bluuebunny/crossref_metadata_2025_split huggingface dataset:
Design and validity of a questionnaire to assess national eHealth architecture (NEHA): a study protocol
Authors: Mousavi Seyyed Meysam , Takian Amirhossein , Tara Mahmood 
Published: December 2018

IntroductioneHealth is critically important to build strong health systems, and accelerate the achievement of sustainable development goals, particularly universal health coverage. To support and strengthen the health system, the eHealth architecture needs to be formulated and established prior to the implementation and development of any national eHealth applications and services. The aim of this study is to design and validate a standard questionnaire to assess the current status of national eHealth architecture (NEHA) components.Methods and analysisThis study will use a mixed-methods design consisting of four phases: (1) item generation through review of evidences and experts’ opinions, (2) face and content validity of the questionnaire, (3) determination of a range of possible scenarios for each item included in the questionnaire and (4) evaluation of reliability. This questionnaire is expected to generate critical and important information about the status of NEHA components that will be useful for monitoring, formulating, developing, implementing and evaluating NEHA. Our paper will contribute, we envisage, to establishment of a socio-technical basis on which governments and other relevant sectors can compare the policy interventions that boost the availability and utilisation of eHealth services within their settings.Ethics and disseminationThe Ethics Committee for Research at the Tehran University of Medical Sciences approved the study protocol. We will obtain informed consent from each participant and collect data anonymously to maintain confidentiality. The translation of the findings into future policy planning will include the production of a series of peer-reviewed articles, presentation of the findings at relevant eHealth conferences and preparation of policy reports to the international organisations aiming to strengthen national capacity for better-informed eHealth architecture.
A randomised controlled trial to assess whether prehabilitation improves fitness in patients undergoing neoadjuvant treatment prior to oesophagogastric cancer surgery: study protocol
Authors: Allen Sophie , Brown Vanessa , Prabhu Pradeep , Scott Michael , Rockall Timothy , Preston Shaun , Sultan Javed 
Published: December 2018

IntroductionNeoadjuvant therapy prior to oesophagogastric resection is the gold standard of care for patients with T2 and/or nodal disease. Despite this, studies have taught us that chemotherapy decreases patients’ functional capacity as assessed by cardiopulmonary exercise (CPX) testing. We aim to show that a multimodal prehabilitation programme, comprising supervised exercise, psychological coaching and nutritional support, will physically, psychologically and metabolically optimise these patients prior to oesophagogastric cancer surgery so they may better withstand the immense physical and metabolic stress placed on them by radical curative major surgery.Methods and analysisThis will be a prospective, randomised, controlled, parallel, single-centre superiority trial comparing a multimodal ‘prehabilitation’ intervention with ‘standard care’ in patients with oesophagogastric malignancy who are treated with neoadjuvant therapy prior to surgical resection. The primary aim is to demonstrate an improvement in baseline cardiopulmonary function as assessed by anaerobic threshold during CPX testing in an interventional (prehab) group following a 15-week preoperative exercise programme, throughout and following neoadjuvant treatment, when compared with those that undergo standard care (control group). Secondary objectives include changes in peak oxygen uptake and work rate (total watts achieved) at CPX testing, insulin resistance, quality of life, chemotherapy-related toxicity and completion, nutritional assessment, postoperative complication rate, length of stay and overall mortality.Ethics and disseminationThis study has been approved by the London-Bromley Research Ethics Committee and registered on ClinicalTrials.gov. The results will be disseminated in a peer-reviewed journal.Trial registration numberNCT02950324; Pre-results.
Life after the loss: protocol for a Danish longitudinal follow-up study unfolding life and grief after the death of a child during pregnancy from gestational week 14, during birth or in the first 4 weeks of life
Authors: Hvidtjørn Dorte , Prinds Christina , Bliddal Mette , Henriksen Tine Brink , Cacciatore Joanne , O’Connor Maja 
Published: December 2018

