FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Cost-free pharmacotherapy in smokers with TIA or stroke: QUIT-MED randomised controlled trial

Por: Reid · R. · Papadakis · S. · Gocan · S. · Bourgoin · A. · Laplante · M. A. · Armstrong · A. · Aitken · D. · Sahlas · D. · Stotts · G. · Cotie · L. · Mullen · K.-A. · Pipe · A. · Mir · H. · Sharma · M.
Objective

To examine whether cost-free (CF) smoking cessation medication was more effective than a prescription for cessation medication in patients after transient ischaemic attack (TIA) or stroke.

Design

Two-site randomised trial.

Setting

Stroke prevention clinics (SPCs) in Ontario, Canada.

Participants

Smokers with TIA or stroke, willing to quit smoking.

Intervention

Smoking status was assessed in SPC attendees. Smokers were advised to quit smoking and received recommendations for cessation medication and counselling. Consenting participants were randomly assigned (1:1) to either a CF medication group or a prescription-only (Rx) group. CF participants immediately received a 12-week supply of cessation medication. Rx participants were given a prescription for 12 weeks of cessation medication. Follow-up counselling was provided for 26 weeks.

Main outcome

The primary outcome was 40-week continuous abstinence verified using a carbon monoxide breath test at 52-week follow-up. Secondary outcomes included abstinence at intermediate timepoints, medication adherence and serious adverse events.

Results

Hundred and ninety-four participants were randomised and 131 (67.5%) completed the trial. The 40-week continuous abstinence rate at 52-week follow-up was 15.5% in the CF group versus 14.0% in the Rx group (OR=1.13; 95% CI 0.51 to 2.53). The 14-week continuous abstinence rate at 26-week follow-up was 18.6% in the CF group versus 16.8% in the Rx group (OR=1.20; 95% CI 0.56 to 2.55). Seven-day point-prevalence abstinence at 12 weeks was 38.1% in the CF group versus 26.9% in the Rx group (OR=1.76; 95% CI 0.94 to 3.28). Medication adherence was higher in the CF group versus the Rx group (47.4%±41.2% vs 25.5±36.8%, p

Conclusions

Our findings were inconclusive; we failed to meet our recruitment target and the effect size was smaller than anticipated. CF medication improved medication adherence.

Trial registration number

NCT00962988; ClinicalTrials.gov Identifier.

Camrelizumab in patients with advanced non-squamous non-small cell lung cancer: a cost-effective analysis in China

Por: Xie · Q. · Zheng · H. · Su · N. · Li · Q.
Objective

Camrelizumab is a selective, humanised, high-affinity IgG4 kappa monoclonal antibody against programmed cell death 1 that shows effective antitumour activity with acceptable toxicity in multiple tumour types. The CameL trial demonstrated that camrelizumab plus chemotherapy (CC) significantly prolonged the median progression-free survival and median overall survival versus chemotherapy alone (CA) in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Our study was conducted to investigate the cost-effectiveness of the two strategies in chemotherapy-naive patients with advanced non-squamous NSCLC.

Design, setting and participants

A Markov simulation model was generated based on the CameL trial. The two simulated treatments included CC and CA.

Primary and secondary outcome measures

Utility was derived from published literature, and costs were calculated based on those at our hospital in Chengdu, China. Incremental cost-effectiveness ratios (ICERs) were calculated to compare the cost-effectiveness of the two treatment arms.

Results

In the overall population, the total costs were $27 223.40 and $13 740.10 for CC and CA treatment, respectively. The CC treatment produced 1.37 quality-adjusted life years (QALYs), and the CA treatment produced 1.17 QALYs. Hence, patients who were in the CC group spent an additional $13 483.30 and generated an increase of 0.20 QALYs, resulting in an ICER of $67 416.50 per QALY.

Conclusions

For chemotherapy-naive patients with advanced non-squamous NSCLC, CC is not considered a cost-effective treatment versus CA in China when considering a willingness-to-pay threshold of $31 500 per QALY.

Trial registration number

NCT03134872

Feasibility and safety of combining repetitive transcranial magnetic stimulation and quadriceps strengthening exercise for chronic pain in knee osteoarthritis: a study protocol for a pilot randomised controlled trial

Por: Chang · W.-J. · Adie · S. · Naylor · J. M. · Chowdhury · N. · Finn · H. · Rizzo · R. R. N. · OHagan · E. · Schabrun · S. M.
Introduction

Knee osteoarthritis is a leading cause of disability, resulting in pain and reduced quality of life. Exercise is the cornerstone of conservative management but effects are, at best, moderate. Early evidence suggests that repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex (M1) may improve the effect of exercise in knee osteoarthritis. This pilot study aims to (1) determine the feasibility, safety and participant-rated response to an intervention adding M1 rTMS to exercise in knee osteoarthritis; (2) elucidate physiological mechanisms in response to the intervention; (3) provide data to conduct a sample size calculation for a fully powered trial.

