Evaluation of a multicomponent intervention consisting of education and feedback to reduce benzodiazepine prescriptions by general practitioners: The BENZORED hybrid type 1 cluster randomized controlled trial.

BACKGROUND: Current benzodiazepine (BZD) prescription guidelines recommend short-term use to minimize the risk of dependence, cognitive impairment, and falls and fractures. However, many clinicians overprescribe BZDs and chronic use by patients is common. There is limited evidence on the effectiveness of interventions delivered by general practitioners (GPs) on reducing prescriptions and long-term use of BZDs. We aimed to evaluate the effectiveness of a multicomponent intervention for GPs that seeks to reduce BZD prescriptions and the prevalence of long-term users. METHODS AND FINDINGS: We conducted a multicenter two-arm, cluster randomized controlled trial in 3 health districts in Spain (primary health centers [PHCs] in Balearic Islands, Catalonia, and Valencian Community) from September 2016 to May 2018. The 81 PHCs were randomly allocated to the intervention group (n = 41; 372 GPs) or the control group (n = 40; 377 GPs). GPs were not blinded to the allocation; however, pharmacists, researchers, and trial statisticians were blinded to the allocation arm. The intervention consisted of a workshop about the appropriate prescribing of BZDs and tapering-off long-term BZD use using a tailored stepped dose reduction with monthly BZD prescription feedback and access to a support web page. The primary outcome, based on 700 GPs (351 in the control group and 349 in the intervention group), compared changes in BZD prescriptions in defined daily doses (DDDs) per 1,000 inhabitants per day after 12 months. The 2 secondary outcomes were the proportion of long-term users (≥6 months) and the proportion of long-term users over age 65 years. Intention-to-treat (ITT) analysis was used to assess all clinical outcomes. Forty-nine GPs (21 intervention group and 28 control group) were lost to follow-up. However, all GPs were included in the ITT analysis. After 12 months, there were a statistically significant decline in total BZD prescription in the intervention group compared to the control group (mean difference: -3.24 DDDs per 1,000 inhabitants per day, 95% confidence interval (CI): -4.96, -1.53, p < 0.001). The intervention group also had a smaller number of long-term users. The adjusted absolute difference overall was -0.36 (95% CI: -0.55, -0.16, p > 0.001), and the adjusted absolute difference in long-term users over age 65 years was -0.87 (95% CI: -1.44, -0.30, p = 0.003). A key limitation of this clustered design clinical trial is the imbalance of some baseline characteristics. The control groups have a higher rate of baseline BZD prescription, and more GPs in the intervention group were women, GPs with a doctorate degree, and trainers of GP residents. CONCLUSIONS: A multicomponent intervention that targeted GPs and included educational meeting, feedback about BZD prescriptions, and a support web page led to a statistically significant reduction of BZD prescriptions and fewer long-term users. Although the effect size was small, the high prevalence of BZD use in the general population suggests that large-scale implementation of this intervention could have positive effects on the health of many patients. TRIAL REGISTRATION: ISRCTN ISRCTN28272199.

Evaluating the Implementation of a Multicomponent Intervention Consisting of Education and Feedback on Reducing Benzodiazepine Prescriptions by General Practitioners: BENZORED Hybrid Type I Cluster Randomized Controlled Trial.

