bluuebunny/crossref_metadata_2025 huggingface dataset:
THE CABE PROJECT: Developing a model to conceptualise the sexual attitudes, behaviours, and experiences of men who have sex with men and Waria in Bali, Indonesia: Protocol for a mixed-methods design within a community-engaged research study
Authors: Septarini Ni Wayan , Burns Sharyn , Maycock Bruce
Published: December 2021

Introduction

The prevalence of sexually transmitted infections (STIs) among MSM (men who have sex with men) and transgender women (waria) in Bali is of significant public health concern. According to the 2015 Integrated Biological and Behavioural Survey (IBBS), HIV prevalence among MSM in Denpasar (the capital city of Bali) was 36% – the highest prevalence in this population reported nationally. In addition, 26% of MSM and 25% of waria in Indonesia were living with HIV in 2015. There is limited research examining the attitudes, behaviours and experiences of MSM in Indonesia, and specifically in Bali. This study will develop a model to help understand the social-cultural context, attitudes, behaviours, and experiences to inform interventions to increase safe sex practices amongst Indonesian MSM and waria who live in Bali.

Methods and analysis

The community-engaged research (CEnR) study, employing a sequential mixed-methods approach, will engage MSM and waria community throughout all five phases. The first two phases will include partnership building and exploratory research (focus group discussions/FGDs). Phase three will include the administration of a survey ( n = 374 Indonesian MSM and waria). Phases four and five include explanatory (in-depth interviews) and dissemination phases, respectively. Multivariate analysis will be employed for the quantitative data (the survey) and thematic analysis will be used to analyse the qualitative data (FGDs and in-depth interviews).

Discussion

The findings of this CEnR will inform culturally congruent interventions for organisation working with MSM and transgender to promote safer sexual health practice and improve general well-being of this community.
Antibiotic cement coating in orthopedic surgery: a systematic review of reported clinical techniques
Authors: Ismat Abdullah , Walter Nike , Baertl Susanne , Mika Joerg , Lang Siegmund , Kerschbaum Maximilian , Alt Volker , Rupp Markus
Published: December 2021

Background

Antibiotic-containing cement and bone graft substitute-coated orthopedic implants provide the advantages of simultaneous local antibiotic delivery and internal stable fixation, aiding in both infection eradication and osseous healing. Standardized protocols pertaining to implant coating techniques in various clinical and particularly intraoperative settings are scarce, and available literature is limited. This systematic review aims to provide a summary of the available current literature reporting on custom-made coating techniques of orthopedic implants, indications, outcomes, and associated complications in clinical use.

Methods

A systematic search of the literature in PubMed, Medline, Embase, and Cochrane Library databases was performed in accordance with PRISMA guidelines. Articles reporting specifically on custom-made coating techniques of orthopedic implants in a clinical setting were eligible.

Results

A total of 41 articles with a cumulative total number of 607 cases were included. Indications for treatment mostly involved intramedullary infections after previous plate osteosynthesis or nailing. A variety of implants ranging from intramedullary nails, plates, wires, and rods served as metal cores for coating. Polymethylmethacrylate (PMMA) bone cement was most commonly used, with vancomycin as the most frequently added antibiotic additive. Chest tubes and silicone tubes were most often used to mold. Common complications are cement debonding and breakage of the metallic implant.

Conclusion

Adequate coating techniques can reduce the burden of treatment and be associated with favorable outcomes. Lack of general consensus and heterogeneity in the reported literature indicate that the perfect all-in-one implant coating method is yet to be found. Further efforts to improve implant coating techniques are warranted.

Level of evidence

III.
The impact of Ramadan on visits related to diabetes emergencies at a tertiary care center
Authors: AlZahrani Abdullah M. , Zawawi Mawaddah M. , Almutairi Naif A. , Alansari Ammar Y. , Bargawi Amina A.
Published: December 2021

Background

Ramadan is the ninth month of the Islamic calendar were Muslims fast from dawn until sunset. This prolonged fasting period might have an impact on patients with diabetes and their disease control. This study aimed to determine the variation in visits at the Emergency Room department (ER) during Ramadan in comparison with other lunar months at a tertiary care hospital in Jeddah city in relation to the diabetes emergencies.

Methodology

A retrospective cross-sectional study was conducted using electronic medical record review of patients with diabetes emergencies who visited ER of a Military hospital, from 9th to 11th lunar months during 2017–2018. Diabetes patients who visited ER and aged more than 18 years old were included. Frequency of ER visits, sociodemographic characteristics and clinical features were determined. Chi-square test, Student ‘s t-test and one-way ANOVA atp < 0.05 were used in assessing associations between variables.

Results

Within the selected study period, a total of 24,498 admissions were recorded in ER. The prevalence of diabetes emergencies visits was only 0.84%. Based on inclusion criteria, a total of 133 subjects were included in the study (54.1% men, 45.9% women). Majority of whom (73.7%) were on insulin therapy, and more than half of whom (51.9%) were type 2 diabetes. There was a significant difference (p = 0.001) in the prevalence of diabetes emergencies visits between the three lunar months Shaban, Ramadan and Shawal, 7, 5 and 4%, respectively. However, the highest prevalence was not in Ramadan. Despite some correlations were identified, the study found no significant differences between frequency of ER visits and various demographic, clinical factors and diabetes profile between Ramadan and other both preceding and succeeding lunar month.

