Dataset Information

Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone: A Randomized Clinical Trial.

ABSTRACT:

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?Conclusions and relevanceThese 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.

SUBMITTER: Ashley T

PROVIDER: S-EPMC7801936 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone: A Randomized Clinical Trial.

Ashley Thomas T Ashley Hannah H Wladis Andreas A Bolkan Håkon A HA van Duinen Alex J AJ Beard Jessica H JH Kalsi Hertta H Palmu Juuli J Nordin Pär P Holm Kristina K Ohene-Yeboah Michael M Löfgren Jenny J

JAMA network open 20210104 1

<h4>Importance</h4>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.<h4>Objective</h4>To determine whether task sharing with MDs and ACs is safe and effe ...[more]

PMID: 33427884

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Project description:ImportanceInguinal hernia is the most common general surgical condition in the world. Although task sharing of surgical care with nonsurgeons represents one method to increase access to essential surgery, the safety and outcomes of this strategy are not well described for hernia repair.ObjectiveTo compare outcomes after inguinal hernia repair with mesh performed by medical doctors and surgeons in Ghana.Design, setting, and participantsThis prospective cohort study was conducted from February 15, 2017, to September 17, 2018, at the Volta Regional Hospital in Ho, Ghana. Following successful completion of a training course, 3 medical doctors and 2 surgeons performed inguinal hernia repair with mesh according to the Lichtenstein technique on 242 men with primary, reducible inguinal hernia.Main outcomes and measuresThe primary end point was hernia recurrence at 1 year. The noninferiority limit was set at 5 percentage points. Secondary end points included postoperative complications at 2 weeks and patient satisfaction, pain, and self-assessed health status at 1 year.ResultsTwo-hundred forty-two patients were included; 119 men underwent operations performed by medical doctors and 123 men underwent operations performed by surgeons. Preoperative patient characteristics were similar in both groups. Two-hundred thirty-seven patients (97.9%) were seen at follow-up at 2 weeks, and 223 patients (92.1%) were seen at follow-up at 1 year. The absolute difference in recurrence rate between the medical doctor group (1 [0.9%]) and the surgeon group (3 [2.8%]) was -1.9 (1-tailed 95% CI, -4.8; P < .001), demonstrating noninferiority of the medical doctors. There were no statistically significant differences in postoperative complications (34 [29.1%] vs 29 [24.2%]), patient satisfaction (112 [98.2%] vs 108 [99.1%]), severe chronic pain (1 [0.9%] vs 4 [3.7%]), or self-assessed health (85.9 vs 83.7 of 100) for medical doctors and surgeons.Conclusions and relevanceThis study shows that medical doctors can be trained to perform elective inguinal hernia repair with mesh in men with good results and high patient satisfaction in a low-resource setting. This finding supports surgical task sharing to combat the global burden of hernia disease.

Project description:ImportanceDespite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair.ObjectiveTo determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs.Design, setting, and participantsThis multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis.InterventionsStandard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair.Main outcomes and measuresMain outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection.ResultsA total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P?<?.001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P?<?.001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P?=?.004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument.Conclusions and relevanceResults of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons.Trial registrationClinicalTrials.gov Identifier: NCT02816658.

Project description:BackgroundSierra Leone is pursuing multiple initiatives to establish in-country postgraduate medical education (PGME), as part of national efforts to strengthen the health workforce. This paper explored the career preferences of junior doctors in Sierra Leone; and the potential benefits and challenges with regards to the development of PGME locally.MethodsJunior doctors (n = 15) who had graduated from the only medical school in Sierra Leone were purposively sampled based on maximum variation (e.g. men/women, years of graduation). In-depth interviews were conducted in October 2013, and digital diaries and two follow-up interviews were used to explore their evolving career aspirations until November 2016. Additionally, 16 semi-structured interviews with key informants were held to gather perspectives on the development of PGME locally. Results were thematically analysed.ResultsAll junior doctors interviewed intended to pursue PGME with the majority wanting primarily a clinical career. Half were interested in also gaining a public health qualification. Major factors influencing career preferences included: prior exposure, practical (anticipated job content), personal considerations (individual interests), financial provision, and contextual (aspirations to help address certain health needs). Majority of doctors considered West Africa but East and South Africa were also location options for clinical PGME. Several preferred to leave the African continent to pursue PGME. Factors influencing decision-making on location were: financial (scholarships), practical (availability of preferred specialty), reputation (positive and negative), and social (children). Key informants viewed the potential benefits of expanding PGME in Sierra Leone as: cost-effectiveness (compared to overseas specialist training), maintaining service delivery during training years, decreasing loss of doctors (some decide not to return after gaining their specialist degree abroad), and enhancing quality control and academic culture of the local medical school. Major perceived challenges were capacity constraints, especially the dearth of specialists required to achieve training programme accreditation.ConclusionsThis study has provided an insight into the career preferences of junior doctors in Sierra Leone. It is timely as there is increasing political and professional momentum to expand PGME locally. Findings may guide those involved in this PGME expansion in terms of how possibly to influence junior doctors in their career decision-making.

