bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II single arm open label multicentre clinical trial to evaluate the efficacy and side effects of a combination of gefitinib and methotrexate to treat tubal ectopic pregnancies (GEM II): study protocol
Authors: Horne Andrew W , Skubisz Monika M , Doust Ann , Duncan W Colin , Wallace Euan , Critchley Hilary O D , Johns Terrance G , Norman Jane E , Bhattacharya Siladitya , Mollison Jill , Rassmusen Michael , Tong Stephen 
Published: July 2013

IntroductionTubal ectopic pregnancy (tEP) is the most common life-threatening condition in gynaecology. tEPs with pretreatment serum human chorionic gonadotrophin (hCG) levels <1000 IU/L respond well to outpatient medical treatment with intramuscular methotrexate (MTX). TEPs with hCG >1000 IU/L take a significant time to resolve with MTX and require multiple outpatient monitoring visits. Gefitinib is an orally active epidermal growth factor receptor (EGFR) antagonist. In preclinical studies, we found that EP implantation sites express high levels of EGFR and that gefitinib augments MTX-induced regression of pregnancy-like tissue. We performed a phase I toxicity study administering oral gefitinib and intramuscular MTX to 12 women with tEPs. The combination therapy did not cause significant toxicities and was well tolerated. We noted that combination therapy resolved the tEPs faster than MTX alone. We now describe the protocol of a larger single arm trial to estimate the efficacy and side effects of combination gefitinib and MTX to treat stable tEPs with hCG 1000–10 000 IU/LMethods and analysisWe propose to undertake a single-arm multicentre open label trial (in Edinburgh and Melbourne) and recruit 28 women with tEPs (pretreatment serum hCG 1000–10 000 IU/L). We intend to give a single dose of intramuscular MTX (50 mg/m2) and oral gefitinib (250 mg) daily for 7 days. Our primary outcome is the resolution of EP to non-pregnant hCG levels <15 IU/L without requirement of surgery. Our secondary outcomes are comparison of time to resolution against historical controls given MTX only, and safety and tolerability as determined by clinical/biochemical assessment.Ethics and disseminationEthical approval has been obtained from Scotland A Research Ethics Committee (MREC 11/AL/0350), Southern Health Human Research Ethics Committee B (HREC 11180B) and the Mercy Health Human Research Ethics Committee (R12/25). Data will be presented at international conferences and published in peer-reviewed journals.Trial registration numberACTRN12611001056987.
Soft drink intake and progression of radiographic knee osteoarthritis: data from the osteoarthritis initiative
Authors: Lu Bing , Ahmad Oneeb , Zhang Fang-Fang , Driban Jeffrey B , Duryea Jeffrey , Lapane Kate L , McAlindon Timothy , Eaton Charles B 
Published: July 2013

ObjectivesWe examine the prospective association of soft drink consumption with radiographic progression of knee osteoarthritis (OA).DesignProspective cohort study.SettingThis study used data from the osteoarthritis initiative (OAI).ParticipantsIn OAI, 2149 participants with radiographic knee OA and having dietary data at baseline were followed up to 12, 24, 36 and 48 months.MeasuresThe soft drink consumption was assessed with a Block Brief Food Frequency Questionnaire completed at baseline. To evaluate knee OA progression, we used quantitative medial tibiofemoral joint space width (JSW) based on plain radiographs. The multivariate linear models for repeated measures were used to test the independent association between soft drink intake and the change in JSW over time, while adjusting for body mass index and other potential confounding factors.ResultsIn stratified analyses by gender, we observed a significant dose–response relationship between baseline soft drink intake and adjusted mean change of JSW in men. With increasing levels of soft drink intake (none, ≤1, 2–4 and ≥5 times/week), the mean decreases of JSW were 0.31, 0.39, 0.34 and 0.60 mm, respectively. When we further stratified by obesity, a stronger dose–response relationship was found in non-obese men. In obese men, only the highest soft drink level (≥5 times/week) was associated with increased change in JSW compared with no use. In women, no significant association was observed.ConclusionsOur results suggest that frequent consumption of soft drinks may be associated with increased OA progression in men. Replication of these novel findings in other studies demonstrating the reduction in soft drink consumption leads to delay in OA progression is needed.
A pilot study on record reviewing with a priori patient selection
Authors: Cihangir Sezgin , Borghans Ine , Hekkert Karin , Muller Hein , Westert Gert , Kool Rudolf B 
Published: July 2013

