An aromatherapy massage intervention on sleep in the ICU: A randomized controlled feasibility study.

We conducted a feasibility randomized controlled trial exploring the effect of aromatherapy massage on sleep in critically ill patients. Patients were randomized to receive aromatherapy massage or usual care, and feasibility of recruitment and outcome data completion was captured. Sleep (depth) was assessed through Bispectral Index monitoring and self/nurse-reported Richards-Campbell Sleep Questionnaires, and the Sleep in the ICU Questionnaire. Thirty-four patients participated: 17 were randomized to aromatherapy massage and 17 to control. Five participants who received the intervention completed outcomes for analysis (alongside eight controls). A larger study was deemed unfeasible in this population, highlighting the value of testing feasibility of complex interventions, such as massage for sleep in ICU.

Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial.

OBJECTIVE: To assess the effectiveness of oral spironolactone for acne vulgaris in adult women. DESIGN: Pragmatic, multicentre, phase 3, double blind, randomised controlled trial. SETTING: Primary and secondary healthcare, and advertising in the community and on social media in England and Wales. PARTICIPANTS: Women (≥18 years) with facial acne for at least six months, judged to warrant oral antibiotics. INTERVENTIONS: Participants were randomly assigned (1:1) to either 50 mg/day spironolactone or matched placebo until week six, increasing to 100 mg/day spironolactone or placebo until week 24. Participants could continue using topical treatment. MAIN OUTCOME MEASURES: Primary outcome was Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week 12 (range 0-30, where higher scores reflect improved QoL). Secondary outcomes were Acne-QoL at week 24, participant self-assessed improvement; investigator's global assessment (IGA) for treatment success; and adverse reactions. RESULTS: From 5 June 2019 to 31 August 2021, 1267 women were assessed for eligibility, 410 were randomly assigned to the intervention (n=201) or control group (n=209) and 342 were included in the primary analysis (n=176 in the intervention group and n=166 in the control group). Baseline mean age was 29.2 years (standard deviation 7.2), 28 (7%) of 389 were from ethnicities other than white, with 46% mild, 40% moderate, and 13% severe acne. Mean Acne-QoL symptom scores at baseline were 13.2 (standard deviation 4.9) and at week 12 were 19.2 (6.1) for spironolactone and 12.9 (4.5) and 17.8 (5.6) for placebo (difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46), adjusted for baseline variables). Scores at week 24 were 21.2 (5.9) for spironolactone and 17.4 (5.8) for placebo (difference 3.45 (95% confidence interval 2.16 to 4.75), adjusted). More participants in the spironolactone group reported acne improvement than in the placebo group: no significant difference was reported at week 12 (72% v 68%, odds ratio 1.16 (95% confidence interval 0.70 to 1.91)) but significant difference was noted at week 24 (82% v 63%, 2.72 (1.50 to 4.93)). Treatment success (IGA classified) at week 12 was 31 (19%) of 168 given spironolactone and nine (6%) of 160 given placebo (5.18 (2.18 to 12.28)). Adverse reactions were slightly more common in the spironolactone group with more headaches reported (20% v 12%; p=0.02). No serious adverse reactions were reported. CONCLUSIONS: Spironolactone improved outcomes compared with placebo, with greater differences at week 24 than week 12. Spironolactone is a useful alternative to oral antibiotics for women with acne. TRIAL REGISTRATION: ISRCTN12892056.

Prevalence and Implications of Low Reticulocyte-Hemoglobin Levels among Extreme Preterm Neonates: A Single-Center Retrospective Study.

This retrospective cohort study aims to determine the epidemiology of iron deficiency among extreme preterm neonates and the association of iron-deficient status during the NICU stay with neurodevelopmental outcomes at 18−24 months. Neonates ≤29 weeks gestational age (GA) born between June 2016 and December 2019, who received routine iron supplementation were enrolled. Iron deficiency was defined as reticulocyte−hemoglobin (Ret-Hb) levels ≤ 29 pg at 36 weeks corrected age. A subcohort of neonates completed standardized developmental assessment at 18−24 months corrected age. Significant neurodevelopmental impairment (sNDI) was defined as either Bayley Scales of Infant Development score < 70 or cerebral palsy or blindness or hearing aided. Among a cohort of 215 neonates [GA 25.8 (1.7) weeks, birthweight 885 (232) g], prevalence of iron deficiency was 55%, 21%, 26%, and 13%, in neonates <24 weeks, 24−25 + 6 weeks, 26−27 + 6 weeks, and ≥ 28 weeks GA, respectively. Male sex and receipt of corticosteroid therapy were associated with iron-deficiency. In the subcohort analysis (n = 69), there was no statistically significant association between Ret-Hb levels at 36 weeks corrected age and the risk of sNDI [OR 0.99 (95% CI 0.85−1.2)]. Male infants and those who received postnatal corticosteroids are likely to have iron-limited erythropoiesis at corrected term despite routine iron-supplementation; however, low Ret-Hb levels during the neonatal period were not associated with significant neurological disability in early childhood.

Children's Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial.

Background: To prevent poor long-term outcomes (deaths and readmissions) the integrated global action plan for pneumonia and diarrhoea recommends under the 'Treat' element of Protect, Prevent and Treat interventions the importance of continued feeding but gives no specific recommendations for nutritional support. Early nutritional support has been practiced in a wide variety of critically ill patients to provide vital cell substrates, antioxidants, vitamins, and minerals essential for normal cell function and decreasing hypermetabolism. We hypothesise that the excess post-discharge mortality associated with pneumonia may relate to the catabolic response and muscle wasting induced by severe infection and inadequacy of the diet to aid recovery. We suggest that providing additional energy-rich, protein, fat and micronutrient ready-to-use therapeutic feeds (RUTF) to help meet additional nutritional requirements may improve outcome. Methods: COAST-Nutrition is an open, multicentre, Phase II randomised controlled trial in children aged 6 months to 12 years hospitalised with suspected severe pneumonia (and hypoxaemia, SpO 2 <92%) to establish whether supplementary feeds with RUTF given in addition to usual diet for 56-days (experimental) improves outcomes at 90-days compared to usual diet alone (control). Primary endpoint is change in mid-upper arm circumference (MUAC) at 90 days and/or as a composite with 90-day mortality. Secondary outcomes include anthropometric status, mortality, readmission at days 28 and 180. The trial will be conducted in four sites in two countries (Uganda and Kenya) enrolling 840 children followed up to 180 days. Ancillary studies include cost-economic analysis, molecular characterisation of bacterial and viral pathogens, evaluation of putative biomarkers of pneumonia, assessment of muscle and fat mass and host genetic studies.   Discussion: This study is the first step in providing an option for nutritional support following severe pneumonia and will help in the design of a large Phase III trial. Registration: ISRCTN10829073 (6 th June 2018) PACTR202106635355751 (2 nd June 2021).

Analyzing the costs of developing and operating an integrated health-system specialty pharmacy: The case of a centralized insurance navigation process for specialty clinic patients.

PURPOSE: Direct and indirect costs related to the growth of specialty pharmacy services and the insurance navigation process for specialty clinic patients are discussed, and development and implementation of a pharmacy-driven and system-wide prior authorization (PA) processing center within a health system are described. SUMMARY: Expensive specialty drugs require PA. Due to the concentration of specialists, health systems with multiple specialties experience higher PA burden and resulting care delays. Although clinic staff typically handle PA requests, health-system specialty pharmacies are well positioned to support patients, clinic staff, and physicians by assuming responsibility for the PA process entirely. University of Utah Health established its Pharmacy Ambulatory Clinical Care Center (PAC3) to centralize PA processing for selected specialty and primary care clinics within the health system. In fiscal year 2019, the PAC3 team (10 pharmacy technician and 1.5 pharmacist full-time equivalents) completed over 13,000 PAs. The pharmacy labor cost increase was significant; however, the benefits gained from increased services, quality, and financial strength surpassed all costs associated with the implementation and maintenance of the pharmacy operation. Other tangible benefits included decreased delays in therapy initiation, increased patient satisfaction, increased clinic visits, and increased staff and provider satisfaction and engagement. CONCLUSION: Increased PA requests associated with specialty drugs have placed considerable stress and staff burden on specialty clinics within health systems. However, development and implementation of an efficient PA processing infrastructure within a health-system specialty pharmacy may reduce the burden, increase financial strength, and improve the patient experience.

Standard and Hypofractionated Dose Escalation to Intraprostatic Tumor Nodules in Localized Prostate Cancer: Efficacy and Toxicity in the DELINEATE Trial.

