Impact of the COVID-19 lockdown on routine childhood vaccination coverage rates in Catalonia (Spain): a public health register-based study.

OBJECTIVE: The aim of this study was to determine the impact of the lockdown measures adopted during the COVID-19 pandemic on routine childhood vaccination coverage rates in Catalonia (Spain) and to estimate its recovery once the progressive return to 'normalcy' had begun. STUDY DESIGN: We conducted a public health register-based study. METHODS: Routine childhood vaccination coverage rates were analysed in three periods: a first pre-lockdown period (from January 2019 to February 2020), a second lockdown period with full restrictions (from March 2020 to June 2020), and, finally, a third post-lockdown period with partial restrictions (from July 2020 to December 2021). RESULTS: During the lockdown period, most of the coverage rates remained stable, concerning the pre-lockdown period; however, when comparing the vaccination coverage rates in the post-lockdown period to the pre-lockdown period, we observed decreases in all types of vaccines and doses analysed, except for coverage with the PCV13 vaccine in 2-year-olds, which experienced an increase. The most relevant reductions were observed in measles-mumps-rubella and diphtheria-tetanus-acellular pertussis vaccination coverage rates. CONCLUSIONS: Since the beginning of the COVID-19 pandemic, there has been an overall decline in routine childhood vaccine coverage rates, and the pre-pandemic rates have not yet been recovered. Immediate and long-term support strategies must be maintained and strengthened to restore and sustain routine childhood vaccination.

School Menu Review Programme (PReME): evaluation of compliance with dietary recommendations during the period 2006-2020 in Catalonia.

BACKGROUND: The School Menu Review Programme (PReME) has been offering complimentary revisions of meal plans to all schools in Catalonia since 2006. This study aims to assess the evolution of compliance with PReME's recommendations in the meals provided by school cafeterias in Catalonia during the period 2006-2020. METHODS: Pre-post study with a sample of 6,387 meal plans from 2221 schools assessed during the period. The information was collected mainly by public health specialists within the annual technical and sanitary inspection of school kitchens and cafeterias. Meal plans were evaluated by Dietitian-Nutritionists team according to the criteria of the National Health System's "Consensus document on nutrition in schools" and the Public Health Agency of Catalonia's current guide "Healthy eating at school". Reports were sent to each participating school. A few months later, a new meal plan and another questionnaire were collected and evaluated in comparison with the first meal plan. Compliance with the recommendations was analysed based on the type of canteen management and the school category. RESULTS: Compliance improved during the study period. The percentage of schools that complied with dietary recommendations in relation to the five PReME indicators (fresh fruit, pulses, daily vegetables, fresh food and olive oil for dressing) has steadily increased since PReME began, (over 70% in all indictors; p = < 0.001), with variations depending on school category and cafeteria management. Furthermore, an improvement in the levels of compliance with de recommended food frequencies was observed. with statistically significant differences for all items (p < 0.001), except for pulses whose compliance had been high since the beginning of the study (p = 0.216). CONCLUSIONS: The positive evolution in compliance with PReME's recommendations provides evidence of the programme's effectiveness, with an improvement in the quality of school meals delivered in Catalonia.

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial.

BACKGROUND: This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45-75 years compared to usual care; and b) an implementation strategy. METHODS: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. RESULTS: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. CONCLUSIONS: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.

BACKGROUND: Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. METHODS: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. DISCUSSION: EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Correction to: Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.

It has been highlighted the original article (1) contained a typesetting mistake in the authorship, and that author Caterine Vicens was omitted.

Promoting physical activity through primary health care: the case of Catalonia.

