Development of the ECLIPSE model of meaningful outcome domains following lower limb amputation and prosthetic rehabilitation, through systematic review and best fit framework synthesis

Background Little is known about which outcome domains characterise meaningful recovery following prosthetic rehabilitation and should be measured. Our previous qualitative work developed a conceptual model of outcome domains which are meaningful to patients. This qualitative synthesis aims to develop that model by exploring views and experiences of recovery captured in the limb loss literature, and use these to produce a second iteration of the model describing outcome domains of importance following prosthetic rehabilitation from the patient's perspective. Methods Systematic searches were conducted using CINAHL, Psychinfo and Web of Science from 2011 to early 2023. Studies with a qualitative design focusing on views and experiences of lower limb prosthetic users were eligible for inclusion. Quality was assessed using the CASP tool. 'Best Fit' framework synthesis was used to synthesise the evidence and develop the conceptual model. Results 40 studies were included, describing the experiences of 539 participants. Data supported the pre-existing conceptual model and led to development of four of the five domains. The newly named ECLIPSE model describes meaningful outcome domains as 1) Being able to participate in important activities and roles, 2) Participating in the way I want to, 3) My prosthesis works for me, 4) If I am in pain, I can manage it, and 5) I am able to accept my new normal. Studies came from 15 countries showing good coverage of high-income settings. Few participants from low-and-middle-income countries were included, it is unclear if the ECLIPSE model describes outcome domains of importance in these settings. Conclusions This synthesis provides a rigorous foundation for understanding outcome domains of importance following lower limb prosthetic rehabilitation from the patient's perspective. The ECLIPSE model is an accessible representation of recovery which could direct rehabilitation programmes, as well as inform the evaluation of prosthetic care through the selection of outcome measures. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was funded by the Institute for life sciences at the University of Southampton ### 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 study are available upon reasonable request to the authors