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REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system

Por: Holder-Murray · J. · Esper · S. A. · Althans · A. R. · Knight · J. · Subramaniam · K. · Derenzo · J. · Ball · R. · Beaman · S. · Luke · C. · La Colla · L. · Schott · N. · Williams · B. · Lorenzi · E. · Berry · L. R. · Viele · K. · Berry · S. · Masters · M. · Meister · K. A. · Wilkinson · T.
Introduction

Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia. Patients enrolled in the trial will be randomised to arms within both domains, with the possibility of adding additional domains in the future.

Methods and analysis

In the PONV domain, patients are randomised to optimal versus supraoptimal prophylactic regimens. In the regional/neuraxial domain, patients are randomised to one of five different single-injection techniques/combination of techniques. The primary study endpoint is hospital-free days at 30 days, with additional domain-specific secondary endpoints of PONV incidence and postoperative opioid consumption. The efficacy of an intervention arm within a given domain will be evaluated at regular interim analyses using Bayesian statistical analysis. At the beginning of the trial, participants will have an equal probability of being allocated to any given intervention within a domain (ie, simple 1:1 randomisation), with response adaptive randomisation guiding changes to allocation ratios after interim analyses when applicable based on prespecified statistical triggers. Triggers met at interim analysis may also result in intervention dropping.

Ethics and dissemination

The core protocol and domain-specific appendices were approved by the University of Pittsburgh Institutional Review Board. A waiver of informed consent was obtained for this trial. Trial results will be announced to the public and healthcare providers once prespecified statistical triggers of interest are reached as described in the core protocol, and the most favourable interventions will then be implemented as a standardised institutional protocol.

Trial registration number

NCT04606264.

Medical device‐related pressure injuries in paediatric patients: An incidence study in a children's hospital

Abstract

Aim

To determine the incidence of pressure injuries from medical devices in children.

Background

Medical devices can cause pressure injuries on skin and soft tissues.

Design

A prospective, descriptive study adhering to STROBE guidelines.

Methods

This study was conducted in the third-level Paediatric Intensive Care Unit of Ege University Hospital in İzmir, Türkiye between April 2019 and October 2019 in Türkiye. Patients aged between 1 month and 18 years with medical devices were observed for pressure injuries using Braden scales and a specific monitoring form.

Results

In this study, we followed 522 medical devices applied to 96 patients. The three most commonly used medical devices were the ECG probe (21%), the blood pressure cuff (16%) and the saturation probe. Out of the 522 medical devices followed, 36 caused pressure injuries (6.8%).

Conclusion

The incidence of medical device-related pressure injuries was found to be high. Effective training and implementation strategies need to be devised for paediatric nurses to prevent pressure injuries associated with medical devices.

Relevance to Clinical Practice

The results of this study reveal that pressure injuries related to medical devices are an important health problem in paediatric hospitals. Therefore, awareness-raising and educational activities among health professionals and nurses should be accelerated.

Patient or Public Contribution

No patient or public contribution in the study.

Factors affecting the implementation of calcium supplementation strategies during pregnancy to prevent pre-eclampsia: a mixed-methods systematic review

Por: Cormick · G. · Moraa · H. · Zahroh · R. I. · Allotey · J. · Rocha · T. · Pena-Rosas · J. P. · Qureshi · Z. P. · Hofmeyr · G. J. · Mistry · H. · Smits · L. · Vogel · J. P. · Palacios · A. · Gwako · G. N. · Abalos · E. · Larbi · K. K. · Carroli · G. · Riley · R. · Snell · K. I. · Thorson · A.
Objectives

Daily calcium supplements are recommended for pregnant women from 20 weeks’ gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia.

Design

Mixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach.

Data sources

MEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022.

Eligibility criteria

We included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date.

Data extraction and synthesis

Two independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators.

Results

Eighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium.

Conclusion

Relevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions.

PROSPERO registration number

CRD42021239143.

Research priorities for childrens cancer: a James Lind Alliance Priority Setting Partnership in the UK

Por: Aldiss · S. · Hollis · R. · Phillips · B. · Ball-Gamble · A. · Brownsdon · A. · Chisholm · J. · Crowther · S. · Dommett · R. · Gower · J. · Hall · N. J. · Hartley · H. · Hatton · J. · Henry · L. · Langton · L. · Maddock · K. · Malik · S. · McEvoy · K. · Morgan · J. E. · Morris · H. · Parke
Objectives

To engage children who have experienced cancer, childhood cancer survivors, their families and professionals to systematically identify and prioritise research questions about childhood cancer to inform the future research agenda.

Design

James Lind Alliance Priority Setting Partnership.

Setting

UK health service and community.