BACKGROUND: In adults, as little as 10 minutes of moderate physical activity (PA) three times a day can help prevent non-communicable diseases and prolong life expectancy. The aim of the study was to evaluate the process and impact of scaling up a complex intervention (PAFES) implemented in Catalonia, aimed to increase the proportion of adults complying with PA recommendations (especially those with cardiovascular risk factors). METHODS: The intervention, piloted in 2005, had three elements: 1) establishing clinical guidelines for PA; 2) identifying local PA resources; 3) PA screening and advice in primary health care (PHC) settings, based on stage of change. Central and local level implementation activities included training, support to municipalities, dissemination through a web page, and promotion of World Physical Activity Day (WPAD). Evaluation followed the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance), identifying 3-6 variables for annual evaluation of each dimension. These included coverage of PA screening and advice and individuals with access to a healthy exercise route (Reach), increased PA level between 2006 and 2010-15 (Effectiveness), PAFES adoption by PHC centres and municipalities (Adoption), process evaluation data (Implementation), and cost (Maintenance). RESULTS: PHC screening coverage increased from 14.4% (2008) to 69.6% (2015) and advice coverage from 8.3% (2012) to 35.6% (2015). In 2015, 82.5% patients had access to a "healthy route" (Reach). The proportion of patients with at least one cardiovascular risk factor who were "sufficiently active" increased from 2006 to 2010-2013 (Effectiveness). By 2015, PAFES was applied by all PHC teams, 8.3% municipalities and 22.7% PHC centres had organized WPAD events (Adoption). The Plan showed good penetration in all health regions by 2013, with relatively low use of resources and estimated cost (Implementation). By 2013 the Plan was embedded within the health system (Maintenance). CONCLUSIONS: In the first application of the RE-AIM framework to evaluate the scaling-up of a PA plan, PAFES showed good results for most RE-AIM indicators. Changes in priority and investment in health promotion programs affect reach, adoption, and effectiveness. It is important to maintain support until programs are strongly embedded into the health system.

Measles, mumps, and rubella vaccination coverage: an ecological study of primary health care and socio-economic factors in Catalonia, Spain.

This study examined the association of socio-economic factors and the structure of primary care centres (PCCs) with measles, mumps, and rubella (MMR) vaccination coverage among the 8-year-old population in Catalonia, Spain. We conducted an ecological study to retrospectively assess the MMR vaccination-recorded status of children born in 2012, using public health data extracted in December 2020. For each of 300 PCCs serving 70,498 children, we calculated vaccination coverage rates from electronic health records and linked these rates to a composite deprivation index corresponding to the territory served by each PCC. We identified a relationship between unfavourable socio-economic factors and higher recorded vaccination coverage. On average, directly managed PCCs had higher vaccination coverage rates than indirectly managed PCCs. Greater utilisation of primary care services by the population was also associated with higher vaccination coverage rates. Further research is needed to generate knowledge valuable for informing more equitable child-vaccination service delivery models.

[Perception in chronic illnesses: linguistic validation of the revised Illness Perception Questionnaire and the Brief Illness Perception Questionnaire for a Spanish population]. / Percepción en enfermedades crónicas: validación lingüística del Illness Perception Questionnaire Revised y del Brief Illness Perception Questionnaire para la población española.

OBJECTIVE: To obtain adapted versions for the Spanish population of a specific version of the Revised Illness Perception Questionnaire Revised (IPQ-R(e)) and the Brief Illness Perception Questionnaire (BIPQ), conceptually and linguistically equivalent to the original questionnaires. DESIGN: Cultural adaptation of questionnaires: linguistic validation. SETTING: Five primary care centres and a tertiary hospital. PARTICIPANTS: A multidisciplinary team was selected. A pilot study was performed on 30 people with chronic diseases (hypertension, diabetes mellitus, stable ischaemic heart disease, asthma, chronic obstructive pulmonary disease or osteoarthritis) METHOD: The project proceeded in 3 phases: I) Double forward-translation, II) Pilot study and III) Double back-translation. Three consensus meetings were held, one in each phase. Another meeting was held with one of the authors of the original questionnaire, where we knew about a short version, the BIPQ. It was also included in the study. Double forward and back-translations were performed and consensus was reached in both stages. RESULTS: Phase I) The majority of IPQ-R(e) items did not raise problems of translation. Phase II) In the pilot study we detected that patients found some difficulties in connection with the comprehension and self administration of some items. Therefore it was decided to employ trained interviewers, to introduce changes in the IPQ-R(e) format and vocabulary and to adapt a specific version with fewer items that solved most of these difficulties Phase III) Back-translations were very similar to the original version. The BIPQ forward and back-translation process caused no difficulties. CONCLUSIONS: After lingüistic validation, IPQ-R(e) and BIPQ versions conceptually and lingüistically equivalent to original instruments were obtained.

