Clarifying the unmet clinical need during medical device innovation in women's health - A narrative review.

Medical technologies are pervasive across women's health, spanning across obstetric and gynecological care. FemTech, the sector responsible for developing these technologies, is growing at 15.6% per annum. However, there are concerns of disconnects between new product development (NPD) and the care afforded to women in consequence of implementing these innovations. The most crucial stage of NPD involves understanding the clinical need. Without a clear need and clinical use case, innovators risk developing solutions which do not address the issues women and caregivers experience. Thus, the product will miss the market and experience limited uptake. Tools for performing clinical needs assessments and defining the use case are being developed. This review provides an analysis of their strengths and weaknesses to inform FemTech innovators of the available resources. We further discuss concepts for creating a unified approach to assessing unmet needs such that technologies have a higher chance of improving women's healthcare.

The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review.

BACKGROUND: Virtual reality is increasingly being utilized by clinicians to facilitate analgesia and anxiolysis within an inpatient setting. There is however, a lack of a clinically relevant review to guide its use for this purpose. OBJECTIVE: To systematically review the current evidence for the efficacy of virtual reality as an analgesic in the management of acute pain and anxiolysis in an inpatient setting. METHODS: A comprehensive search was conducted up to and including January 2019 on PubMed, Ovid Medline, EMBASE, and Cochrane Database of Systematic reviews according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms included virtual reality, vr, and pain. Primary articles with a focus on acute pain in the clinical setting were considered for the review. Primary outcome measures included degree of analgesia afforded by virtual reality therapy, degree of anxiolysis afforded by virtual reality therapy, effect of virtual reality on physiological parameters, side effects precipitated by virtual reality, virtual reality content type, and type of equipment utilized. RESULTS: Eighteen studies were deemed eligible for inclusion in this systematic review; 67% (12/18) of studies demonstrated significant reductions in pain with the utilization of virtual reality; 44% (8/18) of studies assessed the effects of virtual reality on procedural anxiety, with 50% (4/8) of these demonstrating significant reductions; 28% (5/18) of studies screened for side effects with incidence rates of 0.5% to 8%; 39% (7/18) of studies evaluated the effects of virtual reality on autonomic arousal as a biomarker of pain, with 29% (2/7) demonstrating significant changes; 100% (18/18) of studies utilized a head mounted display to deliver virtual reality therapy, with 50% being in active form (participants interacting with the environment) and 50% being in passive form (participants observing the content only). CONCLUSIONS: Available evidence suggests that virtual reality therapy can be applied to facilitate analgesia for acute pain in a variety of inpatient settings. Its effects, however, are likely to vary by patient population and indication. This highlights the need for individualized pilot testing of virtual reality therapy's effects for each specific clinical use case rather than generalizing its use for the broad indication of facilitating analgesia. In addition, virtual reality therapy has the added potential of concurrently providing procedural anxiolysis, thereby improving patient experience and cooperation, while being associated with a low incidence of side effects (nausea, vomiting, eye strain, and dizziness). Furthermore, findings indicated a head mounted display should be utilized to deliver virtual reality therapy in a clinical setting with a slight preference for active over passive virtual reality for analgesia. There, however, appears to be insufficient evidence to substantiate the effect of virtual reality on autonomic arousal, and this should be considered at best to be for investigational uses, at present.

Digital versus Speculum-Based Balloon Catheter Insertion for Labor Induction: A Systematic Review and Meta-Analysis: Digital vs speculum-based balloon IOL.

OBJECTIVES: Induction of labor is commonly undertaken when ongoing pregnancy poses risk to either mother or fetus. Often cervical preparation is required with mechanical methods increasingly popular due to their improved safety. This study evaluates the efficacy, safety, and acceptability of digital versus speculum-based balloon insertion for cervical preparation, aiming to identify gaps and inform future research. DATA SOURCE: PubMed, Ovid MEDLINE, EMBASE, and Scopus were searched from database inception until 30 June 2023. STUDY ELIGIBILITY CRITERIA: Included studies were randomized controlled trials comparing digital versus speculum-based insertion of catheter-related balloons for labor induction in individuals with viable singleton pregnancies, in both inpatient and outpatient settings, written in English. Exclusions included studies not using cervical balloons, comparisons to non-balloon methods, non-human studies, and non-primary literature like guidelines, reviews, commentaries, and opinion pieces. METHODS: Title and abstract screening were performed by four authors. Full-text articles were assessed against inclusion criteria. Selection was agreed upon by consensus among three authors, with a fourth consulted for disputes. Risk of bias was assessed using the Cochrane Risk of Bias Tool 2.0 for randomized trials. A meta-analysis was also performed. RESULTS: Out of 3397 studies, four met the inclusion criteria, all being randomized controlled trials with some concerns in at least one domain but no high risk of bias. Two studies found digital insertion significantly less painful than speculum-based insertion (p<0.001), while one reported no difference (p=0.72). Maternal satisfaction was comparable, with one study favouring digital insertion (p=0.011). Meta-analysis findings for other outcome measures suggest no difference between speculum or digital insertion. However, due to substantial heterogeneity, findings for procedural time, time from induction-to-delivery, and epidural rate should be cautiously interpreted. CONCLUSIONS: Digital insertion for cervical preparation appears associated with reduced pain and higher patient acceptability compared to speculum-based insertion. Additionally, efficacy and safety were comparable, indicating it is a preferable option for clinical use. There was no difference in other procedural, obstetric, or neonatal outcomes, however, more rigorous research employing standardised outcome measures is needed to facilitate a clinically meaningful interpretation.

A randomised controlled trial to assess the feasibility of utilising virtual reality to facilitate analgesia during external cephalic version.

External cephalic version (ECV) is associated with a moderate degree of pain. Virtual reality (VR) is a technology that has shown promise in offering procedural analgesia. We undertook a clinical pilot to assess the viability of VR to reduce pain during ECV. In an open randomised controlled trial (RCT), we randomised 50 women to either VR or standard care each (25 per group). Women receiving VR were administered VR content (Skylights) via a headset. Pre- and post-procedural measures of pain, anxiety, device experience and vital signs were measured. There were no significant differences between groups (VR/no VR) in pain scores (60.68 vs 49.76; p = 0.2), ECV success rates (80% vs 76%; p = 0.7) or anxiety levels. The women receiving VR had a significantly higher anticipation of pain pre-procedurally (70.0 vs 50.0; p = 0.03). 20 (80%) of the VR women indicated that they would use VR again and 22 (88%) indicated they would recommend it to a friend having ECV. There were no significant differences between groups for side effects encountered or changes in vital signs. We have shown that using VR during ECV is feasible and appears safe. Our results inform the design of future RCTs.