Project description:Strong leadership capabilities are essential for effective health services, yet definitions of leadership remain contested. Despite the acknowledged contextual specificity of leadership styles, most leadership theories draw heavily from Western conceptualizations. This cultural bias may attenuate the effectiveness of programmes intended to transform healthcare practice in Sub-Saharan Africa, where few empirical studies on health leadership have been conducted. This paper examines how effective leadership by doctors was perceived by stakeholders in one particular context, Sierra Leone. Drawing together extensive experience of in-country healthcare provision with a series of in-depth interviews with 27 Sierra Leonean doctors, we extended a grounded-theory approach to come to grips with the reach and relevance of contemporary leadership models in capturing the local experiences and relevance of leadership. We found that participants conceptualized leadership according to established leadership models, such as transformational and relational theories. However, participants also pointed to distinctive challenges attendant to healthcare provision in Sierra Leone that required specific leadership capabilities. Context-specific factors included health system breakdown, politicization in the health sector and lack of accountability, placing importance on skills such as persistence, role modelling and taking initiative. Participants also described pressure to behave in ways they deemed antithetical to their personal and professional values and also necessary in order to continue a career in the public sector. The challenge of navigating such ethical dilemmas was a defining feature of leadership in Sierra Leone. Our research demonstrates that while international leadership models were relevant in this context, there is strong emphasis on contingent or situational leadership theories. We further contribute to policy and practice by informing design of leadership development programmes and the establishment of a more enabling environment for medical leadership by governments and international donors.

Project description:BackgroundWe determined the rate of incarceration of inguinal hernia among infants and young children waiting for elective surgery and examined the relation to wait times. We also explored the relation between wait times and the use of emergency department services before surgery.MethodsWe used linked data from administrative databases to identify infants and children less than 2 years of age who underwent surgical repair of an inguinal hernia between Apr. 1, 2002, and Mr. 31, 2004. We determined the rate of hernia incarceration during the wait for surgery and stratified the risk by patient age and sex. We used logistic regression analysis to examine factors associated with hernia incarceration and wait times.ResultsA total of 1065 infants and children less than 2 years old underwent surgical repair of an inguinal hernia during the study period. The median wait time was 35 days (interquartile range 17-77 days). Within 30 days after diagnosis, 126 (11.8%) of the patients had at least 1 emergency department visit; 23.8% of them presented with hernia incarceration. The overall rate of hernia incarceration was 11.9%. The rate was 5.2% with a wait time of up to 14 days (median time from diagnosis to first emergency department visit), as compared with 10.1% with a wait time of up to 35 days (median wait time to surgery) (p < 0.001). Factors associated with an increased risk of incarcerated hernia were age less than 1 year (odds ratio [OR] 2.07, 95% confidence interval [CI] 1.32-3.23), female sex (OR 1.75, 95% CI 1.04-2.93) and emergency department visits (1 visit, OR 2.73, 95% 1.65-4.50; > or = 2 visits, OR 3.77, 95% CI 1.89-7.43). Children less than 1 year old who waited longer than 14 days had a significant 2-fold risk of incarcerated hernia (OR 1.92, 95% CI 1.11-3.32).InterpretationA wait time for surgery of more than 14 days was associated with a doubling of the risk of hernia incarceration among infants and young children with inguinal hernia. Our data support a recommendation that inguinal hernias in this patient population be repaired within 14 days after diagnosis.

Dataset Information

Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Trial registration

Publications

Outcomes After Elective Inguinal Hernia Repair Performed by Associate Clinicians vs Medical Doctors in Sierra Leone: A Randomized Clinical Trial.

Similar Datasets

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