Stakeholder preferences for attributes of digital health technologies to consider in health service funding.

OBJECTIVES: Health service providers are currently making decisions on the public funding of digital health technologies (DHTs) for managing chronic diseases with limited understanding of stakeholder preferences for DHT attributes. This study aims to understand the community, patient/carer, and health professionals' preferences to help inform a prioritized list of evaluation criteria. METHODS: An online best-worst scaling survey was conducted in Australia, New Zealand, Canada, and the United Kingdom to ascertain the relative importance of twenty-four DHT attributes among stakeholder groups using an efficient incomplete block design. The attributes were identified from a systematic review of DHT evaluation frameworks for consideration in a health technology assessment. Results were analyzed with multinomial models by stakeholder group and latent class. RESULTS: A total of 1,251 participants completed the survey (576 general community members, 543 patients/carers, and 132 health professionals). Twelve attributes achieved a preference score above 50 percent in the stakeholder group model, predominantly related to safety but also covering technical features, effectiveness, ethics, and economics. Results from the latent class model supported this prioritization. Overall, connectedness with the patient's healthcare team seemed the most important; with "Helps health professionals respond quickly when changes in patient care are needed" as the most highly prioritized of all attributes. CONCLUSIONS: It is proposed that these prioritized twelve attributes be considered in all evaluations of DHTs that manage chronic disease, supplemented with a limited number of attributes that reflect the specific perspective of funders, such as equity of access, cost, and system-level implementation considerations.

A Reporting Tool for Adapted Guidelines in Health Care: The RIGHT-Ad@pt Checklist.

BACKGROUND: Adaptation of existing guidelines can be an efficient way to develop contextualized recommendations. Transparent reporting of the adaptation approach can support the transparency and usability of the adapted guidelines. OBJECTIVE: To develop an extension of the RIGHT (Reporting Items for practice Guidelines in HealThcare) statement for the reporting of adapted guidelines (including recommendations that have been adopted, adapted, or developed de novo), the RIGHT-Ad@pt checklist. DESIGN: A multistep process was followed to develop the checklist: establishing a working group, generating an initial checklist, optimizing the checklist (through an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review, and a final assessment of adapted guidelines), and approval of the final checklist by the working group. SETTING: International collaboration. PARTICIPANTS: A total of 119 professionals participated in the development process. MEASUREMENTS: Participants' consensus on items in the checklist. RESULTS: The RIGHT-Ad@pt checklist contains 34 items grouped in 7 sections: basic information (7 items); scope (6 items); rigor of development (10 items); recommendations (4 items); external review and quality assurance (2 items); funding, declaration, and management of interest (2 items); and other information (3 items). A user guide with explanations and real-world examples for each item was developed to provide a better user experience. LIMITATION: The RIGHT-Ad@pt checklist requires further validation in real-life use. CONCLUSION: The RIGHT-Ad@pt checklist has been developed to improve the reporting of adapted guidelines, focusing on the standardization, rigor, and transparency of the process and the clarity and explicitness of adapted recommendations. PRIMARY FUNDING SOURCE: None.

Pre-Hospital Administration of Remdesivir During a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Outbreak in a Skilled Nursing Facility.

Completion of a 5-day course of remdesivir was associated with approximately 17-fold increased odds of survival among a sample of 54 nursing home residents with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the course of an outbreak from October to December 2020. Remdesivir was well tolerated; administration was logistically feasible in a pre-hospital environment.

Economic evaluation of physical activity mass media campaigns across the globe: a systematic review.