PURPOSE: To report a planned analysis of the efficacy and toxicity of dose escalation to the intraprostatic dominant nodule identified on multiparametric magnetic resonance imaging using standard and hypofractionated external beam radiation therapy. METHODS AND MATERIALS: DELINEATE is a single centre prospective phase 2 multicohort study including standard (cohort A: 74 Gy in 37 fractions) and moderately hypofractionated (cohort B: 60 Gy in 20 fractions) prostate image guided intensity modulated radiation therapy in patients with National Comprehensive Cancer Network intermediate- and high-risk disease. Patients received an integrated boost of 82 Gy (cohort A) and 67 Gy (cohort B) to lesions visible on multiparametric magnetic resonance imaging. Fifty-five patients were treated in cohort A, and 158 patients were treated in cohort B; the first 50 sequentially treated patients in cohort B were included in this planned analysis. The primary endpoint was late Radiation Therapy Oncology Group rectal toxicity at 1 year. Secondary endpoints included acute and late toxicity measured with clinician- and patient-reported outcomes at other time points and biochemical relapse-free survival for cohort A. Median follow-up was 74.5 months for cohort A and 52.0 months for cohort B. RESULTS: In cohorts A and B, 27% and 40% of patients, respectively, were classified as having National Comprehensive Cancer Network high-risk disease. The cumulative 1-year incidence of Radiation Therapy Oncology Group grade 2 or worse rectal and urinary toxicity was 3.6% and 0% in cohort A and 8% and 10% in cohort B, respectively. There was no reported late grade 3 rectal toxicity in either cohort. Within cohort A, 4 of 55 (7%) patients had biochemical relapse. CONCLUSIONS: Delivery of a simultaneous integrated boost to intraprostatic dominant nodules is feasible in prostate radiation therapy using standard and moderately hypofractionated regimens, with rectal and genitourinary toxicity comparable to contemporary series without an intraprostatic boost.

Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods.

OBJECTIVES: Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer. METHODS: Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview. RESULTS: 150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold. CONCLUSION: Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care.

Filling the gaps: A mixed-methods study exploring the use of patient diaries in the critical care unit.

BACKGROUND: Survivors of critical illness often take time to recovery physically and psychologically from their critical care experience. There is tentative evidence suggesting that the use of a patient or family led diary with entries by nurses, doctors and allied health professionals may help the patient 'fill in the gaps' by making sense of a time they have forgotten. Many have confused or frightening memories and a diary can aid patients and their families in the recovery after critical illness. AIMS: A mixed methods study including a qualitative exploration of the impact of diaries on critical care patients in order to describe the long-term effects of patient diaries. METHODS: A two phase study including a prospective diary intervention and evaluation and subsequent in-depth interviews, using the principles of Grounded Theory. The instruments, Post Traumatic Stress Score-14 (PTSS-14) and EuroQol (EQ-5D-3L), were used to measured post-traumatic stress symptoms and quality of life in the year after diary. A questionnaire about diary use was completed by participants and content analysis of the diary was also undertaken, alongside basic demographics to explore patient characteristics. FINDINGS: For the 50 patients receiving the diary intervention, those completing a diary evaluation, 95% found them helpful and 90% found it helped fill memory gaps. Mean scores for PTSS-14 (cumulative) at four months and 12 months: 30.5 (SD=10.8) and 25.7 (SD=11.7). Mean EuroQol visual analogue scores at four months and 12 months were 77.8 (SD=14.3) and 71.8 (SD=18.5) respectively. Themes from subsequent interviews with eight patients included: providing holistic care, emotional support and empathy and dealing with loss of control. Data confirmed that whilst diaries had broad value in making sense of the critical care experience and their subsequent recovery, not all were able to read them again. Integrated analysis of four data sources suggested the core themes of the diary revealed its value as: a dynamic communication tool integral to holistic care and person-centredness; a reflection of the impact of a critical care event and a resource that helped give a sense of meaning to what had happened. CONCLUSION: Diaries can offer a means of providing clarity for patients who struggle to come to terms with their critical care experience and subsequent recovery, but should be given to patients with forethought and support. It remains unclear which types of patients might benefit most from diaries.

What is the least painful method of anesthetizing a peripheral IV site?

The placement of an intravenous (IV) catheter for the administration of fluids, blood products, and medications is a common intervention for surgical procedures and perianesthesia patients. Although the placement of a peripheral IV may be routine for perianesthesia nurses, it is important to address the patient's level of pain related to the procedure. One technique to diminish the discomfort associated with the IV insertion is anesthetizing the site. The purpose of this study was to compare three methods for anesthetizing peripheral IV catheter sites before insertion to determine which method provides optimal patient comfort during the anesthetizing and IV catheter insertion process. The findings demonstrate that there was no statistical difference in pain when anesthetizing the site using the three methods. However, there was a difference with the IV insertion process. Using 1% lidocaine resulted in the least painful IV insertion.

