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How to facilitate NHS professionals to recognise and use skills gained from global health engagement when back in the UK workforce? A participatory action research project to design, pilot and evaluate a series of online leadership workshops

Por: Spowart · L. · Inman · A. C. · Hardy · L. J. · Dillon · M. J.
Objectives

Leadership knowledge and skills are known to be developed by health professionals during global health experiences overseas. However, volunteers struggle to recognise and use these new skills on return to their workplace. A series of bespoke leadership workshops were designed, delivered and evaluated by leadership experts to help enhance the transferability of leadership skills back to the UK National Health Service.

Design

A mixed-methods participatory action research methodology was employed to explore the impact of the workshops. This approach lends itself to a complex, situated project involving multiple partners. Quantitative and qualitative descriptive data were collected via online survey (n=29 participants) and focus groups (n=18 focus groups) and thematically analysed.

Setting

The authors delivered the tailored leadership workshops online to globally engaged National Health Service (NHS) healthcare professionals based in England who had all worked overseas within the past 5 years.

Participants

29 participants attended: 11 medical doctors; 6 nurses/midwives; 10 allied health professionals; 1 NHS manager and 1 student nurse (who was also working as a healthcare assistant).

Results

Participants were able to network both during the large group discussions and while in smaller breakout groups. Data highlighted the substantial benefits obtained from this networking, with 91% of participants reporting it enriched their learning experience, particularly within a multi-disciplinary context, and by having the time and space for facilitated reflection on leadership. Furthermore, 78% agreed that they learned new skills for influencing change beyond their position and 76% reported they could maximise the impact of this change for themselves and their employer. Participants also reported the development of systems and ethical leadership knowledge that they felt they could transfer to their NHS roles.

Conclusions

This study extends explorations of global health experiences by moving beyond the skills gained while working in low-income and middle-income countries. The innovative online leadership workshops gave agency to individuals to recognise and use the skills gained from global health placements on return to the NHS.

UPDATE trial: investigating the effects of ultra-processed versus minimally processed diets following UK dietary guidance on health outcomes: a protocol for an 8-week community-based cross-over randomised controlled trial in people with overweight or obes

Por: Dicken · S. · Makaronidis · J. · van Tulleken · C. · Jassil · F. C. · Hall · K. · Brown · A. C. · Gandini Wheeler-Kingshott · C. A. M. · Fisher · A. · Batterham · R.
Introduction

Obesity increases the risk of morbidity and mortality. A major driver has been the increased availability of ultra-processed food (UPF), now the main UK dietary energy source. The UK Eatwell Guide (EWG) provides public guidance for a healthy balanced diet but offers no UPF guidance. Whether a healthy diet can largely consist of UPFs is unclear. No study has assessed whether the health impact of adhering to dietary guidelines depends on food processing. Furthermore, our study will assess the impact of a 6-month behavioural support programme aimed at reducing UPF intake in people with overweight/obesity and high UPF intakes.

Methods and analysis

UPDATE is a 2x2 cross-over randomised controlled trial with a 6-month behavioural intervention. Fifty-five adults aged ≥18, with overweight/obesity (≥25 to 2), and ≥50% of habitual energy intake from UPFs will receive an 8-week UPF diet and an 8-week minimally processed food (MPF) diet delivered to their home, both following EWG recommendations, in a random order, with a 4-week washout period. All food/drink will be provided. Participants will then receive 6 months of behavioural support to reduce UPF intake. The primary outcome is the difference in weight change between UPF and MPF diets from baseline to week 8. Secondary outcomes include changes in diet, waist circumference, body composition, heart rate, blood pressure, cardiometabolic risk factors, appetite regulation, sleep quality, physical activity levels, physical function/strength, well-being and aspects of behaviour change/eating behaviour at 8 weeks between UPF/MPF diets, and at 6-month follow-up. Quantitative assessment of changes in brain MRI functional resting-state connectivity between UPF/MPF diets, and qualitative analysis of the behavioural intervention for feasibility and acceptability will be undertaken.

Ethics and dissemination

Sheffield Research Ethics Committee approved the trial (22/YH/0281). Peer-reviewed journals, conferences, PhD thesis and lay media will report results.

