Articles

Intradermal acupuncture for rheumatoid arthritis: study protocol for a randomised controlled trial

Rheumatoid arthritis (RA) is a common autoimmune disease that severely impacts quality of life. Currently available medications for the treatment of RA have adverse side effects. Emerging evidence suggests tha...

Authors: Huifang Luo, Jie Peng, Qing Ma, Zhihua Wei, Changsong Lin, Mingying Zhang, Peiwu Li, Yang Song and Xiangwei Yang

Protocol for a process evaluation of an external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care: the PolyPrime study

The PolyPrime intervention is a theory-based intervention aimed at improving appropriate polypharmacy in older people (aged ≥65 years) in primary care. The intervention consists of an online video which demons...

Authors: Audrey Rankin, Gerard J. Molloy, Cathal A. Cadogan, Heather E. Barry, Ashleigh Gorman, Cristín Ryan, Alan Ferrett, Pat McCarthy, Gerard J. Gormley, Tom Fahey and Carmel M. Hughes

A randomized clinical trial to assess the effectiveness of pre- and post-surgical pelvic floor physiotherapy for bowel symptoms, pelvic floor function, and quality of life of patients with rectal cancer: CARRET protocol

There is scarcity of trials about preventative strategies for low anterior resection syndrome (LARS) in rectal cancer patients. The aim of this study is to evaluate the effectiveness of a pre- and post-surgica...

Authors: Cinara Sacomori, Luz Alejandra Lorca, Mónica Martinez-Mardones, Roberto Ignacio Salas-Ocaranza, Guillermo Patricio Reyes-Reyes, Marta Natalia Pizarro-Hinojosa and Jorge Plasser-Troncoso

Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial

The Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patie...

Authors: Maria Burton, Kate J. Lifford, Lynda Wyld, Fiona Armitage, Alistair Ring, Anthony Nettleship, Karen Collins, Jenna Morgan, Malcolm W. R. Reed, Geoffrey R. Holmes, Mike Bradburn, Jacqui Gath, Tracy Green, Deirdre Revell, Kate Brain and Adrian Edwards

The effectiveness of a psycho-education intervention on mental health literacy in communities affected by the COVID-19 pandemic—a cluster randomized trial of 24 villages in central Uganda—a research protocol

Literature shows a high prevalence of psychological distress (PD) as well as common mental disorders (CMD) such as major depressive disorders (MDD), generalized anxiety disorders (GAD), post-traumatic stress d...

Authors: Dickens Akena, Ronald Kiguba, Wilson W. Muhwezi, Brendan Kwesiga, Gwendolyne Kigozi, Noeline Nakasujja and Hafsa Lukwata

Telerehabilitation program for older adults on a waiting list for physical therapy after hospital discharge: study protocol for a pragmatic randomized trial protocol

Delays in starting physical therapy after hospital discharge worsen deconditioning in older adults. Intervening quickly can minimize the negative effects of deconditioning. Telerehabilitation is a strategy tha...

Authors: Pollyana Ruggio Tristão Borges, Renan Alves Resende, Jane Fonseca Dias, Marisa Cotta Mancini and Rosana Ferreira Sampaio

Listening to Mom in the NICU: effects of increased maternal speech exposure on language outcomes and white matter development in infants born very preterm

Infants born very preterm (< 32 weeks gestational age (GA)) are at risk for developmental language delays. Poor language outcomes in children born preterm have been linked to neurobiological factors, including...

Authors: Edith Brignoni-Pérez, Maya Chan Morales, Virginia A. Marchman, Melissa Scala, Heidi M. Feldman, Kristen Yeom and Katherine E. Travis

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogenei...

Authors: Nathan A. Pearson, Elizabeth Tutton, Alexander Joeris, Stephen Gwilym, Richard Grant, David J. Keene and Kirstie L. Haywood

A randomised controlled unblinded multicentre non-inferiority trial with activated vitamin D and prednisolone treatment in patients with minimal change nephropathy (ADAPTinMCN)

Minimal change nephropathy (MCN) is a common cause of nephrotic syndrome in both adults and children. International guidelines recommend treatment with prednisolone 1 mg/kg/day to adults. This dose is derived ...

