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Food and Drug Administration--General hospital and personal use devices; general provisions. Final rule.

Food and Drug Administration [FDA] is issuing a final rule regarding general provisions applicable to the classification of general hospital and personal use devices. The preamble to this rule responds to general comments received on the proposals regarding classification of general hospital and personal use devices. This action is being taken under the Medical Device Amendments of 1976.

Equipment and Supplies, Hospital↗

Do physicians assess lifestyle health risks during general medical examinations? A survey of general practitioners and obstetrician-gynecologists in Quebec.

BACKGROUND: In Canada several guidelines have been published for the screening of lifestyle health risks during general medical examinations. The authors sought to examine the extent to which such screening practices have been integrated into medical practice, to measure physicians' perceived level of difficulty in assessing these risks and to document physicians' evaluation of their formal medical training in lifestyle risk assessment. METHODS: An anonymous mail survey was conducted in 1995 in Quebec with a stratified random sample of 1086 general practitioners (GPs) and with all 241 obstetrician-gynecologists (Ob-Gyns). The authors evaluated the proportion of physicians who reported routine assessment (with 90% or more of their patients) of substance use, family violence and sexual history during general medical examinations of adult and adolescent patients; the proportion of those who find inquiring about these issues difficult; and the proportion of those who evaluated their medical training in lifestyle risk assessment as adequate or excellent. RESULTS: The overall response rate was 72.6%. Among adult patients, 82.2% of the GPs reported routinely assessing tobacco use, 67.2% alcohol consumption, 34.2% illicit drug use and 3.2% family violence; the corresponding proportions for assessment among adolescent patients were 77.1%, 61.8%, 52.9% and 5.6%. Comparatively fewer Ob-Gyns reported routinely assessing these issues (56.1%, 28.6%, 20.4% and 1.3% respectively among adults and 62.7%, 35.2%, 26.8% and 2.8% respectively among adolescents). In the area of sexual history, condom use was routinely assessed by more Ob-Gyns than GPs (47.0% v. 28.2%); however, the proportion of Ob-Gyns and GPs was equally low for assessing number of partners (24.8% and 23.1%), sexual orientation (18.8% and 16.9%) and STD risk (26.2% and 21.2%). The vast majority of GPs and Ob-Gyns reported finding it difficult to assess family violence (86.5% and 93.0%) and sexual abuse (92.7% and 92.4% respectively). Over 80% of the physicians felt that they had had adequate or excellent medical training in assessing risk behaviours for heart disease and STD risk. The proportion who felt this way about their training in screening for illicit drug use, family violence and sexual abuse ranged between 12.7% and 31.6%. INTERPRETATION: Although morbidity and mortality associated with smoking, alcohol consumption, illicit drug use, unsafe sexual practices, family violence and sexual abuse have been well documented, routine screening for these risk factors during general medical examinations has yet to be integrated into medical practice.

Adolescent↗

Australian divisions of general practice asthma survey 1997. General Practitioner's Asthma Group of the National Asthma Campaign.

AIM: To conduct an attitudinal postal survey of all 118 divisions of general practice known to the National Asthma Campaign. METHOD: A questionnaire aimed to determine the perceived barriers to improved asthma care in the divisions, current asthma projects and the most suitable way that the General Practitioners Asthma Group (GPAG) and the National Asthma Campaign (NAC) could assist divisions of general practice. RESULTS: Eighty seven (74%) replies were received. Twenty-four divisions (28%) were running asthma projects, mostly about asthma education. The greatest barrier to asthma care for the doctor was a lack of time (57% of respondents) and the greatest barrier for the patient was perceived to be a lack of asthma education (34% of respondents). Asthma educators employed by the division or individual surgeries were ranked as the preferred method for overcoming these difficulties. CONCLUSIONS: Divisions of general practice are becoming involved in the management of asthma throughout Australia although there are considerable hurdles to overcome. The role of the GPAG and NAC in this process is discussed.

Asthma↗

Otitis externa in UK general practice: a survey using the UK General Practice Research Database.

