Patient perceived quality of cirrhosis care- adjunctive nurse-based care versus standard medical care: a pragmatic multicentre randomised controlled study.

BACKGROUND: Cirrhosis treatment implies prevention and alleviation of serious disease events. Healthcare providers may, however, fail to meet patients' expectations of collaboration and specific needs of information and support. Individualised nursing care could meet patients' needs. The aim was thus to measure patient-perceived quality of care after adjunctive registered nurse-based intervention Quality Liver Nursing Care Model (QLiNCaM) compared with standard medical care. METHODS: This pragmatic multicentre study consecutively randomised patients to either adjunctive registered nurse-based care, or standard medical care for 24 months (ClinicalTrials.gov NCT02957253). Patients were allocated to either group at an equal ratio, at six Swedish outpatient clinics during 2016-2022. Using the questionnaire 'Quality of care from the patient's perspective', patients rated their perceived lack of quality for the adjunctive registered nurse-based intervention compared with the control group at 12 and 24 months, respectively. RESULTS: In total, 167 patients were recruited. Seven out of 22 items in the questionnaire supported the finding that 'lacking quality' decreased with adjunctive registered nurse-based care (p < 0.05) at 12 months follow-up; however, these differences could not be established at 24 months. CONCLUSION: Additional structured registered nurse-based visits in the cirrhosis outpatient team provided support for improved patient-perceived quality of care during the first 12 months. Registered nurses increase patient involvement and present easy access to cirrhosis outpatient care. Patients express appreciation for personalised information. This study reinforces registered nurses' role in the outpatient cirrhosis team, optimising patient care in compensated and decompensated cirrhosis. TRIAL REGISTRATION: Registered at Clinical Trials 18th of October 2016, [ https://www. CLINICALTRIALS: gov ], registration number: NCT02957253.

Feeling safe or falling through the cracks-Patients' experiences of healthcare in cirrhosis illness: A qualitative study.

INTRODUCTION: Patients with cirrhosis have a long-lasting relationship with medical personnel. Hierarchy in the healthcare contacts and feeling stigmatised may affect the patient's interactions with these care providers. Despite healthcare professionals' awareness of patients' increased self-care needs, patients report getting insufficient information and support. The patients' expectations and experiences of interacting with healthcare professionals in cirrhosis care is hence a research area that needs further investigation. PURPOSE: To capture patients' descriptions of healthcare experiences in relation to cirrhosis illness. MATERIAL AND METHODS: Data comprise semi-structured interviews (N = 18) and open-ended questionnaire responses (N = 86) of patients with cirrhosis. Braun and Clarke's thematic analysis process was used, including both semantic and inductive elements. The study is reported following the COREQ guidelines. FINDINGS: The analysis resulted in two themes: 1) Struggle to be in a dialogue and 2) Being helped or harmed. Six sub-themes were identified concerning aspects of experiences within each theme during the analysis. These sub-themes included: 'getting information', 'being involved', 'being perceived as a person', 'enduring care', 'feeling lost in the healthcare organisation', and 'not being taken care of'. CONCLUSIONS: Patients with cirrhosis express concerns regarding where to turn in the continuum of cirrhosis care. They emphasise the importance of being involved in the dialogue with the healthcare professional, to be perceived as a person with a unique need to be informed. The healthcare organisation and continuity of care are either viewed as confusing or as helping to shape a safe and trustful contact, which was an important difference in feeling helped or harmed. Hence, patients wished for improved collaboration with healthcare professionals and to receive increased information about their disease. Person-centred communication in nurse-led clinics may increase patient satisfaction and prevent patients from falling through the cracks.

Efficacy of a novel device for cryoprevention of oral mucositis: a randomized, blinded, multicenter, parallel group, phase 3 trial.

Cryoprevention (CP) using ice (IC) is an effective strategy to prevent chemotherapy-induced oral mucositis (OM). However, the use of IC may cause adverse reactions and requires water of safe quality to minimize risk of serious infections. This randomized, blinded, parallel group, phase 3 trial was conducted in five Scandinavian centers. Eligible patients were diagnosed with multiple myeloma or lymphoma, scheduled to receive conditioning with high-dose chemotherapy prior to autologous hematopoietic stem cell transplantation (ASCT). Patients were assigned to cooling with IC or a novel intraoral cooling device (ICD). The primary outcome was the highest OM score during the study period, expressed as peak value on the Oral Mucositis Assessment Scale (OMAS-total). When the entire study population (n = 172) was analyzed for peak OMAS-total, the two cooling methods were equally effective. However, when the lymphoma group was analyzed separately, the ICD significantly reduced the peak OMAS-total score to a greater extent compared to IC (x̄ ± SD; 1.77 ± 1.59 vs. 3.08 ± 1.50; p = 0.047). Combined with existing evidence, the results of the present trial confirm that CP is an effective method to prevent OM. ClinicalTrials.gov. NCT03203733.

