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Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Por: 't Hart · J. W. H. · Noordman · B. J. · Palsgraaf-Huisbrink · J. · Dunkelgrun · M. · Zengerink · H. F. · Birnie · E. · van Det · M. J. · Boerma · E.-J. G. · de Castro · S. M. M. · Hazebroek · E. J. · Langenhoff · B. S. · Verhoef · C. · Apers · J. A.
Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial

Por: Gomber · A. · Valeta · F. · Coates · M. M. · Trujillo · C. · Ferrari · G. · Boti · M. · Kumwenda · K. · Mailosi · B. · Nakotwa · D. · Drown · L. · Wroe · E. B. · Thapa · A. · Mithi · V. · Matanje · B. · Msekandiana · A. · Park · P. H. · Kachimanga · C. · Bukhman · G. · Ruderman · T. · Adler
Objectives

To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes.

Design

A 2:1 open randomised controlled feasibility trial.

Setting

Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi.

Participants

45 people living with type 1 diabetes (PLWT1D).

Interventions

Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education.

Outcomes

Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life.

Results

Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention.

Conclusions

This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge.

Trial registration number

PACTR202102832069874.

COS-PPA: protocol to develop a core outcome set for primary progressive aphasia

Por: Volkmer · A. · Copland · D. A. · Henry · M. L. · Warren · J. D. · Varley · R. · Wallace · S. J. · Hardy · C. J.
Introduction

The term primary progressive aphasia (PPA) describes a group of language-led dementias. Disease-modifying treatments that delay, slow or reverse progression of PPA are currently lacking, though a number of interventions to manage the symptoms of PPA have been developed in recent years. Unfortunately, studies exploring the effectiveness of these interventions have used a variety of different outcome measures, limiting comparability. There are more constructs, apart from word retrieval, that are important for people with PPA that have not received much attention in the research literature. Existing core outcome sets (COS) for dementia and non-progressive aphasia do not meet the needs of people with PPA, highlighting a need to develop a specific COS for PPA.

Methods and analysis

This protocol describes a three-stage study to identify a COS for PPA interventions in research and clinical practice. The stage 1 systematic review will identify existing speech, language and communication measures used to examine the effectiveness of interventions for PPA in the research literature. Employing a nominal group technique, stage 2 will identify the most important outcomes for people with PPA and their families. The data collected in stages 1 and 2 will be jointly analysed with the project PPI group and will inform the stage 2 modified Delphi consensus study to identify a core outcome measurement set for PPA among a range of research disciplines undertaking intervention studies for people with PPA.

Ethics and dissemination

Ethical approval for stage 2 of the study has been sought individually in each country at collaborating institutions and is stated in detail in the manuscript. Stage 3 has been granted ethical approval by the Chairs of UCL Language and Cognition Department Ethics, Project ID LCD-2023-06. Work undertaken at stages 1, 2 and 3 will be published in open-access peer-reviewed journal articles and presented at international scientific conferences.

PROSPERO registration number

CRD42022367565.

Factors influencing optimal diabetes care and clinical outcomes in Thai patients with type 2 diabetes mellitus: a multilevel modelling analysis

Por: Surawit · A. · Pongkunakorn · T. · Manosan · T. · Mongkolsucharitkul · P. · Chamnan · P. · Suvarnabhumi · K. · Puangpet · T. · Suta · S. · Pumeiam · S. · Pinsawas · B. · Ophakas · S. · Pisitpornsuk · S. · Utchin · C. · Mayurasakorn · K.
Background

Increasing levels of poor glycaemic control among Thai patients with type 2 diabetes mellitus (T2DM) motivated us to compare T2DM care between urban and suburban primary care units (PCUs), to identify gaps in care, and to identify significant factors that may influence strategies to enhance the quality of care and clinical outcomes in this population.

Methods

We conducted a cross-sectional study involving 2160 patients with T2DM treated at four Thai PCUs from 2019 to 2021, comprising one urban and three suburban facilities. Using mixed effects logistic regression, we compared care factors between urban and suburban PCUs.

