Search

Cognitive impairment is common early after stroke but trajectories over the long term are variable. Some stroke survivors make a full recovery, while others retain a stable impairment or decline. This study explored the perceived advantages and disadvantages of discussing potential cognitive trajectories with stroke survivors and their family members. Stroke survivors at least six-months post-stroke were purposively sampled from an existing pool of research volunteers recruited originally for the OCS-Recovery study. They were invited, alongside a family member, to participate in a semi-structured interview. Interviews were audio recorded, transcribed, and analyzed using reflexive thematic analysis. Twenty-six stroke survivors and eleven family members participated. We identified one overarching theme and three related subthemes. The overarching theme was: One size does not fit all. The subthemes were: (1) Hearing about potential cognitive trajectories helps to develop realistic expectations; (2) Discussions about cognitive trajectories may be motivating; (3) Cognitive decline and post-stroke dementia discussions may be anxiety-provoking and depressing. Healthcare professionals should adopt a person-centred approach to sharing information about post-stroke cognitive trajectories. Discussions should be tailored to individual needs and preferences, with dementia-related topics in particular addressed with the utmost selectivity and sensitivity. [ABSTRACT FROM AUTHOR]

Abstract Background Palliative rehabilitation amalgamates the principles of palliative care and rehabilitation to enhance patients’ quality of life by optimizing physical function and maximizing autonomy despite advancing illness. Alongside providing non-pharmacological symptom management, it emphasizes personalized goal-setting tailored to individual needs. This case illustrates the transformative impact targeted physiotherapy interventions can have on patients’ physical function, morale and motivation in spite of their expected deterioration. Case presentation An 85-year-old male with angioimmunoblastic T cell lymphoma was admitted to home hospice care. He was referred for physiotherapy to optimize his function and mobility despite his short prognosis. A conversation guide was used throughout the duration of therapy to identify personal goals, prescribe and review the use of appropriate interventions, and discuss future therapeutic plans. Within a month he achieved his functional goals, experienced reduced physical dependency, and had increased satisfaction in his ability to participate more actively in self-care. This also resulted in significant improvements in his confidence, mood, and overall well-being. Engaging the patient actively in his care and management journey provided him with significant motivation and hope. Conclusion The case study highlights the vital role of physiotherapists in facilitating transparent communication among patients, healthcare providers, and caregivers throughout palliative rehabilitation. Through open dialogue and utilizing conversation guides, physiotherapists help understand patient preferences, goals, and motivation. This patient-centred approach ensures that therapeutic interventions align with individual needs, enhancing overall patient care and the provision of holistic palliative care.

Abstract Background: Solving complex research challenges requires innovative thinking and alternative approaches to traditional methods. One such example is the problem of arm and hand, or upper limb function in multiple sclerosis (MS), a neurological condition affecting approximately 2.9 million people worldwide and more than 150,000 in the United Kingdom. Historically, clinical trials and research have focused on mobility and walking ability. This excludes a large number of patients who are wheelchair users, limiting their quality of life and restricting access to possibly helpful medications. To address this issue, the ThinkHand campaign was launched in 2016, aiming to raise awareness about the importance of upper limb function in MS and develop alternative ways to measure, record, and account for hand and arm function changes. Main body: The campaign utilised innovative strategies at scientific conferences and online surveys to engage people affected by MS, healthcare professionals, charities, and researchers in discussing the importance of preserving upper limb function. Through co-design and interdisciplinary collaboration, the campaign developed new tools like the low-cost cardboard version of the Nine-Hole Peg Test, facilitating remote monitoring of hand function. Additionally, the campaign co-created the “Under & Over” rehabilitation tool, allowing individuals with advanced MS to participate in a remote rehabilitation program. The impact of the ThinkHand campaign has been significant, helping to shift the focus of both academic and industry-supported trials, including the O’HAND and ChariotMS trials, both using upper limb function as their primary end point. The campaign’s patient-centred approach highlighted the importance of recognising patients’ perspectives in research and challenged established assumptions and practices. It demonstrated the effectiveness of interdisciplinary collaboration, systems thinking, and co-creation with stakeholders in tackling complex problems. Conclusion: The ThinkHand campaign provides valuable insights for health research practices. By involving patients at all stages, researchers can gain a deeper understanding of the impact of disease on their lives, identify gaps and focus research on their needs. Experimentation and iteration can lead to innovative solutions, and openness to unconventional methods can drive widespread change. The ThinkHand campaign exemplifies the potential of patient-centred approaches to address complex research challenges and revolutionise the field of MS research and management. Embracing such approaches will contribute to more inclusive and impactful research in the future.

Objective: There is substantial practice variation in the management of cellulitis with limited prospective studies describing the course of cellulitis after diagnosis. We aimed to describe the demographics, clinical features (erythema, warmth, swelling and pain), patient‐reported disease trajectory and medium‐term follow‐up for ED patients with cellulitis. Methods: Prospective observational cohort study of adults diagnosed with cellulitis in two EDs in Southeast Queensland, Australia. Patients with (peri)orbital cellulitis and abscess were excluded. Data were obtained from a baseline questionnaire, electronic medical records and follow‐up questionnaires at 3, 7 and 14 days. Clinician adjudication of day 14 cellulitis cure was compared to patient assessment. Descriptive analyses were conducted. Results: Three‐hundred patients (mean age 50 years, SD 19.9) with cellulitis were enrolled, predominantly affecting the lower limb (75%). Cellulitis features showed greatest improvement between enrolment and day 3. Clinical improvement continued gradually at days 7 and 14 with persistent skin erythema (41%) and swelling (37%) at day 14. Skin warmth was the feature most likely to be resolved at each time point. There was a discrepancy in clinician and patient assessment of cellulitis cure at day 14 (85.8% vs. 52.8% cured). Conclusions: A clinical response of cellulitis features can be expected at day 3 with ongoing slower improvement over time. Over one third of patients had erythema or swelling at day 14. Patients are less likely than clinicians to deem their cellulitis cured at day 14. Future research should include parallel patient and clinician evaluation of cellulitis to help develop clearer definitions of treatment failure and cure. [ABSTRACT FROM AUTHOR]

Background: Palliative rehabilitation amalgamates the principles of palliative care and rehabilitation to enhance patients' quality of life by optimizing physical function and maximizing autonomy despite advancing illness. Alongside providing non-pharmacological symptom management, it emphasizes personalized goal-setting tailored to individual needs. This case illustrates the transformative impact targeted physiotherapy interventions can have on patients' physical function, morale and motivation in spite of their expected deterioration. Case presentation: An 85-year-old male with angioimmunoblastic T cell lymphoma was admitted to home hospice care. He was referred for physiotherapy to optimize his function and mobility despite his short prognosis. A conversation guide was used throughout the duration of therapy to identify personal goals, prescribe and review the use of appropriate interventions, and discuss future therapeutic plans. Within a month he achieved his functional goals, experienced reduced physical dependency, and had increased satisfaction in his ability to participate more actively in self-care. This also resulted in significant improvements in his confidence, mood, and overall well-being. Engaging the patient actively in his care and management journey provided him with significant motivation and hope. Conclusion: The case study highlights the vital role of physiotherapists in facilitating transparent communication among patients, healthcare providers, and caregivers throughout palliative rehabilitation. Through open dialogue and utilizing conversation guides, physiotherapists help understand patient preferences, goals, and motivation. This patient-centred approach ensures that therapeutic interventions align with individual needs, enhancing overall patient care and the provision of holistic palliative care. [ABSTRACT FROM AUTHOR]

