bluuebunny/crossref_metadata_2025_split huggingface dataset:
The FOOTPATH study: protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis
Authors: Collins Natalie J , Tan Jade M , Menz Hylton B , Russell Trevor G , Smith Anne J , Vicenzino Bill , Munteanu Shannon E , Hinman Rana S , Haines Terry P , Hart Harvi F , Patterson Brooke E , Cleary Gearoid , Donnar Joel W , Maclachlan Liam R , Crossley Kay M 
Published: April 2019

IntroductionPatellofemoral (PF) osteoarthritis (OA) is a common and burdensome subgroup of knee OA, with very little evidence for effective treatments. Prefabricated foot orthoses are an affordable and accessible intervention that have been shown to reduce PF pain in younger adults. Similarities between PF pain and PFOA, as well as our pilot work, suggest that foot orthoses may also be an effective intervention for PFOA. The primary objective of this study is to compare the 3 month efficacy of prefabricated foot orthoses and flat shoe inserts in people with PFOA, on knee pain severity.Methods and analysisThe FOOTPATH Study (FOot OrThoses for PAtellofemoral osteoarTHritis) is a multicentre, randomised, participant- and assessor-blinded superiority trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants with a clinical diagnosis of PFOA will be recruited from three sites in Australia, and randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). The primary outcome is worst knee pain severity during a self-nominated aggravating activity in the previous week (100 mm visual analogue scale) at 3 months, with a secondary endpoint at 12 months. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, self-efficacy and use of co-interventions for knee pain. Blinded, intention-to-treat analyses of primary and secondary patient-reported outcomes will be performed, as well as economic analyses.Ethics and disseminationEthical approval has been granted by La Trobe University’s Human Ethics Committee and The University of Queensland’s Medical Research Ethics Committee. Study outcomes will be disseminated via peer-reviewed journals, conference presentations targeting a range of healthcare disciplines and an open access website with clinician resources.Trial registration numberANZCTRN12617000385347; Pre-results.
Number of blood pressure measurements needed to estimate long-term visit-to-visit systolic blood pressure variability for predicting cardiovascular risk: a 10-year retrospective cohort study in a primary care clinic in Malaysia
Authors: Lim Hooi Min , Chia Yook Chin , Ching Siew Mooi , Chinna Karuthan 
Published: April 2019

ObjectiveTo determine the reproducibility of visit-to-visit blood pressure variability (BPV) in clinical practice. We also determined the minimum number of blood pressure (BP) measurements needed to estimate long-term visit-to-visit BPV for predicting 10-year cardiovascular (CV) risk.DesignRetrospective studySettingA primary care clinic in a university hospital in Malaysia.ParticipantsRandom sampling of 1403 patients aged 30 years and above without any CV event at baseline.Outcomes measuresThe effect of the number of BP measurement for calculation of long-term visit-to-visit BPV in predicting 10-year CV risk. CV events were defined as fatal and non-fatal coronary heart disease, fatal and non-fatal stroke, heart failure and peripheral vascular disease.ResultsThe mean 10-year SD of systolic blood pressure (SBP) for this cohort was 13.8±3.5 mm Hg. The intraclass correlation coefficient (ICC) for the SD of SBP based on the first eight and second eight measurements was 0.38 (p<0.001). In a primary care setting, visit-to-visit BPV (SD of SBP calculated from 20 BP measurements) was significantly associated with CV events (adjusted OR 1.07, 95% CI 1.02 to 1.13, p=0.009). Using SD of SBP from 20 measurement as reference, SD of SBP from 6 measurements (median time 1.75 years) has high reliability (ICC 0.74, p<0.001), with a mean difference of 0.6 mm Hg. Hence, a minimum of six BP measurements is needed for reliably estimating intraindividual BPV for CV outcome prediction.ConclusionLong-term visit-to-visit BPV is reproducible in clinical practice. We suggest a minimum of six BP measurements for calculation of intraindividual visit-to-visit BPV. The number and duration of BP readings to derive BPV should be taken into consideration in predicting long-term CV risk.
Patient expectations of a new treatment for eating disorders combining guided physical exercise and dietary therapy: an interview study of women participating in a randomised controlled trial at the Norwegian School of Sport Sciences
Authors: Pettersen Gunn , Rosenvinge Jan H , Skomakerstuen Tone , Sordal Solveig , Mathisen Therese Fostervold , Sundgot-Borgen Jorunn 
Published: April 2019

