bluuebunny/crossref_metadata_2025_split huggingface dataset:
Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative
Authors: Deane Katherine , Delbecque Laure , Gorbenko Oleksandr , Hamoir Anne Marie , Hoos Anton , Nafria Begonya , Pakarinen Chi , Sargeant Ify , Richards Dawn P , Skovlund Soren Eik , Brooke Nicholas 
Published: March 2019

IntroductionMeaningful patient engagement (PE) can enhance medicines’ development. However, the current PE landscape is fragmentary and lacking comprehensive guidance.MethodsWe systematically searched for PE initiatives (SYNaPsE database/publications). Multistakeholder groups integrated these with their own PE expertise to co-create draft PE Quality Guidance which was evaluated by public consultation. Projects exemplifying good PE practice were identified and assessed against PE Quality Criteria to create a Book of Good Practices (BOGP).ResultsSeventy-six participants from 51 organisations participated in nine multistakeholder meetings (2016–2018). A shortlist of 20relevant PE initiatives (from 170 screened) were identified. The co-created INVOLVE guidelines provided the main framework for PE Quality Guidance and was enriched with the analysis of the PE initiatives and the PE expertise of stakeholders. Seven key PE Quality Criteria were identified. Public consultation yielded 67 responses from diverse backgrounds. The PE Quality Guidance was agreed to be useful for achieving quality PE in practice, understandable, easy to use, and comprehensive. Overall, eight initiatives from the shortlist and from meeting participants were selected for inclusion in the BOGP based on demonstration of PE Quality Criteria and willingness of initiative owners to collaborate.DiscussionThe PE Quality Guidance and BOGP are practical resources which will be continually updated in response to user feedback. They are not prescriptive, but rather based on core principles, which can be applied according to the unique needs of each interaction and initiative. Implementation of the guidance will facilitate improved and systematic PE across the medicines’ development lifecycle.
Elucidating bidirectional relationship between metabolic syndrome and elevated faecal haemoglobin concentration: a Taiwanese community-based cohort study
Authors: Ku Mei-Sheng , Fann Jean Ching-Yuan , Chiu Sherry Yueh-Hsia , Chen Hsiu-Hsi , Hsu Chen-Yang 
Published: March 2019

ObjectivesTo elucidate the bidirectional temporal relationship between elevated faecal haemoglobin (f-Hb) concentration and metabolic syndrome (MetS).DesignA longitudinal cohort study was conducted by utilising data on community-based periodical screening for colorectal cancer with faecal immunochemical test (FIT) and health check-up for MetS.SettingPopulation-based organised integrated service screening in Keelung city, Taiwan.ParticipantsWe enrolled a total of 62,293 community residents aged 40–79 years.Main outcomes and measuresBidirectional outcomes of FIT-positive and MetS were measured.ResultsThe presence of MetS at baseline led to a statistically significant 31% elevated risk of being incident FIT-positive (adjusted HR, (aHR)=1.31, 95% CI: 1.14 to 1.51) whereas the effect of those with FIT-positive at baseline on incident MetS was not statistically significant (aHR=1.06, 95% CI: 0.89 to 1.25) after adjusting for relevant confounders. Such an effect was particularly noted for three individual components (abnormal waist circumference, higher fasting plasma glucose and lower high-density lipoprotein).ConclusionsOur finding on the presence of MetS before FIT-positive based on bidirectional relationship assessment suggests the control of MetS may contribute to reducing the risk of colorectal neoplasia through the early surveillance of f-Hb. However, such a temporal epidemiological finding still needs to be verified by using other external data.
Consumption trends and prescription patterns of opioids from 2011 to 2016: a survey in a Chinese city
Authors: Liu Xiao , Luo Can , Dai Huizhen , Fang Wentong 
Published: March 2019

