bluuebunny/crossref_metadata_2025_split huggingface dataset:
Proposal of quality indicators for cardiac rehabilitation after acute coronary syndrome in Japan: a modified Delphi method and practice test
Authors: Ohtera Shosuke , Kanazawa Natsuko , Ozasa Neiko , Ueshima Kenji , Nakayama Takeo 
Published: January 2017

ObjectivesCardiac rehabilitation is underused and its quality in practice is unclear. A quality indicator is a measurable element of clinical practice performance. This study aimed to propose a set of quality indicators for cardiac rehabilitation following an acute coronary event in the Japanese population and conduct a small-size practice test to confirm feasibility and applicability of the indicators in real-world clinical practice.Design and settingThis study used a modified Delphi technique (the RAND/UCLA appropriateness method), a consensus method which involves an evidence review, a face-to-face multidisciplinary panel meeting and repeated anonymous rating. Evidence to be reviewed included clinical practice guidelines available in English or Japanese and existing quality indicators. Performance of each indicator was assessed retrospectively using medical records at a university hospital in Japan.Participants10 professionals in cardiac rehabilitation for the consensus panel.ResultsIn the literature review, 23 clinical practice guidelines and 16 existing indicators were identified to generate potential indicators. Through the consensus-building process, a total of 30 indicators were assessed and finally 13 indicators were accepted. The practice test (n=39) revealed that 74% of patients underwent cardiac rehabilitation. Median performance of process measures was 93% (IQR 46–100%). ‘Communication with the doctor who referred the patient to cardiac rehabilitation’ and ‘continuous participation in cardiac rehabilitation’ had low performance (32% and 38%, respectively).ConclusionsA modified Delphi technique identified a comprehensive set of quality indicators for cardiac rehabilitation. The single-site, small-size practice test confirmed that most of the proposed indicators were measurable in real-world clinical practice. However, some clinical processes which are not covered by national health insurance in Japan had low performance. Further studies will be needed to clarify and improve the quality of care in cardiac rehabilitation.
Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol
Authors: Mansur Nacime Salomão Barbachan , Faloppa Flávio , Belloti João Carlos , Ingham Sheila J McNeill , Matsunaga Fabio Teruo , Santos Paulo Roberto Dias dos , Santos Bruno Schiefer dos , Carrazzone Oreste Lemos , Peixoto Gabriel , Aoyama Bruno Takeshi , Tamaoki Marcel Jun Sugawara 
Published: January 2017

BackgroundThere is no consensus regarding the treatment of Achilles insertional tendinopathies. Eccentric training remains the main choice in the conservative treatment of this illness; however, the good results in the management of non-insertional Achilles tendinopathy were not replicated in the insertional condition. Low energy shock wave therapy has been described as an alternative to these patients, but has yet to be empirically tested.HypothesisShock wave therapy, adjunctive to the eccentric strengthening protocol, will improve measures of pain and function.DesignDouble blind, placebo-controlled, parallel groups, randomised clinical trial.Materials and methods93 patients with a diagnosis of chronic insertional tendinopathy, referred from primary or secondary healthcare services, will be assessed and enrolled in this study. They will be divided into two groups (randomised by sequentially numbered identical envelopes, which will be administered serially to participants), one containing the combination of low energy shock wave and eccentric exercises, as treatment and the other comprehending the exercises and the placebo treatment (an apparatus placed in the therapeutic head). The assessments will occur in 2, 4, 6, 12 and 24 weeks. Patients will be evaluated primarily by the Victorian Institute of Sport Assessment-Achilles questionnaire and secondarily by the visual analogue scale, Algometry, the American Orthopedic Foot and Ankle Society scale, the Foot and Ankle Outcome Score and the 12-item Short Form Health Survey. We will use comparison of two proportions via relative frequency analysis, the Pearson Correlation the χ2test and the analysis of variance for statistical analyses.DiscussionThis study intends to demonstrate if the association of the eccentric exercise programme with the shock wave therapy can produce good results regarding the treatment of the Achilles insertional tendinopathy. In an attempt to prevent the high costs and complications associated with the surgical intervention, we will try to prove this combination as a viable therapeutic option in the conservative management of this prevalent condition. The strengths of the study are the design and the novelty of the combination of methods. The main limitation is the short follow-up course.Ethics and disseminationThe study is registered in the Clinical Trials database (protocol number: 8094833648737701) and was approved by the University Ethics Committee (number: 1373481).Trial registration number8094833648737701 (NCT02757664); Pre-results.
Ultrasound and NICOM in the assessment of fluid responsiveness in patients with mild sepsis in the emergency department: a pilot study
Authors: Oord Martha , Olgers Tycho J , Doff-Holman Mirjam , Harms Mark P M , Ligtenberg Jack J M , ter Maaten Jan C 
Published: January 2017

