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With the acceleration of innovative drugs launched in the market, clinical trials have become increasingly complex and costly. Integration of patients' perspective and engagement into the clinical research process is essential to the success of the trials, which leads to the emergence of the concept of patient-centric clinical trials. Compared to the conventional paradigm of clinical trials, patient-centric clinical trials have the potential to increase the feasibility of study protocol, to speed recruitment and execution, and to promote the success of trials. It calls for the institutions and investigators of clinical trials to be aware of and adapt to patient-centric initiatives. In this article, we highlight technologies and actions that can be used to enhance patients' engagement in the entire process of drug development, covering protocol development, trial conduction, and result publication.

Objective: To better understand the clinical characteristics and predisposing factors in non-pregnant patients with Listeria monocytogenes (Listeria) sepsis., Methods: Clinical data were collected at Peking Union Medical College Hospital between January 2002 and December 2014. A case with non-pregnant Listeria sepsis is defined as a non-pregnant person with clinically compatible illness and from whom Listeria was isolated from his/her blood culture. We define an underlying condition if a patient has been diagnosed of and/or has been treated for a concurrent baseline disease within 1 month prior to the onset of Listeria sepsis., Results: A total of 35 patients were enrolled. The age of all patients was (49.1 ± 17.0) years. The male to female ratio was 2: 3. Most patients were combined with at least 1 underlying condition (33, 94.3%), including 42.9% patients with an autoimmune disease, 34.3% with malignancies. The majority (91.4%) represented an acute onset (<1 week) with median time of 3 days. Clinical manifestations included fever (34/35, 97.1%), central nervous system (CNS) symptoms (17/35, 48.6%), gastrointestinal tract symptoms (13/35, 37.1%). Fourteen patients had undergone lumber puncture and cerebral spinal fluid (CSF) tests, which revealed abnormalities comparable of Listeria meningitis. Listeria was isolated from CSF in 11 of 14 patients (78.6%). There were 34 patients receiving empiric antibiotics including 54.3% cephalosporins which are resistant to Listeria. Twenty five (71.4%) patients were switched to the target antimicrobials according to positive blood culture. Of the 35 patients with Listeria sepsis, 21 (60.0%) recovered or were cured, however the rest (40.0%) had dismal outcome. Six patients died in hospital, 8 critical patients were discharged and died after transferring to local hospitals., Conclusions: Listeria sepsis is commonly associated with non-pregnant patients with compromised immune function. Clinical presentations include acute fever, CNS symptoms and gastrointestinal symptoms etc. Empiric antibiotics covering Listeria should be considered when sepsis is suspected among susceptible hosts.

Objective: To summarize the clinical characteristics and outcome of maternal listeriosis so as to improve the understanding of disease and the level of diagnosis and treatment., Methods: Retrospectively, 16 cases of maternal listeriosis, who were treated at Peking Union Medical College Hospital between March 2007 and December 2014 were reviewed. Maternal listeriosis is defined when a pregnant woman presents with symptoms as listeriosis, meanwhile Listeria monocytogenes is isolated from sterile tissue or peripheral blood, or from a non-sterile site (uterus swab) or pathological evidence of chorioamnionitis. The neonatal listeriosis is diagnosed as acute listeria sepsis., Results: The mean age of these 16 patients was (30.0 ± 3.9) years old. There were 1, 8, 7 patients with listeriosis diagnosed in the first, second and third trimester of pregnancy, respectively. All had an acute onset of illness (≤ 2 weeks), the median time from onset to presentation was 2.5 days. Clinical manifestations included fever (93.8%, 15/16), leukocytosis (78.6%, 11/14), chorioamnionitis (77.8%, 7/9), gastrointestinal symptoms (37.5%, 6/16) and fetal movement decrease (31.3%, 5/16). Listeria monocytogenes were isolated from blood (6 cases), uterus swab (6 cases), blood plus uterus swab (1 case), and neonates (3 cases). All maternal cases recovered well after the termination of pregnancy, even none of them had received empiric antibiotics sensitive to listeria. A very high proportion of adverse pregnancy outcomes occurred (15/16, 93.8%). There were 8 fetal losses. Seven neonates were complicated with listeria sepsis and treated successfully., Conclusions: The patients with maternal listeriosis commonly presented with acute fever and an extremely high incidence of adverse pregnancy outcomes, however empiric antibiotics can hardly cover this pathogenic bacterium. So both pregnant women and clinicians should maintain a high level of vigilance against listeriosis and pay more attention to dietetic hygiene.