Trial registration number

NCT05627570

Impacts of armed conflicts on tuberculosis burden and treatment outcomes: a systematic review

Por: Gebreyohannes · E. A. · Wolde · H. F. · Akalu · T. Y. · Clements · A. C. A. · Alene · K. A.
Objectives

This systematic review aimed to summarise existing literature on the impacts of armed conflicts on tuberculosis burden and treatment outcomes.

Design

A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature Plus, Scopus, ScienceDirect, Embase and medRxiv.

Data extraction and synthesis

Three reviewers independently screened, selected eligible studies and extracted data. A narrative review was undertaken to summarise the findings qualitatively.

Results

Eleven studies were included in this review, reporting on tuberculosis incidence rates, prevalence and treatment outcomes, including mortality. Overall, the impact of armed conflicts on case notifications was variable. Six studies reported overall increases in tuberculosis case notifications following the onset of conflicts, while three studies reported overall decreases in tuberculosis case notifications. Factors, including limited access to healthcare services, challenges in surveillance and laboratory confirmation, the destruction of health systems and incapacitating the healthcare workforce, contributed to a decrease in the number of notified cases. The higher tuberculosis notification in some of the studies could be attributed to the disruption of tuberculosis prevention and control programmes as well as increased socioeconomic deprivation, including malnutrition, mass migration, poor living conditions and overcrowding that are worsened during conflicts. Armed conflicts without effective interventions were associated with worse tuberculosis treatment outcomes, including lower proportions of people with treatment success and higher proportions of people with loss to follow-up, mortality and treatment failure. However, implementing various interventions in conflict settings (such as establishing a National Tuberculosis Control Programme) led to higher tuberculosis notification rates and treatment success.

Conclusion

The impact of armed conflicts on tuberculosis notification is complex and is influenced by multiple factors. The findings of this review underscore the importance of concerted efforts to control tuberculosis in conflict settings using available resources.

Association between tuberculosis and pregnancy outcomes: a retrospective cohort study of women in Cape Town, South Africa

Por: Meehan · S.-A. · Hesseling · A. C. · von Delft · A. · Marx · F. M. · Hughes · J. A. · Bock · P. · Banke-Thomas · A. · Dunbar · R. · Phelanyane · F. · Smith · M. · Osman · M.
Background

Tuberculosis (TB) remains a leading cause of mortality among women of childbearing age and a significant contributor to maternal mortality. Pregnant women with TB are at high risk of adverse pregnancy outcomes. This study aimed to determine risk factors for an adverse pregnancy outcome among pregnant women diagnosed with TB.

Methods

Using TB programmatic data, this retrospective cohort analysis included all women who were routinely diagnosed with TB in the public sector between October 2018 and March 2020 in two health subdistricts of Cape Town, and who were documented to be pregnant during their TB episode. Adverse pregnancy outcome was defined as either a live birth of an infant weighing

Results

Of 248 pregnant women, half (52%) were living with HIV; all were on antiretroviral therapy at the time of their TB diagnosis. Pregnancy outcomes were documented in 215 (87%) women, of whom 74 (34%) had an adverse pregnancy outcome. Being older (35–44 years vs 25–34 years (adjusted OR (aOR): 3.99; 95% CI: 1.37 to 11.57), living with HIV (aOR: 2.72; 95% CI: 0.99 to 4.63), having an unfavourable TB outcome (aOR: 2.29; 95% CI: 1.03 to 5.08) and having presented to antenatal services ≤1 month prior to delivery (aOR: 10.57; 95% CI: 4.01 to 27.89) were associated with higher odds of an adverse pregnancy outcome.

Conclusions

Pregnancy outcomes among women with TB were poor, irrespective of HIV status. Pregnant women with TB are a complex population who need additional support prior to, during and after TB treatment to improve TB treatment and pregnancy outcomes. Pregnancy status should be considered for inclusion in TB registries.