ObjectiveWe investigated whether combining the caval index, assessment of the global contractility of the heart and measurement of stroke volume with Noninvasive Cardiac Output Monitoring (NICOM) can aid in fluid management in the emergency department (ED) in patients with sepsis.SettingA prospective observational single-centre pilot study in a tertiary care centre.Primary and secondary outcomesUltrasound was used to assess the caval index, heart contractility and presence of B-lines in the lungs. Cardiac output and stroke volume were monitored with NICOM. Primary outcome was increase in stroke volume after a fluid bolus of 500 mL, while secondary outcome included signs of fluid overload.ResultsWe included 37 patients with sepsis who received fluid resuscitation of at least 500 mL saline. The population was divided into patients with a high (>36.5%, n=24) and a low caval index (<36.5%, n=13). We observed a significant increase (p=0.022) in stroke volume after 1000 mL fluid in the high caval index group in contrast to the low caval index group but not after 500 mL of fluid. We did not find a significant association between global contractility of the left ventricle and the response on fluid therapy (p=0.086). No patient showed signs of fluid overload.ConclusionsOur small pilot study suggests that at least 1000 mL saline is needed to induce a significant response in stroke volume in patients with sepsis and a high caval index. This amount seems to be safe, not leading to the development of fluid overload. Therefore, combining ultrasound and NICOM is feasible and may be valuable tools in the treatment of patients with sepsis in the ED. A larger trial is needed to confirm these results.
Ibobbly mobile health intervention for suicide prevention in Australian Indigenous youth: a pilot randomised controlled trial
Authors: Tighe Joseph , Shand Fiona , Ridani Rebecca , Mackinnon Andrew , De La Mata Nicole , Christensen Helen 
Published: January 2017

ObjectivesRates of youth suicide in Australian Indigenous communities are 4 times the national youth average and demand innovative interventions. Historical and persistent disadvantage is coupled with multiple barriers to help seeking. Mobile phone applications offer the opportunity to deliver therapeutic interventions directly to individuals in remote communities. The pilot study aimed to evaluate the effectiveness of a self-help mobile app (ibobbly) targeting suicidal ideation, depression, psychological distress and impulsivity among Indigenous youth in remote Australia.SettingRemote and very remote communities in the Kimberley region of North Western Australia.ParticipantsIndigenous Australians aged 18–35 years.Interventions61 participants were recruited and randomised to receive either an app (ibobbly) which delivered acceptance-based therapy over 6 weeks or were waitlisted for 6 weeks and then received the app for the following 6 weeks.Primary and secondary outcome measuresThe primary outcome was the Depressive Symptom Inventory—Suicidality Subscale (DSI-SS) to identify the frequency and intensity of suicidal ideation in the previous weeks. Secondary outcomes were the Patient Health Questionnaire 9 (PHQ-9), The Kessler Psychological Distress Scale (K10) and the Barratt Impulsivity Scale (BIS-11).ResultsAlthough preintervention and postintervention changes on the (DSI-SS) were significant in the ibobbly arm (t=2.40; df=58.1; p=0.0195), these differences were not significant compared with the waitlist arm (t=1.05; df=57.8; p=0.2962). However, participants in the ibobbly group showed substantial and statistically significant reductions in PHQ-9 and K10 scores compared with waitlist. No differences were observed in impulsivity. Waitlist participants improved after 6 weeks of app use.ConclusionsApps for suicide prevention reduce distress and depression but do not show significant reductions on suicide ideation or impulsivity. A feasible and acceptable means of lowering symptoms for mental health disorders in remote communities is via appropriately designed self-help apps.Trial registration numberACTRN12613000104752.
Compensatory changes in energy balance during dapagliflozin treatment in type 2 diabetes mellitus: a randomised double-blind, placebo-controlled, cross-over trial (ENERGIZE)—study protocol
Authors: Rajeev Surya Panicker , Sprung Victoria S , Roberts Carl , Harrold Jo A , Halford Jason C G , Stancak Andrej , Boyland Emma J , Kemp Graham J , Cuthbertson Daniel J , Wilding John P H 
Published: January 2017

