Journal of Preventive Medicine and Public Health

Special Article

P>0.05 Is Good: The NORD-h Protocol for Several Hypothesis Analysis Based on Known Risks, Costs, and Benefits: Alessandro Rovetta, Mohammad Ali Mansournia; J Prev Med Public Health. 2024;57(6):511-520. Published online September 20, 2024; DOI: https://doi.org/10.3961/jpmph.24.250

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Abstract Summary PDF Supplementary Material

Statistical testing in medicine is a controversial and commonly misunderstood topic. Despite decades of efforts by renowned associations and international experts, fallacies such as nullism, the magnitude fallacy, and dichotomania are still widespread within clinical and epidemiological research. This can lead to serious health errors (e.g., misidentification of adverse reactions). In this regard, our work sheds light on another common interpretive and cognitive error: the fallacy of high significance, understood as the mistaken tendency to prioritize findings that lead to low p-values. Indeed, there are target hypotheses (e.g., a hazard ratio of 0.10) for which a high p-value is an optimal and desirable outcome. Accordingly, we propose a novel method that goes beyond mere null hypothesis testing by assessing the statistical surprise of the experimental result compared to the prediction of several target assumptions. Additionally, we formalize the concept of interval hypotheses based on prior information about costs, risks, and benefits for the stakeholders (NORD-h protocol). The incompatibility graph (or surprisal graph) is adopted in this context. Finally, we discuss the epistemic necessity for a descriptive, (quasi) unconditional approach in statistics, which is essential to draw valid conclusions about the consistency of data with all relevant possibilities, including study limitations. Given these considerations, this new protocol has the potential to significantly impact the production of reliable evidence in public health.

Summary

Key Message
The p-value is largely misused in medicine to classify results as “significant” and “non-significant” according to a sharp arbitrary threshold (typically 0.05), focusing only on the null hypothesis of exactly zero effect. Conversely, the NORD-h protocol offers an easy method to assess the degree of incompatibility (disagreement) between data and various meaningful effect sizes using the “s-value”. Unlike the p-value, the s-value is intuitive, representing the number “s” of consecutive heads in as many fair coin tosses. A simple graphical approach is proposed to avoid rigid cutoffs, promoting a nuanced interpretation of statistical findings based on cost-benefit analysis.

Citations

Citations to this article as recorded by

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Why is p-Value Controversial?
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Compatibility and S values versus traditional reporting in epidemiological studies
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Review

A Systematic Review of the Economic Evaluation of Telemedicine in Japan: Miki Akiyama, Byung-Kwang Yoo; J Prev Med Public Health. 2016;49(4):183-196. Published online June 22, 2016; DOI: https://doi.org/10.3961/jpmph.16.043

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Abstract PDF

Objectives
There is no systematic review on economic evaluations of telemedicine in Japan, despite over 1000 trials implemented. Our systematic review aims to examine whether Japan’s telemedicine is cost-saving or cost-effective, examine the methodological rigorousness of the economic evaluations, and discuss future studies needed to improve telemedicine’s financial sustainability.
Methods
We searched five databases, including two Japanese databases, to find peer-reviewed articles published between January 1, 2000 and December 31, 2014 in English and Japanese that performed economic evaluations of Japan’s telemedicine programs. The methodological rigorousness of the economic analyses was assessed with a well-established checklist. We calculated the benefit-to-cost ratio (BCR) when a reviewed study reported related data but did not report the BCR. All cost values were adjusted to 2014 US dollars.
Results
Among the 17 articles identified, six studies reported on settings connecting physicians for specialist consultations, and eleven studies on settings connecting healthcare providers and patients at home. There are three cost-benefit analyses and three cost-minimization analyses. The remaining studies measured the benefit of telemedicine only, using medical expenditure saved or users’ willingness-to-pay. There was substantial diversity in the methodological rigorousness. Studies on teledermatology and teleradiology indicated a favorable level of economic efficiency. Studies on telehomecare gave mixed results. One cost-benefit analysis on telehomecare indicated a low economic efficiency, partly due to public subsidy rules, e.g., a too short budget period.
Conclusions
Overall, telemedicine programs in Japan were indicated to have a favorable level of economic efficiency. However, the scarcity of the economic literature indicates the need for further rigorous economic evaluation studies.

Summary

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Original Articles

Risk-Based Damage Cost Estimation on Mortality Due to Environmental Problems.: Ye Shin Kim, Yong Jin Lee, Hoa Sung Park, Dong Chun Shin; Korean J Prev Med. 2003;36(3):230-238.

