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1 1 ["Human gut microbiome: hopes, threats and promises"] 10.1136/gutjnl-2018-316723 http://dx.doi.org/10.1136/gutjnl-2018-316723 2018-06-22T16:20:25Z ["Gastroenterology"] 132 230 ["0017-5749", "1468-3288"] Gut <jats:p>The microbiome has received increasing attention over the last 15 years. Although gut microbes have been explored for several decades, investigations of the role of microorganisms that reside in the human gut has attracted much attention beyond classical infectious diseases. For example, numerous studies have reported changes in the gut microbiota during not only obesity, diabetes, and liver diseases but also cancer and even neurodegenerative diseases. The human gut microbiota is viewed as a potential source of novel therapeutics. Between 2013 and 2017, the number of publications focusing on the gut microbiota was, remarkably, 12 900, which represents four-fifths of the total number of publications over the last 40 years that investigated this topic. This review discusses recent evidence of the impact of the gut microbiota on metabolic disorders and focus on selected key mechanisms. This review also aims to provide a critical analysis of the current knowledge in this field, identify putative key issues or problems and discuss misinterpretations. The abundance of metagenomic data generated on comparing diseased and healthy subjects can lead to the erroneous claim that a bacterium is causally linked with the protection or the onset of a disease. In fact, environmental factors such as dietary habits, drug treatments, intestinal motility and stool frequency and consistency are all factors that influence the composition of the microbiota and should be considered. The cases of the bacteria <jats:italic>Prevotella copri</jats:italic> and <jats:italic>Akkermansia muciniphila</jats:italic> will be discussed as key examples.</jats:p> 1 ["http://orcid.org/0000-0003-2040-2448"] ["Patrice D Cani"] [] ["FP7 Ideas: European Research Council", "Fonds Baillet Latour", "Fonds De La Recherche Scientifique - FNRS", "WELBIO"] ["10.13039/100011199", "10.13039/501100010563", "10.13039/501100002661", [""]]
14 14 ["Study protocol for a randomised controlled trial evaluating the effect of prenatal omega-3 LCPUFA supplementation to reduce the incidence of preterm birth: the ORIP trial"] 10.1136/bmjopen-2017-018360 http://dx.doi.org/10.1136/bmjopen-2017-018360 2017-09-26T00:10:18Z [] 0 10 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>Preterm birth accounts for more than 85% of all perinatal complications and deaths. Seventy-five per cent of early preterm births (EPTBs) occur spontaneously and without identifiable risk factors. The need for a broadly applicable, effective strategy for primary prevention is paramount. Secondary outcomes from the docosahexaenoic acid (DHA) to Optimise Mother Infant Outcome trial showed that maternal supplementation until delivery with omega-3 (ω-3) long chain polyunsaturated fatty acid (LCPUFA), predominantly as DHA, resulted in a 50% reduction in the incidence of EPTB and an increase in the incidence of post-term induction or post-term prelabour caesarean section due to extended gestation. We aim to determine the effectiveness of supplementing the maternal diet with ω-3 LCPUFA until 34 weeks’ gestation on the incidence of EPTB.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This is a multicentre, parallel group, randomised, blinded and controlled trial. Women less than 20 weeks’ gestation with a singleton or multiple pregnancy and able to give informed consent are eligible to participate. Women will be randomised to receive high DHA fish oil capsules or control capsules without DHA. Capsules will be taken from enrolment until 34 weeks’ gestation. The primary outcome is the incidence of EPTB, defined as delivery before 34 completed weeks’ gestation. Key secondary outcomes include length of gestation, incidence of post-term induction or prelabour caesarean section and spontaneous EPTB. The target sample size is 5540 women (2770 per group), which will provide 85% power to detect an absolute reduction in the incidence of preterm birth of 1.16% (from 2.45% to 1.29%) between the DHA and control group (two sided α=0.05). The primary analysis will be based on the intention-to-treat principle.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>Australia and New Zealand Clinical Trial Registry Num… 7 [] ["Shao J Zhou", "Karen Best", "Robert Gibson", "Andrew McPhee", "Lisa Yelland", "Julie Quinlivan", "Maria Makrides"] [] ["National Health and Medical Research Council"] ["10.13039/501100000925"]
