Generation Victoria (GenV): protocol for a longitudinal birth cohort of Victorian children and their parents by Elizabeth K. Hughes, William Siero, Alisha Gülenç, Susan A. Clifford, Tony Frugier, Simon M. Hall, Jatender Mohal, Kathryn North, Natasha Zaritski, Sharon Goldfeld, Richard Saffery, Melissa Wake

“…Discussion Launched in the COVID-19 pandemic and committed to diversity and inclusivity, GenV’s parallel consented child and pre-midlife cohorts will be positioned to help address today’s pressing issues such as chronic mental and physical health conditions, inequity, public health crises such as pandemics, and climate harm. …”
Get full text

Phthalate exposure induces microRNA-5010/Nrf2-EGR1/GDF15 signaling expression in prostate cancer by Yuh-Shyan Tsai, Yeong-Chin Jou, Ian Seng Cheong, Hsiu-Ting Tung, Lin-Nei Hsu, Hsin-Tzu Tsai, Tzong-Shin Tzai

“…Urine samples, collected with informed consent, were analyzed for urinary DEHP metabolites using HPLC-MS and ELISA. …”
Get full text

IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers by Sunita Mathur, John Muscedere, David M Maslove, Miranda Hunt, John Gordon Boyd, Stephanie Sibley, Tracy Boyd, Michelle Tryon, Natasha Arianne Jawa, Michaela Hanley, Robin Westphal, Afolasade Fakolade

“…The primary outcome is feasibility, defined as: (1) consent rate >80%, (2) enrolment rate of 4 participants/month, (3) follow-up rate>70% and (4) data capture rate >80%. …”
Get full text

Can electronic monitoring with a digital smart spacer support personalised medication adherence and inhaler technique education in patients with asthma?: Protocol of the randomised... by Job F. M. van Boven, Boudewijn H.J. Dierick, Maria Achterbosch, Sandra Been-Buck, Titia Klemmeier, Susanne J. van de Hei, Paul Hagedoorn, Huib A.M. Kerstjens, Janwillem W.H. Kocks

“…Patients will provide written informed consent. Study findings will be disseminated through conferences and peer-reviewed scientific and professional journals.Trial registration number NL9637.…”
Get full text

Guidelines for Stroke Critical Rehabilitation by PAN Yu, XIE Yuxiao, ZHANG Hao, LYU Zeping, XIE Qing, BAI Dingqun, WAN Chunxiao, JIANG Shan, HE Jing, LIU Shaxing, LI Chong, YANG Bing, LIU Weiming, YANG Guofa, ZHOU Hua, LI Xin, XIE Ruimou, NI Xueyi, MA Di

“…The main contents include: ①principle: severe stroke rehabilitation should follow the principles of early rehabilitation, individualization, safety and control, and comprehensive intervention; ②general rules of rehabilitation implementation; ③rehabilitation implementation process: including the establishment of personal files, signing of the Informed Consent Form, assessment of rehabilitation intervention, rehabilitation assessment, formulation of rehabilitation goals and plans, implementation of rehabilitation training, assessment of rehabilitation efficacy, referral, and follow-up; ④rehabilitation content: timing of intervention, rehabilitation assessment (history), rehabilitation quality control, and rehabilitation quality control. …”
Get full text

Detection of atrial fibrillation in primary care with radial pulse palpation, electronic blood pressure measurement and handheld single-lead electrocardiography: a diagnostic accur... by Wim A M Lucassen, Henk C P M van Weert, Bjorn Winkens, Henri E J H Stoffers, J André Knottnerus, Steven B Uittenbogaart, Nicole Verbiest-van Gurp, Petra M G Erkens

“…Exclusion criteria were terminal illness, inability to give informed consent or visit the practice or having a pacemaker or an implantable cardioverter-defibrillator.Outcomes Diagnostic accuracy of individual tests and test combinations to detect unknown AF.Results We included 4339 patients; 0.8% showed new AF. …”
Get full text

RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study by Andrea Miranda-Mendizabal, Diana Vetter, Juan Zambrano, Jeff Zarp, Victor Chavarría, Anna Giménez-Palomo, Meritxell Gonzalez-Campos, Marc Valenti, Lara Walczer Baldinazzo, Sara Siddi, Maurizio Ferrari, Dinah Weissmann, Chantal Henry, Josep Maria Haro, Lars Vedel Kessing, Eduard Vieta

