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1.  Variability in potentially preventable hospitalisations: an observational study of clinical practice patterns of general practitioners and care outcomes in the Basque Country (Spain) 
BMJ Open  2015;5(5):e007360.
To explain the variability in the frequency of potentially preventable hospitalisations (ambulatory care sensitive conditions, ACSCs) based on factors at multiple levels (individual, health professional, health centre and health district), and specifically using resource efficiency indicators for general practitioners (GPs).
Cross-sectional study. We analysed primary care electronic health records and hospital discharge data using multilevel mixed models.
Primary care network of the Basque Health Service (Spain).
All the residents in the Basque Country ≥14 years of age, covered by the public healthcare system (n=1 959 682), and all the GPs (n=1193) and health centres (n=130).
Main outcome measures
Individuals admitted for ACSCs, over a 12- month period.
Admissions for ACSCs were less frequent among patients who were female, middle-aged or from the highest socioeconomic classes. The health centre variables considered and GP list size were not found to be significant. After adjusting for the variables studied including morbidity, the risk of hospital admission was higher among individuals under the care of GPs with greater than expected numbers of patient visits and prescribing costs (OR=1.27 (95% CI 1.18 to 1.37); 1.16 (1.08 to 1.25)), and who make fewer referrals than the mean among their colleagues (OR=1.33 (1.22 to 1.44)).
When assessing activities and procedure indicators in primary care, we should also define outcome-based criteria. Specifically, GPs who are repeatedly visited by their patients, have higher prescribing costs and are more reluctant to refer patients to specialists obtain poorer outcomes.
PMCID: PMC4442212  PMID: 25986637
2.  Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol 
BMC Family Practice  2015;16:39.
In contrast with the recommendations of clinical practice guidelines, the most common treatment for anxiety and depressive disorders in primary care is pharmacological. The aim of this study is to assess the efficacy of a cognitive-behavioural psychological intervention, delivered by primary care psychologists in patients with mixed anxiety-depressive disorder compared to usual care.
This is an open-label, multicentre, randomized, and controlled study with two parallel groups. A random sample of 246 patients will be recruited with mild-to-moderate mixed anxiety-depressive disorder, from the target population on the lists of 41 primary care doctors. Patients will be randomly assigned to the intervention group, who will receive standardised cognitive-behavioural therapy delivered by psychologists together with usual care, or to a control group, who will receive usual care alone.
The cognitive-behavioural therapy intervention is composed of eight individual 60-minute face-to face sessions conducted in eight consecutive weeks. A follow-up session will be conducted over the telephone, for reinforcement or referral as appropriate, 6 months after the intervention, as required.
The primary outcome variable will be the change in scores on the Short Form-36 General Health Survey. We will also measure the change in the frequency and intensity of anxiety symptoms (State-Trait Anxiety Inventory) and depression (Beck Depression Inventory) at baseline, and 3, 6 and 12 months later. Additionally, we will collect information on the use of drugs and health care services.
The aim of this study is to assess the efficacy of a primary care-based cognitive-behavioural psychological intervention in patients with mixed anxiety-depressive disorder. The international scientific evidence has demonstrated the need for psychologists in primary care. However, given the differences between health policies and health services, it is important to test the effect of these psychological interventions in our geographical setting.
Trial registration
NCT01907035 (July 22, 2013).
PMCID: PMC4373067  PMID: 25879932
Anxiety; Depression; Cognitive-behavioural therapy; Primary care
3.  Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial 
BMC Cancer  2015;15:40.
The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time.
We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance.
As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals.
Trial registration Identifier: NCT01786122 Registration date: 02/05/2013.
PMCID: PMC4327975  PMID: 25655792
Breast cancer; Colorectal cancer; Lung cancer; Metastasis; Physical exercise; Quality of life
4.  Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study 
BMC Family Practice  2014;15:211.