Globally, more people are living into advanced old age, with age-associated frailty, disability and multimorbidity. Achieving equity for all ages necessitates adapting healthcare systems. Clinical practice guidelines (CPGs) have an important place in adapting evidence-based medicine and clinical care to reflect these changing needs. CPGs can facilitate better and more systematic care for older people. But they can also present a challenge to patient-centred care and shared decision-making when clinical and/or socioeconomic heterogeneity or personal priorities are not reflected in recommendations or in their application. Indeed, evidence is often lacking to enable this variability to be reflected in guidance. Evidence is more likely to be lacking about some sections of the population. Many older adults are at the intersection of many factors associated with exclusion from traditional clinical evidence sources with higher incidence of multimorbidity and disability compounded by poorer healthcare access and ultimately worse outcomes. We describe these challenges and illustrate how they can adversely affect CPG scope, the evidence available and its summation, the content of CPG recommendations and their patient-centred implementation. In all of this, we take older adults as our focus, but much of what we say will be applicable to other marginalised groups. Then, using the established process of formulating a CPG as a framework, we consider how these challenges can be mitigated, with particular attention to applicability and implementation. We consider why CPG recommendations on the same clinical areas may be inconsistent and describe approaches to ensuring that CPGs remain up to date. [ABSTRACT FROM AUTHOR]

Background: Solving complex research challenges requires innovative thinking and alternative approaches to traditional methods. One such example is the problem of arm and hand, or upper limb function in multiple sclerosis (MS), a neurological condition affecting approximately 2.9 million people worldwide and more than 150,000 in the United Kingdom. Historically, clinical trials and research have focused on mobility and walking ability. This excludes a large number of patients who are wheelchair users, limiting their quality of life and restricting access to possibly helpful medications. To address this issue, the ThinkHand campaign was launched in 2016, aiming to raise awareness about the importance of upper limb function in MS and develop alternative ways to measure, record, and account for hand and arm function changes. Main body: The campaign utilised innovative strategies at scientific conferences and online surveys to engage people affected by MS, healthcare professionals, charities, and researchers in discussing the importance of preserving upper limb function. Through co-design and interdisciplinary collaboration, the campaign developed new tools like the low-cost cardboard version of the Nine-Hole Peg Test, facilitating remote monitoring of hand function. Additionally, the campaign co-created the "Under & Over" rehabilitation tool, allowing individuals with advanced MS to participate in a remote rehabilitation program. The impact of the ThinkHand campaign has been significant, helping to shift the focus of both academic and industry-supported trials, including the O'HAND and ChariotMS trials, both using upper limb function as their primary end point. The campaign's patient-centred approach highlighted the importance of recognising patients' perspectives in research and challenged established assumptions and practices. It demonstrated the effectiveness of interdisciplinary collaboration, systems thinking, and co-creation with stakeholders in tackling complex problems. Conclusion: The ThinkHand campaign provides valuable insights for health research practices. By involving patients at all stages, researchers can gain a deeper understanding of the impact of disease on their lives, identify gaps and focus research on their needs. Experimentation and iteration can lead to innovative solutions, and openness to unconventional methods can drive widespread change. The ThinkHand campaign exemplifies the potential of patient-centred approaches to address complex research challenges and revolutionise the field of MS research and management. Embracing such approaches will contribute to more inclusive and impactful research in the future. Plain English Summary: Solving complex research challenges requires creative thinking and new ways of doing things. One such challenge is understanding the problems with arm and hand function in multiple sclerosis (MS), a neurological condition that affects more than 150,000 in the United Kingdom. In the past, research focused mainly on walking ability, leaving out many people who use wheelchairs. To tackle this issue, we created the ThinkHand campaign in 2016. Its goal was to raise awareness about the importance of hand and arm function for people with MS (pwMS) and find better ways to measure changes in these functions such that they can become outcomes in clinical trials. This could provide a pathway to better treatments for pwMS who cannot walk. The campaign used various methods, including surveys, social media posts, exhibitions and music to involve pwMS, healthcare professionals, charities, and researchers in discussions about the issues. Working together, they created tools to support pwMS, particularly those at an advanced stage of the disease (pwAMS), to take part in research and measure their hand and arm function. Through our collaborative approach focusing on patients' perspectives, the campaign challenged old ideas and deeply embedded practices. It showed that collaboration between different areas of expertise involving pwMS at all stages of research can help solve complex problems. This campaign teaches us valuable lessons for health research. When researchers listen to patients and try new things, they can better understand how a disease affects people's lives and develop better solutions. In conclusion, we show how embracing a patient-centred approach can address complex research challenges and improve how we study and manage MS and other conditions in the future. [ABSTRACT FROM AUTHOR]

Convexity products for ostomy care have been available many years. However, there still remains confusion regarding both nomenclature regarding convexity products and their clinical application. This gap creates a non-scientific approach to patient care as the clinician often relies on personal experiences creating more of an 'art-based' approach rather than care delivered from evidence. Recent publications are helping to improve the base knowledge of the clinician with new evidence that supports such clinical decision making in clinical practice. Ultimately, this evidence-based approach can improve patient outcomes by facilitating quality care while assisting product developers to create products that are more humanistic and patientcentered. This article explores some of this recent evidence, some clinical applications substantiated by evidence, and the potential for future product developments and ostomy product standardisation. [ABSTRACT FROM AUTHOR]

Purpose Restless Legs Syndrome (RLS) is a widespread condition that affects sleep leading to daytime sleepiness, depression, and reduced quality of life. This study aims to determine and describe how patients with RLS experience their everyday life, with a focus on facilitators and barriers related to Maslow’s hierarchical theory of human needs. Method Semi-structured interviews were analysed with qualitative content analysis resulting in facilitators and barriers affecting the fulfilment of the five human needs. Results Addressing RLS symptoms through medications and a quiet sleep environment fulfils psychological needs. Control over RLS symptoms, engagement in activities, trust in treatments, and social support meet safety and security needs. Social inclusion, close relationships, and meaningful interactions fulfil a sense of belongingness and love needs despite RLS. Competence in managing RLS, effective self-care strategies, confident communication, and trust-building support esteem needs. Finally, comprehensive understanding through person-centred interventions and coping fulfils the self-actualization needs in managing RLS. Conclusion Holistic and person-centred interventions, including facilitators for the fulfilment of physiological, psychological, and social needs could help healthcare professionals to provide holistic care.