BACKGROUND: Physical activity mass media campaigns can deliver physical activity messages to many people, but it remains unclear whether they offer good value for money. We aimed to investigate the cost-effectiveness, cost-utility, and costs of physical activity mass media campaigns. METHODS: A search for economic evaluations (trial- or model-based) and costing studies of physical activity mass media campaigns was performed in six electronic databases (June/2021). The authors reviewed studies independently. A GRADE style rating was used to assess the overall certainty of each modelled economic evaluation. Results were summarised via narrative synthesis. RESULTS: Twenty-five studies (five model-based economic evaluations and 20 costing studies) were included, and all were conducted in high-income countries except for one costing study that was conducted in a middle-income country. The methods and assumptions used in the model-based analyses were highly heterogeneous and the results varied, ranging from the intervention being more effective and less costly (dominant) in two models to an incremental cost of US$130,740 (2020 base year) per QALY gained. The level of certainty of the models ranged from very low (n = 2) to low (n = 3). Overall, intervention costs were poorly reported. CONCLUSIONS: There are few economic evaluations of physical activity mass media campaigns available. The level of certainty of the models was judged to be very low to low, indicating that we have very little to little confidence that the results are reliable for decision making. Therefore, it remains unclear to what extent physical activity mass media campaigns offer good value for money. Future economic evaluations should consider selecting appropriate and comprehensive measures of campaign effectiveness, clearly report the assumptions of the models and fully explore the impact of assumptions in the results. REVIEW REGISTRATION: https://bit.ly/3tKSBZ3.

Economic evaluations of fall prevention exercise programs: a systematic review.

OBJECTIVE: To investigate cost-effectiveness and costs of fall prevention exercise programmes for older adults. DESIGN: Systematic review. DATA SOURCES: Medline, Embase, Web of Science, Scopus, National Institute for Health Research Economic Evaluation Database, Health Technology Assessment database, Tufts Cost-Effectiveness Analysis Registry, Research Papers in Economics and EconLit (inception to May 2022). ELIGIBILITY CRITERIA FOR STUDY SELECTION: Economic evaluations (trial-based or model-based) and costing studies investigating fall prevention exercise programmes versus no intervention or usual care for older adults living in the community or care facilities, and reporting incremental cost-effectiveness ratio (ICER) for fall-related outcomes or quality-adjusted life years (QALY, expressed as cost/QALY) and/or intervention costs. RESULTS: 31 studies were included. For community-dwelling older adults (21 economic evaluations, 6 costing studies), results ranged from more effective and less costly (dominant) interventions up to an ICER of US$279 802/QALY gained and US$11 986/fall prevented (US$ in 2020). Assuming an arbitrary willingness-to-pay threshold (US$100 000/QALY), most results (17/24) were considered cost-effective (moderate certainty). The greatest value for money (lower ICER/QALY gained and fall prevented) appeared to accrue for older adults and those with high fall risk, but unsupervised exercise appeared to offer poor value for money (higher ICER/QALY). For care facilities (two economic evaluations, two costing studies), ICERs ranged from dominant (low certainty) to US$35/fall prevented (moderate certainty). Overall, intervention costs varied and were poorly reported. CONCLUSIONS: Most economic evaluations investigated fall prevention exercise programmes for older adults living in the community. There is moderate certainty evidence that fall prevention exercise programmes are likely to be cost-effective. The evidence for older adults living in care facilities is more limited but promising. PROSPERO REGISTRATION NUMBER: PROSPERO 2020 CRD42020178023.

Health technology assessment for digital technologies that manage chronic disease: a systematic review.