IntroductionAfter the death of a child during pregnancy, birth or in the neonatal period, parents often experience feelings of guilt, disenfranchisement, feelings of betrayal by one’s own body and envy of others. Such bereavement results in high rates of distress: psychologically, emotionally, physiologically and existentially. These data are collected using a national, longitudinal cohort to assess grief in mothers and their partners after the death of a child during pregnancy, birth or in the neonatal period. Our aim is to achieve a general description of grief, emotional health, and existential values after pregnancy or perinatal death in a Danish population.Methods and analysisThe cohort comprises mothers and their partners in Denmark who lost a child during pregnancy from gestational week 14, during birth or in the neonatal period (4 weeks post partum). We began data collection in 2015 and plan to continue until 2024. The aim is to include 5000 participants by 2024, generating the largest cohort in the field to date. Parents are invited to participate at the time of hospital discharge or via the Patient Associations homepage. Data are collected using web-based questionnaires distributed at 1–2, 7 and 13 months after the loss. Sociodemographic and obstetric variables are collected. Validated psychometric measures covering attachment, continuing bonds, post-traumatic stress, prolonged grief, perinatal grief and existential values were chosen to reach our aim.Ethics and disseminationThe study was approved by The Danish National Data Protection Agency (no. 18/15684, 7 October 2014). The results will be disseminated in peer-reviewed and professional journals as well as in layman magazines, lectures and radio broadcasts.
Anaemia among primary care patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD): a multicentred cross-sectional study
Authors: Idris Iliza , Tohid Hizlinda , Muhammad Noor Azimah , A Rashid Mohd Radzniwan , Mohd Ahad Azainorsuzila , Ali Norsiah , Sharifuddin Naemah , Aris Junita Harizon 
Published: December 2018

ObjectivesThis study aimed to determine the prevalence of anaemia among patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) at primary care settings and its associated factors.Design, setting and participantsThis cross-sectional study involved 808 adult patients with T2DM and CKD who were recruited via systematic sampling from 20 public primary care clinics in Peninsular Malaysia. Their sociodemographic, clinical and biomedical profiles were collected through interviews, examination of medical records and blood testing.ResultsThe prevalence of anaemia was 31.7% (256/808). The anaemia was mainly mild (61.5%) and normocytic normochromic (58.7%). About 88.7% of the patients with anaemia were not known to have anaemia prior to the study. Among 36 patients with documented history of anaemia, 80.6% were still anaemic, and only a half received iron therapy. Multivariate regression analysis showed that women (adjusted odd ratio (AOR): 1.57, 95% CI: 1.12 to 2.21, p=0.009) and those with older age (AOR: 1.04, 95% CI: 1.01 to 1.06, p<0.001), CKD stage 3a (AOR: 2.47; 95% CI: 1.25 to 4.87, p=0.009), CKD stage 3b (AOR: 4.36; 95% CI: 2.14 to 8.85, p<0.001), CKD stage 4 (AOR: 10.12; 95% CI: 4.36 to 23.47, p<0.001), CKD stage 5 (AOR: 10.80; 95% CI: 3.32 to 35.11, p<0.001) and foot complication (AOR 3.12, 95% CI: 1.51 to 6.46, p=0.002) were more likely to have anaemia. Having higher body mass index (AOR 0.95, 95% CI: 0.92 to 0.99, p=0.012) and higher diastolic blood pressure (AOR 0.97, 95% CI: 0.95 to 0.99, p<0.001) were associated with lower odds to have anaemia.ConclusionAnaemia among patients with T2DM and CKD in primary care was common, and the majority was unrecognised. Inadequate treatment of anaemia was also prevalent. Therefore, screening of anaemia should be incorporated into the routine assessment of diabetic complications particularly for those with significant associated factors. It is hoped that such strategy could lead to early treatment and hence improve their overall care.Trial registration numberNMRR-15-660-24324.
Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol
Authors: Rantasalo Mikko Tuomas , Palanne Riku , Juutilainen Katarina , Kairaluoma Pekka , Linko Rita , Reponen Elina , Helkamaa Teemu , Vakkuri Anne , Olkkola Klaus T , Madanat Rami , Skants Noora Kati Annukka 
Published: December 2018

