Factors associated with pain and functional impairment five years after total knee arthroplasty: a prospective observational study.

BACKGROUND: Few studies have evaluated the associations between preoperative factors and pain and physical function outcomes after total knee arthroplasty (TKA) from a mid-term perspective. Identification of such factors is important for optimizing outcomes following surgery. Thus, we examined the associations between selected preoperative factors and moderate to severe pain and pain-related functional impairment as measured using the Brief Pain Inventory (BPI), five years after TKA in patients with knee osteoarthritis. METHODS: In this prospective observational study, all patients scheduled for primary unilateral TKA for osteoarthritis were consecutively recruited. Preoperative factors identified from previous meta-analyses were included to assess their associations with pain severity and pain-related functional impairment five years after TKA. Pain severity was the primary outcome, while pain-related functional impairment was the secondary outcome. The BPI was used to evaluate outcomes five years post-TKA. Statistically significant factors from univariate regressions were entered into a multiple logistic regression model to identify those with the strongest associations with pain severity or pain-related functional impairment five years after TKA. RESULTS: A total of 136 patients were included, with a mean age of 67.7 years (SD 9.2) and a majority being female (68%). More severe preoperative pain (OR = 1.34, 95% CI [1.03 to 1.74]), more painful sites (OR = 1.28., 95% CI [1.01 to 1.63]), and more severe anxiety symptoms (OR = 1.14., 95% CI [1.01 to 1.28]) were associated with increased likelihood of moderate to severe pain five years after TKA surgery, while more severe osteoarthritis (OR = 0.13, 95% CI [0.03 to 0.61]) was associated with reduced likelihood of moderate to severe pain five years after TKA. More severe anxiety symptoms (OR = 1.25, 95% CI [1.08 to 1.46]) were also associated with increased likelihood of moderate to severe pain-related functional impairment five years after surgery, while male sex (OR = 0.23, 95% CI [0.05 to 0.98]) was associated with reduced likelihood of pain-related functional impairment five years after surgery. CONCLUSION: The identified preoperative factors should be included in larger prognostic studies evaluating the associations between preoperative factors and mid-term pain severity and physical function outcomes after TKA surgery.

A comparison of the prevalence of dry mouth and other symptoms using two different versions of the Edmonton Symptom Assessment System on an inpatient palliative care unit.

BACKGROUND: Symptom assessment is key to effective symptom management and palliative care for patients with advanced cancer. Symptom prevalence and severity estimates vary widely, possibly dependent on the assessment tool used. Are symptoms specifically asked about or must the patients add them as additional symptoms? This study compared the prevalence and severity of patient-reported symptoms in two different versions of a multi-symptom assessment tool. In one version, three symptoms dry mouth, constipation, sleep problems were among those systematically assessed, while in the other, these symptoms had to be added as an "Other problem". METHODS: This retrospective cross-sectional study included adult patients with advanced cancer at an inpatient palliative care unit. Data were collected from two versions of the Edmonton Symptom Assessment System (ESAS): modified (ESAS-m) listed 11 symptoms and revised (ESAS-r) listed 9 and allowed patients to add one "Other problem". Seven similar symptoms were listed in both versions. RESULTS: In 2013, 184 patients completed ESAS-m, and in 2017, 156 completed ESAS-r. Prevalence and severity of symptoms listed in both versions did not differ. In ESAS-m, 83% reported dry mouth, 73% constipation, and 71% sleep problems, but on ESAS-r, these symptoms were reported by only 3%, 15% and < 1%, respectively. Although ESAS-r severity scores for these three symptoms were higher than on ESAS-m, differences did not reach statistical significance. CONCLUSION: We identified significant differences in patient symptom reporting based on whether symptoms like dry mouth, obstipation and sleep problems were specifically assessed or had to be added by patients as an "Other problem".

Development and evaluation of the Norwegian Fatigue Characteristics and Interference Measure (FCIM) for stroke survivors: cognitive interviews and Rasch analysis.

