Articles

The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial

Current evidence suggests that some of the most effective weight loss approaches are changes in dietary and physical activity behaviors through lifestyle modification programs. The Group Lifestyle Balance (GLB...

Authors: Bärbel Knäuper, Huma Shireen, Kimberly Carrière, Mallory Frayn, Elena Ivanova, Zhen Xu, Ilka Lowensteyn, Gentiana Sadikaj, Aleksandra Luszczynska and Steven Grover

Response to the Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”

Authors: Mounika Pillamarapu, Abhilash Mohan and Gayatri Saberwal

Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”

An article published in this journal analyses the deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India. We wish to rebut some of the inferences and highlight ...

Authors: Mohua Maulik, Jyotsna Gupta, Atul Juneja, Tulsi Adhikari, Saurabh Sharma, Yashmin Panchal, Neha Yadav and Mendu Vishnu Vardhana Rao

How to collect non-medical data in a pediatric trial: diaries or interviews

Non-medical data, such as the amount of time that patients and caregivers spend managing their condition, may be relevant when assessing therapeutic strategies. For chronic pediatric conditions, the time that ...

Authors: Anaïs Le Jeannic, Hassani Maoulida, Sophie Guilmin-Crépon, Corinne Alberti, Nadia Tubiana-Rufi and Isabelle Durand-Zaleski

Pilates and dance to patients with breast cancer undergoing treatment: study protocol for a randomized clinical trial – MoveMama study

Breast cancer is a global public health issue. The side effects of the clinical treatment can decrease the quality of life of these women. Therefore, a healthy lifestyle is essential to minimize the physical a...

Authors: Leonessa Boing, Tatiana do Bem Fretta, Melissa de Carvalho Souza Vieira, Gustavo Soares Pereira, Jéssica Moratelli, Fabiana Flores Sperandio, Anke Bergmann, Fatima Baptista, Mirella Dias and Adriana Coutinho de Azevedo Guimarães

Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis

Randomised controlled trials (RCTs) provide the most reliable information to inform clinical practice and patient care. We aimed to map global clinical research publication activity through RCT-related article...

Authors: Ferrán Catalá-López, Rafael Aleixandre-Benavent, Lisa Caulley, Brian Hutton, Rafael Tabarés-Seisdedos, David Moher and Adolfo Alonso-Arroyo

Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed

The evidence base available to trialists to support trial process decisions—e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants—is thin. One way ...

Authors: Shaun Treweek, Simon Bevan, Peter Bower, Matthias Briel, Marion Campbell, Jacquie Christie, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky, Sandra Galvin, Heidi Gardner, Katie Gillies, Kerenza Hood, Jan Jansen, Roberta Littleford…

Effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors in adults with central obesity: study protocol for a randomised controlled study

The prevalence of central obesity is constantly increasing, and visceral fat is associated with increased production of inflammatory factors and metabolic risk factors. Lutein might retard the development of m...

Authors: Juan Zhou, Dan Zhao, Ning Wang, Zhiwei Zeng, Changyi Wang, Liping Hao and Xiaolin Peng

Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in IgA nephropathy patients with high-risk of end-stage renal disease (TCM-WINE): study protocol for a randomized controlled trial

IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). For high-risk IgAN, which is clinical...

Authors: Shen Li and Jin-pu Li

A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder

Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, an...

Authors: Brittany B. Dennis, Nitika Sanger, Monica Bawor, Leen Naji, Carolyn Plater, Andrew Worster, Julia Woo, Anuja Bhalerao, Natasha Baptist-Mohseni, Alannah Hillmer, Danielle Rice, Kim Corace, Brian Hutton, Peter Tugwell, Lehana Thabane and Zainab Samaan

Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial

Scalp acupuncture has been widely used as treatment for motor dysfunction in children with cerebral palsy in China. Previous studies have failed to provide high-quality evidence to demonstrate the effectivenes...

Authors: Jun Wang, Wei Shi, Dhiaedin Khiati, Bingpei Shi, Xiaojuan Shi, Dandan Luo, Yin Wang, Rencai Deng, Huayu Huang, Jian Li, Weili Yan and Hong Yang

Exploring the recruitment, ethical considerations, conduct and information dissemination of an audiology trial: a pretrial qualitative study (q-COACH)

Randomised controlled trials (RCTs), while still considered the gold standard approach in medical research, can encounter impediments to their successful conduct and the dissemination of results. Pretrial qual...

