bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Generalized Model for Compliant Passive Bipedal Walking: Sensitivity Analysis and Implications on Bionic Leg Design
Authors: Smyrli Aikaterini , Bertos Georgios A. , Papadopoulos Evangelos 
Published: May 2021

Abstract
The passive behavior of a compliant biped walking model, subject to variations in its design, is investigated. A biped gait model is developed that allows for studying the effects of leg impedance, geometry, foot curvature, and inertial properties on the stable gait performed passively. A set of nondimensional parameters has been produced that fully defines the compass gait behavior, eliminating the dependence of our results on scale. Models emerging from parameter combinations were tested on their ability to perform stable passive walking on slope, and the characteristics of the gait performed in each case were recorded. Investigation of parameter ranges allowed us to draw relationships between various gait characteristics and specific, nondimensional parameter selections. By mapping the changes in system behavior under simple design variations, this work facilitates the selection of design parameters at an early stage of designing bionic walking equipment, including prostheses and exoskeletons.
What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis
Authors: Paramasivan Sangeetha , Davies Philippa , Richards Alison , Wade Julia , Rooshenas Leila , Mills Nicola , Realpe Alba , Raj Jeffrey Pradeep , Subramani Supriya , Ives Jonathan , Huxtable Richard , Blazeby Jane M , Donovan Jenny L 
Published: May 2021

IntroductionThe post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India.MethodsOur search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities.ResultsTitles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research.ConclusionThe review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.
Acute flaccid myelitis: long-term outcomes recorded in the CAPTURE study compared with paediatric transverse myelitis
Authors: Greenberg Benjamin , Plumb Patricia , Cutter Gary , Dean Janet , Desena Allen , Hopkins Sarah , Krishnan Chitra , Pardo Carlos , Recio Albert , Schreiner Teri , Yeh E Ann , McCreary Morgan 
Published: May 2021

BackgroundSince 2014, the USA has documented three outbreaks of acute flaccid myelitis (AFM). Unique features and treatment responses of this myelitis variant have not been prospectively studied. This study prospectively measured outcomes in paediatric myelitis patients relative to treatments.MethodsThis was a prospective, multicentre, non-randomised, observational cohort study. The study duration was 5 years and the length of follow-up was 1 year. This study collected data from children and families in North America. Patients were enrolled at academic centres with expertise in myelitis or online via a web portal. Paediatric patients diagnosed with myelitis were eligible for enrolment in the study within 6 months of onset of symptoms. Patients were characterised as transverse myelitis (TM) or the AFM variant based on clinical and radiographic findings.ResultsThe cohort of 90 patients included patients with AFM and TM. Of the 51 patients with AFM there was evidence of two clinically relevant patterns. This included a grey matter restricted form of AFM and a cohort with concomitant white matter that could explain lower extremity motor deficits in patients with lesions restricted to the cervical spine. The improvement in deficits with the use of corticosteroids was similar to what was observed in the TM cohort (p=0.97).ConclusionsClinicians should consider on a case by case basis the approach to therapy for AFM patients. Prospective controlled studies of long-term outcomes would be useful in this growing patient population.
Granulocyte and monocyte apheresis as an adjunctive therapy to induce and maintain clinical remission in ulcerative colitis: a systematic review and meta-analysis
Authors: Kiss Szabolcs , Németh Dávid , Hegyi Péter , Földi Mária , Szakács Zsolt , Erőss Bálint , Tinusz Benedek , Hegyi Péter Jenő , Sarlós Patrícia , Alizadeh Hussain 
Published: May 2021