PURPOSE: There is need for a comprehensive measure of post-stroke fatigue with sound measurement properties. This study aimed to develop the Norwegian Fatigue Characteristics and Interference Measure (FCIM) and assess its content validity, structural validity, and internal consistency. METHOD: This study consisted of three steps: (1) an expert panel developed version 1.0 of the Norwegian FCIM, (2) its content validity was assessed in cognitive interviews with stroke patients (N = 15), (3) a convenience sample of stroke patients (N = 169) completed an online questionnaire with the FCIM, Fatigue Severity Scale, and sociodemographic information; validity and reliability were assessed using Rasch analysis. RESULTS: FCIM version 1.0 included a 10-item characteristics subscale, a 20-item interference subscale, and two pre-stroke fatigue items. The cognitive interviews revealed content validity issues, resulting in two interference items being removed and five items being flagged but retained for Rasch analysis (version 2.0). Rasch analysis led to removal of four items from the characteristics subscale and six more from the interference subscale. The final six-item characteristics subscale and 12-item interference subscale (version 3.0) both showed adequate fit to the Rasch model with indications of unidimensionality and local independence. The interference subscale had a high person separation index. No significant differential item function (DIF) was found in relation to gender, but one item demonstrated DIF in relation to age. CONCLUSION: The cognitive interviews and Rasch analysis demonstrated that the Norwegian version of the FCIM has high content validity, structural validity, and internal consistency. Future research should assess its construct validity, reliability, and responsiveness.

Validation of a short version of the Lee fatigue scale in adults living in Norway: a cross-sectional population survey.

BACKGROUND: Due to the nature of fatigue, a brief reliable measure of fatigue severity is needed. Thus, the aim of our study was to evaluate a short version of the Lee Fatigue Scale (LFS) in the Norwegian general population. METHODS: This cross-sectional survey consists of a representative sample from the Norwegian population drawn by The National Population Register in Norway. The study is part of a larger study (NORPOP) aimed at collecting normative data from several questionnaires focused on health in adults living in Norway. Registered citizens between 18 and 94 years of age were randomly selected stratified by age, sex and geographic region. Of the 4971 respondents eligible for the study, 1792 (36%) responded to the survey. In addition to age and sex, we collected responses on a 5-item version of the LFS measuring current fatige severity. The psychometric properties focusing on internal structure and precision of the LFS items were analyzed by a Rasch rating scale model. RESULTS: Complete LFS scores for analyses were available for 1767 adults. Women had higher LFS-scores than men, and adults < 55 years old had higher scores than older respondents. Our analysis of the LFS showed that the average category on each item advanced monotonically. Two of the five items demonstrated misfit, while the three other items demonstrated goodness-of-fit to the model and uni-dimensionality. Items #1 and #4 (tired and fatigue respectively) showed differential item functioning (DIF) by sex, but no items showed DIFs in relation to age. The separation index of the LFS 3-item scale showed that the sample could be separated into three different groups according to the respondents' fatigue levels. The LFS-3 raw scores correlated strongly with the Rasch measure from the three items. The core dimensions in these individual items were very similarly expressed in the Norwegian language version and this may be a threat to the cultural-related or language validity of a short version of the LFS using these particular items. CONCLUSIONS: The study provides validation of a short LFS 3-item version for estimating fatigue in the general population.

Maternal mental health after infant discharge: a quasi-experimental clinical trial of family integrated care versus family-centered care for preterm infants in U.S. NICUs.

BACKGROUND: Involvement in caregiving and tailored support services may reduce the risk of mental health symptoms for mothers after their preterm infant's neonatal intensive care unit (NICU) discharge. We aimed to compare Family-Centered Care (FCC) with mobile-enhanced Family-Integrated Care (mFICare) on post-discharge maternal mental health symptoms. METHOD: This quasi-experimental study enrolled preterm infant (≤ 33 weeks)/parent dyads from three NICUs into sequential cohorts: FCC or mFICare. We analyzed post-discharge symptoms of perinatal post-traumatic stress disorder (PTSD) and depression using intention-to-treat and per protocol approaches. RESULTS: 178 mothers (89 FCC; 89 mFICare) completed measures. We found no main effect of group assignment. We found an interaction between group and stress, indicating fewer PTSD and depression symptoms among mothers who had higher NICU-related stress and received mFICare, compared with mothers who had high stress and received FCC (PTSD: interaction ß=-1.18, 95% CI: -2.10, -0.26; depression: interaction ß=-0.76, 95% CI: -1.53, 0.006). Per protocol analyses of mFICare components suggested fewer PTSD and depression symptoms among mothers who had higher NICU stress scores and participated in clinical team rounds and/or group classes, compared with mothers who had high stress and did not participate in rounds or classes. CONCLUSION: Overall, post-discharge maternal mental health symptoms did not differ between the mFICare and FCC groups. However, for mothers with high levels of stress during the NICU stay, mFICare was associated with fewer post-discharge PTSD and depression symptoms.