Methods

A steering group oversaw the initiative. Potential research questions were collected in an online survey, then checked to ensure they were unanswered. Shortlisting via a second online survey identified the highest priority questions. A parallel process with children was undertaken. A final consensus workshop was held to determine the Top 10 priorities.

Participants

Children and survivors of childhood cancer, diagnosed before age 16, their families, friends and professionals who work with this population.

Results

Four hundred and eighty-eight people submitted 1299 potential questions. These were refined into 108 unique questions; 4 were already answered and 3 were under active study, therefore, removed. Three hundred and twenty-seven respondents completed the shortlisting survey. Seventy-one children submitted questions in the children’s surveys, eight children attended a workshop to prioritise these questions. The Top 5 questions from children were taken to the final workshop where 23 questions in total were discussed by 25 participants (young adults, carers and professionals). The top priority was ‘can we find effective and kinder (less burdensome, more tolerable, with fewer short and long-term effects) treatments for children with cancer, including relapsed cancer?’

Conclusions

We have identified research priorities for children’s cancer from the perspectives of children, survivors, their families and the professionals who care for them. Questions reflect the breadth of the cancer experience, including diagnosis, relapse, hospital experience, support during/after treatment and the long-term impact of cancer. These should inform funding of future research as they are the questions that matter most to the people who could benefit from research.

Comparing the effectiveness of mother-focused interventions to that of mother-child focused interventions in improving maternal postpartum depression outcomes: A systematic review

by Divya Kumar, Waqas Hameed, Bilal Iqbal Avan

Background

Most empirically researched interventions for postpartum depression (PPD) tend to target mothers’ depression alone. Harmful effects of PPD on physical and mental health of both mother and child has led researchers to investigate the impact of interventions on PPD and child outcomes together. So far, the evidence is limited regarding how these interventions compare with those focusing only on mothers’ depression. This review compares the effectiveness of PPD-improving interventions focusing only on mothers with those focusing on mother and child together.

Methods

Nine electronic databases were searched. Thirty-seven studies evaluating mother-focused (n = 30) and mother-child focused interventions (n = 7) were included. Under each category, three theoretical approaches—psychological, psychosocial and mixed—were compared using standardized qualitative procedures. The review’s primary outcome was maternal PPD.

Results

A higher proportion of mother-focussed interventions [20/30 (66.7%)] brought significant reduction in PPD outcomes as compared to a lower proportion of mother-child focused interventions [4/7 (57.14%)]. Mother-focused mixed approaches [3/3 (100%)] performed better in improving PPD than psychological [16/24 (67%)] or psychosocial approaches [1/3 (33.3%)] alone. Amongst mother-child focused interventions, psychosocial approaches performed well with two-thirds demonstrating positive effects on PPD.

Conclusion

The evidence strongly favors mother-focused interventions for improving PPD with mixed interventions being more effective. Psychosocial approaches performed better with PPD once child-related elements were added, and also seemed best for child outcomes. Psychological approaches were most practiced and effective for PPD, irrespective of the intervention’s focus. Further trials are needed to unpack intervention components that improve PPD and increase uptake, especially in lower-and middle-income countries.

Acceptability of aspirin for cancer preventive therapy: a survey and qualitative study exploring the views of the UK general population

Por: Lloyd · K. E. · Hall · L. H. · Ziegler · L. · Foy · R. · Green · S. M. C. · MacKenzie · M. · Taylor · D. G. · Smith · S. G. · Aspirin for Cancer Prevention AsCaP Steering Committee · Cuzick · Balkwill · Bishop · Burn · Chan · Crooks · Hawkey · Langley · McKenzie · Nedjai · Patrign
Objectives

Aspirin could be offered for colorectal cancer prevention for the UK general population. To ensure the views of the general population are considered in future guidance, we explored public perceptions of aspirin for preventive therapy.

Design

We conducted an online survey to investigate aspirin use, and awareness of aspirin for cancer prevention among the UK general population. We conducted semistructured interviews with a subsample of survey respondents to explore participants’ acceptability towards aspirin for cancer preventive therapy. We analysed the interview data using reflexive thematic analysis and mapped the themes onto the Theoretical Domains Framework, and the Necessity and Concerns Framework.

Setting

Online survey and remote interviews.

Participants

We recruited 400 UK respondents aged 50–70 years through a market research company to the survey. We purposefully sampled, recruited and interviewed 20 survey respondents.

Results

In the survey, 19.0% (76/400) of respondents were aware that aspirin can be used to prevent cancer. Among those who had previously taken aspirin, 1.9% (4/216) had taken it for cancer prevention. The interviews generated three themes: (1) perceived necessity of aspirin; (2) concerns about side effects; and (3) preferred information sources. Participants with a personal or family history of cancer were more likely to perceive aspirin as necessary for cancer prevention. Concerns about taking aspirin at higher doses and its side effects, such as gastrointestinal bleeding, were common. Many described wanting guidance and advice on aspirin to be communicated from sources perceived as trustworthy, such as healthcare professionals.

