Public information about clinical trials and research

Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.     

Folic acid and prevention of neural tube defects

QUESTION Now that flour and pasta have been fortified with folic acid in Canada, do I still need to recommend folic acid supplements to my patients who are of child-bearing age? If I should recommend supplements, when should I recommend them, and what is an appropriate dose?ANSWER Non-pregnant women should consume 400 μg of folic acid daily, and pregnant women should consume 600 μg of folic acid daily. Mean intakes of folate in Canada before fortification were around 200 μg/d or less. Fortification increased intake of folic acid by up to 100 μg/d. You should discuss the importance of folic acid with your patients who are planning pregnancy; it is recommended that a folic acid supplement or prenatal multivitamin containing at least 400 μg of folic acid be consumed daily. The upper limit for folic acid is 1 mg/d. Women in intermediate- to high-risk categories for neural tube defects, such as a previous neural tube defect–affected pregnancy, should take 4 to 5 mg of folic acid daily.     

Simultaneous Multichannel Cardiac Mapping Systems

There is much current interest in simultaneous multichannel cardiac mapping. In this paper we give recommendations for the construction of a cardiac mapping system. Because the field of cardiac mapping is relatively young, optimum mapping techniques and all possible applications have not yet been developed. Therefore, the mapping system should be flexible and it should have many capabilities. The system should be digital; if variable gains are used, the amplifiers should be programmable and controlled by a microprocessor. It should be possible to analyze previous recordings and acquire additional recordings simultaneously. The mapping system should be able to record continuously for at least tens of minutes and preferably for hours. The recorded data stream should be a self-contained unit, holding all important electrophysiologic information as well as the recorded electrode signals. The programs should be written in C under a UNIX operating system. A minimum of 64 channels should be used for epicardial or endocardial mapping and a minimum of 128 channels for three-dimensional intramural mapping. The leakage current requirements for multichannel mapping systems are too stringent and should be re-evaluated. The major limitation to progress in cardiac mapping is neither the hardware nor the software; it is the electrode: its construction, its placement, its fixation, and the interpretation of its recordings.     

Testicular Infarction in a Patient with Epididymitis

To the authors' knowledge, this case is unique to the emergency medicine literature. Although testicular infarction from epididymitis is rare, it should be considered as a complication of severe or unresolving epididymitis. These patients should be Dlaced on broad spectrum antibiotcs, i.e., quinolones; color flow Dopp-er of the testes should be obtained; md urologic consultation should be onsidered for possible admission ind surgical exploration.     

The Diagnosis and Treatment of Obscure Intra—abdominal Lesions

The most common cause of fractures in the elderly is falling.

Urinalysis, hemoglobin determination and a thoracic roentgenogram always should be obtained for the elderly patient with a major fracture. Determination of the sedimentation rate of erythrocytes aids in assessment of the patient for treatment.

Treatment should be selected on an individual basis. Good nursing care is most important, and the patient should be provided with a familiar environment or familiar articles to decrease disorientation and delirium. If surgical intervention is indicated, it should be accomplished with dispatch in accord with good surgical principles.

The physician's obligation to the patient continues after the fracture has healed until the patient is returned to the best possible condition according to the injury sustained.     

Treatment and prevention of ophthalmia neonatorum

Question In my office I occasionally see neonates with conjunctivitis. What are the current recommendations for ocular prophylaxis at birth? Do topical antibiotics alone provide adequate treatment of neonatal conjunctivitis? When is systemic therapy indicated?Answer All infants should receive ocular prophylaxis at birth to prevent gonococcal ophthalmia. Neonates presenting with signs of conjunctivitis should have a conjunctival swab sent for Gram stain and culture. If Gram-negative diplococci are present on the Gram stain results, the infants and their parents should be treated immediately for presumed gonorrhea. Infants with chlamydial infection should be treated with oral antibiotics. Most of all other forms of bacterial conjunctivitis can be treated with topical antibiotics, with the exception of Pseudomonas infection. Infants should be followed during their treatment and upon completion of therapy to ensure resolution of symptoms. For cases in which sexually transmitted bacteria are implicated, the mothers and their sexual partners should be treated.     