Methods and analysis

This is a pilot randomised, assessor-blind, therapist-blind and participant-blind, sham-controlled trial. Thirty individuals with painful knee osteoarthritis will be recruited and randomly allocated to receive either: (1) active rTMS+exercise or (2) sham rTMS+exercise intervention. Participants will receive 15 min of either active or sham rTMS immediately prior to 30 min of supervised muscle strengthening exercise (2x/week, 6 weeks) and complete unsupervised home exercises. Outcome measures of feasibility, safety, pain, function and physiological mechanisms will be assessed before and/or after the intervention. Feasibility and safety will be analysed using descriptive analysis. Within-group and between-group comparisons of pain and function will be conducted to examine trends of efficacy.

Ethics and dissemination

This study has been approved by the University of New South Wales Human Research Ethics Committee (HC210954). All participants will provide written informed consent. The study results will be submitted for peer-reviewed publication.

Trial registration number

ACTRN12621001712897p.

Cost-effectiveness of a dietary and physical activity intervention in adolescents: a prototype modelling study based on the Engaging Adolescents in Changing Behaviour (EACH-B) programme

Por: Kalita · N. · Cooper · K. · Baird · J. · Woods-Townsend · K. · Godfrey · K. · Cooper · C. · Inskip · H. · Barker · M. · Lord · J. · the EACH-B study group
Objective

To assess costs, health outcomes and cost-effectiveness of interventions that aim to improve quality of diet and level of physical activity in adolescents.

Design

A Markov model was developed to assess four potential benefits of healthy behaviour for adolescents: better mental health (episodes of depression and generalised anxiety disorder), higher earnings and reduced incidence of type 2 diabetes and adverse pregnancy outcomes (in terms of preterm delivery). The model parameters were informed by published literature. The analysis took a societal perspective over a 20-year period. One-way and probabilistic sensitivity analyses for 10 000 simulations were conducted.

Participants

A hypothetical cohort of 100 adolescents with a mean age of 13 years.

Interventions

An exemplar school-based, multicomponent intervention that was developed by the Engaging Adolescents for Changing Behaviour programme, compared with usual schooling.

Outcome measure

Incremental cost-effectiveness ratio (ICER) as measured by cost per quality-adjusted life-year (QALY) gained.

Results

The exemplar dietary and physical activity intervention was associated with an incremental cost of £123 per adolescent and better health outcomes with a mean QALY gain of 0.0085 compared with usual schooling, resulting in an ICER of £14 367 per QALY. The key model drivers are the intervention effect on levels of physical activity, quality-of-life gain for high levels of physical activity, the duration of the intervention effects and the period over which effects wane.

Conclusions

The results suggested that such an intervention has the potential to offer a cost-effective use of healthcare-resources for adolescents in the UK at a willingness-to-pay threshold of £20 000 per QALY. The model focused on short-term to medium-term benefits of healthy eating and physical activity exploiting the strong evidence base that exists for this age group. Other benefits in later life, such as reduced cardiovascular risk, are more sensitive to assumptions about the persistence of behavioural change and discounting.

Trail registration number

ISRCTN74109264.

Global impact of COVID-19 on surgeons and team members (GlobalCOST): a cross-sectional study

Por: Jaffry · Z. · Raj · S. · Sallam · A. · Lyman · S. · Negida · A. · Yiu · C. F. A. · Sobti · A. · Bua · N. · Field · R. E. · Abdalla · H. · Hammad · R. · Qazi · N. · Singh · B. · Brennan · P. A. · Hussein · A. · Narvani · A. · Jones · A. · Imam · M. A. · The OrthoGlobe Collaborative · Abbas
Objectives

To investigate the impact of COVID-19 on the well-being of surgeons and allied health professionals as well as the support provided by their institutions.

Design

This cross-sectional study involved distributing an online survey through medical organisations, social media platforms and collaborators.

Setting

It included all staff based in an operating theatre environment around the world.

Participants

1590 complete responses were received from 54 countries between 15 July and 15 December 2020. The average age of participants was 30–40 years old, 64.9% were men and 32.5% of a white ethnic background. 79.5% were surgeons with the remainder being nurses, assistants, anaesthetists, operating department practitioners or classified other.

Main outcome measures

Participants that had experienced any physical illness, changes in mental health, salary or time with family since the start of the pandemic as well as support available based on published recommendations.

