Achieving patient engagement in pharmacovigilance: from high-income countries to lower and -middle-income countries with focus on Africa.

INTRODUCTION: Patient engagement in pharmacovigilance (PEP) has been shown to improve information on adverse drug reactions (ADRs), which may not be found in reports from healthcare professionals. This review shows that there is paucity of information on PEP in lower-middle-income countries (LMICs), particularly Africa. It provides insights into PEP in high-income countries (HICs) compared with Africa to help identify the disparities and system challenges in Africa. AREAS COVERED: We discussed the impact of PEP in HICs in comparison with Africa and incorporated two case studies: PEP in Ghana and medication error reporting in Africa using a scoping review. Recommendations were made to improve medication safety in Africa based on the identified disparities and system challenges. EXPERT OPINION: PEP is at an early stage in LMICs, particularly in Africa, with limited information available regarding patients' contributions to the safety of medicines. There should be further research into patients' roles in pharmacovigilance accompanied by advocacy efforts with policymakers, the development of sustainable funding strategies, benchmarking against experienced pharmacovigilance centers, and the use of technology to improve patient reporting.

SMS-Based Active Surveillance of Adverse Events following Immunization in Children: The VigiVax Study.

Underreporting is the main limitation of spontaneous reporting systems. This cohort-event monitoring study aims to examine the potential of short message service (SMS)-based surveillance compared to traditional surveillance systems. Using VigiVax software, parents of vaccinated children aged two years or younger, in the period March 2021-May 2022, received a single SMS inquiry about adverse events following immunization (AEFI). Responses were collected, validated by health operators and integrated with the information on electronic immunization registries. AEFI reports were automatically submitted to the Italian Pharmacovigilance system. Among 254,160 SMS messages sent, corresponding to 451,656 administered doses (AD), 71,643 responses were collected (28.2% response rate), and 21,231 of them (8.3%) reported AEFI. After a seriousness assessment based on clinical criteria, 50 reports (0.24%) were classified as serious. Among these, a causality assessment identified 31 reports at least potentially related to the vaccination (RR: 6.86/100,000 AD). Febrile seizures following MMRV (measles, mumps, rubella, varicella) vaccination accounted for 11 of these 31 cases, with an incidence of 32 per 100,000 AD. No fatal outcomes were reported. Our findings support the highly favorable risk profile of pediatric vaccinations and the possibility to improve spontaneous reporting through the integration of digital technologies.

Patient-reported outcome and experience domains for diagnostic excellence: a scoping review to inform future measure development.

PURPOSE: "Diagnostic excellence," as a relatively new construct centered on the diagnostic process and its health-related outcomes, can be refined by patient reporting and its measurement. We aimed to explore the scope of patient-reported outcome (PRO) and patient-reported experience (PRE) domains that are diagnostically relevant, regardless of the future diagnosed condition, and to review the state of measurement of these patient-reported domains. METHODS: We conducted an exploratory analysis to identify these domains by employing a scoping review supplemented with internal expert consultations, 24-member international expert convening, additional environmental scans, and the validation of the domains' diagnostic relevance via mapping these onto patient diagnostic journeys. We created a narrative bibliography of the domains illustrating them with existing measurement examples. RESULTS: We identified 41 diagnostically relevant PRO and PRE domains. We classified 10 domains as PRO, 28 as PRE, and three as mixed PRO/PRE. Among these domains, 19 were captured in existing instruments, and 20 were captured only in qualitative studies. Two domains were conceptualized during this exploratory analysis with no examples identified of capturing these domains. For 27 domains, patients and care partners report on a specific encounter; for 14 domains, reporting relates to an entire diagnostic journey over time, which presents particular measurement opportunities and challenges. CONCLUSION: The multitude of PRO and PRE domains, if measured rigorously, would allow the diagnostic excellence construct to evolve further and in a manner that is patient-centered, prospectively focused, and concentrates on effectiveness and efficiency of diagnostic care on patients' well-being.

Sex-specific disparities in disease activity scores among patients with axial spondyloarthritis and their implications for evaluating the response to tumor necrosis factor alpha inhibitor therapy.