ObjectivesTo study the expectations women with bulimia nervosa (BN) or binge eating disorder (BED) had to a new treatment programme based on guided physical exercise and dietary therapy.Design and participantsSemistructured interviews were conducted with six women with BN and four women with BED following a group-based therapy programme. Transcribed interviews were analysed using a text-condensing analytic approach.ResultsThe analysis resulted in three main categories, that is, expectations about (1) increased knowledge, (2) symptom changes and (3) therapeutic expertise. The women expected that learning more about nutrition and physical exercise would give them more energy, less fear of food, physical and mental symptoms and a negative body focus. They also expected therapists to be professional and competent, and able to take care of them.ConclusionThe overall high and positive treatment expectation can, to some extent, reflect enthusiasm about a new and innovative approach to treatment. However, the results also reflect generic and highly adequate outcome expectations, which for the purpose of effectiveness should be incorporated into all treatment efforts at least for patients with eating disorders.Trial registration numberNCT02079935; Results.
Communication skills training for the radiotherapy team to manage cancer patients’ emotional concerns: a systematic review
Authors: van Beusekom Mara Myrthe , Cameron Josie , Bedi Carolyn , Banks Elspeth , Humphris Gerald 
Published: April 2019

ObjectivesMany cancer patients experience high levels of anxiety and concern during radiotherapy, often with long-lasting effects on their well-being. This systematic review aims to describe and determine the effectiveness of communication skills training (CST) for the radiotherapy team (RT) to improve conversations in this setting and to support patients with emotional concerns.DesignSystematic review.InterventionsCST for RT members.Data sourcesOn 17 April 2018, databases Medline, Embase, Scopus and PsycNET were searched.Eligibility criteria, Population, Intervention, Comparison, Outcome(PICO)Quantitative and/or qualitative articles were included that evaluate the effect of a CST for RT members (vs no CST) on communication behaviours and patients’ emotional concerns.Data extraction and synthesisArticles were appraised using the mixed-methods appraisal tool, and a narrative synthesis was performed.ResultsOf the nine included articles, five were randomised controlled trials, three were mixed-methods and one used repeated measurements. Four of the five different CST programmes managed to increase emotional communicative behaviour from the RT, and all studies measuring patient communicative behaviour found an improvement in at least one of the hypothesised outcomes. Two studies examining patient anxiety and concerns found a positive effect of the CST, although one found a negative effect; two other studies without a positive effect on mood made use of both empathic CST and tools.ConclusionsThere are promising indications that CST can be successfully introduced to improve emotional conversations between RT members and patients. With the right support, the RT can play an important role to help patients cope with their emotional concerns. Future work is necessary to confirm initial promising results and to ensure the learnt communication skills are sustained.
Multidimensional analysis of factors responsible for the low prevalence of ambulatory peritoneal dialysis in Germany (MAU-PD): a cross-sectional Mixed-Methods Study Protocol
Authors: Scholten Nadine , Ohnhaeuser Tim , Schellartz Isabell , von Gersdorff Gero , Hellmich Martin , Karbach Ute , Pfaff Holger , Samel Christina , Stock Stephanie , Rascher Katherine , Mettang Thomas 
Published: April 2019