OBJECTIVE: A growing number of evaluation frameworks have emerged over recent years addressing the unique benefits and risk profiles of new classes of digital health technologies (DHTs). This systematic review aims to identify relevant frameworks and synthesize their recommendations into DHT-specific content to be considered when performing Health Technology Assessments (HTAs) for DHTs that manage chronic noncommunicable disease at home. METHODS: Searches were undertaken of Medline, Embase, Econlit, CINAHL, and The Cochrane Library (January 2015 to March 2020), and relevant gray literature (January 2015 to August 2020) using keywords related to HTA, evaluation frameworks, and DHTs. Included framework reference lists were searched from 2010 until 2015. The EUNetHTA HTA Core Model version 3.0 was selected as a scaffold for content evaluation. RESULTS: Forty-four frameworks were identified, mainly covering clinical effectiveness (n = 30) and safety (n = 23) issues. DHT-specific content recommended by framework authors fell within 28 of the 145 HTA Core Model issues. A further twenty-two DHT-specific issues not currently in the HTA Core Model were recommended. CONCLUSIONS: Current HTA frameworks are unlikely to be sufficient for assessing DHTs. The development of DHT-specific content for HTA frameworks is hampered by DHTs having varied benefit and risk profiles. By focusing on DHTs that actively monitor/treat chronic noncommunicable diseases at home, we have extended DHT-specific content to all nine HTA Core Model domains. We plan to develop a supplementary evaluation framework for designing research studies, undertaking HTAs, and appraising the completeness of HTAs for DHTs.

Application of a health technology assessment framework to digital health technologies that manage chronic disease: a systematic review.

BACKGROUND: As health services increasingly make investment decisions in digital health technologies (DHTs), a DHT-specific and comprehensive health technology assessment (HTA) process is crucial in assessing value-for-money. Research in DHTs is ever-increasing, but whether it covers the content required for HTA is unknown. OBJECTIVES: To summarize current trends in primary research on DHTs that manage chronic disease at home, particularly the coverage of content recommended for DHT-specific and comprehensive HTA. METHODS: Medline, Embase, Econlit, CINAHL, and The Cochrane Library (1 January 2015 to 20 March 2020) were searched for primary research studies using keywords related to DHT and HTA domains. Studies were assessed for coverage of the most frequently recommended content to be considered in a nine domain DHT-specific HTA previously developed. RESULTS: A total of 178 DHT interventions were identified, predominantly randomized controlled trials targeting cardiovascular disease/diabetes in high- to middle-income countries. A coverage assessment of the cardiovascular and diabetes DHT studies (112) revealed less than half covered DHT-specific content in all but the health problem domain. Content common to all technologies but essential for DHTs was covered by more than half the studies in all domains except for the effectiveness and ethical analysis domains. CONCLUSIONS: Although DHT research is increasing, it is not covering all the content recommended for a DHT-specific and comprehensive HTA. The inability to conduct such an HTA may lead to health services making suboptimal investment decisions. Measures to increase the quality of trial design and reporting are required in DHT primary research.

Mercury in neonatal and juvenile blacktip sharks (Carcharhinus limbatus). Part II: Effects assessment.

As apex predators, blacktip sharks (Carcharhinus limbatus) are highly susceptible to biomagnified mercury (Hg) particularly in the Gulf of Mexico (GOM), which is known to contain fishes and invertebrates with elevated Hg levels. Blacktip sharks occur in the GOM year-round and are heavily fished both commercially and recreationally, but little is known about how Hg affects the species. In this study, blood, muscle, liver, and kidney samples were collected from neonatal (n = 57) and juvenile (n = 13) blacktip sharks in Charlotte Harbor, Florida. Hg concentrations in neonates and juveniles were found to be elevated in muscle (mean ± SE = 0.59 ± 0.23 mg kg-1), liver (0.39 ± 0.29 mg kg-1), kidney (0.56 ± 0.25 mg kg-1), and blood (0.059 ± 0.041 mg kg-1) compared to other local shark species and conspecifics from other areas. Blood plasma chemistry, hematology, and liver histology were evaluated to assess the relationship between Hg and tissue damage. Plasma chemistry parameters alanine aminotransferase (ALT) and phosphorus (PHOS) were not correlated with tissue Hg or liver condition index. Hematological effects were also not correlated with tissue Hg. However, melanomacrophage presence and lipid deposition, evaluated as part of histopathological analysis, were found to exhibit a statistically significant association with concentrations of Hg in tissue and ALT levels. These results suggest that Hg exposure potentially had a negative effect on the livers of the blacktip sharks evaluated in the present study.

