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AnteayerBMJ Open

Comparative efficacy of different types of acupuncture as adjuvant therapy on carotid atherosclerosis: a protocol for systematic review and network meta-analysis

Por: Wu · X. · Mo · Q. · Yang · Z. · Huang · X. · Liu · J. · Xu · S. · Zhang · N. · Yang · X.
Introduction

Carotid atherosclerosis (CAS) is a disease of the aorta caused by lipid metabolism disorders and local inflammation. Acupuncture combined with traditional western medicine (such as aspirin or atorvastatin) for the treatment of CAS has been widely applied in clinical practice, but there is still a lack of supporting evidence for its efficacy and safety on CAS. Therefore, this systematic review and network meta-analysis (NMA) will summarise the effects of different types of acupuncture treatments on CAS, and a ranking of the therapeutic classes will also be presented, aiming to provide evidence-based medicine for its extensive clinical application.

Methods and analysis

Systematic and NMA searches will be conducted in seven electronic databases: PubMed, EMBASE, Medline, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database and Chongqing VIP databases. The search time is from their inception to December 2020, regardless of language and publication type. Randomised controlled trials and controlled clinical trials that include patients with CAS receiving acupuncture therapy compared with a control group will be considered eligible. The primary outcomes include the carotid intima-media thickness and vessel plaque quantification; the secondary outcomes include the carotid plaque Crouse score, greyscale median, lipid levels, the incidence of cardiovascular events, safety and adverse events. The selection of studies, data extraction, quality assessment and risk of bias assessment will be conducted by two independent reviewers. The NMA will be analysed with Stata V.15.0, RevMan V.5.3 software and WinBUGS V.1.4.3.

Ethics and dissemination

Ethical approval will not be required for this study as it will be based on de-identified, aggregated published data. We will publish the findings in a peer-reviewed journal.

PROSPERO registration number

CRD42020207260.

What the public in England know about antibiotic use and resistance in 2020: a face-to-face questionnaire survey

Por: McNulty · C. · Read · B. · Quigley · A. · Verlander · N. Q. · Lecky · D. M.
Objectives

To describe public attitudes and knowledge around antibiotic activity, resistance and use.

Design

Face-to-face household 18 question survey using computer-assisted data collection undertaken by Ipsos Market and Opinion Research International.

Setting

Randomly selected households across England, January–February 2020.

Participants

2022 adults (aged 15+,) including 521 black, Asian and minority ethnic (BAME) participants, and 406 aged 15–25 years olds.

Main outcome measures

Responses to questions about antibiotic activity, resistance and expectations for antibiotics and trust in healthcare professionals. Analyses were weighted to obtain estimates representative of the population with multivariable analysis undertaken for questions with five or more significant univariate variables.

Results

84% stated they would be pleased if their general practitioner (GP) said they did not need antibiotics. Trust in GPs to make antibiotic decisions remains high (89%) and has increased for nurses (76%) and pharmacists (71%). Only 21% would challenge an antibiotic decision; this was significantly greater in BAME participants (OR 2.5; 95% CI 1.89 to 3.35). 70% reported receiving advice when prescribed antibiotics. Belief in benefits of antibiotics for ear infections was very high (68%). Similar to 2017, 81% agreed that antibiotics work for bacterial, 28% cold and influenza viruses. 84% agreed antibiotic resistant bacteria (ARB) are increasing, only 50% agreed healthy people can carry ARB and 39% agreed there was nothing they personally could do about ARB. Social grade DE and BAME participants, and those with less education had significantly less understanding about antibiotics and resistance.

Conclusions

As trust in healthcare practitioners is high, we need to continue antibiotic education and other interventions at GP surgeries and community pharmacies but highlight that most ear infections are not benefitted by antibiotics. Targeted interventions are needed for socioeconomic DE, BAME groups and previous antibiotic users. We need to explore if increasing perceived personal responsibility for preventing ARB reduces antibiotic use.

Societal economic burden of hypertension at selected hospitals in southern Ethiopia: a patient-level analysis

Por: Sorato · M. M. · Davari · M. · Kebriaeezadeh · A. · Sarrafzadegan · N. · Shibru · T.
Objectives

There is inadequate information on the economic burden of hypertension treatment in Ethiopia. Therefore, this study was conducted to determine the societal economic burden of hypertension at selected hospitals in Southern Ethiopia.

Methods

Prevalence-based cost of illness study from a societal perspective was conducted. Disability-adjusted life years (DALYs) were determined by the current WHO’s recommended DALY valuation method. Adjustment for comorbidity and a 3% discount was done for DALYs. The data entry, processing and analysis were done by using SPSS V.21.0 and Microsoft Excel V.2013.