IntroductionTotal knee arthroplasty is a highly effective treatment for end-stage knee osteoarthritis, and it is usually performed under spinal or general anaesthesia with or without a surgical tourniquet. Some debate about the preferred mode of anaesthesia regarding patient outcomes remains. The aim of this study, which compares general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty, is to determine the optimal type of anaesthesia regimen and assess the effect of a tourniquet on the patient’s recovery following total knee arthroplasty.Methods and analysisThis study is a randomised, controlled, parallel-group, four-arm study comparing spinal and general anaesthesia with and without a tourniquet in 400 patients undergoing fast-track total knee arthroplasty, with a 12-month follow-up. The primary outcome is cumulative intravenous oxycodone consumption by patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative nausea and vomiting, the length of hospital stay, the duration of the surgery, blood loss, demand for surgical unit resources, complications, readmissions, postoperative knee function, range of motion, health-related quality of life, prolonged pain and mortality.Ethics and disseminationThis study’s protocol is in accordance with the declaration of Helsinki. The results of this study will be disseminated in international peer-reviewed journals.Trial registration numberNCT03364088; Pre-results.
Investigating locally relevant risk factors forCampylobacterinfection in Australia: protocol for a case–control study and genomic analysis
Authors: Varrone Liana , Stafford Russell J , Lilly Kim , Selvey Linda , Glass Kathryn , Ford Laura , Bulach Dieter , Kirk Martyn D 
Published: December 2018

IntroductionThe CampySource project aims to identify risk factors for humanCampylobacterinfection in Australia. We will investigate locally relevant risk factors and those significant in international studies in a case–control study. Case isolates and contemporaneous isolates from food and animal sources will be sequenced to conduct source attribution modelling, and findings will be combined with the case–control study in a source-assigned analysis.Methods and analysisThe case–control study will include 1200 participants (600 cases and 600 controls) across three regions in Australia. Cases will be recruited from campylobacteriosis notifications to health departments. Only those with a pure and viableCampylobacterisolate will be eligible for selection to allow for whole genome sequencing of isolates. Controls will be recruited from notified cases of influenza, frequency matched by sex, age group and geographical area of residence. All participants will be interviewed by trained telephone interviewers using a piloted questionnaire.We will collectCampylobacterisolates from retail meats and companion animals (specifically dogs), and all food, animal and human isolates will undergo whole genome sequencing. We will use sequence data to estimate the proportion of human infections that can be attributed to animal and food reservoirs (source attribution modelling), and to identify spatial clusters and temporal trends. Source-assigned analysis of the case–control study data will also be conducted where cases are grouped according to attributed sources.Ethics and disseminationHuman and animal ethics have been approved. Genomic data will be published in online archives accompanied by basic metadata. We anticipate several publications to come from this study.
Should pretest genetic counselling be required for patients pursuing genomic sequencing? Results from a survey of participants in a large genomic implementation study
Authors: Pacyna Joel E , Radecki Breitkopf Carmen , Jenkins Sarah M , Sutton Erica J , Horrow Caroline , Kullo Iftikhar J , Sharp Richard R 
Published: December 2018

PurposeWe assessed the decision-making of individuals pursuing genomic sequencing without a requirement for pretest genetic counselling. We sought to describe the extent to which individuals who decline genetic counselling reported decisional conflict or struggled to make a decision to pursue genomic testing.MethodsWe administered a 100-item survey to 3037 individuals who consented to the Return of Actionable Variants Empirical study, a genomic medicine implementation study supported by the National Institutes of Health (USA) eMERGE consortium. The primary outcomes of interest were self-reported decisional conflict about the decision to participate in the study and time required to reach a decision.ResultsWe received 2895 completed surveys (response rate=95.3%), and of these respondents 97.8% completed the decisional conflict scale in its entirety. A majority of individuals (63%) had minimal or no decisional conflict about the pursuit of genomic sequencing and were able to reach a decision quickly (78%). Multivariable logistic regression analyses identified several characteristics associated with decisional conflict, including lower education, lower health literacy, lower self-efficacy in coping, lack of prior experience with genetic testing, not discussing study participation with a family member or friend, and being male.ConclusionAs genomic sequencing is used more widely, genetic counselling resources may not be sufficient to meet demand. Our results challenge the notion that all individuals need genetic counselling in order to make an informed decision about genomic sequencing.
Does multilocus inherited neoplasia alleles syndrome have severe clinical expression?
Authors: Stradella Agostina , del Valle Jesús , Rofes Paula , Feliubadaló Lídia , Grau Garces Èlia , Velasco Àngela , González Sara , Vargas Gardenia , Izquierdo Ángel , Campos Olga , Tornero Eva , Navarro Matilde , Balmaña-Gelpi Judith , Capellá Gabriel , Pineda Marta , Brunet Joan , Lázaro Conxi 
Published: December 2018