15 15 ["Comparative effectiveness of treatment options for plantar heel pain: a systematic review with network meta-analysis"] 10.1136/bjsports-2017-098998 http://dx.doi.org/10.1136/bjsports-2017-098998 2019-01-21T15:05:26Z ["Physical Therapy, Sports Therapy and Rehabilitation", "Orthopedics and Sports Medicine", "General Medicine"] 62 9 ["0306-3674", "1473-0480"] British Journal of Sports Medicine <jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the comparative effectiveness of current treatment options for plantar heel pain (PHP).</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Systematic review and network meta-analysis (NMA).</jats:p></jats:sec><jats:sec><jats:title>Data sources</jats:title><jats:p>Medline, EMBASE, CINAHL, AMED, PEDro, Cochrane Database, Web of Science and WHO Clinical Trials Platform were searched from their inception until January 2018.</jats:p></jats:sec><jats:sec><jats:title>Study selection</jats:title><jats:p>Randomised controlled trials (RCTs) of adults with PHP investigating common treatments (ie, corticosteroid injection, non-steroidal anti-inflammatory drugs, therapeutic exercise, orthoses and/or extracorporeal shockwave therapy (ESWT)) compared with each other or a no treatment, placebo/sham control.</jats:p></jats:sec><jats:sec><jats:title>Data extraction and analysis</jats:title><jats:p>Data were extracted and checked for accuracy and completeness by pairs of reviewers. Primary outcomes were pain and function. Comparative treatment effects were analysed by random effects NMA in the short term, medium term and long term. Relative ranking of treatments was assessed by surface under the cumulative ranking probabilities (0–100 scale).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Thirty-one RCTs (total n=2450 patients) were included. There was no evidence of inconsistency detected between direct and indirect treatment comparisons in the networks, but sparse data led to frequently wide CIs. Available evidence does not suggest that any of the commonly used treatments for the management of PHP are better than any other, although corticosteroid injections, alone or in combination with exercise, and ESWT were ranked most likely to be effective for the management of short-term, medium-term and long-term pain or function; placebo/sham/control appeared least likely to be effective; and exercise appeared to only be beneficial for … 8 ["http://orcid.org/0000-0002-5064-6446", "http://orcid.org/0000-0002-7703-727X", "http://orcid.org/0000-0002-7248-6703"] ["Opeyemi O Babatunde", "Amardeep Legha", "Chris Littlewood", "Linda S Chesterton", "Martin J Thomas", "Hylton B Menz", "Danielle van der Windt", "Edward Roddy"] [] ["National Health and Medical Research Council", "National Institute for Health Research"] ["10.13039/501100000925", "10.13039/501100000272"]
16 16 ["Development of a consensus core dataset in juvenile dermatomyositis for clinical use to inform research"] 10.1136/annrheumdis-2017-212141 http://dx.doi.org/10.1136/annrheumdis-2017-212141 2017-10-30T16:15:10Z ["Immunology", "General Biochemistry, Genetics and Molecular Biology", "Immunology and Allergy", "Rheumatology"] 49 9 ["0003-4967", "1468-2060"] Annals of the Rheumatic Diseases <jats:sec><jats:title>Objectives</jats:title><jats:p>This study aimed to develop consensus on an internationally agreed dataset for juvenile dermatomyositis (JDM), designed for clinical use, to enhance collaborative research and allow integration of data between centres.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A prototype dataset was developed through a formal process that included analysing items within existing databases of patients with idiopathic inflammatory myopathies. This template was used to aid a structured multistage consensus process. Exploiting Delphi methodology, two web-based questionnaires were distributed to healthcare professionals caring for patients with JDM identified through email distribution lists of international paediatric rheumatology and myositis research groups. A separate questionnaire was sent to parents of children with JDM and patients with JDM, identified through established research networks and patient support groups. The results of these parallel processes informed a face-to-face nominal group consensus meeting of international myositis experts, tasked with defining the content of the dataset. This developed dataset was tested in routine clinical practice before review and finalisation.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A dataset containing 123 items was formulated with an accompanying glossary. Demographic and diagnostic data are contained within form A collected at baseline visit only, disease activity measures are included within form B collected at every visit and disease damage items within form C collected at baseline and annual visits thereafter.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Through a robust international process, a consensus dataset for JDM has been formulated that can capture disease activity and damage over time. This dataset can be incorporated into national and international collaborative efforts, including existing clinical research databases.</jats:p></jats… 23 ["http://orcid.org/0000-0002-5400-9911"] ["Liza J McCann", "Clarissa A Pilkington", "Adam M Huber", "Angelo Ravelli", "Duncan Appelbe", "Jamie J Kirkham", "Paula R Williamson", "Amita Aggarwal", "Lisa Christopher-Stine", "Tamas Constantin", "Brian M Feldman", "Ingrid Lundberg", "Sue Maillard", "Pernille Mathiesen", "Ruth Murphy", "Lauren M Pachman", "Ann M Reed", "Lisa G Rider", "Annet van Royen-Kerkof", "Ricardo Russo", "Stefan Spinty", "Lucy R Wedderburn", "Michael W Beresford"] [] ["Arthritis Research UK"] ["10.13039/501100000341"]