Authors: Tilde Kristensen, Henrik Birn and Per Ivarsen

Principles for the production and dissemination of recruitment material for three clinical trials of an online intervention

Some health research studies recruit participants through electronic mechanisms such as the placement of messages on social media platforms. This raises questions for ethics committee oversight, since effectiv...

Authors: Stefan Rennick-Egglestone

Responding to COVID-19 threats to trial conduct: lessons learned from a feasibility trial of a psychological intervention for South African adolescents

The COVID-19 pandemic has posed challenges to the conduct of clinical trials. Strategies for overcoming common challenges to non-COVID-19 trial continuation have been reported, but this literature is limited t...

Authors: Bronwyn Myers, Claire van der Westhuizen, Megan Pool, Nancy Hornsby and Katherine R. Sorsdahl

Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol

Many therapeutic interventions are performed by physiotherapists to improve upper extremity function and/or activities of daily living (ADL) in stroke patients. Mirror therapy (MT) is a simple technique that c...

Authors: Venkadesan Rajendran, Deepa Jeevanantham, Céline Larivière, Ravinder-Jeet Singh, Lisa Zeman and Padma Papuri

Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol

High blood pressure is an independent risk factor of cardiovascular disease (CVD) and is a major cause of disability and death. Managing a healthy lifestyle has been shown to reduce blood pressure and improve ...

Authors: Fakir M Amirul Islam, Elisabeth A. Lambert, Sheikh Mohammed Shariful Islam, M. Ariful Islam, Dip Biswas, Rachael McDonald, Ralph Maddison, Bruce Thompson and Gavin W. Lambert

Effects of traditional Chinese medicine combined with chemotherapy for extensive-stage small-cell lung cancer patients on improving oncologic survival: study protocol of a multicenter, randomized, single-blind, placebo-controlled trial

Extensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression, and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but...

Authors: Yuyi Chen, Mingwei Yu, Zishen Liu, Yi Zhang, Qiwei Li and Guowang Yang

Efficacy of i-PRF in regenerative endodontics therapy for mature permanent teeth with pulp necrosis: study protocol for a multicentre randomised controlled trial

Dental pulp necrosis, a common health problem, is traditionally treated with root canal therapy; however, it fails in restoring the vitality of damaged pulp. Most studies regarding regenerative endodontic ther...

Authors: Yuee Liang, Rongyang Ma, Lijuan Chen, Xingzhu Dai, Shiya Zuo, Weiyi Jiang, Naiming Hu, Zilong Deng and Wanghong Zhao

Evaluation of the efficacy and safety of recombinant erythropoietin on the improvement of hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial

To evaluate the effect of recombinant erythropoietin on hospitalised COVID-19 patients.

Authors: Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Maryam Haddad, Mohsen Arabi and Mitra KazemiJahromi

Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the in...

Authors: Gholamreza Askari, Babak Alikiaii, Davood Soleimani, Amirhossein Sahebkar, Mahdiye Mirjalili, Awat Feizi, Bijan Iraj and Mohammad Bagherniya

TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis

Adaptive model-based dose-finding designs have demonstrated advantages over traditional rule-based designs but have increased statistical complexity but uptake has been slow especially outside of cancer trials...

Authors: M. Cole, C. Yap, C. Buckley, W. F. Ng, I. McInnes, A. Filer, S. Siebert, A. Pratt, J. D. Isaacs and D. D. Stocken

Correction to: Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN)

Authors: Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann and Wolfgang Hoffmann

Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial

Therapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface prot...

Authors: Nicholas G. Nickols, Matthew B. Goetz, Christopher J. Graber, Debika Bhattacharya, Guy Soo Hoo, Matthew Might, David B. Goldstein, Xinchen Wang, Rachel Ramoni, Kenute Myrie, Samantha Tran, Leila Ghayouri, Sonny Tsai, Michelle Geelhoed, Danil Makarov, Daniel J. Becker…

SENSory re-learning of the UPPer limb (SENSUPP) after stroke: development and description of a novel intervention using the TIDieR checklist

Sensorimotor impairments of upper limb (UL) are common after stroke, leading to difficulty to use the UL in daily life. Even though many have sensory impairments in the UL, specific sensory training is often l...

