Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations.

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.

Impact assessment of the incorporation of the rotavirus vaccine in the province of San Luis - Argentina.

Rotavirus (RV) is the main cause of acute gastroenteritis (AGE) in young children. The San Luis province of Argentina introduced RV vaccination in May 2013. We estimate vaccine impact (RVI) using real-world data. Data on all-cause AGE cases and AGE-related hospitalisations for San Luis and the adjacent Mendoza province (control group) were obtained and analysed by interrupted time-series methods. Regardless of the model used for counterfactual predictions, we estimated a reduction in the number of all-cause AGE cases of 20-25% and a reduction in AGE-related hospitalisations of 55-60%. The vaccine impact was similar for each age group considered (<1 year, <2 years and <5 years). RV vaccination was estimated to have reduced direct medical costs in the province by about 4.5 million pesos from May 2013 to December 2014. Similar to previous studies, we found a higher impact of RV vaccination in preventing severe all-cause AGE cases requiring hospitalisation than in preventing all-cases AGE cases presenting for medical care. An assessment of the economic value of RV vaccination could take other benefits into account in addition to the avoided medical costs and the costs of vaccination.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance.The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. A list of possible items based on a systematic review was created. A two round, modified Delphi panel consisting of representatives from academia, clinical practice, industry, government, and the editorial community was conducted. Out of 44 candidate items, 24 items and accompanying recommendations were developed. The recommendations are contained in a user friendly, 24 item checklist. A copy of the statement, accompanying checklist, and this report can be found on the ISPOR Health Economic Evaluations Publication Guidelines Task Force website (www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope CHEERS will lead to better reporting, and ultimately, better health decisions. To facilitate dissemination and uptake, the CHEERS statement is being co-published across 10 health economics and medical journals. We encourage other journals and groups, to endorse CHEERS. The author team plans to review the checklist for an update in 5 years.

Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study.

OBJECTIVE: To assess the risk of adverse perinatal events of vaccination of pregnant women with an MF59 adjuvanted vaccine. DESIGN: Cross sectional multicentre study. SETTING: 49 public hospitals in major cities in Argentina, from September 2010 to May 2011. PARTICIPANTS: 30,448 mothers (7293 vaccinated) and their 30,769 newborns. MAIN OUTCOME MEASURE: Primary composite outcome of low birth weight, preterm delivery, or fetal or early neonatal death up to seven days postpartum. RESULTS: Vaccinated women had a lower risk of the primary composite outcome (7.0% (n=513) v 9.3% (n=2160); adjusted odds ratio 0.80, 95% confidence interval 0.72 to 0.89). The propensity score analysis showed similar results. Adjusted odds ratios for vaccinated women were 0.74 (0.65 to 0.83) for low birth weight, 0.79 (0.69 to 0.90) for preterm delivery, and 0.68 (0.42 to 1.06) for perinatal mortality. These findings were consistent in further subgroup analysis. No significant differences in maternal outcomes were found. CONCLUSION: This large study using primary data collection found that MF59 adjuvanted A/H1N1 influenza vaccine did not result in an increased risk of adverse perinatal events and suggested a lower risk among vaccinated women. These findings should contribute to inform stakeholders and decision makers on the prescription of vaccination against influenza A/H1N1 in pregnant women.

The cost-effectiveness of screening for oral cancer in primary care.