BACKGROUND: We aimed to investigate whether there are sex differences in disease activity measures among patients with axial spondyloarthritis (axSpA) and to determine any potential impact on the assessment of treatment responses to tumor necrosis factor alpha inhibitors (TNFi). METHODS: Using the Korean College of Rheumatology Biologics and Targeted Therapy (KOBIO) registry data, we compared sex differences in changes in the Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) levels at baseline and one year after TNFi initiation in patients with axSpA. RESULTS: This study included 1,753 patients with axSpA who started or changed TNFi, of whom 1,343 (76.6%) were male. At baseline, the mean BASDAI and ASDAS scores of all patients were 5.98 and 3.6, respectively. The BASDAI changes between baseline and the one-year follow-up were independently associated with sex (𝛽 = 0.343, p = 0.011), whereas ASDAS was not (𝛽 = 0.079, p = 0.235). When judging the effect of TNFi at one-year of treatment, male patients were more likely to be assessed as effective by the BASDAI-based criterion (ΔBASDAI ≥ 50% or ≥ 2; OR 1.700, 95% CI 1.200-2.406), while the ASDAS-based criterion (ΔASDAS ≥ 1.1) showed no significant difference between sexes (OR 0.993, 95% CI 0.678-1.455), after adjusting for other baseline characteristics. CONCLUSIONS: The changes in disease activity before and after TNFi use were significantly different between sexes when measured by BASDAI, but not ASDAS. TNFi treatment effects may be interpreted differently between sexes depending on the disease activity measure used.

Patient's reporting of adverse drug reactions: Which added value in 2023?

Several studies were focused on the qualitative and quantitative analysis of serious adverse drug reactions (ADRs) leading to hospitalisation or death. These figures do not take into account ADRs in ambulatory patients affecting their quality of life. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with health care professional (HCP) reporting. A certain amount of information is crucial in order to determine the drug-reaction relationship. European regulation and patient support programs have contributed widely to increased patient reporting but the quality of ADR reports is still unequal from one country to another. Patient reports of ADRs have contributed enormously to pharmacovigilance signal detection in a number of ways. Over the last decades, countries have developed dedicated websites for direct patient reporting. The increasing involvement of patients in ADR reporting activities facilitated by a web portal was confirmed by some studies. Patients are now recognised as having a legitimate part to play in the decision-making process. The contribution of patient reports to drug safety was acknowledged and consolidated by European Union (EU) PV legislation in 2012 aiming to involve patients more actively, nowadays called "patient centricity in pharmacovigilance". Patient organisations are involved in regulatory issues and collaborate with health institutions on the development of guidelines. However, some studies suggested that a substantial number of patient organisations have potential financial conflicts of interest but limited disclosure practices. Pharmaceutical companies integrate into patient associations, particularly for chronic diseases by different strategies: educational therapeutic or observance support programs. The question of conflict of interest of patient associations is important requiring better transparency.

Patient Reasoning: Patients' and Care Partners' Perceptions of Diagnostic Accuracy in Emergency Care.

OBJECTIVES: In the context of validating a measure of patient report specific to diagnostic accuracy in emergency department or urgent care, this study investigates patients' and care partners' perceptions of diagnoses as accurate and explores variations in how they reason while they assess accuracy. METHODS: In February 2022, we surveyed a national panel of adults who had an emergency department or urgent care visit in the past month to test a patient-reported measure. As part of the survey validation, we asked for free-text responses about why the respondents indicated their (dis)agreement with 2 statements comprising patient-reported diagnostic accuracy: 1) the explanation they received of the health problem was true and 2) the explanation described what to expect of the health problem. Those paired free-text responses were qualitatively analyzed according to themes created inductively. RESULTS: A total of 1,116 patients and care partners provided 982 responses coded into 10 themes, which were further grouped into 3 reasoning types. Almost one-third (32%) of respondents used only corroborative reasoning in assessing the accuracy of the health problem explanation (alignment of the explanation with either test results, patients' subsequent health trajectory, their medical knowledge, symptoms, or another doctor's opinion), 26% used only perception-based reasoning (perceptions of diagnostic process, uncertainty around the explanation received, or clinical team's attitudes), and 27% used both types of reasoning. The remaining 15% used general beliefs or nonexplicated logic (used only about accurate diagnoses) and combinations of general reasoning with perception-based and corroborative. CONCLUSIONS: Patients and care partners used multifaceted reasoning in their assessment of diagnostic accuracy. IMPLICATIONS: As health care shifts toward meaningful diagnostic co-production and shared decision making, in-depth understanding of variations in patient reasoning and mental models informs use in clinical practice. HIGHLIGHTS: An analysis of 982 responses examined how patients and care partners reason about the accuracy of diagnoses they received in emergency or urgent care.In reasoning, people used their perception of the process and whether the diagnosis matched other factual information they have.We introduce "patient reasoning" in the diagnostic measurement context as an area of further research to inform diagnostic shared decision making and co-production of health.

