BACKGROUND AND OBJECTIVES

Mouth retractors are essential in ensuring efficient yet safe exposure of the oral cavity and oropharynx. However, when applied improperly or haphazardly, retractors can cause tissue injuries and compromise patient safety. In addition, there are gaps in the usability of existing designs. This study aimed to identify the issues encountered by otorhinolaryngology surgeons in the use of commercially available mouth retractors, design and fabricate an improved retractor, and explore the use of additive manufacturing (popularly known as 3D printing) for retractor prototyping.

The study used the United States Food and Drug Administration (US FDA) Design Control as its framework. End-user requirements from otorhinolaryngologists were collected through key informant interviews. Results were organized into a Design Input template which was used to guide the design and development process. Prototype designs were iteratively created using computer-aided design software and 3D printing. Once design specifications were satisfied, a beta prototype was fabricated and given to another cohort of otorhinolaryngologists. The participants assessed the usability of the beta prototype. System Usability Scale (SUS) was used to quantify participant's feedback.

Five designs were created in the course of the study. The final prototype was fabricated using a Stereolithography (SLA) 3D printer. Several features were developed to address user requirements. The primary modification was to make the retractor modular to facilitate easier and shorter mounting and assembly. Gingival injury was addressed with the replacement of the maxillary alveolus hook with support bars. Five participants evaluated the beta prototype which received a mean SUS score of 75, well above the 50th percentile threshold.

This study demonstrates the applicability of the US FDA Design Control Process in the local setting to improve the mouth retractor design. Clinical and ergonomic issues were identified and design solutions were proposed and some have been implemented in a low-fidelity prototype. Results of the small-scale usability test suggest that the present form factor can be the basis for further iterations. Future studies can implement the proposed features to address other clinical and ergonomic needs.

BACKGROUND AND OBJECTIVES

Mouth retractors are essential in ensuring efficient yet safe exposure of the oral cavity and oropharynx. However, when applied improperly or haphazardly, retractors can cause tissue injuries and compromise patient safety. In addition, there are gaps in the usability of existing designs. This study aimed to identify the issues encountered by otorhinolaryngology surgeons in the use of commercially available mouth retractors, design and fabricate an improved retractor, and explore the use of additive manufacturing (popularly known as 3D printing) for retractor prototyping.

The study used the United States Food and Drug Administration (US FDA) Design Control as its framework. End-user requirements from otorhinolaryngologists were collected through key informant interviews. Results were organized into a Design Input template which was used to guide the design and development process. Prototype designs were iteratively created using computer-aided design software and 3D printing. Once design specifications were satisfied, a beta prototype was fabricated and given to another cohort of otorhinolaryngologists. The participants assessed the usability of the beta prototype. System Usability Scale (SUS) was used to quantify participant's feedback.

Five designs were created in the course of the study. The final prototype was fabricated using a Stereolithography (SLA) 3D printer. Several features were developed to address user requirements. The primary modification was to make the retractor modular to facilitate easier and shorter mounting and assembly. Gingival injury was addressed with the replacement of the maxillary alveolus hook with support bars. Five participants evaluated the beta prototype which received a mean SUS score of 75, well above the 50th percentile threshold.

This study demonstrates the applicability of the US FDA Design Control Process in the local setting to improve the mouth retractor design. Clinical and ergonomic issues were identified and design solutions were proposed and some have been implemented in a low-fidelity prototype. Results of the small-scale usability test suggest that the present form factor can be the basis for further iterations. Future studies can implement the proposed features to address other clinical and ergonomic needs.

