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".

Effectiveness of a multidisciplinary BIOPSYCHOSOCIAL intervention for non-specific SUBACUTE low back pain in a working population: a cluster randomized clinical trial.

BACKGROUND: Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Current guidelines for the treatment of LBP recommend pharmacological and non-pharmacological strategies. The aim of this study was to compare usual clinical practice with the effectiveness of a biopsychosocial multidisciplinary intervention in reducing disability, severity of pain and improving quality of life in a working population of patients with subacute (2-12 weeks), non-specific LBP. METHODS: Longitudinal cluster randomized clinical trial conducted in 39 Primary Health Care Centres (PHCC) of Barcelona, with patients aged 18-65 years (n = 501; control group = 239; 26 PHCC, intervention group = 262; 13 PHCC). The control group received usual clinical care. The intervention group received usual clinical care plus a biopsychosocial multidisciplinary intervention, which consisted of physiotherapy, cognitive-behavioural therapy and medication. The main outcomes were changes in the Roland Morris Disability Questionnaire (RMDQ), and the minimal clinically important differences. Secondary outcomes were changes in the McGill Pain (MGPQ) and Quality of Life (SF-12) questionnaires. Assessment was conducted at baseline, 3 and 12 months. Analysis was by intention-to-treat and analyst-blinded. Multiple imputations were used. RESULTS: Of the 501 enrolled patients, 421 (84%) provided data at 3 months, and 387 (77.2%) at 12 months. Mean age was 46.8 years (SD: 11.5) and 64.7% were women. In the adjusted analysis of the RMDQ outcome, only the intervention group showed significant changes at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups. In the adjusted analysis of the RMDQ outcome, the intervention group improvement more than the control group at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027). The intervention group presented a significant difference. Both groups presented a minimal clinically important difference, but more difference in the intervention group. The intervention group presented significant differences in the MGPQ scales of current pain intensity and VAS scores at 3 months. No statistically significant differences were found in the physical and mental domains of the SF-12. CONCLUSIONS: A multidisciplinary biopsychosocial intervention in a working population with non-specific subacute LBP has a small positive impact on disability, and on the level of pain, mainly at short-term, but no difference on quality of life. TRIAL REGISTRATION: ISRCTN21392091 (17 oct 2018) (Prospectively registred).

Talking to the people that really matter about their participation in pandemic clinical research: A qualitative study in four European countries.

BACKGROUND: Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. METHODS: Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis. RESULTS: Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain. CONCLUSIONS: This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies.

Family caregiver mistreatment of the elderly: prevalence of risk and associated factors.

BACKGROUND: The detection of elder mistreatment is emerging as a public health priority; however, abusive behaviors exercised by caregivers are little known and rarely detected among primary health care professionals. This study aims to estimate the prevalence of risk of abuse against community-residing elderly with moderate to severe dependency whose caregivers are relatives. In addition, we aim to describe the association between such a risk and socio-demographic variables, cognitive and dependency state of the victim, and the scale of the caregiver's anxiety, depression, and burden. METHODS: Cross-sectional study developed in 72 Primary Health Care teams from Barcelona, Spain. Participants were caregivers and their dependent care recipients (N = 829). Home interviews included the Caregiver Abuse Screen (CASE); self-reported abuse from care recipient; activities of daily living and cognitive state of the care recipient; anxiety and depression in caregivers and Caregiver Burden Scale. The relationship prior to the dependency, positive aspects of caregiving, and social support for the caregiver were also assessed. Multivariate analysis was performed using logistic regression with risk of abuse as dependent variable. RESULTS: Caregivers were mainly women (82.8%) with a mean age of 63.3 years. Caregivers and care recipients lived in the same household in 87.4% of cases, and 86.6% had enjoyed a good previous relationship. Care recipients were women (65.6%), with a mean age of 84.2 years, and 64.2% had moderate to severe cognitive impairment. CASE demonstrated a prevalence of 33.4% (95% CI: 30.3-36.7) of abuse risk by the caregiver. Logistic regression showed as statistically significant: caregiver burden (OR = 2.75; 95% CI: 1.74-4.33), caregiver anxiety (OR = 2.06; 95% CI: 1.40-3.02), caregiver perception of aggressive behavior in the care recipient (OR = 7.24; 95% CI: 4.99-10.51), and a bad previous relationship (OR = 4.66; 95% CI: 1.25-17.4). CONCLUSIONS: Prevalence of risk of abuse is high among family caregivers. Our study has found risk factors in family caregivers that are preventable to an extent, namely: anxiety and feelings of burden. It is essential to become aware of these risk factors and their causes to intervene and help primary as well secondary prevention.