OBJECTIVES: To use a decision-analytic model to determine the incremental costs and outcomes of alternative oral cancer screening programmes conducted in a primary care environment. DESIGN: The cost-effectiveness of oral cancer screening programmes in a number of primary care environments was simulated using a decision analysis model. Primary data on actual resource use and costs were collected by case note review in two hospitals. Additional data needed to inform the model were obtained from published costs, from systematic reviews and by expert opinion using the Trial Roulette approach. The value of future research was determined using expected value of perfect information (EVPI) for the decision to screen and for each of the model inputs. SETTING: Hypothetical screening programmes conducted in a number of primary care settings. Eight strategies were compared: (A) no screen; (B) invitational screen--general medical practice; (C) invitational screen--general dental practice; (D) opportunistic screen--general medical practice; (E) opportunistic screen--general dental practice; (F) opportunistic high-risk screen--general medical practice; (G) opportunistic high-risk screen--general dental practice; and (H) invitational screen--specialist. PARTICIPANTS: A hypothetical population over the age of 40 years was studied. MAIN OUTCOME MEASURES: The main measures were mean lifetime costs and quality-adjusted life-years (QALYs) of each alternative screening scenario and incremental cost-effectiveness ratios (ICERs) to determine the additional costs and benefits of each strategy over another. RESULTS: No screening (strategy A) was always the cheapest option. Strategies B, C, E and H were never cost-effective and were ruled out by dominance or extended dominance. Of the remaining strategies, the ICER for the whole population (age 49-79 years) ranged from pound 15,790 to pound 25,961 per QALY. Modelling a 20% reduction in disease progression always gave the lowest ICERs. Cost-effectiveness acceptability curves showed that there is considerable uncertainty in the optimal decision identified by the ICER, depending on both the maximum amount that the NHS may be prepared to pay and the impact that treatment has on the annual malignancy transformation rate. Overall, however, high-risk opportunistic screening by a general dental or medical practitioner (strategies F and G) may be cost-effective. EVPIs were high for all parameters with population values ranging from pound 8 million to pound 462 million. However, the values were significantly higher in males than females but also varied depending on malignant transformation rate, effects of treatment and willingness to pay. Partial EVPIs showed the highest values for malignant transformation rate, disease progression, self-referral and costs of cancer treatment. CONCLUSIONS: Opportunistic high-risk screening, particularly in general dental practice, may be cost-effective. This screening may more effectively be targeted to younger age groups, particularly 40-60 year olds. However, there is considerable uncertainty in the parameters used in the model, particularly malignant transformation rate, disease progression, patterns of self-referral and costs. Further study is needed on malignant transformation rates of oral potentially malignant lesions and to determine the outcome of treatment of oral potentially malignant lesions. Evidence has been published to suggest that intervention has no greater benefit than 'watch and wait'. Hence a properly planned randomised controlled trial may be justified. Research is also needed into the rates of progression of oral cancer and on referral pathways from primary to secondary care and their effects on delay and stage of presentation.

Análisis de decisión: diagnóstico de diarrea crónica asociada a la infección por HIV / Decision analysis: diagnostic approach in HIV infection associated chronic diarrhea

Chronic diarrhea is still a problem of difficult management in patients with AIDS, even in the HAART (Highly Active Antiretroviral Therapy) era. AIM: To establish the most appropriate diagnostic procedure for HIV infected patients, with CD4 count below 200 cells/ml and chronic diarrhea, starting on HAART. METHODS: Using a decision tree as the tool of a decision analysis, two alternatives were considered for the ethiologic diagnosis in AIDS associated chronic diarrhea. The compared alternatives were a minimal evaluation (stool culture and parasite stool examination), and complete evaluation (adding endoscopies with intestinal biopsies). The decision tree was constructed by TreeAge Data 32 software. Diagnostic and therapeutic data for both alternatives were obtained from medical publications. The outcome was the reported survival estimation for HIV infected patients with CD4 level bellow 200 cells/ml, starting HAART, with and without chronic diarrhea. RESULTS: In the basic analysis, as well as in the sensitivity analysis, a complete evaluation was the alternative that showed the highest expected value: 7.79 years of survival. The minimal evaluation showed a value of 7.05 years of survival. CONCLUSION: In HIV infected patients with chronic diarrhea and CD4 count below 200 cells/ml, starting on HAART, digestive endoscopies with biopsy samples are the best diagnostic approach.

