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PubMed1997

Applied pharmacoeconomics. When can publication be legitimately withheld?

Pharmacoeconomic studies can help decision-makers choose the most efficient drug treatments in our internationally cost-constrained healthcare environment. However, perceptions of bias about the nature of many economic evaluations limit the usefulness of pharmacoeconomic data to decision-makers. In an effort to increase the credibility of pharmacoeconomic studies, several groups have developed methodological guidelines, and one has developed ethical guidelines for these evaluations. In this article, we evaluate issues related to the publication of the results of pharmacoeconomic studies. Pharmacoeconomics is a true science (and should be so treated), rather than a form of marketing. Pharmacoeconomic studies must undergo the same peer review process and be published in serious research journals, as are other types of scientific investigations. Investigators should attempt to publish the results of pharmacoeconomic studies, even (and, perhaps, especially) when the results are not favourable to the sponsor. However, there are acceptable reasons to withhold publication of 'negative' results. For example, when methodological problems plague a study, or when the study addresses an investigational drug not likely to be approved, then researchers are justified in giving up on publication, if they so choose. Similarly, feasibility studies to test methods of data collection or analyses conducted very early in the drug development process need not always be published. Nonetheless, access to all important investigations--regardless of whether the results are positive or negative--will become more important as healthcare becomes more evidence-based, as decisions have impact on large populations of people, and as those in charge of formularies actually begin to use cost-effectiveness analysis to help make choices among competing drugs.

Economics, Pharmaceutical↗
PubMed2005

The Harvard case of Xu Xiping: exploitation of the people, scientific advance, or genetic theft?

A unique history and make-up of a population may make it an attractive research target for population geneticists and pharmaco-genomic investors. The promise of pharmaceutical profits and advances in medical knowledge attracted Harvard researchers and the company Millennium Pharmaceuticals to remote areas in Anhui Province, Central China, leading to international diplomatic disagreements about issues such as the ownership of genetic material and informed consent (IC). This article discusses the role of genomics and genetic sampling in China, the way it is related to population policies (the new eugenics), the national importance of genetic materials and the conflicts it led to between the Chinese government and Harvard University. Here many consider the Xu Xiping case as textbook example of ruthless Western exploitation of development countries, illustrating the cold rationality of science in the process of globalisation. Ten perspectives on this case show that this view is simplistic and contributes little to an understanding of bioethical issues important to the population actually donating the samples. Viewing the Xu Xiping case as the nexus of the intertwinement of international, transnational, national, and local interest groups shows how different interest groups make use of different units of analysis. It also clarifies why the same practice of genetic sampling continues under a different regime, and why the discussion about genetic sampling has shifted from a concern with health care of the poor to an issue of international exploitation, terrorism and development.

Biological Specimen Banks↗
PubMed1993

Advertisements for medicines in leading medical journals in 18 countries: a 12-month survey of information content and standards.

The information content of 6,710 advertisements for medicines in medical journals was surveyed to provide a baseline for monitoring the effect of WHO's Ethical Criteria for Medicinal Drug Promotion. The advertisements (ads) appeared during 12 months (1987-1988) in 23 leading national medical journals in 18 countries. Local participants, mostly doctors or pharmacists, examined them. The presence or absence in each ad of important information was noted. In most ads the generic name appeared in smaller type than the brand name. Indications were mentioned more often than the negative effects of medicines. The ads gave less pharmacological than medical information. However, important warnings and precautions were missing in half, and side effects and contraindications in about 40 percent. Prices tended to be given only in countries where a social security system pays for the medicines. The information content of ads in the developing countries differed surprisingly little from that in the industrialized countries. Almost all the ads (96 percent) included one or more pictures; 58 percent of these were considered irrelevant. The authors believe it is a mistake to regard ads as trivial. If they are not considered seriously they will influence the use of medicines as they are intended to do, but read critically they can provide useful information.

Advertising↗
PubMedDate not supplied

Gifts to physicians from the pharmaceutical and medical manufacturing industry: what every physician should know.