Results

Patients attending suburban PCUs were significantly more likely to undergo eye (adjusted OR (AOR): 1.83, 95% CI 1.35 to 1.72), foot (AOR: 1.61, 95% CI 0.65 to 4.59) and HbA1c (AOR: 1.66, 95% CI 1.09 to 2.30) exams and achieved all ABC (HbA1c, blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C)) goals (AOR: 2.23, 95% CI 1.30 to 3.83). Conversely, those at an urban PCU were more likely to undergo albuminuria exams. Variables significantly associated with good glycaemic control included age (AOR: 1.51, 95% CI 1.31 to 1.79), T2DM duration (AOR: 0.59, 95% CI 0.41 to 0.88), FAACE (foot, HbA1c, albuminuria, LDL-C and eye) goals (AOR: 1.23, 95% CI 1.12 to 1.36) and All8Q (AOR: 1.20, 95% CI 1.05 to 1.41). Chronic kidney disease (CKD) was significantly linked with high triglyceride and HbA1c levels (AOR: 5.23, 95% CI 1.21 to 7.61). Elevated HbA1c levels, longer T2DM duration, insulin use, high systolic BP and high lipid profile levels correlated strongly with diabetic retinopathy (DR) and CKD progression.

Conclusion

This highlights the necessity for targeted interventions to bridge urban–suburban care gaps, optimise drug prescriptions and implement comprehensive care strategies for improved glycaemic control, DR prevention and CKD progression mitigation among in Thai patients with T2DM. The value of the clinical target aggregate (ABC) and the process of care aggregate (FAACE) was also conclusively demonstrated.

How effective is topical miconazole or amorolfine for mild to moderately severe onychomycosis in primary care: the Onycho Trial - a randomised double-blind placebo-controlled trial

Por: Watjer · R. M. · Bonten · T. N. · Sayed · K. · Quint · K. D. · van der Beek · M. T. · Mertens · B. J. A. · Numans · M. E. · Eekhof · J. A. H.
Objectives

To evaluate the efficacy of topical miconazole or amorolfine compared to placebo for mild to moderately severe onychomycosis.

Design

Randomised, double-blind, placebo-controlled trial, with computer-generated treatment allocation at a 1:1:1 ratio.

Setting

Primary care, recruitment from February 2020 to August 2022.

Participants

193 patients with suspected mild to moderately severe onychomycosis were recruited via general practices and from the general public, 111 of whom met the study criteria. The mean age of participants was 51 (SD 13.1), 51% were female and onychomycosis was moderately severe (mean OSI 12.1 (SD 8.0)).

Interventions

Once-daily miconazole 20 mg/g or once-weekly amorolfine 5% nail lacquer solution was compared with placebo (denatonium benzoate solution).

Main outcome measures

Complete, clinical and mycological cure at 6 months. Secondary outcomes were clinical improvement, symptom burden, quality of life, adverse effects, compliance, patient-perceived improvement and treatment acceptability.

Results

Based on intention-to-treat analysis, none of the participants receiving miconazole or amorolfine reached complete cure compared with two in the placebo group (OR not estimable (n.e.), p=0.493 and OR n.e., p=0.240, respectively). There was no evidence of a significant difference between groups regarding clinical cure (OR n.e., p=0.493 and OR 0.47, 95% CI 0.04 to 5.45, p=0.615) while miconazole and amorolfine were less effective than placebo at reaching both mycological cure (OR 0.25, 95% CI 0.06 to 0.98, p=0.037 and OR 0.23, 95% CI 0.06 to 0.92, p=0.029, respectively) and clinical improvement (OR 0.26, 95% CI 0.08 to 0.91, p=0.028 and OR 0.25, 95% CI 0.07 to 0.85, p=0.021, respectively). There was no evidence of a significant difference in disease burden, quality of life, adverse reactions, compliance, patient-perceived improvement or treatment acceptability.

Conclusions

Topical miconazole and amorolfine were not effective in achieving a complete, clinical or mycological cure of mild to moderately severe onychomycosis, nor did they significantly alleviate the severity or symptom burden. These treatments should, therefore, not be advised as monotherapy to treat onychomycosis.