Vascular ulcers are commonly seen in daily practice at all levels of care and have great impact at personal, professional and social levels with a high cost in terms of human and material resources. Given that the application of autologous platelet rich plasma has been shown to decrease healing times in various different studies in the hospital setting, we considered that it would be interesting to assess the efficacy and feasibility of this treatment in primary care. The objectives of this study are to assess the potential efficacy and safety of autologous platelet rich plasma for the treatment of venous ulcers compared to the conventional treatment (moist wound care) in primary care patients with chronic venous insufficiency (C, clinical class, E, aetiology, A, anatomy and P, pathophysiology classification C6).
We will conduct a phase III, open-label, parallel-group, multicentre, randomized study. The subjects will be 150 patients aged between 40 and 100 years of age with an at least 2-month history of a vascular venous ulcer assigned to ten primary care centres. For the treatment with autologous platelet rich plasma, all the following tasks will be performed in the primary care setting: blood collection, centrifugation, separation of platelet rich plasma, activation of coagulation adding calcium chloride and application of the PRP topically after gelification. The control group will receive standard moist wound care. The outcome variables to be measured at baseline, and at weeks 5 and 9 later include: reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, and percentage of patients who require wound care only once a week.
The results of this study will be useful to improve the protocol for using platelet rich plasma in chronic vascular ulcers and to favour wider use of this treatment in primary care.
Trial registration
Current Controlled Trials NCT02213952
PMCID: PMC4311495  PMID: 25547983
Vascular ulcer; Platelet rich plasma; Primary care
5.  Predictors of long-term change of a physical activity promotion programme in primary care 
BMC Public Health  2014;14:108.
Further research is needed to improve the evidence regarding determinants of physical activity (PA) as a crucial step to plan higher effective intervention strategies. The goal of the present study is to identify socio-demographic and clinical characteristics of primary care (PHC) insufficiently active patients that are associated with longitudinal changes in the level of physical activity.
Longitudinal analysis of baseline socio-demographic and clinical predictors of physical activity change in insufficiently active PHC patients who participated in a PA-promoting multi-centre randomized clinical trial conducted from October 2003 through March 2006. The primary outcome measure was the self-reported physical activity assessed with the 7-day Physical Activity Recall (PAR), at baseline, 6, 12 and 24 months. Baseline covariates included sex, age, social class, anthropometric measures and other cardiovascular risk factors or associated diseases (Diabetes, HTA, tobacco use, etc.), and stage of readiness to change PA. Generalized linear mixed models were used to estimate longitudinal association of studied variables on PA change over the three follow-up measurements.
A total of 3691 patients (85% of the 4317 recruited in the trial) with at least one follow-up measurement were included in the longitudinal analysis. At baseline, analysed patients (mean age: 50.6 years; 64.6% women) devoted 34.7 minutes and 2.36 metabolic equivalent hours per week (MET.h/week) to moderate and vigorous physical activity. Older age, male gender, higher social class, lower BMI, diagnosis of diabetes or hypertension, and measurement season were significant predictors of PA longitudinal change. The effect of baseline readiness to change on PA dose was modified by time, showing a positive gradient in favour of those with more readiness to change that increases significantly at 12 and 24 months (p-value interaction < .0001).
Identified baseline characteristics such as readiness to change and risk factors can guide physicians to prioritize time and intervention efforts for maximizing their impact on insufficiently active PHC patients.
PMCID: PMC3933198  PMID: 24491081
Physical activity; Health promotion intervention; Primary health care; Longitudinal predictors
6.  Protocol for assessing the hypotensive effect of evening administration of acetylsalicylic acid: study protocol for a randomized, cross-over controlled trial 
Trials  2013;14:236.
The objective of this study is to evaluate the antihypertensive effect of bedtime administration of low doses of aspirin in patients with treated hypertension and high cardiovascular risk on low-dose aspirin for secondary prevention, in order to optimize their usual treatment and reduce their cardiovascular risk.
