Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Purchasing high-cost medical devices and equipment in hospitals: a systematic review.

OBJECTIVES: To systematically review academic literature for studies on any processes, procedures, methods or approaches to purchasing high-cost medical devices and equipment within hospitals in high-income countries. METHODS: On 13 August 2020, we searched the following from inception: Cost-Effectiveness Analysis Registry, EconLit and ProQuest Dissertations & Theses A&I via ProQuest, Embase, MEDLINE, and MEDLINE in Process via Ovid SP, Google and Google Scholar, Health Management and Policy Database via Ovid SP, IEEE Xplore Digital Library, International HTA Database, NHS EED via CRD Web, Science Citation Index-Expanded, Conference Proceedings Citation Index-Science, and Emerging Sources Citation Index via Web of Science, Scopus, and Zetoc conference search. Studies were included if they described the approach to purchasing (also known as procurement or acquisition) of high-cost medical devices and/or equipment conducted within hospitals in high-income countries between 2000 and 2020. Studies were screened, data extracted and results summarised in tables under themes identified. RESULTS: Of 9437 records, 24 were included, based in 12 different countries and covering equipment types including surgical robots, medical imaging equipment, defibrillators and orthopaedic implants. We found heterogeneity in methods and approaches; including descriptions of processes taking place within or across hospitals (n=14), out of which three reported cost savings; empirical studies in which hospital records or participant data were analysed (n=8), and evaluations or pilots of proposed purchasing processes (n=2). Studies emphasise the importance of balancing technical, financial, safety and clinical requirements for device selection through multidisciplinary involvement (especially clinical engineers and clinicians) in decision-making, and the potential of increasing evidence-based purchasing decisions using approaches such as hospital-based health technology assessments, ergonomics and device 'user trials'. CONCLUSIONS: We highlight the need for more empirical work that evaluates purchasing approaches or interventions, and greater specificity in study reporting (eg, equipment type, evaluation outcomes) to build the evidence base required to influence policy and practice for medical equipment purchasing. PROTOCOL REGISTRATION: This review was registered in Open Science Framework: Shokraneh F, Hinrichs-Krapels S, Chalkidou A et al. Purchasing high-cost medical equipment in hospitals in OECD countries: A systematic review. Open Science Framework 2021; doi:10.17605/OSF.IO/GTXN8. Available at: https://osf.io/gtxn8/ (accessed 12 February 2022).

A Retrospective Clinical Audit of the ImmunoCAP ISAC 112 for Multiplex Allergen Testing.

INTRODUCTION: Complex cases of multiple allergies can be particularly difficult to diagnose using standard methods such as skin prick tests and assessment of a patient's allergic history. Multiplex allergy testing may improve outcomes for allergy patients by avoiding misdiagnosis and providing reassurance. The ImmunoCAP Immuno Solid-Phase Allergen Chip (ISAC) 112 is a CE-marked, molecular, multiplex, allergy test that can test for IgE antibodies to 112 components from 51 allergen sources. However, its clinical utility is unknown and is difficult to estimate due to the complexity of the diagnostic pathway in which it is used. OBJECTIVE: To assess how the ImmunoCAP ISAC 112 is currently being used in UK practice. The patient populations in which it may have the most benefit were examined, and the sequence of other tests implemented alongside ISAC was determined. METHODS: A retrospective audit of 100 patient cases from 2 UK tertiary allergy clinics was performed. Fifty paediatric and fifty adult cases were selected for audit. The indications for ordering an ISAC test, the other tests used alongside ISAC, and changes in management actioned by the ISAC test were investigated. RESULTS: 73.6% of paediatric and 78% of adult patients referred for an ISAC test were suspected to have multiple sensitizations. The sequence of testing varied greatly between cases, but 70% of adult and 98% of paediatric patients had at least one other investigation prior to an ISAC test. In most cases, ISAC testing confirmed clinical suspicion. CONCLUSIONS: A prospective research study is necessary to further investigate the clinical utility and cost-effectiveness of the ISAC. A UK national registry would be of great benefit but will require a large resource base.

Use of the Americans in Motion-Healthy Intervention (AIM-HI) to create a culture of fitness in family practice.

