA/0228). Recruitment is ongoing. Following study completion, results will be submitted for publication in peer-reviewed journals and presented at scientific meetings. Publications will be summarised at www.ibd-response.co.uk.

Trial registration number

ISRCTN96296121.

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R.
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

Shared decision-making for non-operative management versus operative management of hip fractures in selected frail older adults with a limited life expectancy: a protocol for a nationwide implementation study

Por: Zeelenberg · M. L. · Oosterwijk · P. C. · Willems · H. C. · Gosens · T. · Den Hartog · D. · Joosse · P. · Loggers · S. A. I. · Nijdam · T. M. · Pel-Littel · R. E. · Polinder · S. · Schuijt · H. J. · Wijnen · H. H. · Van der Velde · D. · Van Lieshout · E. M. M. · Verhofstad · M. H. J
Background and purpose

Recent research has highlighted non-operative management (NOM) as a viable alternative for frail older adults with hip fractures in the final phase of life. This study aims to guide Dutch physicians and hospitals nationwide in a standardised implementation of shared decision-making regarding surgery or NOM in selected frail older adults with a hip fracture.

Methods and analysis

The patient population for implementation includes frail older adults aged ≥70 years with an acute proximal femoral fracture, nursing home care or a similar level of care elsewhere and at least one additional criterion (ie, malnutrition, severe mobility impairment or ASA≥4). The 2-year implementation study will be conducted in four phases. In phases 1 and 2, barriers and facilitators for implementation will be identified and an implementation protocol, educational materials and patient information will be developed. Phase 3 will involve an implementation pilot in 14 hospitals across the Netherlands. The protocol and educational material will be improved based on healthcare provider and patient experiences gathered through interviews. Phase 4 will focus on upscaling to nationwide implementation and the effect of the implementation on NOM rate will be measured using data from the Dutch Hip Fracture Audit.

Ethics and dissemination

The study was exempted by the local Medical Research Ethics Committee (MEC-2023-0270, 10 May 2023) and Medical Ethics Committee United (W23.083, 26 April 2023). The study’s results will be submitted to an open access international peer-reviewed journal. Its protocols, tools and results will be presented at several national and international academic conferences of relevant orthogeriatric (scientific) associations.

Trial registration number

NCT06079905 .

Linking genetic counseling communication skills to patient outcomes and experiences using a community-engagement and provider-engagement approach: research protocol for the GC-PRO mixed methods sequential explanatory study

Por: Fisher · E. R. · Cragun · D. · Dedrick · R. F. · Lumpkins · C. Y. · Ramirez · M. · Kaphingst · K. A. · Petersen · A. · MacFarlane · I. M. · Redlinger-Grosse · K. · Shire · A. · Culhane-Pera · K. A. · Zierhut · H. A.
Introduction

In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice.

Methods and analysis

A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis.

Ethics and dissemination

This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study’s CABs. A lay summary will also be disseminated to all participants.

De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease

Por: Sanchez · A. · Pijoan · J. I. · Sainz de Rozas · R. · Lekue · I. · San Vicente · R. · Quindimil · J. A. · Rotaeche · R. · Etxeberria · A. · Mozo · C. · Martinez-Cengotitabengoa · M. · Monge · M. · Gomez-Ramirez · C. · Samper · R. · Ogueta Lana · M. · Celorrio · S. · Merino-Inda · N.
Introduction

This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.

Methods and analysis

A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR

Ethics and dissemination

The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.

Trial registration number

NCT04022850.

Comparative analysis of antibodies to four major periodontal bacteria in respiratory diseases: a cohort study

Por: Lund Haheim · A. L. · Olsen · I. · Thelle · D. S. · Ronningen · K. S.
Objectives

To make a descriptive comparison of antibodies to four major periodontal bacteria and their relation to the respiratory diseases asthma and bronchitis/emphysema, and to cancer incidence.

Methods

The serum of a random sample of men with no history of cancer incidence (n=621) was analysed by the ELISA method for antibody levels of four periodontal bacteria; the anaerobes of the so-called red complex Tannerella forsythia (TF), Porphyromonas gingivalis (PG), and Treponema denticola (TD), and the facultative anaerobe Aggregatibacter actinomycetemcomitans (AA). The antibody readings were divided into quartiles and the distribution of cases of the relevant diseases as compared with the non-cases. Comparisons of the quartile distributions were by the Pearson 2 test. Data and serum from the Oslo II study of Norwegian men from 2000 were used. The ELISA analyses were performed on thawed frozen serum. Cancer data from 17.5 years of follow-up were provided by the Norwegian Cancer Registry.