Purpose This article describes intensive care nurses` experiences of using communicative caring touch as stroking the patient`s cheek or holding his hand. Our research question: “What do intensive care nurses communicate through caring touch?” Methods In this qualitative hermeneutically based study data from two intensive care units at Norwegian hospitals are analysed. Eight specialist nurses shared experiences through individual, semi-structured interviews. Results The main theme, Communicating safety and presence has four sub-themes: Amplified presence, Communicating security, trust and care, Creating and confirming relationships and Communicating openness to a deeper conversation. Communicative caring touch is offered from the nurse due to the patient`s needs. Caring touch communicates person-centred care, invites to relationship while respecting the patient’s dignity as a fellow human being. Caring touch conveys a human initiative in the highly technology environment. Conclusion Caring touch is the silent way to communicate care, hope, strength and humanity to critical sick patients. This article provides evidence for a common, but poorly described phenomenon in intensive care nursing.

In the daily challenges that healthcare professionals are called upon to face, pedagogical reflection can be a valuable ally to medicine, assisting professionals in managing the dynamics of the patient relationship. The dialogue between medicine and pedagogy represents an opportunity for interdisciplinarity that allows us to transcend the boundaries of science, fostering a vision of holistic patient care. The Radiotherapy department is an ideal setting to understand the patient’s genuine demand for treatment. This contribution, without claiming to be exhaustive, highlights some of the various personalized practices that the Gemelli ART Radiotherapy Center has implemented to place the patient at the centre of the treatment process. Rather than merely describing and classifying these practices, the focus is on reflecting on the foundations of ethically oriented actions undertaken at the Centre. [ABSTRACT FROM AUTHOR]

The sustainability and viability of the public health services accessible to all has been widely discussed worldwide, due to the aging of the population, increasing burden of chronic diseases and consequent rising of healthcare expenditures. The mortality and burden of cardiovascular disease is one of the most important drivers of public and private expenses and hypertension and non-compliance with medical prescription one of the leading contributors. Therefore, strategies that promote therapeutic adherence are necessary to control cardiovascular disease and its major outcomes. A solution named PACTO was developed and emphasizes the role of the patient as an active partner of health professionals. PACTO is a mHealth solution with a variety of functionalities that accompanies the patient throughout the treatment journey, with multiple incentives that promote behavioural changes. Finally, PACTO may work in interoperability with other applications already in use in primary healthcare, reducing its initial investment and clinical teams' overload, while increasing adherence, patients' health and quality of life, and sustainability of health systems. [ABSTRACT FROM AUTHOR]

Purpose: To assess and identify patients' perceptions about the overall value of physical therapy services for musculoskeletal conditions and how these values were associated with their outcomes. Methods: The association between the perceived value of physical therapy (as a score) and Patient‐Reported Outcomes Measurement Information System (PROMIS) pain interference and physical function at 6‐weeks was assessed in a prospective cohort. Generalised linear models were used to identify relationships between the value of physical therapy score and PROMIS outcomes. Kendall's tau was used to identify correlations between responses and outcomes. Results: A total of 133 participants met the final inclusion criteria. The majority of participants were female (63.9%) with a mean age of 55.53 (SD 15.36) years. A majority of participants (63.9%) reported a previous positive personal experience with physical therapy. There was no significant relationship between perceived value of physical therapy and pain interference (β −0.32, p = 0.07, 95% CI−0.67, 0.03) or physical function (β 0.19, p = 0.29, 95% CI−0.16, 0.54). Stronger beliefs in agreement with the value of non‐invasive treatment were significant, but weakly correlated with lower pain interference (r = −0.18, p = 0.048) and higher physical function scores (r = 0.22, p = 0.03). Conclusions: Participants had an overall positive perception of the value of physical therapy prior to initiating physical therapy, but this perception was not associated with 6‐week pain and function outcomes. A better understanding of the driving factors encouraging patients to seek physical therapy services is needed to provide value‐based care. [ABSTRACT FROM AUTHOR]

Tuberculosis (TB) education seeks to increase patient knowledge about TB, while TB counselling seeks to offer tailored advice and support for medication adherence. While universally recommended, little is known about how to provide effective, efficient, patient-centred TB education and counselling (TEC) in low-income, high HIV-TB burden settings. We sought to characterise stakeholder perceptions of TEC in a public, primary care facility in Kampala, Uganda, by conducting focus group discussions with health workers and TB patients in the TB and HIV clinics. Participants valued TEC but reported that high-quality TEC is rarely provided, because of a lack of time, space, staff, planning, and prioritisation given to TEC. To improve TEC, they recommended adopting practices that have proven effective in the HIV clinic, including better specifying educational content, and employing peer educators focused on TEC. Patients and health workers suggested that TEC should not only improve TB patient knowledge and adherence, but should also empower and assist all those undergoing evaluation for TB, whether confirmed or not, to educate their households and communities about TB. Community-engaged research with patients and front-line providers identified opportunities to streamline and standardise the delivery of TEC using a patient-centred, peer-educator model.

The National Health Service (NHS) cardiac rehabilitation patient care pathway has remained largely unchanged for many years despite, on average, half of all eligible patients declining to engage. To investigate reasons for non-engagement, we explored the experiences of ten cardiac patients who participated in cardiac rehabilitation, dropped out, or declined, as well as experiences of seven people deemed significant others by participants. Our ethnographic study involved participant observations, repeat in-depth semi-structured interviews, and reflexive journaling. Reflexive thematic analysis was conducted, focusing on participants' lived experiences. Utilising Bourdieusian concepts of habitus, capital, and field, this article highlights how personal biography, material conditions, and dispositional inclinations combine to make cardiac health care decision-making individual and complex. Despite this, health professionals were not always attuned to specific circumstances arising from differences in patients' experiences and lifeworlds. By considering service improvement recommendations that acknowledge socio-cultural influences, cardiac rehabilitation can work towards providing patients and their significant others with more appropriate, personalised, and person-centred support. [ABSTRACT FROM AUTHOR]

• It is vital to incorporate patient views into trial design. • We used complex experimental design to find out what pwCF value most when deciding whether to take part in trials. • Location of trial and distance travelled to site were the most important attributes when deciding whether to participate. • Post-trial medicine access, type of medicine, stipend provision and washouts were moderately influential. • Trial design had minimal influence and pwCF do not seem to find placebo-controlled trials off putting. Patient-centred trial design optimises recruitment and retention, reduces trial failure rates and increases the diversity of trial cohorts. This allows safe and effective treatments to reach clinic more quickly. To achieve this, patients' views must be incorporated into trial design. A discrete choice experiment was used to quantify preferences of pwCF for trials features; medicine type, trial location, stipend, washout, drug access on trial completion and trial design. Respondents were presented pairs of hypothetical trial scenarios with different level combinations assigned through experimental design. Respondents were asked to pick their preferred option or decline both. The cross-sectional data were explored using a Random Parameters Logit model. We received 207 eligible responses between Oct2020-Jan2021. The strongest influence on the decision to participate was trial location; pwCF favour participation at their usual clinical centre. Greater travel distances made respondents less willing to participate. Post-trial drug access ranked second. pwCF would rather participate in modulator trials than trials of other drugs. In general, pwCF did not favour a washout period, but were more prepared to washout non-modulators than modulators. Stipend provision was not ranked highly, but higher stipends increased intention to participate. Trial design (placebo vs open-label) had minimal influence on the decision to participate. There are complex interactions between placebos and washouts. We used quantitative methods to systematically elicit preferences of pwCF for clinical trials' features. We explore the relevance of our findings to trial design and delivery in the current CF trials landscape. [ABSTRACT FROM AUTHOR]