Conclusions

Among the general population, those with a personal or family history of cancer may be more receptive towards taking aspirin for preventive therapy. Future policies and campaigns recommending aspirin may be of particular interest to these groups. Multiple considerations about the benefits and risks of aspirin highlight the need to support informed decisions on the medication.

Early Neolithic pastoral land use at Alsónyék-Bátaszék, Hungary (Starčevo culture): New insights from stable isotope ratios

by Magdalena Blanz, Marie Balasse, Delphine Frémondeau, Erika Gál, Anett Osztás, Anna Zs. Biller, Éva Á. Nyerges, Denis Fiorillo, Eszter Bánffy, Maria Ivanova

The earliest introduction of livestock (cattle, goats, sheep, pigs) into the Carpathian Basin was an important step towards farming expansion into continental Europe. This spread beyond the environments of the southern Balkans was accompanied by a reduction in the spectrum of cultivated crops, changes in the relative representation of different domestic animals, and, most likely, adaptations of husbandry practices. How the earliest farmers in the Carpathian Basin kept their domestic stock is still understudied. We explored early animal management and land use strategies at the Starčevo settlement at Alsónyék-Bátaszék, Hungary (Early Neolithic, ca. 5800–5600 cal BC). Settled at the intersection of wide alluvial plains, waterlogged meadows and marshes to the east, and forested hills to the west, early farmers at Alsónyék had a wide variety of options for nourishing their livestock. We performed stable isotope ratio analysis of bone collagen (n = 99; δ13C, δ15N) and tooth enamel (nteeth = 28, sequentially sampled for δ13C and δ18O) from wild and domestic animals to locate them in the landscape and investigate herding practices on a seasonal scale. The bone collagen isotope ratios mostly indicate feeding in open environments. However, results from the sequential analysis of cattle and sheep enamel suggest diverse dietary strategies for winters, including consumption of forest resources, consumption of summer hay and grazing in an open environment. Most pigs appear to have had herbivorous diets, but several individuals likely supplemented their diet with animal protein. Stable isotope ratio results from the Lengyel phase at Alsónyék (ca. 4800–4300 cal BC) suggest more access to animal protein for pigs, and feeding in more open areas by wild boar, red deer and cattle compared to the Starčevo phase. This study’s results demonstrate considerable variability in early animal husbandry practices at Alsónyék.

Influence of physical fitness components on personality factors and risk perception of children and adolescents: a cross-sectional study

Objectives

To examine the associations of cardiorespiratory fitness (VO2 max) and muscular strength with indicators related to the risk scale, such as perceived competence, sensation seeking, competitiveness, risk taking and risk perception in sports.

Design

Cross-sectional study.

Setting

High schools from the Region of Murcia (Spain).

Participants

Three-hundred-and-seventeen adolescents participated (mean age: 13.69±1.2 years old).

Primary and secondary outcome measures

Body mass, body height, Course-Navette test, upper limb strength and psychoeducational factors that determine the propensity towards sports accidents in school children, the Sports Accident Propensity Scale were evaluated. It was performance t-test for independent samples, stepwise multiple linear regression models and a multiple mediation analysis.

Results

The analysis showed significant differences with respect to sex in height, VO2 max, handgrip strength and in all factors of the questionnaire (p=0.02-2 max, strength in the handgrip test and age showed a higher score in factors 1 and 3. Higher scores in factor 2 were associated with better VO2 max and strength in handgrip test. Youngers and better values of strength in the handgrip showed higher score in factors 4 and 5. The mediation analysis with two mediating variables (handgrip strength and VO2 max) showed a significant indirect effect. When handgrip strength and VO2 max were included in the equations, the association between sex and each factor ceased to be significant.

Conclusion

This study highlights the potential benefits of muscular strength (handgrip) and VO2 max in the perceived risk scale, and the variable of age on this.

Trial registration number

Clinical trial: NCT05544370 (pre-results).

Abdominal fat depots and their association with insulin resistance in patients with type 2 diabetes

by Umesh Kumar Garg, Nitish Mathur, Rahul Sahlot, Pradeep Tiwari, Balram Sharma, Aditya Saxena, Raj Kamal Jainaw, Laxman Agarwal, Shalu Gupta, Sandeep Kumar Mathur

Background

Asian-Indians show thin fat phenotype, characterized by predominantly central deposition of excess fat. The roles of abdominal subcutaneous fat (SAT), intra-peritoneal adipose tissue, and fat depots surrounding the vital organs (IPAT-SV) and liver fat in insulin resistance (IR), type-2 diabetes (T2D) and metabolic syndrome (MetS) in this population are sparsely investigated.