Teaching successful use of the diaphragm.

The effectiveness of the diaphragm can be enhanced and the frequency of side effects reduced If: 1) the diaphragm is prescribed only for those patients who meet the necessary medical, anatomical, and psychological requirements; 2) the device is fitted properly; and 3) the patient is carefully instructed in the use and care of the device. The diaphragm should be prescribed only for the patients who are unable to use oral contraceptives or IUDs and who are not allergic to spermicides. Anatomically the patient must have adequate muscle support, a palpable notch behind the symphysis pubis, the cervix must be of sufficient size, the anterior vaginal wall of moderate length, and the uterus and other nearby organs should not be displaced. Psychologically the patient must be sufficiently motivated to insert the device prior to each coital act and endowed with enough self-confidence to insert the device properly. The physician should also ascertain whether the device is acceptable to her partner. Prior to fitting the pelvis should be examined, and the type and size of the device determined by the pelvic findings. The patient must be taught how to insert the device. She should practice inserting the diaphragm in the presence of the examiner. Women should be instructed: 1) to use the device each night; 2) to always use the diaphragm, in combination with a spermicide; 3) to leave the device in place at least 6-8 hours following intercourse; 4) to remove, clean, and inspect the device daily; and 5) to use the device during menstruation. The patient should return for a checkup 2 weeks after the initial visit and then once every year.     

The future of rehabilitation services in Great Britain

After reviewing the overall situation, this paper concludes with the following recommendations:

1. General: The field of disability and rehabilitation has been characterized, during the last 20 or 30 years in Great Britain, by a multiplicity of official reports of high quality. The need is not so much for the establishment of new principles, which are by now quite generally agreed, but for the sweeping away of old structures which impede the implementation of these policies.

2. Hospital services: The establishment of regional (i.e., subnational) hospital rehabilitation centres should be accelerated, with particular regard to geographical distribution. Evaluative research on the remedial therapies should be strongly encouraged, and the potential contribution of clinical psychology should be actively explored and exploited.

3. Community doctors: It should be formally recognized that overall responsibility for longterm chronic illness and disability for the patient living at home rests with the general practitioner (GP). There should be more efficient communication between GP and hospital, and the GP should have the opportunity (with the advice of specialists) to coordinate therapies and assessments for vocational and social help in the community. Within the primary health-care team, practical responsibility for advice and coordination should rest with one specialist paramedical worker.

4. Community services: Local (municipal) authority provision for the disabled should be mandatory, and basic minimum entitlements should be established. Exhortations by central government that local authorities should provide community care, hostels, or sheltered housing for the various groups whose institutionalization is deplored should be replaced by new methods of financing, to provide better geographical uniformity and ensure that policies are actually implemented. Though certain local authority services relevant to disability will always necessarily be separate from health services, those which are most specifically health-related (such as the supply of aids and appliances) should be administered within the health sector.

5. Aids and appliances: Many of the recommendations of the BMA Working Party (21) on aids and appliances remain to be implemented.

6. Vocational rehabilitation: Radical revision and simplification of the system of vocational rehabilitation and help should proceed as rapidly as possible, and the medical profession should take an active interest in this. Special services should be instituted for the training and vocational help of the handicapped school-leaver. All rehabilitation services (as distinct from retraining and placement services) would be placed within the health sector, within centres associated with hospitals.

7. Medical education: Important changes are required in medical education, at both the postgraduate and undergraduate levels.

8. In the longer-term: The increasing emphasis upon disability and rehabilitation is likely both to require quite fundamental changes in society's concepts of health and sickness, and to play an important part in the development of those changes.     