Trial registration number

WHO ICTRP NL8193.

Hospital at home for elderly acute patients: a study protocol for a randomised controlled trial

Por: Thomsen · A. M. L. · Tayyari · N. · Duvald · I. · Kirkegaard · H. · Obel · B. · Nielsen · C. P.
Introduction

The increasing elderly population has led to a growing demand for healthcare services. A hospital at home treatment model offers an alternative to standard hospital admission, with the potential to reduce readmission and healthcare consumption while improving patients’ quality of life. However, there is little evidence regarding hospital at home treatment in a Danish setting. This article describes the protocol for a randomised controlled trial (RCT) comparing standard hospital admission to hospital at home treatment. The main aim of the intervention is to reduce 30-day acute readmission after discharge and improve the quality of life of elderly acute patients.

Methods and analysis

A total of 849 elderly acute patients will be randomised in a 1:2 ratio to either the control or intervention group in the trial. The control group will receive standard hospital treatment in a hospital emergency department while the intervention group will receive treatment at home. The primary outcomes of the trial are the rate of 30-day acute readmission and quality of life, assessed using the European Quality of Life-5 Dimensions-5-Level instrument. Primary analyses are based on the intention-to-treat principle. Secondary outcomes are basic functional mobility, resource use in healthcare, primary and secondary healthcare cost, incremental cost-effectiveness ratio, and the mortality rate 3 months after discharge.

Ethics and dissemination

The RCT was approved by the Ethical Committee, Central Denmark Region (no. 1-10-72-67-20). Results will be presented at relevant national and international meetings and conferences and will be published in international peer-reviewed journals. Furthermore, we plan to communicate the results to relevant stakeholders in the Danish healthcare system.

Trial registration number

NCT05360914.

Chiropractic spinal manipulation and likelihood of tramadol prescription in adults with radicular low back pain: a retrospective cohort study using US data

Por: Trager · R. J. · Cupler · Z. A. · Srinivasan · R. · Casselberry · R. M. · Perez · J. A. · Dusek · J. A.
Objectives

Patients receiving chiropractic spinal manipulation (CSM) for low back pain (LBP) are less likely to receive any opioid prescription for subsequent pain management. However, the likelihood of specifically being prescribed tramadol, a less potent opioid, has not been explored. We hypothesised that adults receiving CSM for newly diagnosed radicular LBP would be less likely to receive a tramadol prescription over 1-year follow-up, compared with those receiving usual medical care.

Design

Retrospective cohort study.

Setting

US medical records-based dataset including >115 million patients attending academic health centres (TriNetX, Inc), queried 9 November 2023.

Participants

Opioid-naive adults aged 18–50 with a new diagnosis of radicular LBP were included. Patients with serious pathology and tramadol use contraindications were excluded. Variables associated with tramadol prescription were controlled via propensity matching.

Interventions

Patients were divided into two cohorts dependent on treatment received on the index date of radicular LBP diagnosis (CSM or usual medical care).

Primary and secondary outcome measures

Risk ratio (RR) for tramadol prescription (primary); markers of usual medical care utilisation (secondary).

Results

After propensity matching, there were 1171 patients per cohort (mean age 35 years). Tramadol prescription was significantly lower in the CSM cohort compared with the usual medical care cohort, with an RR (95% CI) of 0.32 (0.18 to 0.57; p

Conclusions

This study found that US adults initially receiving CSM for radicular LBP had a reduced likelihood of receiving a tramadol prescription over 1-year follow-up. These findings should be corroborated by a prospective study to minimise residual confounding.

Retrospective study investigating naloxone prescribing and cost in US Medicaid and Medicare patients

Por: Manko · C. D. · Ahmed · M. S. · Harrison · L. R. · Kodavatiganti · S. A. · Lugo · N. · Konadu · J. O. · Khan · F. · Massari · C. A. · Sealey · T. K. · Addison · M. E. · Mbah · C. N. · McCall · K. L. · Fraiman · J. B. · Piper · B. J.
Background

Opioid overdoses in the USA have increased to unprecedented levels. Administration of the opioid antagonist naloxone can prevent overdoses.

