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  1. When planning a multicentre clinical trial, it can be difficult to predict the time needed to open individual sites, and this in turn impacts on the total number of sites needed, the budget and the time frame ...

    Authors: Rosemary Greenwood, Julie Pell, Paula Foscarini-Craggs, Katharine Wale, Ian Thomas and Charlotte Bradbury

    Citation: Trials 2020 21:873

    Content type: Letter

    Published on:

  2. Almost 20% of U.S. women remain at risk for cervical cancer due to their inability or unwillingness to participate in periodic clinic-based screening. Self-sampling has been shown to be an effective strategy f...

    Authors: Jane R. Montealegre, Matthew L. Anderson, Susan G. Hilsenbeck, Elizabeth Y. Chiao, Scott B. Cantor, Susan L. Parker, Maria Daheri, Shaun Bulsara, Betsy Escobar, Ashish A. Deshmukh, Maria L. Jibaja-Weiss, Mohammed Zare and Michael E. Scheurer

    Citation: Trials 2020 21:872

    Content type: Study protocol

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  3. Suicide risk among individuals with schizophrenia (SZ) is intractably high, with over 40% of individuals attempting to take their own lives during their lifetime and an estimated 5–10% completing suicide. At p...

    Authors: Katie Beck-Felts, Marianne Goodman, Luz H. Ospina, Melanie Wall, Joseph McEvoy, Lars F. Jarskog, Jacob S. Ballon, Matthew N. Bartels, Richard Buchsbaum, Richard P. Sloan, T. Scott Stroup and David Kimhy

    Citation: Trials 2020 21:871

    Content type: Study protocol

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  4. The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression...

    Authors: Luisa Weiner, Fabrice Berna, Nathalie Nourry, François Severac, Pierre Vidailhet and Amaury C. Mengin

    Citation: Trials 2020 21:870

    Content type: Study protocol

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  5. Tenosynovitis of the long head of the biceps (LHB) brachii is a common disease in patients over 40 years old. It can always result in chronic anterior shoulder pain and limited function. Acupuncture is one of ...

    Authors: Rongrong Li, Yongliang Jiang, Renjie Hu, Xiaofen He and Jianqiao Fang

    Citation: Trials 2020 21:869

    Content type: Methodology

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  6. Resuscitated out-of-hospital cardiac arrest (OHCA) patients who remain comatose at admission are at high risk of morbidity and mortality. This has been attributed to the post-cardiac arrest syndrome (PCAS) whi...

    Authors: Martin A. S. Meyer, Sebastian Wiberg, Johannes Grand, Jesper Kjaergaard and Christian Hassager

    Citation: Trials 2020 21:868

    Content type: Study protocol

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  7. There is an urgent need for treatments that can shorten hospitalization and lower the risk of secondary infection and death in patients with corona disease. The ProPac-COVID trial evaluates whether combination...

    Authors: Pradeesh Sivapalan, Charlotte Suppli Ulrik, Therese Sophie Lappere, Josefin Viktoria Eklöf, Saher Burhan Shaker, Uffe Christian Steinholtz Bødtger, Andrea Browatzki, Christian Niels Meyer, Ulla Møller Weinreich, Christian B. Laursen, Tor Biering-Sørensen, Filip Krag Knop, Jens D. Lundgren and Jens-Ulrik Stæhr Jensen

    Citation: Trials 2020 21:867

    Content type: Update

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    The Letter to this article has been published in Trials 2020 21:513

  8. 1. To compare the safety and efficacy of Hydroxychloroquine with Ribavirin and standard treatment in patients with non-severe COVID-19 infection

    Authors: Prasan Kumar Panda, Arkapal Bandyopadhyay, Budha Charan Singh, Bikram Moirangthem, Gaurav Chikara, Sarama Saha and Yogesh Arvind Bahurupi

    Citation: Trials 2020 21:866

    Content type: Letter

    Published on:

  9. Music therapy improves neuronal activity and connectivity of healthy persons and patients with clinical symptoms of neurological diseases like Parkinson’s disease, Alzheimer’s disease, and major depression. De...