Authors: Håkan Carlsson, Birgitta Rosén, Anders Björkman, Hélène Pessah-Rasmussen and Christina Brogårdh

Using routinely recorded data in a UK RCT: a comparison to standard prospective data collection methods

Routinely recorded data held in electronic health records can be used to inform the conduct of randomised controlled trials (RCTs). However, limitations with access and accuracy have been identified. Objective: U...

Authors: G. A. Powell, L. J. Bonnett, C. T. Smith, D. A. Hughes, P. R. Williamson and A. G. Marson

SAVER: sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia—a phase II randomised control trial study protocol

Sodium valproate (VPA) has been associated with a reduced risk of head and neck cancer development. The potential protective mechanism of action is believed to be via inhibition of histone deacetylase and subs...

Authors: Caroline McCarthy, Joseph Sacco, Stefano Fedele, Michael Ho, Stephen Porter, Triantafillos Liloglou, Bill Greenhalf, Max Robinson, Bridget Young, Silvia Cicconi, Seema Chauhan, Binyam Tesfaye, Richard Jackson, Frances Sherratt and Richard Shaw

0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial

Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead t...

Authors: Sainath Raman, Andreas Schibler, Renate Le Marsney, Peter Trnka, Melanie Kennedy, Adrian Mattke, Kristen Gibbons and Luregn J. Schlapbach

Efficacy and mechanism of traditional Chinese medicine in relieving antibiotic-resistant bacterial diarrhea in children: study protocol for a randomized controlled trial

Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. Antibiotic abuse and resistance are widespread problems...

Authors: Chao-ran Bi, Wei Jing, Xiao-fei Xie and Yan-jing Liu

Stereotactic EEG-guided radiofrequency thermocoagulation versus anterior temporal lobectomy for mesial temporal lobe epilepsy with hippocampal sclerosis: study protocol for a randomised controlled trial

In this report, we aim to describe the design for the randomised controlled trial of Stereotactic electroencephalogram (EEG)-guided Radiofrequency Thermocoagulation versus Anterior Temporal Lobectomy for Mesia...

Authors: Yi-He Wang, Si-Chang Chen, Peng-Hu Wei, Kun Yang, Xiao-Tong Fan, Fei Meng, Jia-Lin Du, Lian-Kun Ren, Yong-Zhi Shan and Guo-Guang Zhao

Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial

There has been increasing focus to improve the quality of recovery following anterior cervical spine surgery (ACSS). Postoperative pain and nausea are the most common reasons for prolonged hospital stay and re...

Authors: Michael J. Mulcahy, Thananchayan Elalingam, Kevin Jang, Mario D’Souza and Matthew Tait

The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial

Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the contr...

Authors: José M. Añón, María Soledad Arellano, Manuel Pérez-Márquez, Claudia Díaz-Alvariño, José A. Márquez-Alonso, Jorge Rodríguez-Peláez, Kapil Nanwani-Nanwani, Ana Martín-Pellicer, Belén Civantos, Alba López-Fernández, Irene Seises, Jorge García-Nerín, Juan C. Figueira, Henar Casero, Javier Vejo, Alexander Agrifoglio…

Cost talk: protocol for a stepped-wedge cluster randomized trial of an intervention helping patients and urologic surgeons discuss costs of care for slow-growing prostate cancer during shared decision-making

Costs of care are important to patients making cancer treatment decisions, but clinicians often do not feel prepared to discuss treatment costs. We aim to (1) assess the impact of a conversation-based decision...

Authors: Mary C. Politi, Rachel C. Forcino, Katelyn Parrish, Marie-Anne Durand, A. James O’Malley and Glyn Elwyn

Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial

The expeditious surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, contr...

Authors: Chun Yang, Xianjian Huang, Junfeng Feng, Li Xie, Jiyuan Hui, Weiping Li and Jiyao Jiang

Survival analysis for AdVerse events with VarYing follow-up times (SAVVY)—estimation of adverse event risks

The SAVVY project aims to improve the analyses of adverse events (AEs), whether prespecified or emerging, in clinical trials through the use of survival techniques appropriately dealing with varying follow-up ...

