A pipeline analysis of advanced therapy medicinal products.

Advanced therapy medicinal products (ATMPs) are innovative biological products categorised as either gene, somatic cell, tissue-engineered or combined therapies. As of March 2022, 12 ATMPs are marketed in the EU and UK. We identified 482 unique ATMPs within 616 technology records from the National Institute for Health and Care Research Innovation Observatory database, 4 of which are currently marketed. These 482 ATMPs were identified in 583 clinical trials. Of the 616 records, 57.1% were for gene therapies and 1.6% were for combined therapies. Records covered various indications, including 130 haematological malignancies and 60 genetic disorders. Marketing authorisation intelligence was included in 14% of records.

Barriers and facilitators to implementation of shared medical appointments in primary care for the management of long-term conditions: a systematic review and synthesis of qualitative studies.

OBJECTIVE: To synthesise the published literature on practitioner, patient and carer views and experiences of shared medical appointments (SMAs) for the management of long-term conditions in primary care. DESIGN: Systematic review of qualitative primary studies. METHODS: A systematic search was conducted using MEDLINE (Ovid), PsycINFO (Ovid), CINAHL (EBSCOhost), Web of Science, Social Science Premium Collection (Proquest) and Scopus (SciVerse) from database starting dates to June 2019. Practitioner, patient and carer perspectives were coded separately. Deductive coding using a framework approach was followed by thematic analysis and narrative synthesis. Quality assessment was conducted using the Critical Appraisal Skills Programme for qualitative studies. RESULTS: We identified 18 unique studies that reported practitioner (n=11), patient (n=14) and/or carer perspectivs(n=3). Practitioners reported benefits of SMAs including scope for comprehensive patient-led care, peer support, less repetition and improved efficiency compared with 1:1 care. Barriers included administrative challenges and resistance from patients and colleagues, largely due to uncertainties and unclear expectations. Skilled facilitators, tailoring of SMAs to patient groups, leadership support and teamwork were reported to be important for successful delivery. Patients' reported experiences were largely positive with the SMAs considered a supportive environment in which to share and learn about self-care, though the need for good facilitation was recognised. Reports of carer experience were limited but included improved communication between carer and patient. CONCLUSION: There is insufficient evidence to indicate whether views and experiences vary between staff, medical condition and/or patient characteristics. Participant experiences may be subject to reporting bias. Policies and guidance regarding best practice need to be developed with consideration given to resource requirements. Further research is needed to capture views about wider and co-occurring conditions, to hear from those without SMA experience and to understand which groups of patients and practitioners should be brought together in an SMA for best effect. PROSPERO REGISTRATION NUMBER: CRD42019141893.

Qualitative systematic review of barriers and facilitators to self-management of chronic obstructive pulmonary disease: views of patients and healthcare professionals.

Self-management interventions for chronic obstructive pulmonary disease (COPD) can improve quality of life, reduce hospital admissions, and improve symptoms. However, many factors impede engagement for patients and practitioners. Qualitative research, with its focus on subjective experience, can provide invaluable insights into such factors. Therefore, a systematic review and synthesis of qualitative evidence on COPD self-management from the perspective of patients, carers, and practitioners was conducted. Following a systematic search and screening, 31 studies were appraised and data extracted for analysis. This review found that patients can adapt to COPD; however, learning to self-manage is often a protracted process. Emotional needs are considerable; frustration, depression, and anxiety are common. In addition, patients can face an assortment of losses and limitations on their lifestyle and social interaction. Over time, COPD can consume their existence, reducing motivation. Support from family can prove vital, yet tinged with ambivalence and burden. Practitioners may not have sufficient time, resources, or appropriate skills or confidence to provide effective self-management support, particularly in regard to patients' psychosocial needs. This can compound patients' capability to engage in self-management. For COPD self-management to be effective, patients' psychosocial needs must be prioritised alongside medication and exacerbation management. In addition, patients' personal beliefs regarding COPD and its management should be reviewed periodically to avoid problematic behaviours and enhance positive adaptions to the disease. Patients with COPD are not a homogenous group and no one intervention will prove effective for all. Finally, practitioners require greater education, training, and support to successfully assist patients.

Understanding the factors affecting self-management of COPD from the perspectives of healthcare practitioners: a qualitative study.

Self-management is recognised as an essential criteria for the provision of high quality care for chronic obstructive pulmonary disease (COPD). The management of COPD is usually delivered by a wide range of healthcare practitioners. This study aimed to understand the factors affecting self-management of COPD from the perspectives of the different multidisciplinary healthcare teams involved in COPD care. Semi-structured interviews were conducted with participants from primary care, specialist respiratory and pulmonary rehabilitation (PR) teams. Purposive sampling and snowballing were employed in participant recruitment. All interviews were audio-recorded and transcribed verbatim and data were analysed thematically. A total of 20 participants (eight primary care practitioners, seven respiratory specialists and five PR practitioners) were interviewed until data saturation was reached. Participants identified a range of complex and interrelated factors affecting COPD self-management that were grouped into three broad categories-patient, practitioner and organisational/system-level factors. Patient-level factors were predominantly considered as barriers, with COPD knowledge and understanding, and the individual patients' life circumstances/context being the most prominent issues. Practitioner-level factors identified were practitioners' speciality, interest and experience in respiratory conditions as the overarching factor that influenced how self-management was understood and practiced. A number of organisational/system-level factors were identified by all practitioners, including inconsistency of referral pathways and the wide variations of different self-management planning tools. Factors affecting self-management of COPD across these three levels need to be tackled equally in order to improve the effectiveness of interventions and to embed and integrate self-management support approaches into routine practice. CHRONIC LUNG DISEASE: A BALANCED APPROACH FOR IMPROVED SELF-MANAGEMENT: Better co-ordination between healthcare services, practitioners and patients may help improve self-management for chronic lung disease. Self-management is crucial for patients with chronic obstructive pulmonary disease (COPD), but it can be difficult for healthcare workers to monitor and support patient progress. Oladapo Ogunbayo at Newcastle University, UK, and co-workers conducted interviews with healthcare practitioners to explore perceived barriers to successful self-management of COPD. Three distinct categories emerged; those at patient level, practitioner level and organisational level, the needs of which should be carefully balanced to improved self-management. Patient knowledge and understanding of COPD, alongside individual life circumstances, were often barriers to effective self-care. Those practitioners with specialist respiratory knowledge took a more holistic approach to self-management than their primary care counterparts. A lack of continuity between services and across self-management planning tools presented further barriers.

Features of self-management interventions for people with COPD associated with improved health-related quality of life and reduced emergency department visits: a systematic review and meta-analysis.

BACKGROUND: Self-management interventions (SMIs) are recommended for individuals with COPD to help monitor symptoms and optimize health-related quality of life (HRQOL). However, SMIs vary widely in content, delivery, and intensity, making it unclear which methods and techniques are associated with improved outcomes. This systematic review aimed to summarize the current evidence base surrounding the effectiveness of SMIs for improving HRQOL in people with COPD. METHODS: Systematic reviews that focused upon SMIs were eligible for inclusion. Intervention descriptions were coded for behavior change techniques (BCTs) that targeted self-management behaviors to address 1) symptoms, 2) physical activity, and 3) mental health. Meta-analyses and meta-regression were used to explore the association between health behaviors targeted by SMIs, the BCTs used, patient illness severity, and modes of delivery, with the impact on HRQOL and emergency department (ED) visits. RESULTS: Data related to SMI content were extracted from 26 randomized controlled trials identified from 11 systematic reviews. Patients receiving SMIs reported improved HRQOL (standardized mean difference =-0.16; 95% confidence interval [CI] =-0.25, -0.07; P=0.001) and made fewer ED visits (standardized mean difference =-0.13; 95% CI =-0.23, -0.03; P=0.02) compared to patients who received usual care. Patients receiving SMIs targeting mental health alongside symptom management had greater improvement of HRQOL (Q=4.37; P=0.04) and fewer ED visits (Q=5.95; P=0.02) than patients receiving SMIs focused on symptom management alone. Within-group analyses showed that HRQOL was significantly improved in 1) studies with COPD patients with severe symptoms, 2) single-practitioner based SMIs but not SMIs delivered by a multidisciplinary team, 3) SMIs with multiple sessions but not single session SMIs, and 4) both individual- and group-based SMIs. CONCLUSION: SMIs can be effective at improving HRQOL and reducing ED visits, with those targeting mental health being significantly more effective than those targeting symptom management alone.

Self-care of long-term conditions: patients' perspectives and their (limited) use of community pharmacies.

