Institute for Clinical and Economic Review - Peterson Health Technology Institute value assessment framework for digital health technologies.

Digital health technologies (DHTs) are a broad and rapidly innovating class of interventions with distinctive pathways for development, regulatory approval, uptake and reimbursement. Given the unique nature of DHTs, existing value assessment frameworks and evidence standards for health technologies such as drugs and devices are not directly applicable. The value assessment framework presented here describes a conceptual model and associated methods to guide assessments of DHTs. The framework seeks to accomplish two goals: to set evidence standards that guide technology developers to generate robust evidence on their products; and to provide reviews that help organizations adopt high-impact DHTs with the strongest evidence for delivering improved clinical outcomes and cost savings. This assessment framework will serve as the roadmap for future evaluations of DHTs by the Institute for Clinical and Economic Review (ICER) and the Peterson Health Technology Institute (PHTI). We believe that all stakeholders will benefit from comprehensive and explicit standards of evidence on the different dimensions necessary to understand the value of DHTs.

Quality of life assessment in testicular non-seminomatous germ cell tumour survivors.

PURPOSE: Patients with Germ cell tumours (GCT) are at risk of long-term toxicities due to multimodality therapy. It is debatable whether there is an impact on the quality of life(QoL) of GCT survivors. METHODS: A case-control study was conducted at a tertiary care centre in India, using the EORTC QLQ C30 questionnaire, to compare the QoL between GCT survivors(disease free > 2 years) and healthy matched controls. A multivariate regression model was used to identify factors affecting QoL. RESULTS: A total of 55 cases and 100 controls were recruited. Cases had a median age of 32 years (interquartile range, IQR 28-40 years), ECOG PS of 0-1(75%), advanced stage III (58%), chemotherapy (94%) and 66% were > 5 years from diagnosis. The median age of controls: 35 years (IQR 28-43 years). A statistically significant difference was seen for emotional (85.8 ± 14.2 vs 91.7 ± 10.4, p 0.005), social(83.0 ± 22.0 vs 95.2 ± 9.6, p < 0.001) and global scales (80.4 ± 21.1 vs 91.3 ± 9.7, p < 0.001). Cases had more nausea and vomiting(3.3 ± 7.4 vs 1.0 ± 3.9, p 0.015), pain(13.9 ± 13.9 vs 4.8 ± 9.8, p < 0.001), dyspnea(7.9 + 14.3 vs 2.7 ± 9.1, p 0.007), and appetite loss(6.7 ± 14.9 vs 1.9 ± 7.9, p 0.016) and greater financial toxicity(31.5 ± 32.3 vs 9.0 ± 16.3, p < 0.001). Adjusting for age, performance status, BMI, stage, chemotherapy, RPLND, recurrent disease, and time since diagnosis, no predictive variables were significant. CONCLUSION: There is a detrimental impact of history of GCT in long term survivors of GCT.

Clinical Value of Patient-Specific Three-Dimensional Printing of Kidney Before Partial Nephrectomy: A Qualitative Assessment.

Objectives: To qualitatively assess the clinical usefulness of patient-specific high-fidelity three-dimensional (3D) print model of kidney before partial nephrectomy (PN) and to identify subset domains where it may help in clinical terms. Materials and Methods: Thirteen 3D models were printed for tumors having RENAL nephrometry score of ≥8. Their usage for PN was assessed prospectively using a qualitative questionnaire to be answered on a Likert scale of 1-10. The questions focused on realistic resemblance, preoperative dry surgical run, intertest comparison, surgical impact, and overall beneficence domains as perceived by primary surgeons with respect to surgical conduct during PN. Results: Mean RENAL score was 9.15 (8-11). Models were rated high (9.07 ± 0.86) for realistic resemblance domain and were rated better than contrast-enhanced computed tomography (CECT) (8.38 ± 0.87) and intraoperative ultrasonography (8.07 ± 1.26) for orientation regarding resection margins. A further marginal improvement to 8.2 ± 0.84 was noted against ultrasound where surgeon did a dry cut preoperatively. Use of superselective arterial approach in four, precise awareness about dissection of a major vessel in four, retroperitoneoscopic approach in one, and surgical margin awareness in three were directly attributed to the model. Overall utility of having a model printed was rated high (8.23 ± 1.3). Conclusion: The 3D print models of complex renal tumors have high realistic resemblance to actual patient's anatomy. They were rated better than preoperative CECT or intraoperative ultrasonography for orientation regarding surgical resection margins. It may also help change or modify the surgical plan in a subset of patients with a potential to improve overall outcomes in these complex cases.

Preparing for and responding to Covid-19's 'second hit'.

While already sobering, Covid-19 mortality projections only account for a portion of morbidity and mortality we should expect from the current outbreak - patients directly affected by Covid-19. Largely missing from current discussions is the indirect impact on a much broader set of patients affected the epidemic - patients who will experience greater morbidity and mortality from a wide range of clinical conditions due to disruptions in the provision of health care and other essential services - what we are describing here as the 'second hit' of Covid-19.

Why US Health Care Should Think Globally.

Why should health care systems in the United States engage with the world's poorest populations abroad while tremendous inequalities in health status and access are pervasive domestically? Traditionally, three arguments have bolstered global engagement: (1) a moral obligation to ensure opportunities to live, (2) a duty to protect against health threats, and (3) a desire to protect against economic downturns precipitated by health crises. We expand this conversation, arguing that US-based clinicians, organizational stewards, and researchers should engage with and learn from low-resource settings' systems and products that deliver high-quality, cost-effective, inclusive care in order to better respond to domestic inequities. Ultimately, connecting "local" and "global" efforts will benefit both populations and is not a sacrifice of one for the other.

