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Severe necrotizing soft tissue infections—Is wound microbiology a prognostic factor for clinical outcome?

Abstract

Necrotizing soft tissue infections (NSTIs) represent similar pathophysiological features, but the clinical course might range from subacute to a rapidly progressive, fulminant sepsis. Initial wound microbiology is the base for the Guiliano classification. The timeline of microbiological colonization has not been described during the clinical course. The role of the different microbiological pathogens on the outcome and mortality is unclear. One hundred eighty patients were included with septic inflammation response syndrome on admission. Initial wound microbiology and the changes in wound microbiology were analysed during the clinical course and correlated with outcome and risk indicators. Overall mortality was 35%. Higher age, a high Charlson Comorbidity Index or ASA score and truncal infections were highly prognostic for a lethal outcome. Microbiological findings revealed significant differences in the persistence of bacteria during the course of disease. Streptococci were only detectable within the first 5 days, whereas other bacteria persisted over a longer period of time. Initial microbiological findings correlated with better prognosis when no causative agent was identified and for gram-negative rods. Varying survival rates were observed for different Streptococci, Staphylococci, Enterococci and other bacteria. The highest odds ratio for a lethal outcome was observed for Enterococci and fungi. Microbiological colonization changes during the clinical course of NSTIs and some microbiologic pathogens are predictive for worsening the outcome and survival. Streptococcus pyogenes is only detectable in the very early phase of NSTI and after 6 days not anymore detectable. Later Enterococci and fungi showed the highest odds ratios for a lethal outcome. Enterococci bacteria and fungi have yet not been considered of clinical relevance in NSTI or even as indicator for worsening the outcome.

The characteristics and acceptance of Technology‐Enabled diabetes prevention programs (t‐DPP) amongst individuals with prediabetes: A scoping review

Abstract

Aim and Objective

As rising global prevalence of diabetes burdens an overstrained healthcare system, it would be prudent to employ primary prevention strategies. This review aims to detail characteristics of technology-enabled diabetes prevention programs (t-DPP) and the technology acceptance amongst prediabetic individuals.

Design

A scoping review.

Review Methods

Summative and direct content analysis.

Data Sources

Seven electronic databases—PubMed, Cochrane, Embase, CINAHL, Scopus, PsycINFO and Web of Science—were searched from inception till 9 June 2022 for primary studies conducted on t-DPP. Initial search identified 2412 unique articles. Removal of duplicates and irrelevant articles resulted in 58 full text articles screened and 17 articles meeting the eligibility criteria. There was no limitation to study type or year of publication, but language was limited to English.

Results

Common t-DPP characteristics include physical activity (n = 17), diet control (n = 16), coaching (n = 12), social support (n = 9) and skills acquisition (n = 12). Technological acceptance of t-DPPs were generally positive as participants found them useful (n = 5) and easy to use (n = 4), with majority of the participants interested (n = 5) and engaging well with it (n = 13). However, personal-, design- and technological-level factors were found to negatively influence t-DPPs acceptance.

Conclusion

This review reported a generally positive technological acceptance. The result encourages remote delivery of diabetes prevention programs, offering researchers a guide to t-DPP development. However, it also highlights the need for integration of behavioural change theories and socio-cultural considerations, with gaps in knowledge amongst men and young adults.

Implications for Nursing

The success of t-DPP can reinforce clinical advice and sustain health behaviours advocated by nurses. Involvement of diabetes-trained nurses would enable continual risk assessment, monitoring and timely intervention to prevent diabetes and potential complications.

Reporting Method

PRISMA-ScR checklist.

Management of acute non-specific low back pain in the emergency department: do emergency physicians follow the guidelines? Results of a cross-sectional survey

Por: Jermini-Gianinazzi · I. · Blum · M. · Trachsel · M. · Trippolini · M. A. · Tochtermann · N. · Rimensberger · C. · Liechti · F. D. · Wertli · M. M.
Objectives

Clinical guidelines for acute non-specific low back pain (LBP) recommend avoiding imaging studies or invasive treatments and to advise patients to stay active. The aim of this study was to evaluate the management of acute non-specific LBP in the emergency departments (ED).

Setting

We invited all department chiefs of Swiss EDs and their physician staff to participate in a web-based survey using two clinical case vignettes of patients with acute non-specific LBP presenting to an ED. In both cases, no neurological deficits or red flags were present. Guideline adherence and low-value care was defined based on current guideline recommendations.

Results

In total, 263 ED physicians completed at least one vignette, while 212 completed both vignettes (43% residents, 32% senior/attending physicians and 24% chief physicians). MRI was considered in 31% in vignette 1 and 65% in vignette 2. For pain management, non-steroidal anti-inflammatory drugs, paracetamol and metamizole were mostly used. A substantial proportion of ED physicians considered treatments with questionable benefit and/or increased risk for adverse events such as oral steroids (vignette 1, 12% and vignette 2, 19%), muscle relaxants (33% and 38%), long-acting strong opioids (25% and 33%) and spinal injections (22% and 43%). Although guidelines recommend staying active, 72% and 67% of ED physicians recommended activity restrictions.