ObjectiveThe goal of treatment in ulcerative colitis (UC) is to induce and maintain remission. The addition of granulocyte and monocyte apheresis (GMA) to conventional therapy may be a promising therapeutic alternative. In this meta-analysis, we aimed to assess the efficacy and safety profile of GMA as an adjunctive therapy.DesignSystematic review and meta-analysis.MethodsWe searched four databases (MEDLINE, Embase, Web of Science and Cochrane Central Register of Controlled Trials) for randomised or minimised controlled trials which discussed the impact of additional GMA therapy on clinical remission induction and clinical remission maintenance compared with conventional therapy alone. Primary outcomes were clinical remission induction and maintenance, secondary outcomes were adverse events (AEs) and steroid-sparing effect. ORs with 95% CIs were calculated. Trial Sequential Analyses were performed to adjusts for the risk of random errors in meta-analyses.ResultsA total of 11 studies were eligible for meta-analysis. GMA was clearly demonstrated to induce and maintain clinical remission more effectively than conventional therapy alone (598 patients: OR: 1.93, 95% CI 1.28 to 2.91, p=0.002, I2=0.0% for induction; 71 patients: OR: 8.34, 95% CI 2.64 to 26.32, p<0.001, I2=0.0% for maintenance). There was no statistically significant difference in the number of AEs (OR: 0.27, 95% CI 0.05 to 1.50, p=0.135, I2=84.2%).ConclusionGMA appears to be more effective as an adjunctive treatment in inducing and maintaining remission in patients with UC than conventional therapy alone.PROSPERO registration numberCRD42019134050.
Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial
Authors: Genberg Becky L. , Wachira Juddy , Steingrimsson Jon A , Pastakia Sonak , Tran Dan N Tina , Said Jamil AbdulKadir , Braitstein Paula , Hogan Joseph W. , Vedanthan Rajesh , Goodrich Suzanne , Kafu Catherine , Wilson-Barthes Marta , Galárraga Omar 
Published: May 2021

IntroductionIn Kenya, distance to health facilities, inefficient vertical care delivery and limited financial means are barriers to retention in HIV care. Furthermore, the increasing burden of non-communicable diseases (NCDs) among people living with HIV complicates chronic disease treatment and strains traditional care delivery models. Potential strategies for improving HIV/NCD treatment outcomes are differentiated care, community-based care and microfinance (MF).Methods and analysisWe will use a cluster randomised trial to evaluate integrated community-based (ICB) care incorporated into MF groups in medium and high HIV prevalence areas in western Kenya. We will conduct baseline assessments with n=900 HIV positive members of 40 existing MF groups. Group clusters will be randomised to receive either (1) ICB or (2) standard of care (SOC). The ICB intervention will include: (1) clinical care visits during MF group meetings inclusive of medical consultations, NCD management, distribution of antiretroviral therapy (ART) and NCD medications, and point-of-care laboratory testing; (2) peer support for ART adherence and (3) facility referrals as needed. MF groups randomised to SOC will receive regularly scheduled care at a health facility. Findings from the two trial arms will be compared with follow-up data from n=300 matched controls. The primary outcome will be VS at 18 months. Secondary outcomes will be retention in care, absolute mean change in systolic blood pressure and absolute mean change in HbA1c level at 18 months. We will use mediation analysis to evaluate mechanisms through which MF and ICB care impact outcomes and analyse incremental cost-effectiveness of the intervention in terms of cost per HIV suppressed person-time, cost per patient retained in care and cost per disability-adjusted life-year saved.Ethics and disseminationThe Moi University Institutional Research and Ethics Committee approved this study (IREC#0003054). We will share data via the Brown University Digital Repository and disseminate findings via publication.Trial registration numberNCT04417127.
Effective fertility counselling for transgender adolescents: a qualitative study of clinician attitudes and practices
Authors: Lai Timothy Chwan , Davies Cristyn , Robinson Kerry , Feldman Debi , Elder Charlotte Victoria , Cooper Charlie , Pang Ken C , McDougall Rosalind 
Published: May 2021

ObjectiveFertility counselling for trans and gender diverse (TGD) adolescents has many complexities, but there is currently little guidance for clinicians working in this area. This study aimed to identify effective strategies for—and qualities of—fertility counselling for TGD adolescents based on clinicians’ experiences.DesignWe conducted qualitative semi-structured individual interviews in 2019 which explored clinician experiences and fertility counselling practices, perspectives of the young person’s experience and barriers and facilitators to fertility preservation access. Data were analysed using thematic analysis.SettingThis qualitative study examined experiences of clinicians at the Royal Children’s Hospital—a tertiary, hospital-based, referral centre and the main provider of paediatric TGD healthcare in Victoria, Australia.ParticipantsWe interviewed 12 clinicians from a range of disciplines (paediatrics, psychology, psychiatry and gynaecology), all of whom were involved with fertility counselling for TGD adolescents.ResultsBased on clinician experiences, we identified five elements that can contribute to an effective approach for fertility counselling for TGD adolescents: a multidisciplinary team approach; shared decision-making between adolescents, their parents and clinicians; specific efforts to facilitate patient engagement; flexible personalised care; and reflective practice.ConclusionsIdentification of these different elements can inform and hopefully improve future fertility counselling practices for TGD adolescents, but further studies examining TGD adolescents’ experiences of fertility counselling are also required.
Net survival differences of breast cancer between stages at diagnosis and age groups in the east coast region of West Malaysia: a retrospective cohort study
Authors: Hanis Tengku Muhammad , Yaacob Najib Majdi , Mohd Hairon Suhaily , Abdullah Sarimah 
Published: May 2021

