Development, validation, and clinical utility of Short-term AdVerse-effects of Electroconvulsive therapy (SAVE) Checklist

Abstract: Background: Electroconvulsive therapy (ECT) is one of the most effective treatments in psychiatry. However, it has many cognitive and non-cognitive adverse effects (AEs). Without a comprehensive clinical tool to evaluate, there are lacunae in the systematic literature on non-cognitive AEs. The current study aimed to develop and validate a checklist of short-term AEs of ECT (SAVE) for clinical and research applications. Methods: A checklist with a 2-phase assessment was developed. Independent ratings of 15 experts with a preset closing criterion based on content validity ratio and index (CVR and CVI) were used for content validation in a two-stage modified Delphi method. The checklist was applied to 104 participants receiving ECTs. Results: The checklist had a good CVR and CVI (≥0.94) with a final tool of 39 items. The tool was sensitive and identified the non-cognitive AEs after ECT. Cardiovascular and musculoskeletal systems displayed the highest incidence, with AEs reaching as high as 90% based on predefined criteria. A significant proportion of participants exhibited delayed recovery in orientation (75.96%), gait (78.85%), and stance (31.73%), highlighting a necessity for meticulous monitoring. Conclusion: SAVE is the first standardized tool to assess short-term ECT-related AEs systematically. This checklist identified a clinically significant incidence of adverse effects that would otherwise remain unnoticed. Its regular use may enhance the safety of ECT and patient comfort by supporting early identification and intervention for AEs. However, given the transient nature of AEs, further studies are needed to determine their predictive validity for long-term consequences. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement the Department of Biotechnology (DBT) - Wellcome Trust India Alliance (IA/CRC/19/1/610005). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics Committee (Behavioural Science Division) of National Institute of Mental Health and Neurosciences (NIMHANS) gave ethical approval for this work with the letter No. NIMHANS/36th iEC (BEH.SC.DIV.)2022 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.