Adjusting perioperative methadone dose for elderly and fragile hip fracture patients (MetaHip-trial) - A statistical analysis plan for an adaptive dose-finding trial.

Background: The elderly population is expanding globally. This gives numerous challenges especially regarding hip fracture patients. In the US alone over 300.000 hip fracture patients are treated each year, and a large amount of those develop opoid addiction. Hip fractures require surgical intervention within 24 h and is associated with significant pain even at rest. Postoperative analgesic treatment need to be optimized to ensure adequate pain relief and to prevent subsequent opioid addiction. Previous studies have shown that methadone effectively decreases post-operative opioid consumption but the studies focused on younger patients undergoing elective surgery. This study focus on the use of methadone on the elderly, fragile patients undergoing acute surgery, by first determining the maximal tolerable dose.The hypothesis is the maximal tolerable doses of these hip-fracture patients lies between 0.10 mg/kg and 0.20 mg/kg. This trial aims to estimate the maximum tolerable dose of methadone when administered to elderly patients undergoing surgery for a hip fracture. Method: This project is an adaptive dose-finding trial. The continuous reassessment method will estimate the maximum tolerable dose of methadone. The primary outcome will be respiratory depression. The statistical analysis plan will be published a priori to the closure of patient recruitment and statistical analysis of database results. Conclusion: The results of this study will give valuable information about the maximally tolerated dose of methadone for postoperative pain relief for elderly patients with hip fractures and potential adverse events.This trial is registered on clinicaltrials.gov with trial registration: NCT05581901. Registered 17 October 2022, https://www.clinicaltrials.gov/ct2/show/NCT05581901?term=methadone&cond = hip&draw = 2&rank = 1.

Orthopaedic patients' experiences of their sleep during hospitalisation and suggestions for improvements.

PURPOSE: To describe orthopaedic patients' perspectives on their sleep quality and their suggestions for improvement initiatives to achieve better sleep quality during hospitalisation. METHODS: In a qualitative design, 265 (50%) of 533 patients from a questionnaire survey responded to two free-text questions. Data were analysed based on a phenomenological-hermeneutic approach inspired by Paul Ricoeur's theory of narrative and interpretation. RESULTS: Three themes emerged: 1) Sleeping environment and preferences tailored to the individual patient, 2) The link between orthopaedic surgery care and sleeping, and 3) Noise challenged a good night's sleep. Good sleep was related to nurses' professional behaviour and the physical environment, such as quality beds and sleeping aids. Single and shared rooms, room lighting, and fresh air all influenced sleep quality. Unfamiliar and uncomfortable sleeping positions posed a challenge for orthopaedic patients but aids such as pillows, and duvets could provide more comfort at night. Offset circadian rhythms could affect sleep quality, as could nausea and vomiting. Pain and lack of pain relief were associated with poor sleep quality. Noise from both nurses and other patients affected sleep quality. Therefore, unnecessary care activities should be kept to a minimum, and a "night noise level" was suggested. CONCLUSION: Patients' sleep disturbance following orthopaedic surgery needs to be addressed by both nurses and hospital management. Patients' involvement is essential to create a sleep environment tailored to individual needs and to provide strategies patients use at home for addressing sleeping problems.

Relatives' experiences of the hospitalisation of older people with COVID-19: A qualitative interview study.

BACKGROUND: During the COVID-19 pandemic, visitors were restricted from hospitals, separating them from hospitalised friends and family to reduce the infection risk. OBJECTIVES: The objective was to explore how relatives of older people acutely admitted to hospital with COVID-19 experienced being a relative, and how they felt about their contact with health care professionals (HCPs) when visitor restrictions prevented their physical presence in the ward. METHOD: This study employed a qualitative design. We used individual qualitative semi-structured interviews and the participants were relatives of acutely admitted older people from three COVID-19 wards in Denmark. A total of 18 relatives participated, 14 female and 4 male, aged between 45 and 83 years. The analysis was guided by Graneheim and Lundman's qualitative content analysis. RESULTS: The analysis derived the following three themes: (1) the importance of trust in a period of uncertainty; (2) the meaning of contact with HCPs, and (3) active but at a distance-a balancing act. The participants' feelings of uncertainty were prominent. The unknown nature of the disease and the unusual situation challenged relatives' trust in HCPs and the health care system. CONCLUSIONS AND RELEVANCE TO PRACTICE: The findings highlight relatives' stress when the possibilities for visiting are restricted and the importance of trust in, and the relationship with HCPs. This study can strengthen HCPs' understanding of relatives' situation when older people are hospitalised during and after the COVID-19 pandemic.

A cross-sectional study of COVID-19 pandemic-related organizational aspects in health care.

AIM: This study explores how healthcare professionals included in the COVID-19 contingency plan experienced organizational changes, and explores factors associated with the experiences. Additionally, the study aimed to identify learning points for future similar scenarios. DESIGN: A cross-sectional study. METHODS: A questionnaire survey of healthcare professionals at three Danish hospitals, June 2020. RESULTS: A total of 1,448 healthcare professionals completed the questionnaire. Hereof, 813 (57%) were relocated to new settings/new jobs. The majority experienced that their relocation was totally (49%) or partially (31%) imposed, and 51% reported that the overall experience of the new job function was satisfactory. Type of profession and whether relocation to the new job function was imposed were the main variables associated with the overall experience of being part of the contingency plan. Suggestions for future scenarios included training adjusted to individual competencies, more targeted information, voluntariness with consideration of individual needs and clarification of expectations.

Orthopaedic nurses' experiences with real-time documentation in a high-tech ward: A qualitative study.

BACKGROUND: Real-time documentation is a novel process that changes nursing workflow; however, nurses' experiences of real-time documentation are unknown. AIM: This study aimed to explore nurses' experiences with real-time documentation in an orthopaedic ward. DESIGN: This qualitative study took a phenomenological-hermeneutic approach. METHODS: Data were generated from three semi-structured focus group interviews with 18 nurses from an orthopaedic ward. Data analysis was based on Ricoeur's theory of narrative and interpretation and included naïve reading, structural analysis and critical interpretation, and discussion. RESULTS: Five themes emerged from the structural analysis: 1) nurses were initially sceptical and outside of their comfort zone; 2) implementation required support from the head nurse and other colleagues; 3) increased time with patients led to better relationships, but nurses lacked time for reflection; 4) increased patient involvement could also present challenges; and 5) documentation became more integrated into orthopaedic nursing. CONCLUSION: Real-time documentation improved orthopaedic nursing documentation and increased patient involvement. Nurses spent more time with patients, leading to better relationships, but they had decreased time with their colleagues and the opportunity to reflect. Real-time documentation leads to changes in workflow, so, nurses should be provided with training and the opportunity to reflect.

How did nurses cope with the fast, comprehensive organisational changes at Danish hospital wards during the COVID-19 pandemic? An interview study based on nurses' experiences.

PURPOSE: The COVID-19 pandemic has influenced hospital work and healthcare workers all over the world. We explored how Danish nurses coped with the fast, comprehensive organisational changes in their workplace and identified barriers to and facilitators for organisations ensuring the best possible conditions for nurses to meet these challenges. The study focuses on the organisational setting and how it did or did not support the nurses in their work. METHODS: A qualitative explorative design was used in interviewing 23 nurses who had worked at a COVID-19 ward in one of three hospitals. Data were collected in the summer of 2020, and the analysis was inspired by Paul Ricoeur's theory of narratives and interpretation. RESULTS: The presence of managers in the wards helped the nurses in the form of psychological and practical support. Working within an organisation that provides a safe environment was essential for nurses. The experience of a safe environment allowed nurses to ask questions, which supported them in finding solutions to specific tasks in the new and critical working environment. Barriers to handling the new situation were an absence of managers and a lack of a sense of belongingness and trust. CONCLUSION: This study highlights the need for management to be present in the ward and for organisational support to be available to nurses so they can provide optimal treatment and care when working in new and unknown conditions during a pandemic. Practical assistance from managers to ease the job is beneficial. Furthermore, the presence of management is essential to provide psychological support and create a safe environment because this allows nurses to ask questions about how to better manage new and critical tasks.