Aims and objectives

Assessment of liver fat, SAT and IPAT-SV by MRI in subjects with T2D and MetS; and to investigate its correlation with IR, specifically according to different quartiles of HOMA-IR.

Methods

Eighty T2D and the equal number of age sex-matched normal glucose tolerant controls participated in this study. Abdominal SAT, IPAT-SV and liver fat were measured using MRI. IR was estimated by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).

Results

T2D and MetS subjects have higher quantity liver fat and IPAT-SV fat than controls (P = 9 x 10−4 and 4 x 10−4 for T2D and 10−4 and 9 x 10−3 for MetS subjects respectively). MetS subjects also have higher SAT fat mass (P = 0.012), but not the BMI adjusted SAT fat mass (P = 0.48). Higher quartiles of HOMA-IR were associated with higher BMI, W:H ratio, waist circumference, and higher liver fat mass (ANOVA Test P = 0.020, 0.030, 2 x 10−6 and 3 x 10−3 respectively with F-values 3.35, 3.04, 8.82, 4.47 respectively). In T2D and MetS subjects, HOMA-IR showed a moderately strong correlation with liver fat (r = 0.467, P −5 and r = 0.493, P −7), but not with SAT fat and IPAT-SV. However, in MetS subjects IPAT-SV fat mass showed borderline correlation with IR (r = 0.241, P r = 0.13, P = 0.26). In non-T2D and non-MetS subjects, no such correlation was seen. On analyzing the correlation between the three abdominal adipose compartment fat masses and IR according to its severity, the correlation with liver fat mass becomes stronger with increasing quartiles of HOMA-IR, and the strongest correlation is seen in the highest quartile (r = 0.59, P −3). On the other hand, SAT fat mass tended to show an inverse relation with IR with borderline negative correlation in the highest quartile (r = -0.284, P P = 0.07).

Conclusion

In individuals suffering from T2D and MetS, IR shows a trend towards positive and borderline negative correlation with liver fat and SAT fat masses respectively. The positive trend with liver fat tends to become stronger with increasing quartile of IR. Therefore, these findings support the theory that possibly exhaustion of protective compartment’s capacity to store excess fat results in its pathological deposition in liver as ectopic fat.

The association between cardiopulmonary exercise testing and postoperative outcomes in patients with lung cancer undergoing lung resection surgery: A systematic review and meta-analysis

by Nabeela Arbee-Kalidas, Hlamatsi Jacob Moutlana, Yoshan Moodley, Moses Mogakolodi Kebalepile, Palesa Motshabi Chakane

Background

Exercise capacity should be determined in all patients undergoing lung resection for lung cancer surgery and cardiopulmonary exercise testing (CPET) remains the gold standard. The purpose of this study was to investigate associations between preoperative CPET and postoperative outcomes in patients undergoing lung resection surgery for lung cancer through a review of the existing literature.

Methods

A search was conducted on PubMed, Scopus, Cochrane Library and CINAHL from inception until December 2022. Studies investigating associations between preoperative CPET and postoperative outcomes were included. Risk of bias was assessed using the QUIPS tool. A random effect model meta-analysis was performed. I2 > 40% indicated a high level of heterogeneity.

Results

Thirty-seven studies were included with 6450 patients. Twenty-eight studies had low risk of bias. V˙O2 peak is the oxygen consumption at peak exercise and serves as a marker of cardiopulmonary fitness. Higher estimates of V˙O2 peak, measured and as a percentagege of predicted, showed significant associations with a lower risk of mortality [MD: 3.66, 95% CI: 0.88; 6.43 and MD: 16.49, 95% CI: 6.92; 26.07] and fewer complications [MD: 2.06, 95% CI: 1.12; 3.00 and MD: 9.82, 95% CI: 5.88; 13.76]. Using a previously defined cutoff value of > 15mL/kg/min for V˙O2 peak, showed evidence of decreased odds of mortality [OR: 0.55, 95% CI: 0.28–0.81] and but not decreased odds of postoperative morbidity [OR: 0.82, 95% CI: 0.64–1.00]. There was no relationship between V˙E/V˙CO2 slope, which depicts ventilatory efficiency, with mortality [MD: -9.60, 95% CI: -27.74; 8.54] however, patients without postoperative complications had a lower preoperative V˙E/V˙CO2 [MD: -2.36, 95% CI: -3.01; -1.71]. Exercise load and anaerobic threshold did not correlate with morbidity or mortality. There was significant heterogeneity between studies.

Conclusions

Estimates of cardiopulmonary fitness as evidenced by higher V˙O2 peak, measured and as a percentage of predicted, were associated with decreased morbidity and mortality. A cutoff value of V˙O2 peak > 15mL/kg/min was consistent with improved survival but not with fewer complications. Ventilatory efficiency was associated with decreased postoperative morbidity but not with improved survival. The heterogeneity in literature could be remedied with large scale, prospective, blinded, standardised research to improve preoperative risk stratification in patients with lung cancer scheduled for lung resection surgery.