Results

We followed a cohort of 406 adult patients with hypertension retrospectively for 10 years from September 2010 to 2020. Two hundred and fifty (61.6%) of patients were women with a mean age of 55.87±11.03 years. Less than 1 in five 75 (18.5%) of patients achieved their blood pressure control target. A total of US$64 837.48 direct cost was incurred due to hypertension. A total of 11 585 years and 579.57 years were lost due to hypertension-related premature mortality and morbidity, respectively. Treated and uncontrolled hypertension accounted for 50.83% (6027) of total years lost due to premature mortality from treated hypertension cohort. Total productivity loss due to premature mortality and morbidity was US$449 394.69. The overall economic burden of hypertension was US$514 232.16 (US$105.55 per person per month).

Conclusion

Societal economic burden of hypertension in Southern Ethiopia was substantial. Indirect costs accounted for more than 8 out of 10 dollars. Treated and uncontrolled hypertension took the lion’s share of economic cost and productivity loss due to premature mortality and morbidity. Therefore, designing and implanting strategies for the prevention of hypertension, early screening and detection, and improving the rate of blood pressure control by involving all relevant stakeholders at all levels is critical to saving scarce health resources.

Cost-effective analysis of mechanical thrombectomy alone in the treatment of acute ischaemic stroke: a Markov modelling study

Por: Han · M. · Qin · Y. · Tong · X. · Ji · L. · Zhao · S. · Liu · L. · Chen · J. · Liu · A.
Objective

Recently, a randomised controlled trial (DIRECT-MT) demonstrated that mechanical thrombectomy (MT) was non-inferior to MT with intravenous alteplase as to the functional outcomes. This study aims to investigate whether MT alone is cost-effective compared with MT with alteplase in China.

Methods

A Markov decision analytic model was built from the Chinese healthcare perspective using a lifetime horizon. Probabilities, costs and outcomes data were obtained from the DIRECT-MT trial and other most recent/comprehensive literature. Base case calculation was conducted to compare the costs and effectiveness between MT alone and MT with alteplase. One-way and probabilistic sensitivity analyses were performed to evaluate the robustness of the results.

Results

MT alone had a lower cost and higher effectiveness compared with MT with alteplase. The probabilistic sensitivity analysis demonstrated that, over a lifetime horizon, MT alone had a 99.5% probability of being cost-effective under the willingness-to-pay threshold of 1x gross domestic product per capita in China based on data obtained from the DIRECT-MT trial. These results remained robust under one-way sensitivity analysis.

Conclusions

MT alone was cost-effective compared with MT with alteplase in China. However, cautions are needed to extend this conclusion to regions outside of China.

Missing Piece Study protocol: prospective surveillance to determine the epidemiology of group A streptococcal pharyngitis and impetigo in remote Western Australia

Por: Barth · D. D. · Mullane · M. J. · Sampson · C. · Chou · C. · Pickering · J. · Nicol · M. P. · Davies · M. R. · Carapetis · J. · Bowen · A. C.
Introduction

Group A β-haemolytic Streptococcus (GAS), a Gram-positive bacterium, causes skin, mucosal and systemic infections. Repeated GAS infections can lead to autoimmune diseases acute rheumatic fever (ARF) and rheumatic heart disease (RHD). Aboriginal and Torres Strait Islander peoples in Australia have the highest rates of ARF and RHD in the world. Despite this, the contemporaneous prevalence and incidence of GAS pharyngitis and impetigo in remote Australia remains unknown. To address this, we have designed a prospective surveillance study of GAS pharyngitis and impetigo to collect coincident contemporary evidence to inform and enhance primary prevention strategies for ARF.

Methods and analysis

The Missing Piece Study aims to document the epidemiology of GAS pharyngitis and impetigo through collection of clinical, serological, microbiological and bacterial genomic data among remote-living Australian children. The study comprises two components: (1) screening of all children at school for GAS pharyngitis and impetigo up to three times a year and (2) weekly active surveillance visits to detect new cases of pharyngitis and impetigo. Environmental swabbing in remote schools will be included, to inform environmental health interventions. In addition, the application of new diagnostic technologies, microbiome analysis and bacterial genomic evaluations will enhance primary prevention strategies, having direct bearing on clinical care, vaccine development and surveillance for vaccine clinical trials.

Ethics and dissemination

Ethical approval has been obtained from the Western Australian Aboriginal Health Ethics Committee (Ref: 892) and Human Research Ethics Committee of the University of Western Australia (Ref: RA/4/20/5101). Study findings will be shared with community members, teachers and children at participating schools, together with academic and medical services. Sharing findings in an appropriate manner is important and will be done in a suitable way which includes plain language summaries and presentations. Finally, findings and updates will also be disseminated to collaborators, researchers and health planners through peer-reviewed journal publications.