Results

32.0% reported becoming physically ill. This was more likely in those with reduced access to personal protective equipment (OR 4.62; CI 2.82 to 7.56; p

Conclusions

This work has highlighted a need and strategies to improve conditions for the healthcare workforce, ultimately benefiting patient care.

Severe COVID-19 outcomes among patients with autoimmune rheumatic diseases or transplantation: a population-based matched cohort study

Por: Marozoff · S. · Lu · N. · Loree · J. M. · Xie · H. · Lacaille · D. · Kopec · J. A. · Esdaile · J. · Avina-Zubieta · J. A.
Objectives

To assess the risk of severe COVID-19 outcomes in patients with autoimmune rheumatic diseases (ARDs) and transplant recipients compared with matched general population comparators.

Design

Population-based matched cohort study using administrative health data sets.

Setting

British Columbia, Canada.

Participants

All adults with test-positive SARS-CoV-2 infections. SARS-CoV-2-positive patients with ARDs and those with transplantation were matched to SARS-CoV-2-positive general population comparators on age (±5 years), sex, month/year of initial positive SARS-CoV-2 test and health authority.

Outcome measures

COVID-19-related hospitalisations, intensive care unit (ICU) admissions, invasive ventilation and COVID-19-specific mortality. We performed multivariable conditional logistic regression models adjusting for socioeconomic status, Charlson Comorbidity Index, hypertension, rural address and number of previous COVID-19 PCR tests.

Results

Among 6279 patients with ARDs and 222 transplant recipients, all SARS-CoV-2 test positive, risk of hospitalisation was significantly increased among patients with ARDs (overall ARDs (adjusted OR (aOR) 1.30; 95% CI 1.19 to 1.43)); highest within ARDs: adult systemic vasculitides (aOR 2.18; 95% CI 1.17 to 4.05) and transplantation (aOR 10.56; 95% CI 6.88 to 16.22). Odds of ICU admission were significantly increased among patients with ARDs (overall ARDs (aOR 1.30; 95% CI 1.11 to 1.51)); highest within ARDs: ankylosing spondylitis (aOR 2.03; 95% CI 1.18 to 3.50) and transplantation (aOR 8.13; 95% CI 4.76 to 13.91). Odds of invasive ventilation were significantly increased among patients with ARDs (overall ARDs (aOR 1.60; 95% CI 1.27 to 2.01)); highest within ARDs: ankylosing spondylitis (aOR 2.63; 95% CI 1.14 to 6.06) and transplantation (aOR 8.64; 95% CI 3.81 to 19.61). Risk of COVID-19-specific mortality was increased among patients with ARDs (overall ARDs (aOR 1.24; 95% CI 1.05 to 1.47)); highest within ARDs: ankylosing spondylitis (aOR 2.15; 95% CI 1.02 to 4.55) and transplantation (aOR 5.48; 95% CI 2.82 to 10.63).

Conclusions

The risk of severe COVID-19 outcomes is increased in certain patient groups with ARDs or transplantation, although the magnitude differs across individual diseases. Strategies to mitigate risk, such as booster vaccination, prompt diagnosis and early intervention with available therapies, should be prioritised in these groups according to risk.

Association between transoesophageal echocardiography monitoring indicators and the incidence of postoperative acute kidney injury in coronary artery bypass grafting: a study protocol for a prospective multicenter cohort study

Por: Liu · B. · Lv · M. · Wang · H. · Sun · Y. · Song · X. · Dong · L. · Feng · H. · Wang · Y.
Introduction

Previous studies on transoesophageal echocardiography in coronary artery bypass grafting mainly focused on whether to change the surgical plan rather than improve the clinical prognosis. Currently, there are sparse studies on the relationship between transoesophageal echocardiography indicators and the prognosis of patients undergoing coronary artery bypass grafting. The primary aim of this study is to explore the association between transoesophageal echocardiography monitoring indicators the respiratory variability of inferior vena cava diameter, tricuspid annular plane systolic excursion and the incidence of acute kidney injury in coronary artery bypass grafting patients.

Methods and analysis

We designed this prospective multicenter cohort study, which included approximately 150 adult patients (≥18 years) undergoing elective coronary artery bypass surgery. Different hospitals will be assessed to obtain information on the prevalence, risk factors, management strategies and outcomes in coronary artery bypass surgery. The cohort will be followed after the coronary artery bypass surgery period, up to 30 days after enrolment. The incidence of postoperative acute kidney injury and baseline data will be presented by descriptive statistics. We will use Freidman inspection and multivariable logistic regression to assess the association between transoesophageal echocardiography monitoring indicators and the incidence of acute kidney injury in coronary artery bypass grafting patients.