IntroductionSodium glucose cotransporter 2 (SGLT2) inhibitors are effective blood-glucose-lowering medications with beneficial effects on body weight in patients with type 2 diabetes mellitus (T2DM). However, observed weight loss is less than that predicted from quantified glycosuria, suggesting a compensatory increase in energy intake or a decrease in energy expenditure. Studies using dual-energy X-ray absorptiometry (DEXA) have suggested most body weight change is due to loss of adipose tissue, but organ-specific changes in fat content (eg, liver, skeletal muscle) have not been determined. In this randomised, double-blind, placebo-controlled crossover study, we aim to study the compensatory changes in energy intake, eating behaviour and energy expenditure accompanying use of the SGLT2 inhibitor, dapagliflozin. Additionally, we aim to quantify changes in fat distribution using MRI, in liver fat using proton magnetic resonance spectroscopy (1H-MRS) and in central nervous system (CNS) responses to food images using blood oxygen level dependent (BOLD) functional MRI (fMRI).Methods and analysisThis outpatient study will evaluate the effect of dapagliflozin (10 mg), compared with placebo, on food intake and energy expenditure at 7 days and 12 weeks. 52 patients with T2DM will be randomised to dapagliflozin or placebo for short-term and long-term trial interventions in a within participants, crossover design. The primary outcome is the difference in energy intake during a test meal between dapagliflozin and placebo. Intake data are collected automatically using a customised programme operating a universal eating monitor (UEM). Secondary outcomes include (1) measures of appetite regulation including rate of eating, satiety quotient, appetite ratings (between and within meals), changes in CNS responses to food images measured using BOLD-fMRI, (2) measures of energy expenditure and (3) changes in body composition including changes in liver fat and abdominal visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT).Ethical approvalThis study has been approved by the North West Liverpool Central Research Ethics Committee (14/NW/0340) and is conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice (GCP).Trial registration numberISRCTN14818531. EUDRACT number 2013-004264-60.
Challenges in data quality: the influence of data quality assessments on data availability and completeness in a voluntary medical male circumcision programme in Zimbabwe
Authors: Xiao Y , Bochner A F , Makunike B , Holec M , Xaba S , Tshimanga M , Chitimbire V , Barnhart S , Feldacker C 
Published: January 2017

