Development and Validation of an Evidence-based Home Pursed Lip Breathing Protocol for Improving Health Outcomes in Patients with COPD

Aim To develop and validate an evidence-based home PLB intervention protocol for improving related health outcomes (e.g. dyspnea, exercise capability, etc.) in COPD patients and to present a detailed intervention development process. Methods Phase one of the Medical Research Council Framework for Developing and Evaluating Complex Interventions was employed to guide the development process of the PLB intervention. The appropriateness of the PLB protocol was finally determined by a panel of experts using the content validity index. Results The preliminary PLB intervention protocol was developed based on several underlying rationales, which encompass the extension of expiration time, enhancement of respiratory muscle strength, augmentation of tidal volume, and integration of the most reliable research evidence obtained from four systematic reviews, six RCTs, five clinical trials, and ten recommendations. The PLB intervention was structured with a designated time ratio of inspiration to expiration, set at 1:2. Additionally, the training parameters of the PLB intervention were established as follows: three sessions per day, each lasting for 10 minutes, over a duration of 8 weeks. The intensity of PLB training was individualized, with the inhalation component adjusted according to each participant’s tolerance level, while emphasizing the exhalation phase to ensure complete expulsion of air from the lungs. Regarding the content validity of the PLB intervention protocol, it demonstrated excellence, as consensus was achieved among all panel experts. Both the item-level and scale-level Content Validity Indices (CVIs) reached the maximum score of 1.0, indicating a high level of agreement and credibility in the content of the protocol as evaluated by the expert panel. Conclusion An optimal evidence-based home PLB protocol has been adapted and developed to manage COPD patients’ health-related outcomes. The protocol is transparent and fully supported by relevant mechanisms, concrete evidence, recommendations, and experts’ consensus. Impact The development of the PLB intervention protocol has shown considerable variation among studies, resulting in inconclusive effects in COPD patients. Moreover, there is currently a dearth of an evidence-based PLB intervention protocol, particularly in the home setting. Consequently, this study, guided by the MRC framework, has successfully formulated an evidence-based home PLB intervention aimed at enhancing the health outcomes of COPD patients ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by the Chinese Nursing Association and Luzhou Science and Technology Bureau, with grant numbers which were separately ZHKYQ202114 and 2022-SYE-54 ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript