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Background: Managing the multimorbidity of diabetes and depression remains a clinical challenge for patients and healthcare professionals due to the fragmented healthcare delivery system. To effectively cope with multimorbidity, there is an urgent need for the health system to transform into people-centered integrated care (PCIC) system globally. Therefore, this paper describes the protocol of community-based integrated care for patients with diabetes and depression (CIC-PDD) project, an integrated and shared-care intervention project. Methods/design: CIC-PDD project is conducted in two phases, namely "care model development" and "implementation and evaluation." In the first phase, CIC-PDD model was designed and developed based on the four criteria of collaborative care model (CCM) and was subsequently adjusted to align with the context of China. The second phase entails a pragmatic, two-arm, cluster randomized controlled implementation trial, accompanied by parallel mixed-methods process evaluation and cost-effectiveness analysis. Discussion: We anticipate CIC-PDD project will facilitate the development and innovation of PCIC model and related theories worldwide, particularly in low- and middle-income countries (LMICs). In addition, CIC-PDD project will contribute to the exploration of primary health care (PHC) in addressing the multimorbidity of physical and mental health issues. Trial registration: ClinicalTrials.gov registration ChiCTR2200065608 (China Clinical Trials Registry https://www.chictr.org.cn). Registered on November 9, 2022. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial. Methods/design: This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements. Discussion: The study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method. Trial registration: ClinicalTrials.gov, NCT04939831, retrospectively registered on 25 June 2021. [ABSTRACT FROM AUTHOR]

Background: Surgical site infection (SSI), as one of the most common hospital-acquired infection, is usually associated with increased morbidity, mortality, and health care burden. SSI is a significant perioperative complication after colon cancer surgery, particularly for left-sided colon cancer. This paper describes the background and design of the "Surgical Site Infection after intracorporeal anastomosis for Left-sided Colon Cancer: study protocol for a non-inferiority multicenter Randomized Controlled Trial (STARS)." The STARS trial aims to compare the incidence of SSI after intracorporeal anastomosis and extracorporeal anastomosis after radical resection of colon cancer and to explore the risk factors of SSI.Methods: A total of 354 left colon cancer patients from 8 hospitals in China will be enrolled in this multi-center randomized controlled study. The primary outcome of this study is the incidence of SSI 30 days after left-sided colon cancer surgery. Secondary outcome measures include operation time, blood loss, conversion rate, incidence of perioperative complications, completeness of resection, number of lymph nodes collected and postoperative recovery characteristics, 3-year disease-free survival, and 5-year overall survival. The first patient was enrolled in January 2021.Discussion: To our knowledge, this is the first prospective multicenter study to investigate whether there is a difference in the SSI incidence after intracorporeal and extracorporeal anastomosis for left-sided colon cancer in China. The results may provide more evidence that supports performing total laparoscopic left-sided colon cancer surgery.Trial Registration: The trial has been registered on ClinicalTrials.gov website (ID: NCT04201717). Registered on September 22, 2020. [ABSTRACT FROM AUTHOR]

Background: Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4).Methods: A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression.Discussion: INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke.Trial Registration: ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper. [ABSTRACT FROM AUTHOR]

Background: In China, psychodynamic psychotherapies are widely used as a treatment for depression. However, very few efficacy studies of psychodynamic therapies have been conducted with the Chinese population. This paper describes a study protocol of a multicenter randomized controlled trial of dynamic interpersonal psychotherapy (DIT), a brief manualized depression-focused intervention, in Chinese adults with major depressive disorder (MDD).Methods: Recruitment is planned in five hospitals. Two hundred forty patients with MDD will be randomly allocated on a 1:1:1 basis to either medication plus DIT, medication plus an active control psychotherapy, or medication alone. Patients will be assessed at baseline and at weeks 2, 4, 8, 12, and 16 during the acute treatment phase and 1, 3, 6, and 12 months posttreatment. The primary outcome is change from baseline in the 17-item Hamilton Depression Rating Scale, administered by independent raters who are blind to treatment allocation. The Hamilton Anxiety Rating Scale, Patient Health Questionnaire-9, Generalized Anxiety Disorder 7-item scale, response, remission and relapse rates, self-assessment of overall efficacy and satisfaction of patients, and side effect profiles are secondary measures.Discussion: This will be the first multicentered RCT in China to assess the efficacy of a brief psychodynamic intervention for MDD. The study has the potential to inform clinical treatment guidelines for the treatment of depression in China.Trial Registration: ChiCTR, ChiCTR1800016970 . Registered on July 5, 2018. [ABSTRACT FROM AUTHOR]

Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affects quality of life. Patients with KOA frequently develop one or more of the following typical symptoms: joint pain, stiffness, joint friction noise and impaired functionality. Traditional Chinese medicine (TCM) has been shown to have a superior effect and a particular advantage in the treatment of KOA; among TCM, the Tong-luo Qu-tong plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high-quality clinical evidences to support the therapeutic effect that Chinese adhesive plaster can have in relieving pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-tong plaster in patients with KOA.Methods/design: This study will be a randomized, double-blind, parallel positive controlled, multi-center clinical trial, a non-inferiority trial design was adopted. A total of 2000 participants older than 40 years, with KOA, will be randomly allocated into an experimental group (n = 1500) and a control group (n = 500). All participants will receive a conventional conservative treatment lasting for 14 days as two courses, once daily. Tong-luo Qu-tong plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score and visual analog scale scores will be measured during the assessment visits (baseline and 1-week and 2-week follow up). In addition, adverse events related to clinical symptoms and signs and results of laboratory tests will be documented during the clinical trials.Discussion: This study will provide reliable evidence of the effectiveness and safety of Tong-luo Qutong plaster in patients with KOA. If the results are favorable, it is expected that the patients with KOA will benefit from this study, many patients may have a good alternative treatment for KOA.Trial Registration: ClinicalTrials.gov, ID: NCT03309501 . Registered on 8 November 2017. [ABSTRACT FROM AUTHOR]

The Consolidated Standards of Reporting Trials (CONSORT) Statement was published in 1996, and first introduced to China in 2001. Although CONSORT has been widely accepted in high-quality international journals, we still need to have more investigation on how many Chinese journals have adopted the CONSORT Statement, and whether the quality of reporting has improved. A systematic search of the "Instructions to authors" in all Chinese medical journals in China Academic Journals (CAJ) Full-text Database was conducted up to February 2012 and only 7 journals officially listed the requirements of the CONSORT Statement. The research articles about randomized controlled trials (RCTs) published in 2002, 2004, 2006, 2008, and 2010 from journals which had specifically adopted the CONSORT Statement, and from 30 top journals based on the Chinese Science Citation Index (CSCI) 2011 as the control group, were identified. The quality of both cohorts of articles was assessed using the revised CONSORT Checklist and Jadad scale. A total of 1221 Chinese medical journals was identified. Only seven journals stated clearly in the "Instructions to authors" that authors should adopt the CONSORT requirement in the clinical trial paper. None of these journals is among the control group in the CSCI 2011. In the selected years, a total of 171 articles from 7 journals which had adopted CONSORT and 232 articles in the control were identified as including RCT trials. The average scores according to the revised CONSORT Checklist were 29.47 for the CONSORT-adopting journals and 25.57 for the control group; while the average scores based on the Jadad scale were 2.53 for CONSORT-adopting journals and 1.97 for the control group. Few journals among Chinese medical journals have adopted the CONSORT Statement. The overall quality of RCT reports in the 7 journals which have adopted CONSORT was better than those in the top 30 journals which have not adopteded CONSORT. The quality of RCT reports in Chinese journals needs further improvement, and the CONSORT Statement could be a very helpful guideline. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is associated with decreased quality of life, high re-admission rate and poor prognosis. In particular, ischemic heart failure (IHF) has a worse prognosis than nonischemic HF. The use of traditional Chinese medicine (TCM) alongside Western medicine to treat HF has developed into an integrative treatment model in China. There have been small clinical trials and experimental studies to demonstrate the efficacy of TCM for treating HF; however, there is still a lack of high-quality trials. Qishen Yiqi dripping pills (QSYQ), a TCM drug, have been commonly used alongside standardized Western medicine to treat IHF. This paper describes the protocol for the clinical assessment of QSYQ in IHF patients. Method: A randomized, double-blind, multicenter, placebo-controlled trial will assess the efficacy and safety of QSYQ in the treatment of IHF. The trial is to enroll 640 IHF patients from 32 hospitals in China. Besides their standardized Western medicine, patients will be randomized to receive treatment of either QSYQ or placebo for 6 months and follow-up monitoring for at least a further 6 months. The primary outcome is increased exercise capacity of patients, which will be measured using the 6-minute walking test (6MWT). The secondary outcomes include composite endpoints: all-cause mortality, frequency of hospitalization or emergency due to cardiovascular events, brain natriuretic peptide levels, left ventricular ejection fraction, and cardiothoracic ratio will be documented, as well as scores on the New York Heart Association classification and Minnesota quality of life index, and information obtained from the four TCM diagnostic methods. Blood lipid tests will also be administered. Discussion: The integrative treatment model of TCM alongside Western medicine has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of QSYQ in the treatment of IHF. [ABSTRACT FROM AUTHOR]