Indirect and Direct 65+ Patient Reporting of Non-Steroidal Anti-Inflammatory Drug-Induced Adverse Drug Reactions as a Source of Information on Polypharmacy and Polypharmacy-Related Risk.

Background and Objectives: Non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-inflammatory and analgesic properties, are commonly used in the treatment of various, particularly frequent, as well as chronic, conditions in older patients. Due to common polypragmasia in these patients and a high risk of adverse drug reactions (ADRs) and drug interactions, pain management poses a therapeutic challenge. This study describes the importance of ADR reports in the identification of polypharmacy and the ensuing interactions. Materials and Methods: Both healthcare professionals (HPs) and non-healthcare professionals (non-HPs) reports collected in the EudraVigilance database of NSAIDs, including most commonly co-reported medications and reported reactions, were analysed and differences between HPs and non-HPs reports were identified. Results: In the analysed period and group, non-HPs reported more reactions but indicated fewer drugs as suspect or concomitant. The outcomes of our analysis indicate more HP engagement and more detailed reports of serious ADRs when compared to non-serious individual case safety reports (ICSRs) by non-HPs, which appeared more detailed. Such reactions as kidney failure and increased risk of bleeding are known adverse reactions to NSAIDs and common symptoms of their interactions, which were described in the available literature. They were much more frequently reported by HPs than by non-HPs. Non-HPs more frequently reported reactions that may have been considered less significant by HPs. Conclusions: The differences between healthcare professionals' (HPs) and non-healthcare professionals' (non-HPs) reports may result from the fact that the reports from patients and their caregivers require a professional medical diagnosis based on symptoms described by the patient or additional diagnostic tests. This means that when appropriately classified, medically verified, and statistically analysed, the data may provide new evidence for the risks of medication use or drug interactions.

Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework.

BACKGROUND: Only 5-10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems including increasing reporting rate. Theory-informed insights into the factors implicated in patient and public underreporting are likely to offer valuable opportunity for the development of effective reporting-interventions and optimization of existing systems. AIM: To collate, summarize and synthesize the reported behavioral determinants using the theoretical domains framework (TDF), that influence patient and public reporting of ADRs. METHOD: Cochrane, CINAHL, Web of science, EMBASE and PubMed were systematically searched on October 25th, 2021. Studies assessing the factors influencing public or patients reporting of ADRs were included. Full-text screening, data extraction and quality appraisal were performed independently by two authors. Extracted factors were mapped to TDF. RESULTS: 26 studies were included conducted in 14 countries across five continents. Knowledge, social/professional role and identity, beliefs about consequences, and environmental context and resources, appeared to be the most significant TDF domains that influenced patient and public behaviors regarding ADR reporting. CONCLUSION: Studies included in this review were deemed of low risk of bias and allowed for identification of key behavioural determinants, which may be mapped to evidence-based behavioral change strategies that facilitate intervention development to enhance rates of ADR reporting. Aligning strategies should focus on education, training and further involvement from regulatory bodies and government support to establish mechanisms, which facilitate feedback and follow-ups on submitted reports.

Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries.

Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country's system should be adopted.

Immediate side effects of Comirnaty COVID-19 vaccine: A nationwide survey of vaccinated people in Israel, December 2020 to March 2021.