Conclusion

Management of acute non-specific LBP in the ED was not in agreement with current guideline recommendations in a substantial proportion of ED physicians. Overuse of imaging studies, the use of long-acting opioids and muscle relaxants, as well as recommendations for activity and work restrictions were prevalent and may potentially be harmful.

Host-microbiota relationship in the pathophysiology of aseptic abscess syndrome: protocol for a multicentre case-control study (ABSCESSBIOT)

Por: Trefond · L. · Billard · E. · Pereira · B. · Richard · D. · Vazeille · E. · Bonnet · R. · Barnich · N. · Andre · M. · Aseptic Abscess Syndrome physicians · Ackermann · Altwegg · Aslangul · Audemard-Verger · Bani Sadr · Besnard · Bonnet · Bouaziz · Bourgaux · Cadiot · Chosidow · Con
Introduction

Aseptic abscess (AA) syndrome is a rare disease whose pathophysiology is unknown. It is often associated with inflammatory bowel disease and characterised by sterile inflammation with collections of neutrophils affecting several organs, especially the spleen. Microbiota are known to influence local and systemic immune responses, and both gut and oral microbiota perturbations have been reported in diseases associated with AA syndrome. However, interactions between these factors have never been studied in AA syndrome. The purpose of this translational case-control study (ABSCESSBIOT) is to investigate gut and/or oral microbiota in patients with AA syndrome compared with healthy controls. Moreover, microbiota associated metabolites quantification and Treg/Th17 balance characterisation will give a mechanistic insight on how microbiota may be involved in the pathophysiology of AA syndrome.

Methods and analysis

This French multicentre case-control study including 30 French centres (University hospital or regional hospital) aims to prospectively enrol 30 patients with AA syndrome with 30 matched controls and to analyse microbiota profiling (in stools and saliva), microbial metabolites quantification in stools and circulating CD4+ T cell populations.

Ethics and dissemination

This study protocol was reviewed and approved by an independent French regional review board (n° 2017-A03499-44, Comité de Protection des Personnes Ile de France 1) on 10 October 2022, and declared to the competent French authority (Agence Nationale de Sécurité du Médicament et des produits de santé, France). Oral and written informed consent will be obtained from each included patient and the control participant. Study results will be reported to the scientific community at conferences and in peer-reviewed scientific journals.

Trial registration number

Clinical Trials web-based platform (NCT05537909).

Correlates of Neisseria gonorrhoeae antimicrobial resistance: cross-sectional results from an open cohort sentinel surveillance network in Quebec, Canada, 2016-2019

Por: Blouin · K. · Lefebvre · B. · Trudelle · A. · Defay · F. · Perrault Sullivan · G. · Ezin Aloffan · L. N. D. · Labbe · A.-C.
Objectives

To examine correlates of Neisseria gonorrhoeae antimicrobial resistance (AMR) to first-line antimicrobials (azithromycin, cefixime and ceftriaxone).

Design and setting

The sentinel surveillance network is an open cohort of gonococcal infection cases from Québec, Canada. Cross-sectional results are reported herein.

Participants

Between 1 January 2016 and 31 December 2019, data from 886 individuals accounting for 941 gonorrhoea cases were included.

Methods

Epidemiological and clinical data were collected using an auto-administered questionnaire, direct case interviews and chart reviews. Antimicrobial susceptibility testing was performed using the agar dilution method. Generalised estimating equations were used for regression.

Results

The prevalence of azithromycin resistance with a minimal inhibitory concentration (MIC) of ≥2 mg/L was 21.3%. In 2016, men who have sex with men were more likely to be infected with an azithromycin-resistant N. gonorrhoeae isolate (adjusted prevalence ratio (aPR)=4.73, 95% CI 1.48 to 15.19) or with an isolate with increased third-generation cephalosporin (3GC) MIC (aPR=5.32, 95% CI 1.17 to 24.11 for cefixime (MIC≥0.06 mg/L) and aPR=4.38, 95% CI 1.53 to 12.54 for ceftriaxone (MIC≥0.03 mg/L)). However, these associations were not maintained between 2017 and 2019, with increased MIC observed in men who have sex exclusively with women and women. Overall, azithromycin resistance was significantly more likely in cases who self-reported HIV infection (aPR=1.65, 95% CI 1.00 to 2.71). Cefixime increased MIC were more likely in individuals 25–34 years old (aPR=2.23, 95% CI 1.18 to 4.21). Cefixime and ceftriaxone increased MIC were both more likely in cases who reported ≥5 sexual partners (cefixime: aPR=2.10, 95% CI 1.34 to 3.27 and ceftriaxone: aPR=1.62, 95% CI 1.14 to 2.30).

Conclusion

Significant correlates of N. gonorrhoeae AMR to first-line antimicrobials were observed. Antimicrobial stewardship may be particularly important for 3GC. Active monitoring and interventions are critical for 3GC non-susceptible strains, especially considering the very low prevalence in Québec.