Objective: To evaluate the clinical diagnostic contribution of (18)F-FDG PET/CT in giant cell arteritis with initial presentation as fever of unknown origin (FUO) ., Methods: Eight cases with initial presentation as FUO diagnosed with the contribution of PET/CT were retrospectively studied in Peking Union Medical College Hospital. The radiologic manifestations of PET/CT were analyzed., Results: Eight patients (4 men and 4 women) with average (63 ± 7) years (range from 55-75 years) were included in our study based on the criteria.Non-specific clinical symptoms were common in these patients, including fatigue, night sweat and weight loss. They all suffered from anemia of chronic disease.Not surprisingly, the inflammatory parameters were elevated significantly in all patients. The medical history, physical examination and routine lab and radiologic examinations couldn't reveal the causes of fever. PET/CT was performed in all of them, which demonstrated intense (18)F-FDG uptake in the area of aorta and its major branches with maximal standard uptake value (SUVmax) 2.1- 4.6 (3.6 ± 0.9).Immunosuppressive agents were effective to control the inflammation activity. The SUV decreased significantly after treatment in the follow-up PET/CT., Conclusions: PET/CT has demonstrated high yield of diagnostic contribution in giant cell arteritis with initial presentation as fever of unknown origin. As to elderly FUO patients presenting with prominent inflammatory reaction, PET/CT may provide potential value to differentiate diagnosis from maligancies.

Objective: To determine the clinical characteristics of HIV infected patients in China in order to improve early recognition and diagnosis of AIDS., Methods: A total of 297 newly diagnosed HIV/AIDS patients were enrolled in Peking Union Medical College Hospital (PUMCH) from January 2001 to December 2012, including 19 patients of primary phase, 115 of asymptomatic phase and 163 of AIDS phase. Clinical characteristics of these patients were retrospectively analyzed., Results: Two hundred and nineteen out of 297 patients reported clinical symptoms with variety. The main systemic symptoms included fever (100 cases, 33.7%), weight loss (50 cases, 16.8%) and fatigue (38 cases, 12.8%). Organ involvement included mucocutaneous (67 cases, 22.6%), respiratory (62 cases, 20.9%), gastrointestinal (40 cases, 13.5%) systems. Patients in AIDS phase were more symptomatic. Seventy-three out of 173 (42.2%)patients have been referred by 2 healthcare providers at least before the diagnosis of HIV infection was confirmed. Initial diagnoses were made in Departments of Infectious Diseases (36.9%), Gastroenterology (16.4%), and Emergency (13.7%). Opportunistic infections accounted for most AIDS defining conditions (ADC), including pneumocystis jiroveci pneumonia (PCP) (36 cases, 22.1%), cytomegalovirus infection (25 cases, 15.3%) and tuberculosis (22 cases, 13.5%). Median peripheral CD(+)4 T lymphocyte count in patients with ADC were 36 cells/µl., Conclusions: Common clinical presentations of HIV/AIDS included fever, weight loss, diarrhea, short of breath and mucocutaneous lesions. Opportunistic infections mainly affected respiratory and gastrointestinal system, with PCP the most common one. The diagnosis of HIV infection was delayed in most cases, suggesting that more efforts are required especially in universal education of clinicians and accurate viral detection.

Objective: To improve the diagnosis and treatment of Q fever endocarditis., Methods: From 2008 to 2013, four cases of Q fever endocarditis were diagnosed in Peking Union Medical College Hospital. Clinical features, laboratory test, management and prognosis were analyzed with literature review., Result: All four cases had long period of fever and heart murmur. Two patients represented with respiratory symptom and one with non-specific rash. General laboratory tests including complete blood cell count, ESR, C-reactive protein(CRP), liver function and radiology of lung did not show specific abnormalities. Signs of endocarditis were shown by ultrasound and important for diagnosis. Repeated blood culture was negative. All of the diagnoses were confirmed by serum antibody detection and the patients recovered well with treatment based on doxycycline or minocycline., Conclusions: Endocarditis is the most common form of chronic Q fever, which is easily misdiagnosed because its blood culture is negative and may accompanied with varied manifestation such as pneumonia and liver injury. For the patients with chronic fever and blood culture negative endocarditis, chronic Q fever should be considered as differential diagnosis. The confirmatory method for diagnosis is serum antibody detection. Early and sufficient treatment may improve the prognosis.