Background: Advances in genomics provide improved opportunities for diagnosis of complex neurogenetic disorders, yet the optimal approach to translate these benefits to the outpatient clinic is unclear. Aims: We retrospectively reviewed referral indications and outcomes of an integrated multidisciplinary team (MDT) clinic pathway for adults with suspected neurogenetic disorders. The associated cost implications were estimated. Methods: Consecutive patients who attended the neurogenomics clinic from January 2017 to April 2020 were included. The clinic comprised neurologists, clinical geneticists and genetic counsellors, who assessed each patient concurrently. Results: Ninety‐nine new patients were referred spanning 45 different clinical diagnoses. Following MDT clinical assessment, 23% (23/99) of referral diagnoses were revised prior to molecular testing. Eighty‐one patients (82%) underwent genetic testing, including 43 exome‐based panels, 15 whole‐genome sequencing, 14 single gene tests, 27 repeat‐primed polymerase chain reaction testing and two chromosomal microarrays. Overall, 33/99 patients (33%) received a diagnosis, either a molecular diagnosis (n = 24, of which 22 were diagnostic and two were predictive) or a clinical diagnosis (n = 9). Of the clinical diagnosis cohort, five patients received a diagnosis without molecular testing and four patients whose negative testing (one diagnostic and three predictive) allowed exclusion of genetic differentials and, hence, confirmation of clinical diagnoses. The diagnostic rate following MDT and diagnostic testing was 30% (28/94), excluding the five predictive testing cases. MDT assessment aligned with eventual molecular diagnoses in 96% of cases. The estimated average costs were AU$1386 per patient undergoing MDT assessment and AU$4159 per diagnosis achieved. Conclusions: We present an integrated multidisciplinary neurogenomics clinic pathway providing a diagnostic yield of 33% (30% excluding predictive testing cases), with costing implications. The relatively high diagnostic yield may be attributed to multidisciplinary input integrating accurate phenotyping of complex disorders and interpretation of genomic findings. [ABSTRACT FROM AUTHOR]

Background: Patient‐centred care (PCC) has been proposed as an appropriate approach for addressing current shifts in healthcare needs. Although the importance of PCC is generally recognised, PCC is poorly understood by patients in the hospital settings. Objectives: To identify patients' experiences of PCC in hospital settings. Methodological design: This systematic review followed the Joanna Briggs Institute's (JBI) guidance for systematic reviews of qualitative evidence and the PRISMA checklist for reporting systematic reviews. The search strategy included peer‐reviewed qualitative studies published after 2010 in English or Finnish. The databases searched were SCOPUS, MEDLINE, CINAHL and Medic. Unpublished studies and grey literature were searched in MedNar. Ten qualitative studies were included, and their quality was assessed by two independent reviewers using JBI quality assessment criteria. The data were analysed using thematic analysis. Setting and participants: Studies were included if they had explored adult patient experiences of PCC in hospital settings. Results: A thematic analysis produced 14 subthemes which were grouped into five analytical themes: the presence of the professional, patient involvement in care, receiving information, the patient–professional relationship and being seen as a person. Conclusions and implications: This review suggests that the implementation and provision of PCC in hospitals is incomplete and patients' involvement in their own care should be in the focus of PCC. The majority of patients experienced receiving PCC, but others did not. The need for improvement of patient involvement was strongly emphasised. Patients highlighted the importance of professionals being present and spending time with patients. Patients felt well‐informed about their care but expressed the need for better communication. Meaningful patient–professional relationships were brokered by professionals demonstrating genuine care and respecting the patient as an individual. To improve the implementation of PCC, patient experiences should be considered in the development of relevant hospital care strategies. In addition, more training in PCC and patient–professional communication should be provided to health care professionals. [ABSTRACT FROM AUTHOR]

Summary: Platform trials bring the promise of making clinical research more efficient and more patient centric. While their use has become more widespread, including their prominent role during the COVID-19 pandemic response, broader adoption of platform trials has been limited by the lack of experience and tools to navigate the critical upfront planning required to launch such collaborative studies. The European Union-Patient-cEntric clinicAl tRial pLatform (EU-PEARL) initiative has produced new methodologies to expand the use of platform trials with an overarching infrastructure and services embedded into Integrated Research Platforms (IRPs), in collaboration with patient representatives and through consultation with U.S. Food and Drug Administration and European Medicines Agency stakeholders. In this narrative review, we discuss the outlook for platform trials in Europe, including challenges related to infrastructure, design, adaptations, data sharing and regulation. Documents derived from the EU-PEARL project, alongside a literature search including PubMed and relevant grey literature (e.g., guidance from regulatory agencies and health technology agencies) were used as sources for a multi-stage collaborative process through which the 10 more important points based on lessons drawn from the EU-PEARL project were developed and summarised as guidance for the setup of platform trials. We conclude that early involvement of critical stakeholder such as regulatory agencies or patients are critical steps in the implementation and later acceptance of platform trials. Addressing these gaps will be critical for attaining the full potential of platform trials for patients. Funding: Innovative Medicines Initiative 2 Joint Undertaking with support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

Abstract Background The huge increase of refugees to Germany caused a great challenge to the health system. We aimed to examine the level of patient-centredness in medical consultations with refugee patients, aided by video interpreters in primary care walk-in clinics (PCWC) in Hamburg. Methods Videotaped consultations (N = 92) of 83 patients from 2017 to 2018 were analysed. Two raters used the Measure of Patient-Centered Communication (MPCC) and the International Classification of primary care (ICPC-2). MPCC scores with regard to patients’ reason for seeking medical care and the procedures taken were explored using variance analyses adjusted for age, gender, and the duration of the consultation. The duration was further explored by Pearson correlations. Results Patient-centredness of all consultations on average was 64% (95% CI 60–67) according to MPCC, with health-related issues affecting the results. The highest level of patient-centredness was achieved in psychological health issues with 79% (65–94), the lowest in respiratory ones with 55% (49–61). Longer consultations resulted in higher MPCC scores. Conclusions The level of patient-centredness varied in the addressed health issues as well as in the duration of the consultation. Despite the variation, video interpreting in consultations supports a solid patient-centredness. Practice implications We recommend the use of remote video interpreting services for outpatient healthcare to support patient-centred communication and to fill the gap of underrepresentation of qualified interpreters on site, regarding a high diversity of spoken languages.