Continuing Medical Education (CME) has been at the cornerstone of life-long learning for physicians for almost four decades. Constraints on physician services and reimbursement during the same period of time have increased the physicians' and CME providers' dependency on financial support from the medical industrial complex for CME activities. In a related arena, the competitive nature of the medical industrial complex has resulted in a frenzy of "enticements," amenities, or gifts for physicians. The busy practitioner is vulnerable to many unethical practices currently being reported and identified by the public, often unjustly presenting a tarnished image of the entire medical profession. The Louisiana State Medical Society Continuing Medical Education Accreditation Committee (LSMS CMEAC) recommended a review article on the current practices, attitudes, and guidelines relating to gifts to physicians from industry and industry's appropriate financial support for CME activities. Dr. Roger Zoorob, a member of the LSMS CMEAC, along with Michele Larzelere, PhD, responded to the committee's request. The LSMS CMEAC is grateful for their contribution. (LSUS CMEAC Chair: Albert Barrocas, MD, Chair of the CMEAC. LSMS CMEAC members and staff: Donnie Batie, MD; William Daly, Jr., MD; Barbara L. Deming, MD; Ricky Hendrix, MD; Benedict E. Idowu, DO; Harold L. Ishler, Jr., MD; Russell C. Klein, MD; Sharda Kumar, MD; Elma I. LeDoux, MD; I. Ricardo Martinez, MD, PhD; Pamela A. Parra, MD, Vice-Chair; William G. Rhea, Jr., MD; Rajasekharan Warrier, MD; Roger Zoorob, MD; Jeanette Harmon, MBA, Director of Administration; and JoAnna Cline, Medical Education Coordinator.)

American Medical Association↗
PubMed2006

Criteria supporting the study of drugs in the newborn.

BACKGROUND: Profound changes in the development and the maturation of neonates' organs and organ systems over variable periods of time potentially place neonates at increased risk and/or at different risks compared with adults or older children on exposure to pharmaceutical agents. Most studies of drugs in neonates focus on pharmacokinetic and pharmacodynamic end points and include insufficient numbers of patients to permit evaluation of safety. Only one fourth to one third of approved drugs have received adequate pediatric study to permit labeling for treatment of all appropriate pediatric populations. OBJECTIVE: The initial goal of the Newborn Drug Prioritization Group was to develop a reproducible, objective process for evaluating drugs most in need of study in the neonatal population based on a universally acceptable priority ranking. The criteria would be applicable across therapeutic classes and would identify those drugs for which immediate study was most needed. METHODS: Because the therapeutic requirements of the neonate are unique in comparison to older infants and children, the National Institute of Child Health and Human Development and the US Food and Drug Administration (FDA) developed the Newborn Drug Development Initiative to address the limited study of off-patent drugs in newborns. In March 2003, they convened a meeting of pediatric pharmacologists and pediatric specialists from the FDA, the American Academy of Pediatrics, the National Institutes of Health, and academic institutions to discuss how to increase the study of drugs for the newborn. One of the working groups was charged to develop generic criteria for overall prioritization of drugs for study in newborns. Because resources are limited, and not all drugs identified by the 4 clinically focused working groups can receive study at the same time, a process for priority ranking is necessary. RESULTS: The panel identified 4 general categories containing different numbers of criteria as important for ranking drugs for priority investigation: (1) the disease and indication, including elements such as the potential for adverse outcomes, frequency in newborns, and level of evidence for treatment of newborns; (2) drug characteristics, including elements such as duration of dosing, lack of age-appropriate formulation, clinically relevant drug-drug and drug-disease interactions, and drug disposition in newborns; (3) feasibility and methodology for newborn studies, including both analytical considerations and clinical end points; and (4) the ethical basis for study, including elements to address benefit or harm due to exposure to the study drug, study methodology, and benefit of the new treatment relative to established standard therapy. Based on these categories, a list of criteria to warrant study of a drug in newborns was developed. CONCLUSION: A process for judicious use of limited resources to rectify these deficiencies remains an urgent public health need.

Animals↗
PubMed2004

[Analysis of the relationship between primary care doctors and the pharmaceutical industry].

