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Informed consent and participant perceptions of influenza vaccine trials in South Africa.

BACKGROUND AND OBJECTIVES: There are few insights from sub-Saharan Africa on research participants' experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa. METHOD: Four to 12 months after completion of the trials, participants were contacted to return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration. RESULTS: A total of 334 participants (93% of the original vaccine trial sample; mean age 68 years, median level of education grade 8, 69% women) completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication. CONCLUSION: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored.

Administration, Intranasal↗

Audit of asthma care in Army general practice.

Asthma is a common condition. General Practitioners in the NHS now receive specific remuneration for running asthma disease management programmes. This paper presents the results of an audit of asthma management in an Army General Practice. The records of all patients were reviewed. In addition a questionnaire survey of patient knowledge and satisfaction was undertaken. The study identified several areas for improvement.

Adolescent↗

Healthcare reforms: implications for the education and training of acute and critical care nurses.

This paper offers a wide ranging analysis of the drivers that resulted in scrutiny of medical, nursing, and healthcare professional roles. It suggests that what is needed is a coherent vision of the future shape of the health workforce. This requires moving beyond the presumption that reforming working practices primarily involves "delegating doctors" responsibilities to nurses. The paper argues that it is self evident that the implications of changes in healthcare roles and the ability of existing professionals to function effectively in the future will require education, training, and human resource investment supportive of the changes. It suggests a clear definition of competence and a national standard to practice is essential for nurses working in acute and acute critical settings. There should therefore be a correlation between levels of practice, levels of education, and remuneration. Furthermore, education programmes for senior nurses should sit coherently alongside the education programmes required by Modernising Medical Careers. Finally, the realisation of the government's service and modernisation agenda will require a culture change within higher education institutions, postgraduate deaneries, professional organisations, workforce development confederations, and NHS trusts.

Acute Disease↗

Use of spirometry and respiratory drugs in Manitobans over 35 years of age with obstructive lung diseases.

BACKGROUND: Previous data indicated that spirometry was underused in people with obstructive disease, especially those with chronic obstructive pulmonary disease (COPD). OBJECTIVE: To examine the use of respiratory drugs in patients with COPD and asthma, and to relate drug use to spirometry. METHODS: Manitoba Health maintains a database of physician services remunerated by fees that includes spirometry. The database contains the diagnosis and patient identifiers, as well as sex, date of birth and residential postal code. Similar identifiers are used in the provincial pharmacare program that records prescriptions dispensed at retail pharmacies. These databases were examined for the time period between 1996 to 2000, and people over 35 years of age diagnosed with asthma, COPD or both were identified. The frequency of spirometry in these patients and their use of respiratory drugs was determined. RESULTS: Spirometry and drug prescription frequencies increased with the number of physician visits (including those for bronchitis), but their patterns differed. Patients with asthma or asthma plus COPD had considerably higher rates of drug prescription and slightly higher spirometry rates than did those with COPD. Patients with asthma and asthma plus COPD who underwent spirometry were slightly more likely to receive drugs than those who did not undergo spirometry; this trend was more striking in patients with COPD. However, approximately 30% of patients with COPD who had five physician visits and who underwent spirometry did not receive drugs; this was true for approximately 10% of similar patients with asthma. Patients with asthma generally received beta-agonists and inhaled steroids; these agents were less commonly given to patients with COPD, who instead were given anticholinergics much more often than were asthmatics. Patients who were diagnosed with asthma plus COPD had beta-agonist and inhaled corticosteroid prescription rates similar to asthmatics, and anticholinergic prescription rates similar to patients with COPD. Theophylline and antileukotriene drugs were used less often than were inhaled agents. In patients with asthma, drugs were frequently discontinued, and during drug use, prescription refills were consistent with an intake of 30.9% of the prescribed doses. In patients with COPD, discontinuing drugs early was uncommon, and refills were consistent with the use of 54% of the prescribed amounts. The same was true of patients with both COPD and asthma. DISCUSSION: Drug prescription was considerably more common in patients labelled with asthma or COPD plus asthma than in patients with COPD. Spirometry was also less common in patients with COPD but had a distinct influence on the frequency of drug prescription. Patterns of drug prescription were predictable, and patterns of drug use indicated poor compliance, in agreement with other data. The results suggest that COPD symptoms may be discounted and patients systematically undertreated or the diagnosis could frequently be applied to people with trivial disease or both.

