Identifying patient and practice characteristics associated with patient-reported experiences of safety problems and harm: a cross-sectional study using a multilevel modelling approach.

This is the author accepted manuscript. The final version is available from BMJ Publishing Group via the DOI in this record.OBJECTIVE: To identify patient and family practice characteristics associated with patient-reported experiences of safety problems and harm. DESIGN: Cross-sectional study combining data from the individual postal administration of the validated Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire to a random sample of patients in family practices (response rate=18.4%) and practice-level data for those practices obtained from NHS Digital. We built linear multilevel multivariate regression models to model the association between patient-level (clinical and sociodemographic) and practice-level (size and case-mix, human resources, indicators of quality and safety of care, and practice safety activation) characteristics, and outcome measures. SETTING: Practices distributed across five regions in the North, Centre and South of England. PARTICIPANTS: 1190 patients registered in 45 practices purposefully sampled (maximal variation in practice size and levels of deprivation). MAIN OUTCOME MEASURES: Self-reported safety problems, harm and overall perception of safety. RESULTS: Higher self-reported levels of safety problems were associated with younger age of patients (beta coefficient 0.15) and lower levels of practice safety activation (0.44). Higher self-reported levels of harm were associated with younger age (0.13) and worse self-reported health status (0.23). Lower self-reported healthcare safety was associated with lower levels of practice safety activation (0.40). The fully adjusted models explained 4.5% of the variance in experiences of safety problems, 8.6% of the variance in harm and 4.4% of the variance in perceptions of patient safety. CONCLUSIONS: Practices' safety activation levels and patients' age and health status are associated with patient-reported safety outcomes in English family practices. The development of interventions aimed at improving patient safety outcomes would benefit from focusing on the identified groups.This research is part-funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). The views expressed are those of the authors and not necessarily those of the NIHR, the NHS or the Department of Health

Measuring patient safety in primary care: The development and validation of the “Patient Reported Experiences and Outcomes of Safety in Primary Care” (PREOS-PC)

This is the author accepted manuscript. The final version is available from Annals of Family Medicine via the DOI in this recordPURPOSE We set out to develop and validate a patient-reported instrument for measuring experiences and outcomes related to patient safety in primary care. METHOD The instrument was developed in a multistage process supported by an international expert panel and informed by a systematic review of instruments, a meta-synthesis of qualitative studies, 4 patient focus groups, 18 cognitive interviews, and a pilot study. The trial version of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) covered 5 domains and 11 scales: practice activation (1 scale); patient activation (1 scale); experiences of patient safety events (1 scale); harm (6 scales); and general perceptions of patient safety (2 scales). The questionnaire was posted to 6,736 patients in 45 practices across England. We used “gold standard” psychometric methods to evaluate its acceptability, reliability, structural and construct validity, and ability to discriminate among practices. RESULTS 1,244 completed questionnaires (18.5%) were returned. Median itemspecific response rate was 91.3% (interquartile range 28.0%). No major ceiling or floor effects were observed. All 6 multi-item scales showed high internal consistency (Cronbach’s α 0.75-0.96). Factor analysis, correlation between scales, and known group analyses generally supported structural and construct validity. The scales demonstrated a heterogeneous ability to discriminate between practices. The final version of PREOS-PC consisted of 5 domains, 8 scales, and 58 items. CONCLUSIONS PREOS-PC is a new multi-dimensional patient safety instrument for primary care developed with experts and patients. Initial testing shows its potential for use in primary care, and future developments will further address its use in actual clinical practice.UK National Institute for Health Research School for Primary Care Research (NIHR SPCR

An overview of self-administered health literacy instruments

This is the final version. Available from Public Library of Science via the DOI in this record.With the increasing recognition of health literacy as a worldwide research priority, the development and refinement of indices to measure the construct is an important area of inquiry. Furthermore, the proliferation of online resources and research means that there is a growing need for self-administered instruments. We undertook a systematic overview to identify all published self-administered health literacy assessment indices to report their content and considerations associated with their administration. A primary aim of this study was to assist those seeking to employ a self-reported health literacy index to select one that has been developed and validated for an appropriate context, as well as with desired administration characteristics. Systematic searches were carried out in four electronic databases, and studies were included if they reported the development and/or validation of a novel health literacy assessment measure. Data were systematically extracted on key characteristics of the instruments: breadth of construct ("generic" vs. "contentor context- specific" health literacy), whether it was an original instrument or a derivative, country of origin, administration characteristics, age of target population (adult vs. pediatric), and evidence for validity. 35 articles met the inclusion criteria. There were 27 original instruments (27/35; 77.1%) and 8 derivative instruments (8/35; 22.9%). 22 indices measured "general" health literacy (22/35; 62.9%) while the remainder measured condition- or context- specific health literacy (13/35; 37.1%). Most health literacy measures were developed in the United States (22/35; 62.9%), and about half had adequate face, content, and construct validity (16/35; 45.7%). Given the number of measures available for many specific conditions and contexts, and that several have acceptable validity, our findings suggest that the research agenda should shift towards the investigation and elaboration of health literacy as a construct itself, in order for research in health literacy measurement to progress.National Institute for Health Research (NIHR

