Development Of Clinical Pathway Research Articles

Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act.

Recent research has raised questions about potential unintended consequences of the Inflation Reduction Act's Drug Price Negotiation Program (DPNP), suggesting that the timelines introduced by the law may reduce manufacturer incentives to invest in post-approval research towards additional indications. Given the role of multiple indications in expanding treatment options in patients with cancer, IRA-related changes to development incentives are especially relevant in oncology. This study aimed to describe heterogeneous drug-level trajectories and timelines of subsequent indications in a cohort of recently approved, multi-indication oncology drugs, including overall, across subgroups of drugs characterized by the timing and pace of additional indications, and by drug type (i.e., small molecule vs. biologic). This cross-sectional study evaluated oncology drugs first approved by the FDA from 2008 to 2018 and later approved for one or more additional indications. Numbers, types, and approval timelines of subsequent indications were recorded at the drug level, with drugs grouped by quartile based on the pacing of post-approval development (i.e., "rapid pace" to "measured pace"). Multi-indication oncology drugs (N = 56/86, 65.1%) had one or more subsequent indication approved in a new: cancer type (60.7%), line of treatment (50.0%), combination (41.1%), mutation (32.1%), or stage (28.6%). The median time between FDA approvals for indications increased from 0.6 years (IQR: 0.48, 0.74) in the "rapid pace" group to 1.6 years (IQR: 1.32, 1.66), 2.4 years (IQR: 2.29, 2.61), and 4.9 years (IQR: 3.43, 6.23) in the "moderate," "measured-moderate," and "measured" pace groups, respectively. Drugs in the "rapid pace" group often received their first subsequent indication approval within 9 months of initial approval (median: 0.7 years; IQR: 0.54, 1.59), whereas the "measured pace" group took a median of 5.7 years (IQR: 3.43, 6.98). Across all multi-indication drugs, the median time to the most recent approval for a subsequent indication was 5.5 years (IQR: 3.18, 7.95). One quarter (25%) of drugs were approved for their most recent subsequent indication after the time at which they would be DPNP-eligible. Approval histories of new oncology drugs demonstrate the role of post-approval indications in expanding treatment options towards new cancer types, stages, lines, combinations, and mutations. Heterogeneous clinical development pathways provide insights into potential unintended consequences of IRA-related changes surrounding post-approval research and development.

End of life care in chronic limb threatening ischemia: a retrospective cohort study

ObjectiveChronic limb-threatening ischemia (CLTI) is the end-stage of peripheral artery disease, defined as 2 or more weeks of rest pain and/or tissue loss from objectively proven obstructive arterial disease. Mortality is high, yet literature on end-of-life and palliative care in this setting is scarce. Palliative care is care that is aimed at alleviating the physiological and psychological symptoms and addresses the social and spiritual needs of patients and family/carers. End-of-life care is an umbrella term for palliative care given alongside disease-modifying care. The aim of this study was to evaluate predictors of end-of-life and palliative care and corresponding outcomes using surgical revascularization and amputation as surrogate markers for CLTI. MethodsThis was a retrospective single-center cohort study of people with CLTI who underwent either surgical revascularization (bypass) or amputation between January 2018 and December 2019. Palliative care input was defined as a dedicated palliative care consultation by a palliative care professional, medical doctor, surgeon, or advanced care practitioner. Data was collected on patient demographics, cause and place of death, and palliative and end-of-life care outcomes, which included documentation of preferred place of care/death and care priorities, family involvement in advance care planning discussions, key workers allocated to coordinate palliative care, use of community palliative care registers, hospice referral, time spent in hospital and the intensive care unit toward the end of life, and realization of documented care objectives. The data was analyzed to determine predictors of palliative care and tangible outcomes. ResultsOne-hundred and eighty-six patients were included (116 bypass and 70 amputation) with a median age of 67.5 years (interquartile range, 58-76 years) and most were male (73.7%) with a median survival of 46 months (interquartile range, 21-54 months) and a 2-year survival of 72% (95% confidence interval, 66%-79%). Palliative care consultations occurred for 10.8% of patients, with the median time from consultation to death of 5 days. Of the deceased, only a few had preferred place of care/death (8.1%), care priorities (18.3%), and family involvement during advance care planning (15.1%) documented in their notes. Cause of death was most commonly due to sepsis (n = 30), malignancy (n = 11), and myocardial infarction (n = 10). Mortality and in-hospital death were significantly higher in patients who underwent amputation in comparison to bypass surgery. There was an association of both cardiac and renal dysfunction with palliative care input. Patients with palliative care input were more likely to have documentation of preferred place of care/death, care priorities, and resuscitation decisions; and family involvement in advance care planning decisions. However, this did not translate into a reduction in hospital readmission or time spent in the hospital or intensive care unit towards the end of life. ConclusionsPatients with CLTI are not being offered palliative care in line with The National Institute for Health and Care Excellence or The Vascular Society of Great Britain and Ireland guidance. There was an association between palliative care input and end-of-life care quality. However, input occurred too close to death to have a very significant effect. Further research, development of clinical pathways and services, and better integration between palliative and vascular services is needed to improve the end-of-life care of patients living with CLTI.