Mobile-Enhanced Family-Integrated Care for Preterm Infants: Nurse and Physician Views About Implementation.

BACKGROUND: The mobile-enhanced family-integrated care (mFICare) model addresses inconsistencies in family-centered care (FCC) delivery, with an evidence-based bundle of staff training, parent participation in rounds, parent classes, parent peer mentors, expanded role for parents in infant caregiving, and a parent-designed app. PURPOSE: Our aim was to explore the views of neonatal intensive care unit (NICU) nurses and physicians about mFICare implementation, including what worked well and what could be improved. METHODS: As part of a larger study to compare mFICare with FCC, we invited registered nurses, nurse practitioners, and fellow and attending physicians at the 3 study sites to participate in a survey about mFICare implementation. Data were analyzed with descriptive statistics and thematic analysis. RESULTS: The majority of the 182 respondents with experience delivering mFICare positively rated parent-led rounds, parent classes, parent skills acquisition, and the nurse-family relationship resulting from participation in mFICare. Respondents were less familiar or neutral regarding the parent peer mentor and app components of mFICare. Most respondents agreed that the mFICare program improved parent empowerment, and they shared suggestions for optimizing implementation. Physicians experienced more challenges with parent participation in rounds than nurses. Three themes emerged from the free-text data related to emotional support for parents, communication between staff and parents, and the unique experiences of families receiving mFICare. IMPLICATIONS FOR PRACTICE AND RESEARCH: The mFICare program was overall acceptable to nurses and physicians, and areas for improvement were identified. With implementation refinement, mFICare can become a sustainable model to enhance delivery of FCC in NICUs.

Parent Readiness for Their Preterm Infant's Neonatal Intensive Care Unit Discharge.

This study aims to examine the influence of hospital experience factors on parental discharge readiness, accounting for key background characteristics. Parents/guardians of infants 33 weeks of gestation or less at birth receiving neonatal intensive care at 6 sites were enrolled from April 2017 to August 2018. Participants completed surveys at enrollment, 3 weeks later, and at discharge. Multiple regression analysis assessed relationships between parental experience, well-being, and perceived readiness for infant discharge, adjusting for socioenvironmental, infant clinical, and parent demographic characteristics. Most (77%) of the 139 parents reported high levels of readiness for their infant's discharge and 92% reported high self-efficacy at discharge. The multiple regression model accounted for 40% of the variance in discharge readiness. Perceptions of family-centered care accounted for 12% of the variance; measures of parent well-being, anxiety, and parenting self-efficacy accounted for an additional 16% of the variance; parent characteristics accounted for an additional 9%; and infant characteristics accounted for less than 3% of the variance. Parental perceptions of the family-centeredness of the hospital experience, anxiety, and parenting self-efficacy accounted for a substantial proportion of the variance in readiness for discharge scores among parents of preterm infant. These influential perceptions are potentially modifiable by nursing-led interventions.

Hospital characteristics associated with nurse staffing during labor and birth: Inequities for the most vulnerable maternity patients.

BACKGROUND: Evidence is limited on nurse staffing in maternity units. PURPOSE: To estimate the relationship between hospital characteristics and adherence with Association of Women's Health, Obstetric and Neonatal Nurses nurse staffing guidelines. METHODS: We enrolled 3,471 registered nurses in a cross-sectional survey and obtained hospital characteristics from the 2018 American Hospital Association Annual Survey. We used mixed-effects linear regression models to estimate associations between hospital characteristics and staffing guideline adherence. FINDINGS: Overall, nurses reported strong adherence to AWHONN staffing guidelines (rated frequently or always met by ≥80% of respondents) in their hospitals. Higher birth volume, having a neonatal intensive care unit, teaching status, and higher percentage of births paid by Medicaid were all associated with lower mean guideline adherence scores. DISCUSSION AND CONCLUSIONS: Important gaps in staffing were reported more frequently at hospitals serving patients more likely to have medical or obstetric complications, leaving the most vulnerable patients at risk.