La diarrea crónica constituye un problema de difícil manejo en pacientes con SIDA, aun en la era de las terapias antirretrovirales de alta eficacia (HAART). Objetivo: Establecer la conducta diagnóstica más adecuada frente a pacientes con infección por HIV, con niveles de linfocitos CD4+ menores a 200 células/mm 3 y diarrea crónica que comienza con HAART. Métodos: Utilizando el análisis de decisión, con un árbol de decisionescomo herramienta, se consideraron dos alternativas para el diagnóstico etiológico de la diarrea crónica asociada al SIDA. Las alternativas comparadas fueron la evaluación mínima (estudios microbiológicos de materia fecal) y la evaluación completa (adicionando estudios endoscópicos con biopsias). La construcción del árbol de decisiones se efectuó con el software TreeAge Data 32. Con datos obtenidos en la literatura, se estimaron las probabilidades diagnósticas y respuestas terapéuticaspara cada rama. En la estimación del resultado final se eligió la expectativa de vida publicada para pacientes con CD4 menores de 200 células/mm 3, que inician HAART, con y sin diarrea crónica. Resultados: Tanto en el escenario de base como en los análisisde sensibilidad llevados a cabo, la evaluación completa resultó la estrategia con mayor valor esperado. La expectativa de vida esperada fue de 7.79 años con ésta y de 7.05 años con la mínima. Conclusión: En pacientes HIV positivos con diarrea crónica, CD4 menores de 200 células/mm 3 y que inician HAART, las endoscopías digestivas con biopsias constituyen el major método para el diagnóstico etiológico.

Validation of a telephone-administered geriatric depression scale in a hispanic elderly population.

OBJECTIVE: To develop and validate a Spanish version of the Geriatric Depression Scale (GDS) for telephone administration. DESIGN, SETTING, AND PATIENTS: The original version of the GDS was translated into Spanish. A random sample of 282 ambulatory elderly individuals was contacted by phone. Those completing the phone GDS (GDS-T) were asked to schedule an appointment within two weeks in which we collected data on demographics, physical exam, functional and mental status, and a face-to-face version of the GDS (GDS-P). We estimated question-to-question kappa statistics and the Pearson correlation coefficient between the GDS-T and GDS-P scores. We evaluated reliability of the GDS-T and GDS-P using the Cronbach's alpha coefficient. We estimated the sensitivity, specificity, and criterion validity of the GDS using the DSM IV criteria for depression as our gold standard. RESULTS: Thirty patients (11%) refused to participate. Of the remaining 252 patients, 169 (67%) attended the personal interview. The Cronbach's alpha coefficient was 0.85 for GSD-P and 0.88 for GDS-T. Sensitivity and specificity were 88% and 82% for GDS-P and 84% and 79% for GDS-T. The prevalence of depression in the group completing both scales was 12.8% using the GDS-P and 14.9% using the GDS-T (P >.05). Among those who only completed the GDS-T, the prevalence was 22.7% (P <.05) suggesting that depressed patients kept their appointments less frequently. CONCLUSIONS: The telephone GDS had high internal consistency and was highly correlated with the validated personal administration of the scale, suggesting that it could be a valid instrument for screening of depression among elderly ambulatory Spanish-speaking patients. Because the depression rate was significantly higher among those not presenting to the personal evaluation, the adoption of GDS-T may help detect and plan early interventions in patients who otherwise would not be identified.

Magnesium for the treatment of nocturnal leg cramps: a crossover randomized trial.