ObjectiveOpioid consumption in China has been very less and has varied widely since 1995. The representatively high level of consumption in Mainland China has never been reported. Our aim was to describe the consumption trends and prescription patterns of opioids in Nanjing, a highly developed city of Mainland China, and compare the results with selected worldwide regions.MethodsApplication data of opioids in 2011–2016 were extracted from the Jiangsu Medicine Information Institute. Six opioids were included. Consumption was expressed in terms of defined daily doses (DDDs), morphine equivalents (MEs) and expenditure. The correlation between consumption of opioids and gross domestic product (GDP), Human Development Index (HDI) and cancer incidence was analysed by Pearson’s correlation test.ResultsDDDs, expenditure and MEs of opioids were, respectively, 256.04, $599.24 and 13.07 g in 2011, and increased to 361.27, $1041.79 and 18.09 g in 2016. DDDs in Nanjing were 2.80-fold that in Mainland China, 1.42-fold that in East and South-East Asia, but only equivalent to 8.89% of the worldwide average level. From 2011 to 2016, the consumption had a linear correlation with GDP, HDI and cancer incidence (p<0.05). However, DDDs varied greatly in countries with similar GDP or HDI. Within 45 Asian countries, the GDP only contributed to 10.47% of change in DDDs, while the HDI contributed to 20.32%. Consumption of non-intravenous opioids or strong opioids always comprised majority of the total consumption. The opioids prescribed predominantly were fentanyl, oxycodone and morphine. Fentanyl and oxycodone account for most of the increase in consumption.ConclusionOpioid consumption has increased >40% from 2011 to 2016, with consumption of fentanyl and oxycodone accounting for most of that increase. The consumption in Nanjing was higher than the average Chinese level, but lower than the global average. An increase in pain control services might be needed, but this need should be highly regulated.
Examination of psychological risk factors for chronic pain following cardiac surgery: protocol for a prospective observational study
Authors: McGillion Michael H , Henry Shaunattonie , Busse Jason W , Ouellette Carley , Katz Joel , Choinière Manon , Lamy Andre , Whitlock Richard , Pettit Shirley , Hare Jacqueline , Gregus Krysten , Brady Katheryn , Dvirnik Nazari , Yang Stephen Su , Parlow Joel , Dumerton-Shore Deborah , Gilron Ian , Buckley D Norman , Shanthanna Harsha , Carroll Sandra L , Coyte Peter C , Ebrahim Shanil , Isaranuwatchai Wanrudee , Guerriere Denise N , Hoch Jeffrey , Khan James , MacDermid Joy , Martorella Geraldine , Victor J Charles , Watt-Watson Judy , Howard-Quijano Kimberly , Mahajan Aman , Chan Matthew T V , Clarke Hance , Devereaux P J 
Published: March 2019

IntroductionApproximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not.Methods and analysesIn this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score.Ethics and disseminationThis protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals.Trial registration numberNCT01842568.
Healthy Eating and Active Lifestyles for Diabetes (HEAL-D): study protocol for the design and feasibility trial, with process evaluation, of a culturally tailored diabetes self-management programme for African-Caribbean communities
Authors: Goff Louise M , Moore Amanda P , Rivas Carol , Harding Seeromanie 
Published: March 2019

IntroductionBlack British communities are disproportionately burdened by type 2 diabetes (T2D) and its complications. Tackling these inequalities is a priority for healthcare providers and patients. Culturally tailored diabetes education provides long-term benefits superior to standard care, but to date, such programmes have only been developed in the USA. The current programme of research aims to develop the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) culturally tailored T2D self-management programme for black British communities and to evaluate its delivery, acceptability and the feasibility of conducting a future effectiveness trial of HEAL-D.Methods and analysisInformed by Medical Research Council Complex Interventions guidance, this research will rigorously develop and evaluate the implementation of the HEAL-D intervention to understand the feasibility of conducting a full-scale effectiveness trial. In phase 1, the intervention will be developed. The intervention curriculum will be based on existing evidence-based T2D guidelines for diet and lifestyle management; codesign methods will be used to foster community engagement, identify the intervention’s underpinning theory, identify the optimal structure, format and delivery methods, ascertain adaptations that are needed to ensure cultural sensitivity and understand issues of implementation. In phase 2, the intervention will be delivered and compared with usual care in a feasibility trial. Process evaluation methods will evaluate the delivery and acceptability of HEAL-D. The effect size of potential primary outcomes, such as HbA1c and body weight, will be estimated. The feasibility of conducting a future effectiveness trial will also be evaluated, particularly feasibility of randomisation, recruitment, retention and contamination.Ethics and disseminationThis study is funded by a National Institute of Health Research Fellowship (CDF-2015-08-006) and approved by National Health Service Research Ethics Committee (17-LO-1954). Dissemination will be through national and international conferences, peer-reviewed publications and local and national clinical diabetes networks.Trial registrationnumberNCT03531177; Pre-results.
ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial
Authors: Redfern Julie , Hyun Karice , Singleton Anna , Hafiz Nashid , Raeside Rebecca , Spencer Lissa , Carr Bridie , Caterson Ian , Cullen John , Ferry Cate , Santo Karla , Hayes Alison , Leung Regina W M , Raadsma Simon , Swinbourne Jessica , Cho Jin G , King Meredith , Roberts Mary , Kok Cindy , Jenkins Christine , Chow Clara 
Published: March 2019