An optimal trauma-informed pathway for PTSD, complex PTSD and other mental health and psychosocial impacts of trauma in prisons: an expert consensus statement

ABSTRACT People in prisons have high levels of trauma exposure throughout their lives. Presentations are often complex, with a high prevalence of PTSD and CPTSD and other mental health comorbidities. Prisons themselves can be stressful and traumatising environments. There are challenges in the delivery of effective treatments for PTSD and CPTSD. There is a need for the development of effective clinical pathways for these conditions that are embedded within trauma-informed organisational approaches. Responding to this need, this report is the result of a multidisciplinary expert consensus meeting and review of the research literature on PTSD, CPTSD, associated comorbidities and optimal approaches to trauma-informed practice. The group consisted of 24 expert representatives from psychology, psychiatry, healthcare, academia, social care and Welsh Government. The meeting commenced with presentations on various aspects of the clinical pathway for PTSD and complex PTSD in prisons, and of applications of trauma-informed practice within prisons. Small sub-groups then provided practical recommendations and solutions relevant to their assigned topic. Findings were presented to all meeting attendees for another round of discussion and debate, until consensus was reached. The resulting recommendations provide guidance to improve identification, treatment and support for people living in prison who have experienced trauma.

Development and validity testing of a matrix to evaluate maturity of clinical pathways: a case study in Saskatchewan, Canada

BackgroundHealthcare systems are transforming into learning health systems that use data-driven and research-informed approaches to achieve continuous improvement. One of these approaches is the use of clinical pathways, which are tools to standardize care for a specific population and improve healthcare quality. Evaluating the maturity of clinical pathways is necessary to inform pathway development teams and health system decision makers about required pathway revisions or implementation supports. In an effort to improve the development, implementation, and sustainability of provincial clinical pathways, we developed a clinical pathways maturity evaluation matrix. To explore the initial content and face validity of the matrix, we used it to evaluate a case pathway within a provincial health authority in Saskatchewan, Canada.MethodsBy using iterative consensus-based processes, we gathered feedback from stakeholders including patient and family partners, policy makers, clinicians, and quality improvement specialists, to rank, retain, or remove enablers and sub-enablers of the draft matrix. We tested the matrix on the Chronic Pain Pathway (CPP) for primary care in a local pilot area and revised the matrix based on feedback from the CPP development team leader.ResultsThe final matrix contains five enablers (i.e., Design, Ownership and Performer, Infrastructure, Performance Management, and Culture), 20 sub-enablers, and three trajectory definitions for each sub-enabler. Supplemental documents were created for six sub-enablers. The CPP scored 15 out of 40 possible points of maturity. Although the pathway scored highest in the Design enabler (10/12), it requires more attention in several areas, specifically the Ownership and Performer and the Performance Management enablers, each of which scored zero. Additionally, the Infrastructure and Culture enablers scored 2/4 and 3/8 points, respectively. These areas of the CPP are in need of improvement in order to enhance the overall maturity of the CPP.ConclusionsWe developed a clinical pathways maturity matrix to evaluate the various dimensions of clinical pathways’ development and implementation. The goals of this initial work were to develop and validate a tool to assess the maturity and readiness of new or existing pathways and to track pathways' revisions and improvements.

Clinical care for severe and persistent eating disorders in pediatric populations: Perspectives of health professionals

ObjectiveModels of treatment for adults with severe and enduring eating disorders focus on harm reduction and improving quality of life. However, there is a notable gap in the pediatric literature in this area. The current study set out to assess the perspectives of health professionals regarding clinical care for young people (e.g., ages 10–25 years) with severe and enduring eating disorders, and to explore perceptions about appropriate treatment options for these presentations.MethodsHealth professionals were invited to complete a two-stage online survey about their experiences with clinical care for pediatric eating disorders through Canadian and Australian professional eating disorder networks. Survey 1 included questions about their experiences in supporting individuals with severe and enduring presentations. Participants who completed Survey 2 reviewed clinical vignettes and shared their perspectives about treatment recommendations and models of care, including for a severe and enduring presentation.ResultsA total of 85 clinicians responded to questions on Survey 1 about severe and enduring eating disorder presentations. A portion of these respondents (n = 25) also participated in Survey 2. The majority of respondents to Survey 1 reported providing clinical care for pediatric severe and enduring eating disorder presentations. Amongst respondents to Survey 2, there was low consensus amongst respondents for the clinical care that would be most appropriate for young people with a severe and enduring eating disorder presentation. Numerous challenges in models of care for severe and enduring presentations in pediatric settings were raised in responses on Survey 2, with clinicians sharing their awareness of models focusing on quality of life, while also raising concerns about the appropriateness of these models for young people.ConclusionsThe preliminary results of this study demonstrate that the majority of clinicians report that they have provided care to young people with severe and enduring presentations. There is a clear need for establishing guidance for clinicians working in pediatric eating disorder settings around models of care focused on quality of life. Engagement with interested parties, including those with lived experience, can clarify the development of terminology and clinical pathways for severe and enduring presentations of pediatric eating disorders.

