Identifying the Need for Good Practices in Health Technology Assessment: Summary of the ISPOR HTA Council Working Group Report on Good Practices in HTA.

The systematic use of evidence to inform healthcare decisions, particularly health technology assessment (HTA), has gained increased recognition. HTA has become a standard policy tool for informing decision makers who must manage the entry and use of pharmaceuticals, medical devices, and other technologies (including complex interventions) within health systems, for example, through reimbursement and pricing. Despite increasing attention to HTA activities, there has been no attempt to comprehensively synthesize good practices or emerging good practices to support population-based decision-making in recent years. After the identification of some good practices through the release of the ISPOR Guidelines Index in 2013, the ISPOR HTA Council identified a need to more thoroughly review existing guidance. The purpose of this effort was to create a basis for capacity building, education, and improved consistency in approaches to HTA-informed decision-making. Our findings suggest that although many good practices have been developed in areas of assessment and some other key aspects of defining HTA processes, there are also many areas where good practices are lacking. This includes good practices in defining the organizational aspects of HTA, the use of deliberative processes, and measuring the impact of HTA. The extent to which these good practices are used and applied by HTA bodies is beyond the scope of this report, but may be of interest to future researchers.

A Brief History of Awareness of the Link Between Alcohol and Fetal Alcohol Spectrum Disorder.

OBJECTIVE: Fetal alcohol spectrum disorder (FASD) is a medical term used to describe a range of mental and physical disabilities caused by maternal alcohol consumption. The role of alcohol as a teratogen and its effects on the cellular growth of the embryo and the fetus were not determined on scientific grounds until the late 1960s. However, the link between alcohol use during pregnancy and its harms to offspring might have been observed frequently over the many thousands of years during which alcohol has been available and used for social and other reasons. METHODS AND RESULTS: Using sources ranging from the biblical Book of Judges (pre-1700) up until the first public health bulletin (1977), we seek to provide an overview of the academic debate around early historical accounts ostensibly attributed to the awareness of alcohol as a prenatal teratogen as well as to describe the social and political influences that sculpted developments leading to the public recognition of FASD. CONCLUSIONS: Our analysis provides a brief overview of the discourse regarding historical awareness of the detrimental effects of prenatal alcohol exposure on fetal development leading to the formal recognition of FASD as a distinct clinical entity. Further research will be required to fully appreciate the scientific, medical, and societal ills associated with prenatal alcohol exposure.

The Standardization of Diagnostic Criteria for Fetal Alcohol Spectrum Disorder (FASD): Implications for Research, Clinical Practice and Population Health.

OBJECTIVE: Fetal Alcohol Spectrum Disorder (FASD) is a preventable disorder caused by maternal alcohol consumption and marked by a range of physical and mental disabilities. Although recognized by the scientific and medical community as a clinical disorder, no internationally standardized diagnostic tool yet exists for FASD. METHODS AND RESULTS: This review seeks to analyse the discrepancies in existing diagnostic tools for FASD, and the repercussions these differences have on research, public health, and government policy. CONCLUSIONS: Disagreement on the adoption of a standardised tool is reflective of existing gaps in research on the conditions and factors that influence fetal vulnerability to damage from exposure. This discordance has led to variability in research findings, inconsistencies in government messaging, and misdiagnoses or missed diagnoses. The objective measurement of the timing and level of prenatal alcohol exposure is key to bridging these gaps; however, there is conflicting or limited evidence to support the use of existing measures.

The Economic Contribution of Industry-Sponsored Pharmaceutical Clinical Trials.

PURPOSE: In pharmaceutical clinical trials, industrial sponsors pay for study drugs and related healthcare services. We conducted a study to determine industry's economic contribution of these trials to the Alberta healthcare system.  Methods: We used data from two trial centers for cancer and non-cancer trials at the University of Alberta. For each trial (cancer, non-cancer), we calculated the cost of drugs provided by the sponsors using the market price, the cost of clinical services, and the cost of administrative services that they paid. We extrapolated these results to all trials in Alberta based on information obtained from the registration website ClinicalTrials.gov.  Results: Our sample consisted of 40 non-cancer and 39 cancer drug trials which were initiated in 2012. The monetary value of the industry sponsors' contribution was $799,055 per non-cancer and $630,243 per cancer drug trial. Drugs (in-trial and post-trial) accounted for 84% of the total contribution of the non-cancer drug trials whereas it represented 93% of all trial-related contributions in the cancer category. The total province-wide contribution of industry-sponsored drug trials which were initiated in 2012 was estimated to be $101 million, including open-label drugs in the non-cancer category.  Conclusions: Industry-sponsored pharmaceutical trials represent a major economic contributor to clinical research within the province.

Life Expectancy of People with Fetal Alcohol Syndrome.