How could mouthwashes affect the color stability and translucency of various types of monolithic zirconia? An in-vitro study

by Rashin Giti, Reza Jebal

Objectives

This study aimed to evaluate the color stability and translucency of various types of monolithic zirconia after immersion in chlorhexidine and Listerine mouthwashes.

Materials and methods

This experimental study was performed on 36 disk-shaped specimens fabricated from low-translucent, high-translucent, and multilayered monolithic zirconia (n = 12 per group). Each group was equally divided and immersed in either 2% chlorhexidine (CHX) or Listerine mouthwash for 2 min daily over 7 days. Changes in color (ΔE) and the translucency parameter (ΔTP) were evaluated and compared. The data were analyzed with one-way ANOVA followed by Tukey’s post-hoc tests (α = 0.05).

Results

Chlorhexidine caused a significantly lower ΔE and a significantly higher ΔTP in multilayered zirconia compared to the low-translucency (ΔE: P = 0.0027, ΔTP: PPP = 0.0165). It also resulted in a significantly higher mean ΔTP in the multilayered zirconia group compared to the low-translucency (P = 0.0003) and high-translucency zirconia groups (P = 0.019).

Conclusions

In both mouthwashes, multilayered monolithic zirconia exhibited the highest color stability among the tested materials; albeit with the most pronounced changes in translucency. Meanwhile, high-translucency monolithic zirconia was more prone to discoloration when exposed to both mouthwashes.

Prediction models of incontinence and sexual function one year after radical prostatectomy based on data from 20 164 prostate cancer patients

by Nora Tabea Sibert, Tobias Kurth, Clara Breidenbach, Simone Wesselmann, Günther Feick, Ernst-Günter Carl, Sebastian Dieng, Mohamad Hatem Albarghouth, Atiqullah Aziz, Stefan Baltes, Elisabeth Bartolf, Jens Bedke, Andreas Blana, Marko Brock, Stefan Conrad, Christopher Darr, Florian Distler, Konstantinos Drosos, Gregor Duwe, Amr Gaber, Markus Giessing, Nina Natascha Harke, Axel Heidenreich, Sameh Hijazi, Andreas Hinkel, Björn Theodor Kaftan, Shatlyk Kheiderov, Thomas Knoll, Gerd Lümmen, Inga Peters, Bülent Polat, Valentin Schrodi, Jens-Uwe Stolzenburg, Zoltan Varga, Julius von Süßkind-Schwendi, Vahudin Zugor, Christoph Kowalski

Background

Incontinence and sexual dysfunction are long-lasting side effects after surgical treatment (radical prostatectomy, RP) of prostate cancer (PC). For an informed treatment decision, physicians and patients should discuss expected impairments. Therefore, this paper firstly aims to develop and validate prognostic models that predict incontinence and sexual function of PC patients one year after RP and secondly to provide an online decision making tool.

Methods

Observational cohorts of PC patients treated between July 2016 and March 2021 in Germany were used. Models to predict functional outcomes one year after RP measured by the EPIC-26 questionnaire were developed using lasso regression, 80–20 splitting of the data set and 10-fold cross validation. To assess performance, R2, RMSE, analysis of residuals and calibration-in-the-large were applied. Final models were externally temporally validated. Additionally, percentages of functional impairment (pad use for incontinence and firmness of erection for sexual score) per score decile were calculated to be used together with the prediction models.

Results

For model development and internal as well as external validation, samples of 11 355 and 8 809 patients were analysed. Results from the internal validation (incontinence: R2 = 0.12, RMSE = 25.40, sexual function: R2 = 0.23, RMSE = 21.44) were comparable with those of the external validation. Residual analysis and calibration-in-the-large showed good results. The prediction tool is freely accessible: https://nora-tabea.shinyapps.io/EPIC-26-Prediction/.

Conclusion

The final models showed appropriate predictive properties and can be used together with the calculated risks for specific functional impairments. Main strengths are the large study sample (> 20 000) and the inclusion of an external validation. The models incorporate meaningful and clinically available predictors ensuring an easy implementation. All predictions are displayed together with risks of frequent impairments such as pad use or erectile dysfunction such that the developed online tool provides a detailed and informative overview for clinicians as well as patients.