This is a prospective phase IV multicentre, randomised, triple-blind, placebo-controlled, cross-over clinical trial. We will include 258 individuals with hypertension treated with low-dose aspirin for secondary prevention. These patients will be randomly recruited, by approximately 40 primary care physicians collaborating in the study, mainly in the Guipúzcoa West, Bilbao and Barcelona areas. The 258 patients will be randomly allocated to treatments to create two comparable groups. In the first period, the intervention group will take aspirin at night and placebo in the morning, while the control group will take their aspirin in the morning and placebo in the evening for 2 months. After a washout period of 15 to 30 days, there will be a second 2-month period for which groups will swap treatments. Participants will undergo ambulatory blood pressure monitoring at baseline, at the end of first period and then again at the beginning and end of the second period. The main outcome measure is the change in mean blood pressure over 24 h, and as secondary outcomes we will also assess changes in systolic and diastolic blood pressure, during the day and night, and the relationship between them. Lastly, we will explore whether non-dipper patients convert into dippers with the intervention.
The goal of this research is to provide the scientific basis for indicating a change in the time of aspirin administration from morning to evening, by primary health practitioners, to improve the patient control of blood pressure and more effectively reduce their cardiovascular risk, by combining this hypotensive effect with the well-known anti-platelet effect of low-dose aspirin.
Trial registration NCT01741922
PMCID: PMC3750457  PMID: 23890047
High blood pressure; Low-dose ASA; Bedtime administration; Secondary prevention
7.  Predictive risk modelling in the Spanish population: a cross-sectional study 
An increase in chronic conditions is currently the greatest threat to human health and to the sustainability of health systems. Risk adjustment systems may enable population stratification programmes to be developed and become instrumental in implementing new models of care.
The objectives of this study are to evaluate the capability of ACG-PM, DCG-HCC and CRG-based models to predict healthcare costs and identify patients that will be high consumers and to analyse changes to predictive capacity when socio-economic variables are added.
This cross-sectional study used data of all Basque Country citizens over 14 years of age (n = 1,964,337) collected in a period of 2 years. Data from the first 12 months (age, sex, area deprivation index, diagnoses, procedures, prescriptions and previous cost) were used to construct the explanatory variables. The ability of models to predict healthcare costs in the following 12 months was assessed using the coefficient of determination and to identify the patients with highest costs by means of receiver operating characteristic (ROC) curve analysis.
The coefficients of determination ranged from 0.18 to 0.21 for diagnosis-based models, 0.17-0.18 for prescription-based and 0.21-0.24 for the combination of both. The observed area under the ROC curve was 0.78-0.86 (identifying patients with a cost higher than P-95) and 0.83-0.90 (P-99). The values of the DCG-HCC models are slightly higher and those of the CRG models are lower, although prescription information could not be used in the latter. On adding previous cost data, differences between the three systems decrease appreciably. Inclusion of the deprivation index led to only marginal improvements in explanatory power.
The case-mix systems developed in the USA can be useful in a publicly financed healthcare system with universal coverage to identify people at risk of high health resource consumption and whose situation is potentially preventable through proactive interventions.
PMCID: PMC3750562  PMID: 23837560
Risk-adjustment; Burden of illness; Actuarial prediction; Health risk stratification
8.  Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial 
BMC Family Practice  2012;13:109.
The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza.
This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation.
The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice.
Trial registration NCT01365013
PMCID: PMC3538670  PMID: 23158830
Pre-diabetes; Primary health care; Prevention; Clinical trial
9.  Monitoring the prevalence of chronic conditions: which data should we use? 
Chronic diseases are an increasing threat to people’s health and to the sustainability of health organisations. Despite the need for routine monitoring systems to assess the impact of chronicity in the population and its evolution over time, currently no single source of information has been identified as suitable for this purpose. Our objective was to describe the prevalence of various chronic conditions estimated using routine data recorded by health professionals: diagnoses on hospital discharge abstracts, and primary care prescriptions and diagnoses.