PENTA as a model for advanced integrated cancer management in low-resource settings.

e13783 Background: Cancer models are reactive, fragmented, and volume-based care, in which the lack of coordination between different layers of care, along with clinical and quality variability, technological pressure, and dominant positions, result in high levels of inefficiency and waste, affecting economic sustainability and hence effective access. This is prohibitive for low-resource settings. Modern healthcare system models in this scenarios should focus on solve this problems. Comprehensive cancer management needs a reorientation towards value- and efficiency-generating architectures.Usual redesigns have focused on direct cost containment through intensified audits or new contracting and payment modalities between stakeholders. However, the real impact of these strategies is marginal, increasing sectoral mistrust and failing to meet the quintuple aim. PENTA is a comprehensive cancer management framework to optimize cancer patient care, with emphasis on clinical governance, data guidance, and clinical-administrative alignment. This is an operational model for stakeholders in low-resource settings. PENTA model has been successfully implemented in health insurance companies in Colombia and in private insurance branch in Peru. Methods: PENTA has been applied since 2020. We employed a work methodology based on the Agile-2 matrix, which allows for fluidity and lower resource consumption. This methodology is hybrid and its execution begins with an initial diagnosis of the process within the partner company. This diagnosis includes prioritizing interventions from each of the axes, but understanding that this is a systemic project that includes 5 fundamental axes. This axes must be worked on simultaneously and interdependently to achieve the greatest value. Axes are: 1. Smart Risk Management, 2. Advanced Clinical Gobernance, 3. Value Audit, 4. Technology Management and 5. Value-based Contracting Focus on managing inefficiencies and waste (optimization model), PENTA can generate early results across various dimensions such as clinical variability and technology costs. Structuring and using a cross-cutting data architecture is fundamental to the model's development into a data control tower. Results: Implementation of a data control tower for cancer cohorts , development of joint clinical pathways (insurer-payer) for prioritized diseases, clinical practice agreements with hierarchical positions on high-cost medications, implementation of mini health technology assessments (HTAs), and generation of new prospective payment modalities based on performance adjustment. The estimated savings generated are $1.5 million for the phase 2 in Colombia and $800,000 for the phase 1 in Peru. Conclusions: PENTA is an agile framework for cancer management that can be sucessfully adapted to low-resource settings.

Variation in care for inpatients with avoidant restrictive food intake disorder leads to development of a novel inpatient clinical pathway to standardize care

IntroductionThere is limited evidence to guide management of patients with avoidant restrictive food intake disorder (ARFID) admitted for medical stabilization. We describe variations in inpatient care which led to the development of a multidisciplinary inpatient clinical pathway (ICP) to provide standardized management and examine differences after the ICP was implemented.MethodsA retrospective review of patients with ARFID admitted to Adolescent Medicine, Gastroenterology, and General Pediatrics at a single academic center was conducted. We compare hospital utilization and use of consulting services during the pre-ICP (2015–2017) and post-ICP (2018–2020) periods.Results110 patients were admitted with ARFID (n = 57 pre- vs. n = 53 post-ICP). Most presented with moderate/severe malnutrition (63% pre vs. 81% post; p = 0.11) and co-morbid anxiety and/or depression (74% pre vs. 92% post; p = 0.01). There was some variation in use of enteral tube feeding by service in both periods (p = 0.76 and p = 0.38, respectively), although overall use was consistent between periods (46% pre vs. 58% post; p = 0.18). Pre-ICP, use of the restrictive eating disorder protocol differed across services (p < 0.001), with only AM using it. Overall, utilization of the restrictive eating disorder protocol decreased from 16% pre-ICP to 2% post-ICP (p = 0.02). There was variation by service in psychiatry/psychology (range 82–100% by service; p = 0.09) and social work consultations (range 17–71% by service; p = 0.001) during the pre-ICP period, though variation was reduced in the post-ICP period (p = 0.99 and p = 0.05, respectively). Implementation of the ICP led to improvements in these consultative services, with all patients in the post-ICP period receiving psychiatry/psychology consultation (p = 0.05) and an increase in social work consults from 44 to 64% (p = 0.03). Nutrition consults were consistently utilized in both periods (98% pre vs. 100% post; p = 0.33).ConclusionThe ICP was developed to standardize inpatient medical stabilization for patients with ARFID. In this single center study, implementation of the ICP increased standardized care for inpatients with ARFID with variation in care reduced: there were improvements in the use of consulting services and a reduction in the use of the restrictive eating disorder protocol. The ICP demonstrates the potential to further standardize and improve care over time.

Development of a Clinical Pathway for Bariatric Surgery as an Integral Part of a Comprehensive Treatment for Adolescents with Severe Obesity in the Netherlands

Introduction: In the Netherlands, bariatric surgery in adolescents is currently only allowed in the context of scientific research. Besides this, there was no clinical pathway for bariatric surgery in adolescents. In this paper, the development of a comprehensive clinical pathway for bariatric surgery in adolescents with severe obesity in the Netherlands is described. Methods: The clinical pathway for bariatric surgery in adolescents consists of an eligibility assessment as well as comprehensive peri- and postoperative care. Regarding the eligibility assessment, the adolescents need to be identified by their attending pediatricians and afterwards be evaluated by specialized pediatric obesity units. If the provided treatment is considered to be insufficiently effective, the adolescent will anonymously be evaluated by a national board. This is an additional diligence procedure specifically established for bariatric surgery in adolescents. The national board consists of independent experts regarding adolescent bariatric surgery and evaluates whether the adolescents meet the criteria defined by the national professional associations. The final step is an assessment by a multidisciplinary team for adolescent bariatric surgery. The various disciplines (pediatrician, bariatric surgeon, psychologist, dietician) evaluate whether an adolescent is eligible for bariatric surgery. In this decision-making process, it is crucial to assess whether the adolescent is expected to adhere to postoperative behavioral changes and follow-up. When an adolescent is deemed eligible for bariatric surgery, he or she will receive preoperative counseling by a bariatric surgeon to decide on the type of bariatric procedure (Roux-en-Y gastric bypass or sleeve gastrectomy). Postoperative care consists of intensive guidance by the multidisciplinary team for adolescent bariatric surgery. In this guidance, several regular appointments are included and additional care will be provided based on the needs of the adolescent and his or her family. Furthermore, the multidisciplinary lifestyle intervention, in which the adolescents participated before bariatric surgery, continues in coordination with the multidisciplinary team for adolescent bariatric surgery, and this ensures long-term counseling and follow-up. Conclusion: The implementation of bariatric surgery as an integral part of a comprehensive treatment for adolescents with severe obesity requires the development of a clinical pathway with a variety of disciplines.

The current status and challenges of perioperative management of patients with a BMI of greater than or equal to 50kg/m 2 undergoing bariatric surgery in China: a multicenter cross-sectional study.

Performing bariatric surgery on patients with a BMI of over 50kg/m 2 is challenging. This study aimed to explore the status and challenges related to the perioperative management of such patients in China. A prospective survey was designed to investigate the perioperative management of patients with a BMI of greater than or equal to 50kg/m 2 undergoing bariatric surgery in China. The questionnaire of our survey included general information, preoperative management measures, surgical procedures performed, technical details regarding anaesthesia, and postoperative management measures. A response from only one attending physician per bariatric centre was accepted. Physicians from a total of 101 hospitals responded to the questionnaire, and the questionnaire data from 98 hospitals were complete. These centres had completed a total of 44702 bariatric surgeries since the launch of such surgery to December 2021. A total of 3280 patients had a BMI exceeding 50kg/m 2 . The preferred surgical procedures for patients with super obesity were sleeve gastrectomy by 62 centres, Roux-en-Y gastric bypass by 11 centres, sleeve gastrectomy plus jejunojejunal bypass by 19 centres, one anastomosis gastric bypass by 1 centre, and duodenal switch by 1 centre. The most worrying issues were cardiopulmonary failure and difficulty in extubation. 91 centres believed that preoperative weight loss was beneficial. A low-calorie diet was the specific measure mainly implemented, only three centres considered using intragastric balloon placement. Postoperative management measures varied greatly. Bariatric surgery has seen rapid development. Chinese physicians show significant differences regarding the perioperative management for patients with a BMI of over 50kg/m 2 . The perioperative risks of these patients remain relatively high, making further development of clinical pathways is necessary.