18 18 ["Post-traumatic growth and its relationship to quality of life up to 9 years after liver transplantation: a cross-sectional study in Spain"] 10.1136/bmjopen-2017-017455 http://dx.doi.org/10.1136/bmjopen-2017-017455 2017-09-17T00:10:22Z [] 0 7 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Objective</jats:title><jats:p>Little is known concerning post-traumatic growth (PTG) after liver transplantation. Against this backdrop the current study analysed the relationship between PTG and time since transplantation on quality of life. Furthermore, it compared PTG between liver transplant recipients and their caregivers.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Cross-sectional case–control study.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>University Hospital in Spain.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>240 adult liver transplant recipients who had undergone only one transplantation, with no severe mental disease, were the participants of the study. Specific additional analyses were conducted on the subset of 216 participants for whom caregiver data were available. Moreover, results were compared with a previously recruited general population sample.</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>All participants completed the Posttraumatic Growth Inventory, and recipients also filled in the 12-Item Short-Form Health Survey. Relevant sociodemographic and clinical parameters were also assessed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In the sample of 240 recipients, longer time since transplantation (&gt;9 years) was associated with more pain symptoms (p=0.026). Regardless of duration, recipients showed lower scores on most quality of life dimensions than the general population. However, high PTG was associated with a significantly higher score on the vitality quality of life dimension (p=0.021). In recipients with high PTG, specific quality of life dimensions, such as bodily pain (p=0.307), vitality (p=0.890) and mental health (p=0.353), even equalled scores in the general population, whereas scores on general health surpassed them (p=0.006). Furthermore, liver transplant recipients (n=216) compared with their caregivers showed higher t… 7 [] ["Mar\u00eda \u00c1ngeles P\u00e9rez-San-Gregorio", "Agust\u00edn Mart\u00edn-Rodr\u00edguez", "Mercedes Borda-Mas", "Mar\u00eda Luisa Avargues-Navarro", "Jos\u00e9 P\u00e9rez-Bernal", "Rupert Conrad", "Miguel \u00c1ngel G\u00f3mez-Bravo"] [] ["Spanish Ministry of Economy and Competitiveness"] [[""]]
20 20 ["Google search histories of patients presenting to an emergency department: an observational study"] 10.1136/bmjopen-2018-024791 http://dx.doi.org/10.1136/bmjopen-2018-024791 2019-02-20T19:00:11Z ["General Medicine"] 0 6 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Objective</jats:title><jats:p>To test patients’ willingness to share and link their prior Google search histories with data from their electronic medical record (EMR), and to explore associations between search histories and clinical conditions.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Cross-sectional study of emergency department (ED) patients from 2016 to 2017.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Academic medical centre ED.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>A total of 703 patients were approached; 334 of a volunteer sample of 411 (81%) reported having a Google account; 165 of those (49%) consented to share their Google search histories and EMR data; 119 (72%) were able to do so. 16 (13%) of those 119 patients had no data and were not included in the final count. Patients under the age of 18 or with a triage level of 1 were considered ineligible and were not approached.</jats:p></jats:sec><jats:sec><jats:title>Main outcome measures</jats:title><jats:p>Health relatedness of searches in the remote past and within 7 days of the ED visit, and associations between patients’ clinical and demographic characteristics and their internet search volume and search content.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The 103 participants yielded 591 421 unique search queries; 37 469 (6%) were health related. In the 7 days prior to an ED visit, the percentage of health-related searches was 15%. During that time, 56% of patients searched for symptoms, 53% for information about a hospital and 23% about the treatment or management of a disease. 53% of participants who used Google in the week leading up to their ED visit searched for content directly related to their chief complaint.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Patients were willing to allow researchers simultaneous access to their Google search histories and their EMR data. The change in vo… 6 [] ["Jeremy M Asch", "David A Asch", "Elissa V Klinger", "Justine Marks", "Norah Sadek", "Raina M Merchant"] [] ["Robert Wood Johnson Foundation"] ["10.13039/100000867"]