Systemic Inflammatory Response Syndrome Following Percutaneous Nephrolithotomy: Assessment of Risk Factors and Their Impact on Patient Outcomes.

OBJECTIVES: To identify perioperative risk factors for postoperative systemic inflammatory response syndrome (SIRS) and suggest possible modifications to reduce morbidity. MATERIAL AND METHODS: We prospectively analysed perioperative data such as history of pervious stone surgery, number and configuration of stones, presence of stent or nephrostomy, any previous positive urine culture, intraoperative renal pelvic urine and stone culture, aspiration of turbid urine on initial puncture, number of tracts required and clearance of stones, operative time and intraoperative hypotension and tachycardia of all patients who underwent percutaneous nephrolithotomy over a period of 15 months. RESULTS: A total of 182 patients were included, average stone size was 2.8 cm, 36.2% had staghorn stones and 15.9% had an indwelling stent or nephrostomy. Despite sterile preoperative urine culture, renal pelvic urine culture (RPUC) was positive in 14.8% (27 patients) and stone culture was positive in 21.9% (40 patients). SIRS developed in 17.5% (32 patients) and septic shock in 1.09% (2 patients). On analysis younger age, positive RPUC and stone culture, longer operative time and intraoperative tachycardia correlated significantly with the development of SIRS. CONCLUSION: Intra-operative cultures are only therapy-guiding cultures during SIRS, as preoperative urine cultures seldom accurately depict bacteriological status of upper tracts and thus should be obtained in all patients.

Deployment of community health workers across rural sub-Saharan Africa: financial considerations and operational assumptions.

OBJECTIVE: To provide cost guidance for developing a locally adaptable and nationally scalable community health worker (CHW) system within primary-health-care systems in sub-Saharan Africa. METHODS: The yearly costs of training, equipping and deploying CHWs throughout rural sub-Saharan Africa were calculated using data from the literature and from the Millennium Villages Project. Model assumptions were such as to allow national governments to adapt the CHW subsystem to national needs and to deploy an average of 1 CHW per 650 rural inhabitants by 2015. The CHW subsystem described was costed by employing geographic information system (GIS) data on population, urban extents, national and subnational disease prevalence, and unit costs (from the field for wages and commodities). The model is easily replicable and configurable. Countries can adapt it to local prices, wages, population density and disease burdens in different geographic areas. FINDINGS: The average annual cost of deploying CHWs to service the entire sub-Saharan African rural population by 2015 would be approximately 2.6 billion (i.e. 2600 million) United States dollars (US$). This sum, to be covered both by national governments and by donor partners, translates into US$ 6.86 per year per inhabitant covered by the CHW subsystem and into US$ 2.72 per year per inhabitant. Alternatively, it would take an annual average of US$ 3750 to train, equip and support each CHW. CONCLUSION: Comprehensive CHW subsystems can be deployed across sub-Saharan Africa at cost that is modest compared with the projected costs of the primary-health-care system. Given their documented successes, they offer a strong complement to facility-based care in rural African settings.

The effect of an integrated multisector model for achieving the Millennium Development Goals and improving child survival in rural sub-Saharan Africa: a non-randomised controlled assessment.

BACKGROUND: Simultaneously addressing multiple Millennium Development Goals (MDGs) has the potential to complement essential health interventions to accelerate gains in child survival. The Millennium Villages project is an integrated multisector approach to rural development operating across diverse sub-Saharan African sites. Our aim was to assess the effects of the project on MDG-related outcomes including child mortality 3 years after implementation and compare these changes to local comparison data. METHODS: Village sites averaging 35,000 people were selected from rural areas across diverse agroecological zones with high baseline levels of poverty and undernutrition. Starting in 2006, simultaneous investments were made in agriculture, the environment, business development, education, infrastructure, and health in partnership with communities and local governments at an annual projected cost of US$120 per person. We assessed MDG-related progress by monitoring changes 3 years after implementation across Millenium Village sites in nine countries. The primary outcome was the mortality rate of children younger than 5 years of age. To assess plausibility and attribution, we compared changes to reference data gathered from matched randomly selected comparison sites for the mortality rate of children younger than 5 years of age. Analyses were done on a per-protocol basis. This trial is registered with ClinicalTrials.gov, number NCT01125618. FINDINGS: Baseline levels of MDG-related spending averaged $27 per head, increasing to $116 by year 3 of which $25 was spent on health. After 3 years, reductions in poverty, food insecurity, stunting, and malaria parasitaemia were reported across nine Millennium Village sites. Access to improved water and sanitation increased, along with coverage for many maternal-child health interventions. Mortality rates in children younger than 5 years of age decreased by 22% in Millennium Village sites relative to baseline (absolute decrease 25 deaths per 1000 livebirths, p=0·015) and 32% relative to matched comparison sites (30 deaths per 1000 livebirths, p=0·033). INTERPRETATION: An integrated multisector approach for addressing the MDGs can produce rapid declines in child mortality in the first 3 years of a long-term effort in rural sub-Saharan Africa. FUNDING: UN Human Security Trust Fund, the Lenfest Foundation, Bill & Melinda Gates Foundation, and Becton Dickinson.