Cost-effectiveness of ovarian stimulation with gonadotrophin and clomiphene citrate in an intrauterine insemination programme for subfertile couples.

Ovarian stimulation with low-dose human menopausal gonadotrophin (HMG) is superior to clomiphene citrate in intrauterine insemination (IUI) cycles with respect to clinical pregnancy rate, but it is unclear whether HMG is also the more cost-effective option. The aim of this study was to compare the cost-effectiveness of ovarian stimulation with low-dose subcutaneously administred HMG (37.5-75 IU per day) to orally administred clomiphene citrate (50 mg/day from day 3-7) in an IUI programme for subfertile couples. A cost-effectiveness analysis was conducted using the results of a randomized trial, including 620 IUI cycles. The primary outcome was the incremental cost-effectiveness ratio (ICER) of using HMG versus clomiphene citrate. Results are presented from the healthcare payer perspective. The total cost per patient associated with one IUI treatment with HMG is €764, whereas it is €558 if clomiphene citrate is used, resulting in an incremental cost of €206 for HMG per treatment. The incremental clinical pregnancy rate of using HMG instead of clomiphene citrate, however, is also 5.7 percentage points higher, resulting in an ICER of HMG versus clomiphene citrate of €3615 per additional clinical pregnancy achieved. On average, HMG was found to be more cost-effective than clomiphene citrate.

Correction: Developing Theory-Driven, Evidence-Based Serious Games for Health: Framework Based on Research Community Insights.

[This corrects the article DOI: 10.2196/11565.].

Developing Theory-Driven, Evidence-Based Serious Games for Health: Framework Based on Research Community Insights.

BACKGROUND: The idea of using serious games to effectuate better outcomes in health care has gained significant traction among a growing community of researchers, developers, and health care professionals. Many now recognize the importance of creating evidence-based games that are purposefully designed to address physical and mental health challenges faced by end users. To date, no regulatory resources have been established to guide the development of serious games for health (SGH). Developers must therefore look elsewhere for guidance. Although a more robust level of evidence exists in the research literature, it is neither structured nor is there any clear consensus. Developers currently use a variety of approaches and methodologies. The establishment of a well-defined framework that represents the consensus views of the SGH research community would help developers improve the efficiency of internal development processes, as well as chances of success. A consensus framework would also enhance the credibility of SGH and help provide quality evidence of their effectiveness. OBJECTIVE: This research aimed to (1) identify and evaluate the requirements, recommendations, and guidelines proposed by the SGH community in the research literature, and; (2) develop a consensus framework to guide developers, designers, researchers, and health care professionals in the development of evidence-based SGH. METHODS: A critical review of the literature was performed in October to November 2018. A 3-step search strategy and a predefined set of inclusion criteria were used to identify relevant articles in PubMed, ScienceDirect, Institute of Electrical and Electronics Engineers Xplore, CiteSeerX, and Google Scholar. A supplemental search of publications from regulatory authorities was conducted to capture their specific requirements. Three researchers independently evaluated the identified articles. The evidence was coded and categorized for analysis. RESULTS: This review identified 5 categories of high-level requirements and 20 low-level requirements suggested by the SGH community. These advocate a methodological approach that is multidisciplinary, iterative, and participatory. On the basis of the requirements identified, we propose a framework for developing theory-driven, evidence-based SGH. It comprises 5 stages that are informed by various stakeholders. It focuses on building strong scientific and design foundations that guide the creative and technical development. It includes quantitative trials to evaluate whether the SGH achieve the intended outcomes, as well as efforts to disseminate trial findings and follow-up monitoring after the SGH are rolled out for use. CONCLUSIONS: This review resulted in the formulation of a framework for developing theory-driven, evidence-based SGH that represents many of the requirements set out by SGH stakeholders in the literature. It covers all aspects of the development process (scientific, technological, and design) and is transparently described in sufficient detail to allow SGH stakeholders to implement it in a wide variety of projects, irrespective of discipline, health care segments, or focus.

Development of CliniPup, a Serious Game Aimed at Reducing Perioperative Anxiety and Pain in Children: Mixed Methods Study.