21 21 ["Association between frontal plane knee control and lower extremity injuries: a prospective study on young team sport athletes"] 10.1136/bmjsem-2017-000311 http://dx.doi.org/10.1136/bmjsem-2017-000311 2018-01-14T01:10:19Z [] 47 6 ["2055-7647"] BMJ Open Sport & Exercise Medicine <jats:sec><jats:title>Background/aim</jats:title><jats:p>Poor frontal plane knee control can manifest as increased dynamic knee valgus during athletic tasks. The purpose of this study was to investigate the association between frontal plane knee control and the risk of acute lower extremity injuries. In addition, we wanted to study if the single-leg squat (SLS) test can be used as a screening tool to identify athletes with an increased injury risk.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A total of 306 basketball and floorball players participated in the baseline SLS test and a 12-month injury registration follow-up. Acute lower extremity time-loss injuries were registered. Frontal plane knee projection angles (FPKPA) during the SLS were calculated using a two-dimensional video analysis.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Athletes displaying a high FPKPA were 2.7 times more likely to sustain a lower extremity injury (adjusted OR 2.67, 95% CI 1.23 to 5.83) and 2.4 times more likely to sustain an ankle injury (OR 2.37, 95% CI 1.13 to 4.98). There was no statistically significant association between FPKPA and knee injury (OR 1.49, 95% CI 0.56 to 3.98). The receiver operating characteristic curve analyses indicated poor combined sensitivity and specificity when FPKPA was used as a screening test for lower extremity injuries (area under the curve of 0.59) and ankle injuries (area under the curve of 0.58).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Athletes displaying a large FPKPA in the SLS test had an elevated risk of acute lower extremity and ankle injuries. However, the SLS test is not sensitive and specific enough to be used as a screening tool for future injury risk.</jats:p></jats:sec> 10 ["http://orcid.org/0000-0003-3056-8169"] ["Anu M R\u00e4is\u00e4nen", "Kati Pasanen", "Tron Krosshaug", "Tommi Vasankari", "Pekka Kannus", "Ari Heinonen", "Urho M Kujala", "Janne Avela", "Jarmo Perttunen", "Jari Parkkari"] [] ["The Foundation of Sports Institute", "the Competitive State Research Financing of The Expert Responsibility Area of Tampere University Hospital", "The Finnish Ministry of Education and Culture"] [[""], [""], [""]]
24 24 ["Protocol for the Lactoferrin Infant Feeding Trial (LIFT): a randomised trial of adding lactoferrin to the feeds of very-low birthweight babies prior to hospital discharge"] 10.1136/bmjopen-2018-023044 http://dx.doi.org/10.1136/bmjopen-2018-023044 2018-10-03T04:55:26Z ["General Medicine"] 50 5 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>Very-low birthweight (VLBW, &lt;1500 g) infants comprise about 1%–1.4% of all births in high-income countries. Every year, about 3000 VLBW babies in Australia and New Zealand receive intensive care. Many die or else survive with severe brain injury, retinopathy, late-onset sepsis or necrotising enterocolitis (NEC), each of which carries substantial risk of disability.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This trial tests whether adding bovine lactoferrin (bLF) to feeds in VLBW infants improves (1) survival to hospital discharge free from brain injury, late-onset sepsis, NEC and treated retinopathy of prematurity (primary composite end point); (2) each component of the primary composite end point and (3) time to reach full enteral feeds, number of blood transfusions, chronic lung disease and length of hospital stay. It includes a cost-effectiveness analysis of bLF in improving survival free from major morbidity, and evaluates the effect of bLF on survival and developmental outcomes at 24 to 36 months corrected gestational age.</jats:p><jats:p>This is a multicentre, two-arm, randomised trial comparing the treatment group receiving bLF added to breast milk or formula milk daily (up to 250 mg/kg/day bLF) versus the control group receiving no bLF supplementation. The intervention is administered until 34 completed weeks corrected gestation or for 2 weeks, whichever is longer, or until discharge home, if earlier. The target sample size of 1500 participants yields 85% power, at the two-sided 5% level significance, to detect a difference in proportions meeting the primary outcome assuming the true probability is 74% in controls and 80.5% in the bLF group.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>This protocol was approved by Northern Sydney Local Human Research Ethics Committee in January 2017 (Version 2.0, Reference 1003-118M) and other relevant ethics committees. The findings … 6 [] ["Andrew Martin", "Alpana Ghadge", "Paolo Manzoni", "Kei Lui", "Rebecca Brown", "William Tarnow-Mordi"] [] ["National Health and Medical Research Council"] ["10.13039/501100000925"]