BACKGROUND: Nocturnal leg cramps are a common health problem in the ambulatory setting. Our objective was to evaluate the efficacy of magnesium in the treatment of nocturnal leg cramps. METHODS: Our study was a crossover randomized double-blind placebo-controlled trial. We included patients from a large university-based ambulatory clinic in Buenos Aires, Argentina, with at least 6 cramps during the previous month. A total of 93 subjects took part in a 4-week washout period with placebo. Those who were still eligible (n = 45) were randomized to receive either (1) an oral dose of 900 mg magnesium citrate twice daily for 1 month, followed by a matching placebo for 1 month, or (2) the placebo first, followed by magnesium. Both groups had a 4-week washout period with placebo between each treatment month. Forty-two patients completed the 4-month study. The main outcome was the number of nocturnal leg cramps, and the secondary outcomes were duration, severity, and sleep disorders caused by those cramps. RESULTS: There were no significant differences between magnesium and placebo in any of the evaluated outcomes. The mean number of cramps was 11.1 (standard deviation [SD] +/- 7.3) for placebo versus 11.8 (SD +/- 7.6) for magnesium (P = .59). We observed a significant period-effect bias: All patients improved over time regardless of the treatment sequence they received. CONCLUSIONS: Magnesium was not effective for the treatment of nocturnal leg cramps. The period-effect bias probably occurred because of a combination of the natural history of this condition, a regression to the mean, and a true placebo effect.

Aspirin for primary prevention of cardiovascular events.

OBJECTIVE: The use of aspirin for primary prevention of cardiovascular events in the general population is controversial. The purpose of this study was to create a versatile model to evaluate the effects of aspirin in the primary prevention of cardiovascular events in patients with different risk profiles. DESIGN: A Markov decision-analytic model evaluated the expected length and quality of life for the cohort's next 10 years as measured by quality-adjusted survival for the options of taking or not taking aspirin. SETTING: Hypothetical model of patients in a primary care setting. PATIENTS: Several cohorts of patients with a range of risk profiles typically seen in a primary care setting were considered. Risk factors considered included gender, age, cholesterol levels, systolic blood pressure, smoking status, diabetes, and presence of left ventricular hypertrophy. The cohorts were followed for 10 years. Outcomes were myocardial infarction, stroke, gastrointestinal bleed, ulcer, and death. MAIN RESULTS: For the cases considered, the effects of aspirin varied according to the cohort's risk profile. By taking aspirin, the lowest-risk cohort would be the most harmed with a loss of 1.8 quality-adjusted life days by taking aspirin; the highest risk cohort would achieve the most benefit with a gain of 11.3 quality-adjusted life days. Results without quality adjustment favored taking aspirin in all the cohorts, with a gain of 0.73 to 8.04 days. The decision was extremely sensitive to variations in the utility of taking aspirin and to aspirin's effects on cardiovascular mortality. The model was robust to other probability and utility changes within reasonable parameters. CONCLUSIONS: The decision of whether to take aspirin as primary prevention for cardiovascular events depends on patient risk. It is a harmful intervention for patients with no risk factors, and it is beneficial in moderate and high-risk patients. The benefits of aspirin in this population are comparable to those of other widely accepted preventive strategies. It is especially dependent on the patient's risk profile, patient preferences for the adverse effects of aspirin, and on the level of beneficial effects of aspirin on cardiovascular-related mortality.

Molecular characterization of HLA class II genes in celiac disease patients of Latin American Caucasian origin.

In the present study, the polymorphic domain of HLA class II genes present in a pediatric population of Argentinian celiac disease patients was analyzed by hybridization to sequence-specific oligonucleotides and DNA sequencing. Sixteen out of 16 DR5/7 heterozygous patients bore the DQA1*0501 and DQB1*0201 alleles implicated in the DQ2 risk specificity. The second exon of DQA1, DQB1 and DRB1 genes from 2 DR5/7 patients was characterized by DNA sequencing. The following alleles were found in both patients: DRB1*1101 and DRB1*0701; DQB1*0301 and DQB1*0201; DQA1*0501 and DQA1*0201. Previous serological analysis in this population had shown the presence of DQ2 in 95% of the patients (40% in controls) and a negative association with DQ1 haplotypes, suggesting the presence of other "permissive" or neutral alleles. The following HLA-DQB1 alleles, besides DQB1*0201, were identified in 31 CD patients: DQB1*0301, 0302, 0401 and 0402. All these alleles share a common pattern of residues between positions 84 and 90, and distinct from that present in DQ1-related alleles.