Tracheostomies of Patients With COVID-19: A Survey of Infection Reported by Health Care Professionals.

BACKGROUND: Health care professionals (HCPs) performing tracheostomies in patients with COVID-19 may be at increased risk of infection. OBJECTIVE: To evaluate factors underlying HCPs' COVID-19 infection and determine whether tracheostomy providers report increased rates of infection. METHODS: An anonymous international survey examining factors associated with COVID-19 infection was made available November 2020 through July 2021 to HCPs at a convenience sample of hospitals, universities, and professional organizations. Infections reported were compared between HCPs involved in tracheostomy on patients with COVID-19 and HCPs who were not involved. RESULTS: Of the 361 respondents (from 33 countries), 50% (n = 179) had performed tracheostomies on patients with COVID-19. Performing tracheostomies on patients with COVID-19 was not associated with increased infection in either univariable (P = .06) or multivariable analysis (odds ratio, 1.48; 95% CI, 0.90-2.46; P = .13). Working in a low- or middle-income country (LMIC) was associated with increased infection in both univariable (P < .001) and multivariable analysis (odds ratio, 2.88; CI, 1.50-5.53; P = .001). CONCLUSIONS: Performing tracheostomy was not associated with COVID-19 infection, suggesting that tracheostomies can be safely performed in infected patients with appropriate precautions. However, HCPs in LMICs may face increased infection risk.

Safety and biomarker effects of candesartan in non-hypertensive adults with prodromal Alzheimer's disease.

Observational studies suggest that angiotensin receptor blockers in hypertensive adults are associated with lower post-mortem indicators of Alzheimer's disease pathology. Candesartan, an angiotensin receptor blocker, has a positive cognitive effect in mild cognitive impairment with hypertension. However, its safety and effects in non-hypertensive individuals with Alzheimer's disease are unclear. This is the first double-blind randomized placebo-controlled trial aimed to assess safety and effects of 1-year therapy of candesartan on biomarkers and clinical indicators of Alzheimer's disease in non-hypertensive individuals with biomarker-confirmed prodromal Alzheimer's disease. Seventy-seven non-hypertensive participants 50 years or older (mean age: 68.1 years; 62% women; 20% African American) with mild cognitive impairment and biomarker confirmed Alzheimer's disease were randomized to escalating doses of once daily oral candesartan (up to 32 mg) or matched placebo. Main outcomes included safety and tolerability of candesartan, cerebrospinal fluid biomarkers (amyloid-ß42, amyloid-ß40, total tau and phospho-tau). Additional exploratory outcomes included PET imaging (Pittsburgh Compound-B (11C-PiB) and 18F-flortaucipir), brain MRI (structural and connectivity measures) and cognitive functioning. Analyses used intention-to-treat approach with group comparisons of safety measures using Chi-square test, and repeated measures mixed effects models were used to assess candesartan effects on main and exploratory outcomes (ClinicalTrials.gov, NCT02646982). Candesartan was found to be safe with no significant difference in safety measures: symptoms of hypotension, renal failure or hyperkalemia. Candesartan was also found to be associated with increases in cerebrospinal fluid Aß40 (between-group mean difference: 1211.95 pg/ml, 95% confidence interval: 313.27, 2110.63) and Aß42 (49.51 pg/ml, 95% confidence interval: -98.05, -0.98) reflecting lower brain amyloid accumulation. Candesartan was associated with decreased 11C-PiB in the parahippocampal region (-0.1104, 95% confidence interval: -0.19, -0.029) which remained significant after false discovery rate correction, and with an increase in functional network connectivity in the subcortical networks. Candesartan was further associated with improved executive function (Trail Making Test Part B) performance (-11.41 s, 95% confidence interval: -11.94, -10.89) and trended for an improved global cognitive functioning reflected by a composite cognitive score (0.002, 95% confidence interval: -0.0002, 0.005). We did not observe significant effects on tau levels, hippocampal volume or other cognitive measures (memory or clinical dementia rating scale-sum of boxes). In conclusion, among non-hypertensive prodromal Alzheimer's disease, candesartan is safe and likely decreases brain amyloid biomarkers, enhances subcortical brain connectivity and has favourable cognitive effects. These findings suggest that candesartan may have an important therapeutic role in Alzheimer's disease, and warrant further investigation given the lack of clear treatment options for this devastating illness.