Conclusion

In contrary with previous studies, a downward trend of prevalence, from Shaban to Ramadan, to Shawal was found. This indicated that fasting during month of Ramadan does not impact negatively on the diabetes emergencies in comparison with other months. Hyperglycemia among type 2 diabetes and insulin treated patients were recorded the highest feature of diabetes emergences visits during the three months studied with no significant differences between the months. These findings highlight the need of type 2 and insulin treated patients to be thoroughly assess by the Primary Care physicians and in-depth health education and guidance should be given to them.
From urban neighbourhood environments to cognitive health: a cross-sectional analysis of the role of physical activity and sedentary behaviours
Authors: Cerin Ester , Barnett Anthony , Shaw Jonathan E. , Martino Erika , Knibbs Luke D. , Tham Rachel , Wheeler Amanda J. , Anstey Kaarin J.
Published: December 2021

Background

There is a dearth of studies on the effects of the neighbourhood environment on adults’ cognitive function. We examined how interrelated aspects of the built and natural neighbourhood environment, including air pollution, correlate with adults’ cognitive function, and the roles of physical activity and sedentary behaviours in these associations.

Methods

We used data from 4,141 adult urban dwellers who participated in the Australian Diabetes, Obesity and Lifestyle 3 study on socio-demographic characteristics, neighbourhood self-selection, physical activity and sedentary behaviours, and cognitive function. Neighbourhood environmental characteristics included population density, intersection density, non-commercial land use mix, and percentages of commercial land, parkland and blue space, all within 1 km residential buffers. We also calculated annual mean concentrations of NO2 and PM2.5. Generalised additive mixed models informed by directed acyclic graphs were used to estimate the total, direct and indirect effects of environmental attributes on cognitive functions and the joint-significance test was used to examine indirect effects via behaviours.

Results

In the total effects models, population density and percentage of parkland were positively associated with cognitive function. A positive association of PM2.5 with memory was also observed. All neighbourhood environmental attributes were directly and/or indirectly related to cognitive functions via other environmental attributes and/or physical activity but not sedentary behaviours. Engagement in transportation walking and gardening frequency partially mediated the positive effects of the neighbourhood environment on cognitive function, while frequency of transportation walking mediated the negative effects.

Conclusions

In the context of a low-density country like Australia, denser urban environments with access to parkland may benefit residents’ cognitive health by providing opportunities for participation in a diversity of activities. A more fine-grained characterisation of the neighbourhood environment may be necessary to tease out the negative and positive impacts of inter-related characteristics of urban neighbourhood environments on cognitive function.
On-site personal protective equipment signage and use by road construction workers in Ghana: a comparative study of foreign- and locally-owned companies
Authors: Yankson Isaac Kofi , Nsiah-Achampong Nana Kwame , Okyere Paul , Afukaar Francis , Otupiri Easmon , Donkor Peter , Mock Charles , Owusu-Dabo Ellis
Published: December 2021

Background

Road construction work has specific risks and safety issues which have not been adequately addressed in most low- and middle-income countries, especially Africa. The objective of this study was to determine the prevalence of personal protective equipment (PPE) use during road construction activities by workers in foreign- owned against locally-owned road construction companies in Ghana.

Methods

An institution-based cross-sectional survey was undertaken during January – March, 2020 to study 389 road construction workers who were actively working on site. They were unobtrusively observed to capture whether or not they wore the appropriate PPE at the time of the survey. The PPE of interest were: hard hat, goggles, shoes, nose masks, hearing protection, gloves and reflective vests/apparel. On-site posted PPE signage was also checked.

Results

Majority of workers were males (96.9%) and labourers (53.5%). Similar numbers of workers in locally-owned (195) and foreign-owned (194) companies were studied. Use of PPE varied considerably by type: shoes (78.7%), reflective vest (44.5%), gloves (30.6%), hard hat (27.0%), nose mask (17.2%), goggles (11.3%) and hearing protection (10.8%). For all types of PPE, use was higher for workers in foreign-owned companies compared with locally-owned companies: goggles (Odds ratio [OR] 55.2), hearing protection (OR 52.0), gloves (OR 23.7), hard hat (OR 20.2), nose mask (OR 17.8), reflective vest (OR 5.3) and shoes (OR 4.1), (p<0.001 for all ORs). No site had any signage to promote PPE use.