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Abstract PDF: OBJECTIVES
To estimate the value of statistical life (VSL) and health damage cost on theoretical mortality estimates due to environmental pollution. METHODS: We assessed the health risk on three environmental problems and eight sub-problems. Willingness to pay (WTP) was elucidated from a questionnaire survey with dichotomous contingent valuation method and VSL (which is the division of WTP by the change of risk reduction) calculated from WTP. Damage costs were estimated by multiplying VSL by the theoretical mortality estimates. RESULTS: VSLs from death caused by air pollution, indoor air pollution and drinking water contamination were about 0.3, 0.5 and 0.3 billion won, respectively. Damage costs of particulate matters (PM10) and radon were higher in the sub-problems and were above 100 billion won. Because damage cost depends on theoretical mortality estimate and WTP, its uncertainty is reduced in the estimating process. CONCLUSION: Health damage cost or risk benefit should be considered as one scientific criterion for decision making in environmental policy.; Summary

Cost-benefit Analysis of Mandatory Prescription in Korea.: Young Keon Jee, Han Joong Kim, Eun Cheol Park, Hye Young Kang; Korean J Prev Med. 2000;33(4):484-494.

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Abstract PDF: OBJECTIVE
To evaluate the relative benefits and the costs associated with the introduction of the new pharmaceutical provision called 'Mandatory Prescription Syste m' which separates the role of physicians from that of pharmacists with respect to the prescription and dispensation of from the perspective of consumers (i.e., patients). METHODS: The costs of the system were measured by considering both direct and indirect costs. Direct costs included additional payments for ambulatory care and dispensing fees that occurred under the new system. Indirect costs consisted of transportation expenses and costs related to time spent for physician consultation, waiting for the prescriptions to be filled, and extra traveling. Benefits identified in this study were the reduction of drug misuse and overuse, and the overall decrease in drug consumption among the Korean population. Sensitivity analysis was performed for the inclusion of benefits for outpatients of hospitals, price elasticity, and increased fees for established patients. RESULTS: The net benefit was estimated to be about minus 1,862 billion won and the benefit-cost ratio was 0.478. This indicates that the costs of 'Mandatory Prescription' outweigh its benefits, relative to the previous system. The sensitivity analysis results for all the variables considered in this study consistently showed the benefit-cost ratio to be less than 1. CONCLUSION: The results of this study suggest that implementing Mandatory Prescription System in Korea might be inefficient from the consumer's perspective. The results of this study do not coincide with the results of previous studies, presumably because of the differences in study design and in which items of costs and benefits were considered.; Summary

Cost-benefit Analysis of Massive Screening for Inborn Errors of Metabolism in Korea.: Chang Yup Kim, Sunmean Kim, Nami Hwang; Korean J Prev Med. 1999;32(3):317-324.

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Abstract PDF: OBJECTIVES
Since 1991, nationwide massive neonatal screen-ing program for phenylketonuria (PKU) and congenital hypothyroidism have been performed in Korea. As in many other countries, efficiency of this program has not been definitely concluded. For the purpose of evaluation of this program, from the perspective of efficiency, a cost-benefit analysis was carried out. METHODS: Costs of the detection and the treatment program were compared with the projected benefit(avoided costs) that results from the prevention of the mental retardation associated with the disorders due to PKU and hypothyroidism. Costs and benefits were discounted at an annual rate of 5 %, and duration of life-long labor was assumed to be 30 years. Cost and benefit were estimated based on the detection rates of one case of PKU per 5,572 and one case of congenital hypothyroidism per 32,554 babies screened during 1991-1997. RESULTS: The benefit-cost ratio was 0.418. The sensitivity analysis for the discount rates and labor durations showed that most cost-benefit ratios were lower than one(1.0) except when discount rate was changed to 3% and detection rate to two- or threefold and/or labor duration to 40 years. CONCLUSIONS: The result of this study suggested that present program of mass screening for PKU and congenital hypothyroidism could not be justified in terms of efficiency. It doesn't coincide with the results of previous studies in major developed countries, presumably because of difference in detection rates and welfare cost for the disabled.; Summary

Cost-Benefit Analysis of Back School Program for Occupational Low Back pain Patients.: Yeong Su Ju, Mi Na Ha, Sang Hwan Han, Ho Jang Kwon, Soo Hun Cho, Chang Yup Kim, Sun Min Kim; Korean J Prev Med. 1996;29(2):347-358.