RECITAL: a non-inferiority randomised control trial evaluating a virtual fracture clinic compared with in-person care for people with simple fractures (study protocol)

Por: Teng · M. J. · Zadro · J. R. · Pickles · K. · Copp · T. · Shaw · M. J. · Khoudair · I. · Horsley · M. · Warnock · B. · Hutchings · O. R. · Petchell · J. F. · Ackerman · I. N. · Drayton · A. · Liu · R. · Maher · C. G. · Traeger · A. C.
Introduction

Most simple undisplaced fractures can be managed without surgery by immobilising the limb with a splint, prescribing medication for pain, and providing advice and early rehabilitation. Recent systematic reviews based on retrospective observational studies have reported that virtual fracture clinics can deliver follow-up care that is safe and cost-effective. However, no randomised controlled trial has investigated if a virtual fracture clinic can provide non-inferior physical function outcomes compared with an in-person clinic for patients with simple fractures.

Methods and analysis

312 participants will be recruited from 2 metropolitan hospitals located in Sydney, Australia. Adult patients will be eligible if they have an acute simple fracture that can be managed with a removable splint and is deemed appropriate for follow-up at either the virtual or in-person fracture clinic by an orthopaedic doctor. Patients will not be eligible if they have a complex fracture that requires a cast or surgery. Eligible participants will be randomised to receive their follow-up care either at the virtual or the in-person fracture clinic. Participants at the virtual fracture clinic will be reviewed within 5 days of receiving a referral through video calls with a physiotherapist. Participants at the in-person fracture clinic will be reviewed by an orthopaedic doctor within 7–10 days of receiving a referral. The primary outcome will be the patient’s function measured using the Patient-Specific Functional Scale at 12 weeks. Secondary outcomes will include health-related quality of life, patient-reported experiences, pain, health cost, healthcare utilisation, medication use, adverse events, emergency department representations and surgery.

Ethics and dissemination

The study has been approved by the Sydney Local Health District Ethics Review Committee (RPAH Zone) (X23-0200 and 2023/ETH01038). The trial results will be submitted for publication in a reputable international journal and will be presented at professional conferences.

Trial registration number

ACTRN12623000934640.

Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study

Por: Rodrigues · C. B. · Soares · P. N. C. · Schmitt · A. C. B. · Sacco · I. C. N.
Introduction

Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.

Methods and analysis

This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.

Ethics and dissemination

This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.

Trial registration number

NCT05639478.

Burden of drug-resistant tuberculosis among contacts of index cases: a protocol for a systematic review

Por: Akalu · T. Y. · Clements · A. C. A. · Gebreyohannes · E. A. · Wolde · H. F. · Shiferaw · F. W. · Alene · K. A.
Introduction

People having close contact with drug-resistant tuberculosis (DR-TB) patients are at increased risk of contracting and developing the disease. However, no comprehensive review has been undertaken to estimate the burden of DR-TB among contacts of DR-TB patients. Therefore, the current systematic review will quantify the prevalence and incidence of DR-TB among contacts of DR-TB patients.

Method and analysis

Systematic searches will be conducted in Medline, Embase, Web of Science, Scopus, Cochrane Central Register of Controlled trials (CENTRAL) and Cumulative Index to Nursing and Allied Health Literature (CINHAL) databases. The search will be conducted without restrictions on time, language and geography. A random-effects meta-analysis will be conducted for effect estimates. The pooled prevalence and incidence of DR-TB will be compared between people with and without contact with DR-TB patients. The presence of heterogeneity between studies will be assessed by Higgins I2 statistics. Subgroup analysis will be conducted to determine the source of heterogeneity. The risk of bias will be assessed using a visual inspection of the funnel plot and Egger’s regression test statistics. Trim and fill analysis will be done in the presence of publication bias. A sensitivity analysis will be conducted by trimming low-quality studies. The systematic review will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines.

Ethics and dissemination

Ethical approval will not be required for this study as it will be a systematic review and meta-analysis based on previously published evidence. The findings of the systematic review will be presented at scientific conferences and published in scientific journals.

Protocol registration

The protocol is published in PROSPERO with registration number CRD42023390339.