Liver cirrhosis turns life into an unpredictable roller coaster: A qualitative interview study.

AIM: To explore how persons living with liver cirrhosis experience day-to-day life. BACKGROUND: Liver cirrhosis is the sixth most common cause of death among adults in Western countries. Persons with advanced liver cirrhosis report poor quality of life, in comparison with other chronic diseases. However, knowledge regarding day-to-day life during earlier stages of the disease is lacking. In other chronic diseases, the suffering process is well explored, while in liver cirrhosis, suffering is insufficiently investigated. DESIGN: An exploratory study, with a qualitative inductive interview approach. METHODS: A purposive maximum variation sample of 20 informants with liver cirrhosis aged 25-71, from two gastroenterology outpatient clinics in mid-Sweden, were interviewed from September 2016 to October 2017. Interview data were analysed inductively with qualitative content analysis. Reporting followed the COREQ guidelines. RESULTS: The experiences of day-to-day life living with liver cirrhosis comprised four sub-themes. Living with liver cirrhosis implied varying levels of deterioration, the most apparent being exhaustion or tiredness. The informants had to find ways of adapting to a new life situation. The insecurity of future health evoked existential reflections such as feeling emotionally and existentially distressed. Shame and guilt were reasons for feeling stigmatised. These sub-themes emerged into one overarching theme of meaning: life turns into an unpredictable roller coaster. This is based on experiences of liver cirrhosis as an unpredictable disease with fluctuating symptoms, worries and disease progression. CONCLUSION: Living with cirrhosis implies an unpredictable condition with a progressive, stigmatising disease. The fluctuating symptoms and deep concerns about future life pose an increased personal suffering. RELEVANCE TO CLINICAL PRACTICE: Within health care, knowledge of the person's experience is vital to enable and fulfil the person's healthcare needs. Clinical registered nurses need a person-centred approach to strengthen their patients to cope with their new life situation.

Prevention of oral mucositis with cryotherapy in children undergoing hematopoietic stem cell transplantations-a feasibility study and randomized controlled trial.

PURPOSE: To evaluate the feasibility of oral cryotherapy (OC) in children and to investigate if OC reduces the incidence of severe oral mucositis (OM), oral pain, and opioid use in children undergoing hematopoietic stem cell transplantation (HSCT). METHODS: Fifty-three children, 4-17 years old, scheduled for HSCT in Sweden were included and randomized to OC or control using a computer-generated list. OC instructions were to cool the mouth with ice for as long as possible during chemotherapy infusions with an intended time of ≥ 30 min. Feasibility criteria in the OC group were as follows: (1) compliance ≥ 70%; (2) considerable discomfort during OC < 20%; (3) no serious adverse events; and (4) ice administered to all children. Grade of OM and oral pain was recorded daily using the WHO-Oral Toxicity Scale (WHO-OTS), Children's International Oral Mucositis Evaluation Scale, and Numerical Rating Scale. Use of opioids was collected from the medical records. RESULTS: Forty-nine children (mean age 10.5 years) were included in analysis (OC = 26, control = 23). The feasibility criteria were not met. Compliance was poor, especially for the younger children, and only 15 children (58%) used OC as instructed. Severe OM (WHO-OTS ≥ 3) was recorded in 26 children (OC = 15, control = 11). OC did not reduce the incidence of severe OM, oral pain, or opioid use. CONCLUSION: The feasibility criteria were not met, and the RCT could not show that OC reduces the incidence of severe OM, oral pain, or opioid use in pediatric patients treated with a variety of conditioning regimens for HSCT. TRIAL REGISTRATION: ClinicalTrials.gov id: NCT01789658.

Nurse-led clinic for patients with liver cirrhosis-effects on health-related quality of life: study protocol of a pragmatic multicentre randomised controlled trial.