Mercury in neonatal and juvenile blacktip sharks (Carcharhinus limbatus). Part I: exposure assessment.

Elasmobranchs are exposed to mercury (Hg) through a variety of pathways in the environment. This study assessed maternal offloading and diet-based Hg exposure for neonatal and juvenile blacktip sharks (Carcharhinus limbatus) from Charlotte Harbor located along southwest Florida's coast, a recognized Hg hotspot. Neonates (n = 57) had highest total Hg (THg) concentrations in the kidney (0.56 ± 0.26 mg kg-1; n = 38) and muscle (0.53 ± 0.17 mg kg-1; n = 57), followed by liver (0.31 ± 0.11 mg kg-1; n = 38), and blood (0.05 ± 0.033 mg kg-1; n = 57). Juveniles (n = 13) exhibited a different distribution with highest THg in the liver (0.868 ± 0.54 mg kg-1; n = 6), followed by the muscle (0.84 ± 0.28 mg kg-1; n = 13), kidney (0.55 ± 0.22 mg kg-1; n = 6), and blood (0.11 ± 0.04 mg kg-1; n = 11). The distribution of THg among tissues and liver-to-muscle ratios indicated that Hg originated primarily from maternal offloading in neonates, whereas juveniles continued to accumulate Hg through dietary exposure post-parturition. Additionally, comparisons between results of the present study and previous Florida blacktip shark surveys suggested that Hg levels have not declined in southwest Florida estuaries for over two decades.

Effect of a Surgical Teaching Video on Resident Performance of a Laparoscopic Salpingo-oophorectomy: A Randomized Controlled Trial.

STUDY OBJECTIVE: To assess the effect of a surgical teaching video on junior resident knowledge and performance of a laparoscopic salpingo-oophorectomy (LSO). DESIGN: Randomized controlled trial. SETTING: Urban tertiary care academic obstetrics and gynecology department. PATIENTS: First- and second-year gynecology residents. INTERVENTIONS: Access to an education video on LSO for 1 week before performing this surgery in the operating room. MEASUREMENTS AND MAIN RESULTS: Twenty-four junior residents were recruited and randomized to either the educational video group or traditional residency training group. All participants completed a demographic survey and knowledge questionnaire before performing an LSO, which was video-recorded. Video recordings of surgical performance were analyzed using the Objective Structured Assessment of Technical Skills (OSATS; 20 points) and an LSO-specific tool (30 points). Participants completed a self-assessment questionnaire before completing the procedure. The primary outcome measure was the difference in OSATS scores. The secondary outcomes were the knowledge questionnaire scores and self-assessed confidence scores. There were no significant differences between demographic variables of the 2 groups. The primary outcome revealed no significant differences in mean (standard deviation) OSATS scores (10.64 [2.05] vs 11.55 [1.85], p = .3) or LSO-specific tool scores (16.45 [2.68] vs 17.85 [2.63], p = .24). However, there was a significant difference in mean knowledge scores between the video and the traditional training (8.42 [0.79] vs 7.11 [1.36], p = .01) groups. In addition, residents in the video group had more confidence in their knowledge of pelvic anatomy (3.83 [0.39] vs 3.00 [1.00] out of 5.00, p = .04). CONCLUSION: For junior learners, the use of an LSO video improved knowledge and confidence in anatomy but did not translate to improved surgical performance in the operating room. Surgical videos are a useful adjunct and complement hands-on technical teaching.

Reproductive Outcomes Following Uterine Artery Occlusion at the Time of Myomectomy: Systematic Review and Meta-analysis.