28 28 ["GCAT|Genomes for life: a prospective cohort study of the genomes of Catalonia"] 10.1136/bmjopen-2017-018324 http://dx.doi.org/10.1136/bmjopen-2017-018324 2018-03-28T06:10:36Z [] 0 4 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Purpose</jats:title><jats:p>The prevalence of chronic non-communicable diseases (NCDs) is increasing worldwide. NCDs are the leading cause of both morbidity and mortality, and it is estimated that by 2030, they will be responsible for 80% of deaths across the world. The Genomes for Life (GCAT) project is a long-term prospective cohort study that was designed to integrate and assess the role of epidemiological, genomic and epigenomic factors in the development of major chronic diseases in Catalonia, a north-east region of Spain.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>At the end of 2017, the GCAT Study will have recruited 20 000 participants aged 40–65 years. Participants who agreed to take part in the study completed a self-administered computer-driven questionnaire, and underwent blood pressure, cardiac frequency and anthropometry measurements. For each participant, blood plasma, blood serum and white blood cells are collected at baseline. The GCAT Study has access to the electronic health records of the Catalan Public Healthcare System. Participants will be followed biannually at least 20 years after recruitment.</jats:p></jats:sec><jats:sec><jats:title>Findings to date</jats:title><jats:p>Among all GCAT participants, 59.2% are women and 83.3% of the cohort identified themselves as Caucasian/white. More than half of the participants have higher education levels, 72.2% are current workers and 42.1% are classified as overweight (body mass index ≥25 and &lt;30 kg/m<jats:sup>2</jats:sup>). We have genotyped 5459 participants, of which 5000 have metabolome data. Further, the whole genome of 808 participants will be sequenced by the end of 2017.</jats:p></jats:sec><jats:sec><jats:title>Future plans</jats:title><jats:p>The first follow-up study started in December 2017 and will end by March 2018. Residences of all subjects will be geocoded during the following year. Several genomic analyses are ongoing, and metabolomic and genomic integrations will be performed t… 13 ["http://orcid.org/0000-0003-4646-3513"] ["Mireia Ob\u00f3n-Santacana", "Mireia Vilardell", "Anna Carreras", "Xavier Duran", "Juan Velasco", "Iv\u00e1n Galv\u00e1n-Femen\u00eda", "Teresa Alonso", "Llu\u00eds Puig", "Lauro Sumoy", "Eric J Duell", "Manuel Perucho", "Victor Moreno", "Rafael de Cid"] [] ["\u2019Ram\u00f3n y Cajal' action from the Spanish Ministry of Economy and Competitiveness", "Ag\u00e8ncia de Gesti\u00f3 d\u2019Ajuts Universitaris i de Recerca (AGAUR)", "Acci\u00f3n de Dinamizaci\u00f3n del ISCIII-MINECO", "Ministry of Health of the Generalitat of Catalunya", "the Catalan Government DURSI"] [[""], [""], [""], [""], [""]]
48 48 ["Cancer and the emotions in 18th-century literature"] 10.1136/medhum-2018-011639 http://dx.doi.org/10.1136/medhum-2018-011639 2019-11-06T22:15:31Z ["Philosophy", "Pathology and Forensic Medicine"] 0 0 ["1468-215X", "1473-4265"] Medical Humanities <jats:p>This essay argues that the emotional rhetoric of today’s breast cancer discourse—with its emphasis on stoicism and ‘positive thinking’ in the cancer patient, and its use of sympathetic feeling to encourage charitable giving—has its roots in the long 18th century. While cancer had long been connected with the emotions, 18th-century literature saw it associated with both ‘positive’ and ‘negative’ feelings, and metaphors describing jealousy, love and other sentiments as ‘like a cancer’ were used to highlight the danger of allowing feelings—even benevolent or pleasurable feelings—to flourish unchecked. As the century wore on, breast cancer in particular became an important literary device for exploring the dangers of feeling in women, with writers of both moralising treatises and sentimental novels connecting the growth or development of cancer with the indulgence of feeling, and portraying emotional self-control as the only possible form of resistance against the disease. If, as Barbara Ehrenreich suggests, today’s discourse of ‘positive thinking’ has been mobilised to make patients with breast cancer more accepting of their diagnosis and more cooperative with punitive treatment regimens, then 18th-century fictional exhortations to stay cheerful served similarly conservative political and economic purposes, encouraging continued female submission to male prerogatives inside and outside the household.</jats:p> 1 ["http://orcid.org/0000-0002-7826-495X"] ["Noelle Gallagher"] [] ["University of Manchester"] ["10.13039/501100000770"]
