Guidelines for medical practice: 1. The reasons why.

Various external special interest groups are promoting attempts to better measure and control the performance of the medical profession, primarily to restrain costs. We can neither afford to ignore the rising costs nor reject efforts by provincial licensing authorities to improve supervision of the quality of care. Furthermore, there is increasing public interest in the outcome of medical treatment and a suspicion that some care may be unnecessary or inappropriate. Much of what physicians do is not based on impeccable or complete scientific evidence, and we have not established a method whereby science can consistently be translated into practice. Optimal practice patterns must be defined to improve the quality of care and to maximize the efficiency with which scarce resources are used. Careful scientific evaluation of data is particularly necessary with the arrival of new drugs and technology. Sensible, flexible guidelines produced by appropriate panels will help promote improved practice. Rigid standards must be avoided to allow for individual consideration and scientific innovation. The recognized difficulties of influencing clinical practice by precept or education and the problems imposed by rapidly changing scientific knowledge are two hurdles to be overcome. Licensing bodies must identify and enforce minimal standards, but optimal practice patterns are better devised by a broader segment of the profession. Intervention by third-party payers, as is prevalent in the United States, intrudes upon physician autonomy and reduces access to care. Physicians must support the development of guidelines for optimal medical practice based on the best existing data and focused on improving the quality of care.     

Ethical problems with the mental health evaluation standards of care for adult gender variant prospective patients

The World Professional Association for Transgender Health's "Standards of Care: The Hormonal and Surgical Sex Reassignment of Gender Dysphoric Persons" (SOC) set forth standards clinicians must meet to ensure ethical care of adequate quality. The SOC also set requirements gender variant prospective patients must meet to receive medical interventions to change their sexual characteristics to those more typical for the sex to which they were not assigned at birth. One such requirement is that mental health professionals must ascertain that prospective patients have met the SOC's eligibility and readiness criteria. This article raises two objections to this requirement: ethically obligatory considerations of the overall balance of potential harms and benefits tell against it, and it violates the principle of respect for autonomy. This requirement treats gender variant prospective patients who request medical intervention as different in kind, not merely degree, from other patient populations, as it constructs the very request as a phenomenon of incapacity. This is ethically indefensible in and of itself, but it is especially pernicious in a sociocultural and political context that already denies gender variant people full moral status.     

Evolution of Point-of-Care Testing in Australia

Currently no mandatory standards or guidelines exist for Point-of-Care Testing (PoCT) in Australia. In 2001, a report on the role and value of ‘near patient testing’ in general practice outlined work that was required to assist the Australian Government to decide how to manage PoCT. Phillips Fox reported that adoption of mandatory accreditation requirements was not justified by the level of risk associated with PoCT.If implemented appropriately, PoCT could be useful with frontline management of chronic disease, relieving stress on general practice and expanding the reach of pathology.Interim PoCT standards in general practice were developed by a Quality Use of Pathology committee, and formed an accreditation framework for the PoCT in General Practice Trial. This trial concluded that PoCT has a role in supporting the primary healthcare team to manage chronic disease patients.While results of the trial are still being considered, the potential impact of funding PoCT in general practice is being treated as part of the wider review of pathology funding currently taking place in Australia.Although Australia has local models from which to draw experience, it has yet to decide the quality framework it would adopt if it was to roll out PoCT in general practice. The quality framework that Australia adopts for PoCT must achieve high quality pathology results that enhance clinical care.     

Safety and efficacy in an accredited outpatient plastic surgery facility: a review of 5316 consecutive cases

Advances in medicine have improved the delivery of health care, making it more technologically superior than ever and, at the same time, more complex. Nowhere is this more evident than in the surgical arena. Plastic surgeons are able to perform procedures safely in office-based facilities that were once reserved only for hospital operating rooms or ambulatory surgery centers. Performing procedures in the office is a convenience to both the surgeon and the patient. Some groups have challenged that performing plastic surgery procedures in an office-based facility compromises patient safety. Our study was done to determine whether outcomes are adversely affected by performing plastic surgery procedures in an accredited outpatient surgical center. A retrospective review was performed on 5316 consecutive cases completed between 1995 and 2000 at Dallas Day Surgical Center, Dallas, Texas, an outpatient surgical facility. Most cases were cosmetic procedures. All cases were analyzed for any potential morbidity or mortality. Complications requiring a return to the operating room were determined, as were infection rates. Events leading to inpatient hospitalization were also included. During this 6-year period, 35 complications (0.7 percent) and no deaths were reported. Most complications were secondary to hematoma formation (77 percent). The postoperative infection rate for patients requiring a return to the operating room was 0.11 percent. Seven patients required inpatient hospitalization following their procedure secondary to arrhythmias, angina, and pulmonary emboli. Patient safety must take precedence over cost and convenience. Any monetary savings or time gained is quickly lost if safety is compromised and complications are incurred. The safety profile of the outpatient facility must meet and even exceed that of the traditional hospital-based or ambulatory care facility. After reviewing our experience over the last 6 years that indicated few complications and no deaths, we continue to support the judicious use of accredited outpatient surgical facilities by board-certified plastic surgeons in the management of plastic surgery patients.     