Seroprevalence of anti-SARS-CoV-2 antibodies and risk of viral exposure among healthcare workers in the South Kivu province, eastern Democratic Republic of the Congo: a cross-sectional study

Por: Chasinga · T. B. · Cikwanine · J.-P. B. · Kribi · S. · Yoyu · J. T. · Hofmann · N. · Grossegesse · M. · Nitsche · A. · Tomczyk · S. · Vietor · A. C. · Leendertz · F. H. · Eckmanns · T. · Kusinza · A. B. · Munguakonkwa · E. · Kalk · A. · Raha · M. · Kambale · N. S. · Ayagirwe · R. B. · Sc
Objectives

Healthcare workers (HCWs) are on the frontline of combating COVID-19, hence are at elevated risk of contracting an infection with SARS-CoV-2. The present study aims to measure the impact of SARS-CoV-2 on HCWs in central sub-Saharan Africa.

Setting

A cross-sectional serological study was conducted at six urban and five rural hospitals during the first pandemic wave in the South Kivu province, Democratic Republic of the Congo (DRC).

Participants

Serum specimens from 1029 HCWs employed during the first pandemic wave were collected between August and October 2020, and data on demographics and work-related factors were recorded during structured interviews.

Primary and secondary outcome measures

The presence of IgG antibodies against SARS-CoV-2 was examined by ELISA. Positive specimens were further tested using a micro-neutralisation assay. Factors driving SARS-CoV-2 seropositivity were assessed by multivariable analysis.

Results

Overall SARS-CoV-2 seroprevalence was high among HCWs (33.1%), and significantly higher in urban (41.5%) compared with rural (19.8%) hospitals. Having had presented with COVID-19-like symptoms before was a strong predictor of seropositivity (31.5%). Personal protective equipment (PPE, 88.1% and 11.9%) and alcohol-based hand sanitizer (71.1% and 28.9%) were more often available, and hand hygiene was more often reported after patient contact (63.0% and 37.0%) in urban compared with rural hospitals, respectively. This may suggest that higher exposure during non-work times in high incidence urban areas counteracts higher work protection levels of HCWs.

Conclusions

High SARS-CoV-2 seropositivity indicates widespread transmission of the virus in this region of DRC. Given the absence of publicly reported cases during the same time period at the rural sites, serological studies are very relevant in revealing infection dynamics especially in regions with low diagnostic capacities. This, and discrepancies in the application of PPE between urban and rural sites, should be considered in future pandemic response programmes.

Effects of transcranial direct current stimulation combined with Pilates-based exercises in the treatment of chronic low back pain in outpatient rehabilitation service in Brazil: double-blind randomised controlled trial protocol

Por: da Silva · A. A. C. · Gomes · S. R. A. · do Nascimento · R. M. · Fonseca · A. K. · Pegado · R. · Souza · C. G. · Macedo · L. d. B.
Introduction

Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors; thus, treatments to reduce symptoms are important to improve the quality of life of this population. We aimed to evaluate the effects of transcranial direct current stimulation (tDCS) combined with Pilates-based exercises compared with sham stimulation on pain, quality of life and disability in patients with chronic non-specific low back pain.

Methods and analysis

This is a protocol for a double-blind randomised controlled trial with participants, outcome assessor and statistician blinded. We will include 36 individuals with a history of non-specific chronic low back pain for more than 12 weeks and minimum pain intensity of 3 points on the Numerical Pain Rating Scale. Individuals will be randomised into two groups: (1) active tDCS combined with Pilates-based exercises and (2) sham tDCS combined with Pilates-based exercises. Three weekly sessions of the protocol will be provided for 4 weeks, and individuals will be submitted to three assessments: the first (T0) will be performed before the intervention protocol, the second (T1) immediately after the intervention protocol and the third (T2) will be a follow-up 1 month after the end of the intervention. We will assess pain, disability, central sensitisation, quality of life, pressure pain threshold, global impression of change, adverse events and medication use. The Numerical Pain Rating Scale and the Roland-Morris Disability Questionnaire will be used at T1 to assess pain and disability, respectively, as primary outcome measures.

Ethics and dissemination

This trial was prospectively registered in ClinicalTrials.gov website and ethically approved by the Ethics and Research Committee of the Faculty of Health Sciences of Trairi (report number: 5.411.244) before data collection. We will publish the results in a peer-reviewed medical journal and on institution websites.