Objective

This study was conducted to reveal the pharmacoepidemiologic patterns in naloxone prescribing to Medicaid patients from 2018 to 2021 as well as Medicare in 2019.

Design

Observational pharmacoepidemiologic study

Setting

US Medicare and Medicaid naloxone claims

Intervention

The Medicaid State Drug Utilisation Data File was utilised to extract information on the number of prescriptions and the amount prescribed of naloxone at a national and state level. The Medicare Provider Utilisation and Payment was also utilised to analyse prescription data from 2019.

Outcome measures

States with naloxone prescription rates that were outliers of quartile analysis were noted.

Results

The number of generic naloxone prescriptions per 100 000 Medicaid enrollees decreased by 5.3%, whereas brand naloxone prescriptions increased by 245.1% from 2018 to 2021. There was a 33.1-fold difference in prescriptions between the highest (New Mexico=1809.5) and lowest (South Dakota=54.6) states in 2019. Medicare saw a 30.4-fold difference in prescriptions between the highest (New Mexico) and lowest states (also South Dakota) after correcting per 100 000 enrollees.

Conclusions

This pronounced increase in the number of naloxone prescriptions to Medicaid patients from 2018 to 2021 indicates a national response to this widespread public health emergency. Further research into the origins of the pronounced state-level disparities is warranted.

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Por: Ben · A. J. · van der Vaart · L. R. · E. Bosmans · J. · Roovers · J.-P. W. R. · Lagro-Janssen · A. L. M. · van der Vaart · C. H. · Vollebregt · A. · PEOPLE group · Milani · Bon · Bongers · Bos · Broekman · Dietz · van Eijndhoven · Hakvoort · Janszen · Kluivers · Link · Massop-Hel
Objective

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Design

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

Setting

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

Participants

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Interventions

Pessary therapy and surgery.

Primary and secondary outcome measures

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

Results

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Conclusions

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

Trial registration number

NTR4883.

Is the QCI framework suited for monitoring outcomes and costs in a teaching hospital using value-based healthcare principles? A retrospective cohort study

Por: van Veghel · W. · van Dijk · S. C. · Klem · T. M. · Weel · A. E. · Bügel · J.-B. · Birnie · E.
Objectives

The objective is to develop a pragmatic framework, based on value-based healthcare principles, to monitor health outcomes per unit costs on an institutional level. Subsequently, we investigated the association between health outcomes and healthcare utilisation costs.

Design

This is a retrospective cohort study.

Setting

A teaching hospital in Rotterdam, The Netherlands.

Participants

The study was performed in two use cases. The bariatric population contained 856 patients of which 639 were diagnosed with morbid obesity body mass index (BMI)

Primary and secondary outcome measures

The quality cost indicator (QCI) was the primary measures and was defined as

QCI = (resulting outcome * 100)/average total costs (per thousand Euros)

where average total costs entail all healthcare utilisation costs with regard to the treatment of the primary diagnosis and follow-up care. Resulting outcome is the number of patients achieving textbook outcome (passing all health outcome indicators) divided by the total number of patients included in the care path.

Results

The breast cancer and bariatric population had the highest resulting outcome values in 2020 Q4, 0.93 and 0.73, respectively. The average total costs of the bariatric population remained stable (avg, 8833.55, min 8494.32, max 9164.26). The breast cancer population showed higher variance in costs (avg, 12 735.31 min 12 188.83, max 13 695.58). QCI values of both populations showed similar variance (0.3 and 0.8). Failing health outcome indicators was significantly related to higher hospital-based costs of care in both populations (p

Conclusions

The QCI framework is effective for monitoring changes in average total costs and relevant health outcomes on an institutional level. Health outcomes are associated with hospital-based costs of care.

Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial

Por: Hopewell · S. · Srikesavan · C. · Evans · A. · Er · F. · Rangan · A. · Preece · J. · Francis · A. · Massa · M. S. · Feldmann · M. · Lamb · S. · Nanchahal · J.
Objective

The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder.

Design

Multicentre, randomised feasibility trial, with embedded qualitative study.