    Authors: Lanlan Pu, Nauman Khalid Qureshi, Joanne Ly, Bingwei Zhang, Fengyu Cong, William C. Tang and Zhanhua Liang

    Citation: Trials 2020 21:864

    Content type: Study protocol

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  10. Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experie...

    Authors: Susan N. Hastings, Karen M. Stechuchak, Ashley Choate, Elizabeth P. Mahanna, Courtney Van Houtven, Kelli D. Allen, Virginia Wang, Nina Sperber, Leah Zullig, Hayden B. Bosworth and Cynthia J. Coffman

    Citation: Trials 2020 21:863

    Content type: Methodology

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  11. We present a study protocol for a randomized, double-blind, placebo-controlled trial that investigates the hypothesis if intervention in the symptomatic phase preceding clinical arthritis (clinically suspect a...

    Authors: Ellis Niemantsverdriet, Yousra J. Dakkak, Leonie E. Burgers, Femke Bonte-Mineur, Gerda M. Steup-Beekman, Sjoerd M. van der Kooij, Hido D. Boom, Cornelia F. Allaart, Pascal H. P. de Jong and Annette H. M. van der Helm-van Mil

    Citation: Trials 2020 21:862

    Content type: Study protocol

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  12. Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related pro...

    Authors: Marthe E. Ford, Gert J. Geurtsen, Erny Groet, Coen A. M. Van Bennekom and Eus J. W. Van Someren

    Citation: Trials 2020 21:861

    Content type: Study protocol

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  13. Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive ...

    Authors: Simon Provoost, Annet Kleiboer, José Ornelas, Tibor Bosse, Jeroen Ruwaard, Artur Rocha, Pim Cuijpers and Heleen Riper

    Citation: Trials 2020 21:860

    Content type: Study protocol

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  14. Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to interve...

    Authors: Sofia Strömmer, Millie Barrett, Kathryn Woods-Townsend, Janis Baird, David Farrell, Joanne Lord, Leanne Morrison, Sarah Shaw, Christina Vogel, Wendy Lawrence, Donna Lovelock, Lisa Bagust, Judit Varkonyi-Sepp, Patsy Coakley, Lyall Campbell, Ross Anderson…

    Citation: Trials 2020 21:859

    Content type: Study protocol

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  15. The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), l...

    Authors: Claire L. Chan, Melanie Smuk, Ratna Sohanpal, Hilary Pinnock and Stephanie J. C. Taylor

    Citation: Trials 2020 21:858

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2020 21:18

  16. Equine-assisted therapy is more often practiced with children and adolescents than with the elderly, although individuals in the second half of life could also profit from it. This group, from the age of 50, i...

    Authors: Julia Schmidt, Andrea Wartenberg-Demand and Simon Forstmeier

    Citation: Trials 2020 21:857

    Content type: Study protocol

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  17. Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recru...

    Authors: Holly C. Mattock, Rachael Ryan, Christine O’Farrelly, Daphne Babalis and Paul G. Ramchandani

    Citation: Trials 2020 21:856

    Content type: Research

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  18. Due to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivors...

    Authors: Raymond Javan Chan, Jon Emery, Katharine Cuff, Laisa Teleni, Camilla Simonsen, Jane Turner, Monika Janda, Daniel Mckavanagh, Lee Jones, Emma McKinnell, Melissa Gosper, Juanita Ryan, Ria Joseph, Bethany Crowe, Jennifer Harvey, Marissa Ryan…

    Citation: Trials 2020 21:855

    Content type: Study protocol

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  19. A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the ef...

    Authors: Daniela Koppold-Liebscher, Christian S. Kessler, Nico Steckhan, Vanessa Bähr, Cornelia Kempter, Manfred Wischnewsky, Marisa Hübner, Barbara Kunz, Marion Paul, Stefanie Zorn, Sophia Sari, Michael Jeitler, Rainer Stange and Andreas Michalsen

    Citation: Trials 2020 21:854

    Content type: Study protocol

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  20. To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of...

    Authors: Ricardo Palacios, Elizabeth González Patiño, Roberta de Oliveira Piorelli, Monica Tilli Reis Pessoa Conde, Ana Paula Batista, Gang Zeng, Qianqian Xin, Esper G. Kallas, Jorge Flores, Christian F. Ockenhouse and Christopher Gast

    Citation: Trials 2020 21:853

    Content type: Letter

    Published on:

  21. The demand for total hip arthroplasty (THA) is quickly rising given the escalating global incidence of hip osteoarthritis, and it is widely accepted that the post-surgery rehabilitation is key to optimize outc...

    Authors: Chiara Busso, Gabriele Castorina, Marco Di Monaco, Daniel Rodriguez, Hadis Mahdavi, Simone Balocco, Marco Trucco, Marco Conti, Alessandro Castagna and Marco Alessandro Minetto

    Citation: Trials 2020 21:852

    Content type: Study protocol

    Published on:

  22. Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly descr...

    Authors: Krister W. Fjermestad, Wendy K. Silverman and Torun M. Vatne

    Citation: Trials 2020 21:851

    Content type: Study protocol

    Published on:

  23. Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial...

    Authors: Yongcan Wu, Caixia Pei, Xiaomin Wang, Mingjie Wang, Demei Huang, Fei Wang, Wei Xiao and Zhenxing Wang

    Citation: Trials 2020 21:850

    Content type: Study protocol

    Published on:

  24. In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported ou...

    Authors: Lisa M. Wintner, Johannes M. Giesinger, Monika Sztankay, Andrew Bottomley and Bernhard Holzner

    Citation: Trials 2020 21:849

    Content type: Study protocol

    Published on:

  25. Primary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation

    Authors: James H. McMahon, Jillian S. Y. Lau, Janine Roney, Benjamin A. Rogers, Jason Trubiano, Joseph Sasadeusz, James S. Molton, Bradley Gardiner, Sue J. Lee, Jennifer F. Hoy, Allen Cheng and Anton Y. Peleg

    Citation: Trials 2020 21:847

    Content type: Letter

    Published on:

  26. To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation.

    Authors: Alexandre Duvignaud, Edouard Lhomme, Thierry Pistone, Racha Onaisi, Rémi Sitta, Valérie Journot, Duc Nguyen, Nathan Peiffer-Smadja, Antoine Crémer, Stéphane Bouchet, Thomas Darnaud, Delphine Poitrenaud, Lionel Piroth, Christine Binquet, Jean-François Michel, Benjamin Lefèvre…

    Citation: Trials 2020 21:846

    Content type: Letter

    Published on:

  27. Bipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant person...

    Authors: Thomas J. Stamm, Julia C. Zwick, Grace O’Malley, Lene-Marie Sondergeld and Martin Hautzinger

    Citation: Trials 2020 21:845

    Content type: Study protocol

    Published on:

  28. Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic eff...

    Authors: Yajie Ji, Siyu Li, Xinyue Zhang, Yu Liu, Qing Lu, Qiong Li, Weili Chen, Jiayu Sheng, Ke Jiang, Hongli Liang, Shanyan Sha, Mengting Li, Zongxin Chen, Peiyi Zheng, Minhong Wang, Yuanyuan Feng…

    Citation: Trials 2020 21:844

    Content type: Study protocol

    Published on:

  29. Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Tradi...

    Authors: Victoria Ka-Ying Hui, Christy Yim-Fan Wong, Eric Ka-Yiu Ma, Fiona Yan-Yee Ho and Christian S. Chan

    Citation: Trials 2020 21:843

    Content type: Study protocol

    Published on:

  30. Articular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis (OA). “Instant MSC Product accompanying Autologous Chondron Transplantation...

    Authors: J. V. Korpershoek, L. A. Vonk, E. C. Kester, L. B. Creemers, T. S. de Windt, M. M. A. Kip, D. B. F. Saris and R. J. H. Custers

    Citation: Trials 2020 21:842

    Content type: Study protocol

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  31. We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill.