Authors: Emilie Francis-Auton, Chris Warren, Jeffrey Braithwaite and Frances Rapport

Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, 1-year follow-up: a cluster-randomised trial

We evaluated an intervention designed to teach 10- to 12-year-old primary school children to assess claims about the effects of treatments (any action intended to maintain or improve health). We report outcome...

Authors: Allen Nsangi, Daniel Semakula, Andrew D. Oxman, Astrid Austvoll-Dahlgren, Matt Oxman, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Yunpeng Ding and Nelson K. Sewankambo

Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725)

According to WHO, medication error (ME) is a subject that requires attention at all levels of care to reduce severe and preventable damage related to medication use. Clinical pharmacy practice standards have b...

Authors: J. Granados, A. Salazar-Ospina, J. P. Botero-Aguirre, A. F. Valencia-Quintero, N. Ortiz and P. Amariles

Health Pregnancy, Healthy Baby: testing the added benefits of pregnancy ultrasound scan for child development in a randomised control trial

The 2016 World Health Organization Antenatal Guidelines and the 2015 South African Maternal and Child Health Guidelines recommend one early antenatal ultrasound scan to establish gestational age and to detect ...

Authors: Linda Richter, Wiedaad Slemming, Shane A. Norris, Alan Stein, Lucilla Poston and Dharmintra Pasupathy

The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study)

Although the wound-healing period for purse-string closure (PSC) after stoma reversal is longer than that required for the primary closure method, the rate of wound infection is reduced. The application of neg...

Authors: Sohyun Kim and Sung Il Kang

Efficacy of switching to bilastine, a histamine H1 receptor antagonist, in patients with chronic spontaneous urticaria (H1-SWITCH): study protocol for a randomized controlled trial

Chronic spontaneous urticaria (CSU) is characterized by the spontaneous appearance of wheals, angioedema, or both for > 6 weeks. Continuous treatment with H1-antihistamines is used as a first-line treatment fo...

Authors: Atsushi Fukunaga, Yoshiko Oda, Ken Washio, Takashi Omori, Yasumasa Kakei, Michihiro Hide and Chikako Nishigori

Effects of school-based physical activity and multi-micronutrient supplementation intervention on growth, health and well-being of schoolchildren in three African countries: the KaziAfya cluster randomised controlled trial protocol with a 2 × 2 factorial design

In low- and middle-income countries, infectious diseases remain a key public health issue. Additionally, non-communicable diseases are a rapidly growing public health problem that impose a considerable burden ...

Authors: Markus Gerber, Serge A. Ayekoé, Johanna Beckmann, Bassirou Bonfoh, Jean T. Coulibaly, Dao Daouda, Rosa du Randt, Lina Finda, Stefanie Gall, Getrud J. Mollel, Christin Lang, Kurt Z. Long, Sebastian Ludyga, Honorati Masanja, Ivan Müller, Siphesihle Nqweniso…

Comparing how patients value and respond to information on risk given in three different forms during dental check-ups: the PREFER randomised controlled trial

This study aims to compare patient preference for, and subsequent change in, oral health behaviour for three forms of risk information given at dental check-ups (verbal advice compared to verbal advice accompa...

Authors: R. Harris, V. Lowers, L. Laverty, C. Vernazza, G. Burnside, S. Brown and L. Ternent

Metta-based group meditation and individual cognitive behavioral therapy (MeCBT) for chronic depression: study protocol for a randomized controlled trial

Depression is a widespread disorder with severe impacts for individuals and society, especially in its chronic form. Current treatment approaches for persistent depression have focused primarily on reducing ne...

Authors: Artjom Frick, Isabel Thinnes and Ulrich Stangier

Blood biomarkers as surrogate endpoints of treatment responses to aerobic exercise and cognitive training (ACT) in amnestic mild cognitive impairment: the blood biomarkers study protocol of a randomized controlled trial (the ACT Trial)

Alzheimer’s disease (AD) is an epidemic with tremendous public health impacts because there are currently no disease-modifying therapeutics. Randomized controlled trials (RCTs) for prevention of AD dementia of...

Authors: Danni Li, Michelle M. Mielke, W. Robert Bell, Cavan Reilly, Lin Zhang, Feng Vankee Lin and Fang Yu

Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial

People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychologi...

