Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

Evaluation of the psychometric performance of the Spanish and Catalan versions of the patient reported experiences and Outcomes of Safety in Primary Care (PREOS-PC)-Compact questionnaire.

BACKGROUND: Patients provide a unique, irreplaceable, and essential perspective in evaluating patient safety. The suite of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) tools are a notable exception to the scarcity of patient-reported patient safety measures. Full evaluation of their performance has only been attempted for the English version, thereby limiting its international applicability. OBJECTIVES: To assess the psychometric performance of the Spanish and Catalan versions of the PREOS-PC-Compact. METHODS: Cross-sectional validation study. We used Classical Test Theory methods to examine scale score distribution, internal consistency, and construct validity; and Item Response Theory (IRT) methods to further explore construct validity. RESULTS: 3287 patients completed the Spanish version, and 1007 the Catalan version. Similar results were obtained for both versions. Confirmatory Factor Analysis supported a single construct for each scale. The correlations between PREOS-PC-Compact scales and known group analysis suggested adequate construct validity (inconclusive for known groups at the provider level). All four multi-item scales demonstrated adequate internal consistency reliability (α > 0.7), which was only confirmed for test-retest reliability for 'Practice activation.' A sample between 60-90 patients per practice was estimated sufficient to produce scores with reliability > 0.7 for all scales except for harm scales. IRT models showed disordered thresholds for 'Practice activation' and 'Harm burden' but showed excellent fit after reducing the response categories. CONCLUSION: The Spanish and Catalan versions of the PREOS-PC-Compact are broadly valid and reliable tools to measure patient safety in Spanish primary care centres; confirmation of lower-than-expected test-rest reliability merits further examination .

[Impact of the COVID-19 pandemic on patient-reported patient safety in Primary Care]. / Impacto de la pandemia de COVID-19 en la seguridad del paciente percibida por los pacientes en Atención Primaria.

OBJECTIVE: To evaluate the impact of the changes introduced in response to the pandemic on patient-reported patient safety in Primary Care. DESIGN: Prospective observational panel study (health center) based on two cross-sectional surveys. SETTING: 29 Primary Health Care centers from three Spanish health regions (Mallorca, Catalunya Central and Camp de Tarragona). PARTICIPANTS: Random sample of patients visiting their centers before (n=2199 patients) and during the pandemic (n=1955 patients) MAIN MEASUREMENTS: We used the PREOS-PC questionnaire, a validated instrument which assesses patient-reported patient safety in Primary Care. We compared mean scores of the "experiences of errors" and "harm" scales in both periods, and built multilevel regression analyzes to study the variations in patient and center characteristics associated with worse levels of safety. A qualitative (content) analysis of patients' experiences during the pandemic was also performed. RESULTS: The "experiences of errors" and "harm" scales scores significantly worsened during the COVID-19 period (92.65 to 88.81 (Cohen's d=0.27); and 96.92 to 79.97 (d=0.70), respectively). Patient and center characteristics associated to worsened scores were: women, people with a lower educational level, worse health status, more years assigned to the center, and health region. CONCLUSIONS: During the pandemic, a perceptible worsening in patient safety perceived by patients treated in Primary Care has been observed, which has differentially affected patients according to their sociodemographic characteristics or health center profiles.

[Patient safety incidents reported before and after the start of the COVID-19 pandemic in Primary Care in Tarragona]. / Incidentes de seguridad del paciente notificados antes y después del inicio de la pandemia de COVID-19 en atención primaria en Tarragona.

OBJECTIVE: To analyse and compare the epidemiology of patient safety incidents reported in Primary Health Care, before and after the start of the COVID-19 pandemic. DESIGN AND SETTING: Analytical descriptive study comparing reported incidents from March 1st 2019 to February 28th 2020, and from March 1st 2020 to February 28th 2021, notified through the TPSC Cloud™ platform accessible from the Intranet corporative in 25 Primary Health Care centres from Tarragona district, in Catalonia (Spain). MEASUREMENTS: Data obtained from voluntary notifications, through electronic, standardized and anonymized forms. VARIABLES: Centre, professional, incident type, risk matrix, causal factors and contributing factors, and avoidability. STATISTICAL ANALYSIS: Every notification was included in descriptive analysis, and another one specifically for adverse events, comparing both periods. RESULTS: 2231 incidents were reported. Comparing both periods, during the pandemic a reduction in the number of reported incidents was observed (only represented 20% of the total). However, the percentage of reported notifications from health care professionals and adverse events that required observation were increased. Causal factors related to attendance and diagnosis were incremented whereas the causal factors related to medication were decreased. In addition, an increase in contributing factors related to the professional was observed. Avoidability was high (>95%) in both periods. CONCLUSIONS: During the pandemic, fewer patient safety incidents have been reported, but proportionally more adverse events, most of which are preventable. The professional himself becomes the main contributing factor.