ImportanceGenetic testing of hereditary cancer using comprehensive gene panels can identify patients with more than one pathogenic mutation in high and/or moderate-risk-associated cancer genes. This phenomenon is known as multilocus inherited neoplasia alleles syndrome (MINAS), which has been potentially linked to more severe clinical manifestations.ObjectiveTo determine the prevalence and clinical features of MINAS in a large cohort of adult patients with hereditary cancer homogeneously tested with the same gene panel.Patients and methodsA cohort of 1023 unrelated patients with suspicion of hereditary cancer was screened using a validated panel including up to 135 genes associated with hereditary cancer and phakomatoses.ResultsThirteen (1.37%) patients harbouring two pathogenic mutations in dominant cancer-predisposing genes were identified, representing 5.7% (13/226) of patients with pathogenic mutations. Most (10/13) of these cases presented clinical manifestations associated with only one of the mutations identified. One case showed mutations in MEN1 and MLH1 and developed tumours associated with both cancer syndromes. Interestingly, three of the double mutants had a young age of onset or severe breast cancer phenotype and carried mutations in moderate to low-risk DNA damage repair-associated genes; two of them presented biallelic inactivation of CHEK2. We included these two patients for the sake of their clinical interest although we are aware that they do not exactly fulfil the definition of MINAS since both mutations are in the same gene.Conclusions and relevanceGenetic analysis of a broad cancer gene panel identified the largest series of patients with MINAS described in a single study. Overall, our data do not support the existence of more severe manifestations in double mutants at the time of diagnosis although they do confirm previous evidence of severe phenotype in biallelic CHEK2 and other DNA repair cancer-predisposing genes.
Dual screen and confirm rapid test does not reduce overtreatment of syphilis in pregnant women living in a non-venereal treponematoses endemic region: a field evaluation among antenatal care attendees in Burkina Faso
Authors: Langendorf Céline , Lastrucci Céline , Sanou-Bicaba Isabelle , Blackburn Kara , Koudika Marie-Hortense , Crucitti Tania 
Published: December 2018

ObjectivesIn resource-limited settings, screening pregnant women for syphilis using rapid diagnostic tests (RDTs) is a key tool in the prevention of congenital syphilis. However, most syphilis RDTs detect only treponemal antibodies (T-RDT), meaning antibiotics may be provided unnecessarily to previously treated pregnant women, particularly in non-venereal treponematoses endemic regions. We estimated the potential reduction in overtreatment when comparing T-RDT (SD Bioline) to a newer rapid test (Dual Path Platform (DPP) Screen and Confirm Assay, Chembio) detecting both treponemal and non-treponemal antibodies.MethodsPregnant women in Déou, Burkina Faso, screened for syphilis during antenatal care (ANC) visits were prospectively enrolled in the study after providing consent. DPP and T-RDT tests were performed on whole blood specimens. Plasma was tested in an international reference laboratory by Treponema pallidum passive particle agglutination (TPPA) and quantitative rapid plasma reagin (RPR). Presumptive active syphilis was defined as a result that was both TPPA and RPR reactive.ResultsOf the 242 pregnant women included in the study, 91 (37.6%) had presumptive active syphilis and 19.0% had RPR titres ≥8. DPP testing did not reduce the number of pregnant women who would have been overtreated compared with T-RDT (0.0% vs 2.5%; p=0.218) and had a higher proportion of underdiagnosis (48.4% vs 2.2%; p<0.001). Seven women with high RPR titres ≥8 would not have received treatment had only DPP testing been used.ConclusionIn the first evaluation comparing DPP with traditional screening methods in pregnant women, we saw no reduction in unnecessarily treated syphilis and an underestimation of those needing treatment. High seroprevalence in the population may indicate the presence of other treponemal infections in the area, and further study of DPP in a variety of Sahelian and other contexts is warranted.
Voice Disorders in Obstructive Sleep Apnea: Prevalence, Risk Factors, and the Role of CPAP
Authors: Roy Nelson , Merrill Ray M. , Pierce Jenny , Sundar Krishna M. 
Published: December 2018