Adrenergic beta-Agonists↗

[Prevalence and risk factors of suspicion abuse in elder population].

BACKGROUND AND OBJECTIVE: We determined the prevalence and associated risk factors in the suspicion of elder abuse in the old population. PATIENTS AND METHOD: We included a total of 209 patients > or = 72 years of age without cognitive deterioration (score in test of Pfeiffer (3/4) 4 points). The questionnaire of suspicion of elder abuse used was one recommended by the Canadian Task Force and the American Medical Association; it consists of 9 questions and the presence of a positive answer is considered as indicative of suspicion of abuse. RESULTS: The prevalence of suspicion of elder abuse was 52.6% (at least one positive answer to the questionnaire). 8.6% affirmatively responded to 2 questions and 2% to 3. Female gender, widowhood, deficiency of studies, living alone or in institutions and having exerted a remunerated work were the associated variables in the bivariant analysis with regard to the suspicion of abuse. In the model of logistic regression, there was a significant association with the civil status and the coexistence of the familiar nucleus, with a greater risk of elder abuse in unmarried and/or widowers (p < 0.001) and in those living alone (p < 0.0001). CONCLUSIONS: There is a high prevalence of suspicion of elder abuse in the old population.

Aged↗

[Impact of caring for grandchildren on the perceived health and social support of the grandmothers].

OBJECTIVE: To find out the impact on health related quality of life and social support perceived by grandmothers caring for their grandchildren part time. DESIGN: Observational cross-sectional study. SETTING: Semi-urban primary care health area, in the metropolitan area of Barcelona, Spain. PARTICIPANTS: Women aged more than 55, randomised from the assigned population. Caregivers were grandmothers who took care of their grandchildren aged less than 8 years old, at least 4 hours a day, for 5 or more days a week without remuneration. VARIABLES: Perceived health was obtained by means of an SF-12 questionnaire and social support by a Duke-UNC questionnaire. Educational level, chronic illness, and characteristics associated with the care of grandchildren were recorded. RESULTS: Of the 129 participants, 44 were caregivers. Mean age was 62.4 (6.3) years. Social support was significantly higher in the group of caregivers than in the remainder (48.5 [40.2-53.7] vs 42.0 [36.0-47.0]; P=.006). No differences in health related quality of life between both groups were found. Perceived mental health was better when parents' work originated the need for care. Social support was greater when the parents were those who demanded the care. CONCLUSION: Grandchildren care improves perceived social support in grandmothers and it has no effect on perceived health status.

Aged↗

Hepatocellular carcinoma associated with hepatitis C virus infection in Japan: projection to other countries in the foreseeable future.

During the turmoil after the end of World War II some 50 years ago, in Japan intravenous methamphetamine was widespread and penetrated the young generation aged 15-25 years and remunerated blood donors. The vicious cycle gave an enormous thrust to the spread of hepatitis C virus (HCV) infection among drug users and blood donors. Their HCV infection was transmitted to the general population through transfusions, folk medicine involving the breaking of the integument and tattooing. Indiscreet and widespread treatment with intravenous injection using contaminated syringes and needles at that time accelerated the transmission of HCV further. An overall result was the outbreak of HCV infection in restricted subpopulations in Japan, which inevitably involved the general population. Abrogation of paid blood donation in 1968, the exclusion of blood units contaminated with hepatitis B virus (HBV) in 1973 and that of HCV since November 1989 (by the second generation tests after February 1992) decreased the risk of posttransfusion hepatitis from >50% in the 1960s to infinitely close to zero at present. Now the incidence of HCV infection in Japan is decreased to 1.8-3.5/100,000 person-years. Mother-to-baby transmission of HBV has been prevented since 1986 by a combined passive and active immunoprophylaxis of the babies at risk with hepatitis B immune globulin and vaccine. What we see today in Japan, however, is an ever-increasing incidence of hepatocellular carcinoma (HCC) that has reached almost 40/100,000 population, with males >50 years accounting for the great majority. Of the HCC cases in Japan, approximately 16% is caused by HBV infection and approximately 80% by HCV infection. The growing incidence of HCC is expected to reach a plateau around the year 2015, and then to start to decrease. The ordeal we have gone through, with special reference to the increasing incidence of HCV-associated HCC, is expected elsewhere in the world with a current profile of age-specific HCV infection like ours a few decades back. For worse or better (probably in this order), Japan is a country far advanced as regards the HCC associated with HCV infection. Our long-term experience related in detail here is hoped to help plan strategies to contain HCV infection and cope with its long-term sequelae in many other countries worldwide.