Analysis of Patient Safety Incidents in Primary Care Reported in an Electronic Registry Application.

OBJECTIVES: (1) To describe the epidemiology of patient safety (PS) incidents registered in an electronic notification system in primary care (PC) health centres; (2) to define a risk map; and (3) to identify the critical areas where intervention is needed. DESIGN: Descriptive analytical study of incidents reported from 1 January to 31 December 2018, on the TPSC Cloud™ platform (The Patient Safety Company) accessible from the corporate website (Intranet) of the regional public health service. SETTING: 24 Catalan Institute of Health PC health centres of the Tarragona region (Spain). PARTICIPANTS: Professionals from the PC health centres and a Patient Safety Functional Unit. MEASUREMENTS: Data obtained from records voluntarily submitted to an electronic, standardised and anonymised form. Data recorded: healthcare unit, notifier, type of incident, risk matrix, causal and contributing factors, preventability, level of resolution and improvement actions. RESULTS: A total of 1544 reports were reviewed and 1129 PS incidents were analysed: 25.0% of incidents did not reach the patient; 66.5% reached the patient without causing harm, and 8.5% caused adverse events. Nurses provided half of the reports (48.5%), while doctors reported more adverse events (70.8%; p < 0.01). Of the 96 adverse events, 46.9% only required observation, 34.4% caused temporary damage that required treatment, 13.5% required (or prolonged) hospitalization, and 5.2% caused severe permanent damage and/or a situation close to death. Notably, 99.2% were considered preventable. The main critical areas were: communication (27.8%), clinical-administrative management (25.1%), care delivery (23.5%) and medicines (18.4%); few incidents were related to diagnosis (3.6%). CONCLUSIONS: PS incident notification applications are adequate for reporting incidents and adverse events associated with healthcare. Approximately 75% and 10% of incidents reach the patient and cause some damage, respectively, and most cases are considered preventable. Adequate and strengthened risk management of critical areas is required to improve PS.

Effectiveness of New Tools to Define an Up-to-Date Patient Safety Risk Map: A Primary Care Study Protocol.

BACKGROUND: Reducing incidents related to health care interventions to improve patient safety is a health policy priority. To strengthen a culture of safety, reporting incidents is essential. This study aims to define a patient safety risk map using the description and analysis of incidents within a primary care region with a prior patient safety improvement strategy organisationally developed and promoted. METHODS: The study will be conducted in two phases: (1) a cross-sectional descriptive observational study to describe reported incidents; and (2) a quasi-experimental study to compare reported incidents. The study will take place in the Camp de Tarragona Primary Care Management (Catalan Institute of Health). In Phase 1, all reactive notifications collected within one year (2018) will be analysed; during Phase 2, all proactive notifications of the second and third weeks of June 2019 will be analysed. Adverse events will also be assessed. Phases 1 and 2 will use a digital platform and the proactive tool proSP to notify and analyse incidents related to patient safety. EXPECTED RESULTS: To obtain an up-to-date, primary care patient safety risk map to prioritise strategies that result in safer practices.

Metodología utilizada para la acreditación externa en calidad en un centro de salud / No disponible

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Acreditación externa de calidad. «Oportunidad de mejora a través de la experiencia» / Accreditation in primary care. External quality accreditation. "An opportunity to improve through experience"

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[Benign prostate hyperplasia. Need to evaluate quality of life in the therapeutic process]. / Hiperplasia benigna de próstata. Necesidad de valorar la calidad de vida en el proceso terapéutico.