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.

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.

Multimorbidity patterns with K-means nonhierarchical cluster analysis.

BACKGROUND: The purpose of this study was to ascertain multimorbidity patterns using a non-hierarchical cluster analysis in adult primary patients with multimorbidity attended in primary care centers in Catalonia. METHODS: Cross-sectional study using electronic health records from 523,656 patients, aged 45-64 years in 274 primary health care teams in 2010 in Catalonia, Spain. Data were provided by the Information System for the Development of Research in Primary Care (SIDIAP), a population database. Diagnoses were extracted using 241 blocks of diseases (International Classification of Diseases, version 10). Multimorbidity patterns were identified using two steps: 1) multiple correspondence analysis and 2) k-means clustering. Analysis was stratified by sex. RESULTS: The 408,994 patients who met multimorbidity criteria were included in the analysis (mean age, 54.2 years [Standard deviation, SD: 5.8], 53.3% women). Six multimorbidity patterns were obtained for each sex; the three most prevalent included 68% of the women and 66% of the men, respectively. The top cluster included coincident diseases in both men and women: Metabolic disorders, Hypertensive diseases, Mental and behavioural disorders due to psychoactive substance use, Other dorsopathies, and Other soft tissue disorders. CONCLUSION: Non-hierarchical cluster analysis identified multimorbidity patterns consistent with clinical practice, identifying phenotypic subgroups of patients.

Health-care users, key community informants and primary health care workers' views on health, health promotion, health assets and deficits: qualitative study in seven Spanish regions.

BACKGROUND: Although some articles have analysed the definitions of health and health promotion from the perspective of health-care users and health care professionals, no published studies include the simultaneous participation of health-care users, primary health care professionals and key community informants. Understanding the perception of health and health promotion amongst these different stakeholders is crucial for the design and implementation of successful, equitable and sustainable measures that improve the health and wellbeing of populations. Furthermore, the identification of different health assets and deficits by the different informants will generate new evidence to promote healthy behaviours, improve community health and wellbeing and reduce preventable inequalities. The objective of this study is to explore the concept of health and health promotion and to compare health assets and deficits as identified by health-care users, key community informants and primary health care workers with the ultimate purpose to collect the necessary data for the design and implementation of a successful health promotion intervention. METHODS: A descriptive-interpretive qualitative research was conducted with 276 participants from 14 primary care centres of 7 Spanish regions. Theoretical sampling was used for selection. We organized 11 discussion groups and 2 triangular groups with health-care users; 30 semi-structured interviews with key community informants; and 14 discussion groups with primary health care workers. A thematic content analysis was carried out. RESULTS: Health-care users and key community informants agree that health is a complex, broad, multifactorial concept that encompasses several interrelated dimensions (physical, psychological-emotional, social, occupational, intellectual, spiritual and environmental). The three participants' profiles consider health promotion indispensable despite defining it as complex and vague. In fact, most health-care users admit to having implemented some change to promote their health. The most powerful motivators to change lifestyles are having a disease, fear of becoming ill and taking care of oneself to maintain health. Health-care users believe that the main difficulties are associated with the physical, social, working and family environment, as well as lack of determination and motivation. They also highlight the need for more information. In relation to the assets and deficits of the neighbourhood, each group identifies those closer to their role. CONCLUSIONS: Generally, participants showed a holistic and positive concept of health and a more traditional, individual approach to health promotion. We consider therefore crucial to depart from the model of health services that focuses on the individual and the disease toward a socio-ecological health model that substantially increases the participation of health-care users and emphasizes health promotion, wellbeing and community participation.