Problems in intervention and evaluation. A case report of a community-based rehabilitation and activation programme for the elderly and disabled

A rehabilitation and activation programme for elderly and disabled home nursing patients and home help clients was launched in Posio, Finland, in 1979. The evaluation of the controlled intervention programme took two years. Only a few positive results were obtained. The self-perceived health of the elderly and disabled improved, and they used outpatient services other than physiotherapy less frequently than did the control group. The difficulties of this evaluative study were many, one problem being the low quality of outcome measures. To carry out interdisciplinary evaluative studies, the following recommendations are proposed, based on the experiences of this study: the staff in charge should have previous experience of research; an outside researcher is recommended; the connected study should not be overemphasized, in order to avoid extra pressures on the workers; the time needed to develop the routines for collecting data and writing reports should be estimated in advance and divided between the collaborators; information should be collected by many methods; possible difficulties should be anticipated; besides a local organizing body, a separate, independent and interdisciplinary supervisory team is important; any intervention should be based on the interest of several instances.     

Human Immunodeficiency Virus Preexposure Prophylaxis: A Quick Guide for Primary Care Practice

Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) is when HIV-negative persons use antiretroviral medication to prevent HIV acquisition. It is up to 96% efficacious. Patients at risk for HIV warrant PrEP, and contraindications include being HIV positive and an estimated glomerular filtration rate (eGFR) < 60 mL/min. PrEP should be prescribed as 1 daily oral tablet of emtricitabine/tenofovir disoproxil fumarate, and repeat HIV and creatinine testing should occur after 1 month of medication use and then every 3 months. Patients who become HIV positive should be referred for care; those with an eGFR that decreases < 60 mL/min should be discontinued and monitored. Marked changes in eGFR or creatinine warrant monitoring.     

我国康复服务的未来发展方向探讨

通过对抽样调查各省市地区残联、民政部、卫生部资料进行整理分析,认为我国康复资源分布与地区经济发展水平密切相关;康复资源集中与医院等级相关;城市集中,农村缺乏;康复需求规模远大于康复服务规模;整体康复资源分布不均;康复服务规范需加强;效率有待提高。提出我国康复未来发展模式应将现有各级康复体系中的资源有效整合,提高其运行效率;结合国家基本政策,充分发展社区康复;在全国范围内建立残疾人康复需求与服务档案;解决好康复机构建设及病人康复经费问题。     

Determinants of factor VIII recovery in cryoprecipitate

Many aspects of the production of cryoprecipitate were studied to determine which methods resulted in the greatest recovery of Factor VIII. The following recommendations resulted: 1) blood should be mixed with anticoagulant throughout phlebotomy; 2) blood should be centrifuged within a few hours of collection; 3) larger satellite bags should be used to contain the usual volume of plasma, for example, 200 ml of plasma should be frozen in a 600-ml capacity bag; 4) plasma should be centrifuged as soon as thawing is complete; 5) cryoprecipitate should be refrozen on dry ice; 6) cryoprecipitate should be stored at or below -30 C.; and 7) prolonged storage of frozen plasma or cryoprecipitate should be avoided. Variations in Factor VIII content from one bag of cryoprecipitate to another, under uniform production conditions, depends largely on two donor-specific attributes which tend to remain constant from time to time, namely, the donor's plasma Factor VIII level and the cryoprecipitability of his Factor VIII.     

Managing Cancer Pain in Patients with Opioid and Substance Use Disorders

ObjectiveTo discuss the assessment and management of pain in patients with substance use disorders.Data SourcesPeer-reviewed articles, book chapters, internet sources.ConclusionPatients should be routinely assessed for SUDs. Pain management should be stratified according to patient risk. An interdisciplinary approach is essential.Implications for Nursing PracticeOncology nurses should be aware of assessment approaches to screen and monitor patients with SUDs. Oncology nurses are an essential part of the interdisciplinary team when monitoring patients with SUDs.     