Relationship between social support and post-discharge mental health symptoms in mothers of preterm infants.

BACKGROUND: Social support is associated with decreased symptoms of postpartum mood and anxiety disorders (PMAD) in mothers of healthy infants, but less is known about social support and PMADs in mothers with preterm infants. The purpose of this study was to examine the relationship between social support and symptoms of PMADs reported by mothers in the months following hospital discharge of their preterm infant. METHODS: Mothers of infants less than 33 weeks gestational age were enrolled from neonatal intensive care units (NICU) at 6 sites. Mothers completed PMAD measures of depression, anxiety and post-traumatic stress approximately 3 months following their infant's discharge. Multivariable regression was used to evaluate relationships between social support and PMAD measures. RESULTS: Of 129 mothers, 1 in 5 reported clinically significant PMAD symptoms of: depression (24%), anxiety (19%), and post-traumatic stress (20%). Social support was strongly inversely associated with all 3 PMADs. Social support explained between 21% and 26% of the variance in depression, anxiety and post-traumatic stress symptoms. CONCLUSION: Increased social support may buffer PMAD symptoms in mothers of preterm infants after discharge. Research is needed to determine effective screening and interventions aimed at promoting social support for all parents during and following their infant's hospitalisation.

Identification and susceptibility testing of oral candidiasis in advanced cancer patients.

BACKGROUND: Patients with advanced cancer are prone to develop different opportunistic oral infection due to anti-cancer treatment or the malignancies themselves. Studies of oral fungal samples show an increased prevalence of non-Candida albicans species in mixed oral infections with Candida albicans. Non-C. albicans and C. albicans are associated with varying degrees of resistance to azoles, which may have implications for treatment. This study aimed to assess the diversity and antifungal susceptibility of Candida species detected in the oral cavity. METHODS: An observational study with microbiological analysis was conducted. Clinical fungal isolates were collected from patients in a hospice unit in 2014-2016. Isolates were re-grown on chromID® Candida plates in 2020. Single colony of each species was re-cultivated and prepared for biochemical identification with a VITEK2® system and verified by gene sequencing. Etest was performed on RPMI agar, and the antifungals fluconazole, amphotericin B, anidulafungin and nystatin were applied. RESULTS: Fifty-six isolates from 45 patients were identified. Seven different Candida species and one Saccharomyces species were detected. The results of biochemical identification were confirmed with sequencing analysis. Thirty-six patients had mono infection, and nine out of 45 patients had 2-3 different species detected. Of C. albicans strains, 39 out of 40 were susceptible to fluconazole. Two non-C. albicans species were resistant to fluconazole, one to amphotericin B and three to anidulafungin. CONCLUSION: C. albicans was the predominant species, with a high susceptibility to antifungal agents. Different Candida species occur in both mono and mixed infections. Identification and susceptibility testing may therefore lead to more effective treatment and may prevent the development of resistance among patients with advanced cancer. TRAIL REGISTRATION: The study Oral Health in Advanced Cancer was registered at ClinicalTrials.gov (#NCT02067572) in 20/02/2014.

Psychometric validation of a patient-reported experience measure of obstetric racism© (The PREM-OB Scale™ suite).

BACKGROUND: Perinatal quality improvement lacks valid tools to measure adverse hospital experiences disproportionately impacting Black mothers and birthing people. Measuring and mitigating harm requires using a framework that centers the lived experiences of Black birthing people in evaluating inequitable care, namely, obstetric racism. We sought to develop a valid patient-reported experience measure (PREM) of Obstetric Racism© in hospital-based intrapartum care designed for, by, and with Black women as patient, community, and content experts. METHODS: PROMIS© instrument development standards adapted with cultural rigor methodology. Phase 1 included item pool generation, modified Delphi method, and cognitive interviews. Phase 2 evaluated the item pool using factor analysis and item response theory. RESULTS: Items were identified or written to cover 7 previously identified theoretical domains. 806 Black mothers and birthing people completed the pilot test. Factor analysis concluded a 3 factor structure with good fit indices (CFI = 0.931-0.977, RMSEA = 0.087-0.10, R2  > .3, residual correlation < 0.15). All items in each factor fit the IRT model and were able to be calibrated. Factor 1, "Humanity," had 31 items measuring experiences of safety and accountability, autonomy, communication, and empathy. A 12-item short form was created to ease respondent burden. Factor 2, "Racism," had 12 items measuring experiences of neglect and mistreatment. Factor 3, "Kinship," had 7 items measuring hospital denial and disruption of relationships between Black mothers and their child or support system. CONCLUSIONS: The PREM-OB Scale™ suite is a valid tool to characterize and quantify obstetric racism for use in perinatal improvement initiatives.

Neonatal outcomes from a quasi-experimental clinical trial of Family Integrated Care versus Family-Centered Care for preterm infants in U.S. NICUs.

BACKGROUND: Family Integrated Care (FICare) benefits preterm infants compared with Family-Centered Care (FCC), but research is lacking in United States (US) Neonatal Intensive Care Units (NICUs). The outcomes for infants of implementing FICare in the US are unknown given differences in parental leave benefits and health care delivery between the US and other countries where FICare is used. We compared preterm weight and discharge outcomes between FCC and mobile-enhanced FICare (mFICare) in the US. METHODS: In this quasi-experimental study, we enrolled preterm infant (≤ 33 weeks)/parent dyads from 3 NICUs into sequential cohorts: FCC or mFICare. Our primary outcome was 21-day change in weight z-scores. Our secondary outcomes were nosocomial infection, bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), and human milk feeding (HMF) at discharge. We used intention-to-treat analyses to examine the effect of the FCC and mFICare models overall and per protocol analyses to examine the effects of the mFICare intervention components. FINDINGS: 253 infant/parent dyads participated (141 FCC; 112 mFICare). There were no parent-related adverse events in either group. In intention-to-treat analyses, we found no group differences in weight, ROP, BPD or HMF. The FCC cohort had 2.6-times (95% CI: 1.0, 6.7) higher odds of nosocomial infection than the mFICare cohort. In per-protocol analyses, we found that infants whose parents did not receive parent mentoring or participate in rounds lost more weight relative to age-based norms (group-difference=-0.128, CI: -0.227, -0.030; group-difference=-0.084, CI: -0.154, -0.015, respectively). Infants whose parents did not participate in rounds or group education had 2.9-times (CI: 1.0, 9.1) and 3.8-times (CI: 1.2, 14.3) higher odds of nosocomial infection, respectively. CONCLUSION: We found indications that mFICare may have direct benefits on infant outcomes such as weight gain and nosocomial infection. Future studies using implementation science designs are needed to optimize intervention delivery and determine acute and long-term infant and family outcomes. CLINICAL TRIAL REGISTRATION: NCT03418870 01/02/2018.

Nurse-Reported Staffing Guidelines and Exclusive Breast Milk Feeding.

BACKGROUND: Nursing care is essential to overall quality of healthcare experienced by patients and families-especially during childbearing. However, evidence regarding quality of nursing care during labor and birth is lacking, and established nurse-sensitive outcome indicators have limited applicability to maternity care. Nurse-sensitive outcomes need to be established for maternity care, and prior research suggests that the initiation of human milk feeding during childbirth hospitalization is a potentially nurse-sensitive outcome. OBJECTIVE: The aim of this study was to determine the relationship between nurse-reported staffing, missed nursing care during labor and birth, and exclusive breast milk feeding during childbirth hospitalization as a nurse-sensitive outcome. METHODS: 2018 Joint Commission PC-05 Exclusive Breast Milk Feeding rates were linked to survey data from labor nurses who worked in a selected sample of hospitals with both PC-05 data and valid 2018 American Hospital Association Annual Survey data. Nurse-reported staffing was measured as the perceived compliance with Association of Women's Health, Obstetric and Neonatal Nurses staffing guidelines by the labor and delivery unit. Data from the nurse survey were aggregated to the hospital level. Bivariate linear regression was used to determine associations between nurse and hospital characteristics and exclusive breast milk feeding rates. Generalized structural equation modeling was used to model relationships between nurse-reported staffing, nurse-reported missed care, and exclusive breast milk feeding at the hospital level. RESULTS: The sample included 184 hospitals in 29 states and 2,691 labor nurses who worked day, night, or evening shifts. Bivariate analyses demonstrated a positive association between nurse-reported staffing and exclusive breast milk feeding and a negative association between missed nursing care and exclusive breast milk feeding. In structural equation models controlling for covariates, missed skin-to-skin mother-baby care and missed breastfeeding within 1 hour of birth mediated the relationship between nurse-reported staffing and exclusive breast milk feeding rates. DISCUSSION: This study provides evidence that hospitals' nurse-reported compliance with Association of Women's Health, Obstetric and Neonatal Nurses staffing guidelines predicts hospital-exclusive breast milk feeding rates and that the rates are a nurse-sensitive outcome.

Risk Factors for Dual Burden of Severe Maternal Morbidity and Preterm Birth by Insurance Type in California.

OBJECTIVES: Among childbearing women, insurance coverage determines degree of access to preventive and emergency care for maternal and infant health. Maternal-infant dyads with dual burden of severe maternal morbidity and preterm birth experience high physical and psychological morbidity, and the risk of dual burden varies by insurance type. We examined whether sociodemographic and perinatal risk factors of dual burden differed by insurance type. METHODS: We estimated relative risks of dual burden by maternal sociodemographic and perinatal characteristics in the 2007-2012 California birth cohort dataset stratified by insurance type and compared effects across insurance types using Wald Z-statistics. RESULTS: Dual burden ranged from 0.36% of privately insured births to 0.41% of uninsured births. Obstetric comorbidities, multiple gestation, parity, and birth mode conferred the largest risks across all insurance types, but effect magnitude differed. The adjusted relative risk of dual burden associated with preeclampsia superimposed on preexisting hypertension ranged from 9.1 (95% CI 7.6-10.9) for privately insured to 15.9 (95% CI 9.1-27.6) among uninsured. The adjusted relative risk of dual burden associated with cesarean birth ranged from 3.1 (95% CI 2.7-3.5) for women with Medi-Cal to 5.4 (95% CI 3.5-8.2) for women with other insurance among primiparas, and 7.0 (95% CI 6.0-8.3) to 19.4 (95% CI 10.3-36.3), respectively, among multiparas. CONCLUSIONS: Risk factors of dual burden differed by insurance type across sociodemographic and perinatal factors, suggesting that care quality may differ by insurance type. Attention to peripartum care access and care quality provided by insurance type is needed to improve maternal and neonatal health.

Improving Family-Centered Care for Infants in Neonatal Intensive Care Units: Recommendations From Frontline Healthcare Professionals.

BACKGROUND: Family-centered care is a philosophy and healthcare delivery model adopted by many neonatal intensive care units (NICUs) worldwide, yet practice varies widely. PURPOSE: The aim of this study was to synthesize recommendations from frontline NICU healthcare professionals regarding family-centered care. METHODS: Data were obtained from the baseline phase of a multicenter quasi-experimental study comparing usual family-centered NICU care (baseline) with mobile-enhanced family integrated care (intervention). Members of the NICU clinical care team completed a family-centered care survey and provided free-text comments regarding practice of family-centered care in their NICU and recommendations for improvement. The comments were analyzed using a directed content analysis approach by a research team that included NICU nurses and parents. RESULTS: Of the 382 NICU healthcare providers from 6 NICUs who completed the survey, 68 (18%) provided 89 free-text comments/recommendations about family-centered care. Almost all comments were provided by nurses (91%). Six main themes were identified: language translation; communication between staff and families; staffing and workflow; team culture and leadership; education; and NICU environment. The need for greater resources for staffing, education, and environmental supports was prominent among the comments, as was team culture and staff-parent communications. IMPLICATIONS FOR PRACTICE: The NICU healthcare professionals identified a range of issues that support or impede delivery of family-centered care and provided actionable recommendations for improvement. IMPLICATIONS FOR RESEARCH: Future research should include economic analyses that will enable determination of the return on investment so that NICUs can better justify the human and capital resources needed to implement high-quality family-centered care.

A mouth rinse based on a tea solution of Salvia officinalis for oral discomfort in palliative cancer care: a randomized controlled trial.