Beyond the consultation room: Proposals to approach health promotion in primary care according to health-care users, key community informants and primary care centre workers.

BACKGROUND: Primary health care (PHC) is the ideal setting to provide integrated services centred on the person and to implement health promotion (HP) activities. OBJECTIVE: To identify proposals to approach HP in the context of primary care according to health-care users aged 45-75 years, key community informants and primary care centre (PCC) workers. METHODS: Descriptive-interpretive qualitative research with 276 participants from 14 PCC of seven Spanish regions. A theoretical sampling was used for selection. A total of 25 discussion groups, two triangular groups and 30 semi-structured interviews were carried out. A thematic interpretive contents analysis was carried out. RESULTS: Participants consider that HP is not solely a matter for the health sector and they emphasize intersectoral collaboration. They believe that it is important to strengthen community initiatives and to create a healthy social environment that encourages greater responsibility and participation of health-care users in decisions regarding their own health and better management of public services and resources. HP, care in the community and demedicalization should be priorities for PHC. Participants propose organizational changes in the PCC to improve HP. PCC workers are aware that HP falls within the scope of their responsibilities and propose to increase their training, motivation, competences and knowledge of the social environment. Informants emphasize that HP should be person-centred approach and empathic communication. HP activities should be appealing, ludic and of proven effectiveness. CONCLUSIONS: According to a socio-ecological and intersectoral model, PHC services must get actively involved in HP together with community and through outreach interventions.

Understanding knee osteoarthritis from the patients' perspective: a qualitative study.

BACKGROUND: No studies of Health Coach Interventions for knee OA sufferers that include patients' perspectives have been published. The study assesses current clinical practice and primary care professionals' advice from the patients' perspective, in order to obtain a participative design for a complex intervention based on coaching psychology. Moreover, wants to analyse the experiences, perceptions, cognitive evaluation, values, emotions, beliefs and coping strategies of patients with knee osteoarthritis, and secondly the impact of these factors in the Self-management of this condition. METHODS: It is an interpretative qualitative study. The study included patients with diagnosis of knee osteoarthritis (OA) from 4 primary health care centres in Barcelona. A theoretical sampling based on a prior definition of participants' characteristics was carried out. Ten semi-structured interviews with knee OA patients were carried out. A content thematic analysis was performed following a mixed-strategy text codification in Lazarus framework and in emerging codes from the data. RESULTS: The results are structured in two blocks: Experiences and perceptions of informants and Experiences of knee osteoarthritis according to the Lazarus model. Regarding experiences and perceptions of informants: Some participants reported that the information was mostly provided by health professionals. Informants know which food they should eat to lose weight and the benefits of weight loss. Moreover, participants explained that they like walking but that sometimes it is difficult to put into practice. Regarding experiences of knee osteoarthritis according Lazarus model: Cognitive evaluation is influenced by cognitive distortions such as obligation, guilt, dramatization and catastrophism. VALUES: Family is the value most associated with wellbeing. Helping others is another recurring value. Emotions: Most participants explain that they feel anxiety, irritability or sadness. Beliefs: To some, physiotherapy helps them feel less pain. However, others explain that it is of no use to them. Participants are aware of the association overweight- pain. Coping strategies: The strategies for coping with emotions aim to reduce psychological distress (anxiety, sadness, anger) and some are more active than others. CONCLUSIONS: The study highlights that patients with knee osteoarthritis require a person-centered approach that provides them with strategies to overcome the psychological distress caused by this condition.

Child and Adolescent Sexual Abuse in Women Seeking Help for Sexual and Reproductive Mental Health Problems: Prevalence, Characteristics, and Disclosure.

This is a multicentric, descriptive, cross-sectional study of child and adolescent sexual abuse in women over 18 years in 24 primary care sexual and reproductive health centers in Catalonia. A total of 1,013 women were recruited; 345 (37.6%, 95% CI: 34.6-40.9) reported exposure to child sexual abuse: 32.4% disclosed being touched in a sexual way, and 9.6% reported completed sexual intercourse. Abuse occured before the age of 13 in 63.4% of respondents. The perpetrator was a relative or an acquaintance in almost 80% of cases. The risk was higher among women of Central or South American origin (OR: 2.86; 95% CI: 1.33-6.12). Only 31.9% of women disclosed the abuse and 17.3% were blamed. Abuse that involved attempted or completed sexual intercourse was significantly associated with recurrence, physical violence, and revictimization in adulthood.