Identifying physical and psychological risk factors for musculoskeletal pain in student musicians to tailor the curriculum: a cross-sectional study protocol

Por: James · C. E. · Schmid · A. · Nguyen-Danse · D. A. · Bruyneel · A.-V.
Introduction

Insufficient identification and understanding of risk factors make musicians engaging in professional practice particularly vulnerable to musculoskeletal pain. To support positive music learning and good mental, physical, and social health, student musicians need health support tailored to their needs and their instrumental practice. However, these preventive actions must be based on sound scientific approaches that reliably identify the most relevant risk factors. MuSa is a cross-sectional study examining contextual and internal risk variables associated with playing-related musculoskeletal disorders in student musicians.

Method and analysis

The design is a monocentric cross-sectional study involving student musicians in Bachelor’s 1, 2, 3 and Master’s 1, 2. Free-form questions will identify students’ lifestyle characteristics and work habits, and validated questionnaires will evaluate the interaction between pain due to music practice and psychological and physical risk factors. All data will first be analysed descriptively. Psychological network analysis will be used to explore the overall correlational structure of the dataset. A subgroup comparative analysis will be then applied according to the instrumental subcategories and work postures, including singers.

Ethics and dissemination

The full protocol was approved by the Swiss Ethics Committee ‘Commission Cantonale d’Ethique de la Recherche sur l’être humain de Genève’ (CCER, no. 2022-02206) on 13 February 2023. Outcomes will be disseminated through publication in peer-reviewed journals and presentations at conferences.

[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial

Por: Koh · E.-S. · Gan · H. K. · Senko · C. · Francis · R. J. · Ebert · M. · Lee · S. T. · Lau · E. · Khasraw · M. · Nowak · A. K. · Bailey · D. L. · Moffat · B. A. · Fitt · G. · Hicks · R. J. · Coffey · R. · Verhaak · R. · Walsh · K. M. · Barnes · E. H. · De Abreu Lourenco · R. · Rosenthal · M.
Introduction

Glioblastoma is the most common aggressive primary central nervous system cancer in adults characterised by uniformly poor survival. Despite maximal safe resection and postoperative radiotherapy with concurrent and adjuvant temozolomide-based chemotherapy, tumours inevitably recur. Imaging with O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) positron emission tomography (PET) has the potential to impact adjuvant radiotherapy (RT) planning, distinguish between treatment-induced pseudoprogression versus tumour progression as well as prognostication.

Methods and analysis

The FET-PET in Glioblastoma (FIG) study is a prospective, multicentre, non-randomised, phase II study across 10 Australian sites and will enrol up to 210 adults aged ≥18 years with newly diagnosed glioblastoma. FET-PET will be performed at up to three time points: (1) following initial surgery and prior to commencement of chemoradiation (FET-PET1); (2) 4 weeks following concurrent chemoradiation (FET-PET2); and (3) within 14 days of suspected clinical and/or radiological progression on MRI (performed at the time of clinical suspicion of tumour recurrence) (FET-PET3). The co-primary outcomes are: (1) to investigate how FET-PET versus standard MRI impacts RT volume delineation and (2) to determine the accuracy and management impact of FET-PET in distinguishing pseudoprogression from true tumour progression. The secondary outcomes are: (1) to investigate the relationships between FET-PET parameters (including dynamic uptake, tumour to background ratio, metabolic tumour volume) and progression-free survival and overall survival; (2) to assess the change in blood and tissue biomarkers determined by serum assay when comparing FET-PET data acquired prior to chemoradiation with other prognostic markers, looking at the relationships of FET-PET versus MRI-determined site/s of progressive disease post chemotherapy treatment with MRI and FET-PET imaging; and (3) to estimate the health economic impact of incorporating FET-PET into glioblastoma management and in the assessment of post-treatment pseudoprogression or recurrence/true progression. Exploratory outcomes include the correlation of multimodal imaging, blood and tumour biomarker analyses with patterns of failure and survival.

Ethics and dissemination

The study protocol V.2.0 dated 20 November 2020 has been approved by a lead Human Research Ethics Committee (Austin Health, Victoria). Other clinical sites will provide oversight through local governance processes, including obtaining informed consent from suitable participants. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results of the FIG study (TROG 18.06) will be disseminated via relevant scientific and consumer forums and peer-reviewed publications.

Trial registration number

ANZCTR ACTRN12619001735145

CompreHensive geriAtRician-led MEdication Review (CHARMER): protocol for a feasibility study of a hospital deprescribing behaviour change intervention

Por: Scott · S. · Atkins · B. · Martin-Kerry · J. M. · Pritchard · M. · Alldred · D. P. · Clark · A. B. · Colles · A. · Hammond · A. · Murphy · K. · Keevil · V. L. · Kellar · I. · Patel · M. · Sims · E. · Taylor · J. · Turner · D. · Witham · M. · Wright · D. · Bhattacharya · D.
Introduction

Over 50% of older adults are prescribed a medicine where the risk of harm outweighs the chances of benefit. During a hospital admission, older adults and carers expect medicines to be reviewed for appropriateness and any inappropriate medicines proactively deprescribed. While the principle of proactive deprescribing is an expectation of good prescribing practice, it is yet to become routine. The CompreHensive geriAtRician-led MEdication Review (CHARMER) study aims to develop and test a five-component behaviour change intervention to equip geriatricians and pharmacists to proactively deprescribe inappropriate medicines with older adults in hospital. This study aims to test the feasibility and acceptability of study processes and CHARMER implementation.