This investigation sought systematically to review and meta-analyze evidence on reproductive outcomes following uterine artery occlusion (UAO) at myomectomy. Databases searched included PubMed, EMBASE, Ovid MEDLINE, Web of Science, and ClinicalTrials.gov. Eligible studies included observational and randomized controlled trials in which patients underwent abdominal, laparoscopic, or robotic myomectomy and in which at least one measure of clinical pregnancy rate, live birth rate, or ovarian reserve was reported. The primary outcome was live birth rate. Secondary outcomes included clinical pregnancy rate, miscarriage rate, adverse pregnancy outcomes, and measures of ovarian reserve. Twelve articles involving 689 women were included in the systematic review. The intervention group underwent UAO at laparoscopic or abdominal myomectomy (UAO+M) (n = 470). The control group underwent myomectomy alone (n = 219). Seven articles involving 420 women were included in the meta-analysis (201 underwent UAO+M; 219 underwent myomectomy alone). Live births occurred in 54 of 201 (27%) women in the UAO+M group and in 74 of 219 (34%) women in the control group. Clinical pregnancies occurred in 73 of 201 (36%) women in the UAO+M group and in 102 of 219 (47%) control subjects. There was no difference in live birth rates (odds ratio 0.89; 95% CI 0.56-1.43; P = 0.51; 7 studies, 420 patients) or clinical pregnancy rates (odds ratio 0.81; 95% confidence interval 0.53-1.24; P = 0.33; 7 studies, 420 patients) between the UAO+M and control groups. Data on miscarriage rates, adverse pregnancy outcomes, and measures of ovarian reserve precluded meta-analysis. In conclusion, UAO at myomectomy is not associated with reductions in live birth or clinical pregnancy rates. Before routine use can be recommended in women desiring future fertility, more research is required on reproductive outcomes and effects on ovarian reserve.

Cost-effectiveness analysis of germ-line BRCA testing in women with breast cancer and cascade testing in family members of mutation carriers.

PURPOSE: To evaluate the cost-effectiveness of BRCA testing in women with breast cancer, and cascade testing in family members of BRCA mutation carriers. METHODS: A cost-effectiveness analysis was conducted using a cohort Markov model from a health-payer perspective. The model estimated the long-term benefits and costs of testing women with breast cancer who had at least a 10% pretest BRCA mutation probability, and the cascade testing of first- and second-degree relatives of women who test positive. RESULTS: Compared with no testing, BRCA testing of affected women resulted in an incremental cost per quality-adjusted life-year (QALY) gained of AU$18,900 (incremental cost AU$1,880; incremental QALY gain 0.10) with reductions of 0.04 breast and 0.01 ovarian cancer events. Testing affected women and cascade testing of family members resulted in an incremental cost per QALY gained of AU$9,500 compared with testing affected women only (incremental cost AU$665; incremental QALY gain 0.07) with additional reductions of 0.06 breast and 0.01 ovarian cancer events. CONCLUSION: BRCA testing in women with breast cancer is cost-effective and is associated with reduced risk of cancer and improved survival. Extending testing to cover family members of affected women who test positive improves cost-effectiveness beyond restricting testing to affected women only.

High Infection Rates for Adult Macaques after Intravaginal or Intrarectal Inoculation with Zika Virus.

Unprotected sexual intercourse between persons residing in or traveling from regions with Zika virus transmission is a risk factor for infection. To model risk for infection after sexual intercourse, we inoculated rhesus and cynomolgus macaques with Zika virus by intravaginal or intrarectal routes. In macaques inoculated intravaginally, we detected viremia and virus RNA in 50% of macaques, followed by seroconversion. In macaques inoculated intrarectally, we detected viremia, virus RNA, or both, in 100% of both species, followed by seroconversion. The magnitude and duration of infectious virus in the blood of macaques suggest humans infected with Zika virus through sexual transmission will likely generate viremias sufficient to infect competent mosquito vectors. Our results indicate that transmission of Zika virus by sexual intercourse might serve as a virus maintenance mechanism in the absence of mosquito-to-human transmission and could increase the probability of establishment and spread of Zika virus in regions where this virus is not present.

Lateral Flow Immunoassays for Ebola Virus Disease Detection in Liberia.