ObjectivesTo investigate whether a priori selection of patient records using unexpectedly long length of stay (UL-LOS) leads to detection of more records with adverse events (AEs) compared to non-UL-LOS.DesignTo investigate the opportunities of the UL-LOS, we looked for AEs in all records of patients with colorectal cancer. Within this group, we compared the number of AEs found in records of patients with a UL-LOS with the number found in records of patients who did not have a UL-LOS.SettingOur study was done at a general hospital in The Netherlands. The hospital is medium sized with approximately 30 000 admissions on an annual basis. The hospital has two major locations in different cities where both primary and secondary care is provided.ParticipantsThe patient records of 191 patients with colorectal cancer were reviewed.Primary and secondary outcome measuresNumber of triggers and adverse events were the primary outcome measures.ResultsIn the records of patients with colorectal cancer who had a UL-LOS, 51% of the records contained one or more AEs compared with 9% in the reference group of non-UL-LOS patients. By reviewing only the UL-LOS group with at least one trigger, we found in 84% (43 out of 51) of these records at least one adverse event.ConclusionsA priori selection of patient records using the UL-LOS indicator appears to be a powerful selection method which could be an effective way for healthcare professionals to identify opportunities to improve patient safety in their day-to-day work.
Non-communicable diseases, infection and survival in a retrospective cohort of Indigenous and non-Indigenous adults in central Australia
Authors: Einsiedel Lloyd , Fernandes Liselle , Joseph Sheela , Brown Alex , Woodman Richard J 
Published: July 2013

ObjectivesWe hypothesise that rising prevalence rates of non-communicable diseases (NCDs) increase infection risk and worsen outcomes among socially disadvantaged Indigenous Australians undergoing a rapid epidemiological transition.DesignAvailable pathology, imaging and discharge morbidity codes were retrospectively reviewed for a period of 5 years prior to admission with a bloodstream infection (BSI), 1 January 2003 to 30 June 2007.Participants558 Indigenous and 55 non-Indigenous community residents of central Australia.Outcome measuresThe effects of NCDs on risk of infection and death were determined after stratifying by ethnicity.ResultsThe mean annual BSI incidence rates were far higher among Indigenous residents (Indigenous, 937/100 000; non-Indigenous, 64/100 000 person-years; IRR=14.6; 95% CI 14.61 to 14.65, p<0.001). Indigenous patients were also more likely to have previous bacterial infections (68.7% vs 34.6%; respectively, p<0.001), diabetes (44.3% vs 20%; p<0.001), harmful alcohol consumption (37% vs 12.7%; p<0.001) and other communicable diseases (human T-lymphotropic virus type 1, 45.2%; strongyloidiasis, 36.1%; hepatitis B virus, 12.9%). Among Indigenous patients, diabetes increased the odds of currentStaphylococcus aureusBSI (OR=1.6, 95% CI 1.0 to 2.5) and prior skin infections (adjusted OR=2.1, 95% CI 1.4 to 3.3). Harmful alcohol consumption increased the odds of currentStreptococcus pneumoniaeBSI (OR=1.57, 95% CI 1.02 to 2.40) and of previous BSI (OR=1.7, 95% CI 1.1 to 2.5), skin infection (OR=1.7, 95% CI 1.1 to 2.6) or pneumonia (OR=4.3, 95% CI 2.8 to 6.7). Twenty-six per cent of Indigenous patients died at a mean (SD) age of 47±15 years. Complications of diabetes and harmful alcohol consumption predicted 28-day mortality (non-rheumatic heart disease, HR=2.9; 95% CI 1.4 to 6.2; chronic renal failure, HR=2.6, 95%CI 1.0 to 6.5; chronic liver disease, HR=3.3, 95% CI 1.6 to 6.7).ConclusionsIn a socially disadvantaged population undergoing a rapid epidemiological transition, NCDs are associated with an increased risk of infection and BSI-related mortality. Complex interactions between communicable diseases and NCDs demand an integrated approach to management, which must include the empowerment of affected populations to promote behavioural change.
Chronic disease multimorbidity transitions across healthcare interfaces and associated costs: a clinical-linkage database study
Authors: Kadam Umesh T , Uttley John , Jones Peter W , Iqbal Zafar 
Published: July 2013