Methods and analysis

A two-arm purposive allocation feasibility study is being undertaken at four acute hospitals in England, UK (three intervention and one control). The target sample is 400 patients across all hospitals. Primary outcome measures are: (1) participant recruitment rate and (2) participant attrition rate. Secondary outcome measures are: (1) hospital readmission rate; (2) mortality rate and (3) quality of life. Quantitative data will be checked for completeness and quality, and practitioner and patient demographics descriptively analysed. We will undertake a rapid qualitative analysis on observations, interviews and study meeting minutes data. A subsequent thematic analysis will be undertaken with codes mapped to the Theoretical Domains Framework and Normalisation Process Theory. Triangulation of qualitative and quantitative data will be undertaken.

Ethics and dissemination

Ethics approval was obtained from Wales Research Ethics Committee 1 (IRAS ID 312494) and study approval from the Health Research Authority (22/WA/0087). Informed consent will be sought from all hospital staff involved in data collection activities and for patients involved in enhanced data collection activities. The findings of this study will be disseminated in peer-reviewed journals and conference presentations.

Trial registration

ISRCTN11899506.

Adverse childhood experiences, the risk of pregnancy complications and adverse pregnancy outcomes: a systematic review and meta-analysis

Por: Mamun · A. · Biswas · T. · Scott · J. · Sly · P. D. · McIntyre · H. D. · Thorpe · K. · Boyle · F. M. · Dekker · M. N. · Doi · S. · Mitchell · M. · McNeil · K. · Kothari · A. · Hardiman · L. · Callaway · L. K.
Background

Adverse childhood experiences (ACEs) have a profound negative impact on health. However, the strength of the association between ACEs and pregnancy complications and adverse pregnancy outcomes is not well quantified or understood.

Objective

To conduct a systematic review and meta-analysis of the association between ACEs and risk of pregnancy complications and adverse pregnancy outcomes.

Search strategy

A comprehensive search was conducted using PubMed, Embase, CINAHL, PsycINFO, ClinicalTrials.gov and Google scholar up to July 2022.

Data collection and analysis

Two reviewers independently conducted the screening and quality appraisal using a validated tool. Meta-analysis using the quality-effects model on the reported odds ratio (OR) was conducted. Heterogeneity and inconsistency were examined using the I2 statistics.

Results

32 studies from 1508 met a priori inclusion criteria for systematic review, with 21 included in the meta-analysis. Pooled analyses showed that exposure to ACEs increased the risk of pregnancy complications (OR 1.37, 95% CI 1.20 to 1.57) and adverse pregnancy outcomes (OR 1.31, 95% CI 1.17 to 1.47). In sub-group analysis, maternal ACEs were associated with gestational diabetes mellitus (OR 1.39, 95% CI 1.11 to 1.74), antenatal depression (OR 1.59, 95% CI 1.15 to 2.20), low offspring birth weight (OR 1.27, 95% CI 1.02 to 1.47), and preterm delivery (OR 1.41, 95% CI 1.16 to 1.71).

Conclusion

The results suggest that exposure to ACEs increases the risk of pregnancy complications and adverse pregnancy outcomes. Preventive strategies, screening and trauma-informed care need to be examined to improve maternal and child health.

Use of geofencing interventions in population health research: a scoping review

Por: Tobin · K. · Heidari · O. · Volpi · C. · Sodder · S. · Duncan · D.
Objectives

Technological advancements that use global positioning system (GPS), such as geofencing, provide the opportunity to examine place-based context in population health research. This review aimed to systematically identify, assess and synthesise the existing evidence on geofencing intervention design, acceptability, feasibility and/or impact.

Design

Scoping review, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidance for reporting.

Data sources

PubMed, CINAHL, EMBASE, Web of Science, Cochrane and PsycINFO for articles in English published up to 31 December 2021.

Eligibility criteria

Articles were included if geofencing was used as a mechanism for intervention delivery. Exclusion criteria: (1) a component or combination of GPS, geographical information system or ecological momentary assessment was used without delivery of an intervention; (2) did not include a health or health-related outcome from the geofencing intervention; or (3) was not a peer-reviewed study.

Data extraction and synthesis

Several researchers independently reviewed all abstracts and full-text articles for final inclusion.

Results

A total of 2171 articles were found; after exclusions, nine studies were included in the review. The majority were published in 5 years preceding the search (89%). Geofences in most studies (n=5) were fixed and programmed in the mobile application carried by participants without their input. Mechanisms of geofencing interventions were classified as direct or indirect, with five studies (56%) using direct interventions. There were several different health outcomes (from smoking to problematic alcohol use) across the five studies that used a direct geofencing intervention.

