To improve the consistency of outcome documentation and address the potential for outcome reporting bias in clinical trials involving integrative Chinese and Western medicine (ICWM) for ulcerative colitis (UC), we aim to develop a customized core outcome set (COS) that incorporates input from various stakeholders. The study design of this COS has been informed by the Core Outcome Measures in Effectiveness Trials Initiative Handbook, with adherence to the guidelines from the Core Outcome Set-STAndards for Reporting statement and Core Outcome Set-STAndardised Protocol Items recommendations. Five groups of stakeholders will be invited to participate in the development of COS for clinical trials with ICWM for UC, including healthcare professionals, patients, COS developers, COS users, and methodologists. The process will involve five stages: (1) conducting a systematic review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains; (2) conducting semi-structured interviews to obtain important outcomes; (3) choosing the most important outcomes by conducting three-round Delphi surveys; (4) achieving a consensus in a face-to-face meeting to discuss the final COS; and (5) publication, dissemination and implementation of COS. Consequently, this specialized COS will be applicable to clinical trials involving both traditional Chinese medicine (TCM) and ICWM interventions. Please cite this article as: Zhang X, Zhang L, Wang J, Lau CT, Wang N, Zhang X, Wang P, Li J, Han F, Bian Z. A protocol for developing, disseminating and implementing a core outcome set for clinical trials of integrative Chinese and Western medicine for ulcerative colitis. J Integr Med. 2025; 23(6):654-659.
Colitis, Ulcerative/therapy* ; Humans ; Medicine, Chinese Traditional ; Clinical Trials as Topic ; Integrative Medicine ; Research Design ; Outcome Assessment, Health Care ; Delphi Technique

Background: In 2008, the Department of Health (DOH) issued Administrative Order 2008-0023 that called for an “effective and efficient monitoring system that will link all patient safety initiatives”. However, there are still no explicit and harmonized targets to measure effectiveness and to provide benchmarks that assess whether previous efforts were helpful. Objective: The study aimed to describe the status of patient safety performance measures and indicators on the international patient safety goals (IPSGs) in select hospitals in the Philippines. Methods: Descriptive, cross-sectional design was used to investigate currently used performance measures and indicators. Data collection included administration of a Hospital Patient Safety Indicators Questionnaire (HPSIQ) that summarized the currently used patient safety measures and indicators in the sampled Level 2 and level 3 hospitals and triangulation by review of documents such as hospital databases, protocols on reporting, and manuals for information gathering regarding patient safety. Performance measures were categorized using the Donabedian framework. Core indicators were identified through review of standards that cut across the six IPSGs and evaluation of overarching processes and concepts in patient safety. Results: Forty-one level 2 and 3 hospitals participated in the study. Most performance indicators were process measures (52%), while structure (31%) and outcome measures (17%) accounted for the rest. There is an obvious lack of structural requirements for patient safety in the hospitals included in this study. Less than half the hospitals surveyed implement risk assessment and management consistently. Reporting of events, near- misses, and patient safety data are widely varied among hospitals. Data utilization for quality improvement is not fully established in many of the hospitals. Patient engagement is not integrated in service delivery and performance measurement but is crucial in promoting patient safety. Conclusion Mechanisms to improve hospitals’ capacity to monitor, anticipate, and reduce risk of patient harm during the provision of healthcare should be provided. Having a unified set of definitions and protocols for measurement will facilitate reliable monitoring and improvement. Leadership and governance, both internal (e.g., hospital administrators) and external (e.g., DOH) that recognize a data-driven approach to policymaking and improvement of service delivery are crucial in promoting patient safety
Patient Safety ; Outcome and Process Assessment, Health Care

BACKGROUND: Many previous studies have reported COVID-19 vaccine effectiveness, but there are few studies in Japan. This community-based, retrospective observational study investigated the association between vaccination status and COVID-19-related health outcomes in COVID-19 patients by SARS-CoV-2 variant type. METHODS: The study participants were 24,314 COVID-19 patients aged 12 or older whose diagnoses were reported to the Nara Prefecture Chuwa Public Health Center from April 2021 to March 2022, during periods when the alpha, delta, and omicron variants of COVID-19 were predominant. The outcome variables were severe health consequences (SHC) (i.e., ICU admission and COVID-19-related death), hospitalization, and extension of recovery period. The explanatory variable was vaccination status at least 14 days prior to infection. Covariates included gender, age, population size, the number of risk factors for aggravation, and the number of symptoms at diagnosis. The generalized estimating equations of the multivariable Poisson regression models were used to estimate the adjusted incidence proportion (AIP) and 95% confidence interval (CI) for each health outcome. We performed stratified analyses by SARS-CoV-2 variant type, but the association between vaccination status and COVID-19-related health outcomes was stratified only for the delta and omicron variants due to the small number of vaccinated patients during the alpha variant. RESULTS: Of the 24,314 participants, 255 (1.0%) had SHC; of the 24,059 participants without SHC, 2,102 (8.7%) were hospitalized; and of the 19,603 participants without SHC, hospitalization, and missing data on recovery period, 2,960 (15.1%) had extension of recovery period. Multivariable Poisson regression models showed that regardless of SARS-CoV-2 variant type or health outcome, those who received two or more vaccine doses had significantly lower risk of health outcomes than those who did not receive the vaccine, and there was a dose-response relationship in which the AIP for health outcomes decreased with an increased number of vaccinations. CONCLUSION A higher number of vaccinations were associated with lower risk of COVID-19-related health outcomes, not only in the delta variant but also in the omicron variant. Our findings suggest that increasing the number of COVID-19 vaccine doses can prevent severe disease and lead to early recovery of patients not requiring hospitalization.
Humans ; COVID-19/prevention & control* ; SARS-CoV-2 ; COVID-19 Vaccines ; Japan/epidemiology* ; Independent Living ; Outcome Assessment, Health Care