Ethics and dissemination

The study has been approved by the ethics committee of Shandong Provincial Qianfoshan Hospital, China (approval number: YXLL-KY-2021(067)). This is an observational study that poses no risk to the patients. All participants will obtain informed consent according to the ethics committee before patient enrolment. Funding sources will have no influence on data handling, analyses or writing of the manuscript. The article is planned for submission in an international peer-reviewed journal.

Trial registration number

NCT05139108.

How can equitable video visit access be delivered in primary care? A qualitative study among rural primary care teams and patients

Por: Goldstein · K. M. · Perry · K. R. · Lewinski · A. · Walsh · C. · Shepherd-Banigan · M. E. · Bosworth · H. B. · Weidenbacher · H. · Blalock · D. V. · Zullig · L. L.
Objective

The COVID-19 pandemic sparked exponential growth in video visit use in primary care. The rapid shift to virtual from in-person care exacerbated digital access disparities across racial groups and rural populations. Moving forward, it is critical to understand when and how to incorporate video visits equitably into primary care. We sought to develop a novel clinical algorithm to guide primary care clinics on how and when to employ video visits as part of care delivery.

Design

Qualitative data collection: one team member conducted all patient semistructured interviews and led all focus groups with four other team members taking notes during groups.

Setting

3 rural primary care clinics in the USA.

Participants

24 black veterans living in rural areas and three primary care teams caring for black veterans living in rural areas.

Primary and secondary outcome measures

Findings from semistructured interviews with patients and focus groups with primary care teams.

Results

Key issues around appropriate use of video visits for clinical teams included having adequate technical support, encouraging engagement during video visits and using video visits for appropriate clinical situations. Patients reported challenges with broadband access, inadequate equipment, concerns about the quality of video care, the importance of visit modality choice, and preferences for in-person care experience over virtual care. We developed an algorithm that requires input from both patients and their care team to assess fit for each clinical encounter.

Conclusions

Informed matching of patients and clinical situations to the right visit modality, along with individual patient technology support could reduce virtual access disparities.

Bedaquiline-based treatment for extensively drug-resistant tuberculosis in South Africa: A cost-effectiveness analysis

by Ginenus Fekadu, Jiaqi Yao, Joyce H. S. You

Background

The treatment success rate of conventional anti-tuberculosis (TB) regimens for extensively drug-resistant TB (XDR-TB) is low, resulting in high morbidity and healthcare cost especially in the high TB burden countries. Recent clinical findings reported improved treatment outcomes of XDR-TB with the bedaquiline (BDQ)-based regimens. We aimed to evaluate the cost-effectiveness of BDQ-based treatment for XDR-TB from the perspective of the South Africa national healthcare provider.

Methods

A 2-year decision-analytic model was designed to evaluate the clinical and economic outcomes of a hypothetical cohort of adult XDR-TB patients with (1) BDQ-based regimen and (2) injectable-based conventional regimen. The model inputs were retrieved from literature and public data. Base-case analysis and sensitivity analysis were performed. The primary model outputs included TB-related direct medical cost and disability-adjusted life years (DALYs).

Results

In the base-case analysis, the BDQ group reduced 4.4152 DALYs with an incremental cost of USD1,606 when compared to the conventional group. The incremental cost per DALY averted (ICER) by the BDQ group was 364 USD/DALY averted. No influential factor was identified in the sensitivity analysis. In probabilistic sensitivity analysis, the BDQ group was accepted as cost-effective in 97.82% of the 10,000 simulations at a willingness-to-pay threshold of 5,656 USD/DALY averted (1× gross domestic product per capita in South Africa).

Conclusion

The BDQ-based therapy appeared to be cost-effective and showed a high probability to be accepted as the preferred cost-effective option for active XDR-TB treatment.

Key factors for effective implementation of healthcare worker support interventions after patient safety incidents in health organisations: a protocol for a scoping review

Por: Guerra-Paiva · S. · Lobao · M. J. · Simoes · J. D. · Donato · H. · Carrillo · I. · Mira · J. J. · Sousa · P.
Introduction

Health organisations should support healthcare workers who are physically and psychologically affected by patient safety incidents (second victims). There is a growing body of evidence which focuses on second victim support interventions. However, there is still limited research on the elements necessary to effectively implement and ensure the sustainability of these types of interventions. In this study, we propose to map and frame the key factors which underlie an effective implementation of healthcare worker support interventions in healthcare organisations when healthcare workers are physically and/or emotionally affected by patient safety incidents.