BACKGROUND: Otitis externa is a common clinical problem in general practice and yet there are remarkably few data available on the demographic characteristics of patients with this condition and the approaches used by general practitioners (GPs) in the United Kingdom (UK) to manage it. AIM: To define the descriptive epidemiology of otitis externa in the general population, to describe the first-line drug treatment used by UK GPs, and to determine factors related to second disease episodes. DESIGN OF STUDY: Epidemiological data survey. SETTING: All cases of otitis externa occurring in 1997 in practices contributing data to the UK General Practice Research Database. METHOD: Data were extracted on age, sex, date of episode of otitis externa, treatment prescribed, co-existing diagnoses of eczema and diabetes, referral to ear, nose, and throat departments and occurrence of subsequent episodes of disease. Arbitrarily a second episode of disease was defined as persistence if it occurred at 28 days or fewer after the first episode and recurrence if it occurred at more than 28 days after the first episode. RESULTS: A diagnosis of otitis externa was common in all age groups and, except in the elderly, was more common in females than males. There was an increase in disease episodes at the end of the summer in all age groups except the 60 years and over group. In the majority of cases GPs prescribed ear drops (85%), but a significant proportion of patients were also prescribed oral antibiotics (21%). Referral to secondary care was uncommon (3%). Among patients prescribed ear-drop formulations, those containing both steroid and antibiotic or steroid alone were used most commonly and were associated with the lower rates of disease persistence but not recurrence. Among patients prescribed antibiotics, penicillins were prescribed most commonly. Disease persistence rates, and to a lesser extent disease recurrence rates, were higher in patients prescribed oral antibiotics. CONCLUSION: Otitis externa is a common condition and GPs can expect to see an excess of cases at the end of the summer. Topical ear drops are the most common treatment used in the UK. Patients prescribed steroid or steroid/antibiotic combination ear drops have fewer subsequent consultations for otitis externa over the following 28 days.

Adolescent↗

[The practice guideline 'Refraction errors' from the Dutch College of General Practitioners: response from the perspective of general medicine].

The objective of the practice guideline 'Refraction errors' from the Dutch College of General Practitioners is to help the general practitioner to deal with patients presenting with gradual loss of vision. The number of ophthalmologists in the Netherlands is small and general practitioners need to differentiate between acute and non-acute ocular conditions. For the first time diagnostic refraction is included as a means of differentiating between a refraction disorder and other ocular pathology. The anamnesis section in the guideline is meagre and the use of a stenopeic opening and the subject of presbyopia are insufficiently emphasised. The underlying assumption that general practitioners are insufficiently capable of carrying out an ophthalmological investigation such as ophthalmoscopy needs to be revised.

Clinical Competence↗

[Are the Danish Society of General Practitioners' clinical guidelines concerning "Identification and investigation of dementia and dementia-like conditions" useful as the basis of dementia investigation in general practice?].

INTRODUCTION: During the last five years better possibilities have appeared for investigation and medical treatment of dementia. Society and the national health authorities have a growing demand for systematical identification of dementia. In 1999, DSAM published a clinical guideline for identifying dementia. The aim of the study was to test the usefulness of that guideline. MATERIAL AND METHODS: A total of 22 out of 29 general practitioners (GPs) agreed to use the guidelines of the Danish Society of General Practitioners (DSAM) and the questionnaires from three consultations in order to systematically identify dementia. At the same time, the GPs gave their opinion about the usefulness of the guidelines. RESULTS: A total of 22 GPs sent results from 69 patients. A group of 49 patients had been CT-scanned, 13 patients had been examined by neuropsychologists, and nine patients had started acetylcholinesterase inhibitor treatment. CONCLUSION: Some GPs found it embarrassing to offer dementia identifying to their patients. Identifying dementia was complicated and time-consuming. Identifying dementia offered opportunities to look further into polypharmacy and cooperation with other health sectors. Necessary but not sufficient preconditions for starting identifying dementia in general practice will be fees, direct admission to CT-scanning and neuropsychologist, and possibly right to prescribe acetylcholinesterase inhibitors. The conclusion was that all GPs found the guidelines of DSAM useful for identifying dementia in general practice.