Frontline nurses' experiences of working in a COVID-19 ward-A qualitative study.

AIM: To explore how nurses experienced working in a newly organized COVID-19 ward with high-risk patients during a new and unknown pandemic. DESIGN: A qualitative explorative study using a phenomenological-hermeneutic approach. METHODS: Semi-structured individual telephone interviews were conducted in June-July 2020 with 23 nurses working in COVID-19 wards from three regional hospitals in Denmark. The nurses had been transferred from other departments at their hospital to the newly organized COVID-19 wards. Data analysis was influenced by Paul Ricoeur's theory of narrative and interpretation, including three analytical levels: naïve reading, structural analysis and critical interpretation and discussion. RESULTS: During the structural analysis four themes were generated: (a) Challenging and uncertain situation, but also a positive experience (b) Professional and personal development (c) Lack of nurses' rights during a pandemic (d) Reward in itself or a desire for financial reward.

Sleep quality among orthopaedic patients in Denmark - A nationwide cross-sectional study.

BACKGROUND: Hospitalised patients sleep less and have a lower quality of sleep compared to patients who recover in their own home. Low sleep quality is associated with complications such as increased pain sensation, delirium and reduced rehabilitation capacity. PURPOSE: To investigate patients' self-reported sleep quality and factors related to sleep quality during admission to a department of Orthopaedic Surgery. METHODS: The Richard-Campbell Sleep Questionnaire was used to assess patients' sleep quality, measured using a VAS 0-100 scale, (a higher score indicating good sleep quality). The moderated Pittsburgh Sleep Quality Index assessed the most severe and frequent barriers to high sleep quality. RESULTS: A total of 533 patients undergoing orthopaedic surgery participated. There was an overall mean sleep quality score of 54. The most common and severe factors impacting sleep quality were; waking during the night, difficulties falling asleep, waking early, waking for toileting or pain. The intensity of the pain was found to be proportional to the quality of sleep. CONCLUSION: Patients reported their overall quality of sleep to be moderately good due to difficulties falling asleep, waking up during the night or early morning and having pain. The results call for better pain management and non-pharmacological nursing interventions to optimise sleep quality.

Psychometric Validation of the Danish Version of the Oswestry Disability Index in Patients With Chronic Low Back Pain.

STUDY DESIGN: Registry-based repeated-measures psychometric validation of the Danish Oswestry Disability Index (ODI). OBJECTIVE: The goal was to use classical and modern psychometric validation methods to assess the measurement properties and the minimally clinical important difference (MCID) of the ODI in a Danish cohort of patients with chronic low back pain being treated with spinal surgery. SUMMARY OF BACKGROUND DATA: Scores for the ODI, EQ-5D, SF-36, leg pain, back pain, and a general rating of pain item from 800 patients with chronic low back pain were extracted from the National Danish Spine Registry (DaneSpine) at baseline and 1-year postspine surgery. METHODS: Confirmatory factor analysis and item response theory (IRT) models were used to assess the psychometric properties of the ODI. MCID was also calculated based on generic legacy PROMs (EQ-5D and SF-36) and follow-up pain scores. RESULTS: While ODI did not fit a Rasch model, adequate fit to a confirmatory factor analysis and a two-parameter item response theory model was found when accounting for differential item functioning across diagnostic subgroups (degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc). In addition, each group exhibited substantially different MCID values. CONCLUSION: The Danish version of the ODI is valid and responsive, but only within each of the four major diagnosis subgroups: degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc. LEVEL OF EVIDENCE: 4.

Parents' experiences of donation to their child before kidney transplantation: A qualitative study.