BackgroundCOVID-19 vaccine safety is of major interest worldwide, since there is no prior experience with it. Israel was one of the first countries to widely use the Comirnaty vaccine.AimWe aimed to assess the vaccine's short-term side effects directly from a large population and to predict influencing factors for self-reporting side effects.MethodsIn a retrospective cohort study, we investigated self-reported systemic vaccine side-effects using electronic surveys sent to vaccinated individuals between 20 December 2020 and 11 March 2021, within 3 days following administration of the first and second dose. We determined predictors for reporting systemic side effects by logistic regression.ResultsA total of 1,213,693 patients received at least one vaccine dose and 301,537 (24.8%) answered at least one survey. Among them, 68,162 (30.4%) and 89,854 (59.9%) individuals filled the first and the second dose surveys, respectively, and reported one or more side effects. Most common side effects were fatigue, headache and myalgia. Several respondents reported facial paraesthesia after first and second dose, respectively (n = 1,675; 0.7% and n = 1,601; 1.1%). Individuals younger than 40 years and women reported side effects more frequently than others, but pregnant women reported less. Pregnancy was a weak predictor for reporting any side effect in general and in particular fatigue, myalgia, headache, chills and fever.ConclusionsWe found further support for minor short-term side effects, within 3 days of receiving the Comirnaty vaccine. These findings from vaccine recipients in general and pregnant women in particular can improve vaccine acceptance.

Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan.

OBJECTIVE: Data collection from patients regarding adverse drug reactions (ADRs) in Japan have greatly stagnated. To examine the factors underlying this stagnation, we investigated the awareness of and opinions about the direct ADR reporting system among the general public and physicians. METHODS: We conducted questionnaire surveys of general citizens and physicians throughout Japan and included the following topics: (1) awareness of the direct patient ADR reporting system, (2) attitude toward this system, (3) reasons for negative opinions of this system, (4) awareness of the physician ADR reporting system, and (5) respondent demographics. RESULTS: Responses were received from 845 citizens and 300 physicians. Most citizens (83.7%) were unaware of the direct patient ADR reporting system. While many citizens supported the idea of the system, 26.7% expressed negative/hesitant opinions. Prominent reasons for negative/hesitant opinions included the patient burden for reporting their own ADRs and expectations that physicians would make reports. Among the general public, the physician reporting system was better known (43.6%). In contrast, many physicians were aware of the direct patient ADR reporting system (65.0%). However, only 46.7% of physicians had supported this system; prominent reasons for disapproval included skepticism toward patients' judgment and the regulatory authorities' assessment. CONCLUSION: Our survey suggests that stagnation in the reporting system is affected by the attitudes of the general public and physicians. In addition to government measures to improve awareness and eliminate reporting hurdles, the involvement of medical staff in patient reporting needs to be improved.

Using patient experiences to evaluate care and expectations in lung cancer: analysis of the English Cancer Patient Experience Survey linked with the national cancer registry.

PURPOSE: Identification of unmet needs in person centred and supportive care could be limited by differences in experience across specific cancer populations. Using the experiences of people with lung cancer, we assess distinctions according to demographic and clinical characteristics. METHODS: The English Cancer Patient Experience Survey was linked to the national cancer registry. The primary outcome was experience of the lung cancer pathway when assessed in multi-question models developed with item response theory. Secondary outcomes were experience by treatment received and in separate dimensions of the care pathway: up to diagnosis, treatment information, and staff support. RESULTS: Responses from 15,967 adults with a lung cancer diagnosis between 2009 and 2015 were included. Positive experiences were more likely to be reported by people aged between 65 and 80 (adjusted coefficient 0.08, 95%CI 0.05;0.11), those living in the most deprived areas (adjusted coefficient 0.10, 95%CI 0.05;0.14), diagnosed at lung cancer stage IIA-B (adjusted coefficient 0.09, 95%CI 0.04;0.14), and those diagnosed through inpatient elective admissions (adjusted coefficient 0.17, 95%CI 0.07;0.28). Specific experiences differed across dimensions of care and within lung cancer treatment groups. CONCLUSIONS: Experiences differed according to gender and ethnicity, supporting previous observations in cancer. In contrast to previous studies, people with lung cancer were more likely to report positive pathway experiences at older ages, living in more deprived areas, or diagnosed after stage I, all frequently associated with worse clinical outcomes. The distinct observations in lung cancer specific analyses suggest potential unmet needs, such as in early stage disease and younger age groups.

