Keeping afloat in a sea of patient safety information: reform and patient views

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recently published reports on patient safety and health quality

Translation and validation of the greek version of a questionnaire measuring patient views on participation in clinical trials

Background The increasing number of clinical research opportunities requires increasing numbers of participants in clinical trials. However, it may become increasingly problematic, as protocols have become increasingly complex. Better understanding of patients’ attitudes towards their potential participation in clinical trials is essential for developing effective clinical trial recruitment strategies. In Greece, limited research has been conducted on this topic so far. This study aims to contribute to filling this gap. Methods A cross-sectional study was conducted. Purposive sampling was used to select participants. The Greek version of a recently developed questionnaire measuring patient views on participation in clinical trials, a 27-item scale distributed into four factors, was tested. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted. Results The four-factor solution derived in our study consisted of the same 27 items and it was different from the six-factor solution that Arnetz et al. proposed. The factors risks and benefits, that consisted of 5 and 3 items respectively in the six-factor solution, were merged into one factor that consisted of 10 items in the four-factor solution. The four factors produced were Risks and benefits (ten items, α = 0,867), Patient’s expectations (six items, α = 0.864), Patient’s participation (five items, α = 0.827), and Cost and convenience (five items, α = 0,770). We found that demographic factors did not impact patients’ opinions about clinical trials participation, except for gender. The participants reported as important for participating in clinical trial: receiving clear and adequate information (95,5 %) and being given the opportunity to ask questions (97,8 %), take part in discussions regarding their own treatment (94,6 %), and voice their concerns and opinions (91,1 %). As factors strongly associated with participants’ willingness to participate in a clinical trial were reported: concerns about the risks of being in a clinical trial (87,5 %), the possible side effects of clinical trials (86,3 %), the type of treatment given in a clinical trial (83,7 %), and whether participation would improve their quality of life (QoL) (81,5 %). Conclusions The preliminary validation of the Greek version of the questionnaire measuring patient perceptions and expectations of participating in clinical trials demonstrated acceptable validity and reliability and could be further tested in larger samples. The findings that emerged from this study are in line with previous literature.

Patient views of therapeutic interchange of ACE inhibitors in Australian primary care: a qualitative study

ObjectivesIn Australia, therapeutic interchange of angiotensin-converting enzyme (ACE) inhibitors could generate savings for patients and the Pharmaceutical Benefits Scheme (PBS). The PBS subsidises nine drugs in the ACE inhibitor class. These drugs are therapeutically equivalent, but the price varies between each drug. Patients are key players in successful therapeutic interchange programmes, but little is known about their views. This study aims to explore patient views of therapeutic interchange of ACE inhibitors in Australian primary care.DesignQualitative exploratory research study using semi-structured interviews, asking participants about therapeutic interchange and their attitude towards hypothetically switching ACE inhibitors. Data were analysed thematically.SettingAustralian primary care.ParticipantsFourteen adults in Australia currently taking an ACE inhibitor, recruited via general practices and pharmacies, social media and professional networks.FindingsFive key themes were identified: participants’ limited understanding of medication; the expectation that a new drug would be ‘the same’; the view that choice, convenience and fear of change outweigh the cost; altruism; and trust in health professionals, particularly participants’ own general practitioner (GP).ConclusionsPatients’ limited understanding of medication changes poses a barrier to therapeutic interchange. Clinicians should explore patients’ understanding and expectations of therapeutic interchange. Counselling from trusted health professionals, particularly GPs, could ameliorate concerns. Policymakers implementing therapeutic interchange programmes should ensure a trusted GP directs medication changes.

Translation and Validation of the Greek Version of a Questionnaire Measuring Patient Views on Participation in Clinical Trials

BackgroundThe increasing number of clinical research opportunities requires increasing numbers of participants in clinical trials. However, it may become increasingly problematic, as protocols have become increasingly complex. Better understanding of patients’ attitudes towards their potential participation in clinical trials is essential for developing effective clinical trial recruitment strategies. In Greece, limited research has been conducted on this topic so far. This study aims to contribute to filling this gap. MethodsA cross-sectional study was conducted. Purposive sampling was used to select participants. The Greek version of a recently developed questionnaire measuring patient views on participation in clinical trials, a 27‐item scale distributed into four factors, was tested. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted.ResultsThe four-factor solution derived in our study consisted of the same 27 items and it was different from the six-factor solution that Arnetz et al. proposed. The factors risks and benefits, that consisted of 5 and 3 items respectively in the six-factor solution, were merged into one factor that consisted of 10 items in the four-factor solution. The four factors produced were Risks and benefits (ten items, α= 0,867), Patient’s expectations (six items, α= 0.864), Patient’s participation (five items, α= 0.827), and Cost and convenience (five items, α= 0,770). We found that demographic factors did not impact patients' opinions about clinical trials participation, except for gender. The participants reported as important for participating in clinical trial: receiving clear and adequate information (95,5%) and being given the opportunity to ask questions (97,8%), take part in discussions regarding their own treatment (94,6%), and voice their concerns and opinions (91,1%). As factors strongly associated with participants’ willingness to participate in a clinical trial were reported: concerns about the risks of being in a clinical trial (87,5%), the possible side effects of clinical trials (86,3%), the type of treatment given in a clinical trial (83,7%), and whether participation would improve their quality of life (QoL) (81,5%).ConclusionThe preliminary validation of the Greek version of the questionnaire measuring patient perceptions and expectations of participating in clinical trials demonstrated acceptable validity and reliability and could be further tested in larger samples. The findings that emerged from this study are in line with previous literature.

P95 Preliminary Findings on Patient Satisfaction with Telepsychiatry – A Systematic Review

Introduction During the COVID-19 pandemic, mental health services have been presented with the unique challenge of providing effective and safe patient care whilst maintaining safety regulations. Telepsychiatry has emerged as a potential solution to this and is now being used across the UK to diagnose and manage mental health conditions. Evidence has shown that its effectiveness is comparable to face to face consultations, however, is much less clear regarding patient satisfaction. We therefore initiated a systematic review to establish whether patients are satisfied with tele-delivery of psychiatric care, and to identify the predictors of a positive experience with telepsychiatry. Methods A preliminary search was performed using five databases (MEDLINE, EMBASE, Cochrane Library, CINAHL, PsycINFO), with a date restriction between 2010-2020 to reflect advances in technology over the past decade. Results Preliminary data shows that patient views on telepsychiatric services are largely positive. Factors that arose in literature potentially affecting this include location, cost, privacy, digital literacy and technological issues including audio/video quality. Conclusion Our study so far shows that patient views on telepsychiatry are generally positive. The review is still in process, however, we anticipate that it will only further support our preliminary findings. These findings will be used to improve patient-centred delivery and provision of telepsychiatric services. We intend to produce a checklist of factors affecting patient satisfaction and test this in a national multicentre study. We are hoping that the study results and the resulting checklist will encourage greater patient involvement in setting up and delivering telepsychiatric services.