64 64 ["Mapping the use of soft systems methodology for change management in healthcare: a scoping review protocol"] 10.1136/bmjopen-2018-026028 http://dx.doi.org/10.1136/bmjopen-2018-026028 2019-04-02T07:34:20Z ["General Medicine"] 0 0 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>It is notoriously challenging to implement evidence-based care and to update and improve healthcare practices. One reason for the difficulty is the complexity of healthcare and the powerful influence of context on implementation and improvement efforts. Thus, there is a need for multifaceted, flexible change methods that takes these complexities into consideration. One approach that has the potential in this regard is soft systems methodology (SSM). However, little is known about how SSM has been applied in healthcare settings, making it difficult to assess the usefulness of SSM for implementation science or improvement research. The aim of the proposed scoping review is to examine and map the use and outcomes of SSM in healthcare.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>The review will adapt the framework outlined by Arksey and O’Malley (2005). Citations will be uncovered through a comprehensive database search of the peer-reviewed literature. Two reviewers will conduct a two-stage review and selection process where the titles/abstracts are examined followed by a screening of full texts of the selected citations. Reference lists of included citations will be snowballed to identify potential additional citations. Inclusion criteria are English language, peer-reviewed empirical papers focusing on the application of SSM in a healthcare setting. Both general information about the citations and information related to the objective of the review will be extracted from the included citations and entered into a data charting form. The extracted information will be reported in diagrams and tables and summarised to present a narrative account of the literature. The proposed review will provide information on the potential for using SSM to affect change in healthcare.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>No primary data will be collected, and thus ethical permission is unnecessar… 3 ["http://orcid.org/0000-0001-6203-0676", "http://orcid.org/0000-0003-0296-4957"] ["Hanna Augustsson", "Kate Churruca", "Jeffrey Braithwaite"] [] ["National Health and Medical Research Council"] ["10.13039/501100000925"]
65 65 ["Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial"] 10.1136/bmjopen-2019-034201 http://dx.doi.org/10.1136/bmjopen-2019-034201 2020-04-07T09:55:55Z ["General Medicine"] 18 0 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>Acute kidney injury (AKI) is a frequent complication after cardiac surgery with adverse short-term and long-term outcomes. Although prevention of AKI (PrevAKI) is strongly recommended, the optimal strategy is uncertain. The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommended a bundle of supportive measures in high-risk patients. In a single-centre trial, we recently demonstrated that the strict implementation of the KDIGO bundle significantly reduced the occurrence of AKI after cardiac surgery. In this feasibility study, we aim to evaluate whether the study protocol can be implemented in a multicentre setting in preparation for a large multicentre trial.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>We plan to conduct a prospective, observational survey followed by a randomised controlled, multicentre, multinational clinical trial including 280 patients undergoing cardiac surgery with cardiopulmonary bypass. The purpose of the observational survey is to explore the adherence to the KDIGO recommendations in routine clinical practice. The second phase is a randomised controlled trial. The objective is to investigate whether the trial protocol is implementable in a large multicentre, multinational setting. The primary endpoint of the interventional part is the compliance rate with the protocol. Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The PrevAKI multicentre study has been approved by the leading Research Ethics Committee of the University of Münster and the respective Research Ethic… 29 ["http://orcid.org/0000-0002-2124-1714"] ["Mira K\u00fcllmar", "Christina Massoth", "Marlies Ostermann", "Sara Campos", "Neus Grau Novellas", "Gary Thomson", "Michael Haffner", "Christian Arndt", "Hinnerk Wulf", "Marc Irqsusi", "Fabrizio Monaco", "Ambra Di Prima", "Mercedes Garcia Alvarez", "Stefano Italiano", "Virginia Cegarra SanMartin", "Gudrun Kunst", "Shrijit Nair", "Camilla L'Acqua", "Eric A J Hoste", "Wim Vandenberghe", "Patrick Honore", "John Kellum", "Lui Forni", "Philippe Grieshaber", "Raphael Weiss", "Joachim Gerss", "Carola Wempe", "Melanie Meersch", "Alexander Zarbock"] [] ["European Society of Intensive Care Medicine"] ["10.13039/501100013347"]