Authors: Regina Stegherr, Claudia Schmoor, Jan Beyersmann, Kaspar Rufibach, Valentine Jehl, Andreas Brückner, Lewin Eisele, Thomas Künzel, Katrin Kupas, Frank Langer, Friedhelm Leverkus, Anja Loos, Christiane Norenberg, Florian Voss and Tim Friede

Improving analysis practice of continuous adverse event outcomes in randomised controlled trials - a distributional approach

Randomised controlled trials (RCTs) provide valuable information for developing harm profiles but current analysis practices to detect between-group differences are suboptimal. Drug trials routinely screen con...

Authors: Anca Chis Ster, Rachel Phillips, Odile Sauzet and Victoria Cornelius

Public access to protocols of contemporary cancer randomized clinical trials

Access to randomized clinical trial (RCT) protocols is necessary for the interpretation and reproducibility of the study results, but protocol availability has been lacking. We determined the prevalence of pro...

Authors: Christopher Babu, Loren Mell, Nancy Lee and Kaveh Zakeri

Recommendations for designing and analysing multi-arm non-inferiority trials: a review of methodology and current practice

Multi-arm non-inferiority (MANI) trials, here defined as non-inferiority trials with multiple experimental treatment arms, can be useful in situations where several viable treatments exist for a disease area o...

Authors: Jake Emmerson, Susan Todd and Julia M. Brown

The Retornus-2 study: impact of respiratory muscle training in subacute stroke patients with dysphagia, study protocol of a double-blind randomized controlled trial

Stroke can lead to varying degrees of oropharyngeal dysphagia, respiratory muscle dysfunction and even increase medical complications such as aspiration, malnutrition and death. Recent studies suggest that ins...

Authors: A. Guillen-Sola, M. Messaggi-Sartor, C. Ramírez-Fuentes, E. Marco and E. Duarte

The development of lived experience-centered word clouds to support research uncertainty gathering in degenerative cervical myelopathy: results from an engagement process and protocol for their evaluation, via a nested randomized controlled trial

AO Spine REsearch objectives and Common Data Elements for Degenerative Cervical Myelopathy [RECODE-DCM] is a multi-stakeholder consensus process aiming to promote research efficiency in DCM. It aims to establi...

Authors: Benjamin M. Davies, Oliver D. Mowforth, Danyal Z. Khan, Xiaoyu Yang, Sybil R. L. Stacpoole, Olesja Hazenbiller, Toto Gronlund, Lindsay Tetreault, Sukhvinder Kalsi-Ryan, Michelle L. Starkey, Iwan Sadler, Ellen Sarewitz, Delphine Houlton, Julia Carter, Evangeline Howard, Vafa Rahimi-Movaghar…

Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-ba...

Authors: Aziza Ajlan, Hassan Aleid, Tariq Zulfiquar Ali, Hala Joharji, Khalid Almeshari, Ahmed Mohammed Nazmi, Yaser Shah, Edward Devol, Dalal Alkortas, Zinah Alabdulkarim, Dieter Broering, Ibrahim Alahmadi, Asad Ullah, Anwar Alotaibi and Ahmed Aljedai

The effect of the mobile “blood pressure management application” on hypertension self-management enhancement: a randomized controlled trial

Self-management of hypertension is of great significance given its increasing incidence and its associated disabilities. In view of the increased use of mobile health in medicine, the present study evaluated t...

Authors: Ali Bozorgi, Hamed Hosseini, Hassan Eftekhar, Reza Majdzadeh, Ali Yoonessi, Ali Ramezankhani, Mehdi Mansouri and Mahnaz Ashoorkhani

A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial

It is currently thought that most—but not all—individuals infected with SARS-CoV-2 develop symptoms, but that the infectious period starts on average two days before the first overt symptoms appear. It is esti...

