Effectiveness of a 6W Multidimensional Model of Care Trajectories-Based Respiratory Rehabilitation Program in Children with Bronchiolitis Obliterans: A Randomized Controlled Trial

This study aims to evaluate the feasibility and preliminary effects of a personalized respiratory rehabilitation program based on the "6W Multidimensional Model" for children with bronchiolitis obliterans (BO). The primary hypothesis is that, compared with usual care, this program can significantly improve intervention adherence among children and their families. The secondary hypotheses are that higher adherence will be accompanied by improvements in pulmonary function, respiratory muscle strength, and exercise tolerance, as well as a reduction in clinical severity, without an increase in adverse reactions.

The dataset contains complete raw data from a controlled trial. The data primarily include: 1) Basic information: anonymized demographic and baseline clinical characteristics of participants; 2) Process and outcome measures: detailed records of session participation data for the intervention group (used to calculate the primary outcome—adherence), as well as raw data from repeated measurements of all participants at three time points—baseline, mid-intervention (4 weeks), and post-intervention (12 weeks)—including pulmonary function, respiratory muscle strength, clinical symptom severity, etc.; and 3) Safety monitoring data: records of all adverse reactions.

Data were collected through clinical assessments, standardized pulmonary function tests, scale-based questionnaires, and research logs. The data files are organized in a "long format" to facilitate repeated measures analysis of variance, testing the "time × group" interaction effect to assess whether the trend of intervention effects over time differs between groups.

The data can be interpreted and used as follows: researchers can first compare adherence between groups to assess feasibility, and then use repeated measures models to analyze secondary outcomes. It is important to note that the correlation between adherence and outcomes cannot be directly equated with causation. This dataset is suitable for validating the implementation effects of complex interventions, exploring determinants of rehabilitation responses, or serving as a resource for methodological comparisons and meta-analyses.

本研究旨在评估基于“6W多维模型”的个性化呼吸康复方案针对闭塞性细支气管炎（bronchiolitis obliterans, BO）患儿的可行性与初步疗效。主要假说为：相较于常规照护，该方案可显著提升患儿及其家庭的干预依从性。次要假说包括：更高的依从性将伴随肺功能、呼吸肌力量与运动耐量的改善，以及临床严重程度的降低，且不会增加不良反应发生率。

本数据集包含一项对照试验的完整原始数据，主要涵盖以下三类内容：
1. 基线信息：受试者的匿名人口学资料与基线临床特征；
2. 过程与结局指标数据：干预组的每一次疗程参与详情记录（用于计算主要结局指标——干预依从性），以及所有受试者在三个时间点（基线、干预中期（4周）、干预结束后（12周））的重复测量原始数据，包括肺功能、呼吸肌力量、临床症状严重程度等；
3. 安全性监测数据：所有不良反应的发生记录。

数据通过临床评估、标准化肺功能检测、量表问卷及研究日志完成采集。数据文件采用长格式（long format）组织，以适配重复测量方差分析，用于检验“时间×组别”交互效应，以评估两组干预效应随时间的变化趋势是否存在差异。

该数据集的解读与使用方式如下：研究者可首先比较组间依从性以评估方案可行性，随后采用重复测量模型分析次要结局。需特别注意：依从性与结局间的相关性不能直接等同于因果关系。本数据集可用于验证复杂干预的实施效果、探索康复应答的决定因素，或作为方法学对比与元分析（meta-analysis）的研究资源。