[Analysis of the implementation of a unified transportation system of the neonatal screening samples in Catalonia.] / Análisis de la implementación de un sistema de transporte unificado de las muestras de cribado neonatal en Cataluña.

The Neonatal Screening Program in Catalonia from its inception fifty years ago until today, has enabled the early diagnosis and treatment of more than 2,000 newborns. In the last decade, the Program has undergone various extensions regarding its panel of diseases and has improved its evaluation with the inclusion of quality indicators in all its stages. One of the pending subjects of the screening program has been the improvement of the quality indexes related to the sample's arrival time to the laboratory after their extraction. The extension of the territory, the dispersion of numerous maternal centers, as well as the diversity and heterogeneity of the sample transport systems, have been an obstacle to quality compliance of these indexes. With the aim of reducing the period of samples arrival to the laboratory and continue to move towards meeting the standards established by the Ministry of Health, in 2020 a unified sample transport system has been implemented for the entire Catalan territory. The times obtained during the first months with the new system, have shown a notable improvement in the results, achieving a reduction of 50% of the days between the extraction of the sample and its arrival at the laboratory.

El Programa de Cribado Neonatal (PCN) de Cataluña ha permitido el diagnóstico y tratamiento precoz de más de 2.000 recién nacidos desde su inicio hace cincuenta años hasta la actualidad. En la última década, el PCN ha experimentado diversas ampliaciones en cuanto a su panel de enfermedades y ha mejorado su evaluación con la inclusión de indicadores de calidad en todas sus etapas. Una de las asignaturas pendientes del programa de cribado ha sido la mejora de los indicadores relativos al tiempo de llegada de las muestras al laboratorio desde su extracción. La extensión territorial, la dispersión de los sesenta y seis centros maternales, así como la diversidad y heterogeneidad de los sistemas de transporte de muestras, han supuesto un obstáculo para el cumplimiento de la calidad de este indicador. Con el objetivo de reducir el período de llegada de las muestras al laboratorio y seguir avanzando en el cumplimiento de los estándares establecidos por el Ministerio de Sanidad, en 2020 se ha implementado un sistema de transporte de muestras unificado para todo el territorio catalán. Los tiempos obtenidos durante los primeros meses con el nuevo sistema muestran una mejora notable de los resultados, consiguiendo una reducción del 50% de los días transcurridos desde la extracción de la muestra hasta su llegada al laboratorio.

WITHDRAWN: Interventions for preventing tobacco smoking in public places.