Antibiofilm and antimicrobial activity of Lactobacillus cell free supernatant against Pseudomonas aeruginosa isolated from burn wounds

Abstract

The present study investigated the antimicrobial and anti-biofilm effects of indigenous Lactobacillus probiotic strains on Pseudomonas aeruginosa isolated from burn wound infection in laboratory conditions. The effect of 7 probiotic strains isolated from infant faeces on the pathogenicity factors of P. aeruginosa, including protease, elastase, antibiofilm and antipyocyanin was measured. Also, diffusion methods in the well and micro broth dilution were used to evaluate the antimicrobial activity of probiotics. All tests were performed in triplicate. A negative control and a positive control were used for each test. SPSS version 22 software was used for statistical analysis, and a p < 0.05 was considered statistically significant. A total of 30 clinical isolates of P. aeruginosa were isolated. The elastolytic activity of P. aeruginosa isolates decreased after adding Cell free supernatant (CFS) of each Lactobacillus. L1, L4, L5, and L6 strains had a 100% inhibitory effect on pathogen isolates. L3 and L7 strains had the lowest inhibitory effect. The inhibitory effect of CFS extracted from lactobacilli on protease production by P. aeruginosa. L1, L4, L5, and L6 strains had an inhibitory effect on all tested isolates. L2, L3, and L7 strains had a less inhibitory effect. L4 strain had the highest inhibitory effect on pyocyanin production by P. aeruginosa (50%), followed by L5 (43.3%), L1 (40%), and L6 (23.3%) strains. L3 and L7 strains had no inhibitory effect on the pyocyanin production of P. aeruginosa isolates. It was found that the CFS of 4 isolates (L1, L4, L5, and L6) was the most active extract and had a 100% inhibitory effect against biofilm formation of all P. aeruginosa strains. The L3 strain had the least inhibitory effect against the biofilm formation of pathogens. Overall, this study showed that probiotics could be promising alternatives to combat the pathogenicity of P. aeruginosa in burn wounds.

Implementation and the effects of a Parkinson Network Therapy (PaNTher) on activities of daily living and health-related quality of life in Parkinsons disease patients: study protocol of an mixed-method observational cohort study in outpatient care

Por: Loidl · V. · Ziegler · K. · Hoppmann · D. · Wagner · C. · Fietzek · U. M. · Ceballos-Baumann · A. O. · Grill · E.
Introduction

Parkinson’s disease (PD) represents the fastest growing neurodegenerative disease with an increasing prevalence worldwide. It is characterised by complex motor and non-motor symptoms that lead to considerable disability. Specialised physiotherapy has been shown to benefit patients with PD. The Parkinson Netzwerk Therapie (PaNTher) was created to improve access to specialised physiotherapy tailored to care priorities of PD patients. This study aims to evaluate the effectiveness, acceptability and needs of the PaNTher network by neurologists and physiotherapists involved in the network in outpatient care.

Methods and analysis

This is a mixed-method, prospective, pragmatic non-randomised cohort study of parallel groups, with data collection taking place in Bavaria, Germany, between 2020 and 2024. Patients with PD insured by the Allgemeine Ortskrankenkasse Bayern (AOK Bayern) living in Bavaria will be recruited for study participation by network partners. Patients in the intervention group must reside in Munich or the surrounding area to ensure provision of specialised physiotherapy in close proximity to their place of residence. Controls receive care as usual. Six and 12 months after baseline, all patients receive a follow-up questionnaire. Mixed-effect regression models will be used to examine changes in impairment of activities of daily living and quality of life of patients with PD enrolled in the programme over time compared with usual care. Qualitative interviews will investigate the implementation processes and acceptability of the PaNTher network among neurologists and physiotherapists. The study is expected to show that the PaNTher network with an integrative care approach will improve the quality and effectiveness of the management and treatment of patients with PD.

Ethics and dissemination

The study has been approved by the ethics committee at the medical faculty of the Ludwig-Maximilians-University Munich (20-318). Results will be published in scientific, peer-reviewed journals and presented at national and international conferences.

Phenomenography: A useful methodology for midwifery research

Abstract

Aims

To outline the theoretical, philosophical, and major assumptions associated with phenomenography and then address the application of a phenomenographical approach within the context of midwifery research.

Background

Phenemonography is a little-known qualitative research approach amongst the main design traditions of phenomenology, grounded theory, case study, and ethnography more typically used within midwifery research. Phenomenography aims to describe the qualitatively different ways that people perceive, conceptualize, or experience a phenomenon. Phenemonography has a distinctly different approach from other qualitative methods as it places emphasis on the ‘collective’ meaning over individual experience.

Methodology

Phenomenography, as an approach, rests within the interpretivist paradigm recognizing that there are multiple interpretations of reality. Phenomenography emphasizes the various ways that people experience the same phenomenon, including both the similarities and differences. The second-order perspective embraced by phenomenography suggests that the researcher directs themselves towards people's understanding of the world; essentially the world is described as it is understood rather than as it is. It is the reporting about how these different realities appear at a collective level that is the output of phenomenographic research.

Findings

A framework for conducting phenomenographic research is illustrated by outlining the steps within the methodological approach required to undertake a research study using phenemonography.

