Predicting time trade-off health state valuations of adolescents in four Pacific countries using the assessment of quality-of-life (AQoL-6D) instrument

Objectives: Pacific Obesity Prevention in Communities (OPIC) is a community-based intervention project targeting adolescent obesity in Australia, New Zealand, Fiji, and Tonga. The Assessment of Quality of Life Mark 2 (AQoL-6D) instrument was completed by 15,481 adolescents to obtain a description of the quality of life associated with adolescent overweight and obesity, and a corresponding utility score for use in a cost–utility analysis of the interventions. This article describes the recalibration of this utility instrument for adolescents in each country.

Methods: The recalibration was based on country-specific time trade-off (TTO) data for 30 multiattribute health states constructed from the AQoL-6D descriptive system. Senior secondary students, in a classroom setting, responded to 10 health state scenarios each. These TTO interviews were conducted for 24 groups, comprising 279 students in the four countries resulting in 2790 completed TTO scores. The TTO scores were econometrically transformed by regressing the TTO scores upon predicted scores from the AQoL-6D to produce country-specific algorithms. The latter incorporated country-specific “corrections” to the Australian adult utility weights in the original AQoL.

Results: This article reports two methodological elements not previously reported. The first is the econometric modification of an extant multi-attribute utility instrument to accommodate cultural and other group-specific differences in preferences. The second is the use of the TTO technique with adolescents in a classroom group setting. Significant differences in utility scores were found between the four countries.

Conclusion: Statistical results indicate that the AQoL-6D can be validly used in the economic evaluation of both the OPIC interventions and other adolescent programs.

Maximising clinical trial participation - how important is the social context?

Individuals participate in clinical research for a variety of reasons, dependant not only on the trial phase and their own clinical status but also their sense of optimism, altruism, clinician influence, or financial gain. Practical factors influencing participation may include geographical access, motivation, availability, and language spoken. Widely-used health psychology models (e.g the Theory of Reasoned Action, the Health Belief Model) demonstrate that, in addition to these factors, the primary reason for non-participation in clinical research is social perception of risk. These models detail how beliefs and attitudes toward clinical research develop within, and are influenced by, an individual's social context. Perceived social benefits and barriers toward participation are considered alongside perceived susceptibility and severity of side-effects from participation, or symptoms of disease. A major factor in such models is the subjective norm i.e. individuals' beliefs that important others expect or wish him/her to perform this behaviour, and the motivation to act in accordance with their expectations or wishes. This includes, but is not limited to, the role of the media, peers and family members, clarification of risk associated with trial participation and discussion of comparative risk, and risk equivalence between trials and same treatment outside trials.
The workshop will involve a 30 minute presentation from the discussion leaders and a 30 minute group-work session to explore how an understanding of the social context of participation in clinical research can maximise appropriate clinical trial participation.

Health beliefs - what role do they play in outcomes research?

Lay beliefs about health and illness are individual and social, influenced by prevailing social and medical ideologies. Health beliefs clearly influence self-care motivation and have an effect on health-promoting behaviour (e.g. attendance at a screening program, food choices, adherence to prescribed medication). Further, the beliefs and attributions that people hold can directly affect physiological systems (e.g. the immune system). Health beliefs have been shown to influence a variety of patient-reported outcomes, including medication adherence, satisfaction and health-related quality of life. It is widely acknowledged that when the patient's beliefs are acknowledged and incorporated, rather than ignored, optimal biomedical patient-reported outcomes are more likely to be achieved. Several psychological models have been developed to predict health behaviours and may be utilised to identify the beliefs that inform such behaviours. These models consider the social milieu, personality, demographic, political and economic predictors of health beliefs. They demonstrate the impact of beliefs such as the causes of illness, effectiveness of healthcare and acceptability of health services, and how manipulating these can result in actual or intended behaviour change. This workshop will introduce health beliefs and discuss the psychological models that underpin the translation of belief into behaviour. The session is interactive, with participants defining health beliefs and their impact on behaviour. Participants will be invited to critique the models and apply their chosen model to a health indication of their choice.