Adult↗

[The level of knowledge of general practitioners regarding the early phase of Lyme borreliosis. Survey conducted among 106 general practitioners].

OBJECTIVE: Determine the level of knowledge of the general practitioners on the early phase of Lyme borreliosis in an endemic area and notably to define the attention paid to the use and interpretation of serologic investigations for the treatment of patients with erythema migrans. METHOD: This was a prospective study conducted from May 15 to June 31, 2001 among 106 randomly selected general practitioners installed in Strasbourg, France. The practitioners were all interviewed in their private practice and by the same person. Three standardized questions were asked, evaluating their level of specific medical training on Lyme borreliosis as well as their practice regarding treatment and diagnosis of erythema migrans. RESULTS: One third of the general practitioners had already accomplished a continued medical education course on Lyme borreliosis. Half of them considered that the diagnosis of erythema migrans was clinical, while the other half believed that serological confirmation was mandatory. However, the answers of those having received specific education on borreliosis were right (p=0.0079) since in this sub-group 72% considered that the diagnosis was exclusively based on clinical examination, versus 41% of the untrained physicians. Eighty-eight percent used the recommended antibiotic regimens to treat erythema migrans. Three practitioners proposed an inefficient treatment that had exposed the patients to the risk of extra-cutaneous complications of the disease. CONCLUSION: Fifty percent of the general practitioners working in endemic areas for Lyme borreliosis still believe that seropositivity against Borrelia burgdorferi is required to diagnose erythema migrans, which is untrue. However, this study shows that a specific education on Lyme borreliosis would significantly improve this score.

Adult↗

[The practice guideline 'Dementia' (second revision) from the Dutch College of General Practitioners; a response from the perspective of general practice].

With growing numbers of older adults in the population, the number suffering from dementia will increase. The general practitioner has to try to determine the difference between Alzheimer's disease and vascular dementia on the one hand, and fronto-temporal dementia and dementia with Lewy bodies on the other hand, while also considering the therapeutic options now and in the future. Support for patients and their family is the responsibility of the general practitioner, who must also consider the patient's driving proficiency and the wishes for euthanasia of the demented older adult. The revised version of the practice guideline 'Dementia' of the Dutch College of General Practitioners is well suited to the work of the general practitioner. It is advisable to read the practice guideline several times and in such cases not only to use the summary card but the entire practice guideline.

Dementia↗

[The practice guideline 'Atrial fibrillation' from the Dutch College of General Practitioners; a response from the perspective of general practice].

The practice guideline 'Atrial fibrillation' (AF) from the Dutch College of General Practitioners is a clearly written survey on the diagnosis and treatment of AF in general practice. Rapid cardioversion is no longer an indication for acute referral in AF. As AF, heart failure and COPD often occur simultaneously among elderly people, the exact cause of the symptoms can be unclear. In these complicated cases, with the risk of polypharmacy, a single consultation between general practitioner and cardiologist would be more effective. For control of the rate of ventricular contraction during the treatment of AF, lipophilic beta-blockers are preferable to hydrophilic beta-blockers because the pharmacokinetics in elderly people are substantially different. When there is a high risk of thrombo-embolic complications with AF, treatment with coumarin derivatives is advised. However, little research has been done on this subject among elderly people in a general practice setting. In this age group, the risk of complications due to treatment with coumarin derivatives is sometimes higher than the advantages it offers. This is why the GP should always consider carefully whether or not elderly people with AF should be treated with coumarin derivatives.

Age Factors↗

General practice east of Eden: an overview of general practice in Eastern Europe.

