UNASSIGNED: To develop a comprehensive framework for selecting outcomes in evaluating the clinical efficacy of Chinese herbal injections and to scientifically select outcomes for the clinical randomized controlled trial (RCT) of Tan-Re-Qing injection intervening AECOPD.
UNASSIGNED: A comprehensive literature review and consensus methods, including focus groups and Delphi surveys, were utilized.
UNASSIGNED: Literature analysis identified 513 publications, encompassing regulatory guidance, guidelines, expert consensus, and RCTs. Initial dimensions include clinical efficacy, safety, and health economics. Primary outcomes should align with study objectives. Recommended evaluation domains include death, treatment outcome, future impact, quality of life, and safety. Commonly recommended outcomes comprise mortality, arterial blood gases, CAT, exacerbation frequency, adverse events, and lung function. Network meta-analysis identified specific therapeutic efficacy markers (white blood cell count, IL-6, IL-8). Quality of life assessment recommended SF-12, EQ-5D, or CAT. Emphasis on AECOPD frequency and lung function was noted. Delphi survey yielded 41 outcomes across various domains for evaluating Tan-Re-Qing in AECOPD.
UNASSIGNED: The findings contribute to developing a robust and reliable trial design for Tan-Re-Qing injection in AECOPD. The methodology employed in this study ensures a systematic and comprehensive approach to the selection of outcomes for the clinical evaluation of future studies in this field.

BACKGROUND: The exclusive breastfeeding rates is low in some countries. Low breastfeeding rates results in higher healthcare expenses and adverse health outcomes for individuals and society. Co-parenting is effective in promoting breastfeeding as it involves shared responsibility and collaboration between parents in raising children. However, the current breastfeeding co-parenting intervention programs exhibits significant variations in components, timing, and duration across studies. An evidence-based breastfeeding co-parenting intervention program is essential for enhancing breastfeeding-related outcomes.
OBJECTIVE: To develop an evidence-based breastfeeding co-parenting intervention program for healthcare providers to guide parents with primiparas on breastfeeding.
METHODS: To form an initial version of the intervention program, a systematic literature review was conducted to consolidate information on current intervention programs. Two rounds of Delphi method were followed to gather expert comments for the program modification to establish the formal version.
RESULTS: Fourteen articles published between 1995 and 2022 were screened. Details of these researches, including starting and ending time, duration and specific contents, were integrated to developed the initial program. Then, six experts completed the two rounds consultation with a positive coefficient of 85.71%, coefficient judgment basis of 0.93, familiarity coefficient of 0.87, authority coefficient of 0.90 and the Kendall\'s W of 0.62. Finally, an evidence-based breastfeeding co-parenting intervention program was constructed in this study, consisting of breastfeeding co-parenting courses, individual counselling and a father\'s support group.
CONCLUSIONS: This research developed a breastfeeding co-parenting intervention program for healthcare providers to guide primiparous parents to improve breastfeeding rates. Through a systematic literature review and Delphi method with good reliability, the program integrates breastfeeding courses, individual counseling, and a father\'s support group. Future research will focus on evaluating its impact and scalability to benefit maternal and infant health globally.
BACKGROUND: ChiCTR.org.cn (ChiCTR2300069648). Registration date: 2023-03-22.

OBJECTIVE: To construct Risk factor assessment table for hyperoxemia in patients after cardiopulmonary bypass heart surgery based on Delphi method, providing a basis for early prediction and assessment of the risk of hyperoxemia in patients after cardiac surgery.
METHODS: A research team was established. Based on the characteristics of extracorporeal circulation cardiac surgery, the Chinese and English literature published by each database until October 2022 was retrieved and the opinions of relevant professional clinicians were combined to screen the risk factors of hyperoxemia in patients after cardiopulmonary bypass heart surgery, and the preliminary draft of the Risk factor assessment table for hyperoxemia in patients after cardiopulmonary bypass heart surgery was drawn up. The Delphi method was used to conduct two rounds of expert letter consultation to supplement and improve the initial draft and finally established the final draft of the Risk factor assessment table for hyperoxemia in patients after cardiopulmonary bypass heart surgery.
RESULTS: The preliminary draft of the Risk factor assessment table for hyperoxemia in patients after cardiopulmonary bypass heart surgery was constructed according to the literature review and the opinions of relevant professional clinicians, which contained 4 dimensions and 21 items. A total of 14 experts were consulted by letter, including 5 senior titles and 9 associate senior titles. Six of them major in critical care and the other eight major in cardiovascular surgery. The effective response rates for the two rounds of questionnaire surveys were 100% and 85.71%, expert familiarity levels were 0.81 and 0.80, judgment coefficients were 0.94 and 0.92, respectively. Expert authority coefficients were both 0.86. Coefficients of variation for the importance and feasibility items in the two rounds ranged from 0.13 to 0.32 and 0.11 to 0.32, 0.06 to 0.26 and 0.06 to 0.35, respectively. The Kendall\'s W for importance and feasibility in the two rounds were 0.264 and 0.162, and 0.258 and 0.144 respectively, indicating statistically significant (all P < 0.05). After two rounds of expert consultations, a comprehensive evaluation and selection process resulted in the final establishment of the Risk factor assessment table for hyperoxemia in patients after cardiopulmonary bypass heart surgery, consisting of 4 dimensions and 23 items, which included general data, past history, operation-related data and postoperative data.
CONCLUSIONS: The Risk factor assessment table for hyperoxemia in patients after cardiopulmonary bypass heart surgery based on the Delphi method is highly scientific and feasible, which can provide reference for clinical assessments of the risk of hyperoxemia in such patients.