Predictive performance of comorbidity for 30-day and 1-year mortality in patients with bloodstream infection visiting the emergency department: a retrospective cohort study

Por: Schuttevaer · R. · Boogers · W. · Brink · A. · van Dijk · W. · de Steenwinkel · J. · Schuit · S. · Verbon · A. · Lingsma · H. · Alsma · J.
Objectives

To investigate whether the Charlson Comorbidity Index (CCI) predicted short-term and long-term mortality in patients with a bloodstream infection visiting the emergency department (ED) and compare it to the often-validated National Early Warning Score (NEWS).

Design

A retrospective cohort study.

Setting

A tertiary hospital in the Netherlands.

Participants

Adult patients attending the ED with a blood culture-proven infection between 2012 and 2017 were included. We collected the comorbidities from the CCI and the vital signs from the NEWS.

Main outcomes

Short-term mortality (30-day) and long-term mortality (1 year). We assessed the predictive performance by discrimination, expressed as the area under the curve (AUC).

Results

We included 1039 patients with a blood culture-proven infection. Mortality was 10.4% within 30 days and 27.8% within 1 year. On average patients had two comorbidities (ranging from 0 to 6). Highly prevalent comorbidities were malignancy (30.2%) and diabetes mellitus (20.5%). The predictive performance of the CCI was highest for 1-year mortality (AUC 0.696 (95%CI) (0.660 to 0.732)) and better compared with the NEWS (AUC (95% CI) 0.594 (0.555 to 0.632)). For prediction of 30-day mortality, the NEWS was superior (AUC (95% CI) 0.706 (0.656 to 0.756)) to the comorbidities of the CCI (AUC (95% CI) 0.568 (0.507 to 0.628)).

Conclusions

We found that presenting comorbidity (ie, the CCI) is most useful to prognosticate long-term outcome in patients with bloodstream infection in the ED. Short-term mortality is more accurately predicted by deviating vital signs (ie, the NEWS).

Comorbidities in osteoarthritis (ComOA): a combined cross-sectional, case-control and cohort study using large electronic health records in four European countries

Por: Swain · S. · Kamps · A. · Runhaar · J. · Dell'Isola · A. · Turkiewicz · A. · Robinson · D. · Strauss · V. · Mallen · C. · Kuo · C.-F. · Coupland · C. · Doherty · M. · Sarmanova · A. · Prieto-Alhambra · D. · Englund · M. · Bierma-Zeinstra · S. M. A. · Zhang · W.
Introduction

Osteoarthritis (OA) is one of the leading chronic conditions in the older population. People with OA are more likely to have one or more other chronic conditions than those without. However, the temporal associations, clusters of the comorbidities, role of analgesics and the causality and variation between populations are yet to be investigated. This paper describes the protocol of a multinational study in four European countries (UK, Netherlands, Sweden and Spain) exploring comorbidities in people with OA.

Methods and analysis

This multinational study will investigate (1) the temporal associations of 61 identified comorbidities with OA, (2) the clusters and trajectories of comorbidities in people with OA, (3) the role of analgesics on incidence of comorbidities in people with OA, (4) the potential biomarkers and causality between OA and the comorbidities, and (5) variations between countries.

A combined case–control and cohort study will be conducted to find the temporal association of OA with the comorbidities using the national or regional health databases. Latent class analysis will be performed to identify the clusters at baseline and joint latent class analysis will be used to examine trajectories during the follow-up. A cohort study will be undertaken to evaluate the role of non-steroidal anti-inflammatory drugs (NSAIDs), opioids and paracetamol on the incidence of comorbidities. Mendelian randomisation will be performed to investigate the potential biomarkers for causality between OA and the comorbidities using the UK Biobank and the Rotterdam Study databases. Finally, a meta-analyses will be used to examine the variations and pool the results from different countries.

Ethics and dissemination

Research ethics was obtained according to each database requirement. Results will be disseminated through the FOREUM website, scientific meetings, publications and in partnership with patient organisations.

Expediting workflow in the acute stroke pathway for endovascular thrombectomy in the northern Netherlands: a simulation model

Objective

The objective of this study is to identify barriers for the timely delivery of endovascular thrombectomy (EVT) and to investigate the effects of potential workflow improvements in the acute stroke pathway.

Design

Hospital data prospectively collected in the MR CLEAN Registry were linked to emergency medical services data for each EVT patient and used to build two Monte Carlo simulation models. The ‘mothership (MS) model’, reflecting patients who arrived directly at the comprehensive stroke centre (CSC); and the ‘drip and ship’ (DS) model, reflecting patients who were transferred to the CSC from primary stroke centres (PSCs).