AIM AND OBJECTIVES: To explore parents' experiences of donation to their child before kidney transplantation. BACKGROUND: Transplantation is the treatment of choice for paediatric patients with end-stage renal disease. Living donor kidney transplantation has shown a higher long-term transplant survival compared to deceased donor transplantation and entails a more controllable process, with shorter waiting time. Besides complex care and treatment of their child, parents must reflect on the prospects of being a donor for their child. However, little is known about the parent donor and parent caregiver perspective. DESIGN: A qualitative exploratory study taking a phenomenological-hermeneutic approach. METHOD: The study was conducted in a Danish university hospital. Interviews were conducted with the parents of seven children, aged between 5-15 years, with end-stage renal disease in the period before kidney transplantation. Data were analysed with inspiration from Ricoeur's theory of interpretation on three levels: naïve reading, structural analysis and critical interpretation and discussion. RESULTS: The decision about donation was experienced as a matter of course and commitment. There were preferences for a kidney from a living donor, including the hope of being accepted as a donor. Being refused as a donor revealed feelings of powerlessness. However, transformation was performed into having a new role providing care and comfort to the child during the transplant process. Asking family and friends about donation could feel like crossing a line. CONCLUSION: The prospect of donating to one's child had an impact on the well-being of the entire family. Parents were in a vulnerable situation and in need of support, regarding both living and deceased donation. Waiting time included hopeful thoughts and reflections on a new caregiver role for the child during transplantation. RELEVANCE TO CLINICAL PRACTICE: Health professionals' attention, engagement and dialogue are essential in order to gain extensive and varied knowledge about the individual parent's experiences and the well-being of the entire family to provide care and support before, during and after the donation and transplantation process.

A Ricoeur-Inspired Approach to Interpret Participant Observations and Interviews.

In-depth knowledge of what it means to patients to receive health care services is crucial to the development of adequate protocols for nursing. Qualitative research allows us to gain important insight into what is experienced by and meaningful to patients. The French philosopher Paul Ricoeur's thoughts have inspired qualitative researchers to conduct various forms of analysis and interpretation that increase our knowledge of ways of being-in-the-world. This article describes and discusses how a specific approach to derive in-depth knowledge of patients' lived experiences can be taken. A combination of participant observations and interviews was used to generate data. Field notes and transcribed interviews were gathered as one collective text and analyzed and interpreted with inspiration from Ricoeur's thoughts on narratives and interpretation. This approach is argued to be a significant way of developing in-depth knowledge of patients' lived experiences. Such knowledge is important within nursing science.

Patients' experiences during the first 12 weeks after discharge in fast-track hip and knee arthroplasty - a qualitative study.

BACKGROUND: Due to the shortened length of stay in fast-track total hip and knee arthroplasty, patients must at a very early stage following surgery take responsibility for their postoperative care and treatment. It is important to establish if this treatment modality of fast-track is not only cost-effective, but meets patients' expectations and needs. AIM: To explore the lived experience of patients in fast-track total hip and knee arthroplasty during the first 12 weeks after discharge. METHODS: A phenomenological-hermeneutic approach was used inspired by Ricoeur's theory of narrative and interpretation. Data were collected through semi-structured interviews with 8 patients 2 and 12 weeks after discharge. FINDINGS: Through the structural analysis 3 themes emerged: 1) Dealing with transition between hospital and home, 2) Pain and self-management of medication, 3) Challenges in rehabilitation. CONCLUSION: Patients appreciated only 1 or 2 days in hospital. However, they were not sufficiently involved in the discharge planning. There was a feeling of uncertainty and being left on their own after discharge, which could affect their pain management and recovery at home. There is a need to develop in partnership with each individual patient a post discharge plan of care and rehabilitation to meet their individual needs, preferences and mode of motivation.

Patient experience in fast-track hip and knee arthroplasty--a qualitative study.