“…Participants will receive an information sheet and must sign the informed consent before the interview. Participants’ data will be pseudonymized at the research sites. …”
Get full text

Strengthening research preparedness for crises: lessons from Norwegian government agencies in using randomized trials and quasi-experimental methods to evaluate public policy inter... by Unni Gopinathan, Ingeborg Elgersma, Therese Dalsbø, Mona Bjørbæk, Atle Fretheim

“…The surveyed agencies stressed the importance of legislation providing clear guidelines on when differential treatment can be justified and when informed consent requirements can be waived, as well as faster and clearer processes for managing privacy concerns related to data access. …”
Get full text

Investigating Smartphone-Based Sensing Features for Depression Severity Prediction: Observation Study by Yannik Terhorst, Eva-Maria Messner, Kennedy Opoku Asare, Christian Montag, Christopher Kannen, Harald Baumeister

“…Participants needed to be 18 years of age, provide written informed consent, and own an Android-based smartphone. Sensor data and EMA were collected via the INSIGHTS app. …”
Get full text

Percutaneous Radiofrequency Ablation of Small (1–2 cm) Hepatocellular Carcinomas Inconspicuous on B-Mode Ultrasonographic Imaging: Usefulness of Combined Fusion Imaging with MRI an... by Min Woo Lee, Hyo Keun Lim, Hyunchul Rhim, Dong Ik Cha, Tae Wook Kang, Kyoung Doo Song, Ji Hye Min, Geum-Youn Gwak, Seonwoo Kim, David S. K. Lu

“…This prospective study was approved by the institutional review board and informed consent was obtained from all patients. Planning US was performed with FI for 126 patients with a single HCC (1–2 cm) to evaluate the feasibility of RFA by grading lesion conspicuity score using a four-point scale. …”
Get full text

Use of an observer tool to enhance learning of anaesthesia resident’s non-technical skills during high-fidelity simulation: a randomised controlled trial by Caroline Havard, Viridiana Jouffroy, Agnès Le Gouez, Marie Bruyère, Samy Figueiredo, Philippe Roulleau, Dan Benhamou, Aurore Margat, Antonia Blanié

“…The objective was to assess the impact of a non-technical OT on anaesthesia residents’ learning of non-technical skills (NTS) during simulation. Methods After consent, residents were randomised into 2 groups: OT+ (with an OT based on NTS to be systematically completed during observation of others) and OT- (without OT). …”
Get full text

The influence of neurovegetative and psychological characteristics of infertile patients with long-term COVID-19 on the effectiveness of assisted reproductive technologies by O.G. Boichuk, I.S. Golovchak, T.V. Kolomiichenko

“…The research protocol was approved by the Local Ethics Committee of the institution mentioned in the work. Informed consent of the women was obtained for the research. …”
Get full text

Effects of traditional Chinese medicine massage therapy on pain, functional activity, muscle activation patterns and proprioception in knee osteoarthritis: a randomised controlled... by Xin Zhou, Cheng Tang, Bowen Zhu, Yangyang Fu, Min Fang, Sitong Fang, Qingguang Zhu, Yuen Yee Janice Hiew

“…A preliminary analysis will test whether TCM massage, in addition to exercise, has statistically better outcomes.Ethics and dissemination The study protocol has received approval from the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine (2023-1357-124-01).All study participants will be required to give written informed consent. The findings of the study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences. …”
Get full text

Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, contro... by Stephanie Book, Elmar Graessel, Julia Schneider, Michael Jeitler, Petra Scheerbaum, Michael Jank, Etienne Hanslian, Melanie DellO’ro, Julia-Sophia Scheuermann, Sophia Bösl, Christian Kessler

“…The treatment phase is 6 months with follow-ups after six and 12 months after baseline.Ethics and dissemination All procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 21-318-1-B). Written informed consent will be obtained from all participants. Results will be published in peer-reviewed scientific journals, conference presentations.Trial registration number ISRCTN10560738.…”
Get full text