INTRODUCTION: Liver cirrhosis affects health-related quality of life (HRQoL) even in its early stages. Morbidity is especially high when the disease decompensates and self-care actions become essential. Nurse involvement in secondary prevention in other chronic diseases has contributed to better symptom control, less need of inpatient care and improved HRQoL. In order to evaluate the impact of nurse involvement in the follow-up of patients with liver cirrhosis, we decided to compare structured nurse-led clinics, inspired by Dorothea Orem's nursing theory and motivational strategies, with a group of patients receiving standard care. The primary outcome is HRQoL and the secondary outcomes are quality of care, visits to outpatient clinics or hospitals, disease progress and health literacy. METHODS AND ANALYSIS: This is a pragmatic, multicentre randomised controlled study conducted at six Swedish hepatology departments. Eligible patients are adults with diagnosed cirrhosis of the liver (n=500). Participants are randomised into either an intervention with nurse-led follow-up group or into a standard of care group. Recruitment started in November 2016 and is expected to proceed until 2020. Primary outcomes are physical and mental HRQoL measured by RAND-36 at enrolment, after 1 and 2 years. ETHICS AND DISSEMINATION: The study is ethically approved by the Regional Ethical Review Board in Uppsala. The results shall be disseminated in international conferences and peer-reviewed articles. TRIAL REGISTRATION NUMBER: NCT02957253; Pre-results.

Protocol for a randomised controlled trial to study cryoprevention of chemotherapy-induced oral mucositis after autologous stem cell transplantation.

INTRODUCTION: A majority of patients who receive myeloablative therapy prior to hematopoetic stem cell transplantation develop oral mucositis (OM). This adverse cytotoxic effect manifests as oral mucosal erythema and ulcerations and frequently necessitates high doses of morphine for pain alleviation. OM may also interfere with food intake and result in parenteral nutrition, weight loss and impaired quality of life. To date, there have been a few studies of evidence-based interventions for prevention of OM. Cooling the oral mucosa using ice chips in conjunction with chemotherapy is known to reduce the severity of OM although clinical application is still limited due to several disadvantages. The primary endpoint of this study is therefore to evaluate the efficacy of an innovative intraoral cooling device (Cooral) compared with ice cooling in reducing the degree of OM, in patients with myeloma or lymphoma. METHOD AND ANALYSIS: A total of 180 patients from four different university hospitals in Sweden will be randomised to ice or Cooral in a proportion of 1:1. The degree of OM will be assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale and WHO scale. Patients will be registered beginning at admission and will continue until discharge or until day +28. The primary variable is analysed in a multiple linear regression model. The significance level used is 5%. ETHICS AND DISSEMINATION: The study protocol, questionnaire, diaries and letter of invitation to participants have been reviewed by the local ethical board in Göteborg. The trial results will be published in a peer-reviewed journal and disseminated to participants. TRIAL REGISTRATION NUMBER: NCT03203733; Pre-results. PROTOCOL VERSION: Version 4, 2017-06-05.

Correction to: Innovative intraoral cooling device better tolerated and equally effective as ice cooling.

Unfortunately, the online published article has error in Table 1. The correct Table 1 is given in the following page.

Innovative intraoral cooling device better tolerated and equally effective as ice cooling.

PURPOSE: Most of the patients who receive myeloablative therapy prior to stem cell transplantation develop oral mucositis (OM). This adverse reaction manifests as oral mucosal erythema and ulcerations and may require high doses of morphine for pain alleviation. OM may also interfere with food intake and result in weight loss, a need for parenteral nutrition, and impaired quality of life. To date, there have been very few studies of evidence-based interventions for the prevention of OM. Cryotherapy, using ice chips, has been shown to reduce in an efficient manner the severity and extent of OM, although clinical applications are still limited due to several shortcomings, such as adverse tooth sensations, problems with infectious organisms in the water, nausea, and uneven cooling of the oral mucosa. The present proof-of-concept study was conducted to compare the tolerability, temperature reduction, and cooling distribution profiles of an intra-oral cooling device and ice chips in healthy volunteers who did not receive myeloablative treatment, and therefore, did not experience the symptoms of OM. METHODS: Twenty healthy volunteers used the cooling device and ice chips for a maximum of 60 min each, using a cross-over design. The baseline and final temperatures were measured at eight intra-oral locations using an infra-red thermographic camera. The thermographic images were analysed using two digital software packages. A questionnaire was used to assess the tolerability levels of the two interventions. RESULTS: The intra-oral cooling device was significantly better tolerated than the ice-chips (p = 0.0118). The two interventions were equally effective regarding temperature reduction and cooling distribution. CONCLUSIONS: The intra-oral cooling device shows superior tolerability in healthy volunteers. Furthermore, this study shows that temperature reduction and cooling distribution are achieved equally well using either method.