The ICD-9-CM codes for diagnoses and Anatomical Therapeutic Chemical (ATC) codes for prescriptions were collected for all patients in the Basque Country over 14 years of age (n=1,964,337) for a 12-month period. We employed a range of different inputs: hospital diagnoses, primary care diagnoses, primary care prescriptions and combinations thereof. Data were collapsed into the morbidity groups specified by the Johns Hopkins Adjusted Clinical Groups (ACGs) Case-Mix System. We estimated the prevalence of 12 chronic conditions, comparing the results obtained using the different data sources with each other and also with those of the Basque Health Interview Survey (ESCAV). Using the different combinations of inputs, Standardized Morbidity Ratios (SMRs) for the considered diseases were calculated for the list of patients of each general practitioner. The variances of the SMRs were used as a measure of the dispersion of the data and were compared using the Brown-Forsythe test.
The prevalences calculated using prescription data were higher than those obtained from diagnoses and those from the ESCAV, with two exceptions: malignant neoplasm and migraine. The variances of the SMRs obtained from the combination of all the data sources (hospital diagnoses, and primary care prescriptions and diagnoses) were significantly lower than those using only diagnoses.
The estimated prevalence of chronic diseases varies considerably depending of the source(s) of information used. Given that administrative databases compile data registered for other purposes, the estimations obtained must be considered with caution. In a context of increasingly widespread computerisation of patient medical records, the complementary use of a range of sources may be a feasible option for the routine monitoring of the prevalence of chronic diseases.
PMCID: PMC3529101  PMID: 23088761
Chronic disease; Prevalence; Information systems; Computerized medical record systems; Health care surveys; Clinical coding
10.  Two-Year Longitudinal Analysis of a Cluster Randomized Trial of Physical Activity Promotion by General Practitioners 
PLoS ONE  2011;6(3):e18363.
We evaluate the effectiveness of a physical activity promotion programme carried out by general practitioners with inactive patients in routine care.
Methods and Findings
Pragmatic, cluster randomised clinical trial conducted in eleven public primary care centres in Spain. Fifty-six general practitioners (GPs) were randomly assigned to intervention (29) or standard care (27) groups. They assessed the physical activity level of a systematic sample of patients in routine practice and recruited 4317 individuals (2248 intervention and 2069 control) who did not meet minimum physical activity recommendations. Intervention GPs provided advice to all patients and a physical activity prescription to the subgroup attending an additional appointment (30%). A third of these prescriptions were opportunistically repeated. Control GPs provided standard care. Primary outcome measure was the change in self-reported physical activity from baseline to six, 12 and 24 months. Secondary outcomes included cardiorespiratory fitness and health-related quality of life.
A total of 3691 patients (85%) were included in the longitudinal analysis and overall trends over the whole 24 month follow-up were significantly better in the intervention group (p<0.01). The greatest differences with the control group were observed at six months (adjusted difference 1.7 MET*hr/wk [95% CI, 0.8 to 2.6], 25 min/wk [95% CI, 11.3 to 38.4], and a 5.3% higher percentage of patients meeting minimum recommendations [95% CI: 2.1% to 8.8%] NNT = 19). These differences were not statistically significant at 12 and 24 months. No differences were found in secondary outcomes. A significant difference was maintained until 24 months in the proportion of patients achieving minimum recommendation in the subgroup that received a repeat prescription (adjusted difference 10.2%, 95% CI 1.5% to 19.4%).
General practitioners are effective at increasing the level of physical activity among their inactive patients during the initial six-months of an intervention but this effect wears off at 12 and 24 months. Only in the subgroup of patients receiving repeat prescriptions of physical activity is the effect maintained in long-term.
Trial Registration NCT00131079
PMCID: PMC3066231  PMID: 21479243
11.  Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care: The EFICAR study protocol 
BMC Public Health  2010;10:33.
Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors.
Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables.
A key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants.
Trial Registration
Clinical Identifier: NCT01033591
PMCID: PMC2835681  PMID: 20100317
12.  Somatisation in primary care: experiences of primary care physicians involved in a training program and in a randomised controlled trial 
BMC Family Practice  2009;10:73.
A new intervention aimed at managing patients with medically unexplained symptoms (MUS) based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT) for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention.
A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out.
Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve.
GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed.