OBJECTIVES: To estimate the life expectancy and specify the causes of death among people with fetal alcohol syndrome (FAS). METHODS: Included were all patients recorded in Alberta provincial databases of inpatients, outpatients, or practitioner claims from 2003 to 2012. People with FAS were identified by ICD-9 code 760.71 and ICD-10 codes Q86.0 and P04.3, and were linked to the Vital Statistics Death Registry to get information about mortality. Life expectancy was estimated by using the life table template developed in the United Kingdom, which is recommended for estimating life expectancy in small areas or populations. RESULTS: The life expectancy at birth of people with FAS was 34 years (95% confidence interval: 31 to 37 years), which was about 42% of that of the general population. The leading causes of death for people with FAS were "external causes" (44%), which include suicide (15%), accidents (14%), poisoning by illegal drugs or alcohol (7%), and other external causes (7%). Other common causes of death were diseases of the nervous and respiratory systems (8% each), diseases of the digestive system (7%), congenital malformations (7%), mental and behavioural disorders (4%), and diseases of the circulatory system (4%). CONCLUSION: The life expectancy of people with FAS is considerably lower than that of the general population. As the cause of FAS is known and preventable, more attention devoted to the prevention of FAS is urgently needed.

Costs of Fetal Alcohol Spectrum Disorder in the Canadian Criminal Justice System.

We reviewed literature to estimate the costs of Fetal Alcohol Spectrum Disorder (FASD) in the Canadian Criminal Justice System (CJS), and to update the total costs of FASD in Canada. The results suggest FASD is costlier than previous estimates. The costs of FASD associated with the CJS are estimated at $3.9 billion a year, with $1.2 billion for police, $0.4 billion for court, $0.5 billion for correctional services, $1.6 billion for victims, and $0.2 billion for third-party. The updated total costs of FASD in Canada are $9.7 billion a year, of which CJS accounts for 40%, healthcare 21%, education 17%, social services 13%, and others 9%.

An economic evaluation of the parent-child assistance program for preventing fetal alcohol spectrum disorder in Alberta, Canada.

Parent-Child Assistance Program (P-CAP) is a 3-year home visitation/harm reduction intervention to prevent alcohol exposed births, thereby births with fetal alcohol spectrum disorder, among high-risk women. This article used a decision analytic modeling technique to estimate the incremental cost-effectiveness ratio and the net monetary benefit of the P-CAP within the Alberta Fetal Alcohol Spectrum Disorder Service Networks in Canada. The results indicate that the P-CAP is cost-effective and support placing a high priority not only on reducing alcohol use during pregnancy, but also on providing effective contraceptive measures when a program is launched.

Incidence and prevalence of fetal alcohol spectrum disorder by sex and age group in Alberta, Canada.

OBJECTIVES: To estimate incidence and prevalence of FASD by sex and age in Alberta, Canada. METHODS: We included all patients recorded in the Alberta provincial health databases of inpatients, outpatients, and practitioner claims from 2003 to 2012. The number of people with FASD were calculated from available data on FAS (ICD-9 code 760.71; ICD-10 codes Q86.0 and P04.3) and estimated prevalence of FASD among individuals diagnosed with 21 FASD-related conditions (identified by a literature review) for which there are ICD codes, such as learning disability, mental retardation, and nervous system defects (Table 1). Fractions of FASD-related diagnoses that can be attributed to alcohol use during pregnancy were estimated by a systematic review. The incidence was measured as the number of new cases per 1000 births. The prevalence was measured as the number of cases per 1000 population in 2012. RESULTS: Annually, 739 to 1884 people were born with FASD in Alberta establishing an incidence of 14.2 to 43.8 per 1000 births, depending on the length of follow-up. There were about 46,000 people living with FASD in Alberta 2012, including 6,000 FAS cases and 40,000 FASD-related cases. The prevalence of FASD was 11.7 (range 8.2 to 15.1) per 1000 population. The incidence and prevalence varied greatly by sex and age group. Generally, male and younger outnumbered female and older. CONCLUSION: This study suggests new incidence and prevalence of FASD, which are higher than what has been commonly used (1%), and its variations among sex and age groups.

Costs of health services utilization of people with fetal alcohol spectrum disorder by sex and age group in Alberta, Canada.

OBJECTIVES: To estimate the annual health services utilization (HSU) cost per person with FASD by sex and age; the lifetime HSU cost per person with FASD by sex, and the annual HSU cost of FASD for Alberta by sex. METHODS: The HSU costs of FASD including physician, outpatient, and inpatient services were described by sex and age. The costs per person-year were estimated by multiplying the average number of hospitalizations, outpatient visits, and physician visits per person-year by the average cost of each service. The annual HSU cost of FASD for Alberta was estimated by multiplying the annual HSU cost per person with FASD by the number of people living with FASD in Alberta in 2012. The lifetime HSU cost per person with FASD was estimated by sex for several lifespans ranging from 10 to 70 years. RESULTS: The annual cost of HSU for people with FASD in Alberta was $259 million, of which FAS accounted for 26%. The annual HSU cost per person with FAS and FASD were $6,200 and $5,600, respectively. The incremental annual HSU cost per person with FAS is $4,100 and with FASD is $3,400 as compared to the general population. The lifetime (70 years) HSU cost per person with FAS was $506,000 and with FASD was $245,000. Males had higher HSU costs than females. HSU costs of FAS and FASD varied greatly by age group. CONCLUSION: The findings suggest that FASD is a public health issue in Alberta and can be used for economic evaluations of FASD intervention and/or prevention in the province.