Conclusions

This scoping review found geofencing to be an emerging technology that is an acceptable and feasible intervention applied to several different populations and health outcomes. Future studies should specify the rationale for the locations that are geofenced and user input. Moreover, attention to mechanisms of actions will enable scientists to understand not only whether geofencing is an appropriate and effective intervention but why it works to achieve the outcomes observed.

Depression, anxiety and quality of life of Afghan women living in urban areas under the Taliban government: a cross-sectional study

Por: Neyazi · A. · Padhi · B. K. · Mohammadi · A. Q. · Ahmadi · M. · Erfan · A. · Bashiri · B. · Neyazi · M. · Ishaqzada · M. · Noormohammadi · M. · Griffiths · M. D.
Objectives

According to the World Health Organization, depression is a common mental health illness that is characterised by a persistent feeling of sadness and loss of interest. The present study examined the association of two mental health variables (ie, depression, anxiety) with quality of life (QoL) and the sociodemographic characteristics of Afghan women living in urban areas under the rule of Taliban government in Afghanistan.

Design

Cross-sectional study administered between 10 November 2021 to 25 December 2021 among women.

Setting

Across major provinces of Afghanistan (Herat, Mazar-e-Sharif, Kabul and Samangan).

Measurements

Data were collected using a pretested structured questionnaire. Data entry was carried out using Microsoft Excel 2016. And then exported to IBM SPSS V.26 for Microsoft Windows. Logistic regression models were used to examine the association of depression, anxiety with QoL and sociodemographic characteristics among women (N=438).

Results

The prevalence of depression symptoms was 80.4%, and the prevalence of mild to extremely severe anxiety was 81.0%. Depression symptoms among Afghan women were associated with being older, having more children, lower education level, other individuals’ bad behaviour, bad events experienced in the past month, and feeling physically ill. Multiple regression analysis indicated that low monthly household income (adjusted OR, AOR 2.260; 95% CI 1.179 to 4.331, p=0.014) poor physical domain of QoL (AOR 4.436; 95% CI 1.748 to 11.256, p=0.002) and poor psychological domain of QoL (AOR 23.499; 95% CI 7.737 to 71.369, p

Conclusion

The prevalence of depression was high among women living under the government of the Taliban in Afghanistan. Considering the high prevalence of depression, anxiety and their impact on QoL and the overall quality of healthcare services, international health organisations should implement programmes for regular screening of depression and anxiety, and there should be psychological counselling services available for vulnerable women living under the government of the Taliban.

Study profile: the Genetics of Glaucoma Study

Por: Gharahkhani · P. · He · W. · Diaz Torres · S. · Wu · Y. · Ingold · N. · Yu · R. · Seviiri · M. · Ong · J.-S. · Law · M. H. · Craig · J. E. · Mackey · D. A. · Hewitt · A. W. · MacGregor · S.
Purpose

Glaucoma, a major cause of irreversible blindness, is a highly heritable human disease. Currently, the majority of the risk genes for glaucoma are unknown. We established the Genetics of Glaucoma Study (GOGS) to identify disease genes and improve genetic prediction of glaucoma risk and response to treatment.

Participants

More than 5700 participants with glaucoma or a family history of glaucoma were recruited through a media campaign and the Australian Government healthcare service provider, Services Australia, making GOGS one of the largest genetic studies of glaucoma globally. The mean age of the participants was 65.30±9.36 years, and 62% were female. Participants completed a questionnaire obtaining information about their glaucoma-related medical history such as family history, glaucoma status and subtypes, surgical procedures, and prescriptions. The questionnaire also obtained information about other eye and systemic diseases. Approximately 80% of the participants provided a DNA sample and ~70% consented to data linkage to their Australian Government Medicare and Pharmaceutical Benefits Scheme schedules.

Findings to date

4336 GOGS participants reported that an optometrist or ophthalmologist has diagnosed them with glaucoma and 3639 participants reported having a family history of glaucoma. The vast majority of the participants (N=4393) had used at least one glaucoma-related medication; latanoprost was the most commonly prescribed drug (54% of the participants who had a glaucoma prescription). A subset of the participants reported a surgical treatment for glaucoma including a laser surgery in 2008 participants and a non-laser operation in 803 participants. Several comorbid eye and systemic diseases were also observed; the most common reports were ocular hypertension (53% of the participants), cataract (48%), hypertension (40%), nearsightedness (31%), astigmatism (22%), farsightedness (16%), diabetes (12%), sleep apnoea (11%) and migraines (10%).

Future plans

GOGS will contribute to the global gene-mapping efforts as one of the largest genetic studies for glaucoma. We will also use GOGS to develop or validate genetic risk prediction models to stratify glaucoma risk, particularly in individuals with a family history of glaucoma, and to predict clinical outcomes (eg, which medication works better for an individual and whether glaucoma surgery is required). GOGS will also help us answer various research questions about genetic overlap and causal relationships between glaucoma and its comorbidities.