BACKGROUND: General practitioners (GPs) in developed countries widely prescribe benzodiazepines (BZDs) for their anxiolytic, hypnotic, and muscle-relaxant effects. Treatment duration, however, is rarely limited, and this results in a significant number of chronic users. Long-term BZD use is associated with cognitive impairment, falls with hip fractures, traffic accidents, and increased mortality. The BENZORED IV trial was a hybrid type-1 trial conducted to evaluate the effectiveness and implementation of an intervention to reduce BZD prescription in primary care. The purpose of this qualitative study was to analyze the facilitators and barriers regarding the implementation of the intervention in primary care settings. METHODS: A qualitative interview study with 40 GPs from three Spanish health districts. Focus group meetings with GPs from the intervention arm of the BENZORED IV trial were held at primary healthcare centers in the three districts. For sampling purposes, the GPs were classified as high or low implementers according to the success of the intervention measured at 12 months. The Consolidated Framework for Implementation Research (CFIR) was used to conduct the meetings and to code, rate, and analyze the data. RESULTS: Three of the 41 CFIR constructs strongly distinguished between high and low implementers: the complexity of the intervention, the individual Stage of Change, and the key stakeholder's engagement. Seven constructs weakly discriminated between the two groups: adaptability in the intervention, external policy and incentives, implementation climate, relative priority, self-efficacy, compatibility, and engaging a formally appointed implementation leader. Fourteen constructs did not discriminate between the two groups, six had insufficient data for evaluation, and eleven had no data for evaluation. CONCLUSIONS: We identified constructs that could explain differences in the efficacy in implementation of the intervention. This information is relevant for the design of successful strategies for implementation of the intervention.

Conocimiento, conducta y actitud ante el Código europeo contra el cáncer por parte de los profesionales sanitarios de atención primaria / Knowledge, conduct and attitude before the European Code against Cancer by health professionals of primary care

OBJETIVO: Determinar si los profesionales de atención primaria (AP) conocen el Código europeo contra el cáncer (CECC) y si ello se relaciona con que practiquen sus recomendaciones. DISEÑO: Observacional descriptivo. Emplazamiento: Centros de AP españoles. PARTICIPANTES: Profesionales de AP. INTERVENCIONES: Cuestionario autoadministrado. Mediciones principales: Factores de riesgo y protectores del cáncer, pruebas de cribado y conocimiento del CECC. RESULTADOS: Respondieron 1.734 profesionales (10,5%), edad media de 48,5 años (DT: 9,2), el 71,5% mujeres. El 50,0% desconoce el CECC; los tutores (OR = 1,61), adscritos al PAPPS (OR=1,51) y que llevan más tiempo trabajando en AP (OR = 2,62) son los que más lo conocen. El 7,2% fuma y el 79,1% bebe alcohol. El 64,1% presenta normopeso y el 19% realiza actividad física. Evita exponerse al sol el 52,7% y usa protectores el 53,8%. El 85,2% nunca se ha realizado un cribado colorrectal, el 11% nunca una citología y el 12% una mamografía. Existe relación entre conocer el CECC y el tabaquismo (p < 0,001), sobrepeso/obesidad (p = 0,024), actividad física (p = 0,003), ingesta de carnes (p < 0,001), mamografía (p < 0,001), citología (p = 0,022), PSA (p = 0,045), así como el fomento de sus consejos entre los pacientes. CONCLUSIONES: El CECC es desconocido por la mitad de los profesionales de AP. La práctica de sus recomendaciones es desigual, siendo la prevalencia de tabaquismo baja, y la protección solar una conducta poco extendida. Los que lo conocen son los que más practican sus recomendaciones

OBJECTIVE: To decide if Primary Care (PC) professionals know the European Code against Cancer (CECC) and if this relates to practice the recommendations with themselves and with their patients. DESIGN: descriptive, observational study. SETTING: Spanish Health Centers. PARTICIPANTS: Health professionals. Interventions self-administered questionnaire. MAIN MEASUREMENTS: cancer protective and risk factors, screening for colorectal, breast, cervix and prostate cancer, level of knowledge of the ECAC. RESULTS: 1734 participants (10.5%), mean age 47.4 years (SD: 8.6), 71.5% female. 50.0% do not know the CECC; tutors (OR = 1.61), assigned to the PAPPS (OR = 1.51) and who have been working in AP for more time (OR = 2.62) are the ones who know it most. 7.2% smoke and 79.1% drink alcohol. 64.1% presented normal weight and 19% performed physical activity. They avoid exposing themselves to the sun 52.7% and use protectors 53.8%. 85.2% have never had a colorectal screening, 11% never had a cytology, and 12% had a mammogram. There is a relationship between knowing the CECC and smoking (P < .001), overweight/obesity (P = .024), physical activity (P = .003), meat intake (P < .001), mammography (P < .001), cytology (P=.022), PSA (P = .045), as well as the promotion of their advice among patients. CONCLUSIONS: The CECC is unknown by half of the AP professionals. The practice of its recommendations is uneven, with the prevalence of low smoking, and sun protection a little extended behavior. Those who know him are the ones who most practice his recommendations

[Knowledge, conduct and attitude before the European Code against Cancer by health professionals of primary care]. / Conocimiento, conducta y actitud ante el Código europeo contra el cáncer por parte de los profesionales sanitarios de atención primaria.