Methods and analysis

This scoping review will be guided by the established methodological Arksey and O’Malley framework, Levac and Joanna Briggs Institute (JBI) recommendations. We will follow the JBI three-step process: (1) a preliminary search conducted on two databases; (2) the definition of clear inclusion criteria and the creation of a list of search terms to be used in the subsequent running of the search on a larger number of databases; and (3) additional searches (cross-checking/cross-referencing of reference lists of eligible studies, hand-searching in target journals relevant to the topic, conference proceedings, institutional/organisational websites and networks repositories). We will undertake a comprehensive search strategy in relevant bibliographic databases (PubMed/MEDLINE, Embase, CINHAL, Web of Science, Scopus, PsycInfo, Epistemonikos, Scielo, Cochrane Library and Open Grey). We will use the Mixed Methods Appraisal Tool V.2018 for quality assessment of the eligible studies. Our scoping review will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews.

Ethics and dissemination

This study will not require ethical approval. Results of the scoping review will be published in a peer-review journal, and findings will be presented in scientific conferences as well as in international forums and other relevant dissemination channels.

Trial registration number

10.17605/OSF.IO/RQAT6.

Preprint from medRxiv available: doi: https://doi.org/10.1101/2022.01.25.22269846.

Effectiveness of mRNA COVID-19 vaccines against Omicron and Delta variants in a matched test-negative case-control study among US veterans

Por: Young-Xu · Y. · Zwain · G. M. · Izurieta · H. S. · Korves · C. · Powell · E. I. · Smith · J. · Balajee · A. · Holodniy · M. · Beenhouwer · D. O. · Rodriguez-Barradas · M. C. · Brown · S. T. · Marconi · V. C.
Objective

To estimate the effectiveness of messenger RNA (mRNA) booster doses during the period of Delta and Omicron variant dominance.

Design

We conducted a matched test-negative case–control study to estimate the vaccine effectiveness (VE) of three and two doses of mRNA vaccines against infection (regardless of symptoms) and against COVID-19-related hospitalisation and death.

Setting

Veterans Health Administration.

Participants

We used electronic health record data from 114 640 veterans who had a SARS-CoV-2 test during November 2021–January 2022. Patients were largely 65 years or older (52%), male (88%) and non-Hispanic white (59%).

Main outcome measures

First positive result for a SARS-CoV-2 PCR or antigen test.

Results

Against infection, booster doses had higher estimated VE (64%, 95% CI 63 to 65) than two-dose vaccination (12%, 95% CI 10 to 15) during the Omicron period. For the Delta period, the VE against infection was 90% (95% CI 88 to 92) among boosted vaccinees, higher than the VE among two-dose vaccinees (54%, 95% CI 50 to 57). Against hospitalisation, booster dose VE was 89% (95% CI 88 to 91) during Omicron and 94% (95% CI 90 to 96) during Delta; two-dose VE was 63% (95% CI 58 to 67) during Omicron and 75% (95% CI 69 to 80) during Delta. Against death, the VE with a booster dose was 94% (95% CI 90 to 96) during Omicron and 96% (95% CI 87 to 99) during Delta.

Conclusions

Among an older, mostly male, population with comorbidities, we found that an mRNA vaccine booster was highly effective against infection, hospitalisation and death. Although the effectiveness of booster vaccination against infection was moderately higher against Delta than against the Omicron SARS-CoV-2 variant, effectiveness against severe disease and death was similarly high against both variants.

Evaluation of the 'Talking Together simulation communication training for 'goals of patient care conversations: a mixed-methods study in five metropolitan public hospitals in Western Australia

Por: Brown · J. · Myers · H. · Eng · D. · Kilshaw · L. · Abraham · J. · Buchanan · G. · Eggimann · L. · Kelly · M.
Introduction

In partnership with Cancer Council Western Australia (WA), the East Metropolitan Health Service in Perth, WA has developed a clinical simulation training programme ‘Talking Together’ using role play scenarios with trained actors as patients/carers. The aim of the training is to improve clinicians’ communication skills when having challenging conversations with patients, or their carers, in relation to goals of care in the event of clinical deterioration.

Methods and analysis

A multisite, longitudinal mixed-methods study will be conducted to evaluate the impact of the communication skills training programme on patient, family/carer and clinician outcomes. Methods include online surveys and interviews. The study will assess outcomes in three areas: evaluation of the ‘Talking Together’ workshops and their effect on satisfaction, confidence and integration of best practice communication skills; quality of goals of patient care conversations from the point of view of clinicians, carers and family/carers; and investigation of the nursing/allied role in goals of patient care.

Ethics and dissemination

This study has received ethical approval from the Royal Perth Hospital, St John of God and Curtin University Human Research Ethics Committees. The outputs from this project will be a series of research papers and conference presentations.

Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep)

Por: Spiegelhalder · K. · Baumeister · H. · Al-Kamaly · A. · Bader · M. · Bauereiss · N. · Benz · F. · Braun · L. · Buntrock · C. · Burkhardt · M. · Cuijpers · P. · Domschke · K. · Dülsen · P. · Franke · M. · Frase · L. · Heber · E. · Helm · K. · Jentsch · T. · Johann · A. · Küchler · A.-M.
Introduction

It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I.

Methods and analysis

In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Medical Centre—University of Freiburg. The results of the study will be published irrespective of the outcome.

Trial registration number

DRKS00021503.

'Well, in dentistry the dentist is always the boss: a multi-method exploration of which organisational characteristics of dental practices most influence the implementation of evidence-based guidance

Por: Cassie · H. · Treweek · S. · McKee · L. · Ramsay · C. · Young · L. · Clarkson · J.
Objective

To investigate which organisational characteristics of primary care dental practices influence the implementation of evidence-based guidance.

Design

A multimethod study set within primary care dentistry in Scotland comprising: (1) Semistructured interviews with dental teams to inform development of a self-report questionnaire exploring the translation of guidance in primary care dentistry and (2) A questionnaire-based survey and case studies exploring which organisational characteristics influence knowledge translation.

Results

Interview data identified three themes: leadership, communication and context. Survey data revealed compliance with recommendations from three topics of dental guidance to be variable, with only 41% (emergency dental care), 19% (oral health assessment and review) and 4% (drug prescribing) of respondents reporting full compliance. Analysis revealed no significant relationship between practice characteristics and compliance with emergency dental care or drug prescribing recommendations. Positive associations were observed between compliance with oral health assessment and review recommendations and having a practice manager, as well as with the type of treatment offered, with fully private practices more likely, and fully National Health Service practices less likely to comply, when compared with those offering a mixture of treatment. Synthesis of the data identified leadership and context as key drivers of guidance uptake.

Conclusions

Evidence-based dental recommendations are not routinely translated into practice, with variable leadership and differing practice contexts being central to poor uptake. Guidelines should aim to tailor recommendations and implementation strategies to reflect the complexities and varying contexts that exist in primary care dentistry, thus facilitating the implementation of evidence-based guidance.

DNA Methylation Analysis to predict Regression of high-grade anal Intraepithelial Neoplasia in HIV+ men (MARINE): a cohort study protocol

Introduction

Anal cancer precursors, or high-grade anal intraepithelial neoplasia (HGAIN), are highly prevalent in HIV-seropositive (HIV+) men who have sex with men (MSM). Around 30% of lesions regress within 1 year, but current histopathological assessment is unable to distinguish between HGAIN likely to regress and HGAIN likely to persist or progress to cancer. We aim to assess if host cell DNA methylation markers can predict regression of HGAIN, thus determining the need for immediate treatment or active surveillance. This could reduce overtreatment and the associated anal and psycho-sexual morbidity.

Methods and analysis

This is an active surveillance cohort study in three centres located in Amsterdam, the Netherlands, in 200 HIV+ MSM diagnosed with HGAIN. Participants will not be treated, but closely monitored during 24 months of follow-up with 6 monthly visits including cytology, and high-resolution anoscopy with biopsies. The primary study endpoint is histopathological regression of each baseline HGAIN lesion at the end of the study. Regression is defined as ≤low grade anal intraepithelial neoplasia in the exit biopsy at 24 months. Regression proportions in lesions with low versus high methylation levels (ASCL1, ZNF582), other biomarkers (HPV genotype, HPV-E4, p16INK4A, Ki-67) and immunological markers at baseline will be compared. Main secondary endpoints are the histological and clinical outcome (ie, the number of octants affected by HGAIN) of each baseline HGAIN lesion and overall HGAIN disease (i.e., all lesions combined) after each visit. The health-related quality of life of the study group will be compared with that of a control group of 50 HIV+ MSM receiving regular HGAIN treatment.

Ethics and dissemination

Ethics approval was obtained from the Institutional Review Board of the Academic Medical Center (Amsterdam, The Netherlands; reference no. 2021_099). Participants are required to provide written informed consent. Findings will be disseminated through publication in peer-reviewed scientific journals and presentations at international scientific conferences; dissemination to policy makers and the target patient group will be achieved through our (inter-)national network, professional associations and collaboration with a patient representative organisation.

Trial registration number

NL9664.