IntroductionSimple and scalable strategies are needed to improve ‘out-of-hospital’ support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation.Methods and analysisPragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to inform scalability and implementation across settings. The intervention group will receive a text message support programme comprising five messages per week for 26 weeks and the control group will continue with standard care. The primary outcome is exercise capacity (6 min walk distance). Secondary outcomes include clinical measures (proportion of people meeting the Australian guideline-recommended blood pressure and cholesterol targets), lifestyle outcomes (smoking rates, achievement of national guidelines for nutrition and physical activity), quality of life, mood (Hospital Anxiety and Depression Scale), medication adherence and attendance at and completion of rehabilitation.Ethics and disseminationPrimary ethics approval was received from the Sydney Local Health District Hospital Human Research Ethics Committee and associated Governance committees at sites. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. At its conclusion, the study will determine the effectiveness and implementation of a simple programme that aims to improve health outcomes and attendance at rehabilitation for people with CVD and chronic respiratory disease.Trial registration numberACTRN12616001167459
Effect of the public disclosure of industry payments information on patients: results from a population-based natural experiment
Authors: Kanter Genevieve P , Carpenter Daniel , Lehmann Lisa , Mello Michelle M 
Published: March 2019

ObjectiveTo determine the effect of the public disclosure of industry payments to physicians on patients’ awareness of industry payments and knowledge about whether their physicians had accepted industry payments.DesignInterrupted time series with comparison group (difference-in-difference analyses of longitudinal survey).SettingNationally representative US population-based surveys. Surveys were conducted in September 2014, shortly prior to the public release of Open Payments information, and again in September 2016.ParticipantsAdults aged 18 and older (n=2180).Main outcome measuresAwareness of industry payments as an issue; awareness that industry payments information was publicly available; knowledge of whether own physician had received industry payments.ResultsPublic disclosure of industry payments information through Open Payments did not significantly increase the proportion of respondents who knew whether their physician had received industry payments (p=0.918). It also did not change the proportion of respondents who became aware of the issue of industry payments (p=0.470) but did increase the proportion who knew that payments information was publicly available (9.6% points, p=0.011).ConclusionsTwo years after the public disclosure of industry payments information, Open Payments does not appear to have achieved its goal of increasing patient knowledge of whether their physicians have received money from pharmaceutical and medical device firms. Additional efforts will be required to improve the use and effectiveness of Open Payments for consumers.
Do data from child protective services and the police enhance modelling of perinatal risk for paediatric abusive head trauma? A retrospective case-control study
Authors: Kelly Patrick , Thompson John M D , Rungan Santuri , Ameratunga Shanthi , Jelleyman Timothy , Percival Teuila , Elder Hinemoa , Mitchell Edwin A 
Published: March 2019

ObjectivesFirst, to investigate whether there is a relationship between a family being known to child protective services or police at the time of birth and the risk of abusive head trauma (AHT, formerly known as shaken baby syndrome). Second, to investigate whether data from child protective services or police improve a predictive risk model derived from health records.DesignRetrospective case control study of child protective service and police records.SettingNine maternity hospitals.Participants142 consecutive cases of AHT admitted to a tertiary children’s hospital from 1991 to 2010 and born in one of the nine participating maternity hospitals. 550 controls matched by the date and hospital of birth.Outcome measureAbusive head trauma.ResultsThere is a relationship between families known to child protective services or police and the risk of AHT. Notification to child protective services: univariable OR 7.24 (95% CI 4.70 to 11.14). Involvement with youth justice: univariable OR 8.94 (95% CI 4.71 to 16.95). Police call-out for partner violence: univariable OR 3.85 (95% CI 2.51 to 5.91). Other violence offence: univariable OR 2.73 (95% CI 1.69 to 4.40). Drug offence: univariable OR 2.82 (95% CI 1.63 to 4.89). However, in multi-variable analysis with data from perinatal health records, notification to child protective services was the only one of these variables to remain in the final model (OR 4.84; 95% CI 2.61 to 8.97) and had little effect on overall predictive power. The area under the receiver operating characteristic curve was 89.5% (95% CI 86.6 to 92.5) using variables from health data alone and 90.9% (95% CI 88.0 to 93.7) when notification was added.ConclusionsFamily involvement with child protective services or police is associated with increased risk of AHT. However, accessing such data at the time of birth would add little predictive power to a risk model derived from routine health information.
Evaluation of metformin in combination with rifampicin containing antituberculosis therapy in patients with new, smear-positive pulmonary tuberculosis (METRIF): study protocol for a randomised clinical trial
Authors: Padmapriyadarsini Chandrasekaran , Bhavani Perumal K , Natrajan Mohan , Ponnuraja Chinnayan , Kumar Hemanth , Gomathy Sivaramakrishnan N , Guleria Randeep , Jawahar Shaheed M , Singh Manjula , Balganesh Tanjore , Swaminathan Soumya 
Published: March 2019