Baseline basophil and basophil-to-lymphocyte status is associated with clinical outcomes in metastatic hormone sensitive prostate cancer.

BACKGROUND: Biomarkers have the potential to provide clinical guidance, but there is limited data for biomarkers in metastatic hormone sensitive prostate cancer (mHSPC). METHODS: We performed a retrospective multicenter review from Winship Cancer Institute at Emory University and Georgia Cancer Center for Excellence at Grady Memorial Hospital (2014-2020) in the United States of America (USA). We collected demographics, disease characteristics, and laboratory data, including complete blood counts (CBC) at the start of upfront therapy. We evaluated overall survival (OS) and progression-free survival (PFS) associated with baseline lab values. RESULTS: 165 patients were included with a median follow-up time of 33.5 months (mo). 105 (63.6%) had Gleason scores of 8-10 and 108 (65.9%) were classified as high-volume disease. 92 patients received upfront docetaxel (55.8%) and 73 received upfront abiraterone (44.2%). Univariate analyses (UVA) and multivariable analyses (MVA) identified worse clinical outcomes (CO) associated with elevated basophils and basophil-to-lymphocyte ratio (BLR). Based on MVA, elevated basophils (defined as ≥0.1, optimal cut) were associated with a hazard ratio (HR) of 3.51 (95% CI 1.65-7.43, P 0.001) for OS and HR of 1.88 (95% CI 1.05-3.38, P 0.034) for PFS. Our MVA also found that BLR ≥0.0142 was associated with HR 2.11 (95% CI 1.09-4.10, P 0.028) for OS; however, PFS was not statistically significant. CONCLUSION: We conclude that elevated baseline basophils and BLR are associated with worse clinical outcomes in mHSPC. Although results require further validation, BLR is a potential prognostic biomarker.

Higher Pain Sensitivity Predicts Efficacy of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Persons With Fibromyalgia: A Randomized Double-Blind Sham-Controlled Trial.

OBJECTIVES: This study investigated the efficacy of a transcutaneous electrical nerve stimulation (TENS) device (Quell®) for persons with symptoms due to fibromyalgia (FM). MATERIALS AND METHODS: One hundred nineteen (N = 119) subjects were randomly assigned to use an active (N = 62) or sham (N = 57) TENS for three months. All subjects completed baseline questionnaires and were administered quantitative sensory testing (QST). Subjects completed the Patients' Global Impression of Change (PGIC, primary outcome measure) and other mailed questionnaires (secondary outcome measures) at six weeks and three months. RESULTS: The subjects averaged 50.4 ± 13.5 years of age, 93.3% were female, and 79.8% were Caucasian. Most showed benefit from using the TENS, but no differences between groups were found on the primary outcome measure after three months (active 3.87 ± 1.85, sham 3.73 ± 1.80, 95% confidence interval [CI] [-0.60, 0.88], p = 0.707). Those with more hypersensitivity showed most improvement on the PGIC at six weeks (0.22, 95% CI [0.01, 0.43], p = 0.042) and three months (0.20, 95% CI [0.00, 0.41], p = 0.049) and among those with higher sensitivity based on QST, the active TENS group showed the most benefit with TENS compared with the sham treatment (1.20, 95% CI [0.22, 2.18], p = 0.017). No TENS-related serious adverse events were reported. Subjects in the sham group correctly identified their treatment 87.5% of the time, while, surprisingly, subjects in the active group correctly identified their treatment only 17.4% of the time. CONCLUSION: This study found no differences between those who were exposed to maximal-frequency active stimulation or minimal-frequency sham stimulation from a wearable TENS in reducing FM-related symptoms. However, those with greater hypersensitivity showed most benefit from TENS. Additional studies to help determine the role individual differences play in the use of TENS in managing FM-related symptoms are needed.

Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial.

PURPOSE: Fibromyalgia is a chronic condition characterized by widespread pain and interference with daily activities. The aim of this study is to assess the benefit of transcutaneous electrical nerve stimulation (TENS) for persons diagnosed with fibromyalgia. PATIENTS AND METHODS: Adults meeting diagnostic criteria for fibromyalgia were randomized in a double-blind trial to receive either an active (n=62) or sham (n=57) wearable TENS device for 3-months. Subjects were classified as having lower or higher pain sensitivity by Quantitative Sensory Testing (QST). Patient Global Impression of Change (PGIC, primary outcome) and secondary efficacy measures including Fibromyalgia Impact Questionnaire (FIQR), Brief Pain Inventory (BPI) and painDETECT questionnaire (PDQ) were assessed at baseline, 6-weeks and 3-months. Treatment effects were determined by a mixed model for repeated measures (MMRM) analysis of the intention-to-treat (ITT) population (N=119). A pre-specified subgroup analysis of pain sensitivity was conducted using an interaction term in the model. RESULTS: No differences were found between active and sham treatment on PGIC scores at 3-months (0.34, 95% CI [-0.37, 1.04], p=0.351) in the ITT population. However, in subjects with higher pain sensitivity (n=60), PGIC was significantly greater for active treatment compared to sham (1.19, 95% CI [0.24, 2.13], p=0.014). FIQR total score (-7.47, 95% CI [-12.46, -2.48], p=0.003), FIQR pain item (-0.62, 95% CI [-1.17, -0.06], p=0.029), BPI Interference (-0.70, 95% CI [-1.30, -0.11], p=0.021) and PDQ (-1.69, 95% CI [-3.20, -0.18], p=0.028) exhibited significant improvements for active treatment compared to sham in the ITT population. Analgesics use was stable and comparable in both groups. CONCLUSION: This study demonstrated modest treatment effects of reduced disease impact, pain and functional impairment from wearable TENS in individuals with fibromyalgia. Subjects with higher pain sensitivity exhibited larger treatment effects than those with lower pain sensitivity. Wearable TENS may be a safe treatment option for people with fibromyalgia. CLINICALTRIALSGOV REGISTRATION: NCT03714425.

Clinical Outcomes and Racial Disparities in Metastatic Hormone-Sensitive Prostate Cancer in the Era of Novel Treatment Options.

BACKGROUND: Docetaxel (DOC) and abiraterone (ABI) in the upfront setting have separately improved clinical outcomes for metastatic hormone-sensitive prostate cancer (mHSPC), but there are no studies comparing drug efficacies or the influence of racial disparities. MATERIALS AND METHODS: We performed a retrospective multicenter review from Winship Cancer Institute at Emory University and Georgia Cancer Center for Excellence at Grady Memorial Hospital (2014-2020) for patients with mHSPC treated with either upfront DOC or ABI. Outcomes evaluated were overall survival (OS), progression-free survival (PFS), and prostate-specific antigen complete response (PSA CR). RESULTS: A total of 168 patients were included, consisting of 92 (54.8%) Black patients and 76 (45.2%) non-Black patients (69 White and 7 Asian or Hispanic). Ninety-four (56%) received DOC and 74 (44%) received ABI. Median follow-up time was 22.8 months with data last reviewed June 2020. For OS, there was no significant difference between ABI versus DOC and Black versus non-Black patients. For PFS, DOC was associated with hazard ratio (HR) 1.7 compared with ABI for all patients based on univariate association and HR 2.27 compared with ABI for Black patients on multivariable analysis. For PSA CR, Black patients were less likely to have a CR (odds ratio [OR] = 0.27). CONCLUSION: ABI and DOC have similar OS with a trend toward better PFS for ABI in a cohort composed of 54% Black patients. Racial disparities were observed as prolonged PFS for Black patients treated with ABI, more so compared with all patients, and less PSA CR for Black patients. A prospective trial comparing available upfront therapies in a diverse racial population is needed to help guide clinical decision-making in the era of novel treatment options. IMPLICATIONS FOR PRACTICE: Overall survival is similar for abiraterone and docetaxel when used as upfront therapy in metastatic hormone-sensitive prostate cancer in a cohort composed of 54% Black patients. There is a trend towards improved progression-free survival for abiraterone in all patients and Black patients. Non-Black patients were more likely to achieve prostate-specific antigen (PSA) complete response regardless of upfront therapy.

Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy.

OBJECTIVE: This pilot study was designed to determine the feasibility, tolerability, safety, and efficacy of group teletherapy for persons with chronic pain. The aim was to present preliminary outcomes of an open trial of group cognitive behavioural therapy (CBT) teletherapy compared with an in-person chronic pain patient group. METHODS: We recruited 47 chronic pain patients to participate in an 8-session, 2-hour-per-week, online, structured, CBT-oriented pain management group using WebEx and compared them with 46 subjects who participated in a parallel, content-matched, in-person, weekly group. Both groups included goal setting, skills training, relaxation exercises, group discussion, and practice assignments. All subjects completed baseline measures, which were repeated post-treatment. Those in the online group participated in weekly telephone interviews and rated the perceived helpfulness of the remote group. RESULTS: The average age of the online group participants was 54.5 ( ± 14.3) years and 70.2% were female, compared with 59.7 ( ± 13.0) years of age and 57.8% females among the in-person group members. On follow-up, both CBT groups showed modest improvements on the outcome measures. Results of this preliminary investigation comparing online teletherapy with in-person CBT suggest similar benefit. Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10). DISCUSSION: Preliminary findings suggest that online group CBT may be as effective in improving coping among persons with chronic pain as in-person groups. More rigorous controlled trials are needed to adequately assess the outcome benefit of online teletherapy for chronic pain.

Online teletherapy for chronic pain: A systematic review.

OBJECTIVE: A systematic review designed to evaluate the benefits of remote group pain management for persons with chronic pain was performed. METHODS: PubMed, EMBASE and PsychINFO databases were searched in April 2019. Eligible studies evaluated teletherapy for chronic pain based on set inclusion and exclusion criteria. Two reviewers independently screened eligible studies, assessed risk of bias and extracted data. Each study design was rated and study quality was assessed using an 11-point scale of methodological quality. RESULTS: Comprehensive searches identified 12 studies that met all inclusion/exclusion criteria and each study was assessed for type of technology, study design, outcome measures, study findings and limitations. No published studies investigated synchronous teletherapy for groups of chronic pain patients. Methods of assessment varied considerably across studies. Strength of evidence was moderate and many of the selected studies had issues with treatment compliance/adherence and selection bias. Teletherapy strategies for persons with chronic pain were shown to improve pain, mood, disability and catastrophising, however half of the studies selected did not meet the criteria for acceptable standards for internal validity. Those trials with limited therapist involvement appeared to be less beneficial and tended to report lower adherence than those which had higher levels of therapist guidance or peer support. CONCLUSIONS: Preliminary findings suggest that teletherapy and remote online cognitive behavioural therapy strategies can be effective in improving quality of life among persons with chronic pain, although the overall quality of evidence is moderate. Controlled trials are needed to assess live remote teletherapy for chronic pain.

Outcome of a High-Frequency Transcutaneous Electrical Nerve Stimulator (hfTENS) Device for Low Back Pain: A Randomized Controlled Trial.

OBJECTIVE: This controlled trial examined the benefit of a high-frequency transcutaneous electrical nerve stimulation (hfTENS) device (the Quell, NeuroMetrix, Inc., Waltham, MA, U.S.A.) for patients with chronic low back pain (CLBP). METHODS: Thirty-five (n = 35) participants were randomly assigned to use the device each day for 3 months (experimental group) and were compared with 33 subjects without the device (treatment-as-usual control group). All patients were instructed to complete baseline questionnaires and were assessed on thresholds of pressure pain and mechanical temporal summation as part of standardized quantitative sensory testing (QST). The subjects also uploaded smartphone applications (apps) for tracking use of the hfTENS and for daily pain assