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AnteayerInternacionales

Spousal support, parent–nurse partnership and caregiver burden among parents of children with chronic diseases: A cross‐sectional study

Abstract

Aim

To examine the effects of spousal support and parent–nurse partnership on caregiver burden of parents of children with chronic disease.

Background

With the trend of increasing the global number of children with chronic diseases, the parental caregiver burden has become increasingly prevalent.

Design

Cross-sectional study.

Methods

The study participants included 115 parents of children diagnosed with chronic disease at a general hospital in South Korea. The study duration was 4 June 2021–30 April 2022. Self-reported measures included the parent–nurse partnership scale, the Korean version of the Parenting Alliance Inventory and the family caregiver burden scale. T-tests, ANOVA, Pearson's correlation coefficients and hierarchical linear multiple regression were conducted using IBM SPSS version 26.0. This study followed STROBE guideline.

Results

Parental caregiver burden was significantly negatively associated with spousal support and parent–nurse partnership. Factors significantly influencing caregiver burden were parental alcohol consumption; child's inherited metabolic disease, cardiovascular disease, disease relating to haematological tumours or kidney disease diagnosis; child's health perceived as poor by parents; child's dependency perceived as high by parents; hospitalization recency; and low spousal support. These factors accounted for 65% of caregiver burden.

Conclusion

Parental caregiver burden was related to spousal support and parent–nurse partnership, but the primary factor affecting caregiver burden was spousal support.

Relevance to clinical practice

The results highlighted the role of healthcare professionals in educating parents of children with chronic diseases to facilitate spousal support and have implications for nursing and community-based interventions to reduce parental caregiver burden. Furthermore, they underlined that policymakers and other stakeholders should pay attention to the parental caregiver burden through government-based, family-centered strategies.

Patient or public contribution

Parents of children with chronic disease were recruited to perform the self-administered survey in the phase of data collection.

Pre‐hospital symptom clusters and symptom network analysis in decompensated cirrhotic patients: A cross‐sectional study

Abstract

Aims

To generate pre-hospital symptom networks, explore core, bridge and sentinel symptoms, identify pre-hospital symptom clusters and analyse relationship between influencing factors and symptom clusters in decompensated cirrhosis patients.

Design

A cross-sectional study design using the Strengthening the Reporting of Observational Studies in Epidemiology checklist.

Methods

Demographical, physiological, psychological and sociological characteristics and the pre-hospital symptoms of 292 decompensated cirrhotic patients were collected from October 2021 to March 2023 in China. Frequencies, percentages, means, standard deviations, independent samples t-tests, one-way analysis of variance, exploratory factor analysis, multiple stepwise regression analysis and network analysis were used for data analysis.

Results

‘I don't look like myself’ and itching were core and bridge symptoms, while bloating and lack of energy were sentinel symptoms in decompensated cirrhotic patients. Monthly family income, anxiety, depression, social support and disease duration influenced the neuropsychological symptom cluster, with worrying as the strongest predictor symptom. Influential factors for cirrhosis-specific symptom cluster included Child-Pugh class, monthly family income, disease duration, anxiety and depression, with itching being the strongest predictor symptom. Monthly family income, disease duration and depression were influential factors for gastrointestinal symptom cluster, with loss of appetite as the strongest predictor symptom.

Conclusions

Neuropsychological, cirrhosis-specific and gastrointestinal symptom clusters were formed in decompensated cirrhotic patients. Through network analysis, direct connections between symptoms, symptom clusters and their influencing factors were revealed, thereby offering clinicians a foundation for effectively managing patients' pre-hospital symptoms.

Impact

Decompensated cirrhosis patients commonly have multiple symptoms, while the management of pre-hospital symptoms is often suboptimal. This study identified neuropsychological, cirrhosis-specific, gastrointestinal symptom clusters and recognized core, bridge and sentinel symptoms in these patients. It also revealed the most prominent symptoms within each cluster. This provides insight into the hierarchy of symptoms, improving symptom management in decompensated cirrhosis.

Patient and Public Involvement

There was no patient or public involvement.

Uncertainty in surrogate decision‐making about end‐of‐life care for people with dementia: An integrative review

Abstract

Aim

To describe uncertainty in surrogate decision-making regarding end-of-life care for people with dementia using Mishel's reconceptualized uncertainty in illness theory.