Setting

Northern region of the Netherlands. One CSC provides EVT, and its catchment area includes eight PSCs.

Participants

248 patients who were treated with EVT between July 2014 and November 2017.

Outcome measures

The main outcome measures were total delay from stroke onset until groin puncture, functional independence at 90 days (modified Rankin Scale 0–2) and mortality.

Results

Barriers identified included fast-track emergency department routing, prealert for transfer to the CSC, reduced handover time between PSC and ambulance, direct transfer from CSC arrival to angiography suite entry, and reducing time to groin puncture. Taken together, all workflow improvements could potentially reduce the time from onset to groin puncture by 59 min for the MS model and 61 min for the DS model. These improvements could thus result in more patients—3.7% MS and 7.4% DS—regaining functional independence after 90 days, in addition to decreasing mortality by 3.0% and 5.0%, respectively.

Conclusions

In our region, the proposed workflow improvements might reduce time to treatment by about 1 hour and increase the number of patients regaining functional independence by 6%. Simulation modelling is useful for assessing the potential effects of interventions aimed at reducing time from onset to EVT.

Sociocultural perspectives on suicidal behaviour at the Coast Region of Kenya: an exploratory qualitative study

Por: Ongeri · L. · Nyawira · M. · Kariuki · S. M. · Theuri · C. · Bitta · M. · Penninx · B. · Newton · C. R. · Tijdink · J.
Objectives

To explore perceived sociocultural factors that may influence suicidality from key informants residing in coastal Kenya.

Design

We used an exploratory qualitative study design.

Setting

Mombasa and Kilifi Counties of Coastal Kenya.

Participants

25 key informants including community leaders, professionals and community members directly and indirectly affected by suicidality.

Methods

We conducted in-depth interviews with purposively selected key informants to collect data on sociocultural perspectives of suicide. Thematic analysis was used to identify key themes using both inductive and deductive processes.

Results

Four key themes were identified from the inductive content analysis of 25 in-depth interviews as being important for understanding cultural perspectives related to suicidality: (1) the stigma of suicidal behaviour, with suicidal victims perceived as weak or crazy, and suicidal act as evil and illegal; (2) the attribution of supernatural causality to suicide, for example, due to sorcery or inherited curses; (3) the convoluted pathway to care, specifically, delayed access to biomedical care and preference for informal healers; and (4) gender and age differences influencing suicide motivation, method of suicide and care seeking behaviour for suicidality.

Conclusions

This study provides an in depth understanding of cultural factors attributed to suicide in this rural community that may engender stigma, discrimination and poor access to mental healthcare in this community. We recommend multipronged and multilevel suicide prevention interventions targeted at changing stigmatising attitudes, beliefs and behaviours, and improving access to mental healthcare in the community.

What research evidence exists about physical activity in parents? A systematic scoping review

Por: Simpson · R. F. · Hesketh · K. R. · Ellis · K. · van Sluijs · E. M.
Objectives

Despite the known benefits of physical activity (PA) to physical and mental health, many people fail to achieve recommended PA levels. Parents are less active than non-parent contemporaries and constitute a large potential intervention population. However, little is known about the breadth and scope of parental PA research. This scoping review therefore aimed to provide an overview of the current evidence base on parental PA.

Methods

Four databases (MEDLINE, Embase, PsycINFO and Scopus) were systematically searched to identify peer-reviewed articles focusing on parental PA from 2005 onwards, including interventional, observational or qualitative study designs. Title and abstract screening was followed by duplicate full-text screening. Data extracted for all articles (100% checked by a second reviewer) included study design, proportion of fathers and ages of children. For interventional/observational studies, PA assessment method and factors examined or targeted based on the socio-ecological model were extracted, and questions addressed in qualitative studies.

Results

Of 14 913 unique records retrieved, 213 articles were included; 27 articles reported on more than one study design; 173 articles reported on quantitative (81 cross-sectional, 26 longitudinal and 76 interventional) and 58 on qualitative data. Most articles originated from North America (62%), and 53% included only mothers, while 2% included only fathers. Articles most frequently represented parents of infants (56% of articles), toddlers (43%), preschoolers (50%) and primary-school aged children (49%). Most quantitative articles only reported self-reported PA (70%). Observational articles focused on individual correlates/determinants (88%). Likewise, most interventions (88% of articles) targeted individual factors. Most qualitative articles explored PA barriers and facilitators (57%).

Conclusions

A range of quantitative and qualitative research has been conducted on parental PA. This review highlights opportunities for evidence synthesis to inform intervention development (such as barriers and facilitators of parental PA) and identifies gaps in the literature, for example, around paternal PA.

Review registration

osf.io/qt9up.