ObjectiveTo investigate multimorbidity transitions from general practice populations across healthcare interfaces and the associated healthcare costs.DesignClinical-linkage database study.SettingPopulation (N=60 660) aged 40 years and over registered with 53 general practices in Stoke-on-Trent.ParticipantsPopulation with six specified multimorbidity pairs were identified based on hypertension, diabetes mellitus (DM), coronary heart disease (CHD), chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF) and chronic kidney disease (CKD).Main outcomes measuresChronic disease registers were linked to accident and emergency (A&E) and hospital admissions for a 3-year time period (2007–2009), and associated costs measured by Healthcare Resource Groups. Associations between multimorbid groups and direct healthcare costs were compared with their respective single disease groups using linear regression methods, adjusting for age, gender and deprivation.ResultsIn the study population, there were 9735 patients with hypertension and diabetes (16%), 3574 with diabetes and CHD (6%), 2894 with diabetes and CKD (5%), 1855 with COPD and CHD (3%), 754 with CHF and COPD (1%) and 1425 with CHF and CKD (2%). Transition, defined as at least one episode in each of the 3-year time periods, was as follows: patients with hypertension and DM had the fewest transitions in the 3-year time period (37% A&E episode and 51% hospital admission), but those with CHF and CKD had the most transitions (67% A&E episode and 79% hospital admission). The average 3-year total costs per multimorbid patient for A&E episodes ranged from £69 to £166 and for hospital admissions ranged from between £2289 and £5344. The adjusted costs were significantly higher for all six multimorbid groups compared with their respective single disease groups.ConclusionsSpecific common multimorbid pairs are associated with higher healthcare transitions and differential costs. Identification of multimorbidity type and linkage of information across interfaces provides opportunities for targeted intervention and delivery of integrated care.
A study protocol for performance evaluation of a new academic intensive care unit facility: impact on patient care
Authors: Ferri Mauricio , Zygun David A , Harrison Alexandra , Stelfox Henry T 
Published: July 2013

BackgroundHealthcare facility construction is increasing because of population demand and the need to replace ageing infrastructure. Research suggests that there may be a relationship between healthcare environment and patient care. To date, most evaluations of new healthcare facilities are derived from techniques used in other industries and focus on physical, financial and architectural performance. However, few studies have evaluated the impact of healthcare facility design on processes and outcomes of patient care.Study aimsThe primary objective of this study was to investigate the impact of relocation to a new intensive care unit (ICU) facility on clinical performance measures. This study also proposes to develop and test a framework for facility performance evaluation using accepted ICU design guidelines and Donabedian's model for healthcare quality.Methods and analysisWe will utilise a mixed-methods, observational, retrospective, controlled, before-and-after design to take advantage of the quasiexperimental conditions created with the construction of a new ICU facility in Calgary, Canada. For the qualitative substudy, we will conduct individual interviews with end-users to understand their impressions and experiences with the new environment and perform thematic analysis. For the quantitative substudy, we will compare process of care indicators and patient outcomes for the 12-month period before and after relocation to the new facility. Two other local ICU facilities that did not undergo structural change during the study period will serve as controls. We will triangulate qualitative and quantitative results utilising a novel framework.Ethics and disseminationThe results of this study will contribute in understanding the impact of new ICU facilities on clinical performance measures centred on patients, their families and healthcare providers. The framework will complement existing building performance evaluation techniques and help healthcare administrators plan new ICU facilities. The University of Calgary Research Ethics Board approved this study protocol.
Adherence management for patients with cancer taking capecitabine: a prospective two-arm cohort study
Authors: Krolop Linda , Ko Yon-Dschun , Schwindt Peter Florian , Schumacher Claudia , Fimmers Rolf , Jaehde Ulrich 
Published: July 2013