Background Self-care support is an 'inseparable' component of quality healthcare for long-term conditions (LTCs). Evidence of how patients view and use community pharmacy (CP) to engage in self-care of LTCs is limited. Objective To explore patients' perspectives of engaging in self-care and use of CP for self-care support. Setting England and Scotland. Method Qualitative design employing semi-structured interviews. LTCs patients were recruited via general practitioners (GPs) and CPs. Interviews were conducted between May 2013 and June 2014; they were audio-recorded, transcribed verbatim and analysed thematically. Results Twenty-four participants were interviewed. Three main themes emerged: engaging in self-care, resources for self-care support and (limited) use of community pharmacy. Participants' LTC 'lived experience' showed that self-care was integral to daily living from being diagnosed to long-term maintenance of health/wellbeing; self-care engagement was very personal and diverse and was based on beliefs and experiences. Healthcare professionals were viewed as providing information which was considered passive and insufficient in helping behavioural change. Non-healthcare sources (family, carers, friends, internet) were important in filling active support gaps, particularly lifestyle management. Participants' use of, and identified need for, community pharmacy as a resource for self-care support of LTCs was limited and primarily focussed on medicines supply. There was low awareness and visibility of CPs' potential roles and capability. Conclusion CP needs to reflect on patients' low awareness of its expertise and services to contribute to self-care support of LTCs. Rethinking how interventions are designed and 'marketed'; incorporation of patients' perspectives and collaboration with others, particularly GPs, could prove beneficial.

How do community pharmacists conceptualise and operationalise self-care support of long-term conditions (LTCs)? An English cross-sectional survey.

OBJECTIVES: To explore community pharmacists' contributions to self-care support of long-term conditions by; investigating their conceptual understanding of self-care principles; identifying self-care support activities they considered important and their engagement in them; and examining barriers and enablers. METHODS: A questionnaire was developed using existing literature and qualitative interviews, piloted and distributed online to a random sample of 10 000 community pharmacists in England between August and November 2014. The questionnaire contained sections addressing the above objectives. Data were analysed using descriptive statistics; free text comments were analysed using content analysis. KEY FINDINGS: A total of 609 responses were received; 334 completed all sections of the survey. Responses to statements exploring conceptual understanding showed that respondents were more likely to agree with self-care principles about patients taking responsibility and being more actively involved in their health and care; they agreed less with self-care principles promoting patient autonomy and independence. Respondents considered medicines-related self-care support activities as a lead role for community pharmacy, which they said they engaged in regularly. Whilst many agreed that other self-care support activities such as supporting self-monitoring and collaborative care planning were important, they indicated only limited engagement. Respondents identified access to patient records and availability of private consultation rooms as their main barriers and enablers, respectively; working relationship with GPs and skill-mix in community pharmacy were viewed as both barriers and enablers. CONCLUSIONS: Community pharmacists in this study conceptualised and operationalised self-care support of long-term conditions (LTCs) from a narrow, medicines-focussed perspective, rather than from a multifaceted, patient-focussed perspective. A concerted and coherent strategy that builds on the strengths, and tackles the identified barriers is needed if community pharmacy is to improve contributions to self-care support of LTCs.

A qualitative study exploring community pharmacists' awareness of, and contribution to, self-care support in the management of long-term conditions in the United Kingdom.

BACKGROUND: Self-care support refers to activities aimed at educating, training and empowering patients with skills and ability to manage [and monitor] their long-term conditions (LTCs). While self-care support by health care professionals has emerged as a distinct concept in the management of LTCs, evidence of community pharmacy's contribution is sparse. OBJECTIVE: The aim was to explore community pharmacy's contribution to self-care support of LTCs. The objectives were to explore how community pharmacists conceptualize self-care support of LTCs and how they operationalize the core elements of this in their practice. METHODS: Semi-structured interviews were conducted with community pharmacists in England (n = 12) and Scotland (n = 12). A framework consisting of the core elements of self-care support (information and advice; skills training and support; technology; support networks; and collaborative care planning) was developed from the literature and was used to structure the interviews and analysis. Analysis was done thematically using the interpretative phenomenological analysis technique. RESULTS: The three main themes that emerged were conceptualization; operationalization of the core elements; and barriers to providing self-care support. Participants conceptualized self-care of LTCs as patients taking responsibility for their own health, performing activities that improved their LTCs and that enabled them to become more independent in managing their LTCs. Their views on self-care support did not reflect this conceptual understanding but was described primarily as providing patients with information and advice rather than actively supporting them. Participants' views of operationalizing the core elements of self-care support was found to be medicines focused, opportunistic and dependent on the services they provided, rather than being patient-centered and proactive. The barriers to providing self-care support of LTCs in community pharmacy were described as priority accorded to dispensing activities, the structure of the community pharmacy contract, lack of incentives to provide self-care support and patients' expectations and lack of awareness of community pharmacy's role in LTCs management. CONCLUSION: Community pharmacists' theoretical understanding of self-care was not reflected in the ways that they portrayed their contributions to self-care support. The current ways in which community pharmacy delivers its services for patient care may need to be re-configured in order to fit into the holistic self-care support paradigm.