Multicohort cross-sectional study of cognitive and behavioural digital biomarkers in neurodegeneration: the Living Lab Study protocol

Por: Crook-Rumsey · M. · Daniels · S. J. C. · Abulikemu · S. · Lai · H. · Rapeaux · A. · Hadjipanayi · C. · Soreq · E. · Li · L. M. · Bashford · J. · Jeyasingh-Jacob · J. · Gruia · D. C. · Lambert · D. · Weil · R. · Hampshire · A. · Sharp · D. J. · Haar · S.
Introduction and aims

Digital biomarkers can provide a cost-effective, objective and robust measure for neurological disease progression, changes in care needs and the effect of interventions. Motor function, physiology and behaviour can provide informative measures of neurological conditions and neurodegenerative decline. New digital technologies present an opportunity to provide remote, high-frequency monitoring of patients from within their homes. The purpose of the living lab study is to develop novel digital biomarkers of functional impairment in those living with neurodegenerative disease (NDD) and neurological conditions.

Methods and analysis

The Living Lab study is a cross-sectional observational study of cognition and behaviour in people living with NDDs and other, non-degenerative neurological conditions. Patients (n≥25 for each patient group) with dementia, Parkinson’s disease, amyotrophic lateral sclerosis, mild cognitive impairment, traumatic brain injury and stroke along with controls (n≥60) will be pragmatically recruited. Patients will carry out activities of daily living and functional assessments within the Living Lab. The Living Lab is an apartment-laboratory containing a functional kitchen, bathroom, bed and living area to provide a controlled environment to develop novel digital biomarkers. The Living Lab provides an important intermediary stage between the conventional laboratory and the home. Multiple passive environmental sensors, internet-enabled medical devices, wearables and electroencephalography (EEG) will be used to characterise functional impairments of NDDs and non-NDD conditions. We will also relate these digital technology measures to clinical and cognitive outcomes.

Ethics and dissemination

Ethical approvals have been granted by the Imperial College Research Ethics Committee (reference number: 21IC6992). Results from the study will be disseminated at conferences and within peer-reviewed journals.

School performances in children with cataract: results from a population-based cohort study

Por: Al-Bakri · M. · Skovgaard · A. M. · Bach-Holm · D. · Larsen · D. A. · Siersma · V. · Kessel · L.
Objectives

Childhood cataract is a chronic condition that may interfere with the child’s learning capacities. We aimed to investigate whether childhood cataract influences academic development by comparing school performance in reading and mathematics in children with cataract to a matched control group.

Design

Nationwide registry-based cohort study.

Settings

Two surgical centres that perform all treatments for childhood cataract in Denmark.

Participants

Children born between 2000 and 2009 diagnosed with cataract before 10 years of age (n=275) and an age-matched and sex-matched control group (n=2473).

Main outcome measures

School performance was assessed as test scores in national tests performed at regular intervals from grade 2 to grade 8 in reading and mathematics. Analyses were corrected for birth origin, child somatic and mental disorder and parental socioeconomic status and mental disorders.

Results

Of 275 children, 85 (30.9%) were operated for bilateral cataract, 79 (28.7%) unilateral cataract and 111 (40,4%) were not operated. We found that children with cataract have lower participation rate in the tests (62.5%) compared with the control cohort (77.2%) (p value=0.0001). After adjusting the pooled analyses for birth origin, somatic and mental disease in the child and parental socioeconomic status and mental disorders, we found that the children with cataract scored significantly lower in mathematics compared with those without cataract (mean difference=–4.78, 95% CI: –8.18 to –1.38, p value=0.006), whereas no difference was found regarding scores in reading (p=0.576). The lower score in mathematics was driven by children who had been operated for bilateral cataract (p-value=0.004).

Conclusion

Children with cataract without somatic or neurodevelopmental comorbidities or psychosocial adversities seem to do well in school, whereas children operated for bilateral cataract have higher frequencies of difficulties in mathematical tasks.

Understanding the valuation of paediatric health-related quality of life: a qualitative study protocol

Introduction

There is evidence from previous studies that adults value paediatric health-related quality of life (HRQoL) and adult HRQoL differently. Less is known about how adolescents value paediatric HRQoL and whether their valuation and decision-making processes differ from those of adults. Discrete choice experiments (DCEs) are widely used to develop value sets for measures of HRQoL, but there is still much to understand about whether and how the methods choices in the implementation of DCE valuation tasks, such as format, presentation and perspective, affect the decision-making process of participants. This paper describes the protocol for a qualitative study that aims to explore the decision-making process of adults and adolescents when completing DCE valuation tasks. The study will also explore the impact of methodological choices in the design of DCE studies (including decisions about format and presentation) on participants’ thinking process.