Age Distribution↗

Assessing the influence of payment on motivations of women participating as oocyte donors.

We report on the motivations of potential ovum donors entering an assisted reproduction program and discuss the potential ramifications of escalating payments to donors. From July 1995 to July 1998, recruitment of ovum donors was directed at healthy women between 21 and 34 years of age. Financial remuneration for services rendered was USD 2,500 from July 1995 through March 1998 and increased to USD 5,000 after that. Donors were screened and consented according to established SART guidelines. The demographic background of the women was similar for women paid USD 2,500 to those receiving USD 5,000. The financial motivation was greater in those receiving USD 5,000 (68%) than USD 2,500 (39%). Some form of expressed altruism was similarly present in both groups (USD 5,000 90%, and USD 2,500 91%). However, altruism expressed as the sole motivation occurred more in those receiving USD 2,500 (61%) compared to USD 5,000 (32%). Financial reimbursement has escalated for the services of ovum donors in order to maintain the increasing demand. While money has become a dominant factor motivating ovum donors, its seductive nature requires even greater attention to adequate informed consent. Young donors may be unable to adequately weigh the risks of ovarian hyperstimulation and oocyte retrieval against the monetary reward.

Adult↗

Disease transmission by blood products: past, present and future.

Transfusion of blood and blood products has been associated with transmission of infectious agents. However, it is probable that blood products are currently very safe and that pooled virus-inactivated products from remunerated donors are now safer than untreated single voluntary donor components. Although the transmission events of the past and the present are reasonably well understood, reliance on a linear approach to predict safety in the future is open to criticism. Indeed, it was not possible to predict the extent or consequences of the AIDS epidemic or of hepatitis C transmission. Moreover, although variant Creutzfeldt-Jakob disease (vCJD) may not be transmitted to any large extent by transfusion of manufactured blood products, this will be due more to good fortune than good judgement - this agent could have escaped the screening, testing and eradication methods on which current confidence in blood product safety depends. Similarly, the emergence of a highly resistant non-enveloped virus, or even of another previously unrecognised disease-causing agent, could result in new threats from transfusion of blood components and products. The ecology of blood transfusion is exquisitely sensitive to variations in starting conditions, a situation typical of a chaotic rather than a linear system. Seemingly trivial events, often apparently unrelated to blood transfusion, have had enormous consequences in this field. Whatever the events that introduced simian immunodeficiency virus to humans or scrapie to cattle, they were a long way from those involved in the manufacture of blood products. In such a setting, reliance on methods that deal effectively with known threats (such as encapsulated viruses and bacteria) without adequate investigation and management of the intrinsic sensitivity to unpredictable events, leaves open the possibility of further infections emerging in the future. It is this reality that will ultimately result in the eradication of the transfusion of donor-derived blood and blood products in the developed world. In addition, all infections with a long disease-free incubation period in the host that can be transmitted in blood will eventually be over-expressed in groups that are exposed to blood either recreationally or professionally. As in the past, this could have occurred before testing or decontamination processes have been developed for emerging pathogens. Failure to be able to rely on completely risk-free donors, in both the voluntary and non-voluntary sides of the blood industry, continues to offer the potential for the transmission of infectious diseases in the future.

Blood Donors↗

Getting research into clinical practice - barriers and solutions.