Potential impacts of the Alberta fetal alcohol spectrum disorder service networks on secondary disabilities: a cost-benefit analysis.

OBJECTIVES: To estimate the break-even effectiveness of the Alberta Fetal Alcohol Spectrum Disorder (FASD) Service Networks in reducing occurrences of secondary disabilities associated with FASD. METHODS: The secondary disabilities addressed within this study include crime, homelessness, mental health problems, and school disruption (for children) or unemployment (for adults). We used a cost-benefit analysis approach where benefits of the service networks were the cost difference between the two approaches: having the 12 service networks and having no service network in place, across Alberta. We used a threshold analysis to estimate the break-even effectiveness (i.e. the effectiveness level at which the service networks became cost-saving). RESULTS: If no network was in place throughout the province, the secondary disabilities would cost $22.85 million (including $8.62 million for adults and $14.24 million for children) per year. Given the cost of network was $6.12 million per year, the break-even effectiveness was estimated at 28% (range: 25% to 32%). DISCUSSION: Although not all benefits associated with the service networks are included, such as the exclusion of the primary benefit to those experiencing FASD, the benefits to FASD caregivers, and the preventative benefits, the economic and social burden associated with secondary disabilities will "pay-off" if the effectiveness of the program in reducing secondary disabilities is 28%.

Everybody's business: economic surveillance of public health services in Alberta, Canada.

BACKGROUND: To address public health risk factors, governments conduct interventions in many different ministries, including non-health ministries. In order to understand the scope and cost of public health in Alberta, we developed a survey of government public health interventions. We included any government ministry or public organization, which includes health as a stated objective. METHODS: A grey literature search was initially conducted, followed by 69 consultations with federal, provincial and municipal organizations. We captured information related to (i) the type of public health service provided; (ii) the associated costs (if available); and (iii) any additional ministry that may collaborate on the initiative. This information was then presented to lead ministry personnel for validation and verification. RESULTS: We covered 15 areas of public health and identified 23 federal and 21 provincial agencies and departments that were providing these services. Public health spending on current operations amounted to $327 per capita, of which 60.5% came from provincial non-health ministries. Capital expenditures were $256 per capita, of which 32.5% were from the federal government. CONCLUSIONS: Public health expenses by non-health ministries were greater than those for health ministries. Capital expenses were much greater than non-capital expenses. In order to measure the full impact of government public health, it is necessary to take a cross-ministerial approach.

A conceptual framework identifying sources of risk to patient safety in primary care.

The potential risks to patient safety in a primary care setting are different than the risks to patient safety in an acute care setting. The main differences arise from the organisational structures of primary care delivery and the greater involvement of patients in their care. To account for these differences, we present the Patient Safety in Primary Care Framework to conceptualise the sources of risk to patient safety.

Routine preoperative electrocardiogram and chest x-ray prior to elective surgery in Alberta, Canada.

PURPOSE: A study was undertaken to evaluate the utilization rates of routine preoperative electrocardiogram (ECG) and chest x-ray (CXR) by sex, age, and most frequent surgery type, and to estimate the total cost of these screening tests. METHODS: We included all patients undergoing elective surgery in Alberta from April 1, 2005 to March 31, 2007, except those with a cancer, trauma, or cardiac diagnosis. The utilization rate was equal to the number of tests divided by the number of elective surgeries. The total cost of the tests was estimated in Canadian dollars under a health care perspective and was equal to the number of tests multiplied by the cost per test. RESULTS: With utilization rates of 13.4% and 23.2%, routine preoperative ECG and CXR tests cost Alberta about $369,000 and $637,000 over 2 yrs, respectively. More than 80% of the cost was incurred by tests on patients aged 50 or older. The utilization rates of tests vary considerably among the most frequent surgeries, but not between men and women. CONCLUSIONS: Routine preoperative testing rates and costs are relatively low in Alberta. It is possible that general evidence widely disseminated over the past number of years regarding unnecessary routines in preoperative testing has had an effect. Further interventions to reduce them would be of little value.

History of the international societies in health technology assessment: International Society for Technology Assessment in Health Care and Health Technology Assessment International.

The International Society for Technology Assessment in Health Care (ISTAHC) was formed in 1985. It grew out of the increasing awareness of the international dimensions of health technology assessment (HTA) and the need for new communication methods at the international level. The main function of ISTAHC was to present an annual conference, which gradually grew in size, and also to generally improve in quality from to year. ISTAHC overextended itself financially early in the first decade of the 2000s and had to cease its existence. A new society, Health Technology Assessment international (HTAi), based on many of the same ideas and people, grew up beginning in the year 2003. The two societies have played a large role in making the field of HTA visible to people around the world and providing a forum for discussion on the methods and role of HTA.