Abstract Background Person-centred care is integral to high-quality health service provision, though concepts vary and the literature is complex. Validated instruments that measure person-centred practitioner skills, and behaviours within consultations, are needed for many reasons, including in training programmes. We aimed to provide a high-level synthesis of what was expected to be a large and diverse literature through a systematic review of existing reviews of validation studies a of instruments that measure person-centred practitioner skills and behaviours in consultations. The objectives were to undertake a critical appraisal of these reviews, and to summarise the available validated instruments and the evidence underpinning them. Methods A systematic search of Medline, EMBASE, PsycINFO and CINAHL was conducted in September 2020. Systematic reviews of validation studies of instruments measuring individual practitioner person-centred consultation skills or behaviours which report measurement properties were included. Review quality was assessed with the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses. Details of the reviews, the included validation studies, and the instruments themselves are tabulated, including psychometric data, and a narrative overview of the reviews is provided. Results Four reviews were eligible for inclusion. These used different conceptualisations of person-centredness and targeted distinct, sometimes mutually exclusive, practitioners and settings. The four reviews included 68 unique validation studies examining 42 instruments, but with very few overlaps. The critical appraisal shows there is a need for improvements in the design of reviews in this area. The instruments included within these reviews have not been subject to extensive validation study. Discussion There are many instruments available which measure person-centred skills in healthcare practitioners and this study offers a guide to what is available to researchers and research users. The most relevant and promising instruments that have already been developed, or items within them, should be further studied rigorously. Validation study of existing material is needed, not the development of new measures.

Introduction: The Syrian crisis, followed by a financial crisis, port explosion, and COVID-19, have put enormous strain on Lebanon's health system. Syrian refugees and the vulnerable host population have a high burden of Non-communicable Diseases (NCD) morbidity and unmet mental health, psychosocial and rehabilitation needs. The International Committee of the Red Cross (ICRC) recently introduced integrated NCD services within its package of primary care in Lebanon, which includes NCD primary health care, rehabilitation, and mental health and psychosocial support services. We aimed to identify relevant outcomes for people living with NCDs from refugee and host communities in northern Lebanon, as well as to define the processes needed to achieve them through an integrated model of care. Given the complexity of the health system in which the interventions are delivered, and the limited practical guidance on integration, we considered systems thinking to be the most appropriate methodological approach. Methods: A Theory of Change (ToC) workshop and follow-up meetings were held online by the ICRC, the London School of Hygiene and Tropical Medicine and the American University of Beirut in 2021. ToC is a participatory and iterative planning process involving key stakeholders, and seeks to understand a process of change by mapping out intermediate and long-term outcomes along hypothesised causal pathways. Participants included academics, and ICRC regional, coordination, and headquarters staff. Results: We identified two distinct pathways to integrated NCD primary care: a multidisciplinary service pathway and a patient and family support pathway. These were interdependent and linked via an essential social worker role and a robust information system. We also defined a list of key assumptions and interventions to achieve integration, and developed a list of monitoring indicators. Discussion: ToC is a useful tool to deconstruct the complexity of integrating NCD services. We highlight that integrated care rests on multidisciplinary and patient-centred approaches, which depend on a well-trained and resourced team, strong leadership, and adequate information systems. This paper provides the first theory-driven road map of implementation pathways, to help support the integration of NCD care for crises-affected populations in Lebanon and globally. [ABSTRACT FROM AUTHOR]

Abstract Background Clinical trials commonly use multiple endpoints to measure the impact of an intervention. While this improves the comprehensiveness of outcomes, it can make trial results difficult to interpret. We examined the impact of integrating patient weights into a composite endpoint on the interpretation of Control of Hypertension in Pregnancy Study (CHIPS) Trial results. Methods Outcome weights were extracted from a previous patient preferences study in pregnancy hypertension (N = 183 women) which identified (i) seven outcomes most important to women (taking medication, severe hypertension, pre-eclampsia, blood transfusion, Caesarean, delivery < 34 weeks, and baby born smaller-than-expected) and (ii) three preference subgroups: (1) ‘equal prioritizers’, 62%; (2) ‘early delivery avoiders’, 23%; and (3) ‘medication minimizers’, 14%. Outcome weights from the preference subgroups were integrated with CHIPS data for the seven outcomes identified in the preference study. A weighted composite score was derived for each participant by multiplying the preference weight for each outcome by the binary outcome if it occurred. Analyses considered equal weights and those from the preference subgroups. The mean composite scores were compared between trial arms (t-tests). Results Composite scores were similar between trial arms with the use of equal weights or those of subgroup (1) (95% confidence intervals [CIs]: − 0.03, 0.02; p > 0.50 for each). ‘Tight’ control was superior when using subgroup (2) weights (95% CIs: 0.002, 0.07; p = 0.03), and ‘less-tight’ control was superior when using subgroup (3) weights (95% CIs: − 0.11, − 0.04; p < 0.01). Conclusions Evidence-based recommendations for ‘tight’ control are consistent with most women’s preferences, but for a sixth of women, ‘less-tight’ control is more preference consistent. Depending on patient preferences, a single trial may support different interventions. Future trials should specify component weights to improve interpretation. Trial registration ClinicalTrials.gov NCT01192412

Background: The huge increase of refugees to Germany caused a great challenge to the health system. We aimed to examine the level of patient-centredness in medical consultations with refugee patients, aided by video interpreters in primary care walk-in clinics (PCWC) in Hamburg. Methods: Videotaped consultations (N = 92) of 83 patients from 2017 to 2018 were analysed. Two raters used the Measure of Patient-Centered Communication (MPCC) and the International Classification of primary care (ICPC-2). MPCC scores with regard to patients' reason for seeking medical care and the procedures taken were explored using variance analyses adjusted for age, gender, and the duration of the consultation. The duration was further explored by Pearson correlations. Results: Patient-centredness of all consultations on average was 64% (95% CI 60–67) according to MPCC, with health-related issues affecting the results. The highest level of patient-centredness was achieved in psychological health issues with 79% (65–94), the lowest in respiratory ones with 55% (49–61). Longer consultations resulted in higher MPCC scores. Conclusions: The level of patient-centredness varied in the addressed health issues as well as in the duration of the consultation. Despite the variation, video interpreting in consultations supports a solid patient-centredness. Practice implications: We recommend the use of remote video interpreting services for outpatient healthcare to support patient-centred communication and to fill the gap of underrepresentation of qualified interpreters on site, regarding a high diversity of spoken languages. [ABSTRACT FROM AUTHOR]

Background: Person-centred care is integral to high-quality health service provision, though concepts vary and the literature is complex. Validated instruments that measure person-centred practitioner skills, and behaviours within consultations, are needed for many reasons, including in training programmes. We aimed to provide a high-level synthesis of what was expected to be a large and diverse literature through a systematic review of existing reviews of validation studies a of instruments that measure person-centred practitioner skills and behaviours in consultations. The objectives were to undertake a critical appraisal of these reviews, and to summarise the available validated instruments and the evidence underpinning them. Methods: A systematic search of Medline, EMBASE, PsycINFO and CINAHL was conducted in September 2020. Systematic reviews of validation studies of instruments measuring individual practitioner person-centred consultation skills or behaviours which report measurement properties were included. Review quality was assessed with the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses. Details of the reviews, the included validation studies, and the instruments themselves are tabulated, including psychometric data, and a narrative overview of the reviews is provided. Results: Four reviews were eligible for inclusion. These used different conceptualisations of person-centredness and targeted distinct, sometimes mutually exclusive, practitioners and settings. The four reviews included 68 unique validation studies examining 42 instruments, but with very few overlaps. The critical appraisal shows there is a need for improvements in the design of reviews in this area. The instruments included within these reviews have not been subject to extensive validation study. Discussion: There are many instruments available which measure person-centred skills in healthcare practitioners and this study offers a guide to what is available to researchers and research users. The most relevant and promising instruments that have already been developed, or items within them, should be further studied rigorously. Validation study of existing material is needed, not the development of new measures. [ABSTRACT FROM AUTHOR]