Trial registration
US NCT00130988
PMCID: PMC2790434  PMID: 19930729
13.  Agreement between the SCORE and D’Agostino Scales for the Classification of High Cardiovascular Risk in Sedentary Spanish Patients 
To evaluate agreement between cardiovascular risk in sedentary patients as estimated by the new Framingham-D’Agostino scale and by the SCORE chart, and to describe the patient characteristics associated with the observed disagreement between the scales.
A cross-sectional study was undertaken involving a systematic sample of 2,295 sedentary individuals between 40–65 years of age seen for any reason in 56 primary care offices. An estimation was made of the Pearson correlation coefficient and kappa statistic for the classification of high risk subjects (≥20% according to the Framingham-D’Agostino scale, and ≥5% according to SCORE). Polytomous logistic regression models were fitted to identify the variables associated with the discordance between the two scales.
The mean risk in males (35%) was 19.5% ± 13% with D’Agostino scale, and 3.2% ± 3.3% with SCORE. Among females, they were 8.1% ± 6.8% and 1.2% ± 2.2%, respectively. The correlation between the two scales was 0.874 in males (95% CI: 0.857–0.889) and 0.818 in females (95% CI: 0.800–0.834), while the kappa index was 0.50 in males (95% CI: 0.44%–0.56%) and 0.61 in females (95% CI: 0.52%–0.71%). The most frequent disagreement, characterized by high risk according to D’Agostino scale but not according to SCORE, was much more prevalent among males and proved more probable with increasing age and increased LDL-cholesterol, triglyceride and systolic blood pressure values, as well as among those who used antihypertensive drugs and smokers.
The quantitative correlation between the two scales is very high. Patient categorization as corresponding to high risk generates disagreements, mainly among males, where agreement between the two classifications is only moderate.
PMCID: PMC2800064  PMID: 20049225
cardiovascular diseases; risk assessment; risk factors; sedentary
14.  Modelling innovative interventions for optimising healthy lifestyle promotion in primary health care: "Prescribe Vida Saludable" phase I research protocol 
The adoption of a healthy lifestyle, including physical activity, a balanced diet, a moderate alcohol consumption and abstinence from smoking, are associated with large decreases in the incidence and mortality rates for the most common chronic diseases. That is why primary health care (PHC) services are trying, so far with less success than desirable, to promote healthy lifestyles among patients. The objective of this study is to design and model, under a participative collaboration framework between clinicians and researchers, interventions that are feasible and sustainable for the promotion of healthy lifestyles in PHC.
Methods and design
Phase I formative research and a quasi-experimental evaluation of the modelling and planning process will be undertaken in eight primary care centres (PCCs) of the Basque Health Service – OSAKIDETZA, of which four centres will be assigned for convenience to the Intervention Group (the others being Controls). Twelve structured study, discussion and consensus sessions supported by reviews of the literature and relevant documents, will be undertaken throughout 12 months. The first four sessions, including a descriptive strategic needs assessment, will lead to the prioritisation of a health promotion aim in each centre. In the remaining eight sessions, collaborative design of intervention strategies, on the basis of a planning process and pilot trials, will be carried out. The impact of the formative process on the practice of healthy lifestyle promotion, attitude towards health promotion and other factors associated with the optimisation of preventive clinical practice will be assessed, through pre- and post-programme evaluations and comparisons of the indicators measured in professionals from the centres assigned to the Intervention or Control Groups.
There are four necessary factors for the outcome to be successful and result in important changes: (1) the commitment of professional and community partners who are involved; (2) their competence for change; (3) the active cooperation and participation of the interdisciplinary partners involved throughout the process of change; and (4) the availability of resources necessary to facilitate the change.
PMCID: PMC2714033  PMID: 19534832
15.  Is integration of healthy lifestyle promotion into primary care feasible? Discussion and consensus sessions between clinicians and researchers 
The adoption of a healthy lifestyle, including physical activity, a healthy diet, moderate alcohol consumption and abstinence from smoking, is associated with a major decrease in the incidence of chronic diseases and mortality. Primary health-care (PHC) services therefore attempt, with rather limited success, to promote such lifestyles in their patients. The objective of the present study is to ascertain the perceptions of clinicians and researchers within the Basque Health System of the factors that hinder or facilitate the integration of healthy lifestyle promotion in routine PHC setting.