Conclusions

Majority of workers used shoes. Less than half of workers used other types of PPE and use of some types (goggles and hearing protection) was minimal. Workers in foreign-owned companies were significantly more likely to use all the seven types of PPE than locally-owned companies. Although there is still room for improvement in foreign-owned companies, locally-owned companies should be able to attain similar PPE use to that in foreign-owned companies. Necessary PPE should be provided and site supervisors should encourage workers to wear PPE when on site.
Cecal volvulus in rural Kenya: delayed presentation contributes to high mortality
Authors: Sylvester Kimutai R. , Ooko Philip B. , Mwachiro Michael M. , Parker Robert K.
Published: December 2021

Background

Cecal volvulus, which is a torsion involving the cecum, terminal ileum, and ascending colon around its own mesentery, results in a closed-loop obstruction. It is a rare reported cause of adult intestinal obstruction. This study aimed to review the clinical presentation, management, and outcomes at a rural, resource-limited referral center.

Methods

We performed a retrospective review of all patients with a diagnosis of cecal volvulus between January 1st, 2009 and December 31st, 2019 at Tenwek Hospital in Bomet, Kenya. The outcome of survival was compared by the time to presentation. Mortality was also compared with prior reports of intestinal obstruction at our institution.

Results

Thirteen patients were identified with a mean age of 52 years and a mean symptom duration of 5 days. All patients presented with abdominal pain and distension. Seven patients (54%) presented with perforation, gangrene, or gross peritoneal contamination. Identified risk factors were Ladds bands with malrotation, adhesions, and a sigmoid tumor. Procedures included primary resection and anastomosis (7), damage control (3) with anastomosis on second-look in 2 of these, simple surgical detorsion (1), and surgical detorsion and cecopexy (2). There were four mortalities (31%), of which all had delayed presentation with perforation and fecal contamination. Delays to presentation were associated with mortality (p = 0.03). Cecal volvulus resulted in increased perioperative mortality compared to all intestinal obstructions presenting to the institution (p < 0.0001).

Conclusions

Cecal volvulus carries a high risk of mortality. A high index of suspicion and early consideration in the differential diagnosis of intestinal obstruction should be considered to reduce the mortality associated with the delay in preoperative diagnosis.
Process mining framework with time perspective for understanding acute care: a case study of AIS in hospitals
Authors: Pang Jianfei , Xu Haifeng , Ren Jun , Yang Jun , Li Mei , Lu Dan , Zhao Dongsheng
Published: December 2021

Background

Acute care for critical illness requires very strict treatment timeliness. However, healthcare providers usually cannot accurately figure out the causes of low efficiency in acute care process due to the lack of effective tools. Besides, it is difficult to compare or conformance processes from different patient groups.

Methods

To solve these problems, we proposed a novel process mining framework with time perspective, which integrates four steps: standard activity construction, data extraction and filtering, iterative model discovery, and performance analysis.

Results

It can visualize the execution of actual clinical activities hierarchically, evaluate the timeliness and identify bottlenecks in the treatment process. We take the acute ischemic stroke as a case study, and retrospectively reviewed 420 patients’ data from a large hospital. Then we discovered process models with timelines, and identified the main reasons for in-hospital delay.

Conclusions

Experiment results demonstrate that the framework proposed could be a new way of drawing insights about hospitals’ clinical process, to help clinical institutions increase work efficiency and improve medical service.
Predictors of patients’ choice of hospitals under universal health coverage: a case study of the Nicaraguan capital
Authors: Monfared Ida G. , Garcia Jonathan , Vollmer Sebastian
Published: December 2021

Background

This study looks at the factors that can shape patients’ choice of healthcare providers. Understanding this process can help with making high quality healthcare more accessible for all. We focus on distance, patient’s health status, (perceived) quality of healthcare facility, and referrals to investigate how these factors compete in shaping patients’ choice of hospitals.

Methods

This study was carried out in Managua, the capital of Nicaragua. Utilizing an exit-survey, patients were interviewed across five public hospitals in 2017 and then six in 2019 when a new highly-equipped hospital was added to the system. We used a multinomial logit model to investigate patients’ preference of a specific hospital over the rest within each wave.

Results

Our results show that being referred to a hospital is the strongest predictor and in some cases, it can increase the relative risk ratio of choosing a facility by a factor of 49 (p < 0.01; 95% CI: 27.39–87.17). For the remaining factors, the hierarchy of importance was less clear-cut yet all these factors remained significantly important at various levels.

Conclusions

Overall, our results highlight the importance of referral systems in making quality healthcare more equitable. Moreover, with distance also being a key predictor and in the absence of an organized referral system, those with low-income would either be further deprived by having to settle with locally available healthcare (regardless of its quality) or face high amounts of out-of-pocket expenditure when seeking help from the private sector.
The effect of steam sterilization on different 3D printable materials for surgical use in veterinary medicine
Authors: Dautzenberg Philipp , Volk Holger A. , Huels Nikolaus , Cieciora Lena , Dohmen Katharina , Lüpke Matthias , Seifert Herman , Harms Oliver
Published: December 2021

Background

Different 3D-printed materials polyactic acid (PLA), polyamide (PA), polycarbonates (PC), acrylonitrile butadiene styrene (ABS) and GreenTEC Pro®I have been considered for surgical templates, but there is a sparity of data about how these materials are affected by steam sterilization. The aim of the current study was to test if and how these materials change morphologically when high temperature, pressure and humidity are applied during the steam sterilization process. The overall aim is to create patient-specific sawing templates for performing corrective osteotomies. After the designing process, test-specimens with five different materials: PLA, PC, ABS, PA and GreenTEC Pro® were 3D-printed in two filling grades (30 and 100%). The FDM method was used for printing. After 3D-printing, the test-specimens were steam sterilized with a standard program lasting 20 min, at a temperature of 121 °C and a pressure of 2–3 bar. In order to measure the deviation of the printed model, we measured the individual test-specimens before and after steam sterilization using a sliding gauge.