AIMS AND OBJECTIVES: To explore the lived experience of patients in fast-track primary unilateral total hip and knee arthroplasty from the first visit at the outpatient clinic until discharge. BACKGROUND: Fast-track has resulted in increased effectiveness, including faster recovery and shorter length of stay to about two days after hip and knee arthroplasty. However, the patient perspective in fast-track with a median length of stay of less than three days has been less investigated. DESIGN: A qualitative design. METHODS: A phenomenological-hermeneutic approach was used, inspired by Paul Ricoeur's theory of narrative and interpretation. Eight patients were included. Semi-structured interviews and participant observation were performed. RESULTS: Three themes emerged: dealing with pain; feelings of confidence or uncertainty - the meaning of information; and readiness for discharge. Generally, the patients were resistant to taking analgesics and found it difficult to find out when to take supplementary analgesics; therefore, nursing staff needed enough expertise to take responsibility. Factors that increased patients' confidence: information about fast-track, meeting staff before admission and involving relatives. In contrast, incorrect or conflicting information and a lack of respect for privacy led to uncertainty. In preparing for early discharge, sufficient pain management, feeling well-rested and optimal use of time during hospitalisation were important. CONCLUSION: The study shows the importance of dealing with pain and getting the right information and support to have confidence in the fast-track programme, to be ready for discharge and to manage postoperatively at home. RELEVANCE TO CLINICAL PRACTICE: In fast-track focusing on early discharge, there is an increased need for evidence-based nursing practice, including a qualified judgement of what is best for the patient in certain situations. The knowledge should be gleaned from: research; the patients' expertise, understanding and situation; and nurses' knowledge, skills and experience.

Nursing in fast-track total hip and knee arthroplasty: A retrospective study.

AIM: To describe the increased activity in total hip arthroplasty (THA) and total knee arthroplasty (TKA) from 2002 to 2012 in a single orthopaedic department, the organisation of fast-track and its consequences for nursing care. METHODS: Retrospective, descriptive design. Data collection; from the hospital administrative database, local descriptions of fast-track, personal contact and discussion with staff. RESULTS: The number of operations increased threefold from 351 operations in 2002 to 1024 operations in 2012. In 2012, THA/TKA patients had a postoperative mean LOS of 2.6/2.8 days. Nurses had gained tasks from surgeons and physiotherapists and thus gained more responsibility, for example, for pain management and mobilisation. Staffing levels in the ward in 2002 and 2012 were almost unchanged; 16.0 and 15.8 respectively. Nurses were undertaking more complicated tasks. CONCLUSION: Nursing care must still focus on the individual patient. Nurses need to have enough education to manage the complex tasks and increased responsibility. To prevent undesirable outcomes in the future, there is a need to pay attention to the nursing quality in balance with the nursing budget. It may, therefore, be considered a worthwhile investment to employ expert/highly qualified professional nurses in fast-track THA and TKA units.

High patient satisfaction in 445 patients who underwent fast-track hip or knee replacement.

BACKGROUND AND PURPOSE: Patient satisfaction is important in fast-track total hip and knee replacement (THR, TKR). We assessed: (1) how satisfied patients were with the treatment; (2) factors related to overall satisfaction; and (3) whether there was a difference between THR and TKR regarding length of stay (LOS) and patient satisfaction. PATIENTS AND METHODS: In this follow-up study, a consecutive series of 445 patients undergoing THR and TKR completed a questionnaire 2 weeks after discharge. LOS and short-term patient satisfaction with the fast-track management were measured. Patient satisfaction was measured using a numerical rating scale (NRS; 0-10). RESULTS: For THR, the median satisfaction score was 9-10 and for TKR it was 8.5-10 in all parameters. Older THR patients had higher overall satisfaction. No association was found between overall satisfaction following THR or TKR and sex comorbidity, or LOS. THR patients had shorter mean LOS than TKR patients, even though the median LOS was 2 days for both groups. THR patients were more satisfied than TKR patients in the first weeks after discharge. INTERPRETATION: Patient satisfaction is high following fast-track THR and TKR, with scores ranging from 8.5 to 10 on the NRS. A qualitative investigation of the first weeks after discharge is required to learn more about how to improve the experience of recovery.

No evidence of a clinically important effect of adding local infusion analgesia administrated through a catheter in pain treatment after total hip arthroplasty.