Identifying Factors Leading to Harm in English General Practices

This is the author accepted manuscript. The final version is available from Lippincott, Williams & Wilkins via the DOI in this record.Objective The aim of the study was to identify the main factors leading to harm in primary care based on the experiences reported by patients. Methods We conducted a mixed-methods, cross-sectional study in 45 primary care centers in England. A random sample of 6736 patients was invited to complete the Patient-Reported Experiences and Outcomes of Safety in Primary Care questionnaire. We fitted structural equation modeling on the quantitative data (n = 1244 respondents) to identify contributory factors and primary incidents leading to harm. We conducted content analyses of responses to seven open-ended questions (n = 386) to obtain deeper insight into patient perceptions of the causes of harm experienced. Results from quantitative and qualitative analyses were triangulated. Results Patients reported harm related to physical health (13%), pain (11%), and mental health (19%) and harm that increased limitations in social activities (14%). Physical harm was associated with incidents affecting diagnosis (β = 0.43; delayed and wrong), and treatment (0.12; delayed, wrong treatment, or dose), which were in turn associated with incidents with patient-provider communication, coordination between providers, appointments, and laboratory tests. Pain was associated with laboratory tests (0.21; caused when collecting blood or tissue samples) and with problems booking an appointment when needed (0.13; delaying treatment for pain). Harm to mental health was associated with incidents related to the following: diagnosis (0.28), patient-provider communication (0.18), appointments (0.17), coordination between different providers (0.14), and laboratory tests (0.12). Harm increasing limitations in social activities was associated with incidents related to diagnosis (0.42) and diagnostic and monitoring procedures (0.20). Conclusions Our findings suggest the need for patient-centered strategies to reduce harm in primary care focusing on the improvement of the quality of diagnosis and patient-provider communication

Building a patient safety toolkit for use in general practice

Despite 340 000 000 primary care consultations annually in the UK, most of the literature on patient safety has focused on hospital-based services. To improve safety in primary care settings, we must know what methods, tools and indicators are available to measure and monitor patient safety. In collaboration with patient safety experts at the University of Dundee, we were able to identify a number of existing tools, and many of these were adopted for use in the Patient Safety Toolkit

Assessing the impact of multi-morbidity and related constructs on patient reported safety in primary care: generalized structural equation modelling of observational data

This is the final version. Available on open access from MDPI via the DOI in this recordData Availability Statement: Ignacio Ricci-Cabello was the grantor of the data in this study.We aimed to examine the complex relationships between patient safety processes and outcomes and multimorbidity using a comprehensive set of constructs: multimorbidity, polypharmacy, discordant comorbidity (diseases not sharing either pathogenesis nor management), morbidity burden and patient complexity. We used cross-sectional data from 4782 patients in 69 primary care centres in Spain. We constructed generalized structural equation models to examine the associations between multimorbidity constructs and patient-reported patient safety (PREOS-PC questionnaire). These associations were modelled through direct and indirect (mediated by increased interactions with healthcare) pathways. For women, a consistent association between higher levels of the multimorbidity constructs and lower levels of patient safety was observed via either pathway. The findings for men replicated these observations for polypharmacy, morbidity burden and patient complexity via indirect pathways. However, direct pathways showed unexpected associations between higher levels of multimorbidity and better safety. The consistent association between multimorbidity constructs and worse patient safety among women makes it advisable to target this group for the development of interventions, with particular attention to the role of comorbidity discordance. Further research, particularly qualitative research, is needed for clarifying the complex associations among men.Instituto de Salud Carlos III (Spanish Ministry of Sciences and Innovation)European Regional Development Fund (ERDF

Routine provision of information on patient-reported outcome measures to healthcare providers and patients in clinical practice

This is the final version. Available from Cochrane Collaboration via the DOI in this record.This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the impact of the routine use of patient-reported outcomes (PROs) in clinical practice on the process of care (including patient-physician communication, professionals awareness of patients' quality of life, diagnosis and recognition rates, treatment rates, health services and resource use, as well as patient behaviour); patients' and professionals' experiences of care; and health outcomes (both generic and disease-specific, using both routinely-used clinical measures and PROs).Spanish Ministry of ScienceInnovation and the European commissionNational Institutes of Health Research (NIHR

Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this recordINTRODUCTION: Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres. METHODS AND ANALYSIS: The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences. TRIAL REGISTRATION NUMBER: NCT03837912; pre-results.Instituto de Salud Carlos III (Spanish Ministry of Sciences, Innovation and Universities