Setting

Four UK National Health Service (NHS) musculoskeletal and related physiotherapy services.

Participants

Adults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder.

Interventions

Participants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2–3 weeks later.

Primary feasibility objectives

(1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months.

Results

Between 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%.

Conclusion

This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment.

Trial registration number

ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214).

Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance

Por: Ramboarina · S. · Crucitti · T. · Gill · K. · Bekker · L. G. · Harding-Esch · E. M. · van de Wijgert · J. H. H. M. · Huynh · B.-T. · Fortas · C. · Harimanana · A. · Mayouya Gamana · T. · Randremanana · R. V. · Mangahasimbola · R. · Dziva Chikwari · C. · Kranzer · K. · Mackworth-You
Introduction

A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test—called the Genital InFlammation Test (GIFT)—for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.

Methods and analysis

We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical (‘diagnostic study’) and a qualitative, modelling and economic (‘an integration into care study’) part. The diagnostic study aims to evaluate GIFT’s performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.

Ethics and dissemination

Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.

The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).

Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).

Trial registration number

NCT05723484.

Implementation of a primary-tertiary shared care model to improve the detection of familial hypercholesterolaemia (FH): a mixed methods pre-post implementation study protocol

Por: Birkenhead · K. · Sullivan · D. · Trumble · C. · Spinks · C. · Srinivasan · S. · Partington · A. · Elias · L. · Hespe · C. M. · Fleming · G. · Li · S. · Calder · M. · Robertson · E. · Trent · R. · Sarkies · M. N.
Introduction

Familial hypercholesterolaemia (FH) is an autosomal dominant inherited disorder of lipid metabolism and a preventable cause of premature cardiovascular disease. Current detection rates for this highly treatable condition are low. Early detection and management of FH can significantly reduce cardiac morbidity and mortality. This study aims to implement a primary-tertiary shared care model to improve detection rates for FH. The primary objective is to evaluate the implementation of a shared care model and support package for genetic testing of FH. This protocol describes the design and methods used to evaluate the implementation of the shared care model and support package to improve the detection of FH.

Methods and analysis

This mixed methods pre-post implementation study design will be used to evaluate increased detection rates for FH in the tertiary and primary care setting. The primary-tertiary shared care model will be implemented at NSW Health Pathology and Sydney Local Health District in NSW, Australia, over a 12-month period. Implementation of the shared care model will be evaluated using a modification of the implementation outcome taxonomy and will focus on the acceptability, evidence of delivery, appropriateness, feasibility, fidelity, implementation cost and timely initiation of the intervention. Quantitative pre-post and qualitative semistructured interview data will be collected. It is anticipated that data relating to at least 62 index patients will be collected over this period and a similar number obtained for the historical group for the quantitative data. We anticipate conducting approximately 20 interviews for the qualitative data.

Ethics and dissemination

Ethical approval has been granted by the ethics review committee (Royal Prince Alfred Hospital Zone) of the Sydney Local Health District (Protocol ID: X23-0239). Findings will be disseminated through peer-reviewed publications, conference presentations and an end-of-study research report to stakeholders.

The application of antimicrobial stewardship knowledge to nursing practice: A national survey of United Kingdom pre‐registration nursing students

Abstract

Aim

To assess student nurses understanding and skills in the application of antimicrobial stewardship knowledge to practice.

Design

Quantitative.

Methods

Cross-sectional survey.

Results

Five hundred and twenty three student nurses responded across 23 UK universities. Although students felt prepared in competencies in infection prevention and control, patient-centred care and interprofessional collaborative practice, they felt less prepared in competencies in which microbiological knowledge, prescribing and its effect on antimicrobial stewardship is required. Problem-based learning, activities in the clinical setting and face-to-face teaching were identified as the preferred modes of education delivery. Those who had shared antimicrobial stewardship teaching with students from other professions reported the benefits to include a broader understanding of antimicrobial stewardship, an understanding of the roles of others in antimicrobial stewardship and improved interprofessional working.

