Impact of Modifying Abicipar Manufacturing Process in Patients with Neovascular Age-Related Macular Degeneration: MAPLE Study Results.

Purpose: To evaluate the impact of modifying the abicipar pegol (abicipar) manufacturing process on the safety and treatment effect of abicipar in patients with neovascular age-related macular degeneration (nAMD).

Methods: A new process for manufacturing abicipar was developed to reduce host cell impurities. In a prospective, Phase 2, multicenter, open-label, 28-week clinical trial, patients (n=123) with active nAMD received intravitreal injections of abicipar 2 mg at baseline (day 1) and weeks 4, 8, 16, and 24.

Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration.

Purpose: To report the 2-year efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) compared with monthly ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD).

Design: Two multicenter, randomized, phase 3 clinical trials with identical protocols (CEDAR and SEQUOIA). Analyses used pooled trial data.

Evaluation of a Managed Surgical Consultation Network in Malawi.

Background: Access to surgery is a challenge for low-income countries like Malawi due to shortages of specialists, especially in rural areas. District hospitals (DH) cater for the immediate surgical needs of rural patients, sending difficult cases to central hospitals (CH), usually with no prior communication.

Methods: In 2018, a secure surgical managed consultation network (MCN) was established to improve communication between specialist surgeons and anaesthetists at Queen Elizabeth and Zomba Central Hospitals, and surgical providers from nine DHs referring to these facilities.

Which Surgical Operations Should be Performed in District Hospitals in East, Central and Southern Africa? Results of a Survey of Regional Clinicians.

Background: In East, Central and Southern Africa (ECSA), district hospitals (DH) are the main source of surgical care for 80% of the population. DHs in Africa must provide basic life-saving procedures, but the extent to which they can offer other general and emergency surgery is debated. Our paper contributes to this debate through analysis and discussion of regional surgical care providers' perspectives.

Characteristics of interpersonal violence in adult victims at the Adult Emergency Trauma Centre (AETC) of Queen Elizabeth Central Hospital.

Introduction: Globally, the burden of interpersonal violence and its significant impact on mortality, morbidity and disability makes it a major public health problem which necessitates intervention. This article examines characteristics of victims of interpersonal violence and violent events in Malawi. The focus is on a population that has been traditionally neglected in literature.

Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study.

Purpose: To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD).

Design: Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis.

Anesthesia Capacity of District-Level Hospitals in Malawi, Tanzania, and Zambia: A Mixed-Methods Study.

Background: District-level hospitals (DLHs) are the main providers of surgical services for rural populations in Sub-Saharan Africa (SSA). Skilled teams are essential for surgical care, and gaps in anesthesia impact negatively on surgical capacity and outcomes. This study, from a baseline of a project scaling-up access to safe surgical and anesthesia care in Malawi, Tanzania, and Zambia, illustrates the deficit of anesthesia care in DLHs.

Evaluation of a surgical supervision model in three African countries-protocol for a prospective mixed-methods controlled pilot trial.

Background: District-level hospitals (DLHs) can play an important role in the delivery of essential surgical services for rural populations in sub-Saharan Africa if adequately prepared and supported. This article describes the protocol for the evaluation of the Scaling up Safe Surgery for District and Rural Populations in Africa (SURG-Africa) project which aims to strengthen the capacity in district-level hospitals (DLHs) in Malawi, Tanzania and Zambia to deliver safe, quality surgery. The intervention comprises a programme of quarterly supervisory visits to surgically active district-level hospitals by specialists from referral hospitals and the establishment of a mobile phone-based consultation network.

Establishment of trauma registry at Queen Elizabeth Central Hospital (QECH), Blantyre, Malawi and mapping of high risk geographic areas for trauma.

Background: Less attention is directed toward gaining a better understanding of the burden and prevention of injuries, in low and middle income countries (LMICs). We report the establishment of a trauma registry at the Adult Emergency and Trauma Centre (AETC) at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi and identify high risk geographic areas.

Methods: We devised a paper based two-page trauma registry form.

The feasibility of a training course for clubfoot treatment in Africa: A mixed methods study.