ObjectivesTo assess availability and completeness of data collected before and after a data quality audit (DQA) in voluntary medical male circumcision (VMMC) sites in Zimbabwe to determine the effect of this process on data quality.Setting4 of 10 VMMC sites in Zimbabwe that received a DQA in February, 2015 selected by convenience sampling.ParticipantsRetrospective reviews of all client intake forms (CIFs) from November, 2014 and May, 2015. A total of 1400 CIFs were included from those 2 months across four sites.Primary and secondary outcomesData availability was measured as the percentage of VMMC clients whose CIF was on file at each site. A data evaluation tool measured the completeness of 34 key CIF variables. A comparison of pre-DQA and post-DQA results was conducted using χ2and t-tests.ResultsAfter the DQA, high record availability of over 98% was maintained by sites 3 and 4. For sites 1 and 2, record availability increased by 8.0% (p=0.001) and 9.7% (p=0.02), respectively. After the DQA, sites 1, 2 and 3 improved significantly in data completeness across 34 key indicators, increasing by 8.6% (p<0.001), 2.7% (p=0.003) and 3.8% (p<0.001), respectively. For site 4, CIF data completeness decreased by 1.7% (p<0.01) after the DQA.ConclusionsOur findings suggest that CIF data availability and completeness generally improved after the DQA. However, gaps in documentation of vital signs and adverse events signal areas for improvement. Additional emphasis on data completeness would help support high-quality programme implementation and availability of reliable data for decision-making.
Patient preferences, knowledge and beliefs about kidney allocation: qualitative findings from the UK-wide ATTOM programme
Authors: Gibbons Andrea , Cinnirella Marco , Bayfield Janet , Wu Diana , Draper Heather , Johnson Rachel J , Tomson Charles R V , Forsythe John L R , Metcalfe Wendy , Fogarty Damian , Roderick Paul , Ravanan Rommel , Oniscu Gabriel C , Watson Christopher J E , Bradley J Andrew , Bradley Clare 
Published: January 2017

ObjectiveTo explore how patients who are wait-listed for or who have received a kidney transplant understand the current UK kidney allocation system, and their views on ways to allocate kidneys in the future.DesignQualitative study using semistructured interviews and thematic analysis based on a pragmatic approach.Participants10 deceased-donor kidney transplant recipients, 10 live-donor kidney transplant recipients, 12 participants currently wait-listed for a kidney transplant and 4 participants whose kidney transplant failed.SettingSemistructured telephone interviews conducted with participants in their own homes across the UK.ResultsThree main themes were identified: uncertainty of knowledge of the allocation scheme; evaluation of the system and participant suggestions for future allocation schemes. Most participants identified human leucocyte anitgen matching as a factor in determining kidney allocation, but were often uncertain of the accuracy of their knowledge. In the absence of information that would allow a full assessment, the majority of participants consider that the current system is effective. A minority of participants were concerned about the perceived lack of transparency of the general decision-making processes within the scheme. Most participants felt that people who are younger and those better matched to the donor kidney should be prioritised for kidney allocation, but in contrast to the current scheme, less priority was considered appropriate for longer waiting patients. Some non-medical themes were also discussed, such as whether parents of dependent children should be prioritised for allocation, and whether patients with substance abuse problems be deprioritised.ConclusionsOur participants held differing views about the most important factors for kidney allocation, some of which were in contrast to the current scheme. Patient participation in reviewing future allocation policies will provide insight as to what is considered acceptable to patients and inform healthcare staff of the kinds of information patients would find most useful.
Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial
Authors: Ander Malin , Wikman Anna , Ljótsson Brjánn , Grönqvist Helena , Ljungman Gustaf , Woodford Joanne , Lindahl Norberg Annika , von Essen Louise 
Published: January 2017

IntroductionA subgroup of adolescents and young adults diagnosed with cancer during adolescence reports elevated levels of anxiety and depressive symptoms and unmet needs for psychological support. Evidence-based psychological treatments tailored for this population are lacking. This protocol describes a feasibility study of a guided-internet-administered self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young persons diagnosed with cancer during adolescence and of the planned study procedures for a future controlled trial.Methods/analysisThe study is an uncontrolled feasibility trial with a pre-post and 3-month follow-up design. Potential participants aged 15–25 years, diagnosed with cancer during adolescence, will be identified via the Swedish Childhood Cancer Registry. 30 participants will be included. Participants will receive YoungCan, a 12-week therapist-guided, internet-administered self-help programme consisting primarily of cognitive–behavioural therapy organised into individually assigned modules targeting depressive symptoms, worry and anxiety, body dissatisfaction and post-traumatic stress. Interactive peer support and psychoeducative functions are also available. Feasibility outcomes include: recruitment and eligibility criteria; data collection; attrition; resources needed to complete the study and programme; safety procedures; participants' and therapists' adherence to the programme; and participants' acceptability of the programme and study methodology. Additionally, mechanisms of impact will be explored and data regarding symptoms of anxiety, depression, post-traumatic stress, body dissatisfaction, reactions to social interactions, quality of life, axis I diagnoses according to the Mini International Neuropsychiatric Interview and healthcare service use will be collected. Exploratory analyses of changes in targeted outcomes will be conducted.Ethics/disseminationThis feasibility protocol was approved by the Regional Ethical Review Board in Uppsala, Sweden (ref: 2016/210). Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences.Trial registration numberISRCTN97835363.
Use of magnesium sulfate before 32 weeks of gestation: a European population-based cohort study
Authors: Wolf H T , Huusom L , Weber T , Piedvache A , Schmidt S , Norman M , Zeitlin J 
Published: January 2017