Conclusion

There are gaps in student nurses' knowledge of the basic sciences associated with the antimicrobial stewardship activities in which nurses are involved, and a need to strengthen knowledge in pre-registration nurse education programmes pertaining to antimicrobial management, specifically microbiology and antimicrobial regimes and effects on antimicrobial stewardship. Infection prevention and control, patient-centred care and interprofessional collaborative practice are areas of antimicrobial stewardship in which student nurses feel prepared. Interprofessional education would help nurses and other members of the antimicrobial stewardship team clarify the role nurses can play in antimicrobial stewardship and therefore maximize their contribution to antimicrobial stewardship and antimicrobial management.

Implications for the Profession

There is a need to strengthen knowledge from the basic sciences, specifically pertaining to antimicrobial management, in pre-registration nurse education programmes.

Patient or Public Contribution

No patient or public contribution.

Impact

What Problem Did the Study Address?

Nurses must protect health through understanding and applying antimicrobial stewardship knowledge and skills (Nursing and Midwifery Council 2018); however, there is no research available that has investigated nurses understanding and skills of the basic sciences associated with the antimicrobial stewardship activities in which they are involved.

What Were the Main Findings?

There are gaps in student nurses' knowledge of the basic sciences (specifically microbiology and prescribing) associated with the antimicrobial stewardship activities in which nurses are involved. Problem-based learning, and activities in the clinical setting, were reported as useful teaching methods, whereas online learning, was seen as less useful.

Where and on Whom Will the Research Have an Impact?

Pre-registration nurse education programmes.

Reporting Method

The relevant reporting method has been adhered to, that is, STROBE.

Promoting resident thriving in nursing homes: A qualitative study

Abstract

Aim

To explore how staff promote resident thriving in an Australian nursing home.

Design

Qualitative research design using content analysis.

Methods

Interviews were held with 14 nursing staff working in an Australian nursing home in March/April 2018. Data were analysed using qualitative content analysis.

Results

Four themes were revealed: promoting personalized care; promoting opportunities for autonomy; promoting connection and meaning; and promoting a curated environment.

Conclusions

Staff promoted resident thriving in relation to everyday care, activities, capabilities, relationships and the lived environment. Interventions that were perceived to promote thriving were described relative to the nurse, the resident, the care team and the wider nursing home context.

Implications for the Profession and/or Patient Care

The findings provide novel insight into the understanding and application of the concept of thriving in long-term care from nursing staffs' perspective.

Impact

What Problem did the Study Address?

Nursing home staff are uniquely positioned to support resident thriving through person-centred care, yet little is known about how staff support promotion of thriving for nursing home residents in their everyday practice.

What were the Main Findings?

Nursing home staff perceived that they promoted thriving by personalizing care and supporting autonomy, connection, meaning and pleasure for residents.

Where and on Whom will the Research have an Impact?

These findings are of interest for the clinicians, educators and researchers who develop, implement and evaluate interventions to improve place-related well-being in nursing homes.

Reporting Method

CORE-Q checklist.

Patient or Public Contribution

No patient or public contribution occurred for this study as this research focused on exploring staffs' perspectives from the specific viewpoint of their personal experience.

The association of teamwork and missed nursing care in acute care setting: A mixed‐methods systematic review

Abstract

Aim(s)

Teamwork among healthcare professionals is a key aspect of patient safety that influences the prevalence of missed nursing care. The association between teamwork and missed care in acute care hospitals is now well established in the literature. Therefore, this review aimed to synthesise the existing empirical evidence on the association between teamwork and missed care in the acute care setting.

Design

A mixed-method systematic review study.

Methods

The search was carried out in February 2023 in four scientific databases, PubMed, ProQuest, Web of Science and Scopus based on their institutional availability. The search produced 1542 studies. The method of thematic analysis was used in data synthesis.

Results

A total of 18 studies were selected that revealed the relationship between teamwork and missed care. The teamwork score was weak to moderate but significantly associated with the overall score of missed care and was found to be a statistically significant predictor of missed care in an acute care setting. Additionally, teamwork represented an important reason for missed care, primarily in the context of poor communication, lack of trust and cooperation in the nursing team and lack of leadership.