Background: There is no available training programme with standard elements for health workers treating clubfoot in Africa. Standardised training with continued mentorship has the potential to improve management of clubfoot. We aimed to evaluate the feasibility of such a training programme among clubfoot providers in Africa, and assess implications for training effectiveness and scale up.

The development of a training course for clubfoot treatment in Africa: learning points for course development.

Background: Clubfoot is a common congenital musculoskeletal disorder that causes mobility impairment. There is a lack of trained mid-level personnel to provide clubfoot treatment in Africa and there is no standard training course. This prospective study describes the collaborative and participatory approach to the development of a training course for the treatment of clubfoot in children in resource constrained settings.

Systemic absorption of nicotine following acute secondhand exposure to electronic cigarette aerosol in a realistic social setting.

Evidence suggests exposure of nicotine-containing e-cigarette aerosol to nonusers leads to systemic absorption of nicotine. However, no studies have examined acute secondhand exposures that occur in public settings. Here, we measured the serum, saliva and urine of nonusers pre- and post-exposure to nicotine via e-cigarette aerosol.

Is overseas volunteering beneficial to the NHS? The analysis of volunteers' responses to a feedback questionnaire following experiences in low-income and middle-income countries.

Introduction: Locally requested and planned overseas volunteering in low-income and middle-income countries by National Health Service (NHS) staff can have benefits for the host or receiving nation, but its impact on the professional development of NHS staff is not proven. The Knowledge and Skills Framework (KSF) and Leadership Framework (LF) are two tools used by employers as a measure of individuals' development. We have used dimensions from both tools as a method of evaluating the benefit to NHS doctors who volunteer overseas.

Do trauma courses change practice? A qualitative review of 20 courses in East, Central and Southern Africa.

Background: Trauma courses have been shown to improve clinical knowledge and patient outcomes. However, little is known about the individual drivers of change in practice amongst course participants in their home clinic environment.

Methods: Front-line healthcare workers participated in a two-day Primary Trauma Care (PTC) course.

A review of existing trauma and musculoskeletal impairment (TMSI) care capacity in East, Central, and Southern Africa.

Background: We conducted an assessment of orthopaedic surgical capacity in the following countries in East, Central, and Southern Africa: Burundi, Ethiopia, Kenya, Malawi, Mozambique, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe.

Methods: We adapted the WHO Tool for Situational Analysis to Assess Emergency and Essential Surgical Care with questions specific to trauma and orthopaedic care. In May 2013-May 2014, surgeons from the College of Surgeons of East, Central and Southern Africa (COSECSA) based at district (secondary) and referral (tertiary) hospitals in the region completed a web-based survey.

A multicountry health partnership programme to establish sustainable trauma training in east, central, and southern African countries using a cascading trauma management course model.

Background: Injury accounts for 267 000 deaths annually in the nine College of Surgeons of East, Central, and Southern Africa (COSECSA-ASESA) countries, and the introduction of a sustainable standardised trauma training programme across all cadres is essential. We have delivered a primary trauma care (PTC) programme that encompasses both a "provider" and "training the trainers" course using a "cascading training model" across nine COSECSA countries. The first "primary course" in each country is delivered by a team of UK instructors, followed by "cascading courses" to more rural regions led by newly qualified local instructors, with mentorship provided by UK instructors.

Trauma and orthopaedic capacity of 267 hospitals in east central and southern Africa.

Background: Trauma and road traffic accidents are predicted to increase significantly in the next decade in low-income and middle-income countries. The College of Surgeons of East, Central, and Southern Africa (COSECSA) covers Ethiopia, Kenya, Tanzania, Uganda, Rwanda, Burundi, Mozambique, Malawi, Zimbabwe, and Zambia. Ministry of Health websites for these ten countries show that 992 hospitals are covering an estimated 318 million people.

How useful are Primary Trauma Care courses in sub-Saharan Africa?

Introduction: More than five million deaths occur each year from injury with the vast majority occurring in low and middle-income countries (LMICs). Africa bears the highest road traffic related mortality rates in the world. Despite this, formal training in trauma management is not widely adopted in these countries.