BACKGROUND: Lateral flow immunoassays (LFIs) are point-of-care diagnostic assays that are designed for single use outside a formal laboratory, with in-home pregnancy tests the best-known example of these tests. Although the LFI has some limitations over more-complex immunoassay procedures, such as reduced sensitivity and the potential for false-positive results when using complex sample matrices, the assay has the benefits of a rapid time to result and ease of use. These benefits make it an attractive option for obtaining rapid results in an austere environment. In an outbreak of any magnitude, a field-based rapid diagnostic assay would allow proper patient transport and for safe burials to be conducted without the delay caused by transport of samples between remote villages and testing facilities. Use of such point-of-care instruments in the ongoing Ebola virus disease (EVD) outbreak in West Africa would have distinct advantages in control and prevention of local outbreaks, but proper understanding of the technology and interpretation of results are important. METHODS: In this study, a LFI, originally developed by the Naval Medical Research Center for Ebola virus environmental testing, was evaluated for its ability to detect the virus in clinical samples in Liberia. Clinical blood and plasma samples and post mortem oral swabs submitted to the Liberian Institute for Biomedical Research, the National Public Health Reference Laboratory for EVD testing, were tested and compared to results of real-time reverse transcription-polymerase chain reaction (rRT-PCR), using assays targeting Ebola virus glycoprotein and nucleoprotein. RESULTS: The LFI findings correlated well with those of the real-time RT-PCR assays used as benchmarks. CONCLUSIONS: Rapid antigen-detection tests such as LFIs are attractive alternatives to traditional immunoassays but have reduced sensitivity and specificity, resulting in increases in false-positive and false-negative results. An understanding of the strengths, weaknesses, and limitations of a particular assay lets the diagnostician choose the correct situation to use the correct assay and properly interpret the results.

Annexin A6 regulates interleukin-2-mediated T-cell proliferation.

Annexin A6 (AnxA6) has been implicated in cell signalling by contributing to the organisation of the plasma membrane. Here we examined whether AnxA6 regulates signalling and proliferation in T cells. We used a contact hypersensitivity model to immune challenge wild-type (WT) and AnxA6(-/-) mice and found that the in vivo proliferation of CD4(+) T cells, but not CD8(+) T cells, was impaired in AnxA6(-/-) relative to WT mice. However, T-cell migration and signalling through the T-cell receptor ex vivo was similar between T cells isolated from AnxA6(-/-) and WT mice. In contrast, interleukin-2 (IL-2) signalling was reduced in AnxA6(-/-) compared with WT T cells. Further, AnxA6-deficient T cells had reduced membrane order and cholesterol levels. Taken together, our data suggest that AnxA6 regulates IL-2 homeostasis and sensitivity in T cells by sustaining a lipid raft-like membrane environment.

Rehabilitation following arthroscopic rotator cuff repair: a review of current literature.

Physical rehabilitation following arthroscopic rotator cuff repair has conventionally involved a 4- to 6-week period of immobilization; there are two schools of thought regarding activity level during this period. Some authors encourage early, more aggressive rehabilitation along with the use of a continuous passive motion device; others propose later, more conservative rehabilitation. Although some studies report trends in improved early range of motion, pain relief, and outcomes scores with aggressive rehabilitation following rotator cuff repair, no definitive consensus exists supporting a clinical difference resulting from rehabilitation timing in the early stages of healing. Rehabilitation timing does not affect outcomes after 6 to 12 months postoperatively. Given the lack of information regarding which patient groups benefit from aggressive rehabilitation, individualized patient care is warranted.

Delayed Solid Tumor Presentations in Adolescent and Young Adults Patients in the Bronx.