Results

PC, PA and ABS showed great morphological deviations from the template after 3D-printing and steam sterilization (> 1%) respectively. ABS proved unsuitable for steam sterilization. PLA and GreenTEC Pro® demonstrated fewer morphological deviations both before and after sterilization. Therefore, we decided to perform a second test just with PLA and Green-TEC Pro® to find out which material has the highest stability and is probably able to be used for clinical application. The smallest deviations were found with the GreenTEC Pro® solid body. After autoclaving, the specimens showed a deviation from the planned body and remained below the 1% limit.

Conclusion

Steam sterilization causes morphological deviations in 3D printed objects. GreenTEC Pro® seems to be a suitable material for clinical use, not only for intraoperative use, but also for precise modeling. Microbiological examination, as well as biomechanical tests, should be performed to further assess whether intraoperative use is possible.
Production of 9,21-dihydroxy-20-methyl-pregna-4-en-3-one from phytosterols in Mycobacterium neoaurum by modifying multiple genes and improving the intracellular environment
Authors: Yuan Chen-Yang , Ma Zhi-Guo , Zhang Jing-Xian , Liu Xiang-Cen , Du Gui-Lin , Sun Jun-Song , Shi Ji-Ping , Zhang Bao-Guo
Published: December 2021

Background

Steroid drugs are essential for disease prevention and clinical treatment. However, due to intricated steroid structure, traditional chemical methods are rarely implemented into the whole synthetic process for generating steroid intermediates. Novel steroid drug precursors and their ideal bacterial strains for industrial production have yet to be developed. Among these, 9,21-dihydroxy-20-methyl-pregna-4-en-3-one (9-OH-4-HP) is a novel steroid drug precursor, suitable for the synthesis of corticosteroids. In this study, a combined strategy of blocking Δ1-dehydrogenation and the C19 pathway as well as improving the intracellular environment was investigated to construct an effective 9-OH-4-HP-producing strain.

Results

The Δ1-dehydrogenation-deficient strain of wild-type Mycobacterium neoaurum DSM 44074 produces 9-OH-4-HP with a molar yield of 4.8%. Hsd4A, encoding a β-hydroxyacyl-CoA dehydrogenase, and fadA5, encoding an acyl-CoA thiolase, were separately knocked out to block the C19 pathway in the Δ1-dehydrogenation-deficient strain. The two engineered strains were able to accumulate 0.59 g L−1 and 0.47 g L−1 9-OH-4-HP from 1 g L−1 phytosterols, respectively. Furthermore, hsd4A and fadA5 were knocked out simultaneously in the Δ1-dehydrogenation-deficient strain. The 9-OH-4-HP production from the Hsd4A and FadA5 deficient strain was 11.9% higher than that of the Hsd4A deficient strain and 40.4% higher than that of the strain with FadA5 deficiency strain, respectively. The purity of 9-OH-4-HP obtained from the Hsd4A and FadA5 deficient strain has reached 94.9%. Subsequently, the catalase katE from Mycobacterium neoaurum and an NADH oxidase, nox, from Bacillus subtilis were overexpressed to improve the intracellular environment, leading to a higher 9-OH-4-HP production. Ultimately, 9-OH-4-HP production reached 3.58 g L−1 from 5 g L−1 phytosterols, and the purity of 9-OH-4-HP improved to 97%. The final 9-OH-4-HP production strain showed the best molar yield of 85.5%, compared with the previous reported strain with 30% molar yield of 9-OH-4-HP.

Conclusion

KstD, Hsd4A, and FadA5 are key enzymes for phytosterol side-chain degradation in the C19 pathway. Double deletion of hsd4A and fadA5 contributes to the blockage of the C19 pathway. Improving the intracellular environment of Mycobacterium neoaurum during phytosterol bioconversion could accelerate the conversion process and enhance the productivity of target sterol derivatives.
Efficacy and safety of various primary treatment strategies for very early and early hepatocellular carcinoma: a network meta-analysis
Authors: Yang Sha , Lin Huapeng , Song Jianning
Published: December 2021

Background

Several treatments are available for treatment of early and very early-stage Hepatocellular Carcinoma, also known as small Hepatocellular Carcinoma (SHCC). However, there is no consensus with regards to the efficacies of these methods. We aimed at identifying the most effective initial treatment strategy for SHCC through Bayesian network meta-analyses.