Design

Integrative literature review using Whittemore and Knafl's approach.

Data Sources

PubMed, CINAHL, EMBASE, Scopus and Web of Science were searched using terms such as uncertainty/unpredictability, decision-making/advance care planning/end-of-life care planning, surrogate/family/caregiver/proxy and dementia. The search was initially conducted on 28 September 2021 and updated on 31 July 2023.

Review Methods

Through systematic screening, 20 research articles were included in the analysis. Content related to uncertainty in surrogate decision-making regarding end-of-life care was extracted and analysed, focusing on the reconceptualized uncertainty in illness theory.

Results

First, surrogate uncertainty exists in various areas of surrogate decision-making regarding end-of-life care. Second, antecedents of surrogate uncertainty include numerous intrinsic and extrinsic factors. Third, surrogates exhibited some negative psychological responses to uncertainty but continually processed and structured their uncertainty through certain approaches, leading them to grow as decision-makers. Finally, research-based evidence on surrogates' processing of uncertainty and shifts to new life perspectives remains limited.

Conclusion

Surrogates' uncertainty in decision-making regarding end-of-life care for people with dementia is well characterized using the reconceptualized uncertainty in illness theory. Healthcare providers should help surrogates manage their uncertainty in surrogate decision-making more constructively throughout the dementia trajectory.

Implications for the Profession and/or Patient Care

The findings highlight the importance of assessing how surrogates process uncertainty and gauging how to help them process uncertainty and transition to new life perspectives.

Impact

This review contributes to healthcare professionals' understanding of surrogates' uncertainty in end-of-life care planning for people with dementia, especially what they are uncertain about, what influences their uncertainty and how they process it.

Reporting Method

This study adheres to the PRISMA reporting guidelines.

Patient or Public Contribution

No patient or public contribution.

Living with multimorbidity: A qualitative exploration of shared experiences of patients, family caregivers, and healthcare professionals in managing symptoms in the United States

Abstract

Aims

To elicit experiences of patients, family caregivers, and healthcare professionals in intermediate care units (IMCUs) in an academic medical centre in Baltimore, MD related to the challenges and intricacies of multimorbidity management to inform development of a multimorbidity symptom management toolkit.

Design

Experience-based co-design.

Methods

Between July and October 2021, patients aged 55 years and older with multimorbidity admitted to IMCUs at an academic medical centre in Baltimore, Maryland, USA were recruited and interviewed in person. Interdisciplinary healthcare professionals working in the IMCU were interviewed virtually. Participants were asked questions about their role in recognizing and treating symptoms, factors affecting the quality of life, symptom burden and trajectory over time, and strategies that have and have not worked for managing symptoms. An inductive thematic analysis approach was used for analysis.

Results

Twenty-three interviews were conducted: 9 patients, 2 family caregivers, and 12 healthcare professionals. Patients' mean age was 67.5 (±6.5) years, over half (n = 5) were Black or Hispanic, and the average number of comorbidities was 3.67. Five major themes that affect symptom management emerged: (1) the patient–provider relationship; (2) open and honest communication; (3) accessibility of resources during hospitalization and at discharge; (4) caregiver support, training, and education; and (5) care coordination and follow-up care.

Conclusion

Patients, caregivers, and healthcare professionals often have similar goals but different priorities for multimorbidity management. It is imperative to identify shared priorities and target holistic interventions that consider patient and caregiver experiences to improve outcomes.

Implications for the Profession and/or Patient Care and Impact

This paper addresses the paucity of research related to the shared experience of disease trajectory and symptom management for people living with multimorbidity. We found that patients, caregivers, and healthcare professionals often have similar goals but different care and communication priorities. Understanding differing priorities will help better design interventions to support symptom management so people with multimorbidity can have the best possible quality of life.

Reporting Method

We have adhered to the Consolidated Criteria for Reporting Qualitative Studies (COREQ) guidelines in our reporting.

Patient or Public Contribution

This study has been designed and implemented with patient and public involvement throughout the process, including community advisory board engagement in the project proposal phase and interview guide development, and member checking in the data collection and analysis phases. The method we chose, experience-based co-design, emphasizes the importance of engaging members of a community to act as experts in their own life challenges. In the coming phases of the study, the public will be involved in developing and testing a new intervention, informed by these qualitative interviews and co-design events, to support symptom management for people with multimorbidity.

Taking Action Against Clinician Burnout Through Reducing the Documentation Burden With an Operating Room Supply Scanning Approach

imageDocumenting surgical supply items in the operating room can be a burdensome task for circulating nurses because of manual input within the electronic medical record. This can lead to documentation fatigue and contribute to nursing burnout. The aim of this quality improvement project was to design and implement a supply item scanning process and evaluate the effect on intraoperative documentation completion time, room turnover time, picklist documentation accuracy, nurse satisfaction, and burnout. The sample included nine acute care hospitals throughout the United States, with 189 total circulating nurses and 31 718 procedures occurring during the study timeframe of 8 months. Results indicated that nurses were able to complete documentation on average 37.33 minutes sooner, and the operating room turnover time decreased by 1.88 minutes. Although nurses reported that their perceived picklist documentation accuracy did not improve, and the presence of new scanning technology did not influence their hospital employment decision, subjective feedback was mostly positive, with most responses citing the helpfulness of scanning for documentation. This study shows that an interdisciplinary team can effectively work to optimize documentation efficiency and performance improvement using a scanning intervention. Lessons learned through this process can translate into optimizations elsewhere in the electronic medical record.

The Use of mHealth in Promoting Therapeutic Adherence: A Scoping Review

imageNonadherence to therapy negatively impacts mortality and quality of life and results in suboptimal efficacy of treatment regimens, threats to patient safety, and increased healthcare costs for disease management. Mobile health solutions can offer users instruments that can promote therapeutic adherence. The objective of this review is to investigate the impact mobile health systems have on therapeutic adherence. Specifically, we want to map the main systems used, the functions implemented, and the different methods of adherence detection used. For this purpose, a scoping review was conducted. The following databases were consulted: PubMed, Cochrane Library, EBSCO (including APA PsycINFO, CINAHL Plus with Full Text, ERIC), including English-language studies published in the last 10 years (2012–2022). The main mobile health systems used are as follows: applications, automated messaging, interactive voice response, and mobile video games. The main features implemented to support medication management were as follows: reminders, self-monitoring instruments, educational support, and caregiver involvement. In conclusion, the use of interactive mobile health instruments intended for use by the patient and/or caregiver can improve objectively and subjectively detected therapeutic adherence. The use of these systems in the therapeutic pathway of users, with a special focus on people with comorbidities and in polypharmacy treatment, represents a challenge to improve caregiver health.

Application of Machine Learning Techniques to Development of Emergency Medical Rapid Triage Prediction Models in Acute Care

imageGiven the critical and complex features of medical emergencies, it is essential to develop models that enable prompt and suitable clinical decision-making based on considerable information. Emergency nurses are responsible for categorizing and prioritizing injuries and illnesses on the frontlines of the emergency room. This study aims to create an Emergency Medical Rapid Triage and Prediction Assistance model using electronic medical records and machine learning techniques. Patient information was retrieved from the emergency department of a large regional teaching hospital in Taiwan, and five supervised learning techniques were used to construct classification models for predicting critical outcomes. Of these models, the model using logistic regression had superior prediction performance, with an F1 score of 0.861 and an area under the receiver operating characteristic curve of 0.855. The Emergency Medical Rapid Triage and Prediction Assistance model demonstrated superior performance in predicting intensive care and hospitalization outcomes compared with the Taiwan Triage and Acuity Scale and three clinical early warning tools. The proposed model has the potential to assist emergency nurses in executing challenging triage assessments and emergency teams in treating critically ill patients promptly, leading to improved clinical care and efficient utilization of medical resources.

Nursing Diagnosis Accuracy in Nursing Education: Clinical Decision Support System Compared With Paper-Based Documentation—A Before and After Study

imageComputer-based technologies have been widely used in nursing education, although the best educational modality to improve documentation and nursing diagnostic accuracy using electronic health records is still under investigation. It is important to address this gap and seek an effective way to address increased accuracy around nursing diagnoses identification. Nursing diagnoses are judgments that represent a synthesis of data collected by the nurse and used to guide interventions and to achieve desirable patients' outcomes. This current investigation is aimed at comparing the nursing diagnostic accuracy, satisfaction, and usability of a computerized system versus a traditional paper-based approach. A total of 66 nursing students solved three validated clinical scenarios using the NANDA-International terminologies traditional paper-based approach and then the computer-based Clinical Decision Support System. Study findings indicated a significantly higher nursing diagnostic accuracy (P

Research Trends and Highlights Toward Virtual Reality in Patients With Cancer: Bibliometric Analysis

imageThis retrospective bibliometric analysis was conducted to explore research trends and identify studies in fields of nursing, virtual reality, and cancer. Data were obtained from the Web of Science database using an advanced search strategy. The study data were analyzed using the R Studio software and visualized using VOSviewer. A total of 594 studies were retrieved and analyzed from January 1995 to December 2021. It was determined that 59.4% of the studies were research articles and that these studies had been conducted by 2771 authors. The reviewed studies were produced by researchers from 25 countries and were published in 29 different journals. Of these, 169 were conducted by researchers in the United States. “Virtual reality” and “nursing” were found to be prominent topics. Studies on virtual reality in patients with cancer in the field of nursing have increased over the past 8 years. Researchers have actively conducted studies in this field. Prominent studies have covered various patients with cancer in all age groups and palliative care processes. It was seen that the majority of the studies were randomized controlled trials, reviews, and systematic reviews. In addition, studies have used virtual reality as a distraction method in the management of symptoms in patients with breast, lung, and pediatric cancers undergoing chemotherapy treatment. This study provides a detailed and up-to-date analysis of the findings obtained from the Web of Science database by emphasizing bibliometric models of virtual reality technologies in nursing patients with cancer. We believe that the current data on the use of virtual reality applications in patients with cancer will guide the clinical practice and scientific studies of healthcare professionals.

Creating Subsets of International Classification for Nursing Practice Precoordinated Concepts: Diagnoses/Outcomes and Interventions Categorized Into Areas of Nursing Practice

imageThe International Classification for Nursing Practice is a comprehensive terminology representing the domain of nursing practice. A categorization of the diagnoses/outcomes and interventions may further increase the usefulness of the terminology in clinical practice. The aim of this study was to categorize the precoordinated concepts of the International Classification for Nursing Practice into subsets for nursing diagnoses/outcomes and interventions using the structure of an established documentation model. The aim was also to investigate the distribution of the precoordinated concepts of the International Classification for Nursing Practice across the different areas of nursing practice. The method was a descriptive content analysis using a deductive approach. The VIPS model was used as a theoretical framework for categorization. The results showed that all the precoordinated concepts of the International Classification for Nursing Practice could be categorized according to the keywords in the VIPS model. It also revealed the parts of nursing practice covered by the concepts of the International Classification for Nursing Practice as well as the parts that needed to be added to the International Classification for Nursing Practice. This has not been identified in earlier subsets as they covered only one specific area of nursing.

Ambulatory Care Coordination Data Gathering and Use

imageCare coordination is a crucial component of healthcare systems. However, little is known about data needs and uses in ambulatory care coordination practice. Therefore, the purpose of this study was to identify information gathered and used to support care coordination in ambulatory settings. Survey respondents (33) provided their demographics and practice patterns, including use of electronic health records, as well as data gathered and used. Most of the respondents were nurses, and they described varying practice settings and patterns. Although most described at least partial use of electronic health records, two respondents described paper documentation systems. More than 25% of respondents gathered and used most of the 72 data elements, with collection and use often occurring in multiple locations and contexts. This early study demonstrates significant heterogeneity in ambulatory care coordination data usage. Additional research is necessary to identify common data elements to support knowledge development in the context of a learning health system.

Exploring the Documentation of Delirium in Patients After Cardiac Surgery: A Retrospective Patient Record Study

imageDelirium is a common disorder for patients after cardiac surgery. Its manifestation and care can be examined through EHRs. The aim of this retrospective, comparative, and descriptive patient record study was to describe the documentation of delirium symptoms in the EHRs of patients who have undergone cardiac surgery and to explore how the documentation evolved between two periods (2005-2009 and 2015-2020). Randomly selected care episodes were annotated with a template, including delirium symptoms, treatment methods, and adverse events. The patients were then manually classified into two groups: nondelirious (n = 257) and possibly delirious (n = 172). The data were analyzed quantitatively and descriptively. According to the data, the documentation of symptoms such as disorientation, memory problems, motoric behavior, and disorganized thinking improved between periods. Yet, the key symptoms of delirium, inattention, and awareness were seldom documented. The professionals did not systematically document the possibility of delirium. Particularly, the way nurses recorded structural information did not facilitate an overall understanding of a patient's condition with respect to delirium. Information about delirium or proposed care was seldom documented in the discharge summaries. Advanced machine learning techniques can augment instruments that facilitate early detection, care planning, and transferring information to follow-up care.

Development and Evaluation of a Mobile Application to Prevent Recurrent Stroke by Enhancing Self-management on Health Outcomes for Stroke Survivors

imageThis study aimed to develop a Mobile Application to Prevent Recurrent Stroke to prevent recurrent stroke by enhancing self-management and to evaluate its effects on stroke survivors' health outcomes. The Mobile Application to Prevent Recurrent Stroke was developed based on social cognitive theory and the model in order of analysis, design, development, implementation, and evaluation process. The Mobile Application to Prevent Recurrent Stroke consisted of health management contents such as information about stroke, its associated risk factors, and required skills to conduct self-management with tailored support and counseling. A quasi-experimental preintervention and postintervention design was used involving a total of 54 stroke survivors. The experimental group (n = 27) was provided the Mobile Application to Prevent Recurrent Stroke for 8 weeks, whereas the control group (n = 27) received an education booklet. The result revealed that medication adherence (P = .002), healthy eating habit (P

Evidence‐based approach to mitigate cumulative stress in pediatric nurses through the development of respite rooms

Abstract

Background

The cumulative stress toll on nurses increased during the COVID-19 pandemic. An evidence-based practice (EBP) project was conducted to understand what is known about the impacts of cumulative stress within nursing and if there are ways to mitigate stress during a nurse's shift.

Aim/Implementation

A project team from three clinical units completed an extensive literature review and identified the need to promote detachment while supporting parasympathetic recovery. Based on this review, leaders from three pediatric clinical units (neonatal intensive care unit, cardiovascular intensive care unit, and acute pulmonary floor) implemented respite rooms.

Outcomes

Follow-up outcomes showed a statistically significant stress reduction. For all shifts combined, the Wilcoxon Signed-Rank Test revealed that perceived stress scores from an 11-point Likert scale (0 = no stress and 10 = maximum perceived stress) were significantly lower in the post-respite room (Md = 3, n = 68) compared to in the pre-respite room (Md = 6, n = 68), Z = −7.059, p < .001, with a large effect size, r = .605. Nurses and other staff frequently utilized respite rooms during shifts.

Implications for Practice

Clinical inquiry and evidence-based practice processes can mitigate cumulative stress and support staff wellbeing. Respite rooms within the hospital can promote a healthy work environment among nurses and promote a self-care culture change. Evidence-based strategies to mitigate cumulative stress using respite rooms are a best practice to promote nurse wellbeing and mitigate cumulative stress.

Factors influencing nurses' intent to provide care involved in coronavirus disease 2019: Theory of planned behaviour perspectives

Abstract

Aims and objectives

To identify the factors influencing the intent to provide care among nurses involved in coronavirus disease 2019 (COVID-19) care.

Background

COVID-19 was first reported in Wuhan, China, in 2019. In 2020, the World Health Organisation declared it a pandemic, leading to 5,827,104 deaths and 421,203,495 confirmed cases as of 19 February 2022. The high transmissibility of COVID-19 has prolonged the pandemic for over 2 years, resulting in deleterious effects on nurses' physical and mental health. The fear of infection and isolation may lead to negative experiences and perceptions among COVID-19 frontline nurses, which may ultimately degrade the quality of patient care. Thus, it is essential to identify factors influencing of nurses' intent to provide care.

Design

Cross-sectional study.

Methods

Data were collected from 169 nurses involved in direct COVID-19 care at a hospital designated for infectious disease care in Korea from August to September 2021 using an online questionnaire. STROBE checklist was followed.

Results

Nurses' intent to provide care significantly differed based on whether they lived with parents and had adequate availability of personal protection equipment. The correlation analysis indicated that the intent to provide care was significantly positively correlated with normative beliefs, control beliefs, attitude towards the behaviour, subjective norms and perceived behavioural control. Perceived behavioural control, control beliefs and attitude towards the behaviour were significant factors influencing nurses' intent to provide COVID-19 care.