Objective: To develop a low-cost 3D-printed Laryngeal Injection Task Trainer (LITT) for simulation of transcutaneous injection laryngoplasty and evaluate its effectiveness among trainees. Methods: Design: Cross-Sectional Time-Motion Study and Post-Training Evaluation Survey Setting: Tertiary University College of Medicine Anatomy Laboratory Participants: Five residents and 2 consultants in Otolaryngology-Head and Neck Surgery were trained using a LITT fabricated through three-dimensional printing of cartilage models and silicone molds through the UP SIBOL Greenhouse and the Philippine General Hospital Craniomaxillofacial Prosthesis Unit. Participants were asked to perform transcutaneous laryngeal injection on the LITT. The duration in performing the procedure from palpation of landmarks to injection of material was measured in seconds and recorded. After the simulation workshop, participants were asked to evaluate the subjective experience with surgical simulation using the modified Michigan Standard Simulation Experience Scale (MiSSES). Results: The mean time in performing transcutaneous laryngeal injection across different training levels for either trans-cricothyroid or trans-thyrohyoid approach was not statistically significant. Mean time in performing transcutaneous laryngeal injection between 2 approaches, the trans-cricothyroid approach (79.32 seconds with SD 34.89) and the trans-thyrohyoid approach (35.16 seconds with SD of 10.88), was statistically significant. Using the MiSSES tool for evaluation of the simulation training, majority of the participants agreed that the LITT allowed self-efficacy in performing the procedure, had adequate fidelity in terms of its characteristics and components, had high educational value in training participants for knowledge and skills on transcutaneous laryngeal injection and that the simulation provided good teaching quality. For the overall rating, all participants concurred, with 83.3% of participants answering strongly agree and 16.7% of participants responding somewhat agree, that the simulation experience was helpful in knowledge and skills development on transcutaneous laryngeal injection. On final evaluation of the LITT, 75% of the participants responded that it can be used in training but should be improved slightly. Conclusion The laryngeal injection task trainer (LITT) had an acceptable fidelity, educational value, teaching quality to improve self-efficacy in performing transcutaneous injection laryngoplasty - with points for improvement in terms of model and set-up stability, color accuracy and consistency of the visual indicator. It is recommended that the LITT be also used for future workshops and possibly further validation studies after applying the points for improvement gathered from this simulation study.

Objectives: This study aims to analyze the cost of patient care among ORL-HNS patients admitted in a tertiary, teaching government hospital in a low- to middle-income country. Methods: This is a prevalence-based, prospective, bottom-up, cost-of-illness analysis among patients of the Department of Otorhinolaryngology-Head and Neck Surgery in a tertiary training government hospital admitted from July 2021 to March 2022. The value assessment method used is the human capital approach. The societal perspective is used for analysis to estimate and reflect payer (insurance providers) and patient perspectives. Results: A total of one hundred fifty seven (157) patients were admitted for elective surgery under the service of ORL-HNS consisting of 75 females and 82 males. The average total overall cost was $3,851.10 (Php 199, 870.50 ± 164, 725.60). The total direct health care cost for all patients within the study period amounted to $3,712.18 (Php 192, 662.22 ± 159, 548.60) while the direct non-health care cost was $58.60. The workforce cost (58.5%) and medication cost (18.8%) comprised the majority of in-patient expenses with a mean cost of $2,221.36 (Php 37,083.66) and $714.51 (Php 44,363.14), respectively. In this study, an average of $80.29 was lost due to illness and hospitalization (± $81.74). The total PHIC coverage pays a range from zero to 67.5% with an average coverage of only 17%. Conclusion Our analysis has shown that workforce and medication expenses are the main cost drivers for the direct healthcare costs among Otolaryngology patients admitted for elective procedures. Stakeholders, such as the otolaryngologists and hospitals should coordinate closely to create a more encompassing coverage of Philhealth to prevent patients from suffering from financial crises due to their illness.
Costs and Cost Analysis ; Otolaryngology ; Philippines

Objective: To describe the prevalence, onset, associated symptoms, and clinical characteristics of COVID-19 in-patients with olfactory and gustatory dysfunction at the Philippine General Hospital from March 2021 to January 2022 and determine the number of patients with olfactory dysfunction/dysgeusia who recovered or expired. : Methods Design: Prospective Cohort Study Setting: COVID-19 Referral Hospital (Tertiary National University Hospital) Participants: COVID-19 RT-PCR positive in-patients, ages 19 and older Results: A total of 207 patients were included. Sixty-four (64) patients reported olfactory dysfunction and 79 reported dysgeusia. Olfactory and gustatory dysfunction were observed early in the course of infection, before day 6 of illness. The average length of hospital stay was 20.36 days; those with olfactory dysfunction stayed for 17.53 days, dysgeusia for 19.92 days, and 21.09 days for those who noted neither. For those subsequently intubated, 0 had olfactory dysfunction, three reported dysgeusia, three had both and six had neither. Thirteen (13) patients in the study expired. Among them, none reported olfactory dysfunction and two had dysgeusia. Conclusions Our results corroborate existing literature that olfactory and gustatory dysfunction as key indicators of COVID-19 with 42.5% of participants reporting these symptoms early, often before day 6 of illness. Ninety-two percent (92%) of those affected recovered and had shorter hospital stays, emphasizing the importance of recognizing these dysfunctions for improved disease detection and outcomes.
Anosmia ; Dysgeusia ; COVID-19 ; Coronavirus

