Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone: A Randomized Clinical Trial.
Autor: | Ashley T; Kamakwie Wesleyan Hospital, Kamakwie, Sierra Leone.; Department of General Surgery, North Cumbria University Hospital, Carlisle, United Kingdom., Ashley H; The Lakes Medical Practice, Penrith, United Kingdom., Wladis A; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden., Bolkan HA; Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.; Clinic of Surgery, Trondheim University Hospital, Trondheim, Norway., van Duinen AJ; Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.; Clinic of Surgery, Trondheim University Hospital, Trondheim, Norway., Beard JH; Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania., Kalsi H; Skåne University Hospital, Skåne, Sweden., Palmu J; Kiruna Hospital, Kiruna, Sweden., Nordin P; Department of Surgery and Perioperative Sciences, Umeå University, Umeå, Sweden., Holm K; Mälarsjukhuset, Eskilstuna, Sweden., Ohene-Yeboah M; Department of Surgery, University of Ghana, Accra, Ghana., Löfgren J; Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. |
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Jazyk: | angličtina |
Zdroj: | JAMA network open [JAMA Netw Open] 2021 Jan 04; Vol. 4 (1), pp. e2032681. Date of Electronic Publication: 2021 Jan 04. |
DOI: | 10.1001/jamanetworkopen.2020.32681 |
Abstrakt: | Importance: Task sharing of surgical duties with medical doctors (MDs) without formal surgical training and associate clinicians (ACs; health care workers corresponding to an educational level between that of a nurse and an MD) is practiced to provide surgical services to people in low-resource settings. The safety and effectiveness of this has not been fully evaluated through a randomized clinical trial. Objective: To determine whether task sharing with MDs and ACs is safe and effective in mesh hernia repair in Sierra Leone. Design, Setting, and Participants: This single-blind, noninferiority randomized clinical trial included adult, healthy men with primary inguinal hernia randomized to receiving surgical treatment from an MD or an AC. In Sierra Leone, ACs practicing surgery have received 2 years of surgical training and completed a 1-year internship. The study was conducted between October 2017 and February 2019. Patients were followed up at 2 weeks and 1 year after operations. Observers were blinded to the study arm of the patients. The study was carried out in a first-level hospital in rural Sierra Leone. Data were analyzed from March to June 2019. Interventions: All patients received an open mesh inguinal hernia repair under local anesthesia. The control group underwent operations performed by MDs, and the intervention group underwent operations performed by ACs. Main Outcomes and Measures: The primary end point was hernia recurrence at 1 year. Outcomes were assessed by blinded observers at 2 weeks and 1 year after operations. Results: A total of 230 patients were recruited (mean [SD] age, 43.0 [13.5] years), and all but 1 patient underwent inguinal hernia repair between October 23, 2017, and February 2, 2018, performed by 5 MDs and 6 ACs. A total of 114 patients were operated on by MDs, and 115 patients were operated on by ACs. There were no crossovers between the study arms. The follow-up rate was 100% at 2 weeks and 94.1% at 1 year. At 1 year, hernia recurrence occurred in 7 patients (6.9%) operated on by MDs and 1 patient (0.9%) operated on by ACs (absolute difference, -6.0 [95% CI, -11.2 to 0.7] percentage points; P < .001). Conclusions and Relevance: These findings demonstrate that task sharing of elective mesh inguinal hernia repair with ACs was safe and effective. The task sharing debate should progress to focus on optimizing surgical training programs for nonsurgeons and building capacity for elective surgical care in low- and middle-income countries. Trial Registration: isrctn.org Identifier: ISRCTN63478884. |
Databáze: | MEDLINE |
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