Patients' perceptions and experiences of patient safety in primary care in England.

BACKGROUND: One of the most remarkable features of patient safety research in primary care is the sparse attention paid to patients' own experiences. OBJECTIVE: To explore patient's perceptions and experiences of patient safety in primary care in England. METHODS: We conducted a qualitative study in the South of England with an opportunistic sample of 27 primary care users. Information was obtained from four patient focus groups. A thematic content analysis was conducted by three analysts and consensus reached within the research team on the key themes that emerged. RESULTS: Participants' conceptualizations of patient safety referred to high standards of health care delivery within a relationship of trust. Participants identified four main factors that they believed could potentially affect patient safety. These included factors related to (i) the patient (attitudes, behaviours and health literacy); (ii) the health professional (attitudes, behaviours and accuracy of diagnoses); (iii) the relationship between patients and health professionals (communication and trust); and (iv) the health care system (workload, resources, care coordination, accessibility, interdisciplinary teamwork and accuracy of health care records). Confidentiality, continuity of care and treatment-related safety emerged as cross-cutting major threats to patient safety. CONCLUSIONS: The exploration of participants' perceptions and experiences allowed the identification of a wide variety of themes that were perceived to impact on patient safety in primary care. The findings of this study could be used to enrich current frameworks that are exclusively based on professional or health care system perspectives.

The burden of cardiovascular morbidity in a European Mediterranean population with multimorbidity: a cross-sectional study.

BACKGROUND: Cardiovascular diseases are highly represented in multimorbidity patterns. Nevertheless, few studies have analysed the burden of these diseases in the population with multimorbidity. The objective of this study was to identify and describe the cardiovascular diseases among the patients with multimorbidity. METHODS: We designed a cross-sectional study in patients ≥19 years old assigned to 251 primary health care centres in Catalonia, Spain. The main outcome was cardiovascular morbidity burden, defined as the presence of one or more of 24 chronic cardiovascular diseases in multimorbid patients (≥2 chronic conditions). Two groups were defined, with and without multimorbidity; the multimorbidity group was further divided into cardiovascular and non-cardiovascular subgroups. The secondary outcomes were: modifiable major cardiovascular risk factors (smoking, hypertension, hypercholesterolaemia, diabetes) and cardiovascular risk score (REGICOR, Registre Gironí del Cor). Other variables analysed were: sex, age (19-24, 25-44, 45-64, 65-79, and 80+ years), number of chronic diseases, urban setting, active toxic habits (smoking and alcohol), physical parameters and laboratory tests. RESULTS: A total of 1,749,710 individuals were included (mean age, 47.4 years [SD: 17.8]; 50.7 % women), of which nearly half (46.8 %) had multimorbidity (95 % CI: 46.9-47.1). In patients with multimorbidity,, the cardiovascular burden was 54.1 % of morbidity (95 % CI: 54.0-54.2) and the four most prevalent cardiovascular diseases were uncomplicated hypertension (75.3 %), varicose veins of leg (20.6 %), "other" heart disease (10.5 %) and atrial fibrillation/flutter (6.7 %). In the cardiovascular morbidity subgroup, 38.2 % had more than one cardiovascular disease. The most prevalent duet and triplet combinations were uncomplicated hypertension & lipid disorder (38.8 %) and uncomplicated hypertension & lipid disorder & non-insulin dependent diabetes (11.3 %), respectively. By age groups, the same duet was the most prevalent in patients aged 45-80 years and in men aged 25-44 years. In women aged 19-44, varicose veins of leg & anxiety disorder/anxiety was the most prevalent; in men aged 19-24, it was uncomplicated hypertension & obesity. Patients with multimorbidity showed a higher cardiovascular risk profile than the non-multimorbidity group. CONCLUSIONS: More than 50 % percent of patients with multimorbidity had cardiovascular diseases, the most frequent being hypertension. The presence of cardiovascular risk factors and the cardiovascular risk profile were higher in the multimorbidity group than the non-multimorbidity group. Hypertension, diabetes and dyslipidaemia constituted the most prevalent multimorbidity pattern.