Formative research based on five consensus meetings held by an expert panel of 12 PHC professionals with clinical and research experience in health promotion, supplied with selected bibliographic material. These meetings were recorded, summarized and the provisional findings were returned to participants in order to improve their validity.
The Health Belief Model, the Theory of Planned Action, the Social Learning Theory, "stages of change" models and integrative models were considered the most useful by the expert panel. Effective intervention strategies, such as the "5 A's" strategy (assess, advise, agree, assist and arrange) are also available. However, none of these can be directly implemented or continuously maintained under current PHC conditions. These strategies should therefore be redesigned by adjusting the intervention objectives and contents to the operation of primary care centres and, in turn, altering the organisation of the centres where they are to be implemented.
It is recommended to address optimisation of health promotion in PHC from a research perspective in which PHC professionals, researchers and managers of these services cooperate in designing and evaluating innovative programs. Future strategies should adopt a socio-ecological approach in which the health system plays an essential role but which nevertheless complements other individual, cultural and social factors that condition health. These initiatives require an adequate theoretical and methodological framework for designing and evaluating complex interventions.
PMCID: PMC2577098  PMID: 18854033
16.  Targeting physical activity promotion in general practice: Characteristics of inactive patients and willingness to change 
BMC Public Health  2008;8:172.
Counselling in routine general practice to promote physical activity (PA) is advocated, but inadequate evidence is available to support this intervention, and its sustainable implementation over time is difficult.
To describe the characteristics of physically inactive adults visiting GPs and the factors associated with their willingness to change PA.
A cross-sectional analysis of 4317 Spanish people aged 20–80 years, selected by systematic sampling among those attending 56 public primary health care practices identified as inactive by their GPs in 2003. PA (7-day PAR), PA stage of change, health-related quality of life (SF-36), cardiovascular risk factors, and social and demographic characteristics were measured. Multivariate mixed effects ordinal logistic models were adjusted to identify factors associated with motivational readiness to change.
At least 70% (95% CI: 67.6% to 72.8%) of patients assessed by GPs did not achieve minimal PA recommendations. In addition, 85% (95% CI: 83% to 86.3%) had at least an additional cardiovascular risk factor. Only 30% (95% CI: 25.8% to 33.5%) were prepared for or attempting a change. A younger age; retirement or work at home; higher education and social class levels; obesity; and hypertension were associated with a higher motivational readiness to change (p < 0.05).
The overburden that would result from counselling such a high proportion of inactive primary care patients justifies a targeted strategy for PA promotion in family practice. Selection of a target population based on readiness to change, the combination of risk factors and socio-demographic characteristics of patients is suggested in order to prioritise promotion efforts.
PMCID: PMC2412873  PMID: 18498623
17.  Design and process of the EMA Cohort Study: the value of antenatal education in childbirth and breastfeeding 
BMC Nursing  2008;7:5.
Antenatal education (AE) started more than 30 years ago with the purpose of decreasing pain during childbirth. Epidural anaesthesia has achieved this objective, and the value of AE is therefore currently questioned. This article describes the protocol and process of a study designed to assess AE results today.
A prospective study was designed in which a cohort of 616 nulliparous pregnant women attending midwife offices of the Basque Health Service were followed for 13 months. Three exposure groups were considered based on the number of AE sessions attended: (a) women attending no session, (b) women attending 1 to 4, and (c) women attending 5 or more sessions. Sociodemographic, personality, and outcome variables related to childbirth and breastfeeding were measured.
It was expected 40% of pregnant women not to have participated in any AE session. However, 93% had attended at least one session. This low exposure variability decreased statistical power of the study as compared to the initially planned power. Despite this, there was a greater than 80% power for detecting as significant differences between exposure groups of, for instance, 10% in continuation of breastfeeding at one and a half months and in visits for false labour. Women attending more sessions were seen to have a mean higher age and educational level, and to belong to a higher socioeconomic group (p < 0.01). Follow-up was completed in 99% of participants.