Development of palliative care clinical practice guidelines and referral care pathways for primary care practitioners in Pakistan

BackgroundDespite a large burden of life-limitingillness, there exists a dearth of services of palliative care in Pakistan. International guidelines have questionable applicability in Pakistan due to the socioeconomic differences. We generated a protocol describing the process of developing comprehensive palliative care guidelines and palliative care referral pathways for primary care practitioners to adopt in Pakistan.MethodsA GRADE-ADOLOPMENT approach with modification has been employed to create guidelines for a Pakistani context. The “National Comprehensive Cancer Network Guidelines Insights: Palliative Care, Version 2.2021” was used as the source guideline. Recommendations from the source guideline were reviewed by two local palliative care specialists to either “Adopt,” “Adapt” or “Exclude”. The finalized recommendations were incorporated into the local palliative care guideline. Clinical diagnosis and referral pathways were made from the finalized guideline. Any gaps in management found in the pathways were filled by taking existing recommendations from other credible guidelines.ResultsTwenty-seven recommendations were adopted without modification. No recommendations were deemed to be adapted and 15 were excluded. The referral care pathways created were reflective of the local guideline and included elements of initial assessment, preliminary management, reassessment, and referral. 6 additional recommendations were made.ConclusionThe described clinical practice guidelines and primary care clinical referral pathways will aid to standardize palliative care provision in Pakistan. These can be used by other resource constrained settings to develop guidelines within their own local context.

Frailty in an Adult Acute Hospital Population: Predictors, Prevalence, and Outcomes.

Frailty is common among older hospital inpatients. While studies describe frailty prevalence in acute hospitals, it is usually based upon retrospective hospital-coded data or brief screening on admission rather than comprehensive geriatric assessment (CGA). Further, little is known about differences between pre-admission and current frailty status. Given this, we investigated the prevalence of pre-frailty and frailty among adult inpatients in a large university hospital after CGA. Of the 410 inpatients available, 398 were included in the study, with a median age of 70 years; 56% were male. The median length of stay (LOS) at review was 8 days. The point prevalence of frailty was 30% versus 14% for pre-frailty. The median Clinical Frailty Scale score pre-admission was 3/9, which was significantly lower than at review, which was 4/9 (p < 0.001). After adjusting for age and sex, frailty was associated with greater odds of prolonged LOS (odds ratio [OR] 1.7, p = 0.045), one-year mortality (OR 2.1, p = 0.006), and one-year institutionalisation (OR 9, p < 0.001) but not re-admission. Frailty was most prevalent on medical and orthopaedic wards. In conclusion, CGA is an important risk assessment for hospitalised patients. Frailty was highly prevalent and associated with poor healthcare outcomes. Frailty status appears to worsen significantly during admission, likely reflecting acute illness, and it may not reflect a patient's true frailty level. The development of frailty clinical care pathways is recommended in order to address the poor prognosis associated with a diagnosis of frailty in this setting.

Factors predictive of hospital admission for children via emergency departments in Australia and Sweden: an observational cross-sectional study

BackgroundIdentifying factors predictive of hospital admission can be useful to prospectively inform bed management and patient flow strategies and decrease emergency department (ED) crowding. It is largely unknown if admission rate or factors predictive of admission vary based on the population to which the ED served (i.e., children only, or both adults and children). This study aimed to describe the profile and identify factors predictive of hospital admission for children who presented to four EDs in Australia and one ED in Sweden.MethodsA multi-site observational cross-sectional study using routinely collected data pertaining to ED presentations made by children < 18 years of age between July 1, 2011 and October 31, 2012. Univariate and multivariate analysis were undertaken to determine factors predictive of hospital admission.ResultsOf the 151,647 ED presentations made during the study period, 22% resulted in hospital admission. Admission rate varied by site; the children’s EDs in Australia had higher admission rates (South Australia: 26%, Queensland: 23%) than the mixed (adult and children’s) EDs (South Australia: 13%, Queensland: 17%, Sweden: 18%). Factors most predictive of hospital admission for children, after controlling for triage category, included hospital type (children’s only) adjusted odds ratio (aOR):2.3 (95%CI: 2.2–2.4), arrival by ambulance aOR:2.8 (95%CI: 2.7–2.9), referral from primary health aOR:1.5 (95%CI: 1.4–1.6) and presentation with a respiratory or gastrointestinal condition (aOR:2.6, 95%CI: 2.5–2.8 and aOR:1.5, 95%CI: 1.4–1.6, respectively). Predictors were similar when each site was considered separately.ConclusionsAlthough the characteristics of children varied by site, factors predictive of hospital admission were mostly similar. The awareness of these factors predicting the need for hospital admission can support the development of clinical pathways.

Design organization and clinical processes around patient characteristics: Evidence from a multiple case study of Hemophilia.