Missing Data - implications for outcomes research and strategies to maximise data integrity

he workshop will firstly provide an overview of the problems associated with missing data within the context of clinical trials and how to minimise these. Missing data will be explored by modeling the impact on a number of datasets. This approach will be invaluable in highlighting how alternative methods for controlling for missing data impact differentially on the interpretation of study findings. Popular strategies involve options based on an assessment of the percentage of missing data. More innovative approaches to the management of missing data (e.g. based upon reliability analyses) will be explored and evaluated and the role of the most popular methods of data management explored in several study designs beyond those of the classic randomised controlled trial. Participants will have the opportunity to appraise and debate existing methods of missing data handling.

Intervenções farmacêuticas na atenção à saúde mental: Uma revisão

Uma revisão dirigida foi realizada nas bases de dados IBECS, LILACS e MEDLINE, até fevereiro/2011, para identificar intervenções farmacêuticas (IF) na atenção farmacêutica em saúde mental e os seus resultados. Para a busca utilizaram-se os descritores em saúde: Pharmaceutical Care, Pharmaceutical Services, Medication Adherence, Pharmacists, Mental Health, Mental Health Services, Mental Health Assistance, Community Mental Health Services, Mentally Ill Persons andMental Disorders. Identificaram-se 1686 publicações, das quais 21 contemplaram os critérios de inclusão. Após exploração do material, apenas cinco estudos tratavam-se de IF. Todos foram conduzidos no nível secundário de atenção, com abordagem individual, por meio do acompanhamento da terapia (3), intervenção educativa por cartas a médicos e pacientes (1), aconselhamento farmacêutico presencial e remoto e inserção de terapia com sistema transdérmico de nicotina (1). Os resultados, tais como promoção da adesão e resolução de problemas relacionados a medicamentos foram positivos para a terapêutica. No entanto, é necessário que as IF monitorem os parâmetros clínicos, as mudanças de hábitos, a melhora na qualidade de vida e os aspectos farmacoeconômicos a fim de avaliar os seus impactos. Palavras-chave:Atenção Farmacêutica. Assistência Farmacêutica. Adesão à Medicação. Farmacêuticos. Saúde Mental. ABSTRACT Pharmaceutical interventions in mental health services: a review A directed review was performed in IBECS, LILACS and MEDLINE databases, until February/2011, in order to identify the studies which developed pharmaceutical interventions (PI) in pharmaceutical care in mental health services and estimated their results. The search was carried out using the follow health science descriptors: Pharmaceutical Care, Pharmaceutical Services, Medication Adherence, Pharmacists, Mental Health, Mental Health Services, Mental Health Assistance, Community Mental Health Services, Mentally Ill Persons andMental Disorders. It was identified 1686 manuscripts, of whose 21 contemplated the inclusion criteria. After the content analysis of the eligible manuscripts, only five developed PI. All of them were conducted in the second level of health care, with individual approach, through: therapy follow-up (3), educational interventions by letters to physicians and patients (1), presence or remote pharmaceutical counseling and inclusion of therapy with nicotine transdermal patch (1). The data, such as adherence promotion and solving drug related problems, were positive for the therapeutic. However, it is necessary that the PI monitor the clinical parameters, the habit changes, the improvement in the quality of life and the pharmacoeconomic aspects, in order to assess their impacts. Keywords: Pharmaceutical Care. Pharmaceutical Services. Medication Adherence. Pharmacists. Mental Health. Mental Disorders.

Avalição da eficácia dos biocurativos em ratos Wistar com lesões de pele causadas por queimaduras

Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

Avaliação da eficácia dos biocurativos em ratos wistar com lesões de pele causadas por queimaduras

