Original Title: Perfiles de solicitud de analítica de rutina en atención primaria: comparación de recomendaciones y estudio de variabilidad y costes en el País Vasco

Authors' objectives: 1. Determine and compare the different routine analytical procedures recommended by several expert committees in accordance with their effectiveness and with regard to the health problems selected: control of healthy adults, arterial hypertension, hypercholesterolemia and diabetes mellitus. 2. Draw up recommendations on GPC to include the most widely-accepted routine analytical procedures for the health issues studied: Proposal for an analytical model. 3. Determine the different routine analytical procedures that are used by Primary Health Care (PHC), with regard to the most frequent health problems found among the population cared for. 4. Analyse the variability between the different procedures designed by different Health Centres for the same problem. 5. Analyse the individual variability that exists between the different application methods used by doctors. 6. Compare the costs of requests for routine analyses and the alternatives proposed in the recommendations.

Authors' results and conclusions: 1. Only three of the seven Primary Health Care Regional Head Offices responded to the questionnaire (response rate 42.8%). Of these, only two of them had any procedure, the third declared it had none.2. The lack of coherence between the attitudes observed in the different health regions of the Basque Country is noteworthy, not only with regard to the existence or absence of protocols but also to the recommendations of existing protocols.3. On several occasions it has been possible to note a lack of coherence between the contents of the procedures of the PHC and those of the health region on which they depend.4. A great lack of consistency can be seen between the different CPG. Some of these do not base their recommendations on systematic reviews of available evidence but on the opinion of experts.5. There is an great deal of variability in the recommendations of the protocols of different health centres in the Autonomous Community of the Basque Country. In general, these protocols do not offer minimum quality criteria, such as the review date or references or the tests on which their recommendations are based.6. The growing tendency observed in the PHC towards the drawing up of CPG which include arterial hypertension, diabetes mellitus and dyslipemia in a single cardiovascular risk procedure, is a welcome sign.7. The disproportionate use, in the first place, of analytical tests in each of the proposed scenarios, is surprising. One in every three doctors includes a GSV test and one in every four requests an ionogram, even when the patient does not suffer from nephropathy, does not have high blood pressure and is not taking diuretics.8. Curiously, there is a tendency to request more analytical tests for men than for women, even in the same scenario.9. But the high percentage of doctors who do not request essential analyses for the proposed scenario, is even more surprising.10. The lack of proportion in the requests for analytical tests causes doctors to request unusual, even outlandish tests in the CPG drawn up in their own health centres.