ObjectiveEstimation of the net survival of breast cancer helps in assessing breast cancer burden at a population level. Thus, this study aims to estimate the net survival of breast cancer at different cancer staging and age at diagnosis in the east coast region of West Malaysia.SettingKelantan, Malaysia.ParticipantsAll breast cancer cases diagnosed in 2007 and 2011 identified from Kelantan Cancer Registry.DesignThis retrospective cohort study used a relative survival approach to estimate the net survival of patients with breast cancer. Thus, two data were needed; breast cancer data from Kelantan Cancer Registry and general population mortality data for Kelantan population.Primary and secondary outcome measuresNet survival according to stage and age group at diagnosis at 1, 3 and 5 years following diagnosis.ResultsThe highest net survival was observed among stage I and II breast cancer cases, while the lowest net survival was observed among stage IV breast cancer cases. In term of age at diagnosis, breast cancer cases aged 65 and older had the best net survival compared with the other age groups.ConclusionThe age at diagnosis had a minimal impact on the net survival compared with the stage at diagnosis. The finding of this study is applicable to other populations with similar breast cancer profile.
Community health workers’ efforts to build health system trust in marginalised communities: a qualitative study from South Africa
Authors: Anstey Watkins Jocelyn , Griffiths Frances , Goudge Jane 
Published: May 2021

IntroductionCommunity health workers (CHWs) enable marginalised communities, often experiencing structural poverty, to access healthcare. Trust, important in all patient–provider relationships, is difficult to build in such communities, particularly when stigma associated with HIV/AIDS, tuberculosis and now COVID-19, is widespread. CHWs, responsible for bringing people back into care, must repair trust. In South Africa, where a national CHW programme is being rolled out, marginalised communities have high levels of unemployment, domestic violence and injury.ObjectivesIn this complex social environment, we explored CHW workplace trust, interpersonal trust between the patient and CHW, and the institutional trust patients place in the health system.Design, participants, settingWithin the observation phase of a 3-year intervention study, we conducted interviews, focus groups and observations with patients, CHWs, their supervisors and, facility managers in Sedibeng.ResultsCHWs had low levels of workplace trust. They had recently been on strike demanding better pay, employment conditions and recognition of their work. They did not have the equipment to perform their work safely, and some colleagues did not trust, or value, their contribution. There was considerable interpersonal trust between CHWs and patients, however, CHWs’ efforts were hampered by structural poverty, alcohol abuse and no identification documents among long-term migrants. Those supervisors who understood the extent of the poverty supported CHW efforts to help the community. When patients had withdrawn from care, often due to nurses’ insensitive behaviour, the CHWs’ attempts to repair patients’ institutional trust often failed due to the vulnerabilities of the community, and lack of support from the health system.ConclusionStrategies are needed to build workplace trust including supportive supervision for CHWs and better working conditions, and to build interpersonal and institutional trust by ensuring sensitivity to social inequalities and the effects of structural poverty among healthcare providers. Societies need to care for everyone.
Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study
Authors: Ezard Nadine , Clifford Brendan , Dunlop Adrian , Bruno Raimondo , Carr Andrew , Liu Zhixin , Siefried Krista J , Lintzeris Nicholas 
Published: May 2021