Methods

Studies published between January, 2010, and February, 2021 were searched in EMBASE, Cochrane Library, PubMed and Web of science databases, and conference proceedings for trials. The included studies reported the survival outcomes of very early and early Hepatocellular Carcinoma patients subjected to radiofrequency ablation (RFA), microwave ablation (MWA), surgical resection (SR), transarterial chemoembolization (TACE), percutaneous ethanol injection (PEI), minimally invasive liver surgery (MIS), stereotactic body radiotherapy (SBRT) and cryoablation (CA). Then, data were extracted from studies that met the inclusion criteria. Patient survival data were retrieved from the published Kaplan–Meier curves and pooled. A Bayesian random-effects model was used to combine direct and indirect evidence.

Results

A total of 2058 articles were retrieved and screened, from which 45 studies assessing the efficacies of 8 different treatments in 11,364 patients were selected. The included studies had high methodological quality. Recurrence free survival* (progression/recurrence/relapse/disease/tumor-free survival were combined and redefined as RFS*) and overall survival (OS) outcomes were highest in MIS-treated patients (HR 0·57, 95% confidence intervals [CI] 0·38–0·85; HR 0.48,95% CI 0.36–0.64, respectively), followed by SR-treated patients (HR 0.60, 95% CI 0.50–0.74; HR 0.62, 95% CI 0.55–0.72, respectively). TACE was highly efficacious (58.9%) at decreasing the rates of major complications. Similar findings were obtained through sensitivity analysis, and in most of the prognostic subgroups.

Conclusions

MIS and SR exhibited the highest clinical efficacies, however, they were associated with higher rates of complications. Ablation is effective in small tumors, whereas SBRT is a relatively promising treatment option for SHCC. More well-designed, large-scale randomized controlled trials should be performed to validate our findings.
Prognostic significance of the neutrophil-to-lymphocyte ratio in peripheral T-cell lymphoma: a meta-analysis
Authors: Liu Jia , Zhang Shengnan , Mi Ruihua , Chen Lin , Yin Qingsong
Published: December 2021

The neutrophil-to-lymphocyte ratio (NLR) as an inflammatory marker may represent changes between inflammation and host immunity that affect the prognosis of peripheral T-cell lymphoma (PTCL). To comprehensively evaluate the NLR in PTCL, we performed a meta-analysis to investigate the relationship between the NLR and overall survival (OS) and progression-free survival (PFS). PubMed, Embase, Cochrane library, and China National Knowledge Infrastructure (CNKI) were searched for all relevant studies. Hazard ratios (HRs) and 95% confidence intervals (CIs) were obtained from each study. Heterogeneity among the included studies was checked to determine whether fixed or random effects model was used. In total, 8 studies with 921 patients were included for the meta-analysis. High NLR significantly correlated with worse OS (HR = 2.20, 95% CI 1.71–2.83, P < 0.05) regardless of region (Asian or non-Asian), sample size (< 60 or ≥ 60), median age (< 60 or ≥ 60), disease type, or cut-off value (NLR < 3.9 or NLR ≥ 3.9). In terms of PFS, the NLR had no prognostic impact for patients with PTCL (HR = 1.12, 95% CI 0.57–2.20, P = 0.742). Our findings suggest that PTCL patients with high NLR are more likely to have worse OS compared to those with low NLR. Therefore, the NLR can serve as a prognostic marker in PTCL.
Neglected malaria parasites in hard-to-reach areas of Odisha, India: implications in elimination programme
Authors: Bal Madhusmita , Rana Ramakanta , Das Arundhuti , Khuntia Hemant Kumar , Somalkar Nilam , Sahoo Niranjan , Ghosal Jyoti , Pati Sanghamitra , Dutta Ambarish , Ranjit Manoranjan
Published: December 2021

Background

Information on the foci of Plasmodium species infections is essential for any country heading towards elimination. Odisha, one of the malaria-endemic states of India is targeting elimination of malaria by 2030. To support decision-making regarding targeted intervention, the distribution of Plasmodium species infections was investigated in hard-to-reach areas where a special malaria elimination drive, namely Durgama Anchalare Malaria Nirakaran (DAMaN) began in 2017.

Methods

A cross-sectional survey was conducted in 2228 households during July to November 2019 in six districts, to evaluate the occurrence of Plasmodium species. The species were identified by polymerase chain reaction (PCR) followed by sequencing, in case of Plasmodium ovale.

Results

Of the 3557 blood specimens tested, malaria infection was detected in 282 (7.8%) specimens by PCR. Of the total positive samples, 14.1% were P. ovale spp. and 10.3% were Plasmodium malariae infections. The majority of P. ovale spp. (75.8%) infections were mixed with either Plasmodium falciparum and/or Plasmodium vivax and found to be distributed in three geophysical regions (Northern-plateau, Central Tableland and Eastern Ghat) of the State, while P. malariae has been found in Northern-plateau and Eastern Ghat regions. Speciation revealed occurrence of both Plasmodium ovale curtisi (classic type) and Plasmodium ovale wallikeri (variant type).