ObjectiveTo develop and evaluate a multiprofessional modular medication management to assure adherence to capecitabine.MethodsThe study was conducted as a prospective, multicentred observational cohort study. All participants received pharmaceutical care consisting of oral and written information. Daily adherence was defined as percentage of days with correctly administered capecitabine doses and assessed using medication event monitoring. According to their daily adherence during the first cycle, patients were identified as initially non-adherent (<90% adherence) or adherent (≥90% adherence). Initially non-adherent patients received additional adherence support.ResultsSeventy-three patients with various tumour entities were enrolled, 58 were initially adherent and 15 non-adherent. Median daily adherence of initially non-adherent patients increased from 85.7% to 97.6% during the observation period of six cycles. Throughout all cycles, median daily adherence of initially adherent patients was 100.0%. Daily adherence was not associated with sociodemographic and disease-related factors. No patient was non-persistent.ConclusionsAn early adherence screening effectively distinguishes between patients adhering and non-adhering to capecitabine. The provision of specific adherence support is associated with enhanced adherence of initially non-adherent patients, whereas initially adherent patients remain adherent for at least six cycles without specific support. Our needs-based approach helps to use available resources for adherence management efficiently.
Explaining the barriers to and tensions in delivering effective healthcare in UK care homes: a qualitative study
Authors: Robbins Isabella , Gordon Adam , Dyas Jane , Logan Philippa , Gladman John 
Published: July 2013

ObjectiveTo explain the current delivery of healthcare to residents living in UK care homes.DesignQualitative interview study using a grounded theory approach.Setting6 UK care homes and primary care professionals serving the homes.ParticipantsOf the 32 participants, there were 7 care home managers, 2 care home nurses, 9 care home assistants, 6 general practitioners (GPs), 3 dementia outreach nurses, 2 district nurses, 2 advanced nurse practitioners and 1 occupational therapist.Results5 themes were identified: complex health needs and the intrinsic nature of residents’ illness trajectories; a mismatch between healthcare requirements and GP time; reactive or anticipatory healthcare?; a dissonance in healthcare knowledge and ethos; and tensions in the responsibility for the healthcare of residents. Care home managers and staff were pivotal to healthcare delivery for residents despite their perceived role in social care provision. Formal healthcare for residents was primarily provided via one or more GPs, often organised to provide a reactive service that did not meet residents’ complex needs. Deficiencies were identified in training required to meet residents’ needs for both care home staff as well as GPs. Misunderstandings, ambiguities and boundaries around roles and responsibilities of health and social care staff limited the development of constructive relationships.ConclusionsHealthcare of care home residents is difficult because their needs are complex and unpredictable. Neither GPs nor care home staff have enough time to meet these needs and many lack the prerequisite skills and training. Anticipatory care is generally held to be preferable to reactive care. Attempts to structure care to make it more anticipatory are dependent on effective relationships between GPs and care home staff and their ability to establish common goals. Roles and responsibilities for many aspects of healthcare are not made explicit and this risks poor outcomes for residents.
Electronic health record-based triggers to detect potential delays in cancer diagnosis
Authors: Murphy Daniel R , Laxmisan Archana , Reis Brian A , Thomas Eric J , Esquivel Adol , Forjuoh Samuel N , Parikh Rohan , Khan Myrna M , Singh Hardeep 
Published: July 2013