Dissemination of evidence-based standards of care

Standards of care pertain to crafting and implementing patient-centered treatment interventions. Standards of care must take into consideration the patient's gender, ethnicity, medical and dental history, insurance coverage (or socioeconomic level, if a private patient), and the timeliness of the targeted scientific evidence. This resolves into a process by which clinical decision-making about the optimal patient-centered treatment relies on the best available research evidence, and all other necessary inputs and factors to provide the best possible treatment. Standards of care must be evidence-based, and not merely based on the evidence - the dichotomy being critical in contemporary health services research and practice. Evidence-based standards of care must rest on the best available evidence that emerges from a concerted hypothesis-driven process of research synthesis and meta-analysis. Health information technology needs to become an every-day reality in health services research and practice to ensure evidence-based standards of care. Current trends indicate that user-friendly methodologies, for the dissemination of evidence-based standards of care, must be developed, tested and distributed. They should include approaches for the quantification and analysis of the textual content of systematic reviews and of their summaries in the form of critical reviews and lay-language summaries.     

Diagnostic imaging at its centennial: the past,the present and the future.

Since the discovery of x-rays by Wilhelm Conrad Röntgen 100 years ago, diagnostic imaging has profoundly influenced the practice of medicine. As a result of discoveries during this period, ultrasonography, nuclear imaging, computed tomography and magnetic resonance imaging, as well as conventional radiography, have assumed a major role in diagnostic medicine. In addition to their traditional role in diagnosis, imaging techniques are becoming an increasingly important factor in innovative treatment methods, and this role is likely to expand. In the current climate of rising health care costs, radiologists and other health care providers who use imaging must increasingly account to health care funders for the cost-effectiveness of imaging in relation to other diagnostic and interventional techniques. They must also assure minimum standards of quality and training, and determine the appropriate role for diagnostic imaging in health care systems of the future.     

Defining the phenotype in human genetic studies: forward genetics and reverse phenotyping

The definition of phenotypes for genetic study is a challenging endeavor. Just as we apply strict quality standards to genotype data, we should expect that phenotypes meet consistently high standards of reproducibility and validity. The methods for achieving accurate phenotype assignment in the research setting--the 'research diagnosis'--are different from the methods used in clinical diagnosis in the patient care setting. We evaluate some of the main challenges of phenotype definition in human genetics, and begin to outline a set of standards to which phenotypes used in genetics studies may aspire with the goal of increasing the quality and reproducibility of linkage and association studies. Revisiting the traditional phenotype definitions through a focus on familial components and heritable endophenotypes is a time-honored approach. Reverse phenotyping, where phenotypes are refined based on genetic marker data, may be a promising new approach. The stakes are high, since the success of gene mapping in genetically complex disorders hinges on the ability to delineate the target phenotype with accuracy and precision.     

Long-term digoxin treatment in general practice.

A questionnaire was sent to several general practitioners and specialists in an attempt to obtain a consensus on standards of care for patients receiving long-term digoxin treatment. The consultants'' suggested standards were slightly more stringent than those of the general practitioners. The records of 42 patients taking digoxin under the care of two general practitioners were studied to see how far their actual care matched up to the suggested standards. The models of management proposed by these patients'' doctors were only slightly different from those suggested by other practitioners, but measured against these models the patients'' care was in some cases inadequate. Nevertheless, there was little relationship between the recorded levels of care and the health of the patient, and it may have been the standard of recording rather than the care that was inadequate. Measuring plasma digoxin levels in these patients proved to be of little value. Medical audit is thus a useful tool in helping the general practitioner to review his work and improve his knowledge, but it may not be a practical or true way of measuring the quality of care.     