Trial registration number

ClinicalTrials.gov (NCT05467566).

Implementation of a Scalable Online Weight Management Programme in Clinical Settings: Protocol for the PROPS 2.0 Programme (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0)

Por: Cho · J. · Noonan · S. H. · Fay · R. · Apovian · C. M. · McCarthy · A. C. · Blood · A. J. · Samal · L. · Fisher · N. · Orav · J. E. · Plutzky · J. · Block · J. P. · Bates · D. W. · Rozenblum · R. · Tucci · M. · McPartlin · M. · Gordon · W. J. · McManus · K. D. · Morrison-Deutsch · C. · Sci
Introduction

There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers.

Methods and analysis

We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women’s Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25–29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation.

Ethics and dissemination

The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future.

Trial registration number

NCT0555925.

Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Por: Mandetta · A. R. H. · Bortoletto · C. C. · Sobral · A. P. T. · Goncalves · M. L. L. · Motta · L. J. · Horliana · A. C. R. T. · Ferrari · R. A. M. · Prates · R. A. · Deana · A. M. · Cordeiro · R. d. C. L. · Pinto · L. A. M. d. S. · Fernandes · K. P. S. · Bussadori · S. K.
Introduction

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Methods and analysis

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the 2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

Trial registration number

NCT05443035.

Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study

Por: Tsantila · F. · Coppens · E. · De Witte · H. · Arensman · E. · Aust · B. · Pashoja · A. C. · Corcoran · P. · Cully · G. · De Winter · L. · Doukani · A. · Dushaj · A. · Fanaj · N. · Griffin · E. · Hogg · B. · Holland · C. · Leduc · C. · Leduc · M. · Mathieu · S. · Maxwell · M. · Ni Dhalaigh
Background

According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices.

Objectives

This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace.

Method

The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance.

Results

Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19.

Conclusions

The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity.

Trial registration number

ISRCTN14582090.

Development and validation of a risk prediction model for pulmonary tuberculosis among presumptive tuberculosis cases in Ethiopia

Por: Wolde · H. F. · Clements · A. C. A. · Alene · K. A.
Background

Early diagnosis and treatment of tuberculosis (TB) is one of the key strategies to achieve the WHO End TB targets. This study aimed to develop and validate a simple, convenient risk score to diagnose pulmonary TB among presumptive TB cases.

Methods

This prediction model used Ethiopian national TB prevalence survey data and included 5459 presumptive TB cases from all regions of Ethiopia. Logistic regression was used to determine which variables are predictive of pulmonary TB. A risk prediction model was developed, incorporating significant variables (p

Results

Of total participants, 94 (1.7%) were confirmed to have TB. The final prediction model included three factors with different scores: (1) TB contact history, (2) chest X-ray (CXR) abnormality and (3) two or more symptoms of TB. The optimal cut-off point for the risk score was 6 and was found to have a good discrimination accuracy (c-statistic=0.70, 95% CI: 0.65 to 0.75). The risk score has sensitivity of 51.1%, specificity of 79.9%, positive predictive value of 4.3% and negative predictive value of 98.9%. After internal validation, the optimism coefficient was 0.003, which indicates the model is internally valid.

Conclusion

We developed a risk score that combines TB contact, number of TB symptoms and CXR abnormality to estimate individual risk of pulmonary TB among presumptive TB cases. Though the score is easy to calculate and internally validated, it needs external validation before widespread implementation in a new setting.

Effectiveness, acceptability, and completeness and quality of intervention reporting of psychological interventions for people with dementia or mild cognitive impairment: protocol for a mixed-methods systematic review

Por: Svedin · F. · Blomberg · O. · Farrand · P. · Brantnell · A. · von Essen · L. · Aberg · A. C. · Woodford · J.
Introduction

Mental health difficulties such as anxiety and depression have negative impacts on psychological well-being and are common in people with dementia and mild cognitive impairment. However, access to psychological treatments is limited. This mixed-method systematic review will: (1) examine the effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment; (2) examine the effectiveness of these psychological interventions to improve mental health and psychological well-being in informal caregivers; (3) examine potential clinical and methodological moderators associated with effectiveness; (4) explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders; and (5) examine the completeness and quality of intervention reporting.

Methods and analysis

Electronic databases (ASSIA, CENTRAL, CINAHL, EMBASE, PsycINFO and MEDLINE) will be systematically searched and supplemented with expert contact, reference and citation checking, and grey literature searches. If possible, we will conduct a meta-analysis to examine the overall effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment and their informal caregivers; and examine potential clinical and methodological moderators associated with effectiveness. We will conduct a deductive framework synthesis, informed by the theoretical framework of acceptability, to explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders. In accordance with Joanna Briggs Institute guidance, we will adopt a convergent segregated approach to data synthesis and integration of quantitative and qualitative findings. We will examine the completeness and quality of intervention reporting according to the Template for Intervention Description and Replication checklist and guide.

Ethics and dissemination

No primary data will be collected, and therefore, ethical approval is not required. Results will be disseminated through a peer-reviewed publication, academic conferences, and plain language summaries.

PROSPERO registration number

CRD42023400514.

Cost-effectiveness analysis of probiotic peanut oral immunotherapy (PPOIT) versus placebo in Australian children with peanut allergy alongside a randomised trial

Por: Huang · L. · Dalziel · K. · Lloyd · M. · Loke · P. · Lozinsky · A. C. · Tang · M.
Objective

To compared the cost-effectiveness of coadministration of a probiotic adjuvant with peanut oral immunotherapy (PPOIT) with placebo (no treatment) in children with peanut allergy.

Design

Prospectively planned cost-effectiveness analysis alongside a randomised control trial.

Setting

The Royal Children’s Hospital, Melbourne, Australia.

Participants

56 children with peanut allergy aged 1–10 years at recruitment.

Intervention

A daily dose of probiotic Lactobacillus rhamnosus CGMCC 1.3724 (NCC4007) and peanut oral immunotherapy administered for 1.5 years.

Main outcomes measures

Costs were considered from a healthcare system perspective and included costs of treatment delivery and adverse events. Effectiveness outcomes included rate of sustained unresponsiveness (SU) and quality-adjusted life years (QALYs). The cost-effectiveness of PPOIT versus placebo was analysed using patient-level data. Time horizon was 10 years from commencement of PPOIT treatment, comprising 1.5 years of treatment (actual data), 4 years of post-treatment follow-up (actual data), and 4.5 years of extrapolation thereafter (modelling).

Results

Healthcare cost per patient over 10 years was higher for PPOIT compared with placebo ($A9355 vs $A1031, p

Conclusions

Cost per QALY gained using PPOIT compared with no treatment is approximately $A20 000 (£10 000) and is well below the conventional value judgement threshold of $A50 000 (£25 000) per QALY gained, thus deemed good value for money ($A1= £0.5 approximately).

Trial registration number

Australian New Zealand Clinical Trials Registry ACTRN12608000594325; Post-results.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK

Por: Walsh · T. S. · Aitken · L. M. · McKenzie · C. A. · Boyd · J. · Macdonald · A. · Giddings · A. · Hope · D. · Norrie · J. · Weir · C. · Parker · R. A. · Lone · N. I. · Emerson · L. · Kydonaki · K. · Creagh-Brown · B. · Morris · S. · McAuley · D. F. · Dark · P. · Wise · M. P. · Gordon · A. C.
Introduction

Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.

Methods and analysis

Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of –2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.

The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.

Ethics and dissemination

The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.

Trial registration number

ClinicalTrials.gov NCT03653832.

Does atrial fibrillation affect prognosis in hospitalised COVID-19 patients? A multicentre historical cohort study in the Netherlands

Por: Spruit · J. R. · Jansen · R. W. M. M. · de Groot · J. R. · de Vries · T. A. C. · Hemels · M. E. W. · Douma · R. A. · de Haan · L. R. · Brinkman · K. · Moeniralam · H. S. · de Kruif · M. · Dormans · T. · Appelman · B. · Reidinga · A. C. · Rusch · D. · Gritters van den Oever · N. C.
Objectives

The aim of this multicentre COVID-PREDICT study (a nationwide observational cohort study that aims to better understand clinical course of COVID-19 and to predict which COVID-19 patients should receive which treatment and which type of care) was to determine the association between atrial fibrillation (AF) and mortality, intensive care unit (ICU) admission, complications and discharge destination in hospitalised COVID-19 patients.