Background: There is growing evidence of the relevance of designing organization of care around patient characteristics; this is especially true in the case of complex chronic diseases.Purpose: The goal of the paper - that focuses on the analysis of the clinical condition hemophilia in three different centers - is to address two different research questions:1. How can we define, within the same clinical condition, different patient profiles homogeneous in terms of intensity of service required (e.g. number of visits or diagnostics)? 2. What are the conditions to re-organize care around these patient profiles in a multidisciplinary and coordinated manner?Research design: The authors have used a multiple case study approach combining both qualitative and quantitative methodologies; in particularly the semi-structured interviews and the direct observation were aimed to map the process in order to come up with an estimate of the cost of the full cycle of care.Study sample: The research methodology has been applied consistently in three different centers. The selection of the structures has been based on two main different criteria: (i) high standards regarding both organizational and clinical aspects and (ii) willingness from management, nurses and physicians to provide data.Results: The study clearly shows that different patient profiles - within the same clinical condition - trigger a different set of diagnostic and therapeutic activities. It is, thus, important considering patient characteristics in the development and implementation of clinical pathways and this will imply relevant differences in terms of organizational and economic impact.Conclusions: These process-based analyses are very much critical especially if we want to move to a bundled and integrated payment system but, as shown by this study itself, require a lot of time and efforts since our healthcare information systems are still fragmented and vertically designed.

‘Look up from the waiting list and see the bigger picture’: a qualitative analysis of clinical specialist physiotherapist perspectives on low back pain care in Ireland

IntroductionHealthcare systems are struggling to deliver high-quality low back pain (LBP) care. In 2012 specialist physiotherapist-led musculoskeletal (MSK) triage services were introduced in Irish hospitals to expedite patient care and alleviate pressure on elective orthopaedic/ rheumatology consultant clinics. Specialist physiotherapists have expertise to inform health service improvement and reform, but their perspectives of LBP healthcare delivery have received scant attention. ObjectivesTo explore specialist physiotherapists’ perspectives on LBP care in Ireland, the barriers and facilitators to quality LBP care and the development of MSK interface services in primary care settings. DesignCross-sectional observational study using an anonymous electronic survey with thematic framework analysis of response data from open-ended questions. ParticipantsThirty-four clinical specialist physiotherapists in Irish MSK triage services. ResultsThematic analysis resulted in six overarching themes, grouped into two categories. One category pertained to LBP healthcare in Ireland with the following three themes: 1) Inadequate health services for patients with LBP; 2) Need for defined LBP clinical pathways; 3) Need for a multisectoral approach to spine health. Themes in the second category, pertaining to the development of community-based MSK interface services, were: 4) Concern regarding isolation from secondary care services; 5) Unrealistic expectations of MSK triage; 6) Improved communication and collaboration with primary care services. ConclusionSpecialist physiotherapists have concerns regarding LBP health services and persistence of a biomedical, secondary care-led approach. They advocate for investment in primary care multi-disciplinary teams, enhanced integration across primary and secondary care, development of a national clinical pathway and a multisectoral approach. Contribution of paper•This study captures, for the first time, the perspectives of specialist physiotherapists on LBP healthcare delivery enabling a better understanding of the ‘on-the-ground’ issues in delivering quality LBP healthcare.•Opportunities for LBP healthcare service improvement are identified at micro, meso and macro health system levels.•The findings can be used to inform the development and implementation of a new national LBP clinical pathway and community-based MSK triage clinics.

Translational PK/PD for the Development of Novel Antibiotics-A Drug Developer's Perspective.

Antibiotic development traditionally involved large Phase 3 programs, preceded by Phase 2 studies. Recognizing the high unmet medical need for new antibiotics and, in some cases, challenges to conducting large clinical trials, regulators created a streamlined clinical development pathway in which a lean clinical efficacy dataset is complemented by nonclinical data as supportive evidence of efficacy. In this context, translational Pharmacokinetic/Pharmacodynamic (PK/PD) plays a key role and is a major contributor to a "robust" nonclinical package. The classical PK/PD index approach, proven successful for established classes of antibiotics, is at the core of recent antibiotic approvals and the current antibacterial PK/PD guidelines by regulators. Nevertheless, in the case of novel antibiotics with a novel Mechanism of Action (MoA), there is no prior experience with the PK/PD index approach as the basis for translating nonclinical efficacy to clinical outcome, and additional nonclinical studies and PK/PD analyses might be considered to increase confidence. In this review, we discuss the value and limitations of the classical PK/PD approach and present potential risk mitigation activities, including the introduction of a semi-mechanism-based PK/PD modeling approach. We propose a general nonclinical PK/PD package from which drug developers might choose the studies most relevant for each individual candidate in order to build up a "robust" nonclinical PK/PD understanding.

The role of healthcare leaders in implementing equitable clinical academic pathways for nurses: An integrative review.