Conclusions

In the present study a considerable number of P. ovale spp. and P. malariae were detected in a wide geographical areas of Odisha State, which contributes around 40% of the country’s total malaria burden. For successful elimination of malaria within the framework of national programme, P. ovale spp. along with P. malariae needs to be incorporated in surveillance system, especially when P. falciparum and P. vivax spp. are in rapid decline.
A cost–benefit analysis framework for preventive health interventions to aid decision-making in Australian governments
Authors: Ananthapavan Jaithri , Moodie Marj , Milat Andrew , Veerman Lennert , Whittaker Elizabeth , Carter Rob
Published: December 2021

Background

Australian governments are increasingly mandating the use of cost–benefit analysis (CBA) to inform the efficient allocation of government resources. CBA is likely to be useful when evaluating preventive health interventions that are often cross-sectoral in nature and require Cabinet approval prior to implementation. This study outlines a CBA framework for the evaluation of preventive health interventions that balances the need for consistency with other agency guidelines whilst adhering to guidelines and conventions for health economic evaluations.

Methods

We analysed CBA and other evaluation guidance documents published by Australian federal and New South Wales (NSW) government departments. Data extraction compared the recommendations made by different agencies and the impact on the analysis of preventive health interventions. The framework specifies a reference case and sensitivity analyses based on the following considerations: (1) applied economic evaluation theory; (2) consistency between CBA across different government departments; (3) the ease of moving from a CBA to a more conventional cost-effectiveness/cost-utility analysis framework often used for health interventions; (4) the practicalities of application; and (5) the needs of end users being both Cabinet decision-makers and health policy-makers.

Results

Nine documents provided CBA or relevant economic evaluation guidance. There were differences in terminology and areas of agreement and disagreement between the guidelines. Disagreement between guidelines involved (1) the community included in the societal perspective; (2) the number of options that should be appraised in ex ante analyses; (3) the appropriate time horizon for interventions with longer economic lives; (4) the theoretical basis and value of the discount rate; (5) parameter values for variables such as the value of a statistical life; and (6) the summary measure for decision-making.

Conclusions

This paper addresses some of the methodological challenges that have hindered the use of CBA in prevention by outlining a framework that is consistent with treasury department guidelines whilst considering the unique features of prevention policies. The effective use and implementation of a preventive health CBA framework is likely to require considerable investment of time and resources from state and federal government departments of health and treasury but has the potential to improve decision-making related to preventive health policies and programmes.
The cost-effectiveness of B-type natriuretic peptide-guided care in compared to standard clinical assessment in outpatients with heart failure in Tehran, Iran
Authors: Rezapour Aziz , Palmer Andrew J. , Alipour Vahid , Hajahmadi Marjan , Jafari Abdosaleh
Published: December 2021

Background

B-type natriuretic peptide (BNP) is commonly used as a diagnostic method for patients with heart failure. This study was designed to evaluate the cost-effectiveness of BNP compared to standard clinical assessment in outpatients with heart failure with reduced ejection fraction (HFrEF) in Tehran, Iran.

Methods

This study was a cost-effectiveness analysis carried on 400 HFrEF outpatients > 45 years who were admitted to Rasoul Akram General Hospital of Tehran, Iran. A Markov model with a lifetime horizon was developed to evaluate economic and clinical outcomes for BNP and standard clinical assessment. Quality-adjusted life-years (QALYs), direct, and indirect costs collected from the patients.

Results

The results of this study indicated that mean QALYs and cost were estimated to be 2.18 QALYs and $1835 for BNP and 2.07 and $2376 for standard clinical assessment, respectively. In terms of reducing costs and increasing QALYs, BNP was dominant compared to standard clinical assessment. Also, BNP had an 85% probability of being cost-effective versus standard clinical assessment if the willingness to pay threshold is higher than $20,800/QALY gained.

Conclusion

Based on the results of the present study, measuring BNP levels represents good value for money, decreasing costs and increasing QALYs compared to standard clinical assessment. It is suggested that the costs of the BNP test be covered by insurance in Iran. The result of the current study has important implications for policymakers in developing clinical guidelines for the diagnosis of heart failure.
Targeted cognitive game training enhances cognitive performance in multiple sclerosis patients treated with interferon beta 1-a
Authors: Menascu Shay , Aloni Roy , Dolev Mark , Magalashvili David , Gutman Keren , Dreyer-Alster Sapir , Tarpin-Bernard Franck , Achiron Ran , Harari Gil , Achiron Anat
Published: December 2021

Background

Prevention of cognitive decline in Multiple Sclerosis (MS) is of major importance. We explored the effect of a 6 months computerized game training program on cognitive performance in MS patients with mild cognitive impairment.

Methods

This was a single-center, randomized prospective study. We enrolled in this study 100 eligible MS patients treated with Interferon-beta-1a (Rebif). All had mild cognitive impairment in either executive function or information processing speed. Patients were randomized 1:1 to either use the cognitive games platform by HappyNeuron (HN) or receive no intervention. Executive function and information processing speed scores were measured at 3 and 6 months from baseline to evaluate the effect of game training on cognitive scores.