Objective: Obstructive sleep apnea (OSA) is characterized by frequent interruptions in breathing related to upper airway collapse during sleep and may adversely affect phonatory function. This study aimed to: (1) establish the prevalence, risks, and quality of life burden of voice disorders in OSA and (2) explore the relation between voice disorders and positive airway pressure (PAP) therapy. Study Design: Cross-sectional, descriptive epidemiology study. Methods: Analyses were based on 94 individuals with OSA (53 men, 41 women; mean age = 54.7 ± 12.8 years) who completed a telephone interview. Results: Twenty-eight percent of participants reported having a current voice disorder. Of those with a current voice disorder, 83% had experienced symptoms for at least a year, and 58% had symptoms for at least 4 years. The prevalence of a current voice disorder was greater in women than men (44% vs 15%, P = .0020) but did not vary significantly across different age groups, body mass index (BMI), apnea/hypopnea index (AHI) severity, or medical history. After adjusting for sex, consistent use of PAP therapy (with humidification) was associated with (1) lower occurrence of voice disorders in women (Mantel-Haenszel [MH] χ2 P = .0195), (2) reduced snoring severity accompanied by fewer voice disorders in men (MH χ2 P = .0101), and (3) fewer reports of acid reflux as a possible trigger for voice problems (MH χ2 P = .0226). Patients with OSA who also had a current voice disorder experienced lower overall quality of life compared to those without. Conclusions: Chronic, longstanding voice disorders are common in women with OSA and produce significant adverse effects on quality of life. Nightly PAP use (with humidification) was associated with fewer voice symptoms and reduced severity of snoring and acid reflux as possible contributors. Further research is necessary to better understand the origin of these voice disorders in OSA and their potential response to treatment.
The relationship between airtightness and ventilation in new UK dwellings
Authors: Crawley Jenny , Wingfield Jez , Elwell Cliff 
Published: December 2018

The UK’s Air Tightness Testing and Measurement Association competent persons scheme collects pressure test data and metadata from the majority of new build dwellings in the UK. This article uses the dataset to investigate the importance of the ventilation strategy in airtightness design and construction. Design and measured airtightness were tested for association with declared ventilation strategy. It was found that ventilation strategy makes a statistically significant difference to airtightness; however, this difference is too small to be practically relevant. Properties with mechanical ventilation and heat recovery (MVHR) were shown to have a mean designed air permeability only 0.46 m3/m2h lower than naturally ventilated dwellings. Seventy-three per cent of homes with MVHR have design airtightness greater than or equal to 5 m3/m2h and 17% of naturally ventilated dwellings have design airtightness less than 5 m3/m2h. We discuss how current design is not maximising the CO2, cost and air quality benefit of each ventilation strategy. A new approach to regulatory compliance is proposed, which explicitly links the designed airtightness and chosen ventilation system. It is suggested that compliance could then be achieved using a set of airtightness ranges linked to appropriate ventilation strategies. This could be expected to result in reduced energy consumption and carbon emissions for new build homes compared to the current approach and would also potentially lead to better outcomes for occupants in terms of indoor air quality. Practical application: Analysis of a large database of the airtightness of new UK dwellings found that ventilation strategy makes very little difference to airtightness design. For dwellings with MVHR, the results suggest that infiltration levels are too high to maximise the energy savings; for naturally ventilated homes, there may be air quality issues. Coupling airtightness design and ventilation strategy can reduce a dwelling’s energy demand and can support achieving the required energy performance rating.