BACKGROUND: Few clinical studies evaluate interventions to reduce oral discomfort among patients in palliative care. AIM: This study examines the efficacy of a Salvia officinalis (SO) based herbal mouth rinse compared to conventional normal saline (NS) in order to improve oral health. DESIGN: A block-randomized controlled trial. Data were collected before and after a 4-day intervention with either SO (n=44) or NS (n=44). Numerical rating scales (NRS, 0-10) and 12 items from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oral Health 17 (EORTC QLQ-OH17) measured patient-reported oral symptoms. An oral examination was performed before and after the intervention. SETTING/PARTICIPANTS: This study included adult patients with late-stage cancer in an inpatient hospice unit. RESULTS: Of the 88 patients included (mean age=63.9 years, SD=10.6), 73 (83%) completed the study. At baseline, 78% reported dry mouth on the EORTC QLQ-OH17, and 80% rated dry mouth ≥4 on the NRS. Total oral health scores based on the 12 EORTC QLQ-OH17 items improved similarly in both groups (p<0.001). However, dry mouth ratings on both the EORTC QLQ-OH17 (p=0.036) and NRS (p=0.045) improved more in the SO group than in the NS group. Plaque on the teeth improved in both the SO (p=0.008) and NS (p=0.018) groups, but plaque on the tongue and erythema only improved with NS. CONCLUSIONS: This study did not detect an overall significant difference between SO and NS. Both mouth rinses improved oral health parameters, indicating that systematic assessment and oral care may reduce oral discomfort. TRIAL REGISTRATION: NCT02067572.

The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis - study protocol for the MultiKnee trial.

BACKGROUND: One in five patients report chronic pain following total knee arthroplasty (TKA) and are considered non-improvers. Psychological interventions such as cognitive behavioral therapy (CBT), combined with exercise therapy and education may contribute to reduced pain an improved function both for patients with OA or after TKA surgery, but the evidence for the effectiveness of such interventions is scarce. This randomized controlled trial with three arms will compare the clinical effectiveness of patient education and exercise therapy combined with internet-delivered CBT (iCBT), evaluated either as a non-surgical treatment choice or in combination with TKA, in comparison to usual treatment with TKA in patients with knee OA who are considered candidates for TKA surgery. METHODS: The study, conducted in three orthopaedic centers in Norway will include 282 patients between ages 18 and 80, eligible for TKA. Patients will be randomized to receive the exercise therapy + iCBT, either alone or in combination with TKA, or to a control group who will undergo conventional TKA and usual care physiotherapy following surgery. The exercise therapy will include 24 one hour sessions over 12 weeks led by a physiotherapist. The iCBT program will be delivered in ten modules. The physiotherapists will receive theoretical and practical training to advise and mentor the patients during the iCBT program. The primary outcome will be change from baseline to 12 months on the pain sub-scale from the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the remaining 4 sub-scales from the KOOS (symptoms, function in daily living, function in sports and recreation, and knee-related quality of life), EQ-5D-5L, the Pain Catastrophizing Scale, the 30-s sit-to-stand test, 40-m walking test and ActiGraph activity measures. A cost-utility analysis will be performed using QALYs derived from the EQ-5D-5L and registry data. DISCUSSION: This is the first randomized controlled trial to investigate the effectiveness of exercise therapy and iCBT with or without TKA, to optimize outcomes for TKA patients. Findings from this trial will contribute to evidence-based personalized treatment recommendations for a large proportion of OA patients who currently lack an effective treatment option. TRIAL REGISTRATION: Clinicaltrials.gov : NCT03771430 . Registered: Dec 11, 2018.

A Multisite Survey of NICU Healthcare Professionals' Perceptions About Family-Centered Care.