    Authors: Omid Safa, Mehdi Hassaniazad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour and Mohammad Fathalipour

    Citation: Trials 2020 21:841

    Content type: Letter

    Published on:

  32. Current urban vector control strategies have failed to contain dengue epidemics and to prevent the global expansion of Aedes-borne viruses (ABVs: dengue, chikungunya, Zika). Part of the challenge in sustaining ef...

    Authors: Pablo Manrique-Saide, Natalie E. Dean, M. Elizabeth Halloran, Ira M. Longini, Matthew H. Collins, Lance A. Waller, Hector Gomez-Dantes, Audrey Lenhart, Thomas J. Hladish, Azael Che-Mendoza, Oscar D. Kirstein, Yamila Romer, Fabian Correa-Morales, Jorge Palacio-Vargas, Rosa Mendez-Vales, Pilar Granja Pérez…

    Citation: Trials 2020 21:839

    Content type: Study protocol

    Published on:

  33. Stable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is tha...

    Authors: Michael Wester, Franziska Koll, Florian Zeman, Astrid Dempfle, Michael Koller, Norbert Frey, Lars S. Maier and Samuel Sossalla

    Citation: Trials 2020 21:838

    Content type: Study protocol

    Published on:

  34. Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life....

    Authors: Suzanne Hagen, Rohna Kearney, Kirsteen Goodman, Lynn Melone, Andrew Elders, Sarkis Manoukian, Wael Agur, Catherine Best, Suzanne Breeman, Melanie Dembinsky, Lucy Dwyer, Mark Forrest, Margaret Graham, Karen Guerrero, Christine Hemming, Aethele Khunda…

    Citation: Trials 2020 21:837

    Content type: Study protocol

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  35. Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to th...

    Authors: Carol Bugge, Rohna Kearney, Melanie Dembinsky, Aethele Khunda, Margaret Graham, Wael Agur, Suzanne Breeman, Lucy Dwyer, Andrew Elders, Mark Forrest, Kirsteen Goodman, Karen Guerrero, Christine Hemming, Helen Mason, Doreen McClurg, Lynn Melone…

    Citation: Trials 2020 21:836

    Content type: Study protocol

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  36. Natural products may provide a source for the discovery and development of adjunctive pharmacological interventions to modulate the inflammatory pathways contributing to chronic disease. Xanthohumol, a flavono...

    Authors: Ryan Bradley, Blake O. Langley, Jennifer J. Ryan, John Phipps, Douglas A. Hanes, Emily Stack, Janet K. Jansson, Thomas O. Metz and Jan Frederik Stevens

    Citation: Trials 2020 21:835

    Content type: Study protocol

    Published on:

  37. Although effective results of many studies support the use of spinal cord stimulation in chronic pain patients, no randomized controlled trial has been undertaken in China to date. CITRIP is a multicenter, pro...

    Authors: Yang Lu, Peng Mao, Guihuai Wang, Wei Tao, Donglin Xiong, Ke Ma, Rongchun Li, Dan Feng, Wanru Duan, Shun Li, Zhijian Fu, Zhiying Feng, Yi Jin, Li Wan, Yan Lu, Daying Zhang…

    Citation: Trials 2020 21:834

    Content type: Study protocol

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  38. Nail bed trauma is one of the most common surgically treated paediatric hand injuries in the UK. Despite surgeons generally expressing a preference to replace the nail plate after repairing the nail bed, there...

    Authors: Jamie R. Stokes, May Ee Png, Abhilash Jain, Aina V. H. Greig, Beverly A. Shirkey, Melina Dritsaki and Jonathan A. Cook

    Citation: Trials 2020 21:833

    Content type: Update

    Published on:

  39. With high rates of HIV and multiple vulnerable subgroups across diverse settings, there is a need for culturally based, HIV stigma reduction interventions. Pregnant women who are living with HIV are especially...