STOPP/START interventions to improve medicines management for people aged 65 years and over: a realist synthesis

Background Drug-related problems and potentially inappropriate prescribing impose a huge burden on patients and the health-care system. The most widely used tools for appropriate prescription in older adults in England and in other European countries are the Screening Tool of Older People’s Prescriptions (STOPP)/Screening Tool to Alert to the Right Treatment (START) tools. STOPP/START tools support medicines optimisation for older adults. Objectives To identify, test and refine the programme theories underlying how interventions based on the STOPP/START tools are intended to work, for whom, in what circumstances and why, as well as the resource use and cost requirements or impacts. Design A realist synthesis. Setting Primary care, hospital care and nursing homes. Patients Patients aged ≥ 65 years. Interventions Any intervention based on the use of the STOPP/START tools. Review methods Database and web-searching was carried out to retrieve relevant evidence to identify and test programme theories about how interventions based on the use of the STOPP/START tools work. A project reference group made up of health-care professionals, NHS decision-makers, older people, carers and members of the public was set up. In phase 1 we identified programme theories about STOPP/START interventions on how, for whom, in what contexts and why they are intended to work. We searched the peer-reviewed and grey literature to identify documents relevant to the research questions. We interviewed experts in the field in our reference group to gain input on our list of candidate context–mechanism–outcome configurations, to identify additional context–mechanism–outcome configurations and to identify additional literature and/or relevant concepts. In phase 2 we reviewed and synthesised relevant published and unpublished empirical evidence and tested the programme theories using evidence from a larger set of empirical studies. Results We developed a single logic model structured around three key mechanisms: (1) personalisation, (2) systematisation and (3) evidence implementation. Personalisation: STOPP/START-based interventions are based on shared decision-making, taking into account patient preferences, experiences and expectations (mechanisms), leading to increased patient awareness, adherence, satisfaction, empowerment and quality of life (outcomes). Systematisation: STOPP/START tools provide a standardised/systematic approach for medication reviews (mechanisms), leading to changes in professional and organisational culture and burden/costs (outcomes). Evidence implementation: delivery of STOPP/START-based interventions is based on the implementation of best evidence (mechanisms), reducing adverse outcomes through appropriate prescribing/deprescribing (outcomes). For theory testing, we identified 40 studies of the impact of STOPP/START-based interventions in hospital settings, nursing homes, primary care and community pharmacies. Most of the interventions used multiple mechanisms. We found support for the impact of the personalisation and evidence implementation mechanisms on selected outcome variables, but similar impact was achieved by interventions not relying on these mechanisms. We also observed that the impact of interventions was linked to the proximity of the selected outcomes to the intervention in the logic model, resulting in a clearer benefit for appropriateness of prescribing, adverse drug events and prescription costs. Limitations None of the available studies had been explicitly designed for evaluating underlying causal mechanisms, and qualitative information was sparse. Conclusions No particular configuration of the interventions is associated with a greater likelihood of improved outcomes in given settings. Study registration This study is registered as PROSPERO CRD42018110795. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 23. See the NIHR Journals Library website for further project information

Healthcare providers' adherence to breast cancer guidelines in Europe : a systematic literature review

Clinical guidelines' (CGs) adherence supports high-quality care. However, healthcare providers do not always comply with CGs recommendations. This systematic literature review aims to assess the extent of healthcare providers' adherence to breast cancer CGs in Europe and to identify the factors that impact on healthcare providers' adherence. We searched for systematic reviews and quantitative or qualitative primary studies in MEDLINE and Embase up to May 2019. The eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and cross-checked by a second author. We conducted a narrative synthesis attending to the modality of the healthcare process, methods to measure adherence, the scope of the CGs, and population characteristics. Out of 8137 references, we included 41 primary studies conducted in eight European countries. Most followed a retrospective cohort design (19/41; 46%) and were at low or moderate risk of bias. Adherence for overall breast cancer care process (from diagnosis to follow-up) ranged from 54 to 69%; for overall treatment process [including surgery, chemotherapy (CT), endocrine therapy (ET), and radiotherapy (RT)] the median adherence was 57.5% (interquartile range (IQR) 38.8-67.3%), while for systemic therapy (CT and ET) it was 76% (IQR 68-77%). The median adherence for the processes assessed individually was higher, ranging from 74% (IQR 10-80%), for the follow-up, to 90% (IQR 87-92.5%) for ET. Internal factors that potentially impact on healthcare providers' adherence were their perceptions, preferences, lack of knowledge, or intentional decisions. A substantial proportion of breast cancer patients are not receiving CGs-recommended care. Healthcare providers' adherence to breast cancer CGs in Europe has room for improvement in almost all care processes. CGs development and implementation processes should address the main factors that influence healthcare providers' adherence, especially patient-related ones. Registration:: PROSPERO (CRD42018092884)