Authors' recommendations: Variability in clinical protocols 1. The variability observed in the protocols that have been analysed makes it recommendable that these be drawn up by wider groups of professionals than the PHC or Regional Health Centre. 2. Scientific Societies, with the necessary institutional support, should lead the process of drawing up protocols for the most prevalent problems in our environment and in accordance with the Health Plan in the Basque Country. 3. These protocols should articulate the attention of these patients between different levels of health care, promoting the means required to attain the goals relating to a reduction in the number of analyses that might be proposed in future assessments, both in administrative and health terms. 4. The profiles required for requesting analyses in the referral notes of the clinical analysis laboratories should be pre-established, in a general manner. This should be promoted by the laboratories as it is very improbable that a reform of this nature could be led by Primary Health Care. 5. From the point of view of cardiovascular illness as a whole, a multi-factor intervention approach seems to be more appropriate than a fragmented approach to each of the problems (Arterial Hypertension, Diabetes Mellitus, Hypercholesterolemia). 6. The information and appraisal aspects included in the Health Plan for the Basque Country should be developed with regard to the fields of cardiovascular illnesses and diabetes. Periodic health check-up: analytical methods for population screening 1. There is only enough scientific evidence to recommend the practice of a glycemia in asymptomatic adults. The glycemia figure should be determined in adults of over 45 years of age every three years. 2. The determining of cholesterolemias is a controversial issue. The working group considers that the development of population-based preventive activities (including opportunist screenings in the doctor’s surgery), must be based on proven tests and, in their absence, as in this case, screening should be discouraged. Arterial Hypertension 1. In the initial examination of a patient suffering from hypertension, only the routine determination of creatinine, ions, glycemia, total cholesterol, proteinuria and haematuria (means of a reactive test strip in urine) should be made. 2. The development of a multi-factor strategy makes it obligatory to add the assessment of the parameters that are included in the calculation of cardiovascular risk to this initial examination. For this reason, it is necessary to include the analytical profile of HDL cholesterol in the initial examination. 3. The determination of other parameters must be based on other kinds of clinical criteria. 4. In the evolutionary control of patients suffering from hypertension, it is advisable to monitor serum creatinine as well as the determination of urinary proteinuria and biochemistry by means of a reactive test strip. Furthermore: • In patients undergoing diuretic treatment it is obligatory to measure the levels of potassium. • Treatment with β-blockers requires the monitoring of lipid levels. • The periodic assessment of cardiovascular risk requires, moreover, a determination of the lipid profile. • If the patient is diabetic, it will also be necessary to monitor the presence of micro-albuminuria. 5. There are no conclusive elements to recommend the periodicity of these tests. The most appropriate attitude, in the opinion of experts, would be to carry out an annual check-up once the absence of secondary effects had been established, shortly after beginning the treatment. Diabetes mellitus 1. According to the scientific evidence available and the recommendations of the different guidelines, the initial examination in diabetic patients should be limited to: basal glucose, glycosylated haemoglobin (HbA1c) on a six-monthly basis, creatinine, total cholesterol, triglycerides and proteinuria (by means of a reactive strip in urine). 2. The determination of other parameters such as the ionogram (Na and K) should be based another types of clinical criteria. 3. In order to watch the evolution of type-II diabetics with acceptable metabolic control, it is advisable to establish periodic monitoring. 4. If the patient is performing an auto-control with reactive test strips, a basal glycemia is recommended every one or two months. 5. In patients with good metabolic control and auto-control with reactive test strips, the controls would be performed on a three-monthly basis. 6. The periodicity of the remaining determinations would not be endorsed by opinions based on evidence. In the opinion of experts, it would be recommendable to determine the total cholesterol and triglycerides on an annual basis. Should disturbances be observed in any of these parameters, their periodicity and type of determination (HDL, LDL, etc.) would depend upon the criteria applicable to the dyslipemias. 7. Likewise, serum creatinine and the systematic detection of microalbuminuria on An annual basis are also recommended. Hypercholesterolemia 1. At the time of diagnosis, a primary or secondary dyslipemia should be differentiated. As a basic analysis, the determination of glycemia, creatinine, urea, GOT, GPT, haemogram and systematic urine analysis are proposed; should hypothyroidism be suspected thyroid function tests will be applied for (TSH). 2. The quantification of lipoproteins LDL, HDL, VLDL may be necessary in the initial examination to classify the type of dyslipemia, genotypically and phenotypically, and the assessment of possible cardiovascular risk factors is required. 3. In patients without cardiovascular disease (dietary treatment and changes in life-style), the monitoring and re-assessment will be carried out three months after beginning the dietary treatment. If the established aims are attained (in accordance with LDL levels), total cholesterol and lipid profile will be applied for after 6 months and later on an annual basis. 4. In the re-assessment of patients with cardiovascular disease, it must be taken into account that the maximum depressor effect of LDL-cholesterol is reached 4-6 weeks after beginning the treatment. For this reason, the first determination must be made 6-8 weeks after treatment is begun. Once a satisfactory control has been attained, and after the appearance of biochemical toxicity has been ruled out, the control will be repeated every 4-6 months. 5. The control of secondary effects will depend upon the drug being used. Patients undergoing treatment with inhibitors of HMG-CoA reductase or with fibrates the determination of GOT, GPT, and CPK every 3-6 months during the first year of treatment would be appropriate. For those patients being treated with nicotine acid, the determination of uric acid would be recommendable. If during the first year of treatment, no adverse effects have appeared, the control of these parameters may be carried out on an annual basis after consulting a doctor, unless muscular symptoms appear. Analytical model proposed According to the scientific evidence described in the previous paragraphs, the annual analytical model proposed in each of the situations studied is as follows: 1. Healthy adult: glucose 2. Arterial hypertension: total cholesterol, HDL cholesterol, triglycerides, creatinine, ionogram (Na-K) in serum and abnormal and sediment in urine. 2. Diabetes Mellitus type II: glucose, total cholesterol, HDL cholesterol, triglycerides, glycosylated haemoglobin in serum and abnormal and sediment and micro-albumin in urine. 3. Polygenic Hypercholesterolemia: total cholesterol, HDL cholesterol and triglycerides. 4. In CPG in Primary Health Care, the co-morbility of the processes studied is frequent. The recommendations may be tackled in a single cardiovascular risk concept, individualised for each combination of the previous pathologies, where, obviously, the timing of the applications may change.

Authors' methods: 1. Systematic review of the scientific evidence in bibliographical databases: Medline and HealthSTAR in Internet. Versión PubMed (1995-1998), Cochrane Library (1998 Issue 4), Spanish Medical Index (1995-1998). The key words used were as follows: Diagnostic tests, Routine Utilisation (MESH), Laboratory tests, Diagnostics test associated with Effectiveness, Diabetes, Hypertension and Hypercholesterolemia. An analysis was also made of the range of proposals made by the most important groups of experts. 2. Identification, selection and exhaustive analysis of selected literature. With the strategy described, a total of 253 articles were identified that might be considered pertinent. The report’s bibliography contains 129 references. 3. Study of the variability and coherence of procedures in medical practice in PHC: a semi-structured questionnaire was sent to a total of 965 PHC doctors in the Basque Country in order to analyse individual variability. After an initial sending and receiving of responses, a second and third questionnaire were sent in order to increase the response rate. 4. Economic study: A study was made of the economic repercussion of the different application profiles observed through a study of unit costs in the Clinical Laboratories of the Mendaro and San Eloy Hospitals and of the Olagibel Ambulatory, as well as of the models proposed in this study.

Project Status: Completed

Year Published: 2000

URL for published report: https://www.euskadi.eus/contenidos/informacion/2000_osteba_publicacion/es_def/adjuntos/2000/d_00_08_perfiles_de_solicitud.pdf

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Basque Office for Health Technology Assessment, Health Department Basque Government (OSTEBA)</p>