Accidents caused by thermal, chemical, electrical or radioactive agents cause skin lesions causing burns of varying degrees. The therapeutic approach aims to restore damaged tissues and involves a wide range of products on the market. This study aims to evaluate the use of biological dressing, biotech product developed at the Blood Center of Botucatu / UNESP obtained from fresh frozen plasma or platelet concentrate with in vitro addition of thrombin and calcium gluconate. This addition in the platelet concentrate, intended to release the active growth factors of the platelets granules on the healing process. The study of the effectiveness of Platelet Gel home made in Wistar rats was established, in agreement with scald burns, comparing efficacy and cost of Platelet Gel with usual hospital -based treatment collagenase + chloramphenicol plus cost analysis through pharmacoeconomics. We used 25 Wistar rats were divided into 3 treatment groups: Group A, Collagenase + Chloramphenicol; Group B, Platelet Gel and C, control. The products were applied every other day for 30 days in animals. In group A, there was the presence of erythema and crust in all animals. The exudates was indentified 2/10 animals. For the Group B, we observed the presence of erythema and crust at all and no presence of exudates. In group C all the animals showed erythema with no presence of exudates and scab occurred in 1/10. Statistical analysis showed significant difference ( p < 0.0 ) for crust formation between Groups B and C. In the histological analysis, group A showed a slight amount of blood vessels and collagen fibers, moderate amounts of macrophages and fibroblasts was observed while B and C groups showed moderate amounts of blood vessels, macrophages and fibroblasts and discreet presence of collagen fibers. The re-epithelialization occurred in most animals of all groups without significant statistical differences. For the aspects of pharmacoeconomics, the platelet gel presented a better cost - effectiveness in relation to treatment based on collagenase / chloramphenicol. In light of the ethical aspects of the raw material is the result of spontaneous blood donation, the proposal should have biological dressings productions the responsibility of public blood transfusion centers for free distribution. This may point to the production chain of Brazilian blood banks like special blood components for use no intravenous.

Adaptação transcultural do formulário POLST: Physician Orders for Life-Sustaining Treatment

Pós-graduação em Saúde Coletiva - FMB

An economic evaluation of antihypertensive therapies based on clinical trials

OBJECTIVE: Hypertension is a major issue in public health, and the financial costs associated with hypertension continue to increase. Cost-effectiveness studies focusing on antihypertensive drug combinations, however, have been scarce. The cost-effectiveness ratios of the traditional treatment (hydrochlorothiazide and atenolol) and the current treatment (losartan and amlodipine) were evaluated in patients with grade 1 or 2 hypertension (HT1-2). For patients with grade 3 hypertension (HT3), a third drug was added to the treatment combinations: enalapril was added to the traditional treatment, and hydrochlorothiazide was added to the current treatment. METHODS: Hypertension treatment costs were estimated on the basis of the purchase prices of the antihypertensive medications, and effectiveness was measured as the reduction in systolic blood pressure and diastolic blood pressure (in mm Hg) at the end of a 12-month study period. RESULTS: When the purchase price of the brand-name medication was used to calculate the cost, the traditional treatment presented a lower cost-effectiveness ratio [US$/mm Hg] than the current treatment in the HT1-2 group. In the HT3 group, however, there was no difference in cost-effectiveness ratio between the traditional treatment and the current treatment. The cost-effectiveness ratio differences between the treatment regimens maintained the same pattern when the purchase price of the lower-cost medication was used. CONCLUSIONS: We conclude that the traditional treatment is more cost-effective (US$/mm Hg) than the current treatment in the HT1-2 group. There was no difference in cost-effectiveness between the traditional treatment and the current treatment for the HT3 group.

Value Assessment of Orphan Drugs and Treatments for Rare Diseases

Thesis (Master's)--University of Washington, 2016-06

A model to assess the cost effectiveness of statins in achieving the UK National Service Framework target cholesterol levels

Background: Coronary heart disease (CHD) is a public health priority in the UK. The National Service Framework (NSF) has set standards for the prevention, diagnosis and treatment of CHD, which include the use of cholesterol-lowering agents aimed at achieving targets of blood total cholesterol (TC) < 5.0 mmol/L and low density lipoprotein-cholesterol (LDL-C) < 3.0 mmol/L. In order to achieve these targets cost effectively, prescribers need to make an informed choice from the range of statins available. Aim: To estimate the average and relative cost effectiveness of atorvastatin, fluvastatin, pravastatin and simvastatin in achieving the NSF LDL-C and TC targets. Design: Model-based economic evaluation. Methods: An economic model was constructed to estimate the number of patients achieving the NSF targets for LDL-C and TC at each dose of statin, and to calculate the average drug cost and incremental drug cost per patient achieving the target levels. The population baseline LDL-C and TC, and drug efficacy and drug costs were taken from previously published data. Estimates of the distribution of patients receiving each dose of statin were derived from the UK national DIN-LINK database. Results: The estimated annual drug cost per 1000 patients treated with atorvastatin was £289 000, with simvastatin £315 000, with pravastatin £333 000 and with fluvastatin £167 000. The percentages of patients achieving target are 74.4%, 46.4%, 28.4% and 13.2% for atorvastatin, simvastatin, pravastatin and fluvastatin, respectively. Incremental drug cost per extra patient treated to LDL-C and TC targets compared with fluvastafin were £198 and £226 for atorvastatin, £443 and £567 for simvastatin and £1089 and £2298 for pravastatin, using 2002 drug costs. Conclusions: As a result of its superior efficacy, atorvastatin generates a favourable cost-effectiveness profile as measured by drug cost per patient treated to LDL-C and TC targets. For a given drug budget, more patients would achieve NSF LDL-C and TC targets with atorvastatin than with any of the other statins examined.