To identify and synthesize empirical evidence on the role of healthcare leaders in the development of equitable clinical academic pathways for nurses. Integrative literature review. Literature was searched using CINAHL, PubMed, ProQuest and Google Scholar databases. A total of 114 eligible articles published between 2010 and2022 were screened, 16 papers were selected. Results highlighted the need for consistent national, regional, and organizational policy approaches to developing clinical academic careers for nurses. Government health departments and National Health boards must focus on increasing engagement in research and evidence-based nursing practice for high-quality patient care. Discriminatory practices and attitudes were identified as barriers. Discrimination due to gender was evident, while the impact of race, ethnicity, and other social categories of identity are under-researched. Educational leaders must unravel misconceptions about research, highlighting its relevance to patient care and bedside nurses' work. Academic leaders together with executive nurses, research funders and professional nursing bodies must create appropriately remunerated career structures. Transformative approaches are required to develop the clinical academic nurse role and understand its value in clinical practice. Multiple elements exist within complex systems that healthcare leaders can navigate collaboratively to develop and implement clinical nurse academic roles. This requires vision, acknowledgement of the value of nursing research and the importance of evidence-based research infrastructures. Findings highlight the collaborative role of healthcare leaders as critical to the success of critical academic careers for nurses. This review can inform those still to formalize this innovative role for nurses. The review complies with the PRISMA guidelines for reporting systematic reviews. This paper contributes evidence about the healthcare leader's role in developing clinical academic pathways for nurses to the wider global clinical community. No patient or public contribution was included in this review.

Evaluation of Analgesic Drug Therapy for Postoperative Pain Management in Cardiovascular Surgery

BackgroundCardiovascular surgery is usually associated with higher degree of postoperative pain, affecting the patient's physical recovery. Multiple clinical measures have been taken to avoid overuse of opioid for postoperative pain management, which led to the development of clinical pathways for analgesic drug treatment using a multimodal approach. ObjectiveTo evaluate the effectiveness and safety of a multimodal postoperative analgesic drug pathway (ADP) for the pain management following cardiovascular surgery. MethodsThis retrospective, controlled, non-randomized study evaluated postoperative ADP in patients undergoing cardiovascular surgery in a tertiary general hospital in Qingdao, China. Effectiveness and safety outcomes were compared before and after the implementation of ADP. Outcome indicators include postoperative pain scores, consumption of opioids in analgesic pumps and incidence of adverse events. ResultsPatients who underwent cardiovascular surgery from September to November 2021 before the implementation of ADP (N = 193) and from September to November 2022 after the implementation of ADP (N = 218) were enrolled. Pain scores were reduced on day 1, 3 and 5 after surgery and in mild pain, the reduction was most significant (P < 0.001). Opioid in analgesic pumps consumption was also significantly reduced and decreased incidence of adverse events such as nausea and vomiting (P = 0.026), respiratory inhibition (P = 0.027), and dizziness and headache (P = 0.028) were noted in cardiovascular surgery patients after ADP implementation. ConclusionsImproved effectiveness and safety were observed following the implementation of ADP. Multimodal analgesic ADP methodology can be effectively used for the postoperative pain management of cardiovascular surgery patients.

"The infinity loop of healthcare innovation: Development of an integrated rehabilitation pathway for spinal surgery through design thinking"

Introduction: One of the biggest fears of most clinical researchers is the translational “valley of death”, where scientific evidence (what is known) is lost in translation towards clinical practice (what is done). Bridging this know-do valley is challenging, and often targeted through developing a clinical “pathway”. Traditional frameworks for pathway development are known to be researcher-centered and linear. To overcome these shortcomings, we propose design thinking as a new framework for developing more user-centered clinical pathways. Whereas today, design thinking is increasingly embraced by healthcare for designing ‘things’ such as medical software or devices, we aim to also pave the way for design thinking in ‘pathway’ design. In particular, we adopted design thinking in developing a rehabilitation pathway for patients undergoing spinal surgery to improve the suboptimal outcomes such as persistent pain, disability and sick leave. &#x0D; Methods: From 2017 to 2022, we adopted the infinity loop of design thinking (revisualization of Stanford’s d.school framework) to develop an evidence-based, integrated rehabilitation pathway for patients following spinal surgery (more specifically lumbar fusion), and reported this in line with the ‘Guideline for reporting research involving design’. The infinity loop includes five phases, which are non-linear (back-and-forth is possible), continuous (‘trying to solve a problem can help you better understand it’), and user-centered: &#x0D; i) Empathize: to understand (explicit and latent) user needs, we observed the current practice in a prospective cohort of 36 patients and engaged through semi-structured interviews with five patients and 31 healthcare providers. &#x0D; ii) Define: we formulated two problem statements, one for each user group (patients and healthcare providers), that together underline the pathway characteristics needed: easy-to-use, evidence-based, interdisciplinary and transmural.&#x0D; iii) Ideate: we summarized the current evidence in a meta-analysis of 18 randomized-controlled trials, and gained 122 consensus statements from a multidisciplinary 31-member expert panel via a modified Delphi study, which was validated by nine patients. &#x0D; iv) Prototype: a time-task prototype of the rehabilitation pathway was created in line with the principles of process mapping. This prototype underwent iterative cycles of mono- and multidisciplinary feedback and improvement and patient involvement on clarity of the final prototype.&#x0D; v) Test: testing is currently ongoing in a tertiary hospital. The effectiveness (in terms of disability and return to work) and implementability of this rehabilitation pathway will be evaluated. Feedback loops with qualitative user feedback through interviews with patients and focus groups with healthcare providers will continuously improve the design.&#x0D; Results: An integrated rehabilitation pathway for spinal surgery was designed, and is ready for implementation. This rehabilitation pathway is evidence-based, addresses the needs of patients and providers, and involves innovative components such as prehabilitation, early mobilization, uniform communication through leaflets, videos and website, and limited postoperative restrictions. This use case provides a practical guide for adopting design thinking in the context of clinical pathway development. &#x0D; Conclusion: The infinity loop of design thinking can serve as an easy-to-use framework for quality improvement in healthcare. By transitioning from researcher-centered to user-centered design, the resulting clinical pathway can facilitate implementability and improve user satisfaction.

