Neurosurgical Randomized Trials in Low- and Middle-Income Countries

BACKGROUND:The setting of a randomized trial can determine whether its findings are generalizable and can therefore apply to different settings. The contribution of low- and middle-income countries (LMICs) to neurosurgical randomized trials has not been systematically described before. OBJECTIVE:To perform a systematic analysis of design characteristics and methodology, funding source, and interventions studied between trials led by and/or conducted in high-income countries (HICs) vs LMICs. METHODS:From January 2003 to July 2016, English-language trials with >5 patients assessing any one neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. Income classification for each country was assessed using the World Bank Atlas method. RESULTS:A total of 73.3% of the 397 studies that met inclusion criteria were led by HICs, whereas 26.7% were led by LMICs. Of the 106 LMIC-led studies, 71 were led by China. If China is excluded, only 8.8% were led by LMICs. HIC-led trials enrolled a median of 92 patients vs a median of 65 patients in LMIC-led trials. HIC-led trials enrolled from 7.6 sites vs 1.8 sites in LMIC-led studies. Over half of LMIC-led trials were institutionally funded (54.7%). The majority of both HIC- and LMIC-led trials evaluated spinal neurosurgery, 68% and 71.7%, respectively. CONCLUSION:We have established that there is a substantial disparity between HICs and LMICs in the number of published neurosurgical trials. A concerted effort to invest in research capacity building in LMICs is an essential step towards ensuring context- and resource-specific high-quality evidence is generated.

International Collaboration in Total Joint Arthroplasty: A Framework for Establishing Meaningful International Alliances

Despite the increase in utilization of total joint arthroplasty (TJA) throughout high-income countries, there is a lack of access to basic surgical care, including TJA, in low- and middle-income countries (LMICs). Multiple strategies, including short-term surgical trips, establishment of local TJA centers, and education-based international academic collaborations, have been used to bridge the gap in access to quality TJA. The authors review the obstacles to providing TJA in LMICs, the outcomes of the 3 strategies in use to bridge gaps, and a framework for the establishment and maintenance of meaningful international collaborations.

Burden of emergency pediatric surgical procedures on surgical capacity in Uganda: a new metric for health system performance

Background: The significant burden of emergency operations in low- and middle-income countries can overwhelm surgical capacity leading to a backlog of elective surgical cases. The purpose of this investigation was to determine the burden of emergency procedures on pediatric surgical capacity in Uganda and to determine health metrics that capture surgical backlog and effective coverage of children’s surgical disease in low- and middle-income countries.

Methods: We reviewed 2 independent and prospectively collected databases on pediatric surgical admissions at Mulago National Referral Hospital and Mbarara Regional Referral Hospital in Uganda. Pediatric surgical patients admitted at either hospital between October 2015 to June 2017 were included. Our primary outcome was the distribution of surgical acuity and associated mortality.

Results: A combined total of 1,930 patients were treated at the two hospitals, and 1,110 surgical procedures were performed. There were 571 emergency cases (51.6%), 108 urgent cases (9.7%), and 429 elective cases (38.6%). Overall mortality correlated with surgical acuity. Emergency intestinal diversions for colorectal congenital malformations (anorectal malformations and Hirschsprung’s disease) to elective definitive repair was 3:1. Additionally, 30% of inguinal hernias were incarcerated or strangulated at time of repair.

Conclusion: Emergency and urgent operations utilize the majority of operative resources for pediatric surgery groups in low- and middle-income countries, leading to a backlog of complex congenital procedures. We propose the ratio of emergency diversion to elective repair of colorectal congenital malformations and the ratio of emergency to elective repair of inguinal hernias as effective health metrics to track this backlog. Surgical capacity for pediatric conditions should be increased in Uganda to prevent a backlog of elective cases.

Hernioplasty Using Low-Cost Mesh Compared to Surgical Mesh in Low- And Middle-Income Countries: A Systematic Review Protocol

Objective: This review aims to assess the differences in surgical outcomes between hernioplasty using low-cost mesh and surgical mesh in adults undergoing elective hernioplasty in low- and middle-income countries.

Introduction: The use of untreated mosquito netting in inguinal hernioplasty in low- and middle-income countries has been well described in the literature, with two recent limited systematic reviews finding equivalent postoperative surgical outcomes. This comprehensive review, across a wider set of databases and gray literature, will assess a broader set of outcomes including patient and surgeon preference and sterility, report more granular complication outcomes, and include other low-cost mesh alternatives such as resterilized surgical mesh and indigenous products, alongside mosquito net mesh.

Inclusion criteria: Adult patients undergoing elective inguinal hernioplasty with mesh in low- and middle-income countries.

Methods: Electronic bibliographic databases (PubMed, Embase, Scopus, Web of Science and the Cochrane Library) and gray literature databases and trial registers will be searched for experimental studies, either randomized or quasi-randomized controlled trials, comparing hernioplasty with surgical mesh versus low-cost mesh, published in any language from 2000 to the present. Two independent reviewers will conduct the literature search, screen titles and abstracts, assess full-text studies for inclusion, assess methodological quality using the Cochrane Risk of Bias 2 tool, and extract data using a custom extraction tool. Synthesis will involve pooling for statistical meta-analysis with either a random-effects or fixed-effects model, as appropriate, and where this is not possible, findings will be presented in narrative form.