COVID-19 seroprevalence in Pakistan: a cross-sectional study

Por: Ahmad · A. M. · Shahzad · K. · Masood · M. · Umar · M. · Abbasi · F. · Hafeez · A.
Objectives

This study adapted WHO’s Unity Study’ protocol to estimate the population prevalence of antibodies to SARS CoV-2 and risk factors for developing SARS-CoV-2 infection.

Design

This population-based, age-stratified cross-sectional study was conducted at the level of households (HH).

Participants

All ages and genders were eligible for the study (exclusion criteria: contraindications to venipuncture- however, no such case was encountered). 4998 HH out of 6599 consented (1 individual per HH). The proportion of male and female study participants was similar.

Primary and secondary outcome measures

Following were the measured outcome measures- these were different from the planned indicators (i.e. two out of the three planned indicators were measured) due to operational reasons and time constraints: -

Primary indicators: Seroprevalence (population and age specific).

Secondary indicators: Population groups most at risk for SARS-CoV-2-infection.

Results

Overall seroprevalence of SARS-CoV-2 antibodies was 7.1%. 6.3% of individuals were IgG positive while IgM positivity was 1.9%. Seroprevalence in districts ranged from 0% (Ghotki) to 17% (Gilgit). The seroprevalence among different age groups ranged from 3.9% (0–9 years) to 10.1% (40–59 years). There were no significant differences in the overall seroprevalence for males and females. A history of contact with a confirmed COVID-19 case, urban residence and mask use were key risk factors for developing SARS-CoV-2 infection.

Conclusions

This survey provides useful estimates for seroprevalence in the general population and information on risk factors for developing SARS-CoV-2 infection in the country. It is premised that similar studies need to be replicated at the population level on a regular basis to monitor the disease and immunity patterns related to COVID-19.

Dutch injection versus surgery trial in patients with carpal tunnel syndrome (DISTRICTS): protocol of a randomised controlled trial comparing two treatment strategies

Por: Palmbergen · W. A. C. · de Bie · R. M. A. · Alleman · T. W. H. · Verstraete · E. · Jellema · K. · Verhagen · W. I. M. · Brekelmans · G. J. F. · de Ruiter · G. C. W. · van de Beek · D. · de Borgie · C. A. J. M. · de Haan · R. · Beekman · R. · Verhamme · C.
Introduction

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. The optimal treatment strategy is still unknown. The objective of the Dutch Injection versus Surgery TRIal in patients with CTS (DISTRICTS) is to investigate if initial surgery of CTS results in a better clinical outcome and is more cost-effective when compared with initial treatment with corticosteroid injection.

Methods and analysis

The DISTRICTS is an ongoing multicenter, open-label randomised controlled trial. Participants with CTS are randomised to treatment with surgery or with a corticosteroid injection. If needed, any additional treatments after this first treatment are allowed and these are not dictated by the study protocol. The primary outcome is the difference between the groups in the proportion of participants recovered at 18 months. Recovery is defined as having no or mild symptoms as measured with the 6-item carpal tunnel symptoms scale. Secondary outcome measurements are among others: time to recovery, hand function, patient satisfaction, quality of life, additional treatments, adverse events, and use of care and health-related costs.

Ethics and dissemination

The study was approved by the Medical Ethical Committee of the Amsterdam University Medical Centers (study number 2017-171). Study results will be disseminated in peer-reviewed journals and conferences.

Trial registration number

ISRCTN Registry: 13164336.

Bladder cancer in Aboriginal and Torres Strait Islander people living in Australia: a scoping review protocol

Por: Pattenden · T. · Samaranayake · D. · Morton · A. · Thangasamy · I.
Introduction

Bladder cancer is the third most common urological malignancy affecting Australians, with key modifiable risk factors. Aboriginal and Torres Strait Islander people suffer from a higher prevalence of cancer-modifiable risk factors, are diagnosed with bladder cancer at a younger age, and have poorer survival rates compared with the general population. A comprehensive overview of the state of current knowledge on bladder cancer in this population is required.

Methods and analysis

A search of MEDLINE, CINAHL, EMBASE and Web of Science databases, along with appropriate grey literature sources will be conducted between the 1 April 2022 and 30 April 2022. The reference lists of all included studies will be reviewed for additional appropriate sources. The national bladder cancer dataset compiled by the Australian Institute of Health and Welfare will also be included as a source. All relevant sources meeting inclusion criteria, published in English, from inception onwards will be included. Dual independent screening of titles and abstracts prior to full-text review will be undertaken for all identified results during the initial searches. Preliminary findings will be reviewed with stakeholders, to seek culturally appropriate feedback on the implications of the results. Results will be reported in tabular form, accompanied by a narrative synthesis with comparisons to the wider bladder cancer population.

