Patient-centered medicine and patient-oriented research: improving health outcomes for individual patients

BACKGROUND: Patient-centered medicine is developing alongside the concepts of personalized medicine and tailored therapeutics. The main objective of patient-centered medicine is to improve health outcomes of individual patients in everyday clinical practice, taking into account the patient’s objectives, preferences, values as well as the available economic resources. DISCUSSION: Patient-centered medicine implies a paradigm shift in the relationship between doctors and patients, but also requires the development of patient-oriented research. Patient-oriented research should not be based on the evaluation of medical interventions in the average patient, but on the identification of the best intervention for every individual patient, the study of heterogeneity and the assignment of greater value to observations and exceptions. The development of information-based technologies can help to close the gap between clinical research and clinical practice, a fundamental step for any advance in this field. SUMMARY: Evidence-based medicine and patient centered medicine are not contradictory but complementary movements. It is not possible to practice patient-centered medicine that is not based on evidence, nor is it possible to practice evidence-based medicine at a distance from the individual patient

Performance Measurement Systems, Competitive Priorities, and Advanced Manufacturing Technologies: Some Evidence from the Aeronautical Sector

Purpose – When acquiring advanced manufacturing technologies (AMT), the greatest caution should be taken regarding the performance measurement system to be used: the decision regarding new investments should not be conditioned by the excessive use of financial indicators to the detriment of the strategic objectives that motivated the investments. It is intended to analyze the aeronautical sector, for which the purchase of AMT is qualifying criteria, with two intentions: first, to identify the performance measurement systems that are used, and second, to test their correspondence with the objectives that motivated the investments. Design/methodology/approach – A survey of the 20 plants in the population was conducted via a postal questionnaire plus a structured interview. The unit of analysis has been maintained through the triangulation of data sources. Findings – The findings suggest that both financial and non-financial indicators are used, with the latter gaining predominance over the former on some occasions, even though there is no clear correspondence between strategy and the measurement of performance. In the light of the findings, the question of what inspires a company’s performance measurement system is still open, especially in those cases where there is no explicit strategy. With regard to practical implications, what seems to be indispensable is an improvement in the determination of the critical variables that should be used to measure performance. Research limitations/implications – Being valuable for academics and practitioners, this contribution relies, rather, on the possibility of a logical extrapolation to circumstances where the findings might apply, and researchers can judge whether the particular findings would be valid. Originality/value – Provides new evidence on the adaptation of the make-up and combination of the type of performance measures currently used by plants in the aeronautical industry, one of the sectors in which technological innovation is of the utmost importance.Publicad

Adopting and Implementing AMT: New Data on Key Factors from the Aeronautical Industry.

The objective of this paper is to take a greater in-depth look at which factors might be considered to be key to the performance of investments made in advanced manufacturing technologies (AMT), given their supposed positive effects, and on the influence that the time these factors are taken into account during the adoption and implementation process can have on that relationship. It provides a specially devised empirical analysis in the aeronautical sector in the south of Spain. A survey of the 20 plants in the population was conducted via a postal questionnaire between July 1999 and April 2001, with a structured interview being held at a later date. The testing of hypotheses was performed by applying the t-test to independent samples. The results show that the only factor that has a clear and positive effect on performance is the training of personnel. It can also be seen that a lack of strategic planning contributes to dampening the effects of investments. These results may be of some help to management staff and public administrators in charge of promoting the process of technological innovation, by indicating actions that need to be taken in order to successfully adopt and implement AMT.

Problems and solutions in calculating quality-adjusted life years (QALYs)

The quality-adjusted life-year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life and quality of life, the QALY was developed as an attempt to combine the value of these attributes into a single index number. The QALY calculation is simple: the change in utility value induced by the treatment is multiplied by the duration of the treatment effect to provide the number of QALYs gained. QALYs can then be incorporated with medical costs to arrive at a final common denominator of cost/QALY. This parameter can be used to compare the cost-effectiveness of any treatment. Nevertheless, QALYs have been criticised on technical and ethical grounds. A salient problem relies on the numerical nature of its constituent parts. The appropriateness of the QALY arithmetical operation is compromised by the essence of the utility scale: while life-years are expressed in a ratio scale with a true zero, the utility is an interval scale where 0 is an arbitrary value for death. In order to be able to obtain coherent results, both scales would have to be expressed in the same units of measurement. The different nature of these two factors jeopardises the meaning and interpretation of QALYs. A simple general linear transformation of the utility scale suffices to demonstrate that the results of the multiplication are not invariant. Mathematically, the solution to these limitations happens through an alternative calculation of QALYs by means of operations with complex numbers rooted in the well known Pythagorean theorem. Through a series of examples, the new calculation arithmetic is introduced and discussed

Treat-to-target and treat-to-budget in rheumatoid arthritis: Measuring the value of Individual therapeutic interventions

Treat-to-target (T2T) and dose tapering after obtaining the therapeutic objective (called “treat-to-budget”-T2B-in this Commentary) are the two most commonly used therapeutic strategies in rheumatoid arthritis. In theory, both strategies could add value to the healthcare system, although they are focused on different objectives: T2T strategy improves outcomes but increases short-term costs, while the cost savings obtained through T2B are associated with higher relapse rates. The systematic implementation of both strategies must be founded on solid evidence of their effectiveness and efficiency. However, the level of evidence between guidelines and individual studies is inconsistent for both strategies and the number and the quality of cost-effectiveness analyses is scarce. Raising the level of evidence requires a move from generalization to individualization by conducting randomized clinical trials that assess each of the many strategies that fall under the umbrella of the overall T2T and T2B concepts. In addition, such studies should consider the therapeutic goals and impact of the disease from the perspective of individual patients, which is only possible by promoting shared decision-makingFee were funded by Lilly Spai

