Updating clinical recommendations for breast, colorectal and lung cancer treatments: an opportunity to improve methodology and clinical relevance.

BACKGROUND: clinical guidelines can improve quality of care summarising available knowledge and proposing recommendations for health care decisions. Being up to date is one of their quality requisites. Little experience is available on when and how guidelines should be updated. We report on the update process of evidence-based clinical recommendations on anticancer drugs. METHODS: three multidisciplinary panels, supported by methodology experts, updated the recommendations. The methodologists were in charge of the qualitative and quantitative synthesis of the evidence. The panels were responsible for the final decision about risk/benefit profile of the drugs and strength of the recommendations. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used. RESULTS: six recommendations out of 15 were completely updated in 8 months time. In four cases, the strength of the recommendation changed; in two of them, we moved from a weak to a strong positive one. Despite the increased certainty about the positive risk/benefit profile, this was translated in a change in the strength of the recommendation only in one case out of three. Three recommendations were refined making them more clinically specific. CONCLUSIONS: accumulation of evidence is an opportunity for guideline panels to refine methodological rigour, clinical relevance and to foster consensus on recommendations. This requires time and resource investments.

Characteristics of Type 2 diabetic patients cared for by general practitioners either with medical nutrition therapy alone or with hypoglycaemic drugs.

The essential role of medical nutrition therapy (MNT) for people with diabetes is widely recognised, and its exclusive use is recommended in mild diabetes according to a stepwise therapeutic approach. We describe the characteristics of MNT-treated Type 2 diabetic patients (vs drugs) cared for by general practitioners (GPs) in order to check that appropriate differences did exist between the two groups, by auditing the data from our local shared-care program for diabetes. We had 16,000 diabetic patients (out of 630,000 inhabitants); 6,800 of them (42.5%) cared for by GPs. Thirty-one percent (2,079 out of 6,800 patients cared for by GPs) were treated with MNT and 69% with drugs. The MNT-treated patients (vs drugs) were younger (66.1 +/- 10.7 vs 67.7 +/- 11.0 yr, p<0.01), had shorter disease duration (8.2 +/- 6.6 vs 11.2 +/- 7.6 yr, p<0.01), lower HbA1c (7.0 +/- 1.1 vs 7.8 +/- 1.6%, p<0.01) and body mass index (BMI) (28.6 +/- 4.6 vs 29.0 +/- 4.9 kg/m2, p<0.01). They had less prevalence of high blood triglycerides (25.4% vs 29.0%, p<0.01). MNT-treated patients had less micro-albuminuria (5.3% vs 8.8%, p<0.01); less retinopathy both non-proliferant (6.5% vs 11.1%, p<0.01), and pre-proliferant (6.8% vs 12.7%, p<0.01), and proliferant (7.0% vs 12.9%, p<0.01); less peripheral neuropathy (3.9% vs 8.3%, p<0.01); and diabetic foot (1.0% vs 2.0%, p<0.01). They had less chronic heart failure (2.7% vs 4.6%, p<0.01), and claudicatio intermittens (3.3% vs 5.3%, p<0.01). In conclusion, the Type 2 diabetic patients cared for by GPs using MNT appropriately had a less severe form of diabetes.

Audit of a shared-care program for persons with diabetes: baseline and 3 annual follow-ups.

In Italy, data on shared-care programs for diabetes are lacking. We described the characteristics of type 2 diabetic population assisted in general practice and evaluated 3 years of follow-up outcomes and performance indicators in a shared-care program in Modena, Italy (1998-2001); only well-controlled diabetic patients were considered. Forty-nine percent of territorial GPs adhered to the project (257 out of 521) and 77% of them sent 6409 paired baseline and follow-up datasheets. Altogether, 97.8% patients had type 2 diabetes, mean age 68.6+/-11.7 years, disease duration 9.6+/-7.5 years, BMI 28.6+/-4.8 kg/m2, HbA(1c) 7.6%+/-1.6%, 16.1% of them were disabled. Among the non-disabled patients, 23.6% had optimal glycemic control (HbA(1c) < or =6.5%); at baseline the prevalence of micro- and macrovascular diabetic complications was: 8.2% microalbuminuria and 2.4% macroalbuminuria plus nephropathy, 11.0% nonproliferative and 3.0% preproliferative retinopathy, 7.0% neuropathy, 1.8% diabetic foot; 8.5% angina, 6.9% TIA or stroke, 6.3% infarction, 5.2% intermittent claudication, 4.1% heart failure. Among the disabled patients 27.9% had optimal glycemic control, but they had more diabetic complications. The performance indicators significantly improved over the 3-year study period: glycemic control indicators increased from 66%-75% to 83%-90% and micro- and macrovascular indicators from 59%-65% to 75%-81%. The outcome indicators also improved: mean HbA(1c) value changed from 7.6%+/-1.6% to 7.3%+/-1.3% and the percentage of people with HbA(1c)< or =6.5% significantly improved over time. Similar trends were observed in both disabled and non-disabled diabetic patients.