Conclusion

Phenomenography is a qualitative research approach that can usefully be applied in many midwifery contexts where a collective understanding of a phenomena is required. Using a phenomenographic approach can provide the midwifery profession with knowledge about variations in how women and midwives think, and how aspects of different phenomena are experienced in within a midwifery setting.

Dietary replacement of soybean meal with black soldier fly larvae meal in juvenile <i>Labeo rohita</i> and <i>Catla catla</i>: Effects on growth, nutritional quality, oxidative stress biomarkers and disease resistance

by Shafaq Fatima, Ayesha Afzal, Hamna Rashid, Saba Iqbal, Rosheen Zafar, Komal Khalid, Ayman Rauf, Maryam Majeed, Aqsa Malik, Chris G. Carter

This experiment aimed to investigate the effects of partial substitution of crude protein from soybean meal (SBM) with black soldier fly (Hermetia illucens) larvae meal (BSFLM) in juvenile rohu (Labeo rohita) and catla (Catla catla). Four isonitrogenous diets (23% crude protein) were formulated to replace 0% (T0), 40% (T40), 80% (T80) and 100% (T100) crude protein from SBM with BSFLM. Triplicate groups of each species (10 fish per replicate) were fed in an eight week growth experiment. After final sampling (n = 20 fish per dietary group), the remaining fish were exposed to bacterial (Staphylococcus aureus) challenge (0.80 CFU/ml) for 15 days. Rohu fed with BSFLM substituted diets showed significantly higher growth and feed conversion ratio as compared to those in T0. Catla fed with BSFLM substituted diets showed slightly higher growth indices. The growth response of rohu to BSFLM substitution was better than that noted in catla in all groups. The chemical composition, amino acids and fatty acids profile, haematological and biochemical parameters, levels of liver function enzymes measured in T0, T40, T80 and T100 were similar between four dietary groups in both species. However, the maximum value of cholesterol and triglycerides were noted in T100 both in catla and rohu. The values of lauric acid, α-linolenic acid, decosahexanoic acid, n3:n6 fatty acids ratio progressively increased with dietary increase of BSFLM in both species. At end of the growth experiment, the levels of catalase, superoxide dismutase and lysozyme increased linearly with the inclusion of BSFLM in both species while malondialdehyde showed similar values between different groups. However, catalase, and superoxide dismutase increased (T0

Experience and impact of gender-based violence in Honiara, Solomon Islands: a cross-sectional study recording violence over a 12-month period

Por: Chadwick · V. · Kluckow · H. · Mapstone · K. · Whiffin · V. · Ryder · B. · Rimon · M. · Hebala · H. · Hill · S. · Martiniuk · A. L.
Objective

This study aims to collect data on the experience and impact of gender-based violence experienced by women attending health clinics in Honiara, Solomon Islands.

Method

Any woman over the age of 18 who attended a local health clinic in Honiara, Solomon Islands during the time of recruitment (ten consecutive weekdays in May 2015) was eligible to participate in an interviewer administered, in-person survey, gathering data on gender-based violence over the past 12 months.

Results

A total of 100 women were recruited into this study. Of these women, 47% of women reported experiencing physical or sexual violence in the past 12 months. The most common perpetrators were the woman’s husband or boyfriend. There are low rates of reporting, particularly through formal avenues such as to police or village leaders. Alcohol was involved in more than half the cases of reported violence.

Conclusion

Women in this study report high rates of gender-based violence. To our knowledge, this is the only study examining women’s personal experience of gender-based violence in the Solomon Islands, with self-reported data on the frequency and nature of the violence, and the impact on women, including physical and mental, utilisation of healthcare services, police and legal involvement. Efforts to reduce gender-based violence should aim to reduce intimate partner violence, increase reporting and address wider social attitudes towards gender equality.

Acute myocardial infarction from a lower-middle income country—A comprehensive report on performance measures and quality metrics using National Cardiovascular Data Registry

by Farhala Baloch, Ainan Arshad, Sher Muhammad Sethi, Javed M. Tai

Introduction

Epidemic of cardiovascular disease (CVD) is widely projected in South Asian population and estimated to get double in two decades. Ischemic heart disease (IHD) is one of the spectrums of CVD and acute myocardial infarction (AMI) being the common manifestations of IHD. National Cardiovascular Data Registry (NCDR) is a registry data that measure their practices and improve quality of care. In this project we aim to see our performance trends in the care of IHD including AMI patients over two year’s period.

Material & methods

A cross sectional study conducted at the Aga Khan University Hospital, Karachi, Pakistan. All patients aged 18 years and above admitted to adult Cardiology units with chest pain and acute coronary syndrome are eligible to be included in NCDR data set. Data on demographics and initial characteristics of patients were extracted from NCDR institutional dataset. The data was then compared between 2019 and 2020 on performance, quality, and efficiency metrics.