Addition of Aprepitant (Emend®) to Standard Antiemetic Regimen Continued for 7 Days after Chemotherapy for Stem Cell Transplantation Provides Significant Reduction of Vomiting.

Chemotherapy-induced nausea/vomiting (CINV) is a major problem for patients treated with high-dose chemotherapy (HDCT) conditioning before stem cell transplantation (SCT), both during chemotherapy and afterwards (delayed nausea/vomiting). The standard of care (5-HT3 antagonist and dexamethasone) appears to be ineffective against delayed nausea and vomiting. The objective of this study was to compare standard antiemetic treatment with standard treatment plus prolonged treatment with aprepitant (Emend®) until 7 days after the end of chemotherapy in patients treated with HDCT before autologous SCT. Ninety-six patients were randomized to the experiment (EXP) group receiving Emend in addition to standard antiemetics or to the control (CTR) group receiving placebo. Emend or placebo treatment started 1 h before the first HDCT dose for SCT and ended 7 days after HDCT. Thirty-eight patients in the EXP group experienced complete response (no vomiting) compared to 16 patients in the CTR group. There was a significant difference between the EXP (0.63 ± 2.71) and the CTR (3.72 ± 4.91) group during 10 days after the end of HDCT (p = 0.001) with regard to the number of vomiting episodes. No difference with regard to days of nausea or in the use of antiemetic rescue was noted between the groups. We conclude that standard antiemetic treatment can be improved by addition of aprepitant continued for 7 days after the end of chemotherapy.

Caphosol(®) mouthwash gives no additional protection against oral mucositis compared to cryotherapy alone in stem cell transplantation. A pilot study.

PURPOSE: To investigate if adding Caphosol(®), a mouthwash solution, to oral cryotherapy (OC) further protects against oral mucositis (OM), a toxic painful complication to high dose chemotherapy. METHOD: The study was a randomised, controlled, study design. Patients ≥16 years scheduled for allogeneic stem cell transplantation were included consecutively and randomised to experimental group receiving OC combined with Caphosol(®) (n = 20) or control group receiving OC only (n = 20). OC was given from start to end of HDCT. Caphosol(®), from day 0 to day 21. RESULT: There were no significant differences regarding age or gender between the groups. Mucositis was assessed with the World Health Organisation (WHO) grading scale. Pain was assessed with a 10 cm visual analogue scale (VAS) from 0 = no pain to 10 = worst imaginable pain. Start and duration of therapy with pain relieving drugs, serum C-reactive protein values, and number of days of hospitalisation were collected from the medical records. Data on OM, oral pain, use of i.v. opioids and total parenteral nutrition were collected during 22 days. There was no significant difference between the groups on OM, oral pain, use of i.v. opioids or TPN between the groups. CONCLUSION: The study showed no additional effect of combining Caphosol(®) with OC.

Parents and children's perceptions of distress related to oral mucositis during haematopoietic stem cell transplantation.

AIM: Oral mucositis is a common and debilitating side effect of haematopoietic stem cell transplantation. Our study investigated parents' and children's experiences of oral mucositis treatment and whether the parents' perceptions accurately reflected the children's views. METHODS: We analysed 71 questionnaires completed by the parents of children who had undergone haematopoietic stem cell transplantation, together with 38 questionnaires completed by children who were 7 years of age or over. RESULTS: The parent proxy and child self-reports showed good to excellent agreement. For example, 86% of the parents and 83% of the children reported oral pain and 44% of the parents and 47% of the children reported difficulty swallowing often or very often. The majority of the parents (61%) were satisfied with the pain treatment that had been given to their child. However, the treatment provided for oral mucositis was not altogether consistent. CONCLUSION: Oral mucositis affected the majority of the children undergoing haematopoietic stem cell transplantation, causing considerable pain and discomfort. The parent proxy reports proved to be reliable and are an important supplement to child self-reports on symptoms related to oral mucositis. But there is a clear need to establish more evidence-based care for children suffering from oral mucositis.

The effect of cryotherapy on oral mucosa: a study in healthy volunteers.