Methods and analysis

An interview protocol has been developed using DCE valuation tasks. Interviews will be conducted online via Zoom with both an adolescent and adult sample. In the interview, the participant will be asked to go through some DCE valuation tasks while ‘thinking aloud’. After completion of the survey, participants will then be asked some predetermined questions in relation to various aspects of the DCE tasks. Interviews will be recorded and transcribed and analysed using a thematic analysis approach.

Ethics and dissemination

Ethics approval for this study has been received for the adult sample (UTS ETH20-9632) as well as the youth sample (UTS ETH22-6970) from the University of Technology Sydney Human Research Ethics Committee. Results from this study will inform the methods to be used in development of value sets for use in the health technology assessment of paediatric interventions and treatments. Findings from this study will also be disseminated through national/international conferences and peer-reviewed journals.

Qualitative exploration of the impact of COVID-19 on the food environment of urban informal settlements of Dhaka, Bangladesh

Por: Hasan · A. M. R. · Smith · G. · Selim · M. A. · Khatun · F. · Mahmood · S. S. · Reidpath · D. D. · Rasheed · S.
Objective

Our study explored the impact of the COVID-19 pandemic on the food environment from the perspective of the urban poor and food vendors.

Design

This was a qualitative study conducted during September 2020 and February 2021.

Setting

The study was carried out in two purposively selected informal settlements of Dhaka City, Bangladesh.

Participants

We conducted 21 in-depth interviews with residents of informal settlements and 10 key informant interviews with food vendors and food aid workers.

Result

The availability of staple foods was not disrupted during the pandemic but some perishables foods became more expensive due to supply chain disruptions and increased transportation costs. Limited market hours affected market access and mobility restrictions adversely affected local vendors. Cart vendors selling perishables incurred business losses they could ill afford. Demand for food reduced as employment disruption lead to reduced purchasing power and, therefore, reduction of quantity, quality and desirability of foods purchased. Respondents reported skipping meals and going hungry. The aid received was considered inadequate to meet needs.

Conclusion

The food environment of the urban poor was disrupted from both supply and demand sides and the organisational response (both government and non-government) was severely inadequate. The social safety net needs to be extended and redesigned to ensure food security and health for the urban working poor in the future.

Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial

Por: Garrison · S. R. · Youngson · E. · Perry · D. A. · Campbell · F. N. · Kolber · M. R. · Korownyk · C. · Allan · G. M. · Green · L. · Bakal · J.
Introduction

BedMed-Frail explores risks and benefits of switching antihypertensives from morning to bedtime in a frail population at greater risk of hypotensive adverse effects.

Methods and analysis

Design: Prospective parallel randomised, open-label, blinded end-point trial.

Participants: Hypertensive continuing care residents, in either long-term care or supportive living, who are free from glaucoma, and using ≥1 once daily antihypertensive.

Setting: 16 volunteer continuing care facilities in Alberta, Canada, with eligible residents identified using electronic health claims data.

Intervention: All non-opted out eligible residents are randomised centrally by the provincial health data steward to bedtime versus usual care (typically morning) administration of once daily antihypertensives. Timing changes are made (maximum one change per week) by usual care facility pharmacists.

Follow-up: Via linked governmental healthcare databases tracking hospital, continuing care and community medical services.

Primary outcome: Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke, or congestive heart failure.

Secondary outcomes: Each primary outcome element on its own, all-cause unplanned hospitalisation or emergency department visit, non-vertebral fracture and, as assessed roughly 135 days postrandomisation, fall in the last 30 days, deteriorated cognition, urinary incontinence, decubitus skin ulceration, inappropriate or disruptive behaviour a minimum of 4 days per week, and receipt of antipsychotic medication or physical restraints in the last 7 days.

Process outcome: Proportion of blood pressure medication doses taken at bedtime (broken down monthly).

Primary outcome analysis: Cox-Proportional Hazards Survival Analysis.

Sample size: The trial will continue until a projected 368 primary outcome events have occurred.

Current status: Enrolment is ongoing with 642 randomisations to date (75% female, mean age 88 years).

Ethics and dissemination

BedMed-Frail has ethical approval from the University of Alberta Health Ethics Review Board (Pro00086129) and will publish results in a peer-reviewed journal.

Trial registration number

NCT04054648.

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial

Por: Wright Nunes · J. A. · Resnicow · K. · Richardson · C. · Levine · D. · Kerr · E. · Saran · R. · Gillespie · B. · Bragg-Gresham · J. · Delacroix · E. L. · Considine · S. · Fan · A. · Ellies · T. · Garcia-Guzman · L. · Grzyb · K. · Klinkman · M. · Rockwell · P. · Billi · J. · Martin · C. · C
Introduction

Chronic kidney disease (CKD) affects 30 million Americans. Early management focused on blood pressure (BP) control decreases cardiovascular morbidity and mortality. Less than 40% of patients with CKD achieve recommended BP targets due to many barriers. These barriers include a lack of understanding of the implications of their diagnosis and how to optimise their health.