There is increased interest in outcome measures that complement the classic goal of endodontics, being the prevention and healing of apical periodontitis. Possible outcome measures can be subdivided into patient‐centred outcomes (PCOs), encompassing data collected by nonpatients aiming to assess the effectiveness of an intervention and patient‐reported outcomes (PROs), which are reported directly by the patient. PROs can be subsequently classed into PRO measures that ascertain patients' view of their symptoms, their functional status, and their health‐related quality of life, and patient‐reported experience measures that focus on aspects including the humanity of care, patient satisfaction, patient preference and adherence, personal costs, expectation fulfilment, and decision regrets. The present review aims to define various patient‐related outcomes and discuss the literature available regarding PCOs and PROs in endodontics. This includes those proposed to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of European Society of Endodontology S3‐level clinical practice guidelines that have been included by all working groups, except for the radiographic assessment of apical periodontitis. Based on limited evidence in the field, it can be summarized that after recall periods of various lengths, endodontic treatment is associated with a high likelihood of tooth survival and limited need for further intervention, including extraction and further restorative procedures. Oral Health‐Related Quality of Life (OHRQoL) is likely to improve following the completion of treatment. Nonetheless, the literature assessing the association between OHRQoL and endodontics is hampered by the use of instruments that have not been previously validated. Amongst the remaining outcome measures discussed in the present review, it is worth highlighting that there is only one study assessing exacerbations in teeth with the presence of endodontic pathosis, which suggests a very low incidence of this adverse effect following endodontic treatment. Patients' expectation fulfilment, adherence, and satisfaction are closely inter‐related and depend also on various nonclinical factors. Further studies assessing PCOs and PROs, in association with healing and prevention of apical periodontitis, are required to better understand endodontic treatment from the perspective of patients. [ABSTRACT FROM AUTHOR]

The success of Local Safety Standards for Invasive Procedures (LocSSIPs) in preventing wrong tooth extraction and other patient safety incidents is based on sustained staff compliance from the outset, ahead of implementation. This paper (the second of two on the topic of LocSSIPs) aims to equip primary care dental practitioners with key practical solutions to implement LocSSIPs successfully and sustainably, and the leadership knowledge to create a long-term, safe, patient-centred and just service. [ABSTRACT FROM AUTHOR]

Abstract Background Complementary Medicine (CM) is widely used internationally but there is limited understanding of the forms of knowledge CM practitioners use in their clinical practice and how they use this knowledge in interactions with patients. This review aims to synthesise the existing evidence on the forms of knowledge that are mobilised, and the role of this knowledge in the interactions between practitioners and patients during CM consultations. It considered a diverse range of CM practice areas to develop a classification of CM practitioners’ knowledge use in consultations. Methods Systematic searches of health and sociology databases were conducted using core concepts, including complementary and alternative medicine, practitioners, and knowledge. Articles were included where they reported on data from recorded CM practitioner and patient consultations and offered insights into the types and applications of knowledge used in these consultations. 16 unique studies were included in the review. Data were extracted, coded and analysed thematically. Results Results demonstrate that diverse sources of knowledge were mobilised by practitioners, predominantly derived from the patients themselves –their bodies and their narratives. This reflected principles of patient-centredness. The use of discipline specific forms of knowledge and references to biomedical sources illustrated ongoing efforts towards legitimacy for CM practice. Conclusion CM practitioners are navigating tensions between what some might see as competing, others as complementary, forms of knowledge. The classification system provides a useful tool for promoting critically reflective practice by CM practitioners, particularly in relation to self-assessment of knowledge translation and patient interactions.

Background: Clinical trials commonly use multiple endpoints to measure the impact of an intervention. While this improves the comprehensiveness of outcomes, it can make trial results difficult to interpret. We examined the impact of integrating patient weights into a composite endpoint on the interpretation of Control of Hypertension in Pregnancy Study (CHIPS) Trial results. Methods: Outcome weights were extracted from a previous patient preferences study in pregnancy hypertension (N = 183 women) which identified (i) seven outcomes most important to women (taking medication, severe hypertension, pre-eclampsia, blood transfusion, Caesarean, delivery < 34 weeks, and baby born smaller-than-expected) and (ii) three preference subgroups: (1) 'equal prioritizers', 62%; (2) 'early delivery avoiders', 23%; and (3) 'medication minimizers', 14%. Outcome weights from the preference subgroups were integrated with CHIPS data for the seven outcomes identified in the preference study. A weighted composite score was derived for each participant by multiplying the preference weight for each outcome by the binary outcome if it occurred. Analyses considered equal weights and those from the preference subgroups. The mean composite scores were compared between trial arms (t-tests). Results: Composite scores were similar between trial arms with the use of equal weights or those of subgroup (1) (95% confidence intervals [CIs]: − 0.03, 0.02; p > 0.50 for each). 'Tight' control was superior when using subgroup (2) weights (95% CIs: 0.002, 0.07; p = 0.03), and 'less-tight' control was superior when using subgroup (3) weights (95% CIs: − 0.11, − 0.04; p < 0.01). Conclusions: Evidence-based recommendations for 'tight' control are consistent with most women's preferences, but for a sixth of women, 'less-tight' control is more preference consistent. Depending on patient preferences, a single trial may support different interventions. Future trials should specify component weights to improve interpretation. Trial registration: ClinicalTrials.gov NCT01192412 [ABSTRACT FROM AUTHOR]

Sandy Lines MBE discusses the latest in the 'cost of staying alive' crisis [ABSTRACT FROM AUTHOR]

Background: Relatively little is understood about real-world provision of oncology care in ambulatory outpatient clinics (OPCs). This study aimed to: 1) develop an understanding of behaviours and practices inherent in the delivery of cancer services in OPC common areas by characterising the organisation and implementation of this care; and 2) identify barriers to, and facilitators of, the delivery of this care in OPC common areas.Methods: A purpose-designed ethnographic study was employed in four public hospital OPCs. Informal field scoping activities were followed by in-situ observations, key informant interviews and document review. A view of OPCs as complex adaptive systems was used as a scaffold for the data collection and interpretation, with the intent of understanding 'work as done'. Data were analysed using an adapted "Qualitative Rapid Appraisal, Rigorous Analysis" approach.Results: Field observations were conducted over 135 h, interviews over 6.5 h and documents were reviewed. Analysis found six themes. Staff working in OPCs see themselves as part of small local teams and as part of a broader multidisciplinary care team. Professional role boundaries could be unclear in practice, as duties expanded to meet demand or to stop patients "falling through the cracks." Formal care processes in OPCs were supported by relationships, social capital and informal, but invaluable, institutional expertise. Features of the clinic layout, such as the proximity of departments, affected professional interactions. Staff were aware of inter- and intra-service communication difficulties and employed strategies to minimise negative impacts on patients. We found that complexity, coordination, culture and capacity underpin the themes that characterise this care provision.Conclusions: The study advances understanding of how multidisciplinary care is delivered in ambulatory settings and the factors which promote or inhibit effective care practice. Time pressures, communication challenges and competing priorities can pose barriers to care delivery. OPC care is facilitated by: self-organisation of participants; professional acumen; institutional knowledge; social ties and relationships between and within professional groups; and commitment to patient-centred care. An understanding of the realities of 'work-as-done' may help OPCs to sustain high-quality care in the face of escalating service demand. [ABSTRACT FROM AUTHOR]