Self-Diagnosis of Surgical Site Infections: Lessons From a Tertiary Care Centre in Karachi, Pakistan

Background and Objective: Surgical site infections (SSIs) usually manifest post-discharge, rendering accurate diagnosis and treatment challenging, thereby catalyzing the development of alternate strategies like self-monitored SSI surveillance. This study aimed to evaluate the diagnostic accuracy of patients and Infection Control Monitors (ICMs) to develop a replicable method of SSI-detection.
Methods: A two-year prospective diagnostic accuracy study was conducted in Karachi, Pakistan between 2015 and 2017. Patients were educated about SSIs and provided with questionnaires to elicit symptoms of SSI during post-discharge self-screening. Results of patient’s self-screening and ICM evaluation at followups were compared to surgeon evaluation.
Results: A total of 348 patients completed the study, among whom 18 (5.5%) developed a SSI. Patient selfscreening had a sensitivity of 39%, specificity of 95%, positive predictive value (PPV) of 28%, and negative predictive value (NPV) of 97%. ICM evaluation had a sensitivity of 82%, specificity of 99%, PPV of 82%, and NPV of 99%.
Conclusion: Patients cannot self-diagnose a SSI reliably. However, diagnostic accuracy of ICMs is significantly higher and they may serve as a proxy for surgeons, thereby reducing the burden on specialized surgical workforce in LMICs. Regardless, supplementing post-discharge follow-up with patient self-screening could
increase SSI-detection and reduce burden on health systems.

Demand and capacity to integrate pelvic organ prolapse and genital fistula services in low-resource settings.

INTRODUCTION AND HYPOTHESIS:
There is a need for expanded access to safe surgical care in low- and middle-income countries (LMICs) as illustrated by the report of the 2015 Lancet Commission on Global Surgery. Packages of closely-related surgical procedures may create platforms of capacity that maximize impact in LMIC. Pelvic organ prolapse (POP) and genital fistula care provide an example. Although POP affects many more women in LMICs than fistula, donor support for fistula treatment in LMICs has been underway for decades, whereas treatment for POP is usually limited to hysterectomy-based surgical treatment, occurring with little to no donor support. This capacity-building discrepancy has resulted in POP care that is often non-adherent to international standards and in non-integration of POP and fistula services, despite clear areas of similarity and overlap. The objective of this study was to assess the feasibility and potential value of integrating POP services at fistula centers.

METHODS:
Fistula repair sites supported by the Fistula Care Plus project were surveyed on current demand for and capacity to provide POP, in addition to perceptions about integrating POP and fistula repair services.

RESULTS:
Respondents from 26 hospitals in sub-Saharan Africa and South Asia completed the survey. Most fistula centers (92%) reported demand for POP services, but many cannot meet this demand. Responses indicated a wide variation in assessment and grading practices for POP; approaches to lower urinary tract symptom evaluation; and surgical skills with regard to compartment-based POP, and urinary and rectal incontinence. Fistula surgeons identified integration synergies but also potential conflicts.

CONCLUSIONS:
Integration of genital fistula and POP services may enhance the quality of POP care while increasing the sustainability of fistula care.

A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled Trial.

Preterm birth (PTB) is a leading cause of infant morbidity and mortality worldwide. Every year, 20 million babies are born with low birthweight (LBW), about 96% of which occur in low-income countries. Despite the associated dangers, in about 40%-50% of PTB and LBW cases, the causes remain unexplained. Existing evidence is inconclusive as to whether occupational physical activities such as heavy lifting are implicated. African women bear the transport burden of accessing basic needs for their families. Ghana’s PTB rate is 14.5%, whereas the global average is 9.6%. The proposed liftless intervention aims to decrease lifting exposure during pregnancy among Ghanaian women. We hypothesize that a reduction in heavy lifting among pregnant women in Ghana will increase gestational age and birthweight.To investigate the effects of the liftless intervention on the incidence of PTB and LBW among pregnant Ghanaian women.A cohort stepped-wedge cluster randomized controlled trial in 10 antenatal clinics will be carried out in Ghana. A total of 1000 pregnant participants will be recruited for a 60-week period. To be eligible, the participant should have a singleton pregnancy between 12 and 16 weeks gestation, be attending any of the 10 antenatal clinics, and be exposed to heavy lifting. All participants will receive standard antenatal care within the control phase; by random allocation, two clusters will transit into the intervention phase. The midwife-led 3-component liftless intervention consists of health education, a take-home reminder card mimicking the colors of a traffic light, and a shopping voucher. The primary outcome are gestational ages of <28, 28-32, and 33-37 weeks. The secondary outcomes are LBW (preterm LBW, term but LBW, and postterm), compliance, prevalence of low back and pelvic pain, and premature uterine contractions. Study midwives and participants will not be blinded to the treatment allocation.Permission to conduct the study at all 10 antenatal clinics has been granted by the Ghana Health Service. Application for funding to begin the trial is ongoing. Findings from the main trial are expected to be published by the end of 2019.To the best of our knowledge, there has been no randomized trial of this nature in Ghana. Minimizing heavy lifting among pregnant African women can reduce the soaring rates of PTB and LBW. The findings will increase the knowledge of the prevention of PTB and LBW worldwide.Pan African Clinical Trial Register (PACTR201602001301205); http://apps.who.int/trialsearch/ Trial2.aspx?TrialID=PACTR201602001301205 (Archived by WebCite at http://www.webcitation.org/71TCYkHzu).RR1-10.2196/10095.