77 77 ["Metabolic and cardiovascular effects of chronic mild hyperuricemia in rodents"] 10.1136/jim-2018-000729 http://dx.doi.org/10.1136/jim-2018-000729 2018-07-24T17:51:06Z ["General Biochemistry, Genetics and Molecular Biology", "General Medicine"] 33 0 ["1081-5589", "1708-8267"] Journal of Investigative Medicine <jats:p>Mildly elevated serum uric acid levels are common in people with metabolic syndrome and type 2 diabetes mellitus (T2DM), but whether elevated uric acid has a causal role in the pathogenesis of diabetes remains uncertain. We tested whether chronic mild hyperuricemia in rodents under controlled laboratory conditions can cause glucose intolerance in otherwise healthy animals, or whether it can worsen glucometabolic control in animals that are genetically predisposed to T2DM. We used an established model of experimental hyperuricemia in rodents with potassium oxonate dietary supplementation, which led to sustained, approximately two-fold elevation of uric acid compared with control animals. We also reversed the hyperuricemic effect of oxonate in some animals by treatment with a xanthine oxidase inhibitor. Manipulation of serum uric acid levels in Sprague-Dawley rats for up to 18 weeks did not affect fasting glucose and glucose tolerance. Blood pressure was also not affected by hyperuricemia in rats fed a Western-type diet. We next sought to determine whether uric acid may aggravate or accelerate the onset of glucometabolic abnormalities in rats already predisposed to T2DM. Chronic oxonate treatment in Zucker diabetic fatty (ZDF) and lean control rats for up to 6 weeks did not affect fasting glucose, insulin, and glucose tolerance in ZDF rats. Taken together, these findings indicate that elevated uric acid does not directly contribute to the pathogenesis of glucose intolerance and T2DM in rodents.</jats:p> 7 [] ["Sun K Park", "Tara R Rosenthal", "Jessica S Williams", "John M Shelton", "Masaya Takahashi", "Shanrong Zhang", "Ion Alexandru Bobulescu"] [] ["National Institutes of Health", "Takeda Pharmaceuticals U.S.A."] ["10.13039/100000002", "10.13039/100007723"]
78 78 ["Construction of the secondary care administrative records frailty (SCARF) index and validation on older women with operable invasive breast cancer in England and Wales: a cohort study"] 10.1136/bmjopen-2019-035395 http://dx.doi.org/10.1136/bmjopen-2019-035395 2020-05-06T10:36:50Z ["General Medicine"] 48 0 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Objectives</jats:title><jats:p>Studies that use national datasets to evaluate the management of older women with breast cancer are often constrained by a lack of information on patient fitness. This study constructed a frailty index for use with secondary care administrative records and evaluated its ability to improve models of treatment patterns and overall survival in women with breast cancer.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Retrospective cohort study.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>Women aged ≥50 years with oestrogen receptor (ER) positive early invasive breast cancer diagnosed between 2014 and 2017 in England.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The secondary care administrative records frailty (SCARF) index was based on the cumulative deficit model of frailty, using International Statistical Classification of Diseases, Injuries and Causes of Death, 10th revision codes to define a set of deficits. The index was applied to administrative records that were linked to national cancer registry datasets. The ability of the SCARF index to improve the performance of regression models to explain observed variation in the rate of surgery and overall survival was evaluated using Harrell’s c-statistic and decision curve analysis. External validation was performed on a dataset of similar women diagnosed in Wales.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The SCARF index captured 32 deficits that cover functional impairment, geriatric syndromes, problems with nutrition, cognition and mood, and medical comorbidities. In the English dataset (n=67 925), the prevalence of frailty in women aged 50–69, 70–79 and ≥80 years was 15%, 28% and 47%, respectively. Adding a frailty measure to regression models containing age, tumour characteristics and comorbidity improved their ability to: (1) discriminate between whether a woman was likely to have surgery and (2) predict over… 11 ["http://orcid.org/0000-0002-4761-8655"] ["Yasmin Jauhari", "Melissa Ruth Gannon", "David Dodwell", "Kieran Horgan", "Karen Clements", "Jibby Medina", "Carmen Tsang", "Thompson Robinson", "Sarah Shuk-Kay Tang", "Ruth Pettengell", "David A Cromwell"] [] ["Healthcare Quality Improvement Partnership"] [[""]]