    Authors: Ohemaa B. Poku, Ari R. Ho-Foster, Patlo Entaile, Supriya Misra, Haitisha Mehta, Shathani Rampa, Melody Goodman, Tonya Arscott-Mills, Evan Eschliman, Valerie Jackson, Tadele Melese, Timothy D. Becker, Marlene Eisenberg, Bruce Link, Vivian Go, Philip Renison Opondo…

    Citation: Trials 2020 21:832

    Content type: Study protocol

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  40. To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear.

    Authors: Janus Christian Jakobsen, Josef Dankiewicz, Theis Lange, Tobias Cronberg, Gisela Lilja, Helena Levin, Jan Bělohlávek, Clifton Callaway, Alain Cariou, David Erlinge, Jan Hovdenes, Michael Joannidis, Per Nordberg, Mauro Oddo, Paolo Pelosi, Hans Kirkegaard…

    Citation: Trials 2020 21:831

    Content type: Update

    Published on:

  41. Glenohumeral osteoarthritis can, in the most severe cases, require surgery with insertion of a shoulder arthroplasty. A design with a stem in the humeral bone canal is currently regarded as the standard treatm...

    Authors: Marc Randall Kristensen Nyring, Bo S. Olsen, Müjgan Yilmaz, Michael M. Petersen, Gunnar Flivik and Jeppe V. Rasmussen

    Citation: Trials 2020 21:830

    Content type: Study protocol

    Published on:

  42. An amendment to this paper has been published and can be accessed via the original article.

    Authors: Charlotte Hanlon, Atalay Alem, Girmay Medhin, Teshome Shibre, Dawit A. Ejigu, Hanna Negussie, Michael Dewey, Lawrence Wissow, Martin Prince, Ezra Susser, Crick Lund and Abebaw Fekadu

    Citation: Trials 2020 21:829

    Content type: Correction

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    The original article was published in Trials 2016 17:76

  43. Primary objectives

    Authors: Maike Janssen, Ulrike Schäkel, Carine Djuka Fokou, Johannes Krisam, Jacek Stermann, Katharina Kriegsmann, Isabella Haberbosch, Jan Philipp Novotny, Stefan Weber, Maria Vehreschild, Martin Bornhäuser, Lars Bullinger, Michael Schmitt, Tobias Liebregts, Peter Dreger, Hanns-Martin Lorenz…

    Citation: Trials 2020 21:828

    Content type: Letter

    Published on:

  44. We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effect...

    Authors: Shin Takayama, Takao Namiki, Takashi Ito, Ryutaro Arita, Hajime Nakae, Seiichi Kobayashi, Tetsuhiro Yoshino, Tomoaki Ishigami, Koichiro Tanaka, Mosaburo Kainuma, Kotaro Nochioka, Airi Takagi, Masaru Mimura, Takuhiro Yamaguchi and Tadashi Ishii

    Citation: Trials 2020 21:827

    Content type: Letter

    Published on:

  45. Multiple myeloma is a plasma cell tumour with approximately 5500 new cases in the UK each year. Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for tho...

    Authors: Samantha Hinsley, Katrina Walker, Debbie Sherratt, Lucy Bailey, Sadie Reed, Louise Flanagan, Sophie McKee, Fiona Brudenell Straw, Bryony Dawkins, David Meads, Holger W. Auner, Martin F. Kaiser, Mark Cook, Sarah Brown and Gordon Cook

    Citation: Trials 2020 21:826

    Content type: Study protocol

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  46. Physician shortage is a major barrier to hypertension (HTN) control in Ghana, with only one physician to 10,000 patients in 2015, thus limiting its capacity for HTN control at the primary care level such as th...

    Authors: Kwaku Poku Asante, Juliet Iwelunmor, Kingsley Apusiga, Joyce Gyamfi, Solomon Nyame, Kezia Gladys Amaning Adjei, Angela Aifah, Kwame Adjei, Deborah Onakomaiya, William F. Chaplin, Gbenga Ogedegbe and Jacob Plange-Rhule

    Citation: Trials 2020 21:825

    Content type: Study protocol

    Published on:

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