OBJECTIVES: To describe the type of relationship between primary care family doctors (PCDs) and the pharmaceutical industry (PI) and its representatives in Aragon, to describe doctors' attitudes to this relationship and to find out how doctors behave towards offers from the industry. DESIGN: Descriptive cross-sectional study, through a self-filled questionnaire with closed replies, of a representative sample of the population under study. SETTING AND PARTICIPANTS: Family doctors working in primary care teams throughout Aragon. RESULTS: The reply rate of 28.17% maintained the study's representativity. Differences in the kind of relationship between PCDs and PI were found in gender (greater relationship of male doctors) and setting (it was greater in urban areas). Doctors working in centres with teaching credentials and woman doctors had a more critical attitude. The tendency to collaborate with the industry's offers was greater in the rural areas and among men. The group of doctors that interacted most with the industry tended to collaborate more with the proposals of the PI. No relationship was found between attitude and conduct of PCDs. CONCLUSIONS: Results confirm both the starting hypotheses: a) the nature of relationships between PCDs and the PI and its representatives affects prescribing behaviour, and b) there are differences between what doctors think they should do and what they really do in their dealings with the PI.

Attitude of Health Personnel↗
PubMed1996

When pharmaceutical manufacturers' employees present grand rounds, what do residents remember?

PURPOSE: To evaluate the educational effect on residents of a grand rounds given by a pharmaceutical company employee. METHOD: Using a retrospective cohort study design, the authors questioned 75 housestaff at a university hospital three months after a February 1990 grand rounds on Lyme disease to determine whether the residents' beliefs about the drug of choice for this disease differed between attendees and non-attendees. Odds ratios, 95% confidence intervals, and logistic regression were used for the analysis of results. RESULTS: The 22 housestaff who had attended the grand rounds were more likely to choose appropriately the cephalosporin manufactured by the speaker's company over other drugs for patients with Lyme disease presenting with second-degree heart block (adjusted odds ratio of 8.4; 95% CI 2.1-38.9). However, they also chose it inappropriately for first-degree heart block (adjusted odds ratio of 7.8; 95% CI 1.6-45.5). None of the attendees, compared with 11 (21%) of the non-attendees, named an oral antibiotic for both of two milder presentations, even though oral therapy would be more appropriate (p = .027). CONCLUSION: The results suggest that grand rounds effectively change residents' beliefs, but a sponsoring company's drug may be favored. Information assimilated in this way may not be well supported by the scientific literature and could result in a choice of treatment that is more expensive than other acceptable treatments.

Choice Behavior↗
PubMedDate not supplied

A framework establishing clear decision criteria for the assessment of drug efficacy.

Much has been published on various aspects of data analysis and reporting from clinical trials within the biopharmaceutical environment. This ranges from regulatory guidelines on the format and content of registration dossiers to recommendations on data presentation and the statistical methodologies that are appropriate for the diverse types of data one observes in clinical trials. Little has been written about designing a clinical trial analysis and reporting package that focuses on the decisions that must be made throughout the drug development process. Pharmaceutical companies today are under enormous pressure to develop drugs quickly and (cost-) efficiently. Because of this, drugs often move into the later phases of drug development before evidence from prior phases is completely understood. This provides a challenge to clinical trialists to design and execute a clinical trial programme which can expedite drug development. The statistician, as a clinical trialist, must strive to determine the optimum analytical methodology that facilitates decision making for this clinical trial programme. This paper proposes a new framework for the assessment of efficacy in drug development called the 'one programme, one p-value' framework. This framework will accelerate drug development by providing clear criteria for the decisions which must be made along the way. The 'one programme, one p-value' framework is based on the notion that the clinical trial programme comprises exploratory and confirmatory phases. The use of the likelihood function in the exploratory phase facilitates the decision whether (or when) to move into the confirmatory phase. The confirmatory phase consists of one confirmatory trial with a single hypothesis test of the drug's efficacy; hence 'one p-value'. Sponsor interaction with regulatory agencies is necessary at each decision point. Finally, the paper considers how analysis and reporting of efficacy data can be accomplished from a clinical trial programme as described.

Clinical Trials as Topic↗
PubMed1992

Impact of pharmaceutical company representatives on internal medicine residency programs. A survey of residency program directors.