OBJECTIVE: To decide if Primary Care (PC) professionals know the European Code against Cancer (CECC) and if this relates to practice the recommendations with themselves and with their patients. DESIGN: descriptive, observational study. SETTING: Spanish Health Centers. PARTICIPANTS: Health professionals. INTERVENTIONS: self-administered questionnaire. MAIN MEASUREMENTS: cancer protective and risk factors, screening for colorectal, breast, cervix and prostate cancer, level of knowledge of the ECAC. RESULTS: 1734 participants (10.5%), mean age 47.4 years (SD: 8.6), 71.5% female. 50.0% do not know the CECC; tutors (OR=1.61), assigned to the PAPPS (OR=1.51) and who have been working in AP for more time (OR=2.62) are the ones who know it most. 7.2% smoke and 79.1% drink alcohol. 64.1% presented normal weight and 19% performed physical activity. They avoid exposing themselves to the sun 52.7% and use protectors 53.8%. 85.2% have never had a colorectal screening, 11% never had a cytology, and 12% had a mammogram. There is a relationship between knowing the CECC and smoking (P<.001), overweight/obesity (P=.024), physical activity (P=.003), meat intake (P<.001), mammography (P<.001), cytology (P=.022), PSA (P=.045), as well as the promotion of their advice among patients. CONCLUSIONS: The CECC is unknown by half of the AP professionals. The practice of its recommendations is uneven, with the prevalence of low smoking, and sun protection a little extended behavior. Those who know him are the ones who most practice his recommendations.

Prevalence and diagnostic value of GPs' gut feelings for cancer and serious diseases: protocol for a prospective observational study of diagnostic validity.

INTRODUCTION: Cancer diagnosis in primary care is an important challenge for general practitioners (GPs) due to the relatively low frequency of any single type of cancer and the heterogeneous signs and symptoms that can be present. In addition to analytical reasoning, GPs may become aware of gut feelings (GFs) as they suspect that a patient may have cancer or another serious disease. We aimed to investigate the prevalence and the predictive value of GFs for the diagnosis of cancer and serious diseases. METHODS AND ANALYSIS: Prospective observational study of diagnostic validity. Participation will be offered to GPs from Majorca and Zaragoza (Spain). They will recruit all patients with a new reason for encounter during one or two workdays. GPs will complete the Gut Feelings Questionnaire (GFQ). Variables regarding patient, GP and consultation will be collected. Two and 6 months after the first visit, incident diagnoses of cancer or other serious diseases, diagnostic tests performed, referrals and new visits will be recorded. Analysis will include a descriptive analysis of the variables and prevalence of GFs, and the sensitivity, specificity, predictive values and likelihood ratios of the GFs (sense of alarm and sense of reassurance) for diagnosing cancer and other serious diseases, as measured with the GFQ. ETHICS AND DISSEMINATION: The study has obtained approval from the Majorcan Primary Care Research Committee and from the Balearic Islands Ethical Committee, with reference number IB 3210/16 PI. The results may help GPs to make more accurate decisions about which patients need further examinations to rule out or to confirm a diagnosis of cancer or a serious disease, and which ones do not. The results will be published as part of the PhD project of the first author and in open access journals, and will be presented at medical conferences.

Intervention to reduce benzodiazepine prescriptions in primary care, study protocol of a hybrid type 1 cluster randomised controlled trial: the BENZORED study.