GPs' satisfaction with the doctor-patient encounter: findings from a community-based survey.

OBJECTIVE: The aim of this study was to explore the characteristics of the doctor-patient relationship from the GP's point of view. METHODS: We performed a cross-sectional 1-day study in family practice. Thirty-three GPs volunteered to fill in a questionnaire at the end of each of 20 consecutive consultations on an index day. Six hundred and sixty-one patients (out of 665) participated in the study. Descriptive frequencies of GPs' judgements about personal experiences during the consultations, and predictors of GP's global satisfaction score on patient encounters were analysed. RESULTS: The mean age of the 33 GPs was 44.7 +/- 3.6 years. Professional skills (62% of the GPs had no doubts on diagnosis, therapy or prognosis) and the quality of the human/interpersonal interaction were major determinants of GPs' satisfaction in the patient-doctor relationship. Doctors felt professionally esteemed by 90% of their patients, and the median value of their global satisfaction score (matching the expectations from an 'ideal patient' to that experienced when meeting the real one) was very high (median 8, range 1-10). Nevertheless, GPs did not know if they were satisfied with the actual encounter with the patient in about one-third of the consultations. CONCLUSIONS: Professional skills and quality of the human/interpersonal interactions are major determinants of GPs' satisfaction in their professional activities.

Changes in long-term glycemic control and performance indicators in a cohort of type 2 diabetic patients cared for by general practitioners: findings from the "Modena Diabetes Project".

BACKGROUND AND AIM: General practitioners (GPs) are being increasingly asked to play a key role in the shared care of people with diabetes mellitus, but data concerning the effects of this in Italy are still scarce. We therefore evaluated the 4-year follow-up changes in outcomes and performance indicators in type 2 diabetic patients cared for by GPs in the framework of the "Modena Diabetes Project". METHODS AND RESULTS: Seventy-four percent of the local GPs participating in the project (387 out of 521) sent 5260 paired baseline and follow-up datasheets. The baseline characteristics of the type 2 diabetic patients (49.6% male) were a mean age of 67.3+/-11.2 years, a mean disease duration of 10.9+/-7.4 years, a mean BMI of 28.7+/-4.8 kg/m2, and a mean HbA1c level 7.56+/-1.52%. After four years follow-up, the individual before/after match-paired outcomes revealed an improvement in glycemic control: HbA1c levels significantly decreased to 7.39+/-1.31%, and the percentage of patients with HbA1c level of <6.5% significantly increased from 15.7% to 22.1%. There was also a significant decrease in body weight (from 78.3+/-14.8 to 77.6+/-14.6 kg) and BMI (from 28.8+/-4.8 to 28.5+/-4.9 kg/m2). The time trends of glycemic control significantly improved during the 4-year follow up, but those of the body weight and BMI values did not. Furthermore, the percentages of performance indicators matching the expected rate of recurrence per each year of follow-up significantly improved during the study period. CONCLUSIONS: Long-term glycemic control and the performance indicators relating to the type 2 diabetic patients participating in our shared care programme progressively improved.

[Identification of individuals with high coronary risk in the Italian population: indications of the Epidemiologic Cardiovascular Observatory]. / L'identificazione degli individui ad elevato rischio coronarico nella popolazione italiana: indicazioni dall'Osservatorio Epidemiologico Cardiovascolare.

BACKGROUND: The absolute global coronary risk has recently been introduced as an indicator of the incidence predicted by the main risk factors. It offers numerous options for the treatment of individuals at high risk. The identification of the absolute global coronary risk is produced through the application of functions obtained by longitudinal studies; their adequacy depends on the characteristics of the population from which they were estimated. The aim of this work was to evaluate the impact of the application of the absolute global coronary risk evaluation using the chart of risk proposed to the Italian physicians and to compare it with the results obtained from the application of other risk functions. METHODS: The database of the Osservatorio Epidemiologico Cardiovascolare (OEC), consisting of men and women aged 35-74 years, has been considered as being representative of the Italian population. The individual risk has been computed using the functions and coefficients from the Framingham study, the PROCAM study and the Seven Countries Study-Italy. The prevalence of high risk factors has been estimated on the basis of the recommendations on coronary prevention of the Task Force of the European Societies. RESULTS: The prevalence of high risk factors estimated by the Framingham function is 23.7% among men and 3.8% among women aged 35-74 years. In men aged 35-64 years, this estimated prevalence decreases from 14.2 to 8.7% when the Framingham function is adjusted using the mean value of the risk factors of the OEC, to 5.2% when the PROCAM function is applied, and to 1.1% when the function of the Seven Countries Study-Italy is employed. CONCLUSIONS: The application of the risk function suggested to the Italian physicians implies that more than 2,700,000 men and more than 500,000 women aged 35-74 years are potential candidates for treatment with lipid-lowering drugs. The comparison between the use of different functions in the OEC sample produces high numerical differences. The over-evaluation of the individual at high risk implies significant human and social costs. It is therefore essential to determine risk functions and coefficients derived from recent Italian studies including all age groups, both sexes and taking into account the different geographic characteristics of our country.

Practice guidelines: useful and "participative" method? Survey of Italian physicians by professional setting.

BACKGROUND: Professional setting might be a key determinant of physicians' attitudes toward practice guidelines, influencing the effect of their implementation. Because no previous surveys have specifically considered this aspect, we evaluated the perceived role and usefulness of guidelines, as well as barriers to and facilitators of their implementation, for hospital, primary care, and nonpracticing clinicians. METHODS: A 43-item self-administered questionnaire was sent to all National Health Service physicians in the province of Modena, Italy (593 primary care physicians, 1049 hospital physicians, and 149 nonpracticing clinicians), and 1199 (66.9%) responded. Opinions and attitudes were assessed using 5-point ordinal scales and an attitude measurement scale. Results were evaluated overall and by professional setting, sex, age, year of graduation, and academic background. RESULTS: Practice guidelines were generally perceived to be less useful than other sources of medical information (eg, personal experience, conferences, colleagues, articles, the Internet, and textbooks [pharmaceutical representatives were the exception]). Most physicians thought that guidelines are developed for cost-containment reasons and expressed concerns about their limited applicability to individual patients and local settings. Most respondents did not favor the involvement of health professionals other than physicians in guideline development and use and preferred nonmonetary incentives for their implementation. Answers to individual items and attitude scores varied significantly across professional settings. Primary care physicians showed, in general, the least favorable attitudes toward practice guidelines, toward nonphysicians participating in guideline development and use, and toward incentives for guideline users. CONCLUSIONS: Physicians perceived practice guidelines as externally imposed and cost-containment tools rather than as decision-supporting tools. Regularly monitoring attitudes toward practice guidelines can be helpful to evaluate potential barriers to their adoption.

Practice guidelines developed by specialty societies: the need for a critical appraisal.

BACKGROUND: There is increasing concern about the quality, reliability, and independence of practice guidelines. Because no information is available on the methodological quality of the guidelines developed by specialty societies, we undertook a survey on those published in peer-reviewed journals. METHODS: Practice guidelines produced by specialty societies and published in English between January, 1988, and July, 1998, where identified through MEDLINE. Their quality was assessed in terms of whether they reported: the type of professionals and stakeholders involved in the development process; the strategy to identify primary evidence; and an explicit grading of recommendations according to the quality of supporting evidence. FINDINGS: Overall, 431 guidelines were eligible for the study. Most did not meet the criteria: 67% did not report any description of the type of stakeholders, 88% gave no information on searches for published studies, and 82% did not give any explicit grading of the strength of recommendations. There was improvement over time for searches (from 2% to 18%, p<0.001) and explicit grading of evidence (from 6% to 27%, p<0.001). All three criteria for quality were met in only 22 (5%) guidelines. INTERPRETATION: Despite improvement over time, the quality of practice guidelines developed by specialty societies is unsatisfactory. Explicit methodological criteria for the production of guidelines shared among public agencies, scientific societies, and patients' associations need to be set up. Common standards of reporting, following the same principles that led to the CONSORT statement for randomised clinical trials, should be promoted.

Use of lipid-lowering drugs from 1990 to 1994: an international comparison among Australia, Finland, Italy (Emilia Romagna Region), Norway and Sweden.