Abstract Background Process evaluations are useful in clarifying results obtained from randomised controlled trials (RCTs). Traditionally, the degree of intervention usage in process evaluations is monitored by measuring dose or evaluating implementation fidelity. From a person-centred perspective, such evaluations should be supplemented with patients’ experiences of meaningful use, given that intervention use should be agreed upon between interested parties and tailored to each patient. This study aimed to elucidate patients’ experiences of a remote person-centred care (PCC) intervention by deepening the understanding of, if, how and for whom the intervention contributed to meaningful use. Methods Patients (n = 86) were recruited from the RCT PROTECT intervention group. A convergent mixed-method approach was implemented. Data were collected in parallel with the ongoing RCT via a survey, including ratings and written comments on meaningful or non-meaningful use. Also, interviews were performed with twelve purposefully selected participants. Descriptive statistics, logistic regression and content analysis were employed. Data sources were integrated in the results. Results Most participants rated the overall intervention as meaningful to use, with the telephone support rated as most meaningful. Interviews and written comments showed that patient ratings on meaningful use were explained by four categories: Not in need, Communication deficiency, Benefits in everyday life and A personal boost. Meaningful use of rating symptoms on the digital platform was predicted by living alone (adjusted odds ratio [aOR] = 2.8 P = .044). A diagnosis of chronic obstructive pulmonary disease (COPD) predicted meaningful use of digital platform direct messaging (aOR = 3.5, P = .045). Moreover, having access to direct-dial telephone contact explained meaningful use among participants with low ratings of technical competence (aOR = 3.6, P = .014). Conclusions The combined digital platform and structured telephone support could be helpful in identifying preventive actions to maintain health for people diagnosed with COPD and chronic heart failure but tends to be more meaningful for those diagnosed with COPD. Overall, lower adoption of the digital platform was seen compared to telephone support. Shortcomings were noted in the digital platform’s implementation that negatively influences experiences of meaningful use. When used, the intervention proved to be an easily applicable and valued tool to support preventive actions in a person-centred manner.

Abstract Background Developments in the care of critically ill patients with severe burns have led to improved hospital survival, but long-term recovery may be impaired. The extent to which patient-centred outcomes are assessed and reported in studies in this population is unclear. Methods We conducted a systematic review to assess the outcomes reported in studies involving critically ill burns patients. Randomised controlled trials (RCTs) and cohort studies on the topics of fluid resuscitation, analgesia, haemodynamic monitoring, ventilation strategies, transfusion targets, enteral nutrition and timing of surgery were included. We assessed the outcomes reported and then classified these according to two suggested core outcome sets. Results A comprehensive search returned 6154 studies; 98 papers met inclusion criteria. There were 66 RCTs, 19 clinical studies with concurrent controls and 13 interventional studies without concurrent controls. Outcome reporting was inconsistent across studies. Pain, reported using the visual analogue scale, fluid volume administered and mortality were the only outcomes measured in more than three studies. Sixty-six studies (67%) had surrogate primary outcomes. Follow-up was poor, with median longest follow-up across all studies 5 days (IQR 3–28). When compared to the suggested OMERACT core outcome set, 53% of papers reported on mortality, 28% reported on life impact, 30% reported resource/economic outcomes and 95% reported on pathophysiological manifestations. Burns-specific Falder outcome reporting was globally poor, with only 4.3% of outcomes being reported across the 98 papers. Conclusion There are deficiencies in the reporting of outcomes in the literature pertaining to the intensive care management of patients with severe burns, both with regard to the consistency of outcomes as well as a lack of focus on patient-centred outcomes. Long-term outcomes are infrequently reported. The development and validation of a core outcome dataset for severe burns would improve the quality of reporting.

Abstract Background Relatively little is understood about real-world provision of oncology care in ambulatory outpatient clinics (OPCs). This study aimed to: 1) develop an understanding of behaviours and practices inherent in the delivery of cancer services in OPC common areas by characterising the organisation and implementation of this care; and 2) identify barriers to, and facilitators of, the delivery of this care in OPC common areas. Methods A purpose-designed ethnographic study was employed in four public hospital OPCs. Informal field scoping activities were followed by in-situ observations, key informant interviews and document review. A view of OPCs as complex adaptive systems was used as a scaffold for the data collection and interpretation, with the intent of understanding ‘work as done’. Data were analysed using an adapted “Qualitative Rapid Appraisal, Rigorous Analysis” approach. Results Field observations were conducted over 135 h, interviews over 6.5 h and documents were reviewed. Analysis found six themes. Staff working in OPCs see themselves as part of small local teams and as part of a broader multidisciplinary care team. Professional role boundaries could be unclear in practice, as duties expanded to meet demand or to stop patients “falling through the cracks.” Formal care processes in OPCs were supported by relationships, social capital and informal, but invaluable, institutional expertise. Features of the clinic layout, such as the proximity of departments, affected professional interactions. Staff were aware of inter- and intra-service communication difficulties and employed strategies to minimise negative impacts on patients. We found that complexity, coordination, culture and capacity underpin the themes that characterise this care provision. Conclusions The study advances understanding of how multidisciplinary care is delivered in ambulatory settings and the factors which promote or inhibit effective care practice. Time pressures, communication challenges and competing priorities can pose barriers to care delivery. OPC care is facilitated by: self-organisation of participants; professional acumen; institutional knowledge; social ties and relationships between and within professional groups; and commitment to patient-centred care. An understanding of the realities of ‘work-as-done’ may help OPCs to sustain high-quality care in the face of escalating service demand.

Plain Language Summary High-quality health care for women and girls should be provided by health workers who are respectful and caring. Health workers should also work with others as a team and help women and girls make their own decisions about their health care. This approach is called patient-centred care. Female genital mutilation (FGM) is a cultural practice associated with poor health outcomes. Women who have experienced FGM have not always received quality health care. We studied the guidance and tools to help health workers provide care to women and girls with or at risk of FGM. This study aimed to understand how health workers are supported to provide woman and girl-centred health care in these documents. We searched for these documents on the websites of health professional associations, government health departments and organisations working in FGM in the United Kingdom, Ireland, Canada, The United States, New Zealand, and Australia. The documents were analysed using a tool that described all the important areas needed to provide patient-centred health care. Of the 124 documents, we found that only 12% contained information about all aspects of patient-centred care. Only one document had details about all the areas that are part of patient-centred care. This study shows that we need to improve the FGM-related guidance provided to health workers to care for and protect women and girls. There is a need for health workers to involve women and girls with or at risk of FGM in designing guidelines and tools and evaluating them to these documents best fit their needs.