INTRODUCTION: Benzodiazepines (BZDs) are mainly used to treat anxiety and sleep disorders, and are often prescribed for long durations, even though prescription guidelines recommend short-term use due to the risk of dependence, cognitive impairment, and falls and fractures. Education of general practitioners (GPs) regarding the prescription of BZDs may reduce the overuse and of these drugs.The aims of this study are to analyse the effectiveness of an intervention targeted to GPs to reduce BZD prescription and evaluate the implementation process. METHODS AND ANALYSIS: The healthcare centres in three regions of Spain (Balearic Islands, Catalonia and Community of Valencia) will be randomly allocated to receive a multifactorial intervention or usual care (control). GPs in the intervention group will receive a 2-hour workshop about best-practice regarding BZD prescription and BZD deprescribing, monthly feedback about their BZD prescribing practices and access to a support web page. Outcome measures for each GP are the defined daily dosage per 1000 inhabitants per day and the proportion of long-term BZD users at 12 months. Data will be collected from the electronic prescription database of the public health system, and will be subjected to intention-to-treat analysis. Implementation will be evaluated by mixed methods following the five domains of the Consolidated Framework For Implementation Research. ETHICS AND DISSEMINATION: This study was approved by the Balearic Islands Ethical Committee of Clinical Research (IB3065/15), l'IDIAP Jordi Gol Ethical Committee of Clinical Research (PI 15/0148) and Valencia Primary Care Ethical Committee of Clinical Research (P16/024). The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN28272199.

Diagnóstico precoz del VIH en atención primaria en España. Resultados de una prueba piloto de cribado dirigido basado en condiciones indicadoras, criterios conductuales y de origen / Early diagnosis of HIV in Primary Care in Spain. Results of a pilot study based on targeted screening based on indicator conditions, behavioral criteria and region of origin

Objetivos: Estimar la prevalencia de la infección por VIH en pacientes diagnosticados con una condición indicadora (CI) para el VIH y/o que habían tenido una conducta de riesgo para su adquisición y/o que provenían de países con elevada prevalencia. Determinar la aceptabilidad y viabilidad de ofrecer la prueba del VIH basada en CI y criterios conductuales y de origen en atención primaria (AP). Diseño: Estudio transversal en una muestra de conveniencia. Emplazamiento: Seis centros de AP en España. Participantes: Los criterios de inclusión fueron: pacientes entre 16 y 65años que presentaban al menos una de las CI propuestas y/o al menos uno de los criterios conductuales y/o de origen propuestos. Participaron 388 pacientes. Intervención: Se ofreció la serología del VIH a todos los pacientes que cumplían con los criterios de inclusión. Mediciones principales: Descripción de la frecuencia de CI, criterios conductuales y de origen. Prevalencia de infección por VIH. Nivel de aceptabilidad y viabilidad de la oferta de la prueba del VIH basada en criterios conductuales y de origen y CI. Resultados: Un total de 174 pacientes presentaron una CI (44,84%). El criterio conductual más común fue: haber mantenido relaciones sexuales desprotegidas alguna vez en la vida con personas que desconocían su estado serológico para el VIH (298; 76,8%). Se diagnosticaron 4 pacientes VIH+ (1,03%). Todos presentaban una CI y eran hombres que mantenían sexo con hombres. El nivel de aceptabilidad en AP fue elevada. Conclusiones: Ofrecer la prueba del VIH a pacientes con CI y criterios conductuales es viable y efectiva en AP (AU)

Objectives: To estimate the prevalence of HIV infection in patients diagnosed with an indicator condition (IC) for HIV and/or risk behavior for their acquisition and/or coming from high prevalence countries. To determine the acceptability and feasibility of offering HIV testing based on IC and behavioral and origin criteria in Primary Care (PC). Design: Cross-sectional study in a convenience sample.Location: Six PC centers in Spain. Participants: The inclusion criteria were: patients between 16 and 65years old who presented at least one of the proposed ICs and/or at least one of the proposed behavioral and/or origin criteria. A total of 388 patients participated. Intervention: HIV serology was offered to all patients who met the inclusion criteria. Main measurements: Description of IC frequency, behavioral and origin criteria. Prevalence of HIV infection. Level of acceptability and feasibility of the HIV screening based on IC and behavioral and origin criteria. Results: A total of 174 patients had an IC (44.84%). The most common behavioral criterion was: having unprotected sex at some time in life with people who did not know their HIV status (298; 76.8%). Four HIV+ patients (1.03%) were diagnosed. All had an IC and were men who had sex with men. The level of acceptability in PC was high. Conclusions: Offering HIV testing to patients with IC and behavioral criteria is feasible and effective in PC (AU)