To survey internal medicine residency program directors regarding interactions between their residents and pharmaceutical company (PC) representatives (PCRs) a questionnaire was sent to the directors of all Accreditation Council for Graduate Medical Education-approved internal medicine residency programs. The survey included 444 program directors, of whom 272 (61.16%) responded. The majority of program directors, 228 (83.8%), allowed PCRs to meet with residents during working hours and 241 (88.6%) permitted PC sponsorship of conferences. About half of the program directors were "moderately" or "very" concerned about the potential adverse effects of PC marketing on resident attitudes and prescribing practices. Seventy percent "agreed" or "strongly agreed" that the benefits of PC sponsorship outweigh the adverse effects and 41.5% believed that refusal to allow PCRs to meet with residents would jeopardize PC funding of other departmental activities. Most program directors reported that alternate funds for conferences were available if PC support was withdrawn. "Unethical" marketing activities were observed by 14.3% of program directors and 37.5% reported that residents had participated in PC-sponsored trips during the 3 years prior to the survey. At the time of this survey, only 35.3% of programs had developed formal policies regulating PCR activities and 25.7% provided residents with formal instruction on marketing issues. Knowledge of the current extent of PCR interactions with residents may be helpful to program directors in developing policies regulating PC-marketing activities.

Attitude of Health Personnel↗
PubMed2003

[A case of fraud in a neurological pharmaceutical clinical trial].

This paper describes the laborious and lengthy path to clarification and disclosure in a case of fraud in a neurological pharmaceutical clinical trial in the Netherlands. A Dutch neurologist was suspected of irregularities within the context of the 'European stroke prevention study 2' (ESPS-2), a multicentre study into medicinal prophylaxis in patients who had suffered a stroke. The Netherlands Society of Neurology (NVN) established an independent inquiry committee for further investigation of the case. The identity of 425 of the 438 patients (97%) included in the trial by the neurologist could be retrieved. The majority of these patients were known to the neurologist with cerebral infarct. For a sample of 115 patients, the general practitioners (GPs) were contacted by means of a questionnaire. Ninety percent of the responding GPs were unaware of their patients' participation in the pharmaceutical clinical trial. A total of forty patients were asked by their GP about participation: 36 (90%; 95%-CI: 76-97) indicated that they had not participated in the trial, and 4 could not remember. The committee concluded that the neurologist had committed fraud, in the sense that he had used the names of existing patients without these patients actually being enrolled in the study. The report of the independent committee was not made public; the committee and the NVN board differed in opinion on the interpretation and implications of the agreements regarding this subject. Following prolonged legal action, the regional Disciplinary Board suspended the neurologist from practice for one year and the court of law sentenced him to 180 days imprisonment or a fee of 130,000 Euro. Based on the experience gained from this case, recommendations in case of suspicion of fraud are discussed, such as the timely appointment of an independent inquiry committee and the establishment of unambiguous agreements regarding the disclosure of the results of the investigation. Possible legal implications should be considered in advance by the organisations involved; statutes should provide regulations for procedural rules. In the Netherlands there now exists a National Body for Scientific Integrity and a committee for the Scientific Integrity of Healthcare Research to prevent scientific misconduct and to stimulate reporting and appropriate handling of this problem.

Clinical Trials as Topic↗
PubMed1978

Quantitative determination of percutaneous absorption of radiolabeled drugs in vitro and in vivo by human skin.

We have measured concentrations of about 30 drugs in the living layers of the skin under conditions which provide data which are applicable in therapeutic treatment. Since the skin is a thin organ and small amounts of drug represent high target concentrations, it is necessary to select a sensitive quantitative method; observation of the kinetics of absorption using radiolabeled drugs is the method of choice. Because of possible hazards--and legal and ethical problems--absorption studies in human skin are commonly performed in vitro. Related in vivo investigations demonstrate the relevance and the limitations of the in vitro experiments. The main hindrance against penetration of drugs is by the horny layer. The barrier-function of this layer--if it is undisturbed--may be described by a multilayer model. The reciprocal function, the reservoir function, is important for the efficiency of topical treatment; it also plays a role in determining the unique pharmacokinetics of drug absorption in the skin and percutaneous resorption. If the horny layer is injured, i.e. in diseased skin, both the barrier and the reservoir functions are disturbed. In consequence, drug concentrations in the skin--and percutaneous resorption--may be greatly enhanced, and topically applied drugs may enter preferentially into diseased areas. The form of application, such as ointment, solution, etc. influences the penetration kinetics in such a specific manner that a specific vehicle for a specific drug should always be postulated. The frequently discussed hazards of side effects due to percutaneous resorption of drugs like corticosteroids are a function of the treated area rather than of its penetration capacity. Thus the indication for local or oral treatment of severe dermatoses should be considered in terms of the affected area. The relatively frequent side effects in the skin itself which originate from unnecessarily high drug concentrations and long term treatment must also be taken into account.