[Multimorbidity patterns in young adults in Catalonia: an analysis of clusters]. / Patrones de multimorbilidad en adultos jóvenes en Cataluña: un análisis de clústeres.

OBJECTIVE: The aim of this study was to identify multimorbidity patterns in patients from 19 to 44 years attended in primary care in Catalonia in 2010. DESIGN: Cross-sectional study. SETTING: 251 primary care centres. PARTICIPANTS: 530,798 people with multimorbidity, aged 19 to 44 years. MAIN OUTCOME MEASURES: Multimorbidity was defined as the coexistence of ≥2 more International Classification system (ICD-10) registered in the electronic health record. Multimorbidity patterns were identified using hierarchical cluster analysis and by sex and age group (19-24 and 25-44). RESULTS: Of the 882,708 people from initial population, 530,798 (60.1%) accomplished multimorbidity criterion. Mean age was 33.0 years (SD: 7.0) and 53.3% were women. Multimorbidity was higher in the 25-to 44-years-old group with respect the younger group (60.5 vs. 58.1%, p<0.001), being higher in women. Most prevalent cluster in all groups included, among others, by dental caries, smoking, dorsalgia, common cold and other anxiety disorders. For both sexes in the 25-to 44-years-old group appeared the cardiovascular-endocrine-metabolic pattern (obesity, lipid disorders and arterial hypertension). CONCLUSIONS: Multimorbidity affects more than half of persons between 19 to 44-years-old. The most prevalent cluster is formed by grouping common diseases (dental caries, common cold, smoking, anxiety disorders and dorsalgias). Another pattern to highlight is the cardiovascular-endocrine-metabolic pattern in the 25- to 44 years-old group. Knowledge of patterns of multimorbidity in young adults could be used to design individualized preventive strategies.

Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

BACKGROUND: The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis. METHODS/DESIGN: Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. PARTICIPANTS: 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. CONTROL GROUP: will receive standard care. MAIN OUTCOME VARIABLE: quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1. DISCUSSION: If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care. TRIAL REGISTRATION: ISRCTN57405925. Registred 20 June 2014.

The workers opinions have a value in the Code of Ethics: Analysis of the contributions of workers in virtual Forum Catalan Institute of Health.

BACKGROUND: The Catalan Institute of Health (CIH) is the largest health services public provider in Catalonia. "CIH Code of Ethics Virtual Forum" (CEVF), was created within the Intranet of the CIH to facilitate participation among their employees. The current study aims to: a) Analyse the CIH workers' assessment of their own, their colleagues' and the organization's observance of ethical values; b) Identify the opinions, attitudes, experiences and practices related to the ethical values from the discourse of the workers that contributed voluntarily to the CEVF. METHODS: Mixed methods study with convergent parallel design: 1. Cross sectional study by means of a self-administered, ad hoc, anonymous questionnaire to assess the observance of the ethical values of the CIH according to the participants. A total of 712 workers responded to the questionnaire. A descriptive, bivariate analysis of the results was carried out. 2. Qualitative study to determine the meaning for the workers of the ethical values put forward by the organization. Their individual opinions and experiences were explored by means of a thematic contents analysis of 225 comments posted in the CEVF. The study was conducted between May and December 2008. RESULTS: The average score for observance of the CE by the respondents themselves was high (over 4/5), between 3.5-4/5 for the observance by their colleagues and close to 3/5 for the CIH management. These results do not change when we compare by gender, age group and professional discipline. The comments on the values are information-rich, they mirror the ethical environment of the institution and show various ethical dilemmas and suggestions. CONCLUSIONS: Results show that it is feasible for a publicly funded health care organization to develop a CE with the participation of employees and the support of the management. Results underscore the relevance of this strategy for the implementation, improvement and update of the CE as a responsibility shared by all workers. Practices consistent with ethical values are rewarded by social approval, enhance employee's confidence and coherence in decision-making and improve public engagement and institutional policies.