OBJECTIVE: Manual therapy is a crucial component in rehabilitation education, yet there is a lack of models for evaluating learning in this area. This study aims to develop a foundational evaluation model for manual therapy learning among rehabilitation students, based on the Delphi method, and to analyze the theoretical basis and practical significance of this model.
METHODS: An initial framework for evaluating the fundamentals of manual therapy learning was constructed through a literature review and theoretical analysis. Using the Delphi method, consultations were conducted with young experts in the field of rehabilitation from January 2024 to March 2024. Fifteen experts completed three rounds of consultation. Each round involved analysis using Dview software, refining and adjusting indicators based on expert opinions, and finally summarizing all retained indicators using Mindmaster.
RESULTS: The effective response rates for the three rounds of questionnaires were 88%, 100%, and 100%, respectively. Expert familiarity scores were 0.91, 0.95, and 0.95; coefficient of judgment were 0.92, 0.93, and 0.93; authority coefficients were 0.92, 0.94, and 0.94, respectively. Based on three rounds of consultation, the model established includes 3 primary indicators, 10 secondary indicators, 17 tertiary indicators, and 9 quaternary indicators. A total of 24 statistical indicators were finalized, with 8 under the Cognitive Abilities category, 10 under the Practical Skills category, and 6 under the Emotional Competence category.
CONCLUSIONS: This study has developed an evaluation model for manual therapy learning among rehabilitation students, based on the Delphi method. The model includes multi-level evaluation indicators covering the key dimensions of Cognitive Abilities, Practical Skills, and Emotional Competence. These indicators provide a preliminary evaluation framework for manual therapy education and a theoretical basis for future research.

UNASSIGNED: This study aimed to develop an efficient tool for assessing children\'s fundamental motor skills, the \"Track style\" Children\'s Fundamental Movement Skills Test (TCFMST), based on theories of motor development integrated with Chinese cultural context and physical education teaching situations.
UNASSIGNED: Starting from a literature analysis, the study selected items from existing fundamental movement skill (FMS) assessments, textbooks, physical education and health standards, and children\'s movement guidelines to construct a pool of test items. Subsequently, the items were screened and optimized using the Delphi method. Finally, the feasibility, discrimination, difficulty, reliability, and validity of the constructed test were examined using testing methods.
UNASSIGNED: The TCFMST includes three dimensions: locomotive skills, body control skills, and manipulative skills, with a total of 10 items. The difficulty and discrimination of each item are appropriate; the correlation coefficients for retest reliability range from 0.789 to 0.943 (p < 0.01). The results of exploratory factor analysis indicate that the common factors align with the hypothesized three dimensions, indicating good structural validity of the test. The concurrent validity results show a correlation coefficient of -0.510 (p < 0.01) between the TCFMST and the total score of TGMD-3, indicating a moderate correlation between the two tests.
UNASSIGNED: The TCFMST developed in this study has good difficulty, discrimination, reliability, and validity. It also features strong operability, a short duration, and high interest. It can serve as an important tool for monitoring children\'s fundamental motor skill levels.

UNASSIGNED: Although there are well-defined guidelines for the management of mild-to-moderate ulcerative colitis (UC), there are still unmet needs. For this reason, we conducted an international expert consensus to standardize the management of patients with mild-to-moderate UC and provide practical guidance to clinicians.
UNASSIGNED: Based on Delphi methodology, 15 statements were approved after two rounds of voting, addressing several aspects of disease management from sequencing to treatment duration, from monitoring to optimization techniques and safety profile.
UNASSIGNED: Growing knowledge of mild-to-moderate UC has led to the development of new ambitious outcomes such as histological remission and disease clearance. Furthermore, noninvasive tools for patient monitoring such as fecal calprotectin and intestinal ultrasound are now available. Their implementation in clinical practice will allow clinicians to tightly monitor disease activity and promptly adapt treatment, avoiding complications and disease progression and targeting better disease control.