The success of current efforts towards evidence-based health services in many countries depends on efficient transfer of research findings to health practitioners. However, there is a lag in research being adopted. In part this is due to difficulties in interpreting or generalising research findings, in part to inertia, organisational structures and information. Clinical guidelines are usually cited as being the most effective product of evidence assessment and means of getting research into practice. The processes by which they are prepared and disseminated are discussed. Current clinical practice requires that health professionals adapt to changing systems and adopt new techniques. Therefore, in future, practice research to evaluate (a) clinical interventions and (b) dissemination and implementation strategies will become increasingly important. Recognised barriers to such research include lack of interest, lack of involvement, lack of time and lack of remuneration. High-quality research in dental primary care requires academics and dental service providers working in partnership on topics that are relevant both to clinicians and policy makers. Good project management, education and training are essential.

Dental Research↗

Cost-effectiveness of implantable defibrillator as first-choice therapy versus electrophysiologically guided, tiered strategy in postinfarct sudden death survivors. A randomized study.

BACKGROUND: Rising costs of health care, partly as a result of costly therapeutic innovations, are of concern to both the medical profession and healthcare authorities. The implantable cardioverter-defibrillator (ICD) is still not remunerated by Dutch healthcare insurers. The aim of this study was to evaluate the cost-effectiveness of early implantation of the ICD in postinfarct sudden death survivors. METHODS AND RESULTS: Sixty consecutive postinfarct survivors of cardiac arrest caused by ventricular tachycardia or fibrillation were randomly assigned either ICD as first choice (n = 29) or a tiered therapy starting with antiarrhythmic drugs and guided by electrophysiological (EP) testing (n = 31). Median follow-up was 729 days (range, 3 to 1675 days). Fifteen patients died, 4 in the early ICD group and 11 in the EP-guided strategy group (P = .07). For quantitative assessment, the cost-effectiveness ratio was calculated for both groups and expressed as median total costs per patient per day alive. Because effectiveness aspects other than mortality are not incorporated in this ratio, other factors related to quality of life were used as qualitative measures of cost-effectiveness. The cost-effectiveness ratios were $63 and $94 for the early ICD and EP-guided strategy groups, respectively, per patient per day alive. This amounts to a net cost-effectiveness of $11,315 per patient per year alive saved by early ICD implantation. Costs in the early ICD group were higher only during the first 3 months of follow-up, but as a result of the high proportion of therapy changes, including arrhythmia surgery and late ICD implantation, costs in the EP-guided strategy group became higher after that. Patients discharged with antiarrhythmic drugs as sole therapy had the lowest total costs. This subset, however, showed extremely high mortality, resulting in a poor cost-effectiveness ratio ($196 per day). Invasive therapies and hospitalization were the major contributors to costs. If quality-of-life measures are taken into account, the cost-effectiveness of early ICD implantation was even more favorable. Recurrent cardiac arrest and cardiac transplantation occurred in the EP-guided strategy group only, whereas exercise tolerance, total hospitalization duration, number of invasive procedures, and antiarrhythmic therapy changes were significantly in favor of early ICD implantation. CONCLUSIONS: In terms of cost-effectiveness, early ICD implantation is superior to the EP-guided therapeutic strategy in postinfarct sudden death survivors.

Anti-Arrhythmia Agents↗

Recommendations for the relationship between sponsors and investigators in the design and conduct of clinical stroke trials.

BACKGROUND: As increasing numbers of clinical trials are being conducted worldwide, there has been concern about the relationship between the sponsors and investigators. Both parties need benchmarks or recommendations to act as a reference point when trials are initiated and conducted. These recommendations are designed to fulfill this role. SUMMARY OF COMMENT: A series of meetings of the International Trial Subcommittee of the International Stroke Liaison Committee, American Stroke Association, were conducted to review a series of draft recommendations that were then modified on the basis of the experience of the committee in the conduct of clinical trials. Consensus was reached on all points of the final document. The recommendations represent the opinions of the authors and do not necessarily reflect the views of the American Stroke Association. The document contains sensible recommendations concerning required sponsor company qualities, trial management structure, protocol development, trial conduct, data management, blinding, data analyses, publication, remuneration, and conflict of interest issues. CONCLUSIONS: The recommendations should provide a simple and practical benchmark for both investigators and sponsors in the conduct of clinical trials. Although designed for trials involving therapies for stroke, the framework allows generalization to other disciplines.