ObjectivesTo examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence.DesignA dose-escalating, phase-2, open-label, single-group study of oral LDX at two Australian drug treatment services.SettingThe study was conducted at two Australian stimulant use disorder treatment clinics.ParticipantsThere were 16 participants: at least 18 years old, MA dependent for at least the preceding 2 years using ICD-10 criteria, reporting use of MA on at least 14 of the preceding 28 days.InterventionsDaily, supervised LDX of 100–250 mg, single-blinded to dose, ascending-descending regimen over 8 weeks (100–250 mg over 4 weeks; followed by 4-week dose reduction regimen, 250–100 mg). Participants were followed through to week 12.OutcomesPrimary outcomes were safety, drug tolerability and regimen completion at the end of week 4. Participants were followed to week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence and neurocognitive functioning.ResultsFourteen of 16 participants (87.5%) completed escalation to 250 mg/day. Two participants withdrew from the trial in the first week: one relocated away from the study site, the other self-withdrew due to a possible, known side effect of LDX (agitation). There was one serious adverse event of suicidal ideation which resolved. All other adverse events were mild or moderate in severity and known side effects of LDX. No participant was withdrawn due to adverse events. MA use decreased from a median of 21 days (IQR: 16–23) to 13 days (IQR: 11–17) over the 4-week escalation period (p=0.013).ConclusionsLDX at a dose of up to 250 mg/day was safe and well tolerated by study participants, warranting larger trials as a pharmacotherapy for MA dependence.Trial registration numberACTRN12615000391572.
Indian media professionals’ perspectives regarding the role of media in suicide prevention and receptiveness to media guidelines: a qualitative study
Authors: Armstrong Gregory , Vijayakumar Lakshmi , Cherian Anish , Krishnaswamy Kannan , Pathare Soumitra 
Published: May 2021

ObjectivesCrime reports of suicide incidents routinely feature in the Indian mass media, with minimal coverage of suicide as a broader public health issue. To supplement our recently published content analysis study, we undertook qualitative interviews to examine media professionals' perspectives and experiences in relation to media reporting of suicide-related news in India.Design and settingIn 2017–2018, we undertook semistructured qualitative interviews with media professionals with experience reporting on suicide-related news. A semistructured interview guide was designed to initiate discussions around their perspectives and experiences in relation to reporting on suicide. Interviews were digitally audio-recorded and transcribed, and a deductive and inductive approach to thematic analysis was used.ParticipantsTwenty-eight interviews were undertaken with media professionals in Delhi, Chandigarh and Chennai.ResultsA clear role for media in suicide prevention framed around educating and informing the public was articulated by several participants and a majority of participants also reported concerns and anecdotal accounts that their reporting may negatively influence vulnerable people in the population. Nonetheless, a fatalistic attitude towards suicide was evident among several participants including dismissing or minimising concerns around imitation suicides. Several participants also expressed doubts around the quality of suicide helplines in India and were hesitant to add such contact details to their reports. Participants were largely very receptive to the idea of developing voluntary media guidelines for the Indian context, although doubts were raised around compliance unless additional initiatives were taken to engage media professionals at the highest levels.ConclusionsOur findings reveal the perspectives of media professionals operating in the Indian context and can be used to support constructive partnerships between media professionals and suicide prevention experts. There is a clear need for a genuine and sustained partnership between suicide prevention experts and media professionals at all levels.
Disease burden from COVID-19 symptoms among inpatients at the temporary military hospitals in Wuhan: a retrospective multicentre cross–sectional study
Authors: He Maihong , Li Xiaoxiao , Tan Qing , Chen Yong , Kong Yue , You Jianping , Lin Xian , Lin Ying , Zheng Qing 
Published: May 2021

ObjectivesWe aimed to establish a set of disability weights (DWs) for COVID-19 symptoms, evaluate the disease burden of inpatients and analyse the characteristics and influencing factors of the disease.DesignThis was a multicentre retrospective cross-sectional descriptive study.SettingThe medical records generated in three temporary military hospitals in Wuhan.ParticipantsMedical records of 2702 inpatients generated from 5 February to 5 April 2020 were randomly selected for this study.Primary and secondary outcome measuresDWs of COVID-19 symptoms were determined by the person trade-off approach. The inpatients’ medical records were analysed and used to calculate the disability-adjusted life years (DALYs). The mean DALY was evaluated across sex and age groups. The relationship between DALY and age, sex, body mass index, length of hospital stay, symptom duration before admission and native place was determined by multiple linear regression.ResultsFor the DALY of each inpatient, severe expiratory dyspnoea, mild cough and sore throat had the highest (0.399) and lowest (0.004) weights, respectively. The average synthetic DALY and daily DALY were 2.29±1.33 and 0.18±0.15 days, respectively. Fever and fatigue contributed the most DALY at 31.36%, whereas nausea and vomiting and anxiety and depression contributed the least at 7.05%. There were significant differences between sex and age groups in both synthetic and daily DALY. Age, body mass index, length of hospital stay and symptom duration before admission were strongly related to both synthetic and daily DALY.ConclusionsAlthough the disease burden was higher among women than men, their daily disease burdens were similar. The disease burden in the younger population was higher than that in the older population. Treatment at the hospitals relieved the disease burden efficiently, while a delay in hospitalisation worsened it.