[Early diagnosis of HIV in Primary Care in Spain. Results of a pilot study based on targeted screening based on indicator conditions, behavioral criteria and region of origin]. / Diagnóstico precoz del VIH en atención primaria en España. Resultados de una prueba piloto de cribado dirigido basado en condiciones indicadoras, criterios conductuales y de origen.

OBJECTIVES: To estimate the prevalence of HIV infection in patients diagnosed with an indicator condition (IC) for HIV and/or risk behavior for their acquisition and/or coming from high prevalence countries. To determine the acceptability and feasibility of offering HIV testing based on IC and behavioral and origin criteria in Primary Care (PC). DESIGN: Cross-sectional study in a convenience sample. LOCATION: Six PC centers in Spain. PARTICIPANTS: The inclusion criteria were: patients between 16 and 65years old who presented at least one of the proposed ICs and/or at least one of the proposed behavioral and/or origin criteria. A total of 388 patients participated. INTERVENTION: HIV serology was offered to all patients who met the inclusion criteria. MAIN MEASUREMENTS: Description of IC frequency, behavioral and origin criteria. Prevalence of HIV infection. Level of acceptability and feasibility of the HIV screening based on IC and behavioral and origin criteria. RESULTS: A total of 174 patients had an IC (44.84%). The most common behavioral criterion was: having unprotected sex at some time in life with people who did not know their HIV status (298; 76.8%). Four HIV+ patients (1.03%) were diagnosed. All had an IC and were men who had sex with men. The level of acceptability in PC was high. CONCLUSIONS: Offering HIV testing to patients with IC and behavioral criteria is feasible and effective in PC.

Factors related with symptom duration until diagnosis and treatment of symptomatic colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) survival depends mostly on stage at the time of diagnosis. However, symptom duration at diagnosis or treatment have also been considered as predictors of stage and survival. This study was designed to: 1) establish the distinct time-symptom duration intervals; 2) identify factors associated with symptom duration until diagnosis and treatment. METHODS: This is a cross-sectional study of all incident cases of symptomatic CRC during 2006-2009 (795 incident cases) in 5 Spanish regions. Data were obtained from patients' interviews and reviews of primary care and hospital clinical records. MEASUREMENTS: CRC symptoms, symptom perception, trust in the general practitioner (GP), primary care and hospital examinations/visits before diagnosis, type of referral and tumor characteristics at diagnosis. Symptom Diagnosis Interval (SDI) was calculated as time from first CRC symptoms to date of diagnosis. Symptom Treatment Interval (STI) was defined as time from first CRC symptoms until start of treatment. Nonparametric tests were used to compare SDI and STI according to different variables. RESULTS: Symptom to diagnosis interval for CRC was 128 days and symptom treatment interval was 155. No statistically significant differences were observed between colon and rectum cancers. Women experienced longer intervals than men. Symptom presentation such as vomiting or abdominal pain and the presence of obstruction led to shorter diagnostic or treatment intervals. Time elapsed was also shorter in those patients that perceived their first symptom/s as serious, disclosed it to their acquaintances, contacted emergencies services or had trust in their GPs. Primary care and hospital doctor examinations and investigations appeared to be related to time elapsed to diagnosis or treatment. CONCLUSIONS: Results show that gender, symptom perception and help-seeking behaviour are the main patient factors related to interval duration. Health service performance also has a very important role in symptom to diagnosis and treatment interval. If time to diagnosis is to be reduced, interventions and guidelines must be developed to ensure appropriate examination and diagnosis during both primary and hospital care.