BACKGROUND: An increasing number of children undergo ambulatory surgery each year, and a significant proportion experience substantial preoperative anxiety and postoperative pain. The management of perioperative anxiety and pain remains challenging in children and is inadequate, which negatively impacts the physical, psychosocial, and economic outcomes. Existing nonpharmacological interventions are costly, time consuming, vary in availability, and lack benefits. Therefore, there is a need for an evidence-based, accessible, nonpharmacological intervention as an adjunct to existing pharmacological alternatives to reduce perioperative anxiety and pain in children undergoing ambulatory surgery. Technology-enabled interventions have been proposed as a method to address the unmet need in this setting. In particular, serious games hold a unique potential to change health beliefs and behaviors in children. OBJECTIVE: The objective of this research was to describe the rationale, scientific evidence, design aspects, and features of CliniPup, a serious game aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. METHODS: The SERES Framework for serious game development was used to create the serious game, CliniPup. In particular, we used a mixed methods approach that consisted of a structured literature review supplemented with ethnographic research, such as expert interviews and a time-motion exercise. The resulting scientific evidence base was leveraged to ensure that the resulting serious game was relevant, realistic, and theory driven. A participatory design approach was applied, wherein clinical experts qualitatively reviewed several versions of the serious game, and an iterative creative process was used to integrate the applicable feedback. RESULTS: CliniPup, a serious game, was developed to incorporate a scientific evidence base from a structured literature review, realistic content collected during ethnographic research such as expert interviews, explicit pedagogical objectives from scientific literature, and game mechanics and user interface design that address key aspects of the evidence. CONCLUSIONS: This report details the systematic development of CliniPup, a serious game aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. Clinical experts validated CliniPup's underlying scientific evidence base and design foundations, suggesting that it was well designed for preliminary evaluation in the target population. An evaluation plan is proposed and briefly described.

A Web-Based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial.

BACKGROUND: As pediatric ambulatory surgeries are rising and existing methods to reduce perioperative anxiety and pain are lacking in this population, a serious game for health (SGH), CliniPup, was developed to address this unmet need. CliniPup was generated using the SERES framework for serious game development. OBJECTIVE: The goal of the research was to clinically evaluate CliniPup as an adjunct therapy to existing pharmacological interventions aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. METHODS: CliniPup was evaluated in a prospective randomized controlled pilot trial in 20 children aged 6 to 10 years who underwent elective surgery and their parents. Study participants were randomly assigned to the test (n=12) or control group (n=8). Children in the test group played CliniPup 2 days prior to surgery, and children in the control group received standard of care. On the day of surgery, pediatric anxiety was measured with the modified Yale Preoperative Anxiety Scale and parental anxiety was assessed with the State-Trait Anxiety Inventory. Pediatric postoperative pain was assessed by the Wong-Baker Faces Pain Rating Scale. Child and parent user experience and satisfaction were also evaluated in the test group using structured questionnaires. RESULTS: Despite the small sample, preoperative anxiety scores were significantly lower (P=.01) in children who played CliniPup prior to surgery compared to controls. Parental preoperative anxiety scores were also lower in the test group (P=.10) but did not reach significance. No significant differences were observed in postoperative pain scores between groups (P=.54). The evaluation of user experience and satisfaction revealed that both children and parents were satisfied with CliniPup and would recommend the game to peers. CONCLUSIONS: Results of the pilot trial introduce CliniPup as a potentially effective and attractive adjunct therapy to reduce preoperative anxiety in children undergoing ambulatory surgery with a trend toward positive impact on parental preoperative anxiety. These results support the use of the SERES framework to generate an evidence-based SGH that results in positive health outcomes for patients. Based on these preliminary findings, we propose a research agenda to further develop and investigate this tool. TRIAL REGISTRATION: ClinicalTrials.gov NCT03874442; https://clinicaltrials.gov/ct2/show/NCT03874442 (Archived by WebCite at http://www.webcitation.org/78KZab8qc).

Development of magnetic particle techniques for long-term culture of bone cells with intermittent mechanical activation.

Magnetic particles were coated with RGD and adhered to primary human osteoblasts. During a 21-day culture, the osteoblasts plus adhered magnetic particles underwent a daily exposure to a time-varying magnetic field via a permanent NdFeB magnet, thus applying a direct mechanical stress to the cells (Bmax approximately 60 mT). After 21 days, preliminary results show that the cells plus magnetic particles were viable and had proliferated. A von-kossa stain showed mineralized bone matrix produced at 21 days in the experimental group whereas the control groups showed no mineralized matrix production. Real-time reverse transcription-polymerase chain reaction at 21 days showed an upregulation of osteopontin from the experimental group in comparison to the control group of cells with adhered particles and no magnet applied. These preliminary results indicate that adherence of RGD-coated 4.5 microm ferromagnetic particles to primary human osteoblasts does not initiate cell necrosis up to 21 days in vitro. Also, mechanical stimulation of human osteoblasts by magnetic particle technology appears to have an influence on osteoblastic activity.