Ethics and dissemination

Ethics review will not be required, as only publicly available data will be analysed. Findings from the scoping review will be published in a peer-reviewed journal and presented at scientific meetings to stakeholders.

Association of plasma apolipoproteins and levels of inflammation-related factors with different stages of Alzheimers disease: a cross-sectional study

Por: Wang · T. · Wang · X. · Yao · Y. · Zhao · C. · Yang · C. · Han · Y. · Cai · Y.
Objective

Blood-based biomarkers for the early diagnosis of Alzheimer’s disease (AD) are a ‘Holy Grail’ of AD research. Growing evidence shows that levels of apolipoproteins and various inflammation-related factors are altered in the peripheral blood of patients with AD. The purpose of this study was to clear and definite whether these biomarkers are differentially expressed at the early stages of AD, and could be a biomarker as an early diagnosis of the disease.

Design

Observation study.

Setting

This study was a part of the Sino Longitudinal Study on Cognitive Decline, an ongoing prospective cohort study (ClinicalTrials.gov identifier: NCT03370744) that centres on Xuanwu Hospital (Beijing, China) in cooperation with an alliance of 94 hospitals from 50 cities across China.

Participants

In the present study, 416 right-handed Chinese Han subjects were recruited through standardised public advertisements from 2014 to 2019.

Outcome measures

Concentrations of plasma apolipoprotein A1, apolipoprotein CIII (ApoCIII), apolipoprotein E (ApoE), A-2-macroglobulin (A2M), complement C3 (C3) and complement factor H (FH) were determined using a commercial multiplex Luminex-based panel in normal controls (NC), subjective cognitive decline (SCD), mild cognitive impairment and AD groups.

Results

For individual analysis, pairwise comparisons showed that: (1) For SCD versus NC, no biomarker showed significant difference; (2) For amnestic mild cognitive impairment (aMCI) versus NC, levels of ApoCIII, ApoE, A2M, C3 and FH increased significantly; and (3) For AD versus NC, amounts of C3 increased. For models differentiating clinical groups, discriminant analysis was performed by including all protein markers, age, sex, genotype and education level in the model. This approach could distinguish between patients with aMCI (area under the curve (AUC): 0.743) and AD (AUC: 0.837) from NC.

Conclusion

Our results suggest that concentrations of certain apolipoproteins and inflammation-related factors are altered at the early stage of AD, and could be useful biomarkers for early diagnosis.

Trial registration number

NCT03370744.

Development of an intervention to improve informational continuity of care in older patients with polypharmacy at the interface between general practice and hospital care: protocol for a participatory qualitative study in Germany

Por: Brueckle · M.-S. · Dinh · T. S. · Klein · A.-A. · Rietschel · L. · Petermann · J. · Brosse · F. · Schulz-Rothe · S. · Gonzalez-Gonzalez · A. I. · Kramer · M. · Engler · J. · Mergenthal · K. · Muth · C. · Voigt · K. · van den Akker · M.
Introduction

Older patients with multimorbidity, polypharmacy and related complex care needs represent a growing proportion of the population and a challenge for healthcare systems. Particularly in transitional care (hospital admission and hospital discharge), medical errors, inappropriate treatment, patient concerns and lack of confidence in healthcare are major problems that may arise from a lack of information continuity. The aim of this study is to develop an intervention to improve informational continuity of care at the interface between general practice and hospital care.

Methods and analysis

A qualitative approach will be used to develop our participatory intervention. Overall, 32 semistructured interviews with relevant stakeholders will be conducted and analysed. The stakeholders will include healthcare professionals from the outpatient setting (general practitioners, healthcare assistants, ambulatory care nurses) and the inpatient setting (clinical doctors, nurses, pharmacists, clinical information scientists) as well as patients and informal caregivers. At a series of workshops based on the results of the stakeholder analyses, we aim to develop a participatory intervention that will then be implemented in a subsequent pilot study. The same stakeholder groups will be invited for participation in the workshops.

Ethics and dissemination

Ethical approval for this study was waived by the Ethics Committee of Goethe University Frankfurt because of the nature of the proposed study. Written informed consent will be obtained from all study participants prior to participation. Results will be tested in a pilot study and disseminated at (inter)national conferences and via publication in peer-reviewed journals.

Trial registation number

Clinical Trials Register: registration number DRKS00027649.

Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial)

Por: Bajpai · M. · Maheshwari · A. · Dogra · V. · Kumar · S. · Gupta · E. · kale · P. · Saluja · V. · Thomas · S. S. · Trehanpati · N. · Bihari · C. · Agarwal · R. · Bharti · P. · Shankar · P. · Hussain · J. · Chhabra · K. · Gupta · A. · Narayanan · A. · Agarwal · S. · Jain · S. · Bhardwaj · A. · K
Importance

No proven treatment is available for severely ill COVID-19. Therapeutic use of COVID-19 convalescent plasma (COPLA) is under investigation.