What are Older Adults’ perspectives and experiences of care transition and outcomes of care after discharge from the Emergency Department? A Qualitative Evidence Synthesis.

Background: Older adults account for 25% of all Emergency Department (ED) attendances and experience high rates of adverse outcomes after being discharged from the ED. Internationally, health policy is promoting Integrated Care for older adults where, ED visits are considered as an integral part of the older adult’s continuum of care. Evidence suggests that by bridging care interventions before and after ED discharge it, can lead to better outcomes for older adults. Currently, it is not known if these bridging care interventions respond to the needs of older adults transitioning from the ED. A comprehensive understanding of older adults’ experiences of transition home from the ED is required. Therefore, a systematic review and synthesis of qualitative studies was completed to describe older adult’s experiences of transition from the ED.&#x0D; Who is it for? Policy Makers, Health Care Professionals, Older Adults, Stakeholder Groups, Non-Profit Organisations, Researchers (Older Adults and Integrated Care).&#x0D; Who did you involve and engage with? The topic was identified as a priority by an Older Person Panel and the study was conceived by an interdisciplinary group of health researchers. Analysis is on-going currently. Preliminary findings of the qualitative synthesis will be shared and identified themes discussed and refined with this Older Person Panel. Further meetings will be convened to discuss key implications of the findings and to develop a lay summary of the findings for dissemination to relevant stakeholders.&#x0D; What did you do? The research question was developed and a protocol for a Qualitative Evidence Synthesis (QES) was registered on PROSPERO. This QES included qualitative studies of older adults (65+) experiences and perspectives of transition from the ED. A full database search was completed using three key search terms: Qualitative Research, ED, and Older Person. 4373 articles were retrieved and 9 articles were included after screening. Included articles were quality assessed using the CASP quality appraisal checklist. Data from the included studies was synthesized using the six-stage approach to meta-ethnography described by Noblit and Hare.&#x0D; Findings and Impact: Key findings/themes of this study include: Fragmented Care when transitioning from the ED, the value of communication, risk of readmission to the ED and symptom management. These findings are relevant for those developing interventions for this population.&#x0D; Learning for International audience: Address ways to improve the delivery of care for the complex needs among older persons when transitioning between Emergency Department and Integrated Care. Assist with the Clinical Pathway Development of older persons between ED and Integrated Care/Community.&#x0D; What are the next steps? A Qualitative Descriptive study using semi structed interviews with older adults to examine their experiences and perspectives of GP Integrated Service i

From Pathways to Partnerships: Building Patient-Centered Clinical Tracks (PCCT) in Outpatient Community Mental Health Settings.

Clinical pathways are structured multidisciplinary care plans used by treatment providers to detail essential steps in the care of patients based on assessment of their current health care needs and motivation and commitment for treatment. Reducing unnecessary variations in care and streamlining treatment processes in mental health settings may promote efficiency and help support quality improvement efforts. (Rotter et al., 2019) In this article we will describe the development of clinical pathways, coined Patient Centered Clinical Tracks (PCCT) in an outpatient community mental health clinic in an academic medical center in New York City. PCCT is comprised of six different clinical pathways that include: Medication & Engagement, Supportive Therapy, Dialectal-Behavior Therapy, Cognitive-Behavioral Therapy/Acceptance Commitment-Therapy, Relational Therapy and THRIVE (a Trauma Specialty Program). We will present the six Clinical Tracks and describe the early implementation of this model. We will explore how this programmatic infrastructure can connect evidence to practice and address multiple systemic challenges faced in a community mental healthsetting with a strong emphasis on training.