Background: More than one-fifth of the world’s population consumes Chinese cuisines regularly, but no evidence-based healthy diets fitting the Chinese food culture are available for implementation. Methods: A multicenter, patient- and outcome assessor–blind, randomized feeding trial was conducted among 265 participants with 130 to 159 mm Hg baseline systolic blood pressure (SBP) for 4 major Chinese cuisines (Shangdong, Huaiyang, Cantonese, Szechuan). After a 7-day run-in period on a control diet matching the usual local diets, participants were randomized to continue with the control diet or the cuisine-based Chinese heart-healthy diet for another 28 days. The primary outcome was SBP, and secondary outcomes included diastolic blood pressure and food preference score. Linear regression models were used to estimate the intervention effects and adjustments for the center. The incremental cost per 1 mm Hg reduction in SBP was also calculated. Results: A total of 265 participants were randomized (135 on the Chinese heart-healthy diet and 130 on the control diet), with 52% women, mean age of 56.5±9.8 years, and mean SBP and diastolic blood pressure of 139.4±8.3 and 88.1±8.0 mm Hg, respectively, at baseline. The change in SBP and diastolic blood pressure from baseline to the end of the study in the control group was –5.0 (95% CI, –6.5 to –3.5) mm Hg and –2.8 (95% CI, –3.7 to –1.9) mm Hg, respectively. The net difference of change between the 2 groups in SBP and diastolic blood pressure were –10.0 (95% CI, –12.1 to –7.9) mm Hg and –3.8 (95% CI, –5.0 to –2.5) mm Hg, respectively. The effect size did not differ among cuisines ( P for interaction=0.173). The mean food preference score was 9.5 (with 10 the best preferred) at baseline, and the net change during intervention was 0.1 (95% CI, –0.1 to 0.2; P =0.558). The incremental cost-effectiveness ratio per 1 mm Hg SBP reduction was CNY 0.4 (USD 0.06) per day. No difference in the number of adverse events was found between the 2 groups ( P =0.259), and none of the adverse events was associated with the intervention. Conclusions: The Chinese heart-healthy diet is effective, palatable, and cost-effective in reducing blood pressure in Chinese adults with high blood pressure, with a clinically significant effect applicable across major Chinese cuisine cultures. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03882645.

Introduction: This study aims to establish normal reference values of peak oxygen uptake (VO_2peak) for cardiorespiratory fitness (CRF) in Chinese adults using cardiorespiratory exercise testing (CPET). Methods: A cross-sectional study was done in four communities, two in the North (Beijing) and two in the South (Hezhou, Guangxi) of China from 1 January 2017 to 31 December 2018, with one urban and one rural in each region. Out of 1642 participants screened, 1114 were eligible and completed CPET using a cycle ergometer (Ergosana320F) without abnormal ECG and were included in the analysis. The 2nd and 98th percentiles of $\stackrel{·}{\mathrm{V}}$O_2peak were used as the lower and upper limits of the normal reference values. Results: Significant difference in mean $\stackrel{·}{\mathrm{V}}$O_2peak was shown between men (27.0 mL·min⁻¹·kg⁻¹) and women (23.7 mL·min⁻¹·kg⁻¹). The mean $\stackrel{·}{\mathrm{V}}$O_2peak decreased with age in both sexes, from 35.8 mL·min⁻¹·kg⁻¹ in age 20–29 years to 20.5 mL·min⁻¹·kg⁻¹ in 70–79 years in men and from 29.2 mL·min⁻¹·kg⁻¹ to 17.0 mL·min⁻¹·kg⁻¹ in women. Thus, the age- and sex-specific normal reference values of $\stackrel{·}{\mathrm{V}}$O_2peak were presented for each 10-year age group by men and women separately. Conclusions: This first community-based study in China provides age- and sex-specific normal references of $\stackrel{·}{\mathrm{V}}$O_2peak as a measure of CRF in Chinese adults, which differed significantly from those established in Western populations. Future studies with national representative samples should be warranted.

Postoperative pulmonary complications (PPCs) are major causes of morbidity, mortality, and prolonged hospital stay in patients after surgery. Using effective strategies to prevent its occurrence is essential to improve outcome. However, despite various efforts, the incidence of PPCs remains elevated in high-risk patients. Anticholinergic inhalation is used to reduce high airway resistance and improve pulmonary function; it may be helpful to decrease the risk of PPCs. Penehyclidine is a long-acting anticholinergic agent which selectively blocks M1 and M3 receptors. We hypothesize that, in high-risk patients, prophylactic penehyclidine inhalation may decrease the incidence of PPCs. This is a randomized, double-blind, placebo-controlled trial with two parallel arms. A total of 864 patients at high risk of PPCs will be enrolled and randomized to receive prophylactic inhalation of either penehyclidine or placebo (water for injection). Study drug inhalation will be administered from the night (7 pm) before surgery until the second day after surgery, in an interval of every 12 hours. The primary outcome is the incidence of PPCs within 30 days after surgery. Secondary outcomes include the time to onset of PPCs (from end of surgery to first diagnosis of PPCs), the number of PPCs (indicates the number of diagnosed individual PPCs), the incidence of postoperative extrapulmonary complications, the length of stay in hospital after surgery, and the 30-day all-cause mortality. Results of the present study will provide evidence to guide clinical practice in using prophylactic inhalation of an anticholinergic to prevent PPCs in high-risk patients. The study was registered prospectively in Chinese Clinical Trial Registry ( www.chictr.org.cn , ChiCTR-IPC-15006603 ) on 14 May 2015 and retrospectively in ClinicalTrials.gov ( NCT02644876 ) on 30 December 2015.

BackgroundThe Measures for Management of Investigator-Initiated Studies (IISs) Conducted by Healthcare Institutions (trial version) (referred to as Management Measures) has been piloted successively in 12 provincial regions across China since 1 October 2021 and took effect nationwide on 1 October 2024. This study aimed to examine the perspectives, attitudes and challenges of administrators and investigators within healthcare institutions in Beijing regarding IIS management to provide further strategic guidance in China.MethodsThis descriptive qualitative study included 13 focus group discussions among 74 participants from 25 healthcare institutions stratified selected in Beijing, including 13 executive-level administrators, 41 functional administrators and 20 investigator representatives. The focus groups were conducted from November to December 2021. The discussion topics focussed on current status of IIS management in healthcare institutions and the participants' attitudes and challenges in implementation of the Management Measures, mainly on the specific management system establishment, independent scientific review, management by study type and whole-process supervision.ResultsOpinions varied among institution presidents/directors regarding the establishment of clinical research management committees and offices, with significant challenges identified in insufficient human resources and difficulties in integrating with existing management models. While scientific review was seen as essential, there was disagreement on how to implement it. Interviewees raised concerns about redundancy for grant-supported projects, unclear distinctions between scientific and ethical reviews, efficiency delays, reviewer qualifications and intellectual property risks. Although management by study type might help control risks, the qualification restrictions on the leading sites and investigators were viewed as excessively stringent. No institution has achieved whole-process supervision of all IISs, primarily due to insufficient human resources, ineffective supervision and management systems, and insufficiently trained professionals.ConclusionsThis study reveals that the current management of IISs is generally weak in Beijing and should be strengthened by implementing Management Measures. However, major challenges existed for the implementation, mainly including: a lack of clear and feasible management models to follow, insufficient human resources for both scientific review and whole-process supervision, and worries about restricting research initiatives. It takes time to overcome these challenges, which may be achieved through building management capacity at national, regional and institutional levels, learning successful management models that were piloted in various regions and further policy research to develop specific guidance.