There are inconsistencies in treatment outcomes, measurement instruments, and criteria for assessing clinical effectiveness in studies related to distal radius fractures (DRF), resulting in potential biases and failing to provide high-quality clinical evidence. To address these challenges, international researchers have reached a consensus on developing the core outcome indicator set for distal radius fractures(COS-DRF). However, it's important to note that the existing COS-DRF framework could not reflect the unique characteristics of Traditional Chinese Medicine (TCM) treatment. Currently, there are no established standards for treatment outcomes and measurement instruments specific to TCM clinical research, nor has a COS-DRF been established for TCM clinical studies in China. In light of these gaps, our research team aims to construct a core set of treatment outcomes for TCM clinical research on distal radius fractures. This involves compiling a comprehensive list of treatment outcomes and measurement instruments, initially derived from a thorough literature review and expert consensus, which will then undergo further refinement and updates based on real-world clinical experiences, incorporating feedback from 2 to 3 rounds of expert consensus or Delphi questionnaire surveys. Our goal is to establish a COS-DRF or CMS-DRF that aligns with the principles and practices of TCM, and provide high-quality evidence for clinical practice.
Humans ; China ; Consensus ; East Asian People ; Outcome Assessment, Health Care ; Wrist Fractures/therapy* ; Medicine, Chinese Traditional ; Review Literature as Topic ; Fracture Fixation/standards*

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.
Drugs, Chinese Herbal/therapeutic use* ; Medicine, Chinese Traditional/methods* ; Outcome Assessment, Health Care ; Reference Standards ; Reproducibility of Results ; Research Design ; Clinical Trials as Topic

Pancreatic surgery is the most complex type of abdominal surgery,with high technical requirements and long learning curve,and the quality of surgery is directly related to the prognosis of the patients. In recent years,more and more indicators have been used to evaluate the quality of pancreatic surgery,such as operation time,intraoperative blood loss,morbidity,mortality, prognosis and so on,and different evaluation systems have been established,including benchmarking,auditing,outcome evaluation based on risk factor adjustment and textbook outcomes. Among them,the benchmark is the most widely used to evaluate surgical quality and is expected to become the standard for comparison among peers. This article reviews existing quality evaluation indicators and benchmarks for pancreatic surgery and anticipates its future application prospects.
Humans ; Benchmarking ; Digestive System Surgical Procedures ; Outcome Assessment, Health Care ; Blood Loss, Surgical ; Risk Factors

Humans ; COVID-19/epidemiology* ; Pandemics ; Outcome Assessment, Health Care ; Health Personnel

This study aims to construct the core outcome set for the clinical trials of adhesive capsulitis treated with acupuncture and moxibustion. Using systematic review, semi-structured interview, Delphi questionnaire survey, analytic hierarchy process and expert consensus meeting, the primary outcomes are obtained, i.e. local tenderness, pain degree during movement, range of motion, changes in range of motion, function score, and score of local symptoms of shoulder joint. The secondary outcomes are myofascial thickness, thickness of the inferior wall of the joint capsule, health status, activity of daily living, incidence of adverse events, laboratory indexes, vital signs, cost-effectiveness, total effective rate, and patient satisfaction. It is expected to provide a reference for the outcome selection in clinical trials and the generation of medical evidences in the treatment of adhesive capsulitis with acupuncture and moxibustion.
Humans ; Acupuncture Therapy ; Bursitis/therapy* ; Consensus ; Moxibustion ; Outcome Assessment, Health Care

Humans ; Antineoplastic Agents/therapeutic use* ; Neoplasms/drug therapy* ; Outcome Assessment, Health Care ; China

Background: Tiered services, differentiated by the financial capacity of patients and related payment arrangements with hospitals, are the norm in Philippine facilities. This study considered how these, together with selected demographic and clinical factors, were associated with surgical care utilization, provision, and outcomes for patients with appendicitis in a public university hospital.

Methods: This was a retrospective cohort study, utilizing data obtained from an electronic patient registry. Patients who underwent emergent appendectomies from January 2017 to December 2018 were included. Data were analyzed using multivariate and logistic regression, with the following dependent variables: time from symptom onset to emergency department consultation (ED Lag), time from consult to surgery (OR Lag), selection for laparoscopic appendectomy (LA), the occurrence of complicated appendicitis (CA), and length of stay (LOS). Morbidities and mortalities were tallied.

Results: There were 1,501 patients included in the study. Young adult males comprised the majority and mostly had non-private accommodations. Non-CA was the impression in more than 80% of cases. Extremes of age were associated with longer ED and OR Lags, greater likelihood of CA, and longer LOS. Patients initially assessed as having CA had shorter OR Lags, were less likely to undergo LA, and had longer LOS. Private patients were more likely to have undergone LA, lower CA odds, and slightly longer LOS.

Conclusions: Variations in surgical care utilization, provision, and outcomes for patients with appendicitis were independently associated with socioeconomic and clinical status differences.