Authors: Timo B. Brakenhoff, Billy Franks, Brianna Mae Goodale, Janneke van de Wijgert, Santiago Montes, Duco Veen, Eskild K. Fredslund, Theo Rispens, Lorenz Risch, Ariel V. Dowling, Amos A. Folarin, Patricia Bruijning, Richard Dobson, Tessa Heikamp, Paul Klaver, Maureen Cronin…

SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults—a study protocol for a prospective randomized double-blind multicenter clinical trial

Small umbilical hernia repair is one of the most common surgical performances in general surgery. Yet, a gold standard procedure for the repair is still lacking today. There is an increasing evidence that mesh...

Authors: M. Melkemichel, S. Bringman, G. Granåsen and B. Widhe

Methods for conducting international Delphi surveys to optimise global participation in core outcome set development: a case study in gastric cancer informed by a comprehensive literature review

Core outcome sets (COS) should be relevant to key stakeholders and widely applicable and usable. Ideally, they are developed for international use to allow optimal data synthesis from trials. Electronic Delphi...

Authors: Bilal Alkhaffaf, Jane M. Blazeby, Aleksandra Metryka, Anne-Marie Glenny, Ademola Adeyeye, Paulo Matos Costa, Ismael Diez del Val, Suzanne S. Gisbertz, Ali Guner, Simon Law, Hyuk-Joon Lee, Ziyu Li, Koji Nakada, Rafael Mauricio Restrepo Nuñez, Daniel Reim, John V. Reynolds…

Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectivenes...

Authors: Lena Violetta Krämer, Nadine Eschrig, Lena Keinhorst, Luisa Schöchlin, Lisa Stephan, Malin Stiene and Jürgen Bengel

The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation

Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access...

Authors: Karin Gallandat, Aurélie Jeandron, Ian Ross, Jaime Mufitini Saidi, Baron Bashige Rumedeka, Vercus Lumami Kapepula, Simon Cousens, Elizabeth Allen, Amy MacDougall and Oliver Cumming

Correction to: Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Authors: Ramy Khojaly, Ruairí Mac Niocaill, Muhammad Shahab, Matthew Nagle, Colm Taylor, Fiachra E. Rowan and May Cleary

Using adalimumab serum concentration to choose a subsequent biological DMARD in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): study protocol for a fully blinded randomised superiority test-treatment trial

A substantial proportion of rheumatoid arthritis (RA) patients discontinues treatment with tumour necrosis factor inhibitors (TNFi) due to inefficacy or intolerance. After the failure of treatment with a TNFi,...

Authors: Maike H. M. Wientjes, Sadaf Atiqi, Gerrit Jan Wolbink, Michael T. Nurmohamed, Maarten Boers, Theo Rispens, Annick de Vries, Ronald F. van Vollenhoven, Bart J. F. van den Bemt and Alfons A. den Broeder

Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer....

Authors: Xiao-Lin Wei, Ru-Zhen Yuan, Yong-Mei Jin, Shu Li, Ming-Yue Wang, Jie-Ting Jiang, Cai-Qin Wu and Kun-Peng Li

IMI2-PainCare-BioPain-RCT3: a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by electroencephalography (EEG)

IMI2-PainCare-BioPain-RCT3 is one of four similarly designed clinical studies aiming at profiling a set of functional biomarkers of drug effects on the nociceptive system that could serve to accelerate the fut...

Authors: André Mouraux, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Giulia Di Stefano, Nanna Brix Finnerup, Luis Garcia-Larrea, Marcus Goetz, Anna Kostenko, Bernhard Pelz, Esther Pogatzki-Zahn, Karin Schubart, Alexandre Stouffs, Andrea Truini, Irene Tracey…

A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial

Almost all Aboriginal children in remote communities have persistent bilateral otitis media affecting hearing and learning throughout early childhood and school years, with consequences for social and educatio...

Authors: Kelvin Kong, Alan Cass, Amanda Jane Leach, Peter Stanley Morris, Amy Kimber, Jiunn-Yih Su and Victor Maduabuchi Oguoma

Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial

Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we ...

Authors: Alice MacLachlan, Karen Crawford, Shona Shinwell, Catherine Nixon and Marion Henderson

Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN)

Up to two-thirds of dementia care is provided by family caregivers who often experience high burden, little support and adverse health outcomes. Enabling and supporting family caregivers to provide care at hom...

Authors: Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann and Wolfgang Hoffmann