Device-specific quality of life: results from the ATLAS trial—avoid transvenous leads in appropriate subjects.
Aims Patient-reported outcomes (PROs) provide important insights into patients' acceptance of their medical devices. Avoid Transvenous Leads in Appropriate Subjects (ATLAS), a randomized, multi-centre, open-label clinical trial, recently reported fewer perioperative complications in subcutaneous imp...
| Publicado en: | European Journal of Cardiovascular Nursing Vol. 23; no. 8; pp. 877 - 886 |
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| Autores principales: | , , , , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
Nov2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=181970294&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 181970294 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14745151 KJC jtl: European Journal of Cardiovascular Nursing issn: 14745151 maglogo: N pubinfo: dt: Nov2024 vid: 23 iid: 8 pid: 622 pub: Oxford University Press / USA artinfo: ui: 181970294 181970294 181970294 10.1093/eurjcn/zvae067 181970294 ppf: 877 ppct: 9 formats: tig: atl: Device-specific quality of life: results from the ATLAS trial—avoid transvenous leads in appropriate subjects. aug: au: Carroll, Sandra L Mondésert, Blandine Krahn, Andrew D Bashir, Jamil G Fisher, Kathryn Nair, Kalpana Healey, Jeff S affil: School of Nursing, McMaster University, 1280 Main Street West, HSC 2J17, Hamilton, ON, Canada L8S 4K1 sug: subj: Patient-Reported Outcomes Evaluation Quality of Life Evaluation Defibrillators, Implantable Adverse Effects Postoperative Complications Prevention and Control Human Male Female Surveys Analysis of Variance Pain Measurement Descriptive Statistics Comparative Studies Linear Regression Data Analysis Software Confidence Intervals Exploratory Research Short Form-36 Health Survey (SF-36) Scales Male Female ab: Aims Patient-reported outcomes (PROs) provide important insights into patients' acceptance of their medical devices. Avoid Transvenous Leads in Appropriate Subjects (ATLAS), a randomized, multi-centre, open-label clinical trial, recently reported fewer perioperative complications in subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous ICD (TV-ICD) patients. This study reports PROs, including device-specific and generic quality of life (QOL), from the ATLAS trial. Methods and results Device-specific QOL was the primary PRO using the Florida Patient Acceptance Survey (FPAS) at 1 and 6 months' post-implantation. Secondary outcomes included generic QOL using the Medical Outcomes Survey (SF-36) pre-implant and 6 months' post-implantation. The FPAS and SF-36 were analysed using analysis of covariance. Pain measured using a Numeric Rating Scale, at 1 and 6 months, anaesthetic, body mass index, and within/between differences were analysed using descriptive statistics and mixed-effects linear models. Of the 503 patients randomized in ATLAS, 404 had complete FPAS data to be included in this analysis. Participant characteristics were balanced. There were no significant differences between S-ICD and TV-ICD for the FPAS or SF-36, across time points. Mean total FPAS scores increased from 73.73 (16.09) to 77.05 (16.13) and 74.43 (15.35) to 78.25 (15.88) for S-ICD and TV-ICD, respectively (P < 0.001). Patient-reported outcomes suggested that both devices were associated with good QOL. Conclusion Device-specific and generic QOL were similar between S-ICD and TV-ICD groups up to 6 months' post-implantation, indicating that regardless of device type, both groups reported good device-specific QOL in ATLAS patients. Subcutaneous ICD patients reported higher pain scores at implant, but pain decreased by 6 months. The findings offer evidence that can be included during shared decision-making. The inclusion of patient partners in ATLAS provided an opportunity to measure PROs that were deemed important to patients. Registration ClinialTrials.gov : NCT02881255 pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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