IntroductionPatients with end-stage kidney failure can be treated either by transplant or by dialysis, which can be administered as haemodialysis (HD) or peritoneal dialysis (PD). Although they are equivalent therapeutic options in terms of mortality, the percentage of patients in Germany treated with PD is currently very low (∼6%) compared with other countries. The aim of our study is to analyse the factors behind this percentage and their relevance to the choice of dialysis treatment in Germany. This includes analyses of regional disparities in the provision of care for dialysis patients as well as the evaluations of costs and the influence of reimbursement structures. This approach should provide further insights to explain the variation in the usage of PD and HD and will help to define starting points for future interventions.Methods and analysisA mixed-methods approach will be applied to several data sources, including administrative data (ambulatory physicians’ claim data, statutory health insurance claim data), quality assurance data from one of the largest German dialysis providers Kuratorium für Dialyse (KfH) and qualitative and quantitative survey data (patients, nephrologists and dialysis nurses). Qualitative data will be analysed content-analytically. Based on the quantitative data, multivariable analyses will be performed and, where possible, hierarchical models will be tested. This multidimensional approach will enable us to account for the different factors influencing the penetration of PD in Germany.Ethics and disseminationEthics approval (17-299) has been obtained from the Ethics Committee of the Medical Faculty of the University of Cologne on 25 April 2018. National and international dissemination will be accomplished by informing healthcare practitioners, patients and professional organisations and other stakeholders via conferences, scientific and non-scientific publications and seminars.Trial registration numberDRKS00012555; Pre-Results.
Genetic components of human pain sensitivity: a protocol for a genome-wide association study of experimental pain in healthy volunteers
Authors: Schmid Annina B , Adhikari Kaustubh , Ramirez-Aristeguieta Luis Miguel , Chacón-Duque Juan-Camilo , Poletti Giovanni , Gallo Carla , Rothhammer Francisco , Bedoya Gabriel , Ruiz-Linares Andres , Bennett David L 
Published: April 2019

IntroductionPain constitutes a major component of the global burden of diseases. Recent studies suggest a strong genetic contribution to pain susceptibility and severity. Whereas most of the available evidence relies on candidate gene association or linkage studies, research on the genetic basis of pain sensitivity using genome-wide association studies (GWAS) is still in its infancy. This protocol describes a proposed GWAS on genetic contributions to baseline pain sensitivity and nociceptive sensitisation in a sample of unrelated healthy individuals of mixed Latin American ancestry.Methods and analysisA GWAS on genetic contributions to pain sensitivity in the naïve state and following nociceptive sensitisation will be conducted in unrelated healthy individuals of mixed ancestry. Mechanical and thermal pain sensitivity will be evaluated with a battery of quantitative sensory tests evaluating pain thresholds. In addition, variation in mechanical and thermal sensitisation following topical application of mustard oil to the skin will be evaluated.Ethics and disseminationThis study received ethical approval from the University College London research ethics committee (3352/001) and from the bioethics committee of the Odontology Faculty at the University of Antioquia (CONCEPTO 01–2013). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations at international conferences.
Protocol for a pilot randomised controlled trial of mindfulness-based cognitive therapy in youth with inflammatory bowel disease and depression
Authors: Ewais Tatjana , Begun Jake , Kenny Maura , Chuang Kai-Hsiang , Barclay Johanna , Hay Karen , Kisely Steve 
Published: April 2019

IntroductionInflammatory bowel disease (IBD) is a chronic autoinflammatory disease of the gastrointestinal tract with peak age of onset during adolescence and young adulthood. Adolescents and young adults (AYAs) with IBD experience higher depression rates compared with peers who are well or have other chronic conditions. Mindfulness-based interventions are of particular interest because of their potential to improve both the course of IBD and depression.Methods and analysisThis study is a parallel design, single-blind, pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) in AYAs with IBD and depression. The trial aims to recruit 64 participants who will be randomly allocated to MBCT or treatment as usual. The primary outcome measure is the depression subscale score from the Depression, Anxiety and Stress Scale. Secondary outcomes include anxiety, stress, post-traumatic growth, IBD-related quality of life, illness knowledge, medication adherence, mindfulness, IBD activity, inflammatory markers, microbiome and brain neuroconnectivity changes. All outcomes other than neuroimaging will be collected at three time points: at baseline, at therapy completion and at 20 weeks. Neuroimaging will be conducted at baseline and at therapy completion. Mixed-effects linear and logistic regression modelling will be used to analyse continuous and dichotomous outcomes, respectively. Participants’ experiences will be explored through focus groups, and thematic analysis will be used to generate relevant themes.Ethics and disseminationThe protocol has been approved by the Mater Hospital Human Research Ethics Committee (HREC) and University of Queensland HREC. Trial findings will be published in peer-reviewed journals and will be presented at scientific conferences.Trial registration numberACTRN12617000876392, U1111-1197-7370; Pre-results.
Does the ‘Chinese New Year effect’ exist? Hospital mortality in patients admitted to internal medicine departments during official consecutive holidays: a nationwide population-based cohort study
Authors: Lin Shu-Man , Wang Jen-Hung , Huang Liang-Kai , Huang Huei-Kai 
Published: April 2019