Clinical Trials as Topic↗

Coping with an embarrassment of riches. How stroke centers may participate in multiple, concurrent clinical stroke trials.

BACKGROUND: The recent remarkable proliferation of multicenter clinical trials investigating novel treatments for acute ischemic stroke has created a new dilemma for stroke investigators. Promising agents and trials are many, competent clinical centers few. May a single clinical center, without scientific bias, participate in multiple, concurrent clinical trials recruiting overlapping populations of subjects with acute stroke? SUMMARY OF COMMENT: Many clinical stroke centers already participate in multiple overlapping trials. I delineate a variety of patient-allotment strategies that are presently used, although often not explicitly stated. Methods include assignment by time window, unique criteria, site, belief in agent efficacy, remuneration, and quota urgency. All have drawbacks, chiefly the introduction of bias into the selection of subjects for clinical trials, compromising the generalizability of trial findings to broader clinical populations. Several solutions are proposed that permit single centers to participate in multiple studies while minimizing or eliminating selection bias, including within-center use of a permuted-block enrollment strategy. The issue of trial allocation among multiple available studies has received insufficient attention from clinical trial designers, epidemiologists, and statisticians. Currently an inescapable problem for clinical stroke investigators, it arises in any clinical medical research field with rapid basic-to-clinical scientific advances. CONCLUSIONS: It is recommended that centers participating in multiple, concurrent clinical trials (1) use an articulated, formal method of patient allocation that is blinded or indifferent to clinical variables; (2) avoid assignment solely according to time since onset or unique patient criteria; and (3) avoid any influence of belief in agent efficacy on allocation.

Acute Disease↗

Evidence that methylphenidate enhances the saliency of a mathematical task by increasing dopamine in the human brain.

OBJECTIVE: Methylphenidate is the most commonly prescribed drug for attention deficit hyperactivity disorder (ADHD), yet its therapeutic mechanisms are poorly understood. The objective of this study was to assess if methylphenidate, by increasing dopamine (neurotransmitter involved in motivation) in brain, would enhance the saliency of an academic task, making it more interesting. METHOD: Healthy subjects (N=16) underwent positron emission tomography with [(11)C]raclopride (dopamine D(2) receptor radioligand that competes with endogenous dopamine for binding) to assess the effects of oral methylphenidate (20 mg) on extracellular dopamine in the striatum. The authors compared the effects of methylphenidate during an academic task (solving mathematical problems with monetary reinforcement) and a neutral task (passively viewing cards with no remuneration). In parallel, the effects of methylphenidate on the interest that the academic task elicited were also evaluated. RESULTS: Methylphenidate, when coupled with the mathematical task, significantly increased extracellular dopamine, but this did not occur when coupled with the neutral task. The mathematical task did not increase dopamine when coupled with placebo. Subjective reports about interest and motivation in the mathematical task were greater with methylphenidate than with placebo and were associated with dopamine increases. CONCLUSIONS: The significant association between methylphenidate-induced dopamine increases and the interest and motivation for the task confirms the prediction that methylphenidate enhances the saliency of an event by increasing dopamine. The enhanced interest for the task could increase attention and improve performance and could be one of the mechanisms underlying methylphenidate's therapeutic effects. These findings support educational strategies that make schoolwork more interesting as nonpharmacological interventions to treat ADHD.

Adult↗

Ethical dimensions of psychotherapy: a personal perspective.

