Intravenous versus subcutaneous trastuzumab: an economic and patient perspective

Since 2005, when the first patients outside of a clinical trial were treated with trastuzumab at The Christie NHS Foundation Trust, a nurse-led service has been developed to facilitate and support a safe treatment pathway for patients. There have been significant developments in the number of patients treated, the mode of administration of the drug and patient choice regarding the location of treatment delivery. This article focuses on the change from intravenous to subcutaneous administration, considering patient experience and choice, particularly in light of the advent of biosimilar drugs, which will necessitate a return to the intravenous route. The relative costs of intravenous and subcutaneous administration are illustrated and the results of a patient survey presented, indicating a strong preference for subcutaneous trastuzumab.

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Gaining patient experience insights

Conference Proceedings of the Academy for Design Innovation Management ◽

10.33114/adim.2019.05.253 ◽

2019 ◽

Vol 2 (1) ◽

Author(s):

Maitane GARCÍA-LÓPEZ ◽

Ester VAL ◽

Ion IRIARTE ◽

Raquel OLARTE

Keyword(s):

Type 1 Diabetes ◽

Patient Experience ◽

Patient Perspective ◽

Continuum Of Care ◽

Theoretical Framework ◽

Cognitive Responses ◽

The Continuum

Taking patient experience as a basis, this paper introduces a theoretical framework, to capture insights leading to new technological healthcare solutions. Targeting a recently diagnosed type 1 diabetes child and her mother (the principal caregiver), the framework showed its potential with effective identification of meaningful insights in a generative session. The framework is based on the patient experience across the continuum of care. It identifies insights from the patient perspective: capturing patients´ emotional and cognitive responses, understanding agents involved in patient experience, uncovering pain moments, identifying their root causes, and/or prioritizing actions for improvement. The framework deepens understanding of the patient experience by providing an integrated and multi-leveled structure to assist designers to (a) empathise with the patient and the caregiver throughout the continuum of care, (b) understand the interdependencies around the patient and different agents and (c) reveal insights at the interaction level.

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Patient Experience in Home Respiratory Therapies: Where We Are and Where to Go

Journal of Clinical Medicine ◽

10.3390/jcm8040555 ◽

2019 ◽

Vol 8 (4) ◽

pp. 555 ◽

Cited By ~ 5

Author(s):

Cátia Caneiras ◽

Cristina Jácome ◽

Sagrario Mayoralas-Alises ◽

José Ramon Calvo ◽

João Almeida Fonseca ◽

...

Keyword(s):

Clinical Research ◽

Patient Experience ◽

Clinical Care ◽

Research Priorities ◽

Specific Patient ◽

Quality Healthcare ◽

Body Of Knowledge ◽

Number Of Patients ◽

Patient Reported ◽

System Sustainability

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.

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P-150 Insights into the gastric and oesophageal cancer patient experience: Results of a pan-European patient survey

Annals of Oncology ◽

10.1016/j.annonc.2021.05.205 ◽

2021 ◽

Vol 32 ◽

pp. S150

Author(s):

Z. Maravic ◽

V. Fotaki ◽

O. Mesalles Naranjo ◽

E. Gasenko ◽

I. Rawicka ◽

...

Keyword(s):

Cancer Patient ◽

Patient Experience ◽

Oesophageal Cancer ◽

Patient Survey

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As predicted by theory: choice and competition in a publicly funded and regulated regional health system yield improved access and cost control

BMC Health Services Research ◽

10.1186/s12913-021-06392-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jonas Wohlin ◽

Clara Fischer ◽

Karin Solberg Carlsson ◽

Sara Korlén ◽

Pamela Mazzocato ◽

...

Keyword(s):

Cost Control ◽

Care Quality ◽

Patient Choice ◽

Public Healthcare ◽

Successful Implementation ◽

Publicly Funded ◽

Public And Private ◽

Bundled Payment ◽

Private Providers ◽

Number Of Patients

Abstract Background New Public Management (NPM) has been widely used to introduce competition into public healthcare. Results have been mixed, and there has been much controversy about the appropriateness of a private sector-mimicking governance model in a public service. One voice in the debate suggested that rather than discussing whether competition is “good” or “bad” the emphasis should be on exploring the conditions for a successful implementation. Methods We report a longitudinal case study of the introduction of patient choice and allowing private providers to enter a publicly funded market. Patients in need of hip or knee replacement surgery are allowed to choose provider, and those are paid a fixed reimbursement for the full care episode (bundled payment). Providers are financially accountable for complications. Data on number of patients, waiting lists and times, costs to the public purchaser, and complications were collected from public registries. Providers were interviewed at three points in time during a nine-year follow-up period. Time-series of the quantitative data were exhibited and the views of actors involved were explored in a thematic analysis of the interviews. Results The policy goals of improving access to care and care quality while controlling total costs were achieved in a sustained way. Six themes were identified among actors interviewed and those were consistent over time. The design of the patient choice model was accepted, although all providers were discontent with the level of reimbursement. Providers felt that quality, timeliness of service and staff satisfaction had improved. Public and private providers differed in terms of patient-mix and developed different strategies to adjust to the reimbursement system. Private providers were more active in marketing and improving operation room efficiency. All providers intensified cooperation with referring physicians. Close attention was paid to following the rules set by the purchaser. Discussion and conclusions The sustained cost control was an effect of bundled payment. What this study shows is that both public and private providers adhere long-term to regulations by a public purchaser that also controls entrance to the market. The compensation was fixed and led to competition on quality, as predicted by theory.

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Establishing a nurse-led thyroid cancer follow-up clinic

British Journal of Nursing ◽

10.12968/bjon.2021.30.4.s28 ◽

2021 ◽

Vol 30 (4) ◽

pp. S28-S35

Author(s):

Andrew Fishburn ◽

Nicola Fishburn

Keyword(s):

Thyroid Cancer ◽

Complex Disease ◽

Disease Recurrence ◽

Patient Survey ◽

Safe Patient Care ◽

Face To Face ◽

Number Of Patients ◽

Risk Of Disease

Thyroid cancer is a complex disease requiring management by a large multidisciplinary team. The number of patients with a diagnosis of thyroid cancer is significantly increasing year-on-year, and traditional models of consultant-led follow up are no longer sustainable. Although nurse-led cancer follow-up clinics are becomining increasingly common, thyroid cancer nurse-led follow-up clinics are rare. An excellent understanding of the disease, treatment and management of risk of disease recurrence is essential for safe patient care, and is discussed in this article. The clinic discussed uses the skill set of head and neck nurse specialists, including psychological support, coping strategies for long-term side effects of treatment and non-medical prescribing. A patient survey of the service revealed high levels of patient satisfaction and a desire to continue face-to-face consultations rather than telephone clinics.

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Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽

10.1186/s12916-021-01955-0 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Asger S. Paludan-Müller ◽

Perrine Créquit ◽

Isabelle Boutron

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Study ◽

Primary Source ◽

European Medicines Agency ◽

Clinical Trial Registries ◽

Number Of Patients ◽

Journal Publications ◽

Clinical Study Reports ◽

Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

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Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

Journal of Wound Care ◽

10.12968/jowc.2021.30.sup5.s7 ◽

2021 ◽

Vol 30 (Sup5) ◽

pp. S7-S14

Author(s):

Thomas E Serena ◽

Neal M Bullock ◽

Windy Cole ◽

John Lantis ◽

Lam Li ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Diabetic Foot ◽

Oxygen Therapy ◽

Wound Closure ◽

Foot Ulcers ◽

Controlled Clinical Trial ◽

Diabetic Foot Ulcers ◽

Open Label ◽

Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

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