Authors: Ratna Sohanpal, Hilary Pinnock, Liz Steed, Karen Heslop Marshall, Claire Chan, Moira Kelly, Stefan Priebe, C. Michael Roberts, Sally Singh, Melanie Smuk, Sarah Saqi-Waseem, Andy Healey, Martin Underwood, Patrick White, Chris Warburton and Stephanie J. C. Taylor

Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder

Only 40–60% of patients with generalized anxiety disorder experience long-lasting improvement with gold standard psychosocial interventions. Identifying neurobehavioral factors that predict treatment success m...

Authors: J. Santiago, E. Akeman, N. Kirlic, A. N. Clausen, K. T. Cosgrove, T. J. McDermott, B. Mathis, M. Paulus, M. G. Craske, J. Abelson, C. Martell, K. Wolitzky-Taylor, J. Bodurka, W. K. Thompson and Robin L. Aupperle

A cluster randomized clinical trial to evaluate the effectiveness of the Implementation of Infant Pain Practice Change (ImPaC) Resource to improve pain practices in hospitalized infants: a study protocol

Hospitalized infants undergo multiple painful procedures daily. Despite the significant evidence, procedural pain assessment and management continues to be suboptimal. Repetitive and untreated pain at this vit...

Authors: Mariana Bueno, Bonnie Stevens, Melanie A. Barwick, Shirine Riahi, Shelly-Anne Li, Alexa Lanese, Andrew R. Willan, Anne Synnes, Carole A. Estabrooks, Christine T. Chambers, Denise Harrison, Janet Yamada, Jennifer Stinson, Marsha Campbell-Yeo, Melanie Noel, Sharyn Gibbins…

Pharmacological conditioning in the treatment of recent-onset rheumatoid arthritis: a randomized controlled trial study protocol

In pharmacological conditioning associations are formed between the effects of medication and contextual factors related to the medication. Pharmacological conditioning with placebo medication can result in co...

Authors: Meriem Manaï, Henriët van Middendorp, Dieuwke S. Veldhuijzen, Joy A. van der Pol, Tom W. J. Huizinga and Andrea W. M. Evers

Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial

People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outco...

Authors: Fiona Gaughran, Dominic Stringer, Michael Berk, Shubulade Smith, David Taylor, Eromona Whiskey, Sabine Landau, Robin Murray, Philip McGuire, Poonam Gardner-Sood, Gabriella Wojewodka, Simone Ciufolini, Harriet Jordan, Jessie Clarke, Lauren Allen, Amir Krivoy…

Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study)

Infliximab (INX) and other tumour necrosis factor inhibitors (TNFi) have revolutionised the treatment of several immune mediated inflammatory diseases. Still, many patients do not respond sufficiently to thera...

Authors: Silje W Syversen, Guro L Goll, Kristin K Jørgensen, Inge C Olsen, Øystein Sandanger, Johanna E Gehin, David J Warren, Joseph Sexton, Cato Mørk, Jørgen Jahnsen, Tore K Kvien, Nils Bolstad and Espen A Haavardsholm

Effects of sang-qi granules on blood pressure and endothelial dysfunction in stage I or II hypertension: study protocol for a randomized double-blind double-simulation controlled trial

Worldwide, hypertension is an important public health challenge because of its high prevalence and the concomitant risks of cardiovascular disease. It induces half of the coronary heart disease and approximate...

Authors: Haoyue Shi, Deshuang Yang, Jiajun Qiao, Rui Sun, Ruihan Li, Chunlin Zhu, Ruiqing Jing, Liping Liu, Li Huang and Lin Li

Danish Evaluation of Your Heart Forecast (DANY): study protocol for a cluster randomised controlled trial on an interactive risk-communication tool aimed at improving adherence of patients with high blood pressure

To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardiovascular disease is a complex and individualised ta...

Authors: Anders Elkær Jensen, Jens Søndergaard, Niels Kristian Kjær, Rod Jackson and Jesper Bo Nielsen

Estimating dose-response for time to remission with instrumental variable adjustment: the obscuring effects of drug titration in Genome Based Therapeutic Drugs for Depression Trial (GENDEP): clinical trial data

Threshold regression, in which time to remission is modelled as a stochastic drift towards a boundary, is an alternative to the proportional hazards survival model and has a clear conceptual mechanism for exam...