ObjectivesThe use of magnesium sulfate (MgSO4) in European obstetric units is unknown. We aimed to describe reported policies and actual use of MgSO4in women delivering before 32 weeks of gestation by indication.MethodsWe used data from the European Perinatal Intensive Care in Europe (EPICE) population-based cohort study of births before 32 weeks of gestation in 19 regions in 11 European countries. Data were collected from April 2011 to September 2012 from medical records and questionnaires. The study population comprised 720 women with severe pre-eclampsia, eclampsia or HELLP and 3658 without pre-eclampsia delivering from 24 to 31 weeks of gestation in 119 maternity units with 20 or more very preterm deliveries per year.ResultsAmong women with severe pre-eclampsia, eclampsia or HELLP, 255 (35.4%) received MgSO4before delivery. 41% of units reported use of MgSO4whenever possible for pre-eclampsia and administered MgSO4more often than units reporting use sometimes. In women without pre-eclampsia, 95 (2.6%) received MgSO4. 9 units (7.6%) reported using MgSO4for fetal neuroprotection whenever possible. In these units, the median rate of MgSO4use for deliveries without severe pre-eclampsia, eclampsia and HELLP was 14.3%. Only 1 unit reported using MgSO4as a first-line tocolytic. Among women without pre-eclampsia, MgSO4use was not higher in women hospitalised before delivery for preterm labour.ConclusionsSevere pre-eclampsia, eclampsia or HELLP are not treated with MgSO4as frequently as evidence-based medicine recommends. MgSO4is seldom used for fetal neuroprotection, and is no longer used for tocolysis. To continuously lower morbidity, greater attention to use of MgSO4is needed.
New predictive model for microsurgical outcome of intracranial arteriovenous malformations: study protocol
Authors: Tong Xianzeng , Wu Jun , Cao Yong , Zhao Yuanli , Wang Shuo 
Published: January 2017

IntroductionAlthough microsurgical resection is currently the first-line treatment modality for arteriovenous malformations (AVMs), microsurgery of these lesions is complicated due to the fact that they are very heterogeneous vascular anomalies. The Spetzler-Martin grading system and the supplementary grading system have demonstrated excellent performances in predicting the risk of AVM surgery. However, there are currently no predictive models based on multimodal MRI techniques. The purpose of this study is to propose a predictive model based on multimodal MRI techniques to assess the microsurgical risk of intracranial AVMs.Methods and analysisThe study consists of 2 parts: the first part is to conduct a single-centre retrospective analysis of 201 eligible patients to create a predictive model of AVM surgery based on multimodal functional MRIs (fMRIs); the second part is to validate the efficacy of the predictive model in a prospective multicentre cohort study of 400 eligible patients. Patient characteristics, AVM features and multimodal fMRI data will be collected. The functional status at pretreatment and 6 months after surgery will be analysed using the modified Rankin Scale (mRS) score. The patients in each part of this study will be dichotomised into 2 groups: those with improved or unchanged functional status (a decreased or unchanged mRS 6 months after surgery) and those with worsened functional status (an increased mRS). The first part will determine the risk factors of worsened functional status after surgery and create a predictive model. The second part will validate the predictive model and then a new AVM grading system will be proposed.Ethics and disseminationThe study protocol and informed consent form have been reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (KY2016-031-01). The results of this study will be disseminated through printed media.Trial registration numberNCT02868008.