Cabazitaxel for Hormone-Relapsed Metastatic Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology based upon the company's submission to NICE. Clinical evidence for cabazitaxel was derived from a multinational randomised open-label phase III trial (TROPIC) of cabazitaxel plus prednisone or prednisolone compared with mitoxantrone plus prednisone or prednisolone, which was assumed to represent best supportive care. The NICE final scope identified a further three comparators: abiraterone in combination with prednisone or prednisolone; enzalutamide; and radium-223 dichloride for the subgroup of people with bone metastasis only (no visceral metastasis). The company did not consider radium-223 dichloride to be a relevant comparator. Neither abiraterone nor enzalutamide has been directly compared in a trial with cabazitaxel. Instead, clinical evidence was synthesised within a network meta-analysis (NMA). Results from TROPIC showed that cabazitaxel was associated with a statistically significant improvement in both overall survival and progression-free survival compared with mitoxantrone. Results from a random-effects NMA, as conducted by the company and updated by the ERG, indicated that there was no statistically significant difference between the three active treatments for both overall survival and progression-free survival. Utility data were not collected as part of the TROPIC trial, and were instead taken from the company's UK early access programme. Evidence on resource use came from the TROPIC trial, supplemented by both expert clinical opinion and a UK clinical audit. List prices were used for mitoxantrone, abiraterone and enzalutamide as directed by NICE, although commercial in-confidence patient-access schemes (PASs) are in place for abiraterone and enzalutamide. The confidential PAS was used for cabazitaxel. Sequential use of the advanced hormonal therapies (abiraterone and enzalutamide) does not usually occur in clinical practice in the UK. Hence, cabazitaxel could be used within two pathways of care: either when an advanced hormonal therapy was used pre-docetaxel, or when one was used post-docetaxel. The company believed that the former pathway was more likely to represent standard National Health Service (NHS) practice, and so their main comparison was between cabazitaxel and mitoxantrone, with effectiveness data from the TROPIC trial. Results of the company's updated cost-effectiveness analysis estimated a probabilistic incremental cost-effectiveness ratio (ICER) of £45,982 per quality-adjusted life-year (QALY) gained, which the committee considered to be the most plausible value for this comparison. Cabazitaxel was estimated to be both cheaper and more effective than abiraterone. Cabazitaxel was estimated to be cheaper but less effective than enzalutamide, resulting in an ICER of £212,038 per QALY gained for enzalutamide compared with cabazitaxel. The ERG noted that radium-223 is a valid comparator (for the indicated sub-group), and that it may be used in either of the two care pathways. Hence, its exclusion leads to uncertainty in the cost-effectiveness results. In addition, the company assumed that there would be no drug wastage when cabazitaxel was used, with cost-effectiveness results being sensitive to this assumption: modelling drug wastage increased the ICER comparing cabazitaxel with mitoxantrone to over £55,000 per QALY gained. The ERG updated the company's NMA and used a random effects model to perform a fully incremental analysis between cabazitaxel, abiraterone, enzalutamide and best supportive care using PASs for abiraterone and enzalutamide. Results showed that both cabazitaxel and abiraterone were extendedly dominated by the combination of best supportive care and enzalutamide. Preliminary guidance from the committee, which included wastage of cabazitaxel, did not recommend its use. In response, the company provided both a further discount to the confidential PAS for cabazitaxel and confirmation from NHS England that it is appropriate to supply and purchase cabazitaxel in pre-prepared intravenous-infusion bags, which would remove the cost of drug wastage. As a result, the committee recommended use of cabazitaxel as a treatment option in people with an Eastern Cooperative Oncology Group performance status of 0 or 1 whose disease had progressed during or after treatment with at least 225 mg/m(2) of docetaxel, as long as it was provided at the discount agreed in the PAS and purchased in either pre-prepared intravenous-infusion bags or in vials at a reduced price to reflect the average per-patient drug wastage.