Oral cryotherapy causes local vasoconstriction, which reduces blood flow and reduces the cytotoxic damage to the oral mucosa, has been shown to reduce oral mucositis after intense cytostatic treatment. The main object of this study was to investigate the effect of oral cryotherapy on the temperature in the oral mucosa, the level of proinflammatory cytokine interleukin-6 (IL-6) in saliva and the effect on blood pressure in healthy volunteers, before and after 1 h of cooling the oral cavity with crushed ice. Twelve healthy volunteers [mean age 32.4 (SD 13.2) (20-56) years] were treated with oral cryotherapy in the form of crushed ice. Temperature measurements were performed in the oral mucosa using infrared thermograph following a flowchart protocol. Blood pressure (BP) was measured with a sphygmomanometer. Saliva was analysed for inflammatory cytokine IL-6, using an enzyme-linked immunosorbent assay (ELISA). All participants fulfilled the cooling session. The temperature in the oral cavity decreased significantly (mean 12.9 °C, p < .002). The systolic BP was marginally but significantly higher after cooling (~5 mmHg, p = .019). We could not detect any differences in cytokine IL-6 levels before and after oral cooling. We conclude that cryotherapy during 1 h lowers the mucosal temperature as much as ~12.9 °C, which explains the significant protective effect against mucosal damage by cytostatic drugs. The cooling caused no increase in IL-6 levels. Systemic blood pressure was marginally increased.

Oral cryotherapy reduces mucositis and improves nutrition - a randomised controlled trial.

AIM AND OBJECTIVE: To investigate if oral cryotherapy during myeloablative therapy may influence frequency and severity of mucositis, nutritional status and infection rate after bone marrow transplantation. BACKGROUND: Patients treated with intensive myeloablative treatment before bone marrow transplantation are all at risk to develop mucositis. Oral mucositis causes severe pain and oral dysfunction, which can contribute to local and systemic infections and bleeding; it may even interrupt cancer therapy. Oral mucositis also decreases the oral food intake, which increases the risk for malnutrition and infection. Reduced food intake, loss of fat and muscles, alterations in energy and substrate metabolism leads to malnutrition. DESIGN: A randomised controlled trial with a random assignment to experimental or control group. METHOD: A stratified randomisation was used with regard to the type of transplantation. Mucositis was measured on WHO mucositis scale. Number of days of total parenteral nutrition, infection rate, weight, albumin levels and days at hospital was compared. RESULTS: There were significantly fewer patients in the experimental group with mucositis grade 3-4 than in the control group and significantly lower number of days in the hospital (allogeneic patients). Less total parenteral nutrition was needed in the experimental group in both settings, and the S-albumin level was significantly better preserved. No significant difference could be found with regard to infection rate. CONCLUSION: Oral cryotherapy reduced mucositis, number of hospital days, the need for total parenteral nutrition and resulted in a better nutritional status. RELEVANCE TO CLINICAL PRACTICE: Nurses caring for patients treated with myeloablative therapy should place high priority to prevent oral mucositis and hereby reduce its side effects.

Oral cryotherapy reduces mucositis and opioid use after myeloablative therapy--a randomized controlled trial.

INTRODUCTION: Mucositis is a major complication in myeloablative therapy, which often necessitates advanced pharmacological pain treatment, including i.v. opioids. Attempts to prevent oral mucositis have included oral cryotherapy, which has been shown to reduce mucositis, but there is a lack of knowledge concerning the effect of oral cryotherapy on opioid use by reducing the mucositis for patients treated with myeloablative therapy before bone marrow transplantation (BMT). AIM: The aim of the present study was to evaluate if oral cryotherapy could delay or alleviate the development of mucositis and thereby reduce the number of days with i.v. opioids among patients who receive myeloablative therapy before BMT. MATERIALS AND METHODS: Eighty patients 18 years and older, scheduled for BMT, were included consecutively and randomised to oral cryotherapy or standard oral care. A stratified randomisation was used with regard to type of transplantation. Intensity of pain, severity of mucositis and use of opioids were recorded using pain visual analogue scale (VAS) scores, mucositis index scores and medical and nursing charts. RESULTS: This study showed that patients receiving oral cryotherapy had less pronounced mucositis and significantly fewer days with i.v. opioids than the control group. In the autologous setting, cryotherapy patients also needed significantly lower total dose of opioids. CONCLUSION: Oral cryotherapy is an effective and well-tolerated therapy to alleviate mucositis and consequently reduce the number of days with i.v. opioids among patients treated with myeloablative therapy before BMT.