A substantial increase in the interest devoted to ethical issues has been a defining feature of my 50 years in psychotherapeutic practice. Reasons include a shift from a paternalistic to a contractual model of the doctor-patient relationship, increased litigiousness, and greater emphasis on the business rather than professional aspects of practice. Many ethical violations stem from misuse of therapist power in the psychotherapeutic relationship. One of the most egregious of these is overt sexual acting out between therapist and patient, a dereliction now viewed much more sternly, largely because of the rise of the women's movement. Therapist power can also be misused for purposes of psychopathological gratification, such as to dominate patients or impose values, and by emphasizing financial rewards over patient needs. A sea change I have observed has been the gradual replacement of a two-party by a three-party system of payment for psychotherapy. Among its most serious consequences in the ethical domain has been the weakening of the therapist's guarantee of absolute confidentiality to the patient. Managed care has further compounded the ethical dilemma by imposing a need to choose between the interests of patients and the organizations from which therapists receive remuneration. In their efforts to ensure parity coverage for psychotherapy, therapists need to respond to certain questions about their claims that their work promotes both individual welfare and the common good. Questions include the professional qualifications for skillful practice of psychotherapy, the evidence for its efficacy, the delimitation of the conditions properly treated by psychotherapy, and the extent to which these conditions fall within the medical model and thus satisfy the criterion of medical necessity. I conclude that, in spite of the efforts needed to maintain ethical standards, the "ethical revolution" that I have witnessed has enhanced the integrity and value of psychotherapy, both for its practitioners and for the public that they serve.

Child↗

Readiness to participate in psychiatric research.

BACKGROUND: The feasibility of clinical trials depends, among other factors, on the number of eligible patients, the recruitment process, and the readiness of patients to participate in research. Seeking patients' views about their experience in research projects may allow investigators to develop more effective recruitment and retention strategies. METHODS: A total of 100 patients consecutively admitted to a psychiatric university hospital were interviewed with respect to their willingness to participate in a study. For a different study scenario, patients were asked whether they would be ready to participate if such a study were organized in the service and to indicate their reasons for refusing or for participating. RESULTS: The general readiness to participate in a study ranged between 70% and 96%. The prospect of remuneration did not notably augment the potential consent rate. The most common and spontaneous motivation for agreeing to take part in a study was to help science progress and to allow future patients to benefit from improved diagnosis and treatment (87%). The presence or lack of a financial incentive was rarely chosen as an argument to agree (23%) or to refuse (7%) to participate. Patients relied mainly on their treating physicians when contemplating possible participation in a study (family physician [65%] and hospital physician [54%]). CONCLUSIONS: Clinicians and, in particular, treating doctors can play an important role in facilitating the recruitment process.

Adult↗

Child psychiatry practice patterns in Ontario.

OBJECTIVES: To examine the demographics, training, distribution, venues of practice, remuneration patterns, and professional affiliations of child psychiatrists in Ontario. METHOD: In July 1997, questionnaires were sent to 229 Ontario psychiatrists. A second mailing was sent to nonresponders in the fall of 1997. The overall response rate was 66.8%. RESULTS: Compared with other research regarding the ratio of child psychiatrists to children with mental health problems, Ontario fares relatively well (1:6148). Generally, Ontario child psychiatrists report having received formalized training in the speciality. Child psychiatrists are disproportionately concentrated in Toronto and in midsize cities with medical schools compared with rural regions. Out-reach services to smaller communities are provided by 30% of child psychiatrists, but it is not clear whether the services are sufficient and equitably available. Approximately 50% of current psychiatrists will be aged 65 years or older in 15 years, and it is unclear whether sufficient numbers will replace them. The profession appears to be reaching an equitable gender representation. Most child psychiatrists belong to the professional organizations that support the profession; however, they are least likely to belong to the Ontario Psychiatric Association (OPA). CONCLUSIONS: An optimal ratio of child psychiatrists per population served still needs to be determined, with special consideration given to the needs of rural communities. The small ratio of child psychiatrists to the population of children with mental health needs highlights the importance of collaborating with other medical and mental health professionals. Recruiting and retaining child psychiatrists will need to be monitored. Child psychiatrists in Ontario need a unified voice to address these issues.

Adult↗

Structural and political models of analysis of the introduction of an innovation in organizations: the case of the change in the method of payment of physicians in long-term care hospitals.

This article presents the results of a study on the introduction of sessional fees remuneration for physicians working in Quebec long-term care hospitals. More generally, this research was concerned with the determinants of the capacity of an organization to implement an innovation. Both a political and a structural model of analysis were empirically probed. We found strong support for the political model and moderate support for the structural model. This article contributes to the understanding of the relative contribution of structural and political determinants in the implementation of changes in organizations.

Family Practice↗