BACKGROUND: Americans in Motion-Healthy Interventions (AIM-HI) is an initiative designed to assist family physicians with positioning fitness (physical activity, nutrition, and emotional well-being) as the treatment of choice for prevention and management of chronic disease. We investigated whether the concept of a culture of fitness would benefit office personnel and carry over to patient care. METHODS: This randomized, controlled trial provided an intervention based on the AIM-HI curriculum to 12 enhanced offices with support for office activities, while 12 traditional offices received only AIM-HI tools with encouragement for use with patients. Before intervention, at 4 months, and at 14 months, we measured the practice personnel's dietary behavior (PrimeScreen), physical activity (International Physical Activity Questionnaire), self-determined (intrinsic) motivation (Treatment Self-Regulation Questionnaire [TSRQ]), perceived ability to carry out health behaviors (Perceived Competence Scale), and readiness to improve and/or maintain health behaviors (Stages of Change). RESULTS: From 24 practices we enrolled 470 subjects; 21 practices completed the study, and data from 341 patients were analyzed. Differential change from baseline between the enhanced and traditional offices was not evident for behavior changes. An overall decrease from baseline in self-reported total physical activity measured as metabolic equivalent-minutes for all surveyed groups occurred over the study time period (4-month ß = -11.97; 14-month ß = -9.01; P = .003). A statistically significant increase occurred at 4 months among participants from the enhanced practices for the TSRQ outcomes of Healthy Eating (baseline, 3.00 ± 0.12; 4 months, 3.26 ± 0.13; P = .013). Among clinicians, TSRQ Healthy Eating scores increased from 3.19 ± 0.13 at baseline to 3.52 ± 0.14 at 4 months (P = .005). However, increases in TSRQ Eating scores were not sustained by 14 months. Stages of Change scores decreased from baseline to 4 months in enhanced group offices. There was also a decrease in Stages of Change scores among staff from baseline to 14 months. CONCLUSIONS: Primary care clinicians and office staff are resistant to health behavior change. External motivation did not seem to help them change. The effect of this intervention on patient care is not yet known.

Changes in malaria indices between 1999 and 2007 in The Gambia: a retrospective analysis.

BACKGROUND: Malaria is a major cause of morbidity and mortality in Africa. International effort and funding for control has been stepped up, with substantial increases from 2003 in the delivery of malaria interventions to pregnant women and children younger than 5 years in The Gambia. We investigated the changes in malaria indices in this country, and the causes and public-health significance of these changes. METHODS: We undertook a retrospective analysis of original records to establish numbers and proportions of malaria inpatients, deaths, and blood-slide examinations at one hospital over 9 years (January, 1999-December, 2007), and at four health facilities in three different administrative regions over 7 years (January, 2001-December, 2007). We obtained additional data from single sites for haemoglobin concentrations in paediatric admissions and for age distribution of malaria admissions. FINDINGS: From 2003 to 2007, at four sites with complete slide examination records, the proportions of malaria-positive slides decreased by 82% (3397/10861 in 2003 to 337/6142 in 2007), 85% (137/1259 to 6/368), 73% (3664/16932 to 666/11333), and 50% (1206/3304 to 336/1853). At three sites with complete admission records, the proportions of malaria admissions fell by 74% (435/2530 to 69/1531), 69% (797/2824 to 89/1032), and 27% (2204/4056 to 496/1251). Proportions of deaths attributed to malaria in two hospitals decreased by 100% (seven of 115 in 2003 to none of 117 in 2007) and 90% (22/122 in 2003 to one of 58 in 2007). Since 2004, mean haemoglobin concentrations for all-cause admissions increased by 12 g/L (85 g/L in 2000-04 to 97 g/L in 2005-07), and mean age of paediatric malaria admissions increased from 3.9 years (95% CI 3.7-4.0) to 5.6 years (5.0-6.2). INTERPRETATION: A large proportion of the malaria burden has been alleviated in The Gambia. Our results encourage consideration of a policy to eliminate malaria as a public-health problem, while emphasising the importance of accurate and continuous surveillance.

Update on enteral nutrition support for cystic fibrosis.

Cystic fibrosis (CF) is an inherited disease affecting the respiratory, gastrointestinal, hepatobiliary, and reproductive systems. Nutrition status in persons with CF is often compromised due to increased energy needs, frequent infections, pancreatic insufficiency, lung disease, or CF-related diabetes. Maintaining good nutrition status has been associated with better pulmonary function, reduced hospitalizations, and increased longevity. Nutrition support as oral supplementation (used in >37% of the CF population) or tube feeding (used in >13% of the CF population) is often required for children and adults with CF. The purpose of this update is to describe current consensus and evidence for enteral nutrition support guidelines, reported complications of enteral feeding in the CF population, evidence of expected outcomes, and to discuss related areas requiring further research. A case report is provided to illustrate potential outcomes of aggressive enteral support.