AIM: To review the status of family medicine in Eastern European countries, specifically the position of the discipline within the health care system, its academic status, and expected trends in the development of the discipline. METHODS: We used available data in the literature and information gathered from personal contacts with members of European Society of General Practice/Family Medicine (ESGP/FM) expert groups, European Academy of Teachers in General Practice (EURACT), and European General Practice Research Network (EGPRN). Personal interviews with key informants from countries that do not have members in these organizations were used. We also performed a Medline search using terms "primary health care" and "family medicine". RESULTS: It was difficult to get standardized information about the issues addressed. In some countries, contact persons and articles were impossible to find. Because of that, information from some countries is lacking (e.g. Belarus, Ukraine, the Kavkaz states and Central Asian republics). The information from the 14 countries showed that family medicine was formally widely recognized as a specific discipline. In 13 of them, there were some programs of vocational training. In 10 countries, academic recognition has resulted in rapid development in the past two decades, especially after 1989, but in Bulgaria and Moldova we found no evidence of family medicine departments. CONCLUSION: The position of general practice in most Central and Eastern European countries is formally adequate, but a lot of effort will still be needed to achieve the desired level of its recognition and quality.

Europe, Eastern↗

General practitioners' perceptions of barriers to their provision of mental healthcare: a report on Mental Health and General Practice Investigation (MaGPIe).

AIM: To explore GP attitudes and perceptions of barriers to providing mental healthcare. METHODS: The MaGPie study included a cross-sectional survey of a random sample of 78 GPs in the lower part of North Island, New Zealand. GPs completed a questionnaire about aspects of their provision of mental healthcare including consultation fees, perceived barriers to providing mental healthcare, and factors likely to increase detection of mental illness in general practice patients. RESULTS: Seventy (90%) GPs completed the questionnaire. GPs reported that consultations with patients with mental health problems took longer and could lead to increased waiting times for other patients. Many GPs subsidised mental health consultations either by not charging for longer consultations or writing-off fees. GPs thought that funded longer consultation times and more training in interviewing techniques would increase recognition of mental health problems in general practice. CONCLUSION: Structural aspects of general practice at the time of this survey presented a barrier to the provision of primary mental healthcare. The subsequent establishment of primary health organisations provides potential for improving primary mental healthcare through specific contracts for mental healthcare allowing variation in consultation length and the addition of mental health professionals to the general practice team.

Adult↗

[The practice guideline 'Heart failure' (first revision) from the Dutch College of General Practitioners; a response from the perspective of general practice].

The practice guideline 'Heart failure' from the Dutch College of General Practitioners will be a source of support for the general practitioner/family physician. Its clear set of diagnostic steps helps the general practitioner to assess heart failure in patients with breathlessness, fatigue, decreased exercise tolerance or ankle swelling. Testing plasma concentrations of natriuretic peptides plays a new and central diagnostic role. This guideline differs from the previous one in another important aspect. Based on many RCT's and reviews the authors have succeeded in developing a detailed but balanced treatment protocol for heart-failure patients in general practice. However, adverse effects from co- and multi-medication in the growing number of frail elderly may reduce the patients' compliance.

Aged↗

Prevalence of STI related consultations in general practice: results from the second Dutch National Survey of General Practice.

BACKGROUND: The role of the GP in the care of sexually transmitted infections (STIs) is unclear. AIM: We studied the prevalence of STI related consultations in Dutch general practice in order to obtain insight into the contribution of the GP in STI control. DESIGN OF STUDY: A descriptive study. SETTING: The study took place within the framework of the second Dutch National Survey of General Practice in 2001, a large nationally representative population-based survey. METHOD: During 1 year, data of all patient contacts with the participating GPs were recorded in electronic medical records. Contacts for the same health problem were clustered into disease episodes and their diagnosis coded according to the International Classification of Primary Care. All STI and STI related episodes were analysed. RESULTS: In total, 1 524 470 contacts of 375 899 registered persons in 104 practices were registered during 1 year and 2460 STI related episodes were found. The prevalence rate of STI was 39 per 10 000 persons and of STI/HIV related questions 23 per 10 000. More than half of all STIs were found in highly urbanised areas and STIs were overrepresented in deprived areas. Three quarters of all STIs diagnosed in the Netherlands are made in general practice. An important number of other reproductive health visits in general practice offer opportunities for meaningful STI counselling and tailored prevention. DISCUSSION: GPs contribute significantly to STI control, see the majority of patients with STI related symptoms and questions and are an important player in STI care. In particular, GPs in urban areas and inner-city practices should be targeted for accelerated sexual health programmes.

