Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme.

INTRODUCTION: Adverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free-text comments which could be useful sources of information. OBJECTIVES: To investigate patients' experiences of ADRs and their impact on patients as described in free-text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency. METHODS: A qualitative review of narrative texts was conducted on free-text data from 2255 patient YC reports from July to December 2015. RESULTS: Three key narrative themes emerged from analysis of the free-text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms. CONCLUSION: Free-text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

Advancing understanding of influences on cervical screening (non)-participation among younger and older women: A qualitative study using the theoretical domains framework and the COM-B model.

BACKGROUND: Effective screening can prevent cervical cancer, but many women choose not to attend their screening tests. OBJECTIVE: This study aimed to investigate behavioural influences on cervical screening participation using the Theoretical Domains Framework (TDF) and COM-B models of behaviour change. DESIGN: A qualitative study and semistructured phone interviews were conducted with women invited for routine screening tests within the national cervical screening programme in Ireland. SETTING AND PARTICIPANTS: Forty-eight women aged 25-65 years were recruited from the national screening register. RESULTS: Seven core themes were identified that mapped to three COM-B components and 11 TDF domains: (1) knowledge of cervical cancer and screening, (2) coping with smear tests, (3) competing motivational processes-automatic and reflective, (4) cognitive resources, (5) role of social support, (6) environmental influences and (7) perceputal and practical influences. A range of knowledge about screening, perceived risk of cervical cancer and human papillomavirus infection was evident. Factors that influenced screening behaviours may be hierarchical-some were assigned greater importance than others. Positive screening behaviours were linked to autonomous motivation. Deficits in physical and psychological capability (inadequate coping skills) were barriers to screening, while physical and social opportunity (e.g. healthcare professional 'champions') could facilitate participation. Older women raised age-related issues (e.g. screening no longer necessary) and had more negative attitudes to screening, while younger women identified practical barriers. CONCLUSIONS: This study provides insight into screening participation and will aid development of theoretically informed interventions to increase uptake. PATIENT OR PUBLIC CONTRIBUTION: Women invited for screening tests through the national screening programme were interviewed. A Public & Patient Involvement (PPI) Panel, established to provide input into all CERVIVA research projects, advised the research team on recruitment materials and were given the opportunity to review and comment on the interview topic guide. This panel is made up of six women with various cervical screening histories and experiences.

The role of healthcare professionals in HPV communication with head and neck cancer patients: A narrative synthesis of qualitative studies.

INTRODUCTION: Prevalence rates of human papillomavirus positive (HPV+) head and neck cancers (HNC) have increased over the last decades. Communicating about HPV is an increasingly relevant part of HNC patient care. This systematic review was conducted to explore healthcare professionals' (HCP) views and experiences of discussing HPV with HNC patients. It also examined perceptions among different HCP groups of their professional roles in HPV discussions. METHODS: A narrative synthesis of qualitative research was conducted. Three databases-Embase, PsycINFO and CINAHL+-were searched from January 2007 to August 2018. Relevant data were extracted and synthesised thematically. RESULTS: Five studies were identified: four were qualitative and one used mixed methods. HCPs varied in their experience and views of discussing HPV. HCPs who engaged in these discussions believed they were beneficial for patients. All HCPs described the need to address their HPV knowledge deficits in order to provide clear HPV information. Changes in professional roles which were linked to HPV communication for HCPs involved in HNC patient care were also evident. CONCLUSIONS: Effective HPV discussions are an important part of patient-provider interactions. Evidence-based interventions and professional development activities which support HCPs in their HPV discussions with patients would be valuable.

Development and preliminary validation of an instrument to enable laypersons to assess suspected side effects from medicines.

PURPOSE: Research into causality assessment tools enabling patients to assess suspected adverse drug reactions (ADRs) is limited. Supporting patients with tools could improve their confidence in discussions with health professionals and encourage reporting of suspected ADRs to regulators. This study describes development and preliminary validation of an instrument: Side Effect Patient ASsessment Tool (SE-PAST). METHODS: SE-PAST was developed from survey and interview data involving patients experiencing suspected ADRs. It included 10 statements enabling causality assessment, covering timing, additional information sources, and experiences, with four options: yes/no/don't know/not applicable. Scoring and weighting resulted in four categories of causal association: highly probable, probable, possible, unlikely. Validation involved obtaining feedback from 31 individuals experiencing an ADR. Further validation involved online distribution through patient support groups and comparison of reported symptoms to known ADRs. RESULTS: Validators found SE-PAST easy to read (31), to understand (27), and to complete (29). A total of 294 respondents completed SE-PAST online, with 98% completing eight or more causality assessment statements. Symptoms were categorised as highly probable (46; 16%), probable (80; 62%), possible (44; 15%), and unlikely (21; 7%). A total of 221 respondents identified one suspected medicine, with 95% of these reporting at least one symptom known to be an ADR. Of 227 providing feedback, 139 (61%) found SE-PAST useful, 160 (71%) felt motivated to discuss their experience with a health professional, and 136 (60%) were encouraged to report to the regulator. CONCLUSION: SE-PAST was easily completed and understood by people experiencing suspected ADRs and could be useful in encouraging patient reporting to health professionals and agencies.

Rehabilitation needs of people with brain tumours in Ireland: Protocol for a prospective, mixed methods action research study ("Brain-RESTORE").

Background: Approximately 480 people annually in Ireland are diagnosed with a primary brain tumour. Brain tumours are a heterogeneous group of conditions, varying in histopathology, location, and progression. A consistent feature is neurological impairment, which can lead to profound effects on physical and cognitive function. There is evidence that people with brain tumours can benefit from rehabilitation, but pathways are poorly described, and no best practice is defined. This leads to significant unmet need. The aim of this study is to understand the rehabilitation needs of people diagnosed with a brain tumour in Ireland, and gain insight to inform policy and practice. Methods: A prospective, mixed methods study with embedded action research will be conducted. Patients (n=122) with a new diagnosis of primary brain tumour, and optionally, a nominated carer or family member, will be recruited through a national neuro-oncology service. Rehabilitation need (Mayo-Portland Adaptability Inventory), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Brain Cancer Module, EuroQol-5D-5L), healthcare utilisation and, optionally, carer needs (Carer Support Needs Assessment Tool) will be assessed at four, eight and 12 months post diagnosis. An embedded qualitative study will invite 30 patients and carers to a semi-structured interview to explore their lived experience of rehabilitation needs and services following brain tumour diagnosis. Finally, using an Action Research approach, healthcare professionals involved in caring for people with brain tumours will be invited to participate in co-operative inquiry groups, to reflect on emerging aggregate findings and identify actions that could be undertaken while the study is underway. Conclusions: By understanding rehabilitation need, the findings will help healthcare professionals and health service providers understand how to prioritise the supports required and encourage policy makers to adequately resource neurorehabilitation to meet the needs of people with a brain tumour diagnosis.

Use of information sources regarding medicine side effects among the general population: a cross-sectional survey.

AIM: To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. BACKGROUND: Side effects from medicines can have considerable negative impact on peoples' daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. METHODS: A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). FINDINGS: Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.