BACKGROUND: Environmental tobacco smoke is a health hazard. Reducing exposure to tobacco smoke in public places is a widespread public health goal. There is, however, considerable variation in the extent to which this goal has been achieved in different settings and societies. There is therefore a need to identify effective strategies for reducing tobacco consumption in public places. OBJECTIVES: To evaluate the effectiveness of interventions to reduce tobacco consumption in public places. SEARCH STRATEGY: We searched the Tobacco Addiction Review Group trials register, MEDLINE and EMBASE in March 2006. We handsearched a key journal and abstracts from international conferences on tobacco. We checked the bibliographies of identified studies and reviews for additional references. SELECTION CRITERIA: We considered randomized and controlled trials, controlled and uncontrolled before-and-after studies and interrupted time series. The main outcome of interest was levels and measures of compliance with bans and restrictions. We considered strategies aimed at populations, including education campaigns, written material, non-smoking and warning signs, and comprehensive strategies. We also considered strategies aimed at individual smokers. DATA COLLECTION AND ANALYSIS: Information relating to the characteristics and content of all kinds of interventions, participants, outcomes and methods of each study was abstracted by one reviewer and checked by two others. Studies were combined using qualitative narrative synthesis. MAIN RESULTS: Twenty of 25 studies reporting information about interventions to reduce smoking in public places met all the inclusion criteria. Three were controlled before-and-after studies and 17 were uncontrolled before-and-after studies. The most effective strategies used comprehensive, multi-component approaches to implement policies banning smoking within institutions. Less comprehensive strategies, such as posted warnings and educational material, had a moderate effect. Five studies showed that prompting individual smokers had an immediate effect, but such strategies are unlikely to be acceptable as a public health intervention. AUTHORS' CONCLUSIONS: Carefully planned and resourced, multi-component strategies effectively reduced smoking within public places. Less comprehensive strategies were less effective. Most studies were done in the USA and, despite increasing evidence from Europe, there is a need to identify ways in which these strategies can be adopted and used in countries with different attitudes to tobacco use. Future studies should also consider the use of more rigorous experimental designs.

[Sick leave due to tobacco use in workers aged 35-64. Catalonia, 2007-2016]. / La incapacidad temporal atribuible al consumo de tabaco en trabajadores de 35-64 años. Cataluña, 2007-2016.

OBJECTIVE: Few recent studies have researched into the size and trends of the impact of tobacco use on productivity losses. The objective of this work was to describe the percentage of episodes and non work-related sick leave days with a duration over 5 days due to tobacco use in Catalonia in the period 2007-2016 in relation to the total sick-leave episodes and sick leave days in patients aged 35-64. METHODS: Descriptive study of 3,627,107 episodes and 237,219,230 days in sick-leave by any cause, except those work-related, in workers aged 35-64. Population etiological fractions were used. The annual percentage of number of episodes and sick-leave days due to tobacco use in relation with total episodes and sick-leave days was calculated and a trend test was performed. RESULTS: The percentage of sick-leave episodes and days due to tobacco use was higher in men (3.9%; 5.5% respectively) than in women (2.3%; 1.5% respectively). The trend for sick-leave due to tobacco use was positive, with a maximum OR in 2013. For the number of sick-leave episodes due to tobacco use, the corrected Z was 25.3 in men (p<0.001) and 49.4 in women (p<0.001). For sick-leave days due to tobacco use, the corrected Z was 36.9 in men (p<0.001) and 250.4 in women (p< 0.001). CONCLUSIONS: About 3% of sick-leave episodes with a duration over than 5 days are due to tobacco use, with a positive trend in both sexes. It is necessary to continue reinforcing the tobacco prevention and control policies in order to improve such trends for years to come.

OBJETIVO: Pocos estudios recientes han investigado en nuestro medio la magnitud y las tendencias del impacto del consumo de tabaco en la pérdida de productividad. El objetivo de este trabajo fue describir la proporción de episodios y de días en incapacidad temporal no profesional de duración superior a 5 días y atribuible al consumo de tabaco en Cataluña en el período 2007-2016, respecto del total de incapacidad temporal en trabajadores de 35-64 años. METODOS: Estudio descriptivo de 3.627.107 episodios y 237.219.230 días de incapacidad temporal por todas las causas, excepto las de origen profesional, en trabajadores de 35-64 años. Se aplicaron las fracciones etiológicas poblacionales. Se calculó la proporción anual de episodios y de días en incapacidad temporal atribuible (ITA) respecto de la incapacidad temporal (IT) por todas las causas y se realizó un test de tendencia. RESULTADOS: El porcentaje de episodios y de días en ITA por consumo de tabaco fue superior en hombres (3,9%; 5,5% respectivamente) que en mujeres (2,3%; 1,5% respectivamente). La tendencia de la ITA fue ascendente, con un OR máximo en 2013. Para los episodios de ITA, la Z corregida fue 25,3 en hombres (p<0,001) y 49,4 en mujeres (p<0,001). Para los días en ITA, la Z corregida fue 36,9 en hombres (p<0,001) y 250,4 en mujeres (p<0,001). CONCLUSIONES: Alrededor de un 3% de los episodios de IT de 5 días o más son atribuibles al tabaco, con una tendencia ascendente en ambos sexos. Es necesario continuar reforzando las políticas de prevención y control del tabaquismo para mejorar esta tendencia.