Adult↗

[The practice guideline 'Diabetes mellitus type 2' (second revision) from the Dutch College of General Practitioners; a response from the perspective of general practice].

The publication of the practice guideline 'Diabetes mellitus' by the Dutch College of General Practitioners in 1989 marked the start of an era of publication of several guidelines that helped general practitioners using evidence-based medicine in clinical practice; the guidelines also helped to teach students. The second revision of this guideline presents many improvements, especially simplifications in the medication-schedules. However, the new recommendation to use thiazolidines is based on only one large study and has some unpractical aspects. The new guidelines do not mention preventive action, nor advice regarding early detection. Clinical practice has changed in recent years with the introduction of nurses specialising in diabetes and, despite published research on this subject, the guidelines do not give any recommendations for this. What is also missing are national clinical guidelines for doctors specialising in internal medicine. When patients do not respond to treatment according to the general practitioners' guidelines and are referred to a specialist in internal medicine, the treatment is diverse and seems to be doctor-dependent. It is important that treatment there be standardised as well so that general practitioners can refer more effectively.

Diabetes Mellitus, Type 2↗

[Diagnosis and treatment in general practice. 6. Attitudes of general practitioners--a study in Copenhagen County].

We assume that general practitioners' (GPs) attitudes have considerable significance for their daily work, partly because the "free enterprise" structure permits GPs a fair degree of work autonomy, partly because several studies point to notable variations in GP behaviour which have not been explained by other variables. General practitioners seem to have developed an official professional ideology which differs in some respects from the ideology of other doctors. The core issues of Danish GP ideology, according to commission reports, textbooks and research can be summarized into four main principles: 1. A holistic (bio-psycho-social) model of disease, 2. The GP as a family doctor, 3. The GP as a "gate-keeper" (the central referral role) and 4. General practice as a "free enterprise". We mailed attitude questionnaires to a random sample of 100 practices in the county of Copenhagen. The purpose of the study was to establish the extent to which GPs would agree to the above ideology, and also to look for systematic differences between groups of doctors. The response rate was 76%. We found overall agreement to the family doctor principle among GPs which is in accordance with earlier studies. Attitudes to the "free enterprise" principle of practice organization were favorable in a similarly homogeneous way, and a significant minority favored even further liberalization. Disagreements were more pronounced concerning the holistic (bio-psychosocial) model of disease. Just over half of respondents adhered fully to the model, but doctors from high-income areas were significantly less enthusiastic than other doctors about the model. Similarly, most general practitioners favored the "gate-keeper" role.(ABSTRACT TRUNCATED AT 250 WORDS)

Attitude of Health Personnel↗

Assessing alcohol consumption in general practice patients--a comparison between questionnaire and interview (findings of the Medical Research Council's general practice research framework study on lifestyle and health).