Setting

Data from a historical cohort study in eight hospitals (both academic and non-academic) in the Netherlands between January 2020 and July 2021 were used in this study.

Participants

3064 hospitalised COVID-19 patients >18 years old.

Primary and secondary outcome measures

The primary outcome was the incidence of new-onset AF during hospitalisation. Secondary outcomes were the association between new-onset AF (vs prevalent or non-AF) and mortality, ICU admissions, complications and discharge destination, performed by univariable and multivariable logistic regression analyses.

Results

Of the 3064 included patients (60.6% men, median age: 65 years, IQR 55–75 years), 72 (2.3%) patients had prevalent AF and 164 (5.4%) patients developed new-onset AF during hospitalisation. Compared with patients without AF, patients with new-onset AF had a higher incidence of death (adjusted OR (aOR) 1.71, 95% CI 1.17 to 2.59) an ICU admission (aOR 5.45, 95% CI 3.90 to 7.61). Mortality was non-significantly different between patients with prevalent AF and those with new-onset AF (aOR 0.97, 95% CI 0.53 to 1.76). However, new-onset AF was associated with a higher incidence of ICU admission and complications compared with prevalent AF (OR 6.34, 95% CI 2.95 to 13.63, OR 3.04, 95% CI 1.67 to 5.55, respectively).

Conclusion

New-onset AF was associated with an increased incidence of death, ICU admission, complications and a lower chance to be discharged home. These effects were far less pronounced in patients with prevalent AF. Therefore, new-onset AF seems to represent a marker of disease severity, rather than a cause of adverse outcomes.

Burden, determinants, consequences and care of multimorbidity in rural and urbanising Telangana, India: protocol for a mixed-methods study within the APCAPS cohort

Por: Lieber · J. · Banjara · S. K. · Mallinson · P. A. C. · Mahajan · H. · Bhogadi · S. · Addanki · S. · Birk · N. · Song · W. · Shah · A. S. · Kurmi · O. · Iyer · G. · Kamalakannan · S. · Kishore Galla · R. · Sadanand · S. · Dasi · T. · Kulkarni · B. · Kinra · S.
Introduction

The epidemiological and demographic transitions are leading to a rising burden of multimorbidity (co-occurrence of two or more chronic conditions) worldwide. Evidence on the burden, determinants, consequences and care of multimorbidity in rural and urbanising India is limited, partly due to a lack of longitudinal and objectively measured data on chronic health conditions. We will conduct a mixed-methods study nested in the prospective Andhra Pradesh Children and Parents’ Study (APCAPS) cohort to develop a data resource for understanding the epidemiology of multimorbidity in rural and urbanising India and developing interventions to improve the prevention and care of multimorbidity.

Methods and analysis

We aim to recruit 2100 APCAPS cohort members aged 45+ who have clinical and lifestyle data collected during a previous cohort follow-up (2010–2012). We will screen for locally prevalent non-communicable, infectious and mental health conditions, alongside cognitive impairments, disabilities and frailty, using a combination of self-reported clinical diagnosis, symptom-based questionnaires, physical examinations and biochemical assays. We will conduct in-depth interviews with people with varying multimorbidity clusters, their informal carers and local healthcare providers. Deidentified data will be made available to external researchers.

Ethics and dissemination

The study has received approval from the ethics committees of the National Institute of Nutrition and Indian Institute of Public Health Hyderabad, India and the London School of Hygiene and Tropical Medicine, UK. Meta-data and data collection instruments will be published on the APCAPS website alongside details of existing APCAPS data and the data access process (www.lshtm.ac.uk/research/centres-projects-groups/apcaps).