BackgroundDelayed diagnosis of cancer can lead to patient harm, and strategies are needed to proactively and efficiently detect such delays in care. We aimed to develop and evaluate ‘trigger’ algorithms to electronically flag medical records of patients with potential delays in prostate and colorectal cancer (CRC) diagnosis.MethodsWe mined retrospective data from two large integrated health systems with comprehensive electronic health records (EHR) to iteratively develop triggers. Data mining algorithms identified all patient records with specific demographics and a lack of appropriate and timely follow-up actions on four diagnostic clues that were newly documented in the EHR: abnormal prostate-specific antigen (PSA), positive faecal occult blood test (FOBT), iron-deficiency anaemia (IDA), and haematochezia. Triggers subsequently excluded patients not needing follow-up (eg, terminal illness) or who had already received appropriate and timely care. Each of the four final triggers was applied to a test cohort, and chart reviews of randomly selected records identified by the triggers were used to calculate positive predictive values (PPV).ResultsThe PSA trigger was applied to records of 292 587 patients seen between 1 January 2009 and 31 December 2009, and the CRC triggers were applied to 291 773 patients seen between 1 March 2009 and 28 February 2010. Overall, 1564 trigger positive patients were identified (426 PSA, 355 FOBT, 610 IDA and 173 haematochezia). Record reviews revealed PPVs of 70.2%, 66.7%, 67.5%, and 58.3% for the PSA, FOBT, IDA and haematochezia triggers, respectively. Use of all four triggers at the study sites could detect an estimated 1048 instances of delayed or missed follow-up of abnormal findings annually and 47 high-grade cancers.ConclusionsEHR-based triggers can be used successfully to flag patient records lacking follow-up of abnormal clinical findings suspicious for cancer.
An evaluation of the referral process in the emergency department
Authors: Croft Susan J , Barnes Jane , Ginnis Clare , Chatters Robin , Mason Suzanne 
Published: July 2013

IntroductionMaking an effective telephone referral is an important skill for an emergency department (ED) clinician. It is essential for patient safety that the information is conveyed in a succinct manner to the correct inpatient specialty. The aim of this study was to assess: the impact of grade of staff making the referral; specialty referred to; and condition or patient problem. It also aimed to identify current problems or barriers in the referral process.MethodsThis prospective study took place in one large teaching hospital in the UK. There were two parts: data collection to obtain information on each referral made by ED staff; and questionnaires administered to obtain opinions on the current referral process from both staff making and receiving the referrals.ResultsData were collected over 6 days and included 362 referrals. The mean evaluation of the referral process (scored 0–4) for all referrals was 3.34 (SD 0.95). 22 ED staff responding (64.7%) felt that some specialties were more difficult to refer to than others. 60.6% of non-ED staff accepting referrals felt they would like some form of senior ED screening process prior to referral compared with 20.6% of ED staff. The most common topics commented on were communication, education and process.DiscussionThere are differences in understanding and opinion between ED and non-ED staff about the referral process. There are also factors which influence ease of referral: specialty referring to and patient problem. More intervention studies are required to identify solutions that can be implemented and sustained in routine practice.
Number of medications and road traffic crashes in senior Swedish drivers: a population-based matched case-control study
Authors: Monárrez-Espino Joel , Laflamme Lucie , Elling Berty , Möller Jette 
Published: July 2013

ObjectiveThis study investigated the relationship between the number of different medications dispensed (NDMD) to senior drivers and the risk of injurious road traffic crashes (RTCs).DesignA matched case-control study with data from various population-based national registers was conducted. Cases were drivers aged 50–80 years involved in a crash in Sweden between 2005 and 2009. Only the first non-alcohol-related RTC was studied. Controls were residents with a valid license who did not crash. Four controls were matched by sex, age (year and month of birth), and place of residence. Exposure to NDMD prior to the crash date was assessed using four time periods: 1–8, 1–15, 1–30 and 1–90 days. Conditional logistic regression was used and analyses adjusted for civil status, occupation and dispensation of medications affecting the cardiovascular or nervous systems (C/N).ResultsORs (95% CI) increased progressively with the NDMD. For 1–8 days the OR ranged from 1.15 (1.10 to 1.20) for 1–2 medications to 1.27 (1.13 to 1.42) for five or more medications. The magnitude of the effect declined gradually with longer exposure periods, but remained when five or more medications were used. Adjusting for C/N medications resulted in slightly higher effects; for 1–8 days it ranged from 1.16 (1.10 to 1.23) for 1–2 medications to 1.35 (1.17 to 1.56) for five or more, with similar trends by exposure period. The highest effects were seen for single crashes and for drivers aged 66–80 years.ConclusionsThe NDMD was linked to the likelihood of a senior driver being involved in an injurious RTC. The strength of the association steadily increased with increased NDMD, especially when medications were taken closer to the index date, or when more than five medications were dispensed.