OBJECTIVE: To compare the overall utilisation pattern of lipid-lowering drugs between 1990 and 1994 in Australia, Finland, Italy, Norway and Sweden as well as the pattern of use with respect to age and gender in Italy and Sweden. METHODS: Data were retrieved from regulatory authorities in each country for the 5-year period and analysed according to the ATC/DDD methodology (Anatomical Therapeutic Chemical classification/Defined Daily Doses). Utilisation was calculated as the DDDs for 1000 inhabitants per day for all drugs of the ATC category B04 (serum lipid-reducing agents). Data from Sweden and Italy were also compared with respect to gender and age. RESULTS: In 1994, Australia demonstrated the highest degree of utilisation (11.9 DDD) and the Nordic Countries the lowest (Sweden 5.6; Norway 4.9; Finland 4.0). In all countries except Italy, a steady increase was observed; in Italy, utilisation of these drugs reached a maximum in 1992 (11.5 DDD), but then underwent a reduction which was caused by restrictions in the reimbursement status in 1993 (10.4) and 1994 (6.7). Administration of statins increased in all countries, becoming the most used group of the B04 class. In 1988, the number of different drugs listed by each national health service ranged from 4 (Norway) to 16 (Italy); in 1994 it ranged from 6 (Norway) to 9 (Sweden). Analysis with respect to gender showed the opposite pattern in Sweden (males 4.6 and females 3.3 in 1992; 6.2 and 4.5, respectively, in 1994) than in Italy (males 10.8 and females 17.8 in 1992; 6.4 and 9.2, respectively, in 1994). Exposure was highest in people aged 60-69 years in both countries, followed by age group 50-59 in Sweden and 70-79 in Italy. CONCLUSIONS: Large variations in the utilisation of lipid-lowering drugs exist between countries, with Australia and Italy much higher than others. Of the drugs in the ATC category B04, the use of statins predominates in all countries, but to varying degrees. The large difference in the degree of drug utilisation with respect to age and gender between Italy and Sweden suggests major deviations from evidence-based medicine.

Overview of randomized clinical trials of oral branched-chain amino acid treatment in chronic hepatic encephalopathy.

BACKGROUND: The role of oral branched-chain amino acid supplements in the prevention and treatment of chronic hepatic encephalopathy is not yet established, and conflicting opinions are expressed in authoritative textbooks. We aimed to review and pool the published controlled studies by means of meta-analytical techniques. METHODS: A computerized search of published papers identified nine studies, controlled against placebo, energy, alimentary proteins, or casein. Their quality score was calculated according to the protocol of Chalmers. The value of the portal-systemic encephalopathy index was chosen as main outcome, because of lack of more significant clinical outcomes. To cope with differences in trial design and data presentation, individual data were requested to authors. RESULTS: After 18 months, we received the individual data of only two studies, thus precluding any meta-analysis. Two studies, accounting for over 60% of total enrolled patients, were in favor of branched-chain amino acids. Their quality score was much better than that of the remaining seven negative small studies, carrying a significant risk of type II error. CONCLUSIONS: Based on the results of the two largest, long-term studies, the use of oral branched-chain amino acids in the prevention and treatment of chronic encephalopathy may only be proposed for patients with advanced cirrhosis, intolerant to alimentary proteins. Large, multicenter, long-term studies, considering more important clinical outcomes, are needed to provide definite answers to an aged question.

Use of benzodiazepines in the Italian general population: prevalence, pattern of use and risk factors for use.

This study was conducted to determine the prevalence and profile of use of benzodiazepines in the Italian population and risk factors for use. Between November 1992 and February 1993, 62 general practitioners submitted a validated self-administered questionnaire on health status and drug use to a randomised sample of 3100 subjects ( > or = 18 years of age, stratified by sex and age), of whom 2803 responded (response, rate 90.4%). Main outcome measures were point estimate (past-week) of all the drugs taken by each individual, dosage and length of use and source of the prescription. The overall past-week prevalence of use of benzodiazepines was 8.6% (5.0% males and 11.8% females). In the elderly ( > or = 65 years) 18.8% reported current use (9.0% males and 24.7% females). Fifty-six per cent of the persons exposed to a benzodiazepine were chronic users (daily, for more than 6 months), and 70.1% in subjects > or = 65 years. The average daily dose taken was relatively low: 61% of short-term users and 51% of chronic users used less than half a defined daily dose (DDD). Female sex, older age, unemployment and retirement were independently associated with the use of benzodiazepines. Benzodiazepine use in Italy appeared to be relatively high (about 9% of subjects reported current use 57% of whom were chronic users). Women were prescribed a benzodiazepine twice as often as men and one out of four elderly women was on treatment. Although the average dosage used was rather low, the high prevalence and the elevated proportion of chronic users should encourage drug information campaigns and educational interventions to promote a more conservative use of these drugs especially in the elderly.