Results

In all, 52 men had reported asthma and 23 men had bronchitis/emphysema at the health screening. Results on cancer incidence are given for all respiratory cancers, n=23, and bronchi and lung cancers separately, n=18. Stratified analyses were performed for the four endpoints showing significant association with low levels of TD antibodies for bronchitis; p=0.035. Both TF and TD were significant for low levels of antibodies among daily smokers; p=0.030 for TF and p

Conclusion

A low level of TD was associated with bronchitis/emphysema compared with the rest of the cohort. In the total study sample, low levels of antibodies to both TF and TD were associated with daily smoking.

Predictive factors of clot propagation in patients with superficial venous thrombosis towards deep venous thrombosis and pulmonary embolism: a systematic review and meta-analysis

Por: van Royen · F. S.-A. · van Smeden · M. · van Doorn · S. · Rutten · F. H. · Geersing · G.-J.
Objective

A subset of patients with superficial venous thrombosis (SVT) experiences clot propagation towards deep venous thrombosis (DVT) and/or pulmonary embolism (PE). The aim of this systematic review is to identify all clinically relevant cross-sectional and prognostic factors for predicting thrombotic complications in patients with SVT.

Design

Systematic review.

Data sources

PubMed/MEDLINE and Embase were systematically searched until 3 March 2023.

Eligibility criteria

Original research studies with patients with SVT, DVT and/or PE as the outcome and presenting cross-sectional or prognostic predictive factors.

Data extraction and synthesis of results

The CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling (CHARMS) checklist for prognostic factor studies was used for systematic extraction of study characteristics. Per identified predictive factor, relevant estimates of univariable and multivariable predictor—outcome associations were extracted, such as ORs and HRs. Estimates of association for the most frequently reported predictors were summarised in forest plots, and meta-analyses with heterogeneity were presented. The Quality in Prognosis Studies (QUIPS) tool was used for risk of bias assessment and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) for assessing the certainty of evidence.

Results

Twenty-two studies were included (n=10 111 patients). The most reported predictive factors were high age, male sex, history of venous thromboembolism (VTE), absence of varicose veins and cancer. Pooled effect estimates were heterogenous and ranged from OR 3.12 (95% CI 1.75 to 5.59) for the cross-sectional predictor cancer to OR 0.92 (95% CI 0.56 to 1.53) for the prognostic predictor high age. The level of evidence was rated very low to low. Most studies were scored high or moderate risk of bias.

Conclusions

Although the pooled estimates of the predictors high age, male sex, history of VTE, cancer and absence of varicose veins showed predictive potential in isolation, variability in study designs, lack of multivariable adjustment and high risk of bias prevent firm conclusions. High-quality, multivariable studies are necessary to be able to identify individual SVT risk profiles.

PROSPERO registration number

CRD42021262819.

Chronic disease prevention and screening outcomes for patients with and without financial difficulty: a secondary analysis of the BETTER WISE cluster randomised controlled trial

Por: Aubrey-Bassler · K. · Patel · D. · Fernandes · C. · Lofters · A. K. · Campbell-Scherer · D. · Meaney · C. · Moineddin · R. · Wong · T. · Pinto · A. D. · Shea-Budgell · M. · McBrien · K. · Grunfeld · E. · Manca · D. P.
Objective

Building on Existing Tools To improvE chronic disease pRevention and screening in primary care Wellness of cancer survIvorS and patiEnts (BETTER WISE) was designed to assess the effectiveness of a cancer and chronic disease prevention and screening (CCDPS) programme. Here, we compare outcomes in participants living with and without financial difficulty.

Design

Secondary analysis of a cluster-randomised controlled trial.

Setting

Patients of 59 physicians from 13 clinics enrolled between September 2018 and August 2019.

Participants

596 of 1005 trial participants who responded to a financial difficulty screening question at enrolment.

Intervention

1-hour CCDPS visit versus usual care.

Outcome measures

Eligibility for a possible 24 CCDPS actions was assessed at baseline and the primary outcome was the percentage of eligible items that were completed at 12-month follow-up. We also compared the change in response to the financial difficulty screening question between baseline and follow-up.

Results

55 of 265 participants (20.7%) in the control group and 69 of 331 participants (20.8%) in the intervention group reported living with financial difficulty. The primary outcome was 29% (95% CI 26% to 33%) for intervention and 23% (95% CI 21% to 26%) for control participants without financial difficulty (p=0.01). Intervention and control participants with financial difficulty scored 28% (95% CI 24% to 32%) and 32% (95% CI 27% to 38%), respectively (p=0.14). In participants who responded to the financial difficulty question at both time points (n=302), there was a net decrease in the percentage of participants who reported financial difficulty between baseline (21%) and follow-up (12%, p

Conclusion

The BETTER intervention improved uptake of CCDPS manoeuvres in participants without financial difficulty, but not in those living with financial difficulty. Improving CCDPS for people living with financial difficulty may require a different clinical approach or that social determinants be addressed concurrently with clinical and lifestyle needs or both.