The Silence of the Unblown Whistle: The Nevada Hepatitis C Public Health Crisis

In 2008, one of the worst public health crises occurred in the state of Nevada, where authorities discovered up to 63,000 patients were potentially exposed to hepatitis C infection, largely due to substandard infection control and other negligent practices at two endoscopy clinics in Las Vegas. In the subsequent grand jury proceedings that followed, it was discovered that several clinic employees not only participated in these egregious practices, but doctors, nurses, and other health care professionals witnessed yet failed to report these incidents, largely due to fears of whistleblower retaliation. In response, the Nevada state legislature attempted to strengthen whistleblower protection laws, but it remains unclear if such laws actually protect employees who attempt to report patient safety concerns. As the push for quality patient outcomes becomes more prominent with health care reform, whistleblower concerns must be effectively addressed to ensure that health care professionals can report patient safety concerns without fear of retaliation.     

Responsibility for control; ethics of patient preparation for self-management of chronic disease

Patient self-management (SM) of chronic disease is an evolving movement, with some forms documented as yielding important outcomes. Potential benefits from proper preparation and maintenance of patient SM skills include quality care tailored to the patient's preferences and life goals, and increase in skills in problem solving, confidence and success, generalizable to other parts of the patient's life. Four central ethical issues can be identified. 1) insufficient patient/family access to preparation that will optimize their competence to SM without harm to themselves, 2) lack of acknowledgement that an ethos of patient empowerment can mask transfer of responsibility beyond patient/family competency to handle that responsibility, 3) prevailing assumptions that preparation for SM cannot result in harm and that its main purpose is to deliver physician instructions, and 4) lack of standards for patient selection, which has the potential to exclude individuals who could benefit from learning to SM. Technology assessment offers one framework through which to examine available data about efficacy of patient SM and to answer the central question of what conditions must be put in place to optimize the benefits of SM while assuring that potential harms are controlled.     

Treating anemia of chronic kidney disease in the primary care setting: cardiovascular outcomes and management recommendations

Background

Recent policy and organisational changes within UK primary care have emphasised graduated access to care, speed of access to the first available general practitioner (GP) and care being provided by a range of healthcare professionals. These trends have been strengthened by the current GP contract and Quality and Outcomes Framework (QOF). Concern has been expressed that the potential for personal care is being diminished as a result and that this will reduce quality standards. This paper presents data from a study that explored with patients and GPs what personal care means and whether it has continuing importance to them.

Methods

A semi-structured questionnaire was used to interview participants and Framework Analysis supported analysis of emerging themes. Twenty-nine patients, mainly women with young children, and twenty-three GPs were interviewed from seven practices in Lothian, Scotland, ranged by practice size and relative deprivation score.

Results and Discussion

Personal care was defined mainly, though not exclusively, as care given within the context of a continuing relationship in which there is an interpersonal connection and the doctor adopts a particular consultation style. Defined in this way, it was reported to have benefits for both health outcomes and patients' experience of care. In particular, such care was thought to be beneficial in attending to the emotions that can be elicited when seeking and receiving health care and in enabling patients to be known by doctors as legitimate seekers of care from the health service. Its importance was described as being dependent upon the nature of the health problem and patients' wider familial and social circumstances. In particular, it was found to provide support to patients in their parenting and other familial caring roles.

Conclusion

Personal care has continuing salience to patients and GPs in modern primary care in the UK. Patients equate the experience of care, not just outcomes, with high quality care. As it is mainly conceptualised and experienced as care within the context of a continuing relationship, policies and organisational arrangements that support and give incentives to this must be in place. These preferences are not strongly reflected in the QOF. Specific questions need to be addressed by future audit and research on the impact of the contract on these aspects of service.     

Training strategies for research investigators and technicians

Training programs for research personnel are discussed as a key resource that must be part of an effective animal care and use program. Because of the legal responsibility to ensure that research staff are qualified to use animals, many institutions have justified the necessity for a training coordinator and/or trainers for their animal care and use programs. Effective training programs for research personnel must meet the needs of the client base (research scientists and staff) so that they are relevant, practical, and timely. To meet these objectives, it is useful to involve the scientific staff in the analysis of their learning needs. To meet a performance standard necessary for quality research, a large percentage of the institutional staff must participate in the training program. Often it is the principal investigators who set the tone for their staff members regarding the importance of receiving training. Garnering support from this client base will create a culture that encourages training and engenders a positive attitude about humane animal care and use. One effective approach is to incorporate nonanimal models as alternatives to live animals to teach humane handling techniques and methods, thereby contributing to refinement, reduction, and replacement (the 3Rs). Also discussed are the necessity of timely feedback from clients, documentation of personnel training for regulatory purposes, and the collection of training metrics, which assists in providing justification for the granting of additional fiscal support for the program. Finally, the compliance procedures and opportunities for essential refresher training are discussed and related to high performance standards, humane animal use, and quality research, all of which contribute to the 3Rs.     