Objective: This pilot human trial demonstrates the ability of the investigational newborn hearing screening device to provide acoustic stimulation to produce evoked potentials, as well as its ability to capture and acquire auditory evoked potentials, especially the auditory brainstem response (ABR) wave V. This pilot study also demonstrates the ease of recognizing and identifying ABR waves in the graphical presentation of the evoked potentials over time. Methods: Fourteen normal-hearing adults or a total of twenty-eight (28) normal-hearing adult ears underwent auditory brainstem response testing using the investigational hearing screening device. A commercially available auditory brainstem response detection device was used to confirm that the acquired ABR waves of the investigational device are normal. The ABR waves displayed by the investigation device were also reviewed by the clinical audiologists to determine their recognizability and identifiability. Results: The pilot trial demonstrates the ability of the investigational newborn hearing screening device in providing acoustic stimulation to produce evoked potentials, and in acquiring and capturing ABR waves, specifically the wave V, among normal-hearing adult ears. The clinical audiologists recognized and identified the ABR wave V among the evoked potentials at 40dB, 60dB, and 80dB acoustic stimulation. About eighty-nine percent (89.2%) of all ears tested had identifiable and recognizable wave V upon acoustic stimulation at 40dB. Conclusion The investigational hearing screening device: (1) can provide acoustic stimulation to produce evoked potentials, (2) can accurately capture and acquire these evoked potentials, (3) can present these evoked potentials in a voltage per time graphical display which an audiologist and trained HCP can easily read and interpret (diagnostic ABR), and (4) can present wave V auditory brainstem potentials that can be easily identified by an audiologist and trained HCP (screening ABR).
Infant, Newborn ; Acoustics ; Pilot Projects

Objectives: This study explores the potential of the HeLe Service Delivery Model, a community-based newborn hearing screening (NHS) program supported by a web-based referral system, in improving provision of hearing care services. Methods: This prospective observational study evaluated the HeLe Service Delivery Model based on records review and user perspectives. We collected system usage logs from July to October 2018 and data on patient outcomes. Semi-structured interviews and review of field reports were conducted to identify implementation challenges and facilitating factors. Descriptive statistics and content analysis were used to analyze quantitative and qualitative data, respectively. Results: Six hundred ninety-two (692) babies were screened: 110 in the RHUs and 582 in the Category A NHS hospital. Mean age at screening was 1.4±1.05 months for those screened in the RHU and 0.46±0.74 month for those in the Category A site. 47.3% of babies screened at the RHU were ≤1 month old in contrast to 86.6% in the Category A hospital. A total of 10 babies (1.4%) received a positive NHS result. Eight of these ten patients were referred via the NHS Appointment and Referral System; seven were confirmed to have bilateral profound hearing loss, while one patient missed his confirmatory testing appointment. The average wait time between screening and confirmatory testing was 17.1±14.5 days. Facilitating factors for NHS implementation include the presence of champions, early technology adopters, legislations, and capacity-building programs. Challenges identified include perceived inconvenience in using information systems, cost concerns for the patients, costly hearing screening equipment, and unstable internet connectivity. The lack of nearby facilities providing NHS diagnostic and intervention services remains a major block in ensuring early diagnosis and management of hearing loss in the community. Conclusion The eHealth-enabled HeLe Service Delivery Model for NHS is promising. It addresses the challenges and needs of community-based NHS by establishing a healthcare provider network for NHS in the locale, providing a capacity-building program to train NHS screeners, and deploying health information systems that allows for documentation, web-based referral and tracking of NHS patients. The model has the potential to be implemented on a larger scale — a deliberate step towards universal hearing health for all Filipinos.
Neonatal Screening ; Hearing Loss ; Health Information Systems ; Community Health Services ; Delivery of Health Care