IntroductionShorter duration of treatment for the management of drug-susceptible pulmonary tuberculosis (TB) would be a significant improvement in the care of patients suffering from the disease. Besides newer drugs and regimens, other modalities like host-directed therapy are also being suggested to reach this goal. This study’s objective is to assess the efficacy and safety of metformin-containing anti-TB treatment (ATT) regimen in comparison to the standard 6-month ATT regimen in the treatment of patients with newly diagnosed sputum smear-positive drug-sensitive pulmonary TB.Methods and analysisWe are conducting a multicentric, randomised open-label controlled clinical trial to achieve the study objective. The intervention group will receive isoniazid (H), rifampicin (R), ethambutol (E) and pyrazinamide (Z) along with 1000 mg of daily metformin (Met) for the first 2 months while the control group will receive only HRZE. After 2 months, both the groups will receive HRE daily for 4 months. The primary endpoint is time to sputum culture conversion. Secondary endpoints will include time to detection ofMycobacterium tuberculosisin sputum, pharmacokinetics and pharmacogenomics of study drugs, drug–drug interactions, safety and tolerability of the various combinations and measurement of autophagy and immune responses in the study participants.Ethics and disseminationThe ethics committee of the participating institutes have approved the study. Results from this trial will contribute to evidence towards constructing a shorter, effective and safe regimen for patients with TB. The results will be shared widely with the National Programme managers, policymakers and stakeholders through open access publications, dissemination meetings, conference abstracts and policy briefs. This is expected to provide a new standard of care for drug-sensitive patients with pulmonary TB who will not only reduce the number of clinic visits and lost to follow-up of patients from treatment but also reduce the burden on the healthcare system.Trial registration numberCTRI/2018/01/011176; Pre-results.
Local prevalence of extended-spectrum beta-lactamase (ESBL) producingEnterobacteriaceaeintestinal carriers at admission and co-expression of ESBL and OXA-48 carbapenemase inKlebsiella pneumoniae: a prevalence survey in a Spanish University Hospital
Authors: Díaz-Agero Pérez Cristina , López-Fresneña Nieves , Rincon Carlavilla Angela L , Hernandez Garcia Marta , Ruiz-Garbajosa Patricia , Aranaz-Andrés Jesús María , Maechler Friederike , Gastmeier Petra , Bonten Marc J M , Canton Rafael 
Published: March 2019

ObjectiveTo assess the prevalence of extended-spectrum beta-lactamase (ESBL)-producingEnterobacteriaceae(ESBL-E) faecal carriers at admission in a University Hospital in Spain.DesignPrevalence survey.SettingPneumology, gastroenterology, urology and neurosurgery units at a university tertiary hospital in Madrid (Spain).ParticipantsA total of 10 643 patients aged 18 and older admitted from March 2014 to April 2016 with a rectal swab taken at admission or as soon as possible within the first 48 hours.Primary and secondary outcome measuresPrevalence of ESBL-E faecal carriers and prevalence of ESBL-E infections at admission.ResultsThe prevalance of ESBL-E carriers at admission was 7.69% (CI 95% 7.18 to 8.19). Most of the isolates wereEscherichia coli(77.51%), followed byKlebsiella pneumoniae(20.71%). Eighty-eight (10.41%) of ESBL-E were simultaneous ESBL and carbapenemase (CP) producers, 1.83% in the case ofE. coliand 42.86% amongK. pneumoniaeisolates. Of the ESBL typed, 52.15% belonged to the cefotaximases (CTX-M-15) type and 91.38% of the CP were oxacillinase (OXA-48) type. Only 0.43% patients presented an active infection by ESBL-E at admission.ConclusionsThe prevalence found in our study is very similar to that found in literature. However, we found a high percentage of simultaneous ESBL and CP producers, particularly inK. pneumoniae. Despite the high prevalence of colonised patients, the ESBL-infection rate at admission was very low.