Parental reporting of adverse drug reactions in South Africa: An online survey.

BACKGROUND: The high incidence of adverse drug reactions (ADRs) in children is of global concern. Enhancing the reporting of ADRs could contribute to making safer medicines available to children. AIM: To assess parents' awareness of reporting ADRs and their knowledge on the reporting procedures in South Africa. SETTING: South African parents with online access. METHOD: A quantitative descriptive study was conducted based on an anonymous voluntarily web-based self-administered questionnaire that was distributed through Facebook® and LinkedIn™ to parents in South Africa. RESULTS: The questionnaire was completed voluntarily by 206 respondents. The majority of participants (70.9%) were aware of the term ADR. Significant associations between not being aware of the term ADR and single marital status, lower education level, not having private medical aid and accessing public clinics for medical services were found. The majority (66.5%) of participants did report an ADR to a healthcare professional whilst only 15% reported it to a product manufacturer. More than half of the participants (58.7%) knew how to report ADRs whilst 72.8% knew what type of ADRs to report. Almost a third (32.5%) did not know where more information on ADR reporting could be found or how ADRs could be reported (31.5%). CONCLUSION: The majority of the respondents were aware of the term ADR, indicative of a good knowledge basis on which ADRs to report and the importance of reporting ADRs. However, gaps in the respondents' knowledge were identified which highlighted specific groups of individuals to be targeted to increase ADR awareness and improve the knowledge on the reporting process.

Improving domain definition and outcome instrument selection: Lessons learned for OMERACT from imaging.

OBJECTIVES: Imaging is one of the most rapidly evolving fields in medicine. Unfortunately, many imaging technologies have been applied as measurement instruments without rigorous evaluation of the evidence supporting their truth, discriminatory capability and feasibility for that context of use. The Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Instrument Selection Algorithm (OFISA) is used to evaluate such evidence for use of an instrument in a research setting. The objectives of this work are to: [1] define and describe the key conceptual aspects that are essential for the evaluation of imaging as an outcome measurement instrument and [2] describe how these aspects can be assessed through OFISA. METHODS: Experts in imaging and/or methodology met to formalize concepts and define key steps. These concepts were discussed with a team of patient research partners with interest in imaging to refine technical and methodological aspects into comprehensible information. A workshop was held at OMERACT2020 and feedback was incorporated into existing OMERACT process for domain and instrument selection. RESULTS: Three key lessons were identified: (1) a clear definition of the domain we want to measure is a necessary prerequisite to the selection of a good instrument, (2) the sources of variability that can directly influence the instrument should be clearly identified, (3) incorporating these first two lessons into OFISA improves the quality of every instrument selection process. CONCLUSIONS: The incorporation of these lessons in the updated OMERACT Filter (now 2.2) will improve the quality of the selection process for all types of outcome measurement instruments.

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs' safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

Inflammatory bowel disease patients provide reliable self-reported medical information: A multicentre prospective pharmacovigilance monitoring system.

PURPOSE: To assess the agreement between patient-reported and health care provider-reported medical information in inflammatory bowel disease (IBD). METHODS: This multicentre, prospective, event monitoring study enrolled adult Crohn's disease (CD) and ulcerative colitis (UC) patients treated with a biological in four medical centers in the Netherlands. At two-monthly intervals, patients completed questionnaires on biological use, combination therapy and indication. The patient-reported information was compared with their electronic health records (EHRs) and analysed for percentage agreement and Cohen's kappa. A reference population from a prospective IBD registry was used to assess the representativeness of the study population. RESULTS: In total, 182 patients (female 50.5%, mean age 42.2 years, CD 76.9%) were included in the analysis. At baseline, 51.0% of the patients were prescribed an immunomodulator (43.9% thiopurines, 7.1% methotrexate), and patients were prescribed biologicals as follows: 59.3% infliximab, 30.2% adalimumab, 9.3% vedolizumab, and 1.1% ustekinumab. Agreement on patient-reported indication and biological use was almost perfect (κ = 0.878 and κ = 1.000, respectively); substantial for combination therapy (κ = 0.672). Gender, age, type of IBD, biological use and combination therapy were comparable with the reference population. CONCLUSION: Systematic patient-reporting by questionnaires was reliable in retrieving indication and treatment specific information from IBD patients. These results indicate that the use of patient-reporting outcomes in daily IBD practice can ensure reliable information collection.