Results

In both executive function and information processing speed, the game Training group showed significant improvement after 3 and 6 months. The Non-Training group showed mild deterioration in both domains at 3 months, and further deterioration that became significant at 6 months in executive function. Furthermore, at 6 months, the percent of patients in the Training group that improved or remained stable in both cognitive domains was significantly higher compared to the Non-Training group.

Conclusions

Our findings suggest that cognitive game training has a beneficial effect on cognitive performance in MS patients suffering from mild cognitive impairment. While further evaluation is required to assess the longevity of that effect, we nonetheless recommend to MS patients to be engaged in cognitive gaming practice as part of a holistic approach to treating their condition.
The biology of medicinal resource substitution in Salvia
Authors: Cui Ning , Chen Tiezhu , Liao Baosheng , Xu Jiang , Li Xiwen
Published: December 2021

Background

The decrease of wild reserves and the sharp increase of market demand have led to resource substitution, but it is still not clear how to discover medicinal alternative resources. Here we reveal the biology of medicinal resource substitution in the case of Salvia.

Methods

A hypothesis was put forward that phylogeny and ecology were the main factors which determined alternative species selection. Phylogenetic analysis was performed based on chloroplast genomes. Spatial climatic pattern was assessed through three mathematical models.

Results

Salvia miltiorrhiza and alternative species were mainly located in Clade 3 in topology, and their growth environment was clustered into an independent group 3 inferred from principal component analysis. Correlation and Maxent major climate factor analyses showed that the ecological variations within each lineage were significantly smaller than the overall divergent between any two lineages. Mantel test reconfirmed the inalienability between phylogeny and ecology (P = 0.002). Only the species that are genetically and ecologically related to S. miltiorrhiza can form a cluster with it.

Conclusions

Phylogenetic relationship and geographical climate work together to determine which species has the potential to be selected as substitutes. Other medicinal plants can learn from this biology towards developing alternative resources.
Effects of the peripherally acting μ-opioid receptor antagonist methylnaltrexone on acute pancreatitis severity: study protocol for a multicentre double-blind randomised placebo-controlled interventional trial, the PAMORA-AP trial
Authors: Knoph Cecilie Siggaard , Cook Mathias Ellgaard , Fjelsted Camilla Ann , Novovic Srdan , Mortensen Michael Bau , Nielsen Liv Bjerre Juul , Hansen Mark Berner , Frøkjær Jens Brøndum , Olesen Søren Schou , Drewes Asbjørn Mohr
Published: December 2021

Background

Moderate to severe acute pancreatitis (AP) is associated with a high rate of complications and increased mortality, yet no targeted pharmacologic treatment currently exists. As pain is a dominant symptom in AP, patients are exposed to excess levels of both endo- and exogenous opioids, which may have harmful effects on the course of AP. This trial investigates the effects of the peripherally acting μ-opioid receptor antagonist (PAMORA) methylnaltrexone on disease severity and clinical outcomes in patients with moderate to severe AP.

Methods

PAMORA-AP is a multicentre, investigator-initiated, double-blind, randomised, placebo-controlled, interventional trial, which will be conducted at four referral centres for acute pancreatitis in Denmark. Ninety patients with early-onset AP (pain onset within 48 h) as well as predicted moderate to severe disease (two or more systemic inflammatory response syndrome criteria upon admission) will be prospectively included. Subsequently, participants will be randomised (1:1) to intravenous treatment with either methylnaltrexone or matching placebo (Ringer’s lactate) during 5 days of admission. The primary endpoint will be the group difference in disease severity as defined and measured by the Pancreatitis Activity Scoring System (PASS) score 48 h after randomisation. Secondary endpoints include daily PASS scores; disease severity according to the Atlanta classification; quantification of need for analgesics, nutritional support, intravenous fluid resuscitation and antibiotics; duration of hospital admissions, readmission rates and mortality. Pain intensity and gut function will be self-reported using validated questionnaires. Exploratory endpoints include circulating levels of pro-and anti-inflammatory markers, polyethylene glycol recovery from the urine, circulating levels of blood markers of intestinal permeability, the prevalence of pancreatic complications on computed tomography (CT) scans, and colon transit time assessed using a CT-based radiopaque marker method.

Discussion

This trial aims to evaluate the PAMORA methylnaltrexone as a novel targeted pharmacotherapy in patients with moderate to severe AP with the potential benefit of improved patient outcomes.