Development and validation of an early warning score to identify COVID-19 in the emergency department based on routine laboratory tests: a multicentre case-control study

Por: Boer · A.-K. · Deneer · R. · Maas · M. · Ammerlaan · H. S. M. · van Balkom · R. H. H. · Thijssen · W. A. H. M. · Bennenbroek · S. · Leers · M. · Martens · R. J. H. · Buijs · M. M. · Kerremans · J. J. · Messchaert · M. · van Suijlen · J. J. · van Riel · N. A. W. · Scharnhorst · V.
Objectives

Identifying patients with a possible SARS-CoV-2 infection in the emergency department (ED) is challenging. Symptoms differ, incidence rates vary and test capacity may be limited. As PCR-testing all ED patients is neither feasible nor effective in most centres, a rapid, objective, low-cost early warning score to triage ED patients for a possible infection is developed.

Design

Case–control study.

Setting

Secondary and tertiary hospitals in the Netherlands.

Participants

The study included patients presenting to the ED with venous blood sampling from July 2019 to July 2020 (n=10 417, 279 SARS-CoV-2-positive). The temporal validation cohort covered the period from July 2020 to October 2021 (n=14 080, 1093 SARS-CoV-2-positive). The external validation cohort consisted of patients presenting to the ED of three hospitals in the Netherlands (n=12 061, 652 SARS-CoV-2-positive).

Primary outcome measures

The primary outcome was one or more positive SARS-CoV-2 PCR test results within 1 day prior to or 1 week after ED presentation.

Results

The resulting ‘CoLab-score’ consists of 10 routine laboratory measurements and age. The score showed good discriminative ability (AUC: 0.930, 95% CI 0.909 to 0.945). The lowest CoLab-score had high sensitivity for COVID-19 (0.984, 95% CI 0.970 to 0.991; specificity: 0.411, 95% CI 0.285 to 0.520). Conversely, the highest score had high specificity (0.978, 95% CI 0.973 to 0.983; sensitivity: 0.608, 95% CI 0.522 to 0.685). The results were confirmed in temporal and external validation.

Conclusions

The CoLab-score is based on routine laboratory measurements and is available within 1 hour after presentation. Depending on the prevalence, COVID-19 may be safely ruled out in over one-third of ED presentations. Highly suspect cases can be identified regardless of presenting symptoms. The CoLab-score is continuous, in contrast to the binary outcome of lateral flow testing, and can guide PCR testing and triage ED patients.

Factors associated with discontinuation among long-acting reversible contraceptive users: a multisite prospective cohort study in urban public health facilities in Ethiopia

Por: Mihretie · G. S. · Abebe · S. M. · Abebaw · Y. · Gedefa · L. · Gure · T. · Alemayehu · B. A. · Amenu · D. · Tadesse · D. · Fanta · G. A. · Abubeker · F. A. · Yemane · A. · G/Michael · A. D. · Teklu · A. M. · Damtew · M. H. · Girma · B.
Objective

The study aims to determine discontinuation among long-acting reversible contraceptive users at 3, 6, 9 and 12 months after initiation and its associated factors among new long-acting reversible contraceptive (LARC) users.

Design

A facility-based multicentre prospective cohort study was conducted with a sample size of 1766 women.

Setting

The study was conducted in five large cities of Ethiopia (Addis Ababa, Gondar, Mekelle, Jimma and Harar) between March 2017 and December 2018. Various referral hospitals and health centres that are found in those cities are included in the study.

Participants

The study population was all women who were new users of LARCs and initiated LARCs in our selected public health facilities during the enrolment period.

Interventions

A pretested structured questionnaire was administered at enrolment and at 6 and 12 months to determine discontinuation proportion and factors associated with discontinuation.

Result

From the total of 1766 women sampled for the study only 1596 (90.4%) participants completed all the questionnaires including the 12-month follow-up study. The overall proportion of discontinuation of LARCs at 12 months was 21.8% (95% CI 19.8 to 23.9). The overall discontinuation proportions at 3, 6, 9 and 12 months were 2.94%, 8.53%, 3.94% and 6.36%, respectively. Location of method initiation (adjusted HR (aHR)=5.77; (95% CI 1.16 to 28.69)) and dissatisfaction with the method (aHR=0.09; (95% CI 0.03 to 0.21)) were found to be the predictors of discontinuation among intrauterine contraceptive device users. Being satisfied with the method (aHR=0.21; (95% CI 0.15 to 0.27)), initiation after post abortion (aHR=0.48; (95% CI: 0.26, 0.89)) and joint decision with partner for method initiation (aHR=0.67; (95% CI: 0.50, 0.90)) were inversely associated with implant discontinuation.

Conclusion

The majority of LARC users discontinue the method in the first 6 months after insertion and dissatisfaction with the method increased the likelihood of removal during the first year of LARC use.