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Abstract PDF: Although occupational low back pain accounts for 20~40% of all occupational illness and injury, there are limited numbers of studies regarding the effectiveness of back school program. The objective of this study was to evaluate the economic benefit of back school program for early return to work of occupational low back pain patients in the current occupational injury compensation and management system. The cost-benefit analysis in this study was conducted to evaluate the relative magnitude of benefit to cost. The total cost was estimated by calculating the value of components in back school program according to governmental budget protocol. The back school program was consisted of three major approaches, pain center, work-hardening program and functional restoration program and each of components had various facilities and experts. The total amount of cost was estimated as 250,866,220 won per year. The most promising type of back school program were quite intensive (a 3 to 5-week stay in a specialized center), therefore, if we adopted the 5-week stay course, 10 courses could be held in a year. Following to the medical act, 20 patients per doctor could participate in a each course, ie, total 200 patients in a year. As a result, we could estimate the cost of 1,254,331 won a patient. we estimated the benefit by using data of a few local labor offices about average medical treatment beneficiary and off-duty beneficiary of 46 occupational low back pain patients in 1994. Ullman and Larsson(1977) mentioned that the group of chronic low back pain patients who participated in back school program needed less time to recover by 48.4% of beneficiary duration. And in the trying to estimate the benefit, we asked 10 rehabilitation board certificate doctors about reduction proportion of treatment cost by introducing back school program. The answered reduction proportions were in the range of 30~45%, average 39%. As a final result, we could see that the introduction of back school program in treatment of chronic occupational low back pain patients could produce the benefit to cost ratio as 3.90 and 6.28. And we could conclude that the introduction of back school program was beneficial to current occupational injury compensation and management system.; Summary

Cost-Benefit Analysis on Rubella Vaccination Policy.: Young Jeon Shin, Bo Youl Choi, Hung Bae Park, Ok Ryun Moon, Bae Joong Yoon; Korean J Prev Med. 1994;27(2):337-365.

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Abstract PDF: Rubella is a viral disease with mild constitutional symptoms and generalized rashes ln childhood, it is an inconsequential illness, but when it occurs during early pregnant period, there are significant risks of heart defects, cataract, mental retardation to the fetus. The series of congenital defects induced by rubella is called 'congenital rubella syndrome'. Many research have been performed to find out more effective prevention program on rubella. The objectives of this study are, first, to calculate the incidence rate of acute rubella infection and congenital rubella syndrome in korea, second, to evaluate economic efficiency of several rubella vaccination policies and to offer data for the most reasonable decision on vaccination policy. Study populations are 663,312 children of one year-old in 1992. The author has performed cost-benefit analyses according to the three vaccination policies-U.S.A.'s. U.K's and Sweden's. In this study, the author got the incidence rate of acute rubella infection using the catalytic model. In the meantime, the author used 50 per 100,000 live births as the incidence rate of congenital rubella syndrome. The discount rate used in this study was 5 percent per annum. The sensitivity analyses were done with different discount rates (4%, 7%) and different incidence rate of congenital rubella syndrome (10,100 per 100,000 live births): The study results are as follows: 1. Without vaccination, lifetime expenditures per patient for acute rubella infection amount to 14,822 won and the total expenditures to about 3.1 billion won. Meanwhile, lifetime expenditures per patient for congenital rubella syndrome amount to about 91 million won and the total expenditures to about 16.3 billion won without vaccination. 2. The cost of vaccination for a child of one year old was 2,322 won and the total cost for the one year old children was about 1.5 billion won(American style). The cost for vaccination of female children at fifteen was about 339 million won (British style). And the cost of vaccination at one for both sex and female children at fifteen was about 1.9billion won (Swedish style). 3. The benefit to cost ratios of vaccination or female children at fifteen that is the british mode of rubella vaccination, was 60.0 at the level of 80 % population coverage and 48.6 at 100% coverage. It shows much higher benefit to cost ratio than those of the other two vaccination policies. 4. Both net benefits of vaccination at one (American style) and that of vaccinations at one and fifteen (Swedish style) range from about 17.0 billion to 17.8 billion won, those were larger than that of vaccinations of female children at fifteen(British style, about 16.0 billion). 5. In marginal cost-benefit analysis of only additional program or revaccination, the benefit to cost ratios were 3.6(80% coverage rate) or 0.6 (100% coverage rate). It implies that additional program was less efficient or inefficient 6. In sensitively analysis with different discount rates (4% or 7%) and different incidence rates of congenital rubella syndrome (l0 or 100 per 100,000 live births), the benefit to cost ratios has fluctuated in wide range. However, all the ratios of vaccination of female children at fifteen were higher than those of the others. Even under the most conservative assumption, the benefit to cost ratios of all the rubella vaccination policies were higher than 3.3. In conclusion all the rubella vaccination policies found to be cost-effective and particularly the vaccination of female children at fifteen was strongly recommended.; Summary

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