Conclusion

This study showed that nurses perceived behavioural control and positive behaviour towards providing COVID-19 care fundamentally influenced their intent to provide care.

Relevance to clinical practice

In clinical practice, the safety and rights of individual nurses who participated in COVID-19-related patient care are promoted, and ultimately, the quality of patient care is improved. Furthermore, active support at the organisation and government level is needed to strengthen the capabilities necessary for nursing patients with infectious diseases.

Implications for long COVID: A systematic review and meta‐aggregation of experience of patients diagnosed with COVID‐19

Abstract

Aims and Objectives

This review aims to synthesize the available evidence of what patients experience when infected with COVID-19, both in hospital and post-discharge settings.

Design

This review was conducted using the Joanna Briggs Institute (JBI) methodology for qualitative systematic reviews and evidence synthesis. Reporting of results was presented according to the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) checklist.

Background

Coronavirus disease 2019 (COVID-19) continues to be a public health crisis worldwide. Many patients diagnosed with COVID-19 have varied levels of persisting mental disorders. Previous studies have reported the degree, prevalence and outcome of psychological problems. Minimal research explored the experience of patients with long COVID. The real-life experience of patients with COVID-19 from diagnosis to post-discharge can deepen the understanding of nurses, physicians and policymakers.

Methods

All studies describing the experience of patients were included. Two authors independently appraised the methodological quality of the included studies using the JBI Critical Appraisal Checklist for Qualitative Research 2020.

Results

This systematic review aggregated patients’ experience of being diagnosed with COVID-19 in both hospitalized and post-discharge settings. Finally, 17 studies met inclusion criteria and quality appraisal guidelines. The selected studies in the meta-synthesis resulted in 12 categories, and further were concluded as five synthesized findings: physical symptoms caused by the virus, positive and negative emotional responses to the virus, positive coping strategies as facilitators of epidemic prevention and control, negative coping strategies as obstacles of epidemic prevention and control, and unmet needs for medical resource.

Conclusions

The psychological burden of patients diagnosed with COVID-19 is heavy and persistent. Social support is essential in the control and prevention of the epidemic. Nurses and other staff should pay more attention to the mental health of the infected patients both in and after hospitalization.

Relevance to clinical practice

Nurses should care about the persistent mental trauma of COVID-19 survivors and provide appropriate psychological interventions to mitigate the negative psychological consequences of them. Besides, nurses, as healthcare professionals who may have the most touch with patients, should evaluate the level of social support and deploy it for them. It is also needed for nurses to listen to patient's needs and treat them with carefulness and adequate patience in order to decrease the unmet needs of patients.

‘I'm still here, I'm alive and breathing’: The experience of Black Americans with long COVID

Abstract

Aims and Objectives

In this study, we aimed to characterize the impact of long COVID on quality of life and approaches to symptom management among Black American adults.

Background

As a novel condition, qualitative evidence concerning long COVID symptoms and their impact on quality of life can inform the refinement of diagnostic criteria and care plans. However, the underrepresentation of Black Americans in long COVID research is a barrier to achieving equitable care for all long COVID patients.

Design

We employed an interpretive description study design.

Methods

We recruited a convenience sample of 15 Black American adults with long COVID. We analysed the anonymized transcripts from race-concordant, semi-structured interviews using an inductive, thematic analysis approach. We followed the SRQR reporting guidelines.

Results

We identified four themes: (1) The impact of long COVID symptoms on personal identity and pre-existing conditions; (2) Self-management strategies for long COVID symptoms; (3) Social determinants of health and symptom management; and (4) Effects on interpersonal relationships.

Conclusion

Findings demonstrate the comprehensive ramifications of long COVID on the lives of Black American adults. Results also articulate how pre-existing conditions, social risk factors, distrust due to systemic racism, and the nature of interpersonal relationships can complicate symptom management.

Relevance to Clinical Practice

Care approaches that support access to and implementation of integrative therapies may be best suited to meet the needs of long COVID patients. Clinicians should also prioritize eliminating patient exposure to discrimination, implicit bias, and microaggressions. This is of particular concern for long COVID patients who have symptoms that are difficult to objectively quantify, such as pain and fatigue.

No Patient or Public Contribution

While patient perspectives and experiences were the focus of this study, patients were not involved with the design or conduct of the study, data analysis or interpretation, or writing the manuscript.

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