[Radiation-oncology horizon 2030: From microbiota to plasma laser]. / Oncologie-radiothérapie horizon 2030 : du microbiote au laser plasma.

Advances in physical, technological and biological fields have made radiation oncology a discipline in continual evolution. New current research areas could be implemented in the clinic in the near future. In this review in the form of several interviews, various promising themes for our specialty are described such as the gut microbiota, tumor organoids (or avatar), artificial intelligence, connected therapies, nanotechnologies and plasma laser. The individual prediction of the best therapeutic index combined with the integration of new technologies will ideally allow highly personalized treatment of patients receiving radiation therapy.

Perceived occurrence of an adverse event affects patient-reported outcomes after total hip replacement.

BACKGROUND: Dislocation, periprosthetic fracture and infection are serious complications of total hip replacement (THR) and which negatively impact on patients' outcomes including satisfaction, quality of life, mental health and function. The accuracy with which patients report adverse events (AEs) after surgery varies. The impact of patient self-reporting of AEs on patient-reported outcome measures (PROMs) after THR is yet to be investigated. Our aim was to determine the effect of confirmed and perceived AEs on PROMs after primary THR. METHODS: A prospective single-centre cohort study of patients undergoing primary THR, with one-year follow-up, was performed. Participants completed forms pre-operatively and 3, 6, 9 and 12 months post-operatively, including Work Productivity and Activity Impairment (WPAI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol-5D-3 L (EQ5D), Self-Administered Patient Satisfaction (SAPS) and AE reporting questionnaires. Results were reported in three groups: No AE, reported but not confirmed AE and confirmed AE. A generalised linear model was used to compare among groups using robust standard errors (SE). RESULTS: Forty-one AEs were reported in a cohort of 417 patients (234 females), with 30 AEs reported by 3 months. Eleven (27 reported) infections, two (six reported) periprosthetic fractures and two (eight reported) dislocations were confirmed. Those in the no AE group reported significantly better outcomes that the reported AE group as measured by WOMAC Co-Eff 14.27 (p = 0.01), EQ5D - 0.128 (p = 0.02) and SAPS - 9.926 (p = 0.036) and the combined reported and confirmed AE groups as measured by WOMAC Co-Eff 13.72 (p = 0.002), EQ5D - 0.129 (p = 0.036) and SAPS - 11.512 (p = 0.004). No significant differences were seen in WPAI among groups. CONCLUSIONS: Patients who report AEs have worse outcomes than those who do not, regardless of whether the AEs can be confirmed by standard medical record review methods. The observed negative trends suggest that patient perception of AEs may influence patient outcome in a similar way to those with confirmed AEs.

Fifteen years of patient reporting -what have we learned and where are we heading to?

INTRODUCTION: In April 2003, the Netherlands Pharmacovigilance Centre Lareb successfully implemented patient reporting to their spontaneous reporting system. The number of reports by patients rapidly grew, prompting the need to evaluate the value of the patient reporting scheme and to compare experiences with other countries. The aim of this article is to summarize our 15-year experience of working with direct patient reporting in pharmacovigilance and to discuss necessary steps in order to optimize the use of patient reports in the future. AREAS COVERED: This article is based on Lareb studies on patient reporting from 2004 onwards and covers the evolution of the Dutch patient reporting system, the value of patient participation in pharmacovigilance, the impact of patient reporting on the spontaneous reporting system and future steps to strengthen patient reporting. EXPERT OPINION: After 15 years of experience with patient reporting we conclude that patients can add value to pharmacovigilance. We recognize that there is a big leap between allowing patients to report and actual patient involvement in pharmacovigilance. It is our belief that increased patient involvement in pharmacovigilance is a way to improve pharmacovigilance, enhancing the general public's trust in medicines.