Background: Treatment for drug-sensitive tuberculosis (TB) is taken for at least 6 months and problems with adherence are common. Therefore, there is substantial interest in the possible use of eHealth interventions to support patients to take their treatment. Electronic medication monitors have been shown to improve adherence to TB medication, but the impact on clinical outcomes is unknown. We aim to evaluate the impact of a medication monitor-based treatment strategy for drug-sensitive TB patients on a composite poor outcome measured over 18 months from start of TB treatment.Methods/design: We will conduct an open, pragmatic, cluster randomised superiority trial, with 24 counties/districts in three provinces in China, randomised 1:1 to implement the intervention or standard of care. Adults (aged ≥ 18 years) with a new episode of GeneXpert-positive and rifampicin-sensitive pulmonary TB, who plan to be in the study area for the next 18 months, and will receive daily fixed-dose combination tablets for 6 months of treatment are eligible. The intervention is centred around a medication monitor that holds a 1-month supply of medication and has three key functions: as an audio and visual reminder for patients to take their daily medication; reminds patients of upcoming monthly visit; and records date and time whenever the box is opened. At the monthly follow-up visit, the doctor downloads these data to generate a graphical display of the last month's adherence record for discussion with the patient and potentially to switch the patient to more intensive management. The primary outcome is a composite poor outcome measured over 18 months from start of TB treatment, defined as either of poor outcome at the end of treatment (death, treatment failure, or loss to follow-up) or subsequent recurrence (culture positive for TB at 12 or 18 months or re-starting TB treatment in the follow-up period). An economic evaluation will also be conducted as part of this study.Discussion: This trial will assess whether a medication monitor-based treatment strategy can improve clinical outcomes for TB patients. Several trials of other eHealth interventions for TB treatment are ongoing and are summarised in this paper. This trial will provide an important part of the emerging evidence base for the potential of eHealth to improve TB treatment outcomes.Trial Registration: This trial was registered with Current Controlled Trials (identifier: ISRCTN35812455 ). Registered on May 19, 2016. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is associated with decreased quality of life, high re-admission rate and poor prognosis. In particular, ischemic heart failure (IHF) has a worse prognosis than nonischemic HF. The use of traditional Chinese medicine (TCM) alongside Western medicine to treat HF has developed into an integrative treatment model in China. There have been small clinical trials and experimental studies to demonstrate the efficacy of TCM for treating HF; however, there is still a lack of high-quality trials. Qishen Yiqi dripping pills (QSYQ), a TCM drug, have been commonly used alongside standardized Western medicine to treat IHF. This paper describes the protocol for the clinical assessment of QSYQ in IHF patients.Method: A randomized, double-blind, multicenter, placebo-controlled trial will assess the efficacy and safety of QSYQ in the treatment of IHF. The trial is to enroll 640 IHF patients from 32 hospitals in China. Besides their standardized Western medicine, patients will be randomized to receive treatment of either QSYQ or placebo for 6 months and follow-up monitoring for at least a further 6 months. The primary outcome is increased exercise capacity of patients, which will be measured using the 6-minute walking test (6MWT). The secondary outcomes include composite endpoints: all-cause mortality, frequency of hospitalization or emergency due to cardiovascular events, brain natriuretic peptide levels, left ventricular ejection fraction, and cardiothoracic ratio will be documented, as well as scores on the New York Heart Association classification and Minnesota quality of life index, and information obtained from the four TCM diagnostic methods. Blood lipid tests will also be administered.Discussion: The integrative treatment model of TCM alongside Western medicine has developed into a treatment model in China. The rigorous design of the trial will assure an objective and scientific assessment of the efficacy and safety of QSYQ in the treatment of IHF. [ABSTRACT FROM AUTHOR]