Adequate prior estimation of variability in the exposure under study is essential for designing cohort studies. Sociodemographic characteristics may play a confounding role in studies assessing AE and should be controlled in design and analyses. Quality control during the study process and continued collaboration from both public system midwives and eligible pregnant women resulted in a negligible loss rate.
PMCID: PMC2386782  PMID: 18435856
18.  The diagnostic challenges presented by patients with medically unexplained symptoms in general practice 
To describe the complexity of somatizing patients’ symptomatology and the difficulties involved in the diagnostic process.
Cross-sectional study of patients with medically unexplained symptoms.
Basque Health Service primary care centres in Bizkaia, Spain.
The study comprised 156 patients selected at random from a list of 468 patients who had presented, over the course of their lives, six or more medically unexplained somatic symptoms for females and four or more for males, identified retrospectively by their practitioners.
Main outcome measures
Physicians interviewed these patients using the somatoform symptoms section of the Composite International Diagnostic Interview (CIDI), and the Primary Care Evaluation of Mental Disorders (PRIME-MD). The Medical Outcomes Survey Short Form 36 (SF-36) was filled in at home. Organic diseases whose diagnosis was established during the previous year were included in the study by consulting patients’ medical records.
Patients were found to have a median of three medically explained and 12 medically unexplained symptoms. Mental disorders were found in 83% of cases, associated with other morbidity categories in 78%. The predictive value of symptoms was lower than 26% for diagnosing broad disease categories.
These results depict an extremely difficult scenario for dichotomous diagnostic strategies aimed at classifying patients’ symptoms as either organic or functional. Rather than struggling to choose one of these hypotheses, it is suggested that both of them should always be addressed concurrently.
PMCID: PMC3406656  PMID: 18570008
Family physician; family practice; general practitioner; health-related quality of life; predictive value; primary healthcare; somatization; somatizing patients
19.  Predictors of long-term outcome of a smoking cessation programme in primary care. 
BACKGROUND: It would be helpful for general practitioners to know which smokers are the most or the least likely to achieve long-term cessation, so that efforts in promoting lifestyle changes can be prioritised. AIM: To identify predictors of abstinence and assess effectiveness over a two-year follow-up of a smoking cessation programme in routine general practice. DESIGN OF STUDY: Quasi-experimental non-randomised controlled trial. SETTING: Primary healthcare centres of the Basque Health Service, Spain. METHOD: All smokers attending seven intervention (n = 1203) and three control (n = 565) practices during one year (from September 1995 to October 1996) were included. The associations between attempts to stop smoking, relapses, and sustained biochemically confirmed abstinence between 12 and 24 months' follow-up, with baseline characteristics and patients' preference with regard to three possible therapeutic options, were assessed by means of logistic regression and survival analyses. RESULTS: Sustained abstinence was biochemically confirmed in 7.3% of smokers in the intervention practices (relative probability = 2.8, 95% confidence interval [CI] = 1.6 to 4.7; probability difference = 4.7%, 95% CI = 2.7% to 6.7%); in 5% of smokers who received advice and a handout (adjusted odds ratio [AOR] = 1.9, 95% CI = 1.0 to 3.4), in 16% who received advice, a handout and follow-up (AOR = 6.6, 95% CI = 2.9 to 14.6), and in 22% who received advice, a handout, follow-up and nicotine patches (AOR = 13.1, 95% CI = 6.6 to 25.9). Positive predictors included previous attempts to stop smoking (AOR = 1.8, 95% CI = 1.1 to 2.7), and age (for each 10 years AOR = 1.32, 95% CI = 1.13 to 1.44). The Fagerström nicotine dependence score was negatively associated (for each point AOR = 0.89, 95% CI = 0.82 to 0.97). CONCLUSION: The intensity of the programme can be tailored to the probability of long-term cessation estimated by the statistical model including these predictors.
PMCID: PMC1314508  PMID: 12817354

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