Lifestyle is an important factor affecting people\'s health. Evaluating and promoting healthy lifestyles among occupational population can not only improve work ability and efficiency, but also contribute to the prevention a variety of potential diseases. This study developed a preliminary index system based on literature review and group discussion. Two rounds of expert consultation were conducted on 12 experts using Delphi method. The questionnaire recovery rate of the two rounds of Delphi survey was over 85%, the expert authority coefficient was over 0.70, and Kendall W was 0.450 and 0.446, which were significant (P < 0.001). The weighting coefficient of each indicator was calculated using the hierarchical analysis method. Among them, the weighting coefficients of physical health lifestyle, mental health lifestyle, social adaptation lifestyle and occupational health lifestyle were 0.4133, 0.2922, 0.1078 and 0.1867, respectively. The consistency index CI = 0.024 and the consistency ratio CR = 0.027 of the first-level index judgment matrix. The weighting coefficient is acceptable and the indicators do not cause logical confusion. The healthy lifestyle assessment tool of the occupational population constructed in this study consists of 4 primary indicators, 13 secondary indicators and 45 tertiary indicators, which can provide a standardized and operable assessment tool for monitoring and evaluating the healthy lifestyle of the Chinese occupational population. At the same time, the weight analysis of various indicators through the analytic hierarchy process can also provide reference for the key areas of occupational health intervention.

Background: Clinical nutritionists are responsible for nutritional therapy in clinical practice, which significantly enhances patients\' nutritional status. This study aims to develop and validate a competency evaluation scale to effectively assess the abilities of clinical nutritionists. Methods: The competency evaluation scale for clinical nutritionists was developed based on the iceberg model, utilizing literature review, semi-structured interviews, and the Delphi method. The weights of each indicator were calculated using the Analytic Hierarchy Process (AHP), and the validity and reliability of the scale were confirmed through questionnaire surveys. Results: The competency evaluation scale of clinical nutritionists comprised five primary indicators, twelve secondary indicators, and sixty-six tertiary indicators. The primary indicators, including professional theoretical knowledge, professional practical skills, humanistic practice ability, interpersonal communication ability, and professional development capability, have respective weights of 0.2168, 0.2120, 0.2042, 0.2022, and 0.1649. The Cronbach\'s α coefficients of the five dimensions of the scale were 0.970, 0.978, 0.969, 0.962, and 0.947, respectively. The results of the Exploratory Factor Analysis showed that the prerequisites for factor analysis were satisfied. Additionally, Bartlett\'s test of sphericity yielded a significance level of p < 0.001, confirming the scale\'s reliability and validity. Conclusions: The competency evaluation scale for clinical nutritionists developed in this study is of high scientific reliability and validity, which provides assessment criteria for the training and assessment of clinical nutritionists.

BACKGROUND: Teachers are recognized as \'key agents\' for the delivery of physical activity programs and policies in schools. The aim of our study was to develop and evaluate a tool to assess teachers\' capability, opportunity, and motivation to deliver school-based physical activity interventions.
METHODS: The development and evaluation of the Capability, Opportunity, and Motivation to deliver Physical Activity in School Scale (COM-PASS) involved three phases. In Phase 1, we invited academic experts to participate in a Delphi study to rate, provide recommendations, and achieve consensus on questionnaire items that were based on the Capability, Opportunity, and Motivation Behavior (COM-B) model. Each item was ranked on the degree to which it matched the content of the COM-B model, using a 5-point scale ranging from \'1 = Poor match\' to \'5 = Excellent match\'. In Phase 2, we interviewed primary and secondary school teachers using a \'think-aloud\' approach to assess their understanding of the items. In Phase 3, teachers (n = 196) completed the COM-PASS to assess structural validity using confirmatory factor analysis (CFA).
RESULTS: Thirty-eight academic experts from 14 countries completed three rounds of the Delphi study. In the first round, items had an average rating score of 4.04, in the second round 4.51, and in the third (final) round 4.78. The final tool included 14 items, which related to the six constructs of the COM-B model: physical capability, psychological capability, physical opportunity, social opportunity, reflective motivation, and automatic motivation. In Phase 2, ten teachers shared their interpretation of COM-PASS via a 20-min interview, which resulted in minor changes. In Phase 3, CFA of the 3-factor model (i.e., capability, opportunity, and motivation) revealed an adequate fit to the data (χ2 = 122.6, p < .001, CFI = .945, TLI = .924, RMSEA = .066). The internal consistencies of the three subscale scores were acceptable (i.e., capability: α = .75, opportunity: α = .75, motivation: α = .81).
CONCLUSIONS: COM-PASS is a valid and reliable tool for assessing teachers\' capability, opportunity, and motivation to deliver physical activity interventions in schools. Further studies examining additional psychometric properties of the COM-PASS are warranted.

BACKGROUND: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs.
METHODS: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS.
BACKGROUND: https://www.comet-initiative.org/Studies/Details/1580.
RESULTS: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life.
CONCLUSIONS: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.
UNASSIGNED: CRD42020197293.