Motivational interviewing interactions and the primary health care challenges presented by smokers with low motivation to stop smoking: a conversation analysis.

BACKGROUND: Research indicates that one third of smokers have low motivation to stop smoking. The purpose of the study was to use Conversational Analysis to enhance understanding of the process in Motivational Interviewing sessions carried out by primary care doctors and nurses to motivate their patients to quit smoking. The present study is a substudy of the Systematic Intervention on Smoking Habits in Primary Health Care Project (Spanish acronym: ISTAPS). METHODS: Motivational interviewing sessions with a subset of nine participants (two interview sessions were conducted with two of the nine) in the ISTAPS study who were current smokers and scored fewer than 5 points on the Richmond test that measures motivation to quit smoking were videotaped and transcribed. A total of 11 interviews conducted by five primary health care professionals in Barcelona, Spain, were analysed. Qualitative Content Analysis was used to develop an analytical guide for coding transcriptions. Conversation Analysis allowed detailed study of the exchange of words during the interaction. RESULTS: Motivational Interviewing sessions had three phases: assessment, reflection on readiness to change, and summary. The interaction was constructed during an office visit, where interactional dilemmas arise and can be resolved in various ways. Some actions by professionals (use of reiterations, declarations, open-ended questions) helped to construct a framework of shared relationship; others inhibited this relationship (focusing on risks of smoking, clinging to the protocol, and prematurely emphasizing change). Some professionals tended to resolve interactional dilemmas (e.g., resistance) through a confrontational or directive style. Interactions that did not follow Motivational Interviewing principles predominated in seven of the interviews analysed. CONCLUSIONS: Conversational analysis showed that the complexity of the intervention increases when a health professional encounters individuals with low motivation for change, and interactional dilemmas may occur that make it difficult to follow Motivational Interview principles. Incorporating different forms of expression during the Motivational Interviewing could help to build patient-centred health care relationships and, for patients with low motivation to stop smoking, offer an opportunity to reflect on tobacco use during the office visit. The study findings could be included in professional training to improve the quality of motivational interviewing.

Burden of multimorbidity, socioeconomic status and use of health services across stages of life in urban areas: a cross-sectional study.

BACKGROUND: The burden of chronic conditions and multimorbidity is a growing health problem in developed countries. The study aimed to determine the estimated prevalence and patterns of multimorbidity in urban areas of Catalonia, stratified by sex and adult age groups, and to assess whether socioeconomic status and use of primary health care services were associated with multimorbidity. METHODS: A cross-sectional study was conducted in Catalonia. Participants were adults (19+ years) living in urban areas, assigned to 251 primary care teams. MAIN OUTCOME: multimorbidity (≥2 chronic conditions). Other variables: sex (male/female), age (19-24; 25-44; 45-64; 65-79; 80+ years), socioeconomic status (quintiles), number of health care visits during the study. RESULTS: We included 1,356,761 patients; mean age, 47.4 years (SD: 17.8), 51.0% women. Multimorbidity was present in 47.6% (95% CI 47.5-47.7) of the sample, increasing with age in both sexes but significantly higher in women (53.3%) than in men (41.7%). Prevalence of multimorbidity in each quintile of the deprivation index was higher in women than in men (except oldest group). In women, multimorbidity prevalence increased with quintile of the deprivation index. Overall, the median (interquartile range) number of primary care visits was 8 (4-14) in multimorbidity vs 1 (0-4) in non-multimorbidity patients. The most prevalent multimorbidity pattern beyond 45 years of age was uncomplicated hypertension and lipid disorder. Compared with the least deprived group, women in other quintiles of the deprivation index were more likely to have multimorbidity than men until 65 years of age. The odds of multimorbidity increased with number of visits in all strata. CONCLUSIONS: When all chronic conditions were included in the analysis, almost 50% of the adult urban population had multimorbidity. The prevalence of multimorbidity differed by sex, age group and socioeconomic status. Multimorbidity patterns varied by life-stage and sex; however, circulatory-endocrine-metabolic patterns were the most prevalent multimorbidity pattern after 45 years of age. Women younger than 80 years had greater prevalence of multimorbidity than men, and women's multimorbidity prevalence increased as socioeconomic status declined in all age groups. Identifying multimorbidity patterns associated with specific age-related life-stages allows health systems to prioritize and to adapt clinical management efforts by age group.