BACKGROUND AND PURPOSE: Postoperative analgesia after primary total hip arthroplasty (THA) using opioids is associated with troublesome side effects such as nausea and dizziness, and epidural analgesic means delayed mobilization. Thus, local infiltration analgesia (LIA) during surgery prolonged with local infusion analgesia (LINFA) into the soft tissue in the hip region through a catheter in the first postoperative days has gained major interest in THA fast-track settings within a short period of time. LIA at the time of surgery is a validated treatment. We investigated the additional effect of giving postoperative LINFA after THA in patients already having LIA during surgery. PATIENTS AND METHODS: 60 consecutive patients undergoing non-cemented THA were randomized into two groups in a double-blind and controlled study. During surgery, all patients received standardized pain treatment with LIA. Postoperatively, they were treated either with a solution of Ropivacain, Ketorolac, and Adrenaline (LINFA group) or placebo (placebo group) administered through a catheter to the hip 10 and 22 h after surgery. Pain score, opioid consumption, and length of stay (LOS) were evaluated. RESULTS: After adjustment for multiple testing, there was no statistically significant postoperative difference between the LINFA group and the placebo group regarding pain and tiredness. We found some evidence of a short-term effect on nausea and vomiting. Opioid consumption and length of stay were similar in the two groups. INTERPRETATION: We found some evidence of a short-term effect of LINFA on nausea and vomiting, but no evidence of an effect on postoperative pain and tiredness. Thus, LINFA cannot be recommended as a standard pain treatment in patients with THA.

Room for improvement in the treatment of hip fractures in Denmark.

INTRODUCTION: Treatment of hip fractures has evolved since the introduction of fast-track surgical programs in the late 1990s. The aim of our study was to describe the quality of treatment and care related to fast-track hip fracture surgery in Denmark by external audit of patient records. MATERIAL AND METHODS: This was a national multicenter audit of hospital charts from each hospital treating ≥ 50 hip fracture patients per year (n = 594). RESULTS: The study demonstrated significant variability in treatment and care of patients with hip fractures among the regions of Denmark. Pain management, nutritional screening, ambulation characteristics, training in activities of daily living, and rehabilitation planning were consistently inadequate. Length of stay was 7-11 days. CONCLUSION: Although the principles for fast-track surgery have been adapted to some extent at all departments in Denmark with an annual treatment of at least 50 patients with hip fractures, no single department has implemented the whole package. Hospital stay has been reduced since the introduction of fast-track regimes, and improvements were seen in many of the quality indicators. Implications for future practice include better adherence to clinical guidelines, a more homogeneous documentation system in nursing, promotion of evidence-based standards, and improved treatment and care of the physical and psychological consequences of hospitalization.

Aromatic components of food as novel eliciting factors of pseudoallergic reactions in chronic urticaria.

BACKGROUND: Pseudoallergic reactions (PARs) against both additives and natural foods have been reported to elicit chronic urticaria, but in natural food the responsible ingredients are largely unknown. OBJECTIVE: The study was aimed at identifying novel pseudoallergens in food and focused on evaluating tomatoes, white wine, and herbs as frequently reported food items eliciting wheal responses in urticaria. METHODS: In 33 patients with chronic urticaria and PARs to food (proved by means of elimination diet and subsequent re-exposure with provocation meals), oral provocation tests were performed with field-grown tomatoes, organically grown white wine (whole food, steam distillates, and residues), oily extracts from herbs, and food additives. In addition, skin biopsy specimens from patients were studied for in vitro mast-cell histamine release with tomato distillate alone or on subsequent stimulation with anti-IgE, substance P, and C5a. RESULTS: Seventy-six percent of patients reacted to whole tomato (steam distillate, 45%; residue, 15%), 50% to food additives, 47% to herbs, and 44% to whole wine (extract, 27%; residue, 0%). Histamine, protein, and high levels of salicylate were only found in residues. The tomato distillate was further analyzed by means of mass spectroscopy, identifying low molecular-weight aldehydes, ketones, and alcohol as major ingredients. In vitro histamine release was not caused by tomato extract itself but was enhanced by means of subsequent stimulation with substance P and C5a but not by anti-IgE. CONCLUSION: Aromatic volatile ingredients in food are novel agents eliciting PARs in chronic urticaria. Histamine, salicylate, and a direct mast-cell histamine release are not involved in this reactivity to naturally occurring pseudoallergens.