Staff perceptions towards virtual reality-motivated treadmill exercise for care home residents: a qualitative feedback study with key stakeholders and follow-up interview with technology developer

Por: Bradwell · H. L. · Cooper · L. · Edwards · K. J. · Baxter · R. · Tomaz · S. A. · Ritchie · J. · Gaudl · S. · Veliz-Reyes · A. · Ryde · G. C. · Krizaj · T. · Warren · A. · Chatterjee · A. · Willis · K. · Haynes · R. · Hennessy · C. H. · Whittaker · A. C. · Asthana · S. · Jones · R. B. · On
Objectives

Health and care resources are under increasing pressure, partly due to the ageing population. Physical activity supports healthy ageing, but motivating exercise is challenging. We aimed to explore staff perceptions towards a virtual reality (VR) omnidirectional treadmill (MOTUS), aimed at increasing physical activity for older adult care home residents.

Design

Interactive workshops and qualitative evaluation.

Settings

Eight interactive workshops were held at six care homes and two university sites across Cornwall, England, from September to November 2021.

Participants

Forty-four staff participated, including care home, supported living, clinical care and compliance managers, carers, activity coordinators, occupational therapists and physiotherapists.

Interventions

Participants tried the VR treadmill system, followed by focus groups exploring device design, potential usefulness or barriers for care home residents. Focus groups were audio-recorded, transcribed verbatim and thematically analysed. We subsequently conducted a follow-up interview with the technology developer (September 2022) to explore the feedback impact.

Results

The analysis produced seven key themes: anticipated benefits, acceptability, concerns of use, concerns of negative effects, suitability/unsuitability, improvements and current design. Participants were generally positive towards VR to motivate care home residents’ physical activity and noted several potential benefits (increased exercise, stimulation, social interaction and rehabilitation). Despite the reported potential, staff had safety concerns for frail older residents due to their standing position. Participants suggested design improvements to enhance safety, usability and accessibility. Feedback to the designers resulted in the development of a new seated VR treadmill to address concerns about falls while maintaining motivation to exercise. The follow-up developer interview identified significant value in academia–industry collaboration.

Conclusion

The use of VR-motivated exercise holds the potential to increase exercise, encourage reminiscence and promote meaningful activity for care home residents. Staff concerns resulted in a redesigned seated treadmill for those too frail to use the standing version. This novel study demonstrates the importance of stakeholder feedback in product design.

Determinants of practice for providing decision coaching to facilitate informed values-based decision-making: protocol for a mixed-methods systematic review

Por: Berger-Höger · B. · Lewis · K. B. · Cherry · K. · Finderup · J. · Gunderson · J. · Kaden · J. · Kienlin · S. · Rahn · A. C. · Sikora · L. · Stacey · D. · Steckelberg · A. · Zhao · J.
Introduction

Decision coaching is a non-directive approach to support patients to prepare for making health decisions. It is used to facilitate patients’ involvement in informed values-based decision-making and use of evidence-based health information. A recent systematic review revealed low certainty evidence for its effectiveness with and without evidence-based information. However, there may be opportunities to improve the study and use of decision coaching in clinical practice by systematically investigating its determinants of practice. We aim to conduct a systematic review to identify and synthesise the determinants of practice for providing decision coaching to facilitate patient involvement in decision-making from multiple perspectives that influence its use.

Methods and analysis

We will conduct a mixed-methods systematic review guided by the Cochrane’ Handbook of Systematic Reviews. We will include studies reporting determinants of practice influencing decision coaching with or without evidence-based patient information with adults making a health decision for themselves or a family member. Systematic literature searches will be conducted in Medline, EMBASE, Cochrane CENTRAL and PsycINFO via Ovid and CINAHL via EBSCO including quantitative, qualitative and mixed-methods study designs. Additionally, experts in the field will be contacted.

Two reviewers will independently screen and extract data. We will synthesise determinants using deductive and inductive qualitative content analysis and a coding frame developed specifically for this review based on a taxonomy of barriers and enablers of shared decision-making mapped onto the major domains of the Consolidated Framework for Implementation Research. We will assess the quality of included studies using the Mixed Methods Appraisal Tool.

Ethics and dissemination

Ethical approval is not required as this systematic review involves only previously published literature. The results will be published in a peer-reviewed journal, presented at scientific conferences and disseminated to relevant consumer groups.

PROSPERO registration number

CRD42022338299.

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