Administration, Topical↗
PubMed2003

Evaluation of physiologically based models of pregnancy and lactation for their application in children's health risk assessments.

In today's scientific and regulatory climates, an increased emphasis is placed on the potential health impacts for children exposed either in utero or by nursing to drugs of abuse, pharmaceuticals, and industrial or consumer chemicals. As a result, there is a renewed interest in the development and application of biologically based computational models that can be used to predict the dosimetry (or ultimately response) in a developing embryo, fetus, or newborn. However, fundamental differences between animal and human development can create many unique challenges. For example, unlike models designed for adults,biologically based models of pre-and postnatal development must deal with rapidly changing growth dynamics (maternal embryonic, fetal, and neonatal), changes in the state of differentiation of developing tissues, uniquely expressed or uniquely functioning signal transduction or enzymatic pathways, and unusual routes of exposure (e.g., maternal-mediated placental transfer and lactation). In cases where these challenges are overcome or addressed, biological modeling will likely prove useful in assessments geared toward children's health, given the contributions that this approach has already made in cancer and non-cancer human health risk assessments. Therefore, the purpose of this review is to critically evaluate the current state of the art in physiologically based pharmacokinetic (PBPK) and pharmacodynamic (PD) modeling of the developing embryo, fetus, or neonate and to recommend potential steps that could be taken to improve their use in children's health risk assessments. The intent was not to recommend improvements to individual models per se, but to identify areas of research that could move the entire field forward. This analysis includes a brief summary of current risk assessment practices for developmental toxicity, with an overview of developmental biology as it relates to species-specific dosimetry. This summary should provide a general context for understanding the tension that exists in modeling between describing biological proceses in exquisite detail vs. the simplifications that are necessary due to lack of data (or through a sensitivity analysis, determined to be of little impact) to develop individual PBPK or PD models. For each of the previously published models covered in this review, a description of the underlying assumptions and model structures as well as the data and methods used in model development and validation are highlighted. Although several of the models attempted to describe target tissues in the developing embryo, fetus, or neonate of laboratory animals, extrapolations to humans were largely limited to maternal blood or milk concentrations. Future areas of research therefore are recommended to extend the already significant progress that has been made in this field and perhaps address many of the technical policy, and ethical issues surrounding various approaches for decreasing the uncertainty in extrapolating from animal models to human pregnancies or neonatal exposures.

Animals↗
PubMed2005

Challenges for the clinical development of new nucleoside reverse transcriptase inhibitors for HIV infection.

There is a need for new antiretroviral drugs with activity against HIV isolates resistant to currently available agents and improved short and long-term tolerability profiles. Clinical trial designs for nucleotide and nucleoside reverse transcriptase inhibitors (NRTIs) are restricted by the characteristics of these agents (for example, their cross-resistance, resistance threshold and interaction profiles), the ethical need to ensure that patients are not maintained on suboptimal regimens, and regulatory requirements (for example, with regards to trial designs and patient populations). For example, consideration of cross-resistance profiles must influence the way in which an NRTI in development is sequenced to minimize any impact on future treatment options. The resistance threshold is determined by the number of mutations required to diminish sensitivity to a given drug. Pharmacokinetic or pharmacodynamic interactions restrict how NRTIs may be combined during clinical development. Doses may be selected on the basis of results from short-term monotherapy studies in treatment-naive patients, but such studies cannot establish the long-term efficacy or tolerability of new agents used in combination regimens. Confirmatory studies in treatment-naive populations do not meet the medical and regulatory needs for clinical data in treatment-experienced populations, while studies in treatment-experienced populations are subject to numerous clinical and logistical difficulties. Intensification, switch and hybrid study designs all offer suitable approaches to the evaluation of NRTIs with novel resistance profiles. Switch studies are particularly useful for agents with resistance profiles that suggest a specific sequencing approach in treatment and for those with the potential, based on pharmacokinetic data, for interactions with other agents. The successful development of new NRTIs will depend upon a thorough appreciation of these many and complex issues, not only among those involved in the design of clinical studies, but also those contributing to their review and conduct.

Anti-HIV Agents↗
PubMed2003

"Death was a blessing"--should it ever be pharmaceutically hastened? British pharmacists' views.