Impact of economic incentives on quality of professional life and on end-user satisfaction in primary care.

BACKGROUND: A new economic incentive scheme based on (i) quality of care objectives for physicians, and (ii) professional development for both physicians and nurses, was introduced in primary care teams. OBJECTIVE: To assess weather the implementation of these economic incentive schemes has had an impact on the quality of professional life (QPL) of both physicians and nurses and on end-user satisfaction. METHODS: Before-after study. Participants are 257 primary care teams in Catalonia, Spain, in the period 2002-2003. QPL and end-user satisfaction were used as outcome measures. RESULTS: QPL was improved in terms of the dimension "perception of support from the management structure" among physicians (4.897 versus 5.220; p<0.001) as well as nurses (5.272 versus 5.638; p<0.001). Further, physicians perceived an increase in the dimension "demands made upon them" (6.124 versus 6.364; p<0.001), differently from the nurses group (5.8191 versus 5.929; p=0.063). Overall, user satisfaction did not vary significantly, although a positive relationship was found between "perception of support from the management structure" and user satisfaction among nurses (beta=0.078, p=0.007), and a negative relationship between "demands made upon them" and user satisfaction in the case of physicians (beta=-0.057, p=0.011). CONCLUSIONS: Incentives related to quality of care annual targets may increase physicians' perception of burden and it may have a negative impact on consumer satisfaction. Incentives on long-term professional development seem to be related to an increase in professionals' perception of support from the management structure. Among nurses, this increase is related to an improvement of user satisfaction.

[Trends in the nutritional status of the Spanish population: results from the Catalan nutrition monitoring system (1992-2003)]. / Tendencias del estado nutricional de la población española: resultados del sistema de monitorización nutricional de Cataluña (1992-2003).

BACKGROUND: The purpose of this study was to evaluate the changes in the nutricional habits and nutricional status of the Catalan population over 10 years interval of the two Catalan Nutricional Surveys conducted in 1992-93 and 2002-03. METHODS: 2641 individuals in 1992-93 and 2060 individuals in 2002-03 aged 10 to 75 years participated in the surveys. Two 24 hour recall, a food frequency questionnaire, and a general questionnaire with information on physical activity, knowledge and opinions on nutrition and supplements use were administered. Weight (Kg), height (cm) and waist circumference (WC) (cm) were measured. A subsample of the population underwent a biochemical evaluation. Total cholesterol, HDL cholesterol, LDL cholesterol, tryglicerides and beta-carotene, alpha-tocopherol and retinol were measured. RESULTS: A decrease in the consumption of fruit, vegetables, potatoes, meat and fish and an increase in the consumption of dairy products and fast food (in young individuals) were reported. An increase in the mean value of Body Mass Index (BMI) was observed among males, and an increase in WC mean value was observed in males and females. BMI value decreased in females (except among the younger ones). The prevalence of obesity increased among males (from 9.9% to 16.6%), but not in females. Both total cholesterol and HDL cholesterol decreased. A decrease was observed in the percentage of population with sedentary habits during leisure time. CONCLUSIONS: There is a need for an effective nutrition policy promoting healthy nutrition in accordance with the ongoing dietary guidelines.

Effectiveness of a brief primary care intervention to reduce passive smoking in babies: a cluster randomised clinical trial.