Conclusion

The review findings contribute to a deeper understanding of the intricate dynamics between teamwork and missed care and provide valuable information to healthcare professionals and institutions looking to optimise teamwork and mitigate instances of missed care in the acute care setting.

Implications for the Profession and/or Patient Care

Recognising how teamwork influences the occurrence of missed care, healthcare organisations can strategically implement targeted interventions to enhance collaboration, address communication gaps, foster trust, and provide effective leadership.

Impact

This review suggests that improving teamwork seems to be one of the most important strategies focused on mitigating missed care in acute care settings.

Reporting Method

The reporting of this review followed the PRISMA 2020 checklist.

Patient or Public Contribution

No patient or public contribution.

Relatives' needs in terms of bereavement care throughout euthanasia processes: A qualitative study

Abstract

Aim

To explore relatives' needs in terms of bereavement care during euthanasia processes, how healthcare providers respond to these needs, and the degree of commonality between relatives' and healthcare providers' reports.

Design

A phenomenological design was employed, utilising reflexive thematic analysis to examine interviews conducted with relatives (N = 19) and healthcare providers (N = 47).

Results

Relatives' needs throughout euthanasia processes are presented in five main themes and several subthemes, with similar findings between both sets of participants. Although relatives infrequently communicated their needs explicitly to healthcare providers, they appreciated it when staff proactively met their needs. Healthcare providers aimed to assist with the relatives' grief process by tending to their specific needs. However, aftercare was not consistently offered, but relatives did not have high expectations for professional follow-up care.

Conclusion

Our research offers important directions for healthcare professionals, empowering them to provide needs-based bereavement care during euthanasia processes. Moreover, it emphasises the importance of recognising the unique needs of relatives and proactively addressing them in the period before the loss to positively contribute to relatives' grief process.

Implications for the profession and/or patient care

Insights into relatives' needs in the context of euthanasia. Good practices on how healthcare providers can attend to relatives' needs before, during and after the loss

Impact

Current literature and guidelines on needs-based bereavement care in the context of euthanasia and, more generally, assisted dying, are limited. These findings provide concrete directions for practice in supporting (nearly) bereaved relatives in the context of euthanasia, potentially mitigating adverse health outcomes.

Reporting method

Standards for Reporting Qualitative Research (SRQR checklist).

Patient or Public contribution

Relatives of deceased cancer patients were involved in the conduct of the study.

First‐line managers' experience of guideline implementation during the COVID‐19 pandemic

Abstract

Aim(s)

To explore first-line managers' experience of guideline implementation in orthopaedic care during the COVID-19 pandemic.

Design

A descriptive, qualitative study.

Methods

Semi-structured interviews with 30 first-line nursing and rehabilitation managers in orthopaedic healthcare at university, regional and local hospitals. The interviews were analysed by thematic analysis.

Results

First-line managers described the implementation of guidelines related to the pandemic as different from everyday knowledge translation, with a swifter uptake and time freed from routine meetings in order to support staff in adoption and adherence. The urgent need to address the crisis facilitated guideline implementation, even though there were specific pandemic-related barriers such as staffing and communication issues. An overarching theme, Hanging on to guidelines for dear life, is substantiated by three themes: Adapting to facilitate change, Anchoring safety through guidelines and Embracing COVID guidelines.

Conclusion

A health crisis such as the COVID-19 pandemic can generate enabling elements for guideline implementation in healthcare, despite prevailing or new hindering components. The experience of guideline implementation during the COVID-19 pandemic can improve understanding of context aspects that can benefit organizations in everyday translation of evidence into practice.

Implications for the Profession and/or Patient Care

Recognizing what enabled guideline implementation in a health crisis can help first-line managers to identify local enabling context elements and processes. This can facilitate future guideline implementation.

Impact

During the COVID-19 pandemic, the healthcare context and staff's motivation for guideline recognition and adoption changed. Resources and ways to bridge barriers in guideline implementation emerged, although specific challenges arose. Nursing managers can draw on experiences from the COVID-19 pandemic to support implementation of new evidence-based practices in the future.

Reporting Method

This study adheres to the EQUATOR guidelines by using Standards for Reporting Qualitative Research (SRQR).

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
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