Clinical pharmacology facing the real-world setting: Pharmacovigilance, pharmacoepidemiology and the economic evaluation of drugs

Adverse drug reaction; Effectiveness; PharmacoeconomicsReacció adversa als fàrmacs; Eficàcia; FarmacoeconomiaReacción adversa a medicamentos; Eficacia; FarmacoeconomíaTraditionally, clinical pharmacology has focused its activities on drug-organism interaction, from an individual or collective perspective. Drug efficacy assessment by performing randomized clinical trials and analysis of drug use in clinical practice by carrying out drug utilization studies have also been other areas of interest. From now on, Clinical pharmacology should move from the analysis of the drug-individual interaction to the analysis of the drug-individual-society interaction. It should also analyze the clinical and economic consequences of the use of drugs in the conditions of normal clinical practice, beyond clinical trials. The current exponential technological development that facilitates the analysis of real-life data offers us a golden opportunity to move to all these other areas of interest. This review describes the role that clinical pharmacology has played at the beginning and during the evolution of pharmacovigilance, pharmacoepidemiology and economic drug evaluations in Spain. In addition, the challenges that clinical pharmacology is going to face in the following years in these three areas are going to be outlined too

Patient involvement in clinical research: Why, when, and how

The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient

Management Of Tizanidine Withdrawal Syndrome: A Case Report

Most drugs that act on the central nervous system (CNS) require dose titration to avoid withdrawal syndrome. Tizanidine withdrawal syndrome is caused by adrenergic discharge due to its alpha(2)-agonist mechanism and is characterized by hypertension, reflex tachycardia, hypertonicity, and anxiety. Although tizanidine withdrawal syndrome is mentioned as a potential side effect of cessation, it is not common and there have been few reports. We present the case of a 31-year-old woman with tizanidine withdrawal syndrome after discontinuing medication prescribed for a muscle contracture (tizanidine). She showed high adrenergic activity with nausea, vomiting, generalized tremor, dysthermia, hypertension, and tachycardia. Symptoms were reversed and successful reweaning was achieved by restarting tizanidine followed by slow downward titration. Withdrawal syndrome should be considered when drugs targeting the CNS are suddenly stopped. Weaning regimens should be closely monitored for acute withdrawal reactions

Do new cancer drugs offer good value for money? The perspectives of oncologists, health care policy makers, patients, and the general population

Background: In oncology, establishing the value of new cancer treatments is challenging. A clear definition of the different perspectives regarding the drivers of innovation in oncology is required to enable new cancer treatments to be properly rewarded for the value they create. The aim of this study was to analyze the views of oncologists, health care policy makers, patients, and the general population regarding the value of new cancer treatments. Methods: An exploratory and qualitative study was conducted through structured interviews to assess participants’ attitudes toward cost and outcomes of cancer drugs. First, the participants were asked to indicate the minimum survival benefit that a new treatment should have to be funded by the Spanish National Health System (NHS). Second, the participants were requested to state the highest cost that the NHS could afford for a medication that increases a patient’s quality of life (QoL) by twofold with no changes in survival. The responses were used to calculate incremental cost-effectiveness ratios (ICERs). Results: The minimum improvement in patient survival means that justified inclusions into the NHS were 5.7, 8.2, 9.1, and 10.4 months, which implied different ICERs for oncologists (€106,000/quality-adjusted life year [QALY]), patients (€73,520/QALY), the general population (€66,074/QALY), and health care policy makers (€57,471/QALY), respectively. The costs stated in the QoL-enhancing scenario were €33,167, €30,200, €26,000, and €17,040, which resulted in ICERs of €82,917/QALY for patients, €75,500/QALY for the general population, €65,000/QALY for oncologists, and €42,600/QALY for health care policy makers, respectively. Conclusion: All estimated ICER values were higher than the thresholds previously described in the literature. Oncologists most valued gains in survival, whereas patients assigned a higher monetary value to treatments that enhanced QoL. Health care policy makers were less likely to pay more for therapeutic improvements compared to the remaining participantsThe study was funded by Eli & Lilly and C

Toward a clinical practice guide in pharmacogenomics testing for functional polymorphisms of drug-metabolizing enzymes. Gene/drug pairs and barriers perceived in Spain

The development of clinica lpractice recommendations or guidelines for the clinical use of biomarkers is an issue of great importance withr regard to adverse drug reactions.The poten-tial of pharmacogenomicbiomarkers has been extensively investigated in recent years.However,several barriers to implementing the use of pharmacogenomics testing exist.We conducted a survey among members of the Spanish Societies of Pharmacology and Clinical Pharmacology to obtain information about the perception of such barriers and to compare the perceptions of participants about the relative importance of majorgene/drug pairs.Of 11 potential barriers,the highest importance was attributed to lack of institutional support for pharmacogenomic stesting,and to the issues related to the lack of guidelines.Of the proposed gene/drug pairs the highest importance was assigned to HLA-B/abacavir, UGT1A1/irinotecan, and CYP2D6/tamoxifen.In this perspective article,we compare the relative importance of 29 gene/drugpairs in the Spanish study with that of the same pairs in the American Society for Clinical Pharmacology and Therapeutic sstudy,and we provide suggestions and areas of focus to develop a guide for clinical practice in pharmacogenomics testingThe work in the author’s laboratory is financed by Grants PS09/00943, PS09/00469, RETICS RIRAAF RD07/0064/0016, and CIBERehd from Instituto de Salud CarlosIII,Madrid, Spain, and by Grants GR10068 from Junta de Extremadura, Spain. Financed in part with FEDER funds from the European Unio