Objective

To compare the efficacy of COPLA with standard medical therapy (SMT) alone in severe COVID-19 patients.

Design, setting and participants

A multicentric, open-labelled, phase-III randomised controlled trial conducted at two treatment centres with COPLA collected at the third dedicated centre in North-India, the coordinating centre during trial from June 2020 to December 2020. The study population comprised 400 participants in the ratio of 1:1 in each treatment group.

Intervention

One group received COPLA with SMT (n=200), and another group received SMT only (n=200).

Main outcome measures

Primary outcome was time to clinical improvement measured by a two-point reduction in the ordinal scale. Secondary outcomes included duration of O2 therapy, the proportion of patients on mechanical ventilation at day-7, mortality, SARS-CoV-2 antibody levels, cytokine levels and incidence of adverse events.

Results

The median time to a two-point reduction in the ordinal scale in both groups was 9 days (IQR=7–13) (p=0.328). The median duration of O2 therapy was 8 days (IQR=6–12) in COPLA and 10 days (IQR=6–12) in SMT group (p=0.64). The PaO2/FiO2 ratio showed significant improvement at 7 days in COPLA group(p=0.036). There was no difference in mortality till 28 days in both groups (p=0.62). However, if COPLA was given within 3 days of hospital admission, a significant reduction in ordinal scale was observed (p=0.04). Neutralising antibody titres in COPLA group (80 (IQR 80–80)) were higher than SMT group (0 (IQR 0–80)) at 48 hours (p=0.001). COPLA therapy led to a significant reduction in TNF-α levels at 48 hours (p=0.048) and D-dimer at 7 days (p=0.02). Mild allergic reactions were observed in 3 (1.5%) patients in COPLA group.

Conclusion and relevance

Convalescent plasma with adequate antibody titres should be transfused in COVID-19 patients along with SMT in the initial 3 days of hospitalisation for better clinical outcomes.

Trial registration number

NCT04425915.

Development of a multicomponent intervention to increase parental vaccine confidence and young peoples access to the universal HPV vaccination programme in England: protocol for a co-design study

Por: Fisher · H. · Chantler · T. · Denford · S. · Finn · A. · Hickman · M. · Mounier-Jack · S. · Roderick · M. · Tucker · L. · Yates · J. · Audrey · S.
Introduction

Persistent infection with HPV can result in cancers affecting men and, especially, women. Lower uptake exists by area and different population groups. Increasing parental confidence about, and adolescent access to, the universal HPV vaccination programme may help reduce inequalities in uptake. However, the evidence-base for interventions to address uptake for schools-based HPV vaccination programmes is currently lacking. This study protocol outlines how a multicomponent intervention to address this evidence gap will be codesigned with parents.

Methods and analysis

The proposed research will be undertaken in localities covered by two immunisation teams in London and the south-west of England. The ‘person-based approach’ to intervention development will be followed. In the first phase, an exploratory qualitative study will be undertaken with key stakeholders (n=8) and parents (n=40) who did not provide consent for their adolescent child to be vaccinated. During the interviews, parents’ views on ways to improve parental confidence about, and adolescents’ access to, HPV vaccination will be sought. The findings will be used to inform the co-design of a preliminary plan for a targeted, multicomponent intervention. In the second phase, at least two parent working groups (n=8) will be convened and will work with creative designers to co-design communication materials aimed at increasing parents’ confidence in vaccination. At least two workshops with each parent group will be organised to obtain feedback on the intervention plan and communication materials to ensure they are fit for purpose. These findings will inform a protocol for a future study to test the effectiveness of the intervention at increasing HPV vaccination uptake.

Ethics and dissemination

The National Health Services Research Ethics Service and London School of Hygiene & Tropical Medicine Observational / Interventions Research Ethics Committee provided approvals for the study (reference 22/SW/0003 & 26902, respectively). We will work with parent advisory groups to inform our dissemination strategy and co-present our findings (eg, at community events or through social media). We will disseminate our findings with academics and healthcare professionals through webinars and academic conferences, as well as peer-reviewed publications.

Peripherally inserted central catheters versus non-tunnelled ultrasound-guided central venous catheters in newborns: a retrospective observational study

Por: Bayoumi · M. A. A. · van Rens · R. · Chandra · P. · Shaltout · D. · Gad · A. · Elmalik · E. E. · Hammoudeh · S.
Objectives

We aimed to compare the success rates and other catheter-related parameters between peripherally inserted central catheters (PICCs) and non-tunnelled ultrasound-guided central venous catheters (USG-CVCs) including femoral, jugular, brachiocephalic and subclavian lines.