Trial registration

ClinicalTrials.govNCT04743570. Registered on 28 January 2021. EudraCT 2020-002313-18.
Cast OFF-2: 1 week of plaster cast immobilization for non-reduced distal radius fractures—a study protocol for an implementation study
Authors: Boersma Emily , van de Krol Erik , Tromp Tjarda , van der Sanden Maria Nijhuis - , Edwards Michael
Published: December 2021

Background

The distal radius fracture (DRF) is a common fracture, with the majority of these fractures being stable. Of all diagnosed fractures, 17% is a DRF, of which a large part is extra-articular and one-third is non-displaced. There is a large variation in treatment advisements for non-reduced DRF. Four to 5 weeks of immobilization is often the usual practice. Existing evidence shows that 1 week of immobilization is safe and does not lead to an increase in secondary displacement. Additionally, shorter immobilization periods may lead to less outpatient clinic visits and less home care for elderly people and may lead to earlier return to work and other social activities. Therefore, shorter immobilization periods for non-reduced distal radius fractures may also prove to be cost-effective.

In this study, we aim to successfully implement 1 week of plaster cast immobilization for non-reduced distal radius fractures in twelve medical centers and to evaluate the functional outcome and cost-effectiveness.

Methods

This study will be performed using a multicenter randomized stepped wedge design in 12 centers. We aim to include in the study 440 patients with an isolated non-reduced DRF between the age of 18 and 85 years old. The patients in the intervention group will be treated with plaster cast immobilization for 1 week. Acceptability of the study protocol, patient-reported outcomes, quality of life, complications, pain catastrophizing score, pain and patient satisfaction, and cost-effectiveness will be measured. The total follow-up will be 12 months.

Discussion

The strength of this study is the combination of implementing 1 week of plaster cast immobilization for non-reduced DRF and the evaluation of functional outcome, acceptability of the study protocol, and cost-effectiveness in actual practice.

Trial registration

Netherlands Trial Register NL9278. Registered on 17 February 2021
A survey of knowledge, perceptions and use of core outcome sets among clinical trialists
Authors: Bellucci Chiara , Hughes Karen , Toomey Elaine , Williamson Paula R. , Matvienko-Sikar Karen
Published: December 2021

Background

Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists’ knowledge, perceptions and experiences of COS.

Methods

An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists’ familiarity with and understanding of COS, along with experiences of COS use and development.

Results

Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%).

Conclusions

Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS.
Effects of balance training on static and dynamic balance performance in healthy children: role of training duration and volume
Authors: Muehlbauer Thomas
Published: December 2021

Objective

Improvements in balance performance through balance training programs in children have been reported in several studies. However, the influence of balance training modalities (e.g., training period, frequency, volume) on the training effectiveness have not yet been studied. To address this shortfall, the present study investigated the effects of balance training duration and volume (i.e., 240 min during 4 weeks versus 360 min during 6 weeks) on measures of static and dynamic balance performance in healthy children (N = 29) aged 10 years.

Results

Irrespective of balance training duration and volume, significant pre- to post-test improvements were found for variables of static (i.e., one-legged stance on foam ground, reduced number of floor contacts: p = .041, ηp2 = .15) and dynamic (i.e., Lower Quarter Y Balance test, increased anterior reach distance: p = .038, ηp2 = .15) balance performance but no group × test interactions were detected. These findings indicate that balance training is effective to improve static and dynamic balance performance in healthy children, but the effectiveness seems unaffected by the applied training duration and volume.

Trial Registration Current Controlled Trials ISRCTN75170753 (retrospectively registered at 12th April, 2021).
An unusual case of bone regeneration of a necrotic mandible with pathologic fracture in an elderly hemodialysis patient with medication-related osteonecrosis of the jaw: a case report and review of the literature
Authors: Yoshizawa Kunio , Moroi Akinori , Iguchi Ran , Takayama Akihiro , Goto Junko , Takayama Yutaka , Ueki Koichiro
Published: December 2021

Background

Bisphosphonates are frequently used for osteoporosis. Medication-related osteonecrosis of the jaw, a complication of bone-modifying agents, including bisphosphonates or angiogenic inhibitors, can be challenging to treat in elderly patients with numerous preexisting conditions. Achieving good treatment outcomes is especially difficult in patients with pathological fractures accompanied with extraoral fistulae.

Case presentation

We report an unusual case of prominent bone regeneration following palliative surgical treatment in a 72-year-old Japanese female patient undergoing hemodialysis. She previously had severe osteoporosis due to renal osteodystrophy and was receiving antiresorptive intravenous bisphosphonate. Computed tomography revealed a discontinuous left lower mandibular margin with a pathologic fracture and extensive, morphologically irregular sequestrum formation (80 × 35 × 20 mm). The patient was diagnosed with stage III medication-related osteonecrosis of the jaw and pathologic mandibular fracture. Immediately before the surgery, the anticoagulant used for dialysis was changed from heparin to nafamostat mesylate to reduce the risk of intraoperative bleeding. Sequestrectomy was performed under general anesthesia. Postoperative infection was not observed, the intraoral and submandibular fistula disappeared, and, surprisingly, prominent spontaneous bone regeneration was observed postoperatively at 6 months. Despite the severe systemic condition of the patient, the conservative surgical approach with sequestrectomy has yielded desirable results for more than 6 years since the surgery.

Conclusions

This rare report of spontaneous bone regeneration in a patient of advanced age and poor general condition is the oldest case of mandibular regeneration ever reported.