OBJECTIVES: To investigate the views and experiences of British pharmacists in physician-assisted suicide (PAS) and voluntary active euthanasia (VAE) and to examine whether differences in views were associated with personal characteristics. METHOD: A postal questionnaire was mailed to a random sample of 500 registered pharmacists, with addresses in England or Wales, stratified according to sex and community/hospital working environments. MAIN OUTCOME MEASURE: Pharmacists' reports of their views and experiences of PAS and VAE. RESULTS: Completed questionnaires were received from 295 respondents (response rate: 59%). The majority of respondents (83%) reported that at times, a person had the right to choose their own manner of death; 61% and 53% thought that there should be changes in the Law to legalise VAE and PAS, respectively. If it were legal to do so, 63% stated that they would be willing to dispense medication for VAE and 64% for PAS. However, only 45% agreed that the pharmacist should have a role in advising the prescriber on the choice and dose of drugs used. Sex, age, and years registered as a pharmacist were not found to be significantly associated with views on the practices of PAS and VAE. However, pharmacists who reported having a religion were significantly less likely to favour such practices. On comparing the views of community and hospital pharmacists, community pharmacists were significantly less likely than expected to want to be informed about the intended purpose of lethal drugs. CONCLUSION: In this survey, while over half of British pharmacists did not disagree in principle to the legalisation of VAE and/or PAS, they were less supportive of direct involvement in such procedures. Religion was a discriminatory factor associated with negative views of VAE and PAS. The significant minority of pharmacists not wanting to know the purpose of drugs they suspected might be for PAS or VAE is not in accordance with professional accountability, reflecting the complex and sometimes conflicting legal and moral aspects of such practices when deciding upon a course of action.

Adult↗
PubMed1999

How to get serious answers to the serious question: "How have you been?": subjective quality of life (QOL) as an individual experiential emergent construct.

Medical, scientific and societal progress has been such that, in a universalist humanist perspective such as the WHO's, it has become an ethical imperative for the primary endpoints in evidence based health care research to be expressed in e.g. Quality Adjusted Life Years (QALYs). The classical endpoints of discrete health-related functions and duration of survival are increasingly perceived as unacceptably reductionistic. The major problem in 'felicitometrics' is the measurement of the 'quality' term in QALYs. That the mental, physical and social domains, each containing many dimensions and items, all contribute to QOL is uncontroversial. What is controversial, is the weight of the different dimensions in overall QOL. It has been shown to be very different between different patient populations. In human individuals, assuredly complex systems, the many dimensions and items of QOL observably interact, probably sometimes in chaotic ways. In these conditions, the weights of isolated items in individuals become for all practical purposes meaningless. Therefore, the much used multi-item questionnaires at best describe, but do not evaluate QOL, neither in individuals, nor in populations. For example, allergic patients treated with cetirizine scored better than those on placebo on all dimensions of the SF-36, a standard QOL questionnaire. Here there is no serious doubt that the treatment improved QOL, because it is highly unlikely that any important dimension on which the patient groups would have scored otherwise is missing in the SF-36. However, whether piracetam treatment of acute stroke, which improved the surrogate endpoints neurological and functional scores, also improved QOL is plausible, but will be proven only when comprehensive QOL measurement will have been done. And suppose in randomised populations of end-stage metastatic solid cancer patients, one would compare palliative last-line chemotherapy with only palliative care, and one would, as can be expected, find no significant differences in average survival, and chemotherapy superior for the mental domain, but inferior for the physical comfort domain: we would not know which treatment, on aggregate, would be the better. The problem is that QOL is an individual and emergent construct, the resultant of a great many interactions, and of a different order than its contributing components. Overall QOL can therefore best be captured only as the Gestalt of a global self-assessment. Just as people in everyday life, while acting under uncertainty, make global assessments all the time, so they can seriously answer the serious question: 'How have you been?' A solemn, practical, non peer-relativistic, non-cultural, experiential, and well tolerated way to obtain such responses is Anamnestic Comparative Self Assessment (ACSA), in which the subjects' memories of the best and the worst times in their life experience define their individual scale of QOL. ACSA is thus both exquisitely idiosyncratic, and yet can in a universalist humanistic perspective be considered generic. Using both a multi-item questionnaire and a global assessment allows by one logistic regression, to estimate the weights of the dimensions and items in populations, and thus identify those whose improvement would most contribute to the QOL of the greatest number. A combined approach to measurement of QOL is necessary to maximise the utility of QOL interventions.

Delivery of Health Care↗