Authors: Jennifer Hellier, Richard Emsley and Andrew Pickles

Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda

Many HIV-positive patients do not appropriately adhere to their antiretroviral medication (ART). This leads to higher viral loads and greater probability of HIV transmission. Present bias—a tendency to give in...

Authors: Sebastian Linnemayr, Chad Stecher, Uzaib Saya, Sarah MacCarthy, Zachary Wagner, Larissa Jennings and Barbara Mukasa

Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial

The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-...

Authors: Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Hani A. Aziz Jokhdar, Adel Alothman, Hanan H. Balkhy, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Ziad A. Memish, Sameeh Ghazal, Sarah Al Faraj, Fahad Al-Hameed, Asim AlSaedi…

Treatment of non-high-risk acute promyelocytic leukemia with realgar-indigo naturalis formula (RIF) and all-trans retinoid acid (ATRA): study protocol for a randomized controlled trial

Acute promyelocytic leukemia (APL) is a highly curable disease when treated with all-trans retinoid acid (ATRA) and arsenic trioxide (ATO). The combination of ATO and ATRA has become the standard therapeutic p...

Authors: Xinxin Zhang, Li Liu, Yazhou Yao, Sha Gong, Mengchang Wang, Jieying Xi, Limei Chen, Suhua Wei, Huiyun Zhang, Chenyang Zhao and Huaiyu Wang

Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people

Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The Online Remote Behavioural Intervention for Tics (ORBIT) study is a randomized controlled trial ...

Authors: K. Khan, C. Hollis, C. L. Hall, E. B. Davies, D. Mataix-Cols, P. Andrén, T. Murphy, B. J. Brown, E. Murray and C. Glazebrook

Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial)

Plantar fasciopathy has a lifetime prevalence of 10%. Patients experience sharp pain under the heel, often for several months or years. Multiple treatments are available, but no single treatment appears superi...

Authors: Henrik Riel, Bill Vicenzino, Jens Lykkegaard Olesen, Martin Bach Jensen, Lars Holger Ehlers and Michael Skovdal Rathleff

Reducing violent discipline by teachers using Interaction Competencies with Children for Teachers (ICC-T): study protocol for a matched cluster randomized controlled trial in Tanzanian public primary schools

Despite the existing national and international plans of action to end violent discipline strategies used by teachers in schools, they still prevail in Tanzanian schools. This underlines the need to implement ...

Authors: Faustine Bwire Masath, Katharin Hermenau, Mabula Nkuba and Tobias Hecker

Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study

Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. Since pharmacological treatments may have substantial side...

Authors: Lina Samira Bahr, Markus Bock, Daniela Liebscher, Judith Bellmann-Strobl, Liane Franz, Alexandra Prüß, Dania Schumann, Sophie K. Piper, Christian S. Kessler, Nico Steckhan, Andreas Michalsen, Friedemann Paul and Anja Mähler

A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study

Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progr...

Authors: Aliza Werner-Seidler, Kit Huckvale, Mark E. Larsen, Alison L. Calear, Kate Maston, Lara Johnston, Michelle Torok, Bridianne O’Dea, Philip J. Batterham, Susanne Schweizer, S. Rachel Skinner, Katharine Steinbeck, Julie Ratcliffe, Ju-Lee Oei, George Patton, Iana Wong…

Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial

Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, ...

Authors: Esther Aleo Luján, Amanda Lopez-Picado, Ana Rivas, Belén Joyanes Abancens, Marina Laura Rodríguez Rojo, Patricia Fernández García, Carmen Soto Beauregard, Jaime Rodríguez Alarcón, Carlos González Perrino, Borja San Pedro de Urquiza, Eva Arias, Diamelis Rodriguez, Carmen Esteban Polonio and Maria José Torrejón

Treatment of hospital-acquired pneumonia with multi-drug resistant organism by Buzhong Yiqi decoction based on Fuzheng Quxie classical prescription: study protocol for a randomized controlled trial

Drug resistance in China is becoming a more and more serious issue. Infection by drug-resistant bacteria has become a major disease that seriously threatens the health of Chinese people and affects national me...