BACKGROUND: Family-centered care contributes to improved outcomes for preterm and ill infants. Little is known about the perceptions of neonatal intensive care unit (NICU) healthcare professionals regarding the degree to which their NICU practices or values family-centered care. PURPOSE: The aims of this study were to describe attitudes and beliefs of NICU healthcare professionals about family-centered care and to explore professional characteristics that might influence those views. METHODS: Data were derived from the baseline phase of a multicenter quasi-experimental study comparing usual family-centered NICU care with mobile-enhanced family-integrated care. Neonatal intensive care unit healthcare professionals completed the Family-Centered Care Questionnaire-Revised (FCCQ-R), a 45-item measure of 9 core dimensions of Current Practice and Necessary Practice for family-centered care. RESULTS: A total of 382 (43%) NICU healthcare professionals from 6 NICUs completed 1 or more of the FCCQ-R subscales, 83% were registered nurses. Total and subscale scores on the Necessary Practice scale were consistently higher than those on the Current Practice scale for all dimensions of family-centered care (mean: 4.40 [0.46] vs 3.61 [0.53], P < .001). Only years of hospital experience and NICU site were significantly associated with Current Practice and Necessary Practice total scores. IMPLICATIONS FOR PRACTICE: Ongoing assessment of the perceptions of NICU healthcare professionals regarding their current practice and beliefs about what is necessary for the delivery of high-quality family-centered care can inform NICU education, quality improvement, and maintenance of family-centered care during the COVID-19 pandemic. IMPLICATIONS FOR RESEARCH: Further research is needed to identify additional factors that predict family-centered care perceptions and behaviors.

Psychometric properties of a short version of Lee Fatigue Scale used as a generic PROM in persons with stroke or osteoarthritis: assessment using a Rasch analysis approach.

BACKGROUND: Fatigue is a common symptom associated with a wide range of diseases and needs to be more thoroughly studied. To minimise patient burden and to enhance response rates in research studies, patient-reported outcome measures (PROM) need to be as short as possible, without sacrificing reliability and validity. It is also important to have a generic measure that can be used for comparisons across different patient populations. Thus, the aim of this secondary analysis was to evaluate the psychometric properties of the Norwegian 5-item version of the Lee Fatigue Scale (LFS) in two distinct patient populations. METHODS: The sample was obtained from two different Norwegian studies and included patients 4-6 weeks after stroke (n = 322) and patients with osteoarthritis on a waiting list for total knee arthroplasty (n = 203). Fatigue severity was rated by five items from the Norwegian version of the LFS, rating each item on a numeric rating scale from 1 to 10. Rasch analysis was used to evaluate the psychometric properties of the 5-item scale across the two patient samples. RESULTS: Three of the five LFS items ("tired", "fatigued" and "worn out") showed acceptable internal scale validity as they met the set criterion for goodness-of-fit after removal of two items with unacceptable goodness-of-fit to the Rasch model. The 3-item LFS explained 81.6% of the variance, demonstrated acceptable unidimensionality, could separate the fatigue responses into three distinct severity groups and had no differential functioning with regard to disease group. The 3-item version of the LFS had a higher separation index and better internal consistency reliability than the 5-item version. CONCLUSIONS: A 3-item version of the LFS demonstrated acceptable psychometric properties in two distinct samples of patients, suggesting it may be useful as a brief generic measure of fatigue severity. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02338869; registered 10/04/2014 (stroke study).

Fatigue management for adults living with HIV: A randomized controlled pilot study.

Fatigue is a prevalent symptom for adults living with HIV infection. The purpose of this randomized clinical trial was to pilot test a behavioral-educational intervention to reduce fatigue. The intervention included education about daytime behaviors as well as nighttime sleep behaviors. Participants were HIV-positive, between 45 and 75 years old, unemployed, and experiencing fatigue. They were randomized to intervention (n = 25) or control (n = 26) after obtaining baseline measures, administered the intervention or attention control, and followed with monthly assessments for 3 months. Primary outcome measures included the Fatigue Severity Scale (FSS) and fatigue symptom burden using the four-dimension structure of the Memorial Symptom Assessment Scale that includes occurrence, frequency, severity, and distress of a symptom. Other measures included the International Physical Activity Questionnaire, step counts with a Fitbit Flex, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, and Sleep Behavior Rating Scale. Compared with attention controls, the intervention group had significantly (p < .05) lower FSS scores and fatigue symptom burden over time, particularly in the frequency dimension. Secondary outcomes for reducing daytime naps and improving sleep quality were also significant (p < .05). This intervention, focused on both daytime and nighttime behaviors, demonstrated promising effects for reducing fatigue among adults living with HIV. Results provide useful direction for larger clinical trials to reduce fatigue in adults living with other types of chronic illness.