Impact of multimorbidity: acute morbidity, area of residency and use of health services across the life span in a region of south Europe.

BACKGROUND: Concurrent diseases, multiple pathologies and multimorbidity patterns are topics of increased interest as the world's population ages. To explore the impact of multimorbidity on affected patients and the consequences for health services, we designed a study to describe multimorbidity by sex and life-stage in a large population sample and to assess the association with acute morbidity, area of residency and use of health services. METHODS: A cross-sectional study was conducted in Catalonia (Spain). Participants were 1,749,710 patients aged 19+ years (251 primary care teams). PRIMARY OUTCOME: Multimorbidity (≥2 chronic diseases). Secondary outcome: Number of new events of each acute disease. Other variables: number of acute diseases per patient, sex, age group (19-24, 25-44, 45-64, 65-79, and 80+ years), urban/rural residence, and number of visits during 2010. RESULTS: Multimorbidity was present in 46.8% (95% CI, 46.7%-46.8%) of the sample, and increased as age increased, being higher in women and in rural areas. The most prevalent pair of chronic diseases was hypertension and lipid disorders in patients older than 45 years. Infections (mainly upper respiratory infection) were the most common acute diagnoses. In women, the highest significant RR of multimorbidity vs. non-multimorbidity was found for teeth/gum disease (aged 19-24) and acute upper respiratory infection. In men, this RR was only positive and significant for teeth/gum disease (aged 65-79). The adjusted analysis showed a strongly positive association with multimorbidity for the oldest women (80+ years) with acute diseases and women aged 65-79 with 3 or more acute diseases, compared to patients with no acute diseases (OR ranged from 1.16 to 1.99, p < 0.001). Living in a rural area was significantly associated with lower probability of having multimorbidity. The odds of multimorbidity increased sharply as the number of visits increased, reaching the highest probability in those aged 65-79 years. CONCLUSIONS: Multimorbidity is related to greater use of health care services and higher incidence of acute diseases, increasing the burden on primary care services. The differences related to sex and life-stage observed for multimorbidity and acute diseases suggest that further research on multimorbidity should be stratified according to these factors.

Living with gout. Experiences, impact and challenges of the disease. Qualitative study through focus groups.

OBJECTIVE: To delve into the experiences of people living with gout regarding its causes and triggers, recommended treatments and therapeutic measures, and the impact of living with this problem. SUBJECTS AND METHODS: Descriptive qualitative study. Opinion sampling, looking for discursive variability according to sex, age, socioeconomic position and treatments. Three focus groups were made with 11, 6 and 7 people, following a pre-established script of topics. Analysis following thematic content analysis procedures. RESULTS: Participants were 19 men and 5 women, of different ages, socioeconomic status and treatments. Frequent comorbidities: hypertension and hypercholesterolemia. Genetics and the lack of renal elimination of urate were mentioned as causes of gout. They reported little knowledge of the causes and need more explanations about them. As triggers of the attack they identified: excess food and/or alcohol, trauma, stress or not following the treatment. Various drug treatment and expressed concern about their possible adverse effects were listed. Difficulties in adherence to the recommendations were also described. Non-pharmacological measures: rest, cold, proper footwear, walking, drinking water, and diet were also described. Chronic gout has an important impact on the daily life of patients and their families. Pain invalidates and leads to difficulties in performing daily activities. Irritations and mood swings were reported, which affect their family relationships. CONCLUSIONS: These findings provide proposals to improve the care of people with gout. Information on its causes, the triggers of the crisis, dietary recommendations and exercise should be improved. The variability of treatments and recommendations on lifestyle should be analysed in depth.