Assistive technology policy: a position paper from the first global research,innovation, and education on assistive technology (GREAT) summit

Abstract

Increased awareness, interest and use of assistive technology (AT) presents substantial opportunities for many citizens to become, or continue being, meaningful participants in society. However, there is a significant shortfall between the need for and provision of AT, and this is patterned by a range of social, demographic and structural factors. To seize the opportunity that assistive technology offers, regional, national and sub-national assistive technology policies are urgently required. This paper was developed for and through discussion at the Global Research, Innovation and Education on Assistive Technology (GREAT) Summit; organized under the auspices of the World Health Organization’s Global Collaboration on Assistive Technology (GATE) program. It outlines some of the key principles that AT polices should address and recognizes that AT policy should be tailored to the realities of the contexts and resources available. AT policy should be developed as a part of the evolution of related policy across a number of different sectors and should have clear and direct links to AT as mediators and moderators for achieving the Sustainable Development Goals. The consultation process, development and implementation of policy should be fully inclusive of AT users, and their representative organizations, be across the lifespan, and imbued with a strong systems-thinking ethos. Six barriers are identified which funnel and diminish access to AT and are addressed systematically within this paper. We illustrate an example of good practice through a case study of AT services in Norway, and we note the challenges experienced in less well-resourced settings. A number of economic factors relating to AT and economic arguments for promoting AT use are also discussed. To address policy-development the importance of active citizenship and advocacy, the need to find mechanisms to scale up good community practices to a higher level, and the importance of political engagement for the policy process, are highlighted. Policy should be evidence-informed and allowed for evidence-making; however, it is important to account for other factors within the given context in order for policy to be practical, authentic and actionable.

• Implications for Rehabilitation

• The development of policy in the area of asssitive technology is important to provide an overarching vision and outline resourcing priorities.

• This paper identifies some of the key themes that should be addressed when developing or revising assistive technology policy.

• Each country should establish a National Assistive Technology policy and develop a theory of change for its implementation.

     

The role of the emergency department in the management of patients with atypical chest pain

There is often an inconsistent approach to the management of patients with chest pain which is not due to myocardial infarction. The stratification of risk groups, utility of diagnostic tests and current practice in the USA are discussed. Recommendations for a change in our current practice are:

• 1 Patients with unstable angina, acute myocardial infarction and those with a high suspicion of acute myocardial infarction should be admitted to hospital.
• 2 Those patients with atypical chest pain should be considered for early exercise testing in or from the emergency department.
• 3 In the absence of the facility for exercise testing in or from the emergency department, patients with atypical chest pain should be admitted to hospital.

     

THE TREATMENT OF TUBERCULOSIS WITH CYANOCUPROL

Cyanocuprol is markedly effective in tuberculosis, and we believe that it will play an important part in clinical medicine. It may be used more generally than tuberculin. The amount of the dose is closely related to the reaction and the final results. It should be determined for each patient after a careful examination of his symptoms. The maximum dose of 8.5 cc. should in no case be exceeded. The shortest interval between injections should be 2 weeks. If the drug is given after a shorter interval, no improvement is observed and the effects are sometimes dangerous. In order to obtain the best results the patient should be placed under conditions of complete physical and mental rest after the injection; this applies even to light cases. Care should also be taken to secure rest for the lesion. During the period of the treatment irritants to the lesion, such as potassium iodide or tuberculin, should be avoided; apricot juice, guaiacol and its derivatives, and iodol are contraindicated. No marked idiosyncrasy has been noted and no accumulative effects have been observed.     

An Alternative Approach to Atopic Dermatitis: Part II-Summary of Cases and Discussion

In the first part of this Review, we presented case-series whereKampo treatment was introduced for those atopic dermatitis (AD)patients who had failed with conventional therapy, in an attemptto prove that there exists a definite subgroup of AD patientsfor whom Kampo treatment is effective. In this second part,we will first provide the summary of the results for 140 ADpatients we treated in 2000. The results suggest that Kampotreatment is effective for more than half of AD patients whofail with conventional therapy. In the Discussion, we will examinethe evidential basis for conventional AD therapy and discusshow Kampo treatment should be integrated into the guidelinesfor AD therapy. We contend that Kampo treatment should be triedbefore systematic immunosuppressive agents are considered. Aseach Kampo treatment is highly individualized, it should beregarded more as ‘art’ than technology, and specialcare should be taken to assess its efficacy in clinical trial.