Letter to the editor: SeqXML and OrthoXML: standards for sequence and orthology information

There is a great need for standards in the orthology field. Users must contend with different ortholog data representations from each provider, and the providers themselves must independently gather and parse the input sequence data. These burdensome and redundant procedures make data comparison and integration difficult. We have designed two XML-based formats, SeqXML and OrthoXML, to solve these problems. SeqXML is a lightweight format for sequence records-the input for orthology prediction. It stores the same sequence and metadata as typical FASTA format records, but overcomes common problems such as unstructured metadata in the header and erroneous sequence content. XML provides validation to prevent data integrity problems that are frequent in FASTA files. The range of applications for SeqXML is broad and not limited to ortholog prediction. We provide read/write functions for BioJava, BioPerl, and Biopython. OrthoXML was designed to represent ortholog assignments from any source in a consistent and structured way, yet cater to specific needs such as scoring schemes or meta-information. A unified format is particularly valuable for ortholog consumers that want to integrate data from numerous resources, e.g. for gene annotation projects. Reference proteomes for 61 organisms are already available in SeqXML, and 10 orthology databases have signed on to OrthoXML. Adoption by the entire field would substantially facilitate exchange and quality control of sequence and orthology information.     

Medical physics in radiotherapy: The importance of preserving clinical responsibilities and expanding the profession's role in research,education, and quality control

Medical physicists have long had an integral role in radiotherapy. In recent decades, medical physicists have slowly but surely stepped back from direct clinical responsibilities in planning radiotherapy treatments while medical dosimetrists have assumed more responsibility. In this article, I argue against this gradual withdrawal from routine therapy planning. It is essential that physicists be involved, at least to some extent, in treatment planning and clinical dosimetry for each and every patient; otherwise, physicists can no longer be considered clinical specialists. More importantly, this withdrawal could negatively impact treatment quality and patient safety. Medical physicists must have a sound understanding of human anatomy and physiology in order to be competent partners to radiation oncologists. In addition, they must possess a thorough knowledge of the physics of radiation as it interacts with body tissues, and also understand the limitations of the algorithms used in radiotherapy. Medical physicists should also take the lead in evaluating emerging challenges in quality and safety of radiotherapy. In this sense, the input of physicists in clinical audits and risk assessment is crucial. The way forward is to proactively take the necessary steps to maintain and advance our important role in clinical medicine.     

Reuse of haemodialysis equipment: convenience and cost effectiveness.

The shortage of resources for providing renal replacement makes it essential to reduce revenue costs wherever possible. Assuming that haemodialysis is likely to remain a mainstay of renal replacement, a policy of reusing the expensive disposable dialysers and blood lines could offer substantial cost savings. Such reuse has been shown to be safe and to maintain efficiency, but it must also take account of convenience to the patient, especially those dialysing at home. A survey of patients treated with home dialysis shows that the rate of reuse of the complete extracorporeal circuit was highest for those patients who had automated reuse systems.     

Measuring the quality of later life.

This paper examines quality of life as a scientific construct with a wide range of applications. The assessment of patients'' quality of life is assuming increasing importance in medicine and health care. Illnesses, diseases and their treatments can have significant impacts on such areas of functioning as mobility, mood, life satisfaction, sexuality, cognition and ability to fulfil occupational, social and family roles. The emerging quality of life construct may be viewed as a paradigm shift in outcome measurement since it shifts the focus of attention from symptoms to functioning. This holistic approach more clearly establishes the patient as the centre of attention and subsumes many of the traditional measures of outcome. Quality of life assessment is particularly relevant to ageing populations both for healthy elderly and for those who develop chronic diseases where maintenance of quality of life rather than cure may be the primary goal of treatment. This paper introduces the concept of quality of life and describes the significant difficulties in definition, measurement and interpretation that must be addressed before such measures can be used as reliable and valid indicators of disease impact and treatment outcomes. It is argued that approaches to quality of life assessment in the elderly should incorporate advances in knowledge about the psychological adaptation to ageing. Consequently, the unique perspective of the individual on his or her own quality of life must be incorporated into outcome assessments aimed at improving the quality of health care. Incorporating measures of subjective outcome such as quality of life into policy decisions on resource allocation in health care will prove one of the major challenges for health services over the next decade.     

Guidelines for medical practice: 2. A possible strategy.

The recognition that much current medical practice is based on incomplete scientific evidence has led to calls for the generation of guidelines for optimal patterns of practice. These guidelines must be developed from a synthesis of existing scientific data ideally obtained from randomized clinical trials. However, at present we may have to rely on less satisfactory data and the views of experts in the field. The primary purpose of these initiatives must be to improve patient care. The Ontario Medical Association has made recommendations on how such guidelines should be produced, and in a recent survey a substantial majority of family physicians supported them. There is general agreement that the coordinating body should be independent of government and other interested parties. In addition, the medical profession must have the primary role, and a number of medical organizations should also be represented. We propose a possible structure for a group charged with developing guidelines for medical practice at a provincial level and on an experimental basis. Recommendations are made on its membership, function and relationship with other organizations. The identification and diffusion of justifiable, scientific practice patterns will help reduce waste of scarce resources, maintain the role of the profession as guardian of the quality of care and ultimately benefit the patient.     

The development of patient information leaflets. Care of the mouth after radiotherapy

Objectives: Describe the methodology used to produce a patient leaflet on care of the mouth after radiotherapy. Design: Prospective study to design a patient information leaflet. Setting and Subjects : Patients undergoing radiotherapy for oral cancer. Intervention: After a review of the relevant literature, a patient questionnaire was produced. This was then completed by patients undergoing radiotherapy treatment and gave an indication of the problems being encountered. Healthcare professionals were surveyed for their views. A leaflet was then produced according to published guidelines. It was taken back to another group of patients and a further version produced after input from a health promotion group. Results: A leaflet was produced after wide consultation and survey. Conclusion: Considerable effort must to be put into the production of patient information leaflet. It must be discussed with patients in the target group if it is to be sensitive, understood and find acceptance among its users     

The quality of health care in prison: results of a year's programme of semistructured inspections.

OBJECTIVES: To assess, as part of wider inspections by HM Inspectorate of Prisons, the extent and quality of health care in prisons in England and Wales. DESIGN: Inspections based on a set of "expectations" derived mainly from existing healthcare quality standards published by the prison service and existing ethical guidelines; questionnaire survey of prisoners. SUBJECTS: 19 prisons in England and Wales, 1996-7. MAIN OUTCOME MEASURES: Appraisals of needs assessment and the commissioning and delivery of health care against the inspectorate''s expectations. RESULTS: The quality of health care varied greatly. A few prisons provided health care broadly equivalent to NHS care, but in many the health care was of low quality, some doctors were not adequately trained to do the work they faced, and some care failed to meet proper ethical standards. Little professional support was available to healthcare staff. CONCLUSIONS: The current policy for improving health care in prisons is not likely to achieve its objectives and is potentially wasteful. The prison service needs to recognise that expertise in the commissioning and delivery of health care is overwhelming based in the NHS. The current review of the provision of health care in prisons offers an opportunity to ensure that prisoners are not excluded from high quality health care.     

An Introduction to a Symposium in Geriatric Dentistry: Issues in Gerontology

The papers in this collection address geriatric dentistry at a time when society is rapidly becoming older. More than ever before, all dental care providers must understand the special needs of elderly patients and the unique biological features of the aged person that affect the diagnosis and prognosis of oral pathology. Attitudes about aging in the elderly must be discussed within the context of the health care setting so we can address the needs for social change, particularly in the dental and medical professions. This symposium brings together a series of papers on topics that are being researched in geriatric dentistry. The topics are diverse, including methods to finance dental care, psychiatric considerations, temporomandibular joint dysfunction, prosthodontics, artificial saliva and nutritional factors, immunology and the new frontiers in dental science, periodontal disease and oral cancer. And as an epilogue to our theme, a dentist with a primarily geriatric practice reflects on the difficulties and the rewards of the elderly patient. Improving the quality of life is the goal of aging research and to investigate aging legitimately we must ask in a systematic manner, what is aging? In this introduction, we discuss briefly the several theories of aging that are guiding research efforts.