This cluster randomised control trial hypothesises that the combination of early primary care CKD education, and motivational interviewing (MI)-based health coach support, will improve patient behaviours aligned with BP control by increasing patient knowledge, self-efficacy and motivation. The results will aid in sustainable interventions for future patient-centric education and coaching support to improve quality and outcomes in patients with CKD stages 3–5. Outcomes in patients with CKD stages 3–5 receiving the intervention will be compared with similar patients within a control group. Continuous quality improvement (CQI) and systems methodologies will be used to optimise resource neutrality and leverage existing technology to support implementation and future dissemination. The innovative approach of this research focuses on the importance of a multidisciplinary team, including off-site patient coaching, that can intervene early in the CKD care continuum by supporting patients with education and coaching.

Methods and analysis

We will test impact of BP control when clinician-delivered education is followed by 12 months of MI-based health coaching. We will compare outcomes in 350 patients with CKD stages 3–5 between intervention and control groups in primary care. CQI and systems methodologies will optimise education and coaching for future implementation and dissemination.

Ethics and dissemination

This study was approved by the University of Michigan Institutional Review Boards (IRBMED) HUM00136011, HUM00150672 and SITE00000092 and the results of the study will be published on ClinicalTrials.gov, in peer-reviewed journals, as well as conference abstracts, posters and presentations.

Trial registration number

NCT04087798.

Risk of sexual dysfunctions in breastfeeding females: protocol for a systematic review and meta-analysis

Por: Smetanina · D. · Awar · S. A. · Khair · H. · Alkaabi · M. · Das · K. M. · Ljubisavljevic · M. · Statsenko · Y. · Zareba · K. T.
Background

Epidemiological studies do not provide accurate statistics on the percentage of breastfeeding women experiencing sexual dysfunctions and restraining from sexual activity. The data vary between 40% and 83% in the first group and 20–50% in the second one. Despite excessive studies on contributors to intimacy changes, breast feeding received little attention from researchers. The relationship between lactation and postpartum sexual dysfunctions remains unclear. This systematic review and meta-analysis will synthesise available data and establish the link between breast feeding and sexuality problems.

Methods and analysis

A comprehensive literature search will be performed in biomedical databases PubMed/Medline, Scopus, Web of Science, EMBASE and CINAHL. We will extract peer-reviewed original studies written in English, Arabic or Polish from 2000 to June 2023. We will also search for reports from international health organisations and local health authorities. The preliminary search was performed on 04 April 2023. The studies must provide data on dysfunction prevalence/incidence and the strength of the relationship between breast feeding and sexuality in generally healthy women. The Covidence software will be used to perform literature screening, data extraction and quality assessment of individual studies. We will use a random-effects model meta-analysis to calculate pooled weighted frequency measures and effect size. Between-study heterogeneity will be assessed with the I2 test.

Ethics and dissemination

This meta-analysis does not require ethical approval because it synthesises data from previously published original studies. The final work will be published in a peer-reviewed journal and presented at scientific conferences.

PROSPERO registration number

CRD42023411053.

Effect of dexmedetomidine on postoperative nausea and vomiting in patients under general anaesthesia: an updated meta-analysis of randomised controlled trials

Por: Zhao · W. · Li · J. · Wang · N. · Wang · Z. · Zhang · M. · Zhang · H. · Liu · M. · He · J. · Yu · D.
Objectives

To explore the effect of dexmedetomidine (DEX) on postoperative nausea and vomiting (PONV) in adult patients after general anaesthesia.

Design

Systematic review and meta-analysis.

Eligibility criteria for selecting studies

Randomised controlled trials (RCTs) comparing the efficacy of DEX with placebo or a single drug on PONV in adult patients after general anaesthesia.

Data sources

We searched the PubMed, the Web of Science, the Cochrane Library and Embase (1 January 2000 to 30 June 2022) to select the relevant RCTs.

Data analysis

All the relevant data were analysed by using RevMan V.5.4. Heterogeneity was tested for each outcome, and random-effect or fixed-effect models was selected according to the level of heterogeneity. The primary outcome was the incidence of PONV. The secondary outcomes were the incidence of bradycardia, perioperative opioid consumption, extubation time and the length of hospitalisation.

Results

A total of 18 trials involving 2018 patients were included in this meta-analysis. Notably, 15 updated studies were not involved in the previous meta-analysis. The incidence of PONV in DEX group was lower than that in the control group (OR=0.49, 95% CI: 0.36 to 0.67) and the perioperative opioid consumption in DEX group was also decreased significantly (standard mean difference (SMD)=–1.04, 95% CI: –1.53 to –0.54). Moreover, the length of hospitalisation (SMD=–2.29, 95% CI: –4.31 to –0.28) and the extubation time (SMD=–0.75, 95% CI: –1.26 to –0.25) in DEX group were shorter. Whereas, more number of patients receiving DEX might increase the occurrence of bradycardia (OR=1.60, 95% CI: 1.13 to 2.27).

Conclusions

DEX could decrease the occurrence of PONV in adult patients under general anaesthesia and promote the recovery after surgery. However, DEX might increase the occurrence of bradycardia.

PROSPERO registration number

CRD 42022341548.

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