Trial registration number

ISRCTN21333761.

Scaling hypertension treatment in 24 low-income and middle-income countries: economic evaluation of treatment decisions at three blood pressure cut-points

Por: Hutchinson · B. · Walter · A. · Campbell · N. · Whelton · P. K. · Varghese · C. · Husain · M. J. · Nugent · R. · Kostova · D. · Honeycutt · A.
Objective

Estimate the incremental costs and benefits of scaling up hypertension care in adults in 24 select countries, using three different systolic blood pressure (SBP) treatment cut-off points—≥140, ≥150 and ≥160 mm Hg.

Intervention

Strengthening the hypertension care cascade compared with status quo levels, with pharmacological treatment administered at different cut-points depending on the scenario.

Target population

Adults aged 30+ in 24 low-income and middle-income countries spanning all world regions.

Perspective

Societal.

Time horizon

30 years.

Discount rate

4%.

Costing year

2020 USD.

Study design

Data sources

Institute for Health Metrics and Evaluation’s Epi Visualisations database—country-specific cardiovascular disease (CVD) incidence, prevalence and death rates. Mean SBP and prevalence—National surveys and NCD-RisC. Treatment protocols—WHO HEARTS. Treatment impact—academic literature. Costs—national and international databases.

Outcome measures

Health outcomes—averted stroke and myocardial infarction events, deaths and disability-adjusted life-years; economic outcomes—averted health expenditures, value of averted mortality and workplace productivity losses.

Results of analysis

Across 24 countries, over 30 years, incremental scale-up of hypertension care for adults with SBP≥140 mm Hg led to 2.6 million averted CVD events and 1.2 million averted deaths (7% of expected CVD deaths). 68% of benefits resulted from treating those with very high SBP (≥160 mm Hg). 10 of the 12 highest-income countries projected positive net benefits at one or more treatment cut-points, compared with 3 of the 12 lowest-income countries. Treating hypertension at SBP≥160 mm Hg maximised the net economic benefit in the lowest-income countries.

Limitations

The model only included a few hypertension-attributable diseases and did not account for comorbid risk factors. Modelled scenarios assumed ambitious progress on strengthening the care cascade.

Conclusions

In areas where economic considerations might play an outsized role, such as very low-income countries, prioritising treatment to populations with severe hypertension can maximise benefits net of economic costs.

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

Por: Gumber · L. · Agbeleye · O. · Inskip · A. · Fairbairn · R. · Still · M. · Ouma · L. · Lozano-Kuehne · J. · Bardgett · M. · Isaacs · J. D. · Wason · J. M. · Craig · D. · Pratt · A. G.
Objective

International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.

Design

Systematic review.

Data sources

Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.

Eligibility criteria

All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.

Data extraction and synthesis

Search results were independently screened by at least two reviewers and data were extracted into a proforma.

Results

38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.

Conclusions

International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.

Open science framework registration number

osf-registrations-yvtjb-v1.

Systematic RADaR analysis of responses to the open-ended question in the Culture of Care Barometer survey of a Dutch hospital

Objectives

Systematically measuring the work environment of healthcare employees is key to continuously improving the quality of care and addressing staff shortages. In this study, we systematically analyse the responses to the one open-ended question posed in the Dutch version of the Culture of Care Barometer (CoCB-NL) to examine (1) if the responses offered new insights into healthcare employees’ perceptions of their work environment and (2) if the original CoCB had any themes missing.

Design

Retrospective text analysis using Rigorous and Accelerated Data Reduction technique.

Setting

University hospital in the Netherlands using the CoCB-NL as part of the annual employee survey.

Participants

All hospital employees were invited to participate in the study (N=14 671). In total, 2287 employees responded to the open-ended question.

Results

2287 comments were analysed. Comments that contained more than one topic were split according to topic, adding to the total (n=2915). Of this total, 372 comments were excluded because they lacked content or respondents indicated they had nothing to add. Subsequently, 2543 comments were allocated to 33 themes. Most comments (n=2113) addressed the 24 themes related to the close-ended questions in the CoCB-NL. The themes most commented on concerned questions on ‘organisational support’. The remaining 430 comments covered nine additional themes that addressed concerns about work environment factors (team connectedness, team effectiveness, corporate vision, administrative burden and performance pressure) and themes (diversity and inclusion, legal frameworks and collective bargaining, resilience and work–life balance, and personal matters).

Conclusions

Analysing responses to the open-ended question in the CoCB-NL led to new insights into relevant elements of the work environment and missing themes in the COCB-NL. Moreover, the analysis revealed important themes that not only require attention from healthcare organisations to ensure adequate improvements in their employees’ work environment but should also be considered to further develop the CoCB-NL.

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