Design

This was a retrospective observational study.

Setting

The study was performed in a level III neonatal intensive care unit (NICU) in Qatar, as a single-site study.

Participants

This study included 1333 neonates who required CVC insertion in the NICU from January 2016 to December 2018. Of those, we had 1264 PICCs and 69 non-tunnelled USG-CVCs.

Outcome measures

The success rate and other catheter-related complications in the two groups.

Results

The overall success rate was 88.4% in the USG-CVCs (61/69) compared with 90% in the PICCs (1137/1264) group (p=0.68). However, the first prick success rate was 69.4% in USG-CVCs (43/69) compared with 63.6% in the PICCs (796/1264) group. Leaking and central line-associated blood stream infection (CLABSI) were significantly higher in the USG-CVC group compared with the PICC group (leaking 16.4% vs 2.3%, p=0.0001) (CLABSI 8.2% vs 3.1%, p=0.03). CLABSI rates in the PICC group were 1.75 per 1000 catheter days in 2016 and 3.3 in 2017 compared with 6.91 in 2016 (p=0.0001) and 14.32 in 2017 (p=0.0001) for the USG-CVCs. USG-CVCs had to be removed due to catheter-related complications in 52.5% of the cases compared with 29.9% in PICCs, p=0.001. In 2018, we did not have any non-tunnelled USG-CVCs insertions in our NICU.

Conclusions

The overall complication rate, CLABSI and leaking are significantly higher in non-tunnelled USG-CVCs compared with the PICCs. However, randomised controlled trials with larger sample sizes are desired. Proper central venous device selection and timing, early PICC insertion and early removal approach, dedicated vascular access team development, proper central venous line maintenance, central line simulation workshops and US-guided insertions are crucial elements for patient safety in NICU.

Clinical and imaging characteristics of patients with COVID-19 predicting hospital readmission after emergency department discharge: a single-centre cohort study in Italy

Por: Galli · M. G. · Djuric · O. · Besutti · G. · Ottone · M. · Amidei · L. · Bitton · L. · Bonilauri · C. · Boracchia · L. · Campanale · S. · Curcio · V. · Lucchesi · D. M. F. · Mulas · C. S. · Santi · F. · Ferrari · A. M. · Giorgi Rossi · P. · Luppi · F. · On behalf of the Reggio Emilia C
Objective

We aimed at identifying baseline predictive factors for emergency department (ED) readmission, with hospitalisation/death, in patients with COVID-19 previously discharged from the ED. We also developed a disease progression velocity index.

Design and setting

Retrospective cohort study of prospectively collected data. The charts of consecutive patients with COVID-19 discharged from the Reggio Emilia (Italy) ED (2 March 2 to 31 March 2020) were retrospectively examined. Clinical, laboratory and CT findings at first ED admission were tested as predictive factors using multivariable logistic models. We divided CT extension by days from symptom onset to build a synthetic velocity index.

Participants

450 patients discharged from the ED with diagnosis of COVID-19.

Main outcome measure

ED readmission within 14 days, followed by hospitalisation/death.

Results

Of the discharged patients, 84 (18.7%) were readmitted to the ED, 61 (13.6%) were hospitalised and 10 (2.2%) died. Age (OR=1.05; 95% CI 1.03 to 1.08), Charlson Comorbidity Index 3 versus 0 (OR=11.61; 95% CI 1.76 to 76.58), days from symptom onset (OR for 1-day increase=0.81; 95% CI 0.73 to 0.90) and CT extension (OR for 1% increase=1.03; 95% CI 1.01 to 1.06) were associated in a multivariable model for readmission with hospitalisation/death. A 2-day lag velocity index was a strong predictor (OR for unit increase=1.21, 95% CI 1.08 to 1.36); the model including this index resulted in less information loss.

Conclusions

A velocity index combining CT extension and days from symptom onset predicts disease progression in patients with COVID-19. For example, a 20% CT extension 3 days after symptom onset has the same risk as does 50% after 10 days.

Correction: Interventions for social isolation in older adults who have experienced a fall: a systematic review

Tricco AC, Thomas SM, Radhakrishnan A, et al. Interventions for social isolation in older adults who have experienced a fall: a systematic review. BMJ Open 2022;12:e056540. doi: 10.1136/bmjopen-2021-056540

This article was previously published with an error.

The following statement has been added in the Funding statement:

GM and JF were in part supported by the Health Research Board (Ireland) and the HSC Public Health Agency (Grant number CBES-2018–001) through Evidence Synthesis Ireland and Cochrane Ireland.

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