Introduction: Access to appropriate and timely care underpins the Republic Act 9707 or the Universal Newborn Hearing Screening and Intervention Act of 2009. However, less than 10% of babies born every year have been screened for hearing loss. The Hearing for Life (HeLe) research program aims to increase the rate of newborn hearing screening (NHS) nationwide through the development and deployment of novel digital health or eHealth technologies in government rural primary care health centers (PCHC). The HeLe is also built on the global call for increased and systematic use of eHealth to strengthen health systems. Effectiveness of eHealth innovations requires acknowledgment of the product’s life cycle; one consideration is organizational readiness at this development stage of the HeLe. Objective: This study assessed readiness of the eight PCHC selected to use the HeLe technologies. Methods: This research utilized the Khoja-Durrani-Scott (KDS) eHealth evaluation tool to assess the PCHC’s readiness level prior to the implementation of HeLe. The KDS tool was distributed through a self-administered survey; data was analyzed using descriptive statistics. Readiness is measured in terms of seven dimensions or outcomes resulting from the use of the HeLe technologies. Results: The study revealed that the eight PCHC were most to least ready, in decreasing order, in the following areas: Ethical, Health, Technology, Social & Cultural, Readiness & Change Management, as well as Economic, and Policy outcomes. The study affirms the PCHCs’ value for equity in health care, i.e., providing accessible NHS services in the community setting closest to where the families and their newborns are. Likewise, results confirm the PCHC staff’s preparedness for another set of innovations, through agreement with statements on Technology, Social & Cultural as well as Readiness & Change Management parameters. Conclusions The results informed the training and technical support strategies to be implemented by the HeLe program proponents. However, even in this early development phase of the HeLe technologies, the PCHC are already concerned with how to sustain NHS services after the research. Fully aware that the HeLe ICT tools need to be maintained and upgraded, the PCHC views that economic and policy support should also be in place to ensure continuous delivery of the ICT-enabled NHS services. While results are illustrative, usefulness is limited by the small sample size and character of the study sites. Nevertheless, social dimensions still have to be carefully considered as innovative NHS tools are introduced to primary care health workers nationwide. Researchers have to be deliberate in working with broader health systems and policy advocacy efforts to allow novel NHS technologies to be smoothly introduced at the community level and frontlines of care.
Telemedicine ; Health ; Technology ; Change Management ; Policy ; Ethics ; Primary Health Care

Objectives: We present in this article the design and evaluation of a blended learning approach for training community healthcare providers in performing newborn hearing screening (NHS). Methods: We developed a blended learning course for training community healthcare providers on eHealth-enabled NHS, following Bloom’s revised taxonomy of educational objectives. The training involved three components: computer-based training (CBT), face-to-face (FTF) training, and on-site coaching. We used surveys and post-training interviews following Level 1 Kirkpatrick’s training evaluation model to get initial feedback on the training program. Results: Thirty-one community healthcare providers from five rural health units and a private hearing screening center, with a mean age of 42.2 ± 12.0 years, participated in the pilot. 93.5% of the participants agreed that the program content met stated objectives and was relevant to their practice. The length of the course was perceived to be adequate. Overall satisfaction with the program was rated at 8.5 ± 0.9 (with ten as the highest). The majority expressed that the CBT and FTF course were satisfactory at 93.5% and 100%, respectively. All participants agreed that the course enhanced their knowledge of newborn hearing screening and telehealth. Positive reviews were received from participants on the use of CBT to improve theoretical knowledge before FTF training. Participants declared that FTF training and on-site coaching helped improved NHS skills and implementation. Conclusion Competent community healthcare providers are critical to strengthening the performance of the health system, and advances in the education and technology sectors offer promising potential in upskilling local healthcare providers. The increasing access of Filipino healthcare providers to improved information and communications technology (ICT) is a significant catalyst for pedagogical innovation, like the use of blended learning in the continuous professional development of health practitioners. As ICTs gradually penetrate the health sector, the challenge we now face is not whether but how we can use innovations in education strategies to benefit healthcare providers.
Infant, Newborn ; Telemedicine

Objective: Newborn hearing screening (NHS) in the Philippines has been mandated by law since 2009. However, lack of awareness and knowledge about NHS remains a challenge, especially among healthcare providers. This paper describes the pilot implementation of a computer-based training (CBT) course on NHS and teleaudiology among primary healthcare providers (PHCPs) in rural Philippines. Methods: A four-module web-based training course on newborn hearing screening and teleaudiology in an online learning management system (LMS) was field-tested among PHCPs from eight rural communities in the Philippines. Participants were given four weeks to complete the course. Results: Forty-two PHCPs participated in the CBT. Thirty-four (81%) completed the whole course (mean attrition rate of 4.8% per module) at a mean duration of 10.2 days. Baseline data shows that participants had no NHS training, although the majority (83%) had information and communications technology (ICT) training. Comparison of preand post-test mean scores showed a 24.0% (p<0.001) significant increase in the post-test in all four modules. Passing rates (i.e., score ≥70%) from pre- to post-test increased by 54.6% (range: 38-80% increase). Usability of the CBT was rated high with a mean score of 4.32 out of 5 (range: 4.13 to 4.47), covering all eight parameters. Participants expressed general satisfaction and a positive attitude on CBT to improve knowledge on NHS and teleaudiology. Conclusion Even in low resource settings where gaps in ICT infrastructure exist, eLearning can be used as an alternative approach to increase awareness and support training of healthcare providers on newborn hearing screening.
Infant, Newborn ; Telemedicine