ObjectiveOur study aimed to compare the mortality risk among patients admitted to internal medicine departments during official consecutive holidays (using Chinese New Year holidays as an indicator) with that of weekend and weekday admissions.DesignNationwide population-based cohort study.SettingTaiwan’s National Health Insurance Research Database.PatientsPatients admitted to internal medicine departments in acute care hospitals during January and February each year between 2001 and 2013 were identified. Admissions were categorised as: Chinese New Year holiday (n=10 779), weekend (n=35 870) or weekday admissions (n=143 529).Outcome measuresORs for in-hospital mortality and 30-day mortality were calculated using multivariate logistic regression with adjustment for confounders.ResultsBoth in-hospital and 30-day mortality were significantly higher for patients admitted during the Chinese New Year holidays and on weekends compared with those admitted on weekdays. Chinese New Year holiday admissions had a 38% and 40% increased risk of in-hospital (OR=1.38, 95% CI 1.27 to 1.50, p<0.001) and 30-day (OR=1.40, 95% CI 1.31 to 1.50, p<0.001) mortality, respectively, compared with weekday admissions. Weekend admissions had a 17% and 19% increased risk of in-hospital (OR=1.17, 95% CI 1.10 to 1.23, p<0.001) and 30-day (OR=1.19, 95% CI 1.14 to 1.24, p<0.001) mortality, respectively, compared with weekday admissions. Analyses stratified by principal diagnosis revealed that the increase in in-hospital mortality risk was highest for patients admitted on Chinese New Year holidays with a diagnosis of ischaemic heart disease (OR=3.43, 95% CI 2.46 to 4.80, p<0.001).ConclusionsThe mortality risk was highest for patients admitted during Chinese New Year holidays, followed by weekend admissions, and then weekday admissions. Further studies are necessary to identify the underlying causes and develop strategies to improve outcomes for patients admitted during official consecutive holidays.
The utility of diagnostic selective nerve root blocks in the management of patients with lumbar radiculopathy: a systematic review
Authors: Beynon Rebecca , Elwenspoek Martha Maria Christine , Sheppard Athena , Higgins John Nicholas , Kolias Angelos G , Laing Rodney J , Whiting Penny , Hollingworth William 
Published: April 2019

ObjectiveLumbar radiculopathy (LR) often manifests as pain in the lower back radiating into one leg (sciatica). Unsuccessful back surgery is associated with significant healthcare costs and risks to patients. This review aims to examine the diagnostic accuracy of selective nerve root blocks (SNRBs) to identify patients most likely to benefit from lumbar decompression surgery.DesignSystematic review of diagnostic test accuracy studies.Eligibility criteriaPrimary research articles using a patient population with low back pain and symptoms in the leg, SNRB administered under radiological guidance as index test, and any reported reference standard for the diagnosis of LR.Information sourcesMEDLINE (Ovid), MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Science Citation Index, Biosis, LILACS, Dissertation abstracts and National Technical Information Service from inception to 2018.MethodsRisk of bias and applicability was assessed using the QUADAS-2 tool. We performed random-effects logistic regression to meta-analyse studies grouped by reference standard.Results6 studies (341 patients) were included in this review. All studies were judged at high risk of bias. There was substantial heterogeneity across studies in sensitivity (range 57%–100%) and specificity (10%–86%) estimates. Four studies were diagnostic cohort studies that used either intraoperative findings during surgery (pooled sensitivity: 93.5% [95% CI 84.0 to 97.6]; specificity: 50.0% [16.8 to 83.2]) or ‘outcome following surgery’ as the reference standard (pooled sensitivity: 90.9% [83.1 to 95.3]; specificity 22.0% [7.4 to 49.9]). Two studies had a within-patient case-control study design, but results were not pooled because different types of control injections were used.ConclusionsWe found limited evidence which was of low methodological quality indicating that the diagnostic accuracy of SNRB is uncertain and that specificity in particular may be low. SNRB is a safe test with a low risk of clinically significant complications, but it remains unclear whether the additional diagnostic information it provides justifies the cost of the test.
One-shot dilation versus serial dilation technique for access in percutaneous nephrolithotomy: a systematic review and meta-analysis
Authors: Peng Pan-xin , Lai Shi-cong , Ding Zhen-shan , He Yu-hui , Zhou Li-hua , Wang Xu-ming , Zhang Guan 
Published: April 2019