Introduction. Sponsors of clinical trials propose variations of home visits and virtual contact points with the patients instead of visits at the clinical sites, as well as other digital and remote solutions. The objective of the study was to search and analyse the experience and practice of European countries on applying decentralized elements and a hybrid approach of conducting clinical trials’ activities and procedures, as well as to establish the applicable rules and regulation. Material and methods. A questionnaire survey was conducted among European countries in the period December 2020 – February 2021, by email communication. Results. In most of the countries, it was not forbidden, and respondents indicated the opportunity of medical specialists to help patients at their home. 37.50% of the countries indicated that the applicable legislation cannot be related to the medical or clinical trials legislation or national commercial law but “Other”. Based on the practice, all or some of the activities can be done as a home care. 68.75% responded negatively to the application of the “site-less” model, but 81.25% considered that the combination of on-site and home visits can be better than only visits at sites. Conclusion. Based on this research, the implementation of decentralized elements in the clinical trials in Europe is often based on a case-by-case evaluation only. Notwithstanding the application of various national requirements and acts, they are either fragmentary, or not specifically applicable for such cases.

Background: Recruitment and retention of participants in clinical trials for Parkinson's disease (PD) is challenging. A qualitative study embedded in the PD STAT multi-centre randomised controlled trial of simvastatin for neuroprotection in PD explored the motivators, barriers and challenges of participants, care partners and research staff. Objective: To outline a set of considerations informing a patient-centred approach to trial recruitment, retention, and delivery. Method: We performed semi-structured interviews and focus groups with a subset of trial participants and their care partners. Quantitative and qualitative data were obtained through surveys circulated among the 235 participants across 23 UK sites at the beginning, middle and end of the 2-year trial. We also interviewed and surveyed research staff at trial closure. Results: Twenty-seven people with PD, 6 care partners and 9 researchers participated in interviews and focus groups. A total of 463 trial participant survey datasets were obtained across three timepoints, and 53 staff survey datasets at trial closure. Trial participants discussed the physical and psychological challenges they faced, especially in the context of OFF state assessments, relationships, and communication with research staff. Care partners shared their insights into OFF state challenges, and the value of being heard by research teams. Research staff echoed many concerns with suggestions on flexible, person-centred approaches to maximising convenience, comfort, and privacy. Conclusion: These considerations, in favour of person-centred research protocols informed by the variable needs of participants, care partners and staff, could be developed into a set of recommendations for future trials. [ABSTRACT FROM AUTHOR]

This article reads Charlotte Brontë's letters documenting her sister Emily Brontë's experience of tuberculosis in late 1848, considering how the correspondence has cultivated a one-sided account of Emily's final months. Rereading the letters analytically, I argue that the differences between the sisters that Charlotte articulates gravitate around her implicit conception of the "good" consumptive, with Emily's resistance positioning her unfairly as a "bad" patient. Informed by Roy Porter's conception of "patient centred", I read against the grain of Charlotte's letters to challenge dominant accounts of Emily's illness and death. I suggest that when considered contextually and from Emily's point of view, Charlotte letters offer alternate ways to understand Emily's experience of tuberculosis and her behaviour in her final months. [ABSTRACT FROM AUTHOR]

Background: Developments in the care of critically ill patients with severe burns have led to improved hospital survival, but long-term recovery may be impaired. The extent to which patient-centred outcomes are assessed and reported in studies in this population is unclear. Methods: We conducted a systematic review to assess the outcomes reported in studies involving critically ill burns patients. Randomised controlled trials (RCTs) and cohort studies on the topics of fluid resuscitation, analgesia, haemodynamic monitoring, ventilation strategies, transfusion targets, enteral nutrition and timing of surgery were included. We assessed the outcomes reported and then classified these according to two suggested core outcome sets. Results: A comprehensive search returned 6154 studies; 98 papers met inclusion criteria. There were 66 RCTs, 19 clinical studies with concurrent controls and 13 interventional studies without concurrent controls. Outcome reporting was inconsistent across studies. Pain, reported using the visual analogue scale, fluid volume administered and mortality were the only outcomes measured in more than three studies. Sixty-six studies (67%) had surrogate primary outcomes. Follow-up was poor, with median longest follow-up across all studies 5 days (IQR 3–28). When compared to the suggested OMERACT core outcome set, 53% of papers reported on mortality, 28% reported on life impact, 30% reported resource/economic outcomes and 95% reported on pathophysiological manifestations. Burns-specific Falder outcome reporting was globally poor, with only 4.3% of outcomes being reported across the 98 papers. Conclusion: There are deficiencies in the reporting of outcomes in the literature pertaining to the intensive care management of patients with severe burns, both with regard to the consistency of outcomes as well as a lack of focus on patient-centred outcomes. Long-term outcomes are infrequently reported. The development and validation of a core outcome dataset for severe burns would improve the quality of reporting. [ABSTRACT FROM AUTHOR]

Objectives: To identify key attributes of healthcare quality relevant to patients and kin and to compare them to Lachman's multidimensional quality model.Methods: Four focus groups with patients and kin were conducted using a semi-structured interview guide and a purposive sampling method. Classical content analysis and constant comparison method were used to focus data analysis on individual and group level.Results: Communication with patients, kin and professionals emerged as a new dimension from interview transcripts. Other identified key attributes largely corresponded with Lachman's multidimensional quality model. They were mainly classified in dimensions: 'Partnership and Co-Production', 'Dignity and Respect' and 'Effectiveness'. Technical quality dimensions were linked to organisational aspects of care in terms of staffing levels and time. The dimension 'Eco-friendly' was not addressed by patients or kin.Conclusions: The results enhance the comprehension of healthcare quality and contribute to its academic understanding by validating Lachman's multidimensional quality model from patients' and kin's perspective. The model robustness is increased by including communication as a quality dimension surrounding technical domains and core values.Practice Implications: The key attributes can serve as a holistic framework for healthcare organisations to design their quality management system. An instrument can be developed to measure key attributes. [ABSTRACT FROM AUTHOR]

Participation in clinical work is important for medical students' professional development. However, students often report that they experience a passive observer role, and further research on contextual factors that influence student participation is needed. The theory of practice architectures contributes a new perspective to this challenge by elucidating how cultural-discursive, material-economic, and social-political arrangements enable and constrain student participation in clinical work. The aim of this study was to explore how practice architectures in clinical learning environments enable and constrain medical students' participation. The study was designed as an ethnographic field study in three student clinics: 106 h of observation. Analysis comprised ethnographic analysis followed by application of the theory of practice architectures. The ethnographic analysis resulted in six themes: setting the scene, when to call for help, my room – my patient, getting in a routine, I know something you don't, and my work is needed. Applying the theory of practice architectures showed that material-economic arrangements, such as control of the consultation room and essential artefacts, were crucial to student participation and position in the clinical workplace. Furthermore, co-production of a student mandate to independently perform certain parts of a consultation enabled a co-productive student position in the hierarchy of care-producers. The findings offer a conceptually generalisable model for the study of material and social dimensions of clinical learning environments. Although not all clinical learning environments may wish to or have the resources to implement a student clinic, the findings offer insights into general issues about the arrangements of student participation relevant to most clinical teaching contexts. [ABSTRACT FROM AUTHOR]

Copyright of Nordic Nursing Research / Nordisk Sygeplejeforskning is the property of H. Aschehoug & Co. (W. Nygaard) AS and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)