Three-month follow-up of durability of response to the third dose of the SARS-CoV-2 BNT162b2 vaccine in adults aged 60 years and older: a prospective cohort study

Por: Eliakim-Raz · N. · Stemmer · A. · Leibovici-Weisman · Y. · Ness · A. · Awwad · M. · Ghantous · N. · Erez · N. · Bareket-Samish · A. · Levy-Barda · A. · Ben-Zvi · H. · Moskovits · N. · Bar-Haim · E. · Stemmer · S. M.
Objective

To evaluate the durability of response 3 months after the third BNT162b2 vaccine in adults aged 60 years and older.

Design

Prospective cohort study.

Setting

Single tertiary centre.

Participants

Healthcare workers/family members aged ≥60 years old who received the third BNT162b2 dose.

Interventions

Blood samples were drawn immediately before (T0), 10–19 days (T1) and 74–103 days (T2) after the third dose.

Primary and secondary outcome measures

Anti-spike IgG titres were determined using a commercial assay and seropositivity was defined as ≥50 arbitrary units (AU)/mL. Neutralising antibody titres were determined at T2. Adverse events, COVID-19 infections and Clinical Frailty Scale (CFS) levels were documented.

Results

The analysis included 97 participants (median age, 70 years (IQR, 66–74), 58% CFS level 2). IgG titres, which increased significantly from T0 to T1 (median, 440 AU/mL (IQR, 294–923) and median, 25 429 AU/mL (IQR, 14 203–36 114), respectively; p

Conclusions

Anti-spike IgG and neutralising antibody levels remain adequate 3 months after the third BNT162b2 vaccine in healthy adults aged ≥60 years, although the decline in IgG is concerning. A third dose of vaccine in this population should be top priority.

Defining adequacy of staffing in general hospital wards: a Delphi study

Por: van der Mark · C. J. E. M. · Kraan · J. · Hendriks · P. H. J. · Vermeulen · H. · Oostveen · C. J. v.
Objectives

To gain consensus on the items that determine adequacy of shift staffing.

Design

This was a three-round Delphi study to establish consensus on what defines adequacy of shift staffing in a general hospital ward. A literature review, focus group and five semistructured expert interviews were used to generate items for the Delphi study.

Setting

Multicentre study in The Netherlands.

Participants

Nurses, head nurses, nursing managers, and capacity consultants and managers working for Dutch hospitals.

Results

Twenty-six items were included in the Delphi study. One hundred and sixty-eight, 123 and 93 participants were included in the first, second and third round, respectively. After three rounds, six items were included (mostly related to direct patient care) and nine items were excluded. No consensus was reached on 12 items, including one item that was added after the first round.

Conclusions

This is the first study to specify items that determine adequacy of staffing. These items can be used to measure adequacy of staffing, which is crucial for enhancing nurse staffing methods. Further research is needed to refine the items of staffing adequacy and to further develop and psychometrically test an instrument for measuring staffing adequacy.

Patient preferences for atopic dermatitis medications in the UK, France and Spain: a discrete choice experiment

Por: Thomas · C. · Raibouaa · A. · Wollenberg · A. · Capron · J.-P. · Krucien · N. · Karn · H. · Tervonen · T.
Objectives

We aimed to quantify patient preferences for efficacy, safety and convenience features of atopic dermatitis (AD) treatments.

Design and setting

Online discrete choice experiment survey.

Participants

Adults in the UK, France and Spain who had used AD treatments during the past 2 years.

Primary and secondary outcome measures

Preferences for attributes were analysed using a multinomial logit model. Willingness to make trade-offs was expressed as the maximum acceptable decrease (MAD) in the probability of achieving clear/almost clear skin at week 16.

Results

The survey was completed by 404 patients (44.1±12.0 years; 65% women; 64% moderate/severe eczema). Most patients (68%) had no prior experience of using self-injectable treatments for AD or any other illness. Participants most valued increasing the chance of achieving a meaningful reduction in itch at week 16 from 20% to 50%, followed by reducing the risks of serious infections from 6% to 0% and of eye inflammation from 20% to 0%. Participants were willing to accept a decrease in the possibility of achieving clear/almost clear skin to obtain a treatment that can be paused (MAD=24.1%), requires occasional check-ups (MAD=16.1%) or no check-ups (MAD=20.9%) over frequent check-ups, is administered as a one time per day or two times per day oral pill versus a subcutaneous injection every 2 weeks (MAD=16.6%), has a 2-day over 2-week onset of action (MAD=11.3%), and can be used for flare management (MAD=5.8%).

Conclusions

Although patients with AD most valued treatment benefits and risks, they were willing to tolerate reduced efficacy to obtain a rapid onset, oral administration, less frequent monitoring and a treatment that can be paused. Understanding patients’ preferences for AD therapies, including new targeted therapies, can aid shared decision-making between clinicians and patients and support health technology assessments.

❌