ObjectiveThe purpose of this study was to systematically review the outcomes of the use of one-shot dilation (OSD) and serial tract dilation for percutaneous nephrolithotomy (PCNL).MethodsA systematic review and meta-analysis was conducted. The randomised controlled trials (RCTs) included in the study were identified from EMBASE, MEDLINE and the Cochrane Central Register of Controlled Trials. The last search was performed on 30 April 2018. Summary effects were calculated as risk ratios (RRs) with 95% CIs or mean differences (MDs) with 95% CIs. The endpoints included access time, fluoroscopy time, successful dilation rate, stone-free rate, postoperative decrease in haemoglobin levels, transfusion rate, complication rate and length of postoperative hospital stay.ResultsA total of seven RCTs were included in the study, with clinical data reported for 697 patients. The overall access time was approximately 110 s shorter in the OSD group than in the serial dilation group (MD, −110.14; 95% CI −161.99 to −58.30; p<0.0001). The fluoroscopy time was shorter with OSD in all RCTs. In addition, the decrease in postoperative haemoglobin levels was approximately 2.3g/L less in patients in the OSD group than in those in the serial dilation group (MD, −0.23; 95% CI−0.39 to −0.07; p=0.004). No relationship was found between the successful dilation rate, stone-free rate, transfusion rate, or complication rate and the method of tract dilation.ConclusionOSD is a safe and efficacious tract dilation technique that can reduce the access time, fluoroscopy time and postoperative decrease in haemoglobin level. No difference was found in the successful dilation rate, stone-free rate, transfusion rate or rate of complications between the OSD and serial dilation groups. The difference in the length of postoperative hospital stay was uncertain. OSD may be a better method of tract creation for PCNL.
Comparative evaluation of novel screening strategies for colorectal cancer screening in China (TARGET-C): a study protocol for a multicentre randomised controlled trial
Authors: Chen Hongda , Li Ni , Shi Jufang , Ren Jiansong , Liu Chengcheng , Zhang Yueming , Jiang Zheng , Zhang Zhihui , Dai Min 
Published: April 2019

IntroductionScreening for colorectal cancer (CRC) is effective in reducing the disease burden. However, high-level evidence from randomised controlled trials on the effectiveness of CRC screening modalities is still lacking. We will conduct a large-scale multicentre randomised controlled trial in China to evaluate the effectiveness and cost-effectiveness of different CRC screening strategies.Methods and analysis20 000 eligible participants aged 50–74 years are enrolled in five provinces in China. After providing signed informed consent, the participants will be randomised into one of the three screening groups: (1) one-time colonoscopy (n=4000), (2) annual faecal immunochemical test (FIT) (n=8000) and (3) annual risk-adapted screening strategy (n=8000). The risk-adapted screening strategy will use an established CRC risk scoring system, the Asia-Pacific Colorectal Screening score. Participants at high risk of CRC will be referred for colonoscopy, while participants at low risk will be referred for an FIT. Information on clinical reports, epidemiological risk factors and health economic factors will be collected and stored in a web-based data management system. We will further request the participants to donate blood, faecal and saliva samples before conducting the colonoscopy. The primary outcome will be the detection rate of advanced colorectal neoplasia and the secondary outcomes will include the rates of CRC-related mortality, incidence of CRC, participation and complications. The study will last for at least 4 years and the cohort will be followed for 10 years to adequately answer the scientific questions.Ethics and disseminationThis study was approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, the Chinese Academy of Medical Sciences and Peking Union Medical College (18-013/1615). The results of the study will be submitted for publication in peer-reviewed journals and will be discussed by policy and decision makers.Trial registration numberChiCTR1800015506.