OBJECTIVE: To relate the symptoms of benign prostate hyperplasia (BPH) to their repercussions on quality of life. DESIGN: Multi-centred, observational, prospective study. SETTING: Primary care. PARTICIPANTS: Men with BPH in 2000-2003. Inclusion criteria were: agreeing to take part, being aged 50-79, and having moderate symptoms evaluated by means of the IPSS questionnaire. EXCLUSION CRITERIA: Previous treatment for BPH and having a chronic or disabling illness that might affect perception of quality of life. The presence of irritative and obstructive symptoms was appraised. MAIN MEASUREMENTS: The IPSS questionnaire appraising predominant symptoms and, through the last question, quality of life was self-administered. Descriptive statistics were worked out and differences in proportions of the different groups were analysed by the chi2 test, with differences taken as significant at P < .05. RESULTS: We got 536 replies, with average age 66.2. Nycturia was the most common symptom, suffered by 88.1% of patients. A total of 256 patients (47.8%) had irritation as main clinical symptom, and 280 (52.2%), obstruction. On analysing repercussions on quality of life, it was found that obstructive symptoms were worse tolerated: 65.7% versus 9.4% of the group with irritation. CONCLUSIONS: In treating BPH, we must bear in mind preferences of patients. They tolerate obstructive symptoms worse, and these are a criterion for referral to specialists and even surgery.

Hiperplasia benigna de próstata. Necesidad de valorar la calidad de vida en el proceso terapéutico / Benign prostate hyperplasia. Need to evaluate quality of life in the therapeutic process

Objetivo. Relacionar la sintomatología de la hiperplasia benigna de próstata (HBP) con la repercusión sobre la calidad de vida. Diseño. Multicéntrico, observacional y prospectivo. Emplazamiento. Atención primaria. Participantes. Varones de 50 a 79 años con HBP durante el período 2000-2003 con sintomatología moderada (cuestionario IPSS). Criterios de exclusión. Tratamiento previo para la HBP y presentar alguna enfermedad crónica o invalidante que pudiera alterar la percepción de la calidad de vida. Mediciones principales. Se autoadministró el cuestionario IPSS y se valoró la sintomatología predominante y mediante la última pregunta la calidad de vida. Se realizó un estadística descriptiva y se analizó mediante la prueba de la χ2. Resultados. Se realizaron 536 registros; la edad media fue de 66,2 años. Entre los síntomas destaca la nicturia como el más frecuente, con 88,1% de los registros. Se hallaron 256 pacientes (47,8%) con predominio de clínica irritativa y en 280 pacientes (52,2%), obstructiva. Al analizar la repercusión sobre la calidad de vida se obtuvo que los síntomas obstructivos son los peor tolerados (el 65,7 frente al 9,4% del grupo de clínica irritativa). Conclusiones. En el tratamiento de la HBP debemos tener en cuenta las preferencias del paciente, que tolera peor la sintomatología obstructiva que coincide con la que presenta criterio de derivación hacia una consulta especializada e incluso criterio quirúrgico

Objective. To relate the symptoms of benign prostate hyperplasia (BPH) to their repercussions on quality of life. Design. Multi-centred, observational, prospective study. Setting. Primary care. Participants. Men with BPH in 2000-2003. Inclusion criteria were: agreeing to take part, being aged 50-79, and having moderate symptoms evaluated by means of the IPSS questionnaire. Exclusion criteria. Previous treatment for BPH and having a chronic or disabling illness that might affect perception of quality of life. The presence of irritative and obstructive symptoms was appraised. Main measurements. The IPSS questionnaire appraising predominant symptoms and, through the last question, quality of life was self-administered. Descriptive statistics were worked out and differences in proportions of the different groups were analysed by the χ2 test, with differences taken as significant at P<.05. Results. We got 536 replies, with average age 66.2. Nycturia was the most common symptom, suffered by 88.1% of patients. A total of 256 patients (47.8%) had irritation as main clinical symptom, and 280 (52.2%), obstruction. On analysing repercussions on quality of life, it was found that obstructive symptoms were worse tolerated: 65.7% versus 9.4% of the group with irritation. Conclusions. In treating BPH, we must bear in mind preferences of patients. They tolerate obstructive symptoms worse, and these are a criterion for referral to specialists and even surgery