BACKGROUND: Tobacco smoke pollution (TSP) has major negative effects on infant health. Our objectives were to determine the effectiveness of a brief primary care intervention directed at parents who smoke in reducing babies' TSP exposure, and to establish variables related to greater exposure. METHOD: A multicentre, open, cluster-randomised clinical trial in Catalonia. The 83 participating primary health paediatric teams of the Catalan Health Service recruited 1101 babies whose parents were smokers. The intervention group (IG) received a brief TSP intervention; the control group (CG) received the usual care. Outcomes were measured by parents' reported strategies to avoid TSP exposure. Baseline clinical data and characteristics of each baby's TSP exposure were collected, along with infant hair samples and parents' tobacco use and related attitudes/behaviours. At 3-month and 6-month follow-up, behavioural changes to avoid TSP exposure were recorded; the association between reported parental behaviours and nicotine concentration in infant hair samples was tested in a random sample of 253 babies at baseline and 6 months. RESULTS: During follow-up, TSP-avoidance strategies improved more in the IG than in the CG: 35.4% and 26.9% ( p=0.006) at home, and 62.2% and 53.1% in cars (p=0.008). Logistic regression showed adjusted ORs for appropriate measures in the IG versus CG of 1.59 (95% CI 1.21 to 2.09) at home and 1.30 (95% CI 0.97 to 1.75) in cars. Hair samples showed that 78.7% of the babies tested were exposed. Reduced nicotine concentration was associated with improved implementation of effective strategies reported by parents at home (p=0.029) and in cars (p=0.014). CONCLUSIONS: The intervention produced behavioural changes to avoid TSP exposure in babies. The proportion of babies with nicotine (>=1ng/mg) in hair samples at baseline is a concern. TRIAL REGISTRATION NUMBER: Clinical Trials.gov Identifier: NCT00788996.

[Peripheral artery disease of the lower limbs and morbidity/mortality in type 2 diabetics]. / Arteriopatía periférica de extremidades inferiores y morbimortalidad en pacientes diabéticos tipo 2.

OBJECTIVE: To study the relationship between the presence of peripheral artery disease (PAD) and the morbidity and mortality at 6 years, and the ankle-brachial index (ABI) as a predictor of morbidity and mortality in type 2 diabetes mellitus. DESIGN: Retrospective cohort study. Six years follow-up. SETTING: Urban health centre. PARTICIPANTS: A total of 269 type 2 diabetics, of which 63 had PAD in 1996: 20 were previously diagnosed and 43 had an ABI of < or =0.90. PRINCIPAL MEASUREMENTS: An appointed was made with the patients to find out the incidence of fatal and non-fatal microvascular and macrovascular events and the histories were reviewed. Six patients were excluded as all their data were not available. RESULTS: Thirty nine patients had died, of whom 19 had PAD in 1996 (30.1%) and 20 did not (9.7%) (P = .001). Sixteen patients died in the group with an ABI < or =0.9 (30.2%) and 21 (10.1%) in the group with normal ABI values (P = .001). 7 (13.2%) patients died due to a cardiovascular cause with a pathological ABI, and 8 (3.9%) with a normal value (P = .009). The presence of PAD has been associated with a higher probability of having a non-fatal episode of ischaemic cardiac disease (P = .04), a cerebrovascular accident (CVA) (P < .001) and ulcers (P = .006). A low ABI has been associated with a higher probability of presenting with a fatal or non-fatal cardiovascular event (P < .001). After the multivariate analysis an increase was observed in cardiovascular (odds ratio [OR] =2.81; 95% confidence interval [CI], 1.16-6.78), CVA (OR = 3.47; 95% CI, 1.19-10.07), and cardiac failure (OR = 6.75; 95% CI, 1.34-33.81), morbidity and mortality in diabetics with an ABI of < or = 0.90. CONCLUSIONS: The type 2 diabetics with PAD present with a higher morbidity and mortality. The ABI is a good predictor of cardiovascular disease and heart failure morbidity and mortality.