Is reflexology as effective as aromatherapy massage for symptom relief in an adult outpatient oncology population?

AIM: To test whether reflexology was inferior to aromatherapy massage for ameliorating self-selected problems or concerns. DESIGN: Non-blinded, randomised study with a 1:1 allocation. Adult outpatients recruited from a UK cancer centre, randomised by the minimisation method to either four aromatherapy massage or four reflexology sessions. OUTCOME MEASURES: MYCaW scores at baseline and completion; VAS (relaxation) pre and post-sessions. ANALYSIS: Unpaired t-test for the primary outcome; analysis of variance tests for repeated measures for VAS (relaxation); descriptive statistics (means and 95% confidence intervals) and content analysis for patient comments. RESULTS: 115 subjects (58 aromatherapy massage, 57 reflexology) recruited. Reflexology was found to be no less effective than aromatherapy massage for MYCaW first concerns (p = 0.046). There was no statistical difference between groups for MYCaW second concerns or overall well-being scores, proportions of patients gaining clinical benefit, VAS scores over time (p = 0.489) or between groups (p = 0.408) or in the written responses.

Is guided imagery effective in reducing pain and anxiety in the postoperative total joint arthroplasty patient?

PURPOSE: To evaluate the effect of guided imagery as an intervention to reduce pain and anxiety in patients undergoing a total joint arthroplasty. SAMPLE: A total of 121 patients scheduled for elective total joint arthroplasty. METHODS: The design for this study was a 2-group quasi-experimental design. The intervention group listened to a guided imagery CD containing a message to develop a sense of relaxation and harmony. The intervention and control groups were compared on self-reported pain and anxiety levels postoperatively on Days 1, 2, and 3. RESULTS: There was no significant difference in pain and anxiety levels between the groups. However, the intervention group had lower levels of anxiety and pain at all time points. Both groups followed a similar anxiety and pain pattern with the highest reported levels at Day 2. CONCLUSIONS: Conduct further research of guided imagery as an intervention for reducing pain and anxiety utilizing randomized controlled trials with a diverse sample of patients.

The role of electrophysiology study in risk stratification of sudden cardiac death.

Patients with ischemic heart disease and left ventricular systolic dysfunction are at high risk of sudden cardiac death. However, most of these high-risk patients will never develop potential fatal ventricular arrhythmias. Thus, modalities that stratify patients according to their risk of sudden cardiac death are needed. The electrophysiology study has, for decades, been used to prognosticate on patients' risk of sudden cardiac death. Recent data from the Multicenter Unsustained Tachycardia Trial (MUSTT) and Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) demonstrate that in patients with ischemic heart disease and left ventricular systolic dysfunction, an electrophysiology study can help identify patients who are at high risk of sudden cardiac death. However, in these patient populations, the prognostic ability of an electrophysiology study is only modest and the negative predictive value is poor. In the future, combining the results of noninvasive modalities with invasive electrophysiology testing may improve our prognostic ability. Furthermore, expanding the role of the electrophysiology study to include therapeutic ablations may alter a patient's future risk of sudden cardiac death.

Induction of early inflammatory gene expression in a murine model of nonresuscitated, fixed-volume hemorrhage.

The etiology of many end-organ problems associated with hemorrhage has been attributed to the inflammatory response to hemorrhage. In a murine model of nonresuscitated, fixed-volume hemorrhage, we sought to elucidate the role that hemorrhagic insult alone plays in the generation of the early inflammatory cascade. Differences could be appreciated as early as 1 h post-hemorrhage, with consistent differences detected by 3 h in all of the major cytokine genes studied. Significant upregulation of IL-1beta , IL-6, TNF-alpha, and IL-10 mRNA expression was observed in both the liver and lung samples of mice subjected to fixed-volume hemorrhage when compared with sham-hemorrhaged mice. The cyclooxygenase-2 (COX-2) and inducible nitric oxide synthetase (iNOS) genes also were upregulated in the livers and lungs of hemorrhaged mice. Finally, expression of the genes that encode the Toll-like receptors (TLR)-2 and -4 was increased by hemorrhage. Taken collectively, these data demonstrate that the initial inflammatory cascade associated with hemorrhage occurs within hours after the initial hemorrhagic event, and can be associated with significant modulation of expression of key pro- and anti-inflammatory cytokine, enzyme, and TLR genes, suggesting that these may be possible new therapeutic targets.