A self-administered questionnaire, the Health Survey Questionnaire (HSQ) was distributed to patients registered with 47 group general practices. The HSQ assesses alcohol consumption using a quantity frequency scale and includes the four CAGE questions and a question on whether respondents think they have an alcohol problem. A random stratified sample of those patients who returned an HSQ (2666 men and 1537 women) were subsequently invited to attend their general practice for an interview with the practice nurse, where weekly alcohol consumption was estimated using both a quantity frequency scale and a systematic enquiry about alcohol consumption for the week immediately preceding the interview. The latter method was taken as the 'gold standard'. Excessive drinkers were defined as men whose weekly consumption by this method was not less than 35 units per week and women drinking at least 21 units per week. After weighing the results to take account of the sampling bias in favour of the excessive drinkers, 11.7% of men and 2.9% of women were excessive drinkers according to the estimate of alcohol consumption at interview. This compares with the 7.6% of men and 2.7% of women who were heavy drinkers by the HSQ quantity frequency scale. The two interview estimates were comparable but in general the HSQ tended to underestimate consumption compared with these estimates. The questionnaire was found to be most effective in screening for excessive drinkers if all the patients who indicated concern about their drinking (i.e. those who were with CAGE positive or had a self-assessed drinking problem), as well as all of those who were above the limits for the trial on the quantity frequency scale, were selected as being potentially excessive drinkers. In the weighted sample, 14.8% of men and 6.9% of women were in this group. Using these selection criteria and taking the interview as the standard for determining the excessive drinkers a sensitivity of 58.6% and specificity of 91.08% was obtained for men, with a positive predictive value of 46.1% and a negative predictive value of 94.3%. For women the test was more sensitive (69.7%) and more specific (95.0%) and had a better negative predictive value (99.1%) than for men. The positive predictive value for women at 29.6% was not as good as that obtained for men. This analysis shows that the HSQ is a fairly effective tool for detecting excessive drinkers in general practices with a small proportion of false positive results. It is both economical and acceptable to patients in a wide range of practice settings.

Alcohol Drinking↗

Complementary medicine and the general practitioner: a survey of general practitioners in the Wellington area.

A questionnaire was sent to 226 general practitioners in the Wellington region to determine the relationship between the general practitioner and complementary medicine. A 77% response rate was achieved. Twenty-four % of doctors had received training and 54% wanted further training in a complementary therapy; 27% currently practised at least one therapy. The majority of doctors (94%) knew of complementary practitioners in their locality; 77% indicated they referred to other medical practitioners for complementary therapies and 80% to nonmedical practitioners. Acupuncture, hypnosis and chiropractic were the most popular therapies. The general practitioner's role was perceived as ranging from comprehensive provider of both conventional and complementary medicine to selective practitioner of some options. It is concluded that complementary medicine is of considerable interest to general practitioners; there is demand for more training and information to be made available for doctors and for better referral networks to be developed between the practitioners.

Acupuncture Therapy↗

Annual night visiting rates in 129 general practices in one family health services authority: association with patient and general practice characteristics.

BACKGROUND: Rates of night visiting by general practitioners have increased steadily over the last 30 years and vary widely between general practices. AIM: An ecological study was carried out to examine night visiting rates by general practices in one family health services authority, and to determine the extent to which differences in night visiting rates between practices could be explained by patient and practice characteristics. METHOD: The study examined the variation in annual night visiting rates, based on night visit fees claimed between April 1993 and March 1994, among 129 general practices in Merton, Sutton and Wandsworth Family Health Services Authority, London. RESULTS: Practices' annual night visiting rates varied from three per 1000 to 75 per 1000 patients. The percentages of the practice population aged under five years and aged five to 14 years were both positively correlated with night visiting rates (r = 0.38 and r = 0.35, respectively), as were variables associated with social deprivation such as the estimated percentage of the practice population living in one-parent households (r = 0.24) and in households where the head of household was classified as unskilled (r = 0.20). The percentage of the practice population reporting chronic illness was also positively associated with night visiting rates (r = 0.26). The percentages of the practice population aged 35 to 44 years and 45 to 54 years were both negatively associated with night visiting rates (r = -0.34 and r = -0.31, respectively) as was the estimated list inflation for a practice (r = -0.31). There was no significant correlation between night visiting rates and the distance of the main practice surgery from the nearest hospital accident and emergency department. There was also no association between night visiting rates and permission to use a deputizing service. In a stepwise multiple regression model, the multiple correlation coefficient was 0.56 with four factors (percentage of the practice population aged under five years, percentage aged 35-44 years, percentage who were chronically ill and estimated list inflation) explaining 32% of the variation in night visiting rates. CONCLUSION: Only about one third of the variation in night visiting rates between practices could be explained by patient and practice variables derived from routine data. Population-based research using data collected on individual patients and practices is required to improve current understanding of the patient and practice characteristics that influence the demand for night visits and of why night visiting rates vary so widely between practices.

Adolescent↗