Impact of pharmacist-led educational intervention on knowledge of self-management among asthmatic patients: a prospective cohort study by Ahmad Khan, Saima Mushtaq, Amjad Khan, Nafees Ahmad, Shahzadi Sidra Saleem, Rubina Aman, Shahzadi Sadia Saleem, Ayesha Bibi, Saifullah Mehsud, Ivan R Green, Sheikh Abdur Rashid, Kifayat Ullah Shah

“…This study aims to assess the impact of pharmacist-led educational intervention on knowledge of self-management among asthmatic patients.Design A pre–post cohort study.Setting Outpatient department of a tertiary care hospital affiliated with Quaid-i-Azam University, Pakistan.Participants Approximately 265 adult asthmatic patients selected through a spirometry process, aged ≥18 years, were approached. 240 patients gave consent to participate in the study and were divided into control and treatment groups.Interventions The educational intervention consisted of individual patient counselling using educational material with time varied according to each patient’s comprehension and previous knowledge.Primary and secondary outcome measures Assessment consisted of a 14-item Asthma Self-Management Knowledge Questionnaire (ASMQ) quantifying a patient’s self-management knowledge through an ASMQ score and its change following an educational intervention.Results Disease self-management knowledge was low with an average raw ASMQ score of 4.1 (max 14); which equates to a transformed score of 29.34 (max 100) and the proportion of patients who correctly answered more than 50% of questions were 16.7% preintervention. …”
Get full text

Human Papillomavirus Prevalence in Oral and Oropharyngeal Rinse and Gargle Specimens of Dental Patients and of an HIV-Positive Cohort from Pretoria, South Africa by Neil H. Wood, Koketso S. Makua, Ramokone L. Lebelo, Nina Redzic, Ina Benoy, Olivier M. Vanderveken, Johannes Bogers

“…Following ethical clearance and informed consent, patients attending a regional HIV-management clinic and patients attending a dental hospital were recruited to this study. …”
Get full text

Epidemiology, clinical spectrum, and outcomes of severe malaria in Eastern Uganda: a prospective study by Cate Namayanja, George Paasi, Jimmy Patrick Alunyo, Denis Amorut, Charles Benard Okalebo, William Okiror, Paul Ongodia, Grace Abongo, Rita Muhindo, Yovani A. M. Lubaale, Peter Olupot-Olupot

“…Children aged 60 days to 12 years who at admission tested positive for malaria and fulfilled the clinical World Health Organization criteria for surveillance of severe malaria were enrolled into the study following appropriate informed consent. Data were collected using a customized proforma on social demographic characteristics, clinical presentation, treatment, and outcomes. …”
Get full text

Trial of alginates in throat symptoms: protocol for a pragmatic, multicentre, placebo controlled, double blind, parallel, randomised controlled trial of liquid alginate (Gaviscon A... by David Hamilton, Ruth Wood, Dawn Teare, Miranda Morton, Rebecca Maier, James O’Hara, Tony Fouweather, Julian McGlashan, Julie Thompson, Richard Joyce, Hesther Smith, Lysbeth Evans

“…All participants will provide informed consent prior to any trial specific activity taking place. …”
Get full text

Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study by Samir Jaber, Karim Asehnoune, Fanny Feuillet, Mickael Vourc’h, Donatien Huard, Gabrielle Baud, Arthur Guichoux, Marielle Surbled, Melanie Tissot, Anne Chiffoleau, Christophe Guitton

“…Intent-to-treat and per-protocol analysis are planned for the primary outcome.Ethics and dissemination The study project has been approved by an independent ethics committee. Written informed consent will be obtained before study inclusion. Participant recruitment begins in September 2018. …”
Get full text

Personality traits and their relationship with oral health related quality of life among adolescents in Saudi Arabia by Danah Sahmi Alhajri, Danah Abdullatif Alhammad, Lulwah Fouad Alabdulqader, Reem Rashed Alasbly, Muhanad Alhareky, Mazin Algahtani, Asim Al-Ansari, Muhammad Ashraf Nazir

“…The participants responded to a self-administered questionnaire after providing informed consent. The questionnaire included demographic information and Arabic versions of the Big Five Personality Inventory and the Child Oral Health Impact Profile-Short Form to evaluate personality traits and OHRQoL, respectively. …”
Get full text