Result

In 2019 to 2020, 1542 patients with acute coronary syndrome and stable ischemic heart disease were admitted. Out of these, 1042 patients (67.8%) were males. According to our data, the 2020 mortality rate was about 5.25%. In 2019 and 2020, bleeding rates were 1.1% and 1.6%, respectively. Our data showed 100% PCI in 90 minutes in 2019 while 87% in 2020. According to the appropriateness criteria for PCI, 80% were appropriate, while 20% were possibly appropriate in both years. The median length of stay following a procedure was 2 days in 2019 and 1 day in 2020.

Conclusion

This study described the common and unique characteristics of patients with myocardial infarction representing population from South Asian region. Overall, the procedural performance measure and outcome metrics are up to the international benchmarks. Cultural, financial, and pandemic effects identified certain challenges.

Prevalence and factors associated with cognitive frailty in heart failure: a systematic review and meta-analysis protocol

Por: Bolaji · O. A. · Shoar · S. · Ouedraogo · F. · Demelash · S. · Adabale · O.
Introduction

Heart failure (HF) is a global health issue affecting millions of people worldwide. Cognitive frailty, a syndrome characterised by physical frailty and cognitive impairment without dementia, is increasingly recognised in this population. Cognitive frailty is associated with worse outcomes, including increased hospitalisation, disability and mortality. This systematic review and meta-analysis aimed to investigate the incidence, prevalence and predictors of cognitive frailty in HF patients.

Methods

A systematic search will be conducted in MEDLINE/PubMed, EMBASE/Ovid, Web of Science and Google Scholar from inception to the latest search date. Eligible studies will report original data on adult patients (age ≥18 years) with HF, focusing on the incidence, prevalence and predictors of cognitive frailty. Two investigators will independently extract data and assess study quality using the Newcastle-Ottawa Scale and mixed-methods appraisal tool. Meta-analyses and meta-regression will be performed to estimate the pooled prevalence of cognitive frailty in HF patients and to identify predictors associated with increased risk, respectively. Subgroup analyses will be conducted to explore potential sources of heterogeneity.

Ethics and dissemination

This systematic review does not require ethical approval and informed consent, as it does not use identifiable patient data. The results of this study will be submitted for publication in a peer-reviewed medical journal. This comprehensive meta-analysis of the literature on cognitive frailty among HF patients will inform tailored interventions and management strategies, ultimately improving patients’ quality of life and outcomes.

Evaluating the performance of artificial intelligence software for lung nodule detection on chest radiographs in a retrospective real-world UK population

Por: Maiter · A. · Hocking · K. · Matthews · S. · Taylor · J. · Sharkey · M. · Metherall · P. · Alabed · S. · Dwivedi · K. · Shahin · Y. · Anderson · E. · Holt · S. · Rowbotham · C. · Kamil · M. A. · Hoggard · N. · Balasubramanian · S. P. · Swift · A. · Johns · C. S.
Objectives

Early identification of lung cancer on chest radiographs improves patient outcomes. Artificial intelligence (AI) tools may increase diagnostic accuracy and streamline this pathway. This study evaluated the performance of commercially available AI-based software trained to identify cancerous lung nodules on chest radiographs.

Design

This retrospective study included primary care chest radiographs acquired in a UK centre. The software evaluated each radiograph independently and outputs were compared with two reference standards: (1) the radiologist report and (2) the diagnosis of cancer by multidisciplinary team decision. Failure analysis was performed by interrogating the software marker locations on radiographs.

Participants

5722 consecutive chest radiographs were included from 5592 patients (median age 59 years, 53.8% women, 1.6% prevalence of cancer).

Results

Compared with radiologist reports for nodule detection, the software demonstrated sensitivity 54.5% (95% CI 44.2% to 64.4%), specificity 83.2% (82.2% to 84.1%), positive predictive value (PPV) 5.5% (4.6% to 6.6%) and negative predictive value (NPV) 99.0% (98.8% to 99.2%). Compared with cancer diagnosis, the software demonstrated sensitivity 60.9% (50.1% to 70.9%), specificity 83.3% (82.3% to 84.2%), PPV 5.6% (4.8% to 6.6%) and NPV 99.2% (99.0% to 99.4%). Normal or variant anatomy was misidentified as an abnormality in 69.9% of the 943 false positive cases.

Conclusions

The software demonstrated considerable underperformance in this real-world patient cohort. Failure analysis suggested a lack of generalisability in the training and testing datasets as a potential factor. The low PPV carries the risk of over-investigation and limits the translation of the software to clinical practice. Our findings highlight the importance of training and testing software in representative datasets, with broader implications for the implementation of AI tools in imaging.

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