82 82 ["Determinants of imbalanced sex ratio at birth in Nepal: evidence from secondary analysis of a large hospital-based study and nationally-representative survey data"] 10.1136/bmjopen-2018-023021 http://dx.doi.org/10.1136/bmjopen-2018-023021 2019-01-31T10:06:09Z ["General Medicine"] 31 0 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Objectives</jats:title><jats:p>To quantify sex ratios at births (SRBs) in hospital deliveries in Nepal, and understand the socio-demographic correlates of skewed SRB. Skewed SRBs in hospitals could be explained by sex selective abortion, and/or by decision to have a son delivered in a hospital—increased in -utero investments for male fetus. We use data on ultrasound use to quantify links between prenatal knowledge of sex, parity and skewed SRBs.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Secondary analysis of: (1) de-identified data from a randomised controlled trial, and (2) 2011 Nepal Demographic and Health Survey (NDHS).</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Nepal.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>(1) 75 428 women who gave birth in study hospitals, (2) NDHS: 12 674 women aged 15–49 years.</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>SRB, and conditional SRB of a second child given first born male or female were calculated.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Using data from 75 428 women who gave birth in six tertiary hospitals in Nepal between September 2015 and March 2017, we report skewed SRBs in these hospitals, with some hospitals registering deliveries of 121 male births per 100 female births. We find that a nationally representative survey (2011 NDHS) reveals no difference in the number of hospital delivery of male and female babies. Additionally, we find that: (1) estimated SRB of second-order births conditional on the first being a girl is significantly higher than the biological SRB in our study and (2) multiparous women are more likely to have prenatal knowledge of the sex of their fetus and to have male births than primiparous women with the differences increasing with increasing levels of education.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Our analysis supports sex-selective abortion a… 6 [] ["Elina Pradhan", "Erin Pearson", "Mahesh Puri", "Manju Maharjan", "Dev Chandra Maharjan", "Iqbal Shah"] [] ["Susan Thompson Buffett Foundation", "Harvard T.H. Chan School of Public Health"] ["10.13039/100007447", "10.13039/100008548"]
84 84 ["How far are we from a medication use process aiming at well-informed adherent patients with long-term medications in Finland? Qualitative study"] 10.1136/bmjopen-2019-036526 http://dx.doi.org/10.1136/bmjopen-2019-036526 2020-06-22T07:06:08Z ["General Medicine"] 72 0 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Objective</jats:title><jats:p>Finland is one of the few countries that has established a national Medicines Information (MI) Strategy. The ultimate goal of the strategy is a well-implemented medication use process resulting in well-informed adherent patients. This study aimed at evaluating the implementation of the strategy 3 years after its launch.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>The evaluation applied a pragmatic approach and was conducted by interviewing stakeholders involved in the National MI Network enhancing the MI Strategy’s implementation. The network comprises national key stakeholders producing and using MI. Data were deductively analysed according to the medication use process of the MI Strategy using the framework method, complemented with inductively derived categories.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>National implementation of the MI Strategy throughout the healthcare system after the first operational period (2012–2014) in 2015.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>The members of the National MI Network (n=79/111, participation rate 71%, representing 42/53 stakeholder organisations).</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>A new conceptual framework was developed based on stakeholders’ views on well-implemented actions and actions needing development in the medication use process at (1) infrastructure (<jats:italic>macro</jats:italic>), (2) healthcare professionals (<jats:italic>meso</jats:italic>) and (3) patient (<jats:italic>micro</jats:italic>) levels.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Medication counselling by community pharmacists was the primary implemented action, followed by physicians’ actions while starting a new medication, and advice given by nurses. The major development needs concerned (1) poor access to patient information and its transfer in healthcare, particularly the lack of r… 4 ["http://orcid.org/0000-0001-7846-3492"] ["Niina Mononen", "Marika Pohjanoksa-M\u00e4ntyl\u00e4", "Marja SA Airaksinen", "Katri H\u00e4meen-Anttila"] [] ["Elli Turunen Fund of the Finnish Cultural Foundation"] [[""]]

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