Adolescent and young adults (AYAs) require support from their parents and caregivers. While there are formal programs available for patients with complex medical problems, <20% of pediatric practices are performing transition readiness processes in patients aged 12-17 years to effective transition. Although cancer is the most common cause of disease-related death in AYAs in high-income countries, AYA oncology patients have not attained the same clinical improvements as pediatric patients, and their outcomes remain poorer. While there are published data on an expected degree of lag time for patients presenting with solid tumors, due to the underlying biology and slow growth of the cancer, we have recently witnessed extreme delays in the presentation to medical care. In this article, we share the cases of two young adults.

Women's Preferences for Hypofractionated Radiation Therapy for Treatment of Early-Stage Breast Cancer: A Discrete Choice Experiment.

PURPOSE: The primary treatment recommended for early-stage breast cancer is breast conserving surgery followed by external beam radiation therapy of the whole breast. Previously, radiation therapy for early-stage breast cancer was given using more fractions over longer durations. Guidelines support treatments with fewer fractions over a shorter time (hypofractionated radiation therapy). This study aimed to understand women's preferences for different features of treatments for early-stage breast cancer. METHODS AND MATERIALS: A discrete choice experiment with 12 choice tasks was conducted, describing the treatments by extent of surgery, duration of radiation treatment, need to relocate for treatment, local side effects, changes in breast appearance, costs, and difficulty with daily activities during and after treatment. Participants were women with breast cancer and from the general population. Mixed logit analyses were conducted and trade-offs between attributes estimated. RESULTS: Four hundred twenty respondents completed the discrete choice experiment. The relative importance of attributes varied by respondent characteristics; the most influential attribute for younger women was type of surgery (breast conserving surgery). Type of surgery did not influence older women's preferences. Shorter treatment duration, avoiding relocation, fewer local side effects, and less difficulty with daily activities all positively influenced treatment preference. Younger women were willing to accept 32 to 40 days of radiation treatment before a treatment that included mastectomy was potentially acceptable. CONCLUSIONS: Attributes of treatment such as duration, need for relocation, side effects, and effects on normal daily activities during and after treatment significantly influenced women's preference for treatment, including surgery. Our findings have the potential for real impact for patients and services including supporting one-on-one clinical discussions, supporting program and patient resource development, and informing service funding, organization, and delivery.

'Integrating Ethics and Equity with Economics and Effectiveness for newborn screening in the genomic age: A qualitative study protocol of stakeholder perspectives.

BACKGROUND: Newborn bloodspot screening is a well-established population health initiative that detects serious, childhood-onset, treatable conditions to improve health outcomes. With genomic technologies advancing rapidly, many countries are actively discussing the introduction of genomic assays into newborn screening programs. While adding genomic testing to Australia's newborn screening program could improve outcomes for infants and families, it must be considered against potential harms, ethical, legal, equity and social implications, and economic and health system impacts. We must ask not only 'can' we use genomics to screen newborns?' but 'should we'?' and 'how much should health systems invest in genomic newborn screening?'. METHODS: This study will use qualitative methods to explore understanding, priorities, concerns and expectations of genomic newborn screening among parents/carers, health professionals/scientists, and health policy makers across Australia. In-depth, semi-structured interviews will be held with 30-40 parents/carers recruited via hospital and community settings, 15-20 health professionals/scientists, and 10-15 health policy makers. Data will be analysed using inductive content analysis. The Sydney Children's Hospital Network Human Research Ethics Committee approved this study protocol [2023/ETH02371]. The Standards for Reporting Qualitative Research will guide study planning, conduct and reporting. DISCUSSION: Few studies have engaged a diverse range of stakeholders to explore the implications of genomics in newborn screening in a culturally and genetically diverse population, nor in a health system underpinned by universal health care. As the first study within a multi-part research program, findings will be used to generate new knowledge on the risks and benefits and importance of ethical, legal, social and equity implications of genomic newborn screening from the perspective of key stakeholders. As such it will be the foundation on which child and family centered criteria can be developed to inform health technology assessments and drive efficient and effective policy decision-making on the implementation of genomics in newborn screening.