Authors: Dong Deng, Zhenyi Chen, Liyang Jia, Jianhong Bu, Miaoqing Ye, Lihua Sun, Yun Gen, Wen Zhang, Gang Chen and Bangjiang Fang

Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was developed with the aim of further improving the diagnostic performance of endoscopic ultrasound. Although novel puncture needles have been spec...

Authors: Masahiro Itonaga, Satoru Yasukawa, Toshio Shimokawa, Mamoru Takenaka, Nobuyasu Fukutake, Takeshi Ogura, Junichi Sakagami, Hideyuki Shiomi, Yasushi Okura, Osamu Inatomi, Hisakazu Matsumoto, Akira Kurita, Azumi Suzuki, Kiyohito Tanaka and Masayuki Kitano

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered...

Authors: Mathias Lühr Hansen, Adelina Pellicer, Christian Gluud, Eugene Dempsey, Jonathan Mintzer, Simon Hyttel-Sørensen, Anne Marie Heuchan, Cornelia Hagmann, Ebru Ergenekon, Gabriel Dimitriou, Gerhard Pichler, Gunnar Naulaers, Guoqiang Cheng, Hercilia Guimarães, Jakub Tkaczyk, Karen B. Kreutzer…

Effects of acupuncture on the hypothalamus-pituitary-adrenal axis in chronic insomnia patients: a study protocol for a randomized controlled trial

Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China, while there is no clinical study related to its therapeutic ...

Authors: Chengyong Liu, Shiyu Zheng, Wenzhong Wu, Xiaoqiu Wang, Shan Qin, Yanan Zhao, Hanqing Xi and Qingyun Wan

INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer’s Symptomatic Expression (INCREASE), a randomized controlled trial: rationale, study design, and protocol

The course of Alzheimer’s disease (AD) includes a 10–20-year preclinical period with progressive accumulation of amyloid β (Aβ) plaques and neurofibrillary tangles in the absence of symptomatic cognitive or fu...

Authors: Daniela C. Moga, Brooke F. Beech, Erin L. Abner, Frederick A. Schmitt, Riham H. El Khouli, Ashley I. Martinez, Lynne Eckmann, Mark Huffmyer, Rosmy George and Gregory A. Jicha

Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial

Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are f...

Authors: Jingyi Zhao, Xinyu Yan, Jianqing Gai, Jinshuai Han, Hong Zhang, Hui Luo, Shaoting Huang and Junge Wang

Evaluating the therapeutic efficacy of the Chinese herbal medicine Yishen Tongbi decoction in patients with active rheumatoid arthritis: protocol for a randomized, controlled, noninferiority trial

Rheumatoid arthritis (RA) is a common chronic autoimmune disease that seriously affects the quality of life of patients because of damage to joints. Presently, RA is mainly treated with disease-modifying antir...

Authors: Lianyu Zhao, Meilin Li, Yanping Xu, Lijuan Liu, Mingying Zhang and Guangxing Chen

Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial

An incentive spirometer (IS) is a mechanical device that promotes lung expansion. It is commonly used to prevent postoperative lung atelectasis and decrease pulmonary complications after cardiac, lung, or abdo...

Authors: Shao-Kai Sum, Ya-Chuan Peng, Shun-Ying Yin, Pin-Fu Huang, Yao-Chang Wang, Tzu-Ping Chen, Heng-Hsin Tung and Chi-Hsiao Yeh

A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial

In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which...

Authors: Pamela Martyn-Nemeth, Jennifer Duffecy, Laurie Quinn, Chang Park, Dan Mihailescu and Sue Penckofer

Nurse-led care versus physician-led care in the management of rheumatoid arthritis and psoriatic arthritis (StaerkeR): study protocol for a multi-center randomized controlled trial

In Germany, the care of patients with inflammatory arthritis could be improved. Although specialized rheumatology nurses could take over substantial aspects of patient care, this hardly occurs in Germany. Thus...

Authors: Anna Mai, Jürgen Braun, Jens-Peter Reese, Benjamin Westerhoff, Ulrike Trampisch, Renate Klaassen-Mielke, Nina Timmesfeld, Hans J. Trampisch and Dietmar Krause

The efficacy of iCBT added to treatment as usual for alcohol-dependent patients in primary care: study protocol for a randomized controlled trial

Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol-dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment-seeking in ...

Authors: Karin Hyland, Anders Hammarberg, Erik Hedman-Lagerlöf, Magnus Johansson and Sven Andreasson