Knowledge and attitudes of primary healthcare patients regarding population-based screening for colorectal cancer.

ABSTRACT: BACKGROUND: The aim of this study was to assess the extent of knowledge of primary health care (PHC) patients about colorectal cancer (CRC), their attitudes toward population-based screening for this disease and gender differences in these respects. METHODS: A questionnaire-based survey of PHC patients in the Balearic Islands and some districts of the metropolitan area of Barcelona was conducted. Individuals between 50 and 69 years of age with no history of CRC were interviewed at their PHC centers. RESULTS: We analyzed the results of 625 questionnaires, 58% of which were completed by women. Most patients believed that cancer diagnosis before symptom onset improved the chance of survival. More women than men knew the main symptoms of CRC. A total of 88.8% of patients reported that they would perform the fecal occult blood test (FOBT) for CRC screening if so requested by PHC doctors or nurses. If the FOBT was positive and a colonoscopy was offered, 84.9% of participants indicated that they would undergo the procedure, and no significant difference by gender was apparent. Fear of having cancer was the main reason for performance of an FOBT, and also for not performing the FOBT, especially in women. Fear of pain was the main reason for not wishing to undergo colonoscopy. Factors associated with reluctance to perform the FOBT were: (i) the idea that that many forms of cancer can be prevented by exercise and, (ii) a reluctance to undergo colonoscopy if an FOBT was positive. Factors associated with reluctance to undergo colonoscopy were: (i) residence in Barcelona, (ii) ignorance of the fact that early diagnosis of CRC is associated with better prognosis, (iii) no previous history of colonoscopy, and (iv) no intention to perform the FOBT for CRC screening. CONCLUSION: We identified gaps in knowledge about CRC and prevention thereof in PHC patients from the Balearic Islands and the Barcelona region of Spain. If fears about CRC screening, and CRC per se, are addressed, and if it is emphasized that CRC is preventable, participation in CRC screening programs may improve.

Diagnosis delay and follow-up strategies in colorectal cancer. Prognosis implications: a study protocol.

BACKGROUND: Controversy exists with regard to the impact that the different components of diagnosis delay may have on the degree of invasion and prognosis in patients with colorectal cancer. The follow-up strategies after treatment also vary considerably. The aims of this study are: a) to determine if the symptoms-to-diagnosis interval and the treatment delay modify the survival of patients with colorectal cancer, and b) to determine if different follow-up strategies are associated with a higher survival rate. METHODS/DESIGN: Multi-centre study with prospective follow-up in five regions in Spain (Galicia, Balearic Islands, Catalonia, Aragón and Valencia) during the period 2010-2012. Incident cases are included with anatomopathological confirmation of colorectal cancer (International Classification of Diseases 9th revision codes 153-154) that formed a part of a previous study (n = 953).At the time of diagnosis, each patient was given a structured interview. Their clinical records will be reviewed during the follow-up period in order to obtain information on the explorations and tests carried out after treatment, and the progress of these patients.Symptoms-to-diagnosis interval is defined as the time calculated from the diagnosis of cancer and the first symptoms attributed to cancer. Treatment delay is defined as the time elapsed between diagnosis and treatment. In non-metastatic patients treated with curative intention, information will be obtained during the follow-up period on consultations performed in the digestive, surgery and oncology departments, as well as the endoscopies, tumour markers and imaging procedures carried out.Local recurrence, development of metastases in the follow-up, appearance of a new tumour and mortality will be included as outcome variables.Actuarial survival analysis with Kaplan-Meier curves, Cox regression and competitive risk survival analysis will be performed. DISCUSSION: This study will make it possible to verify if the different components of delay have an impact on survival rate in colon cancer and rectal cancer. In consequence, this multi-centre study will be able to detect the variability present in the follow-up of patients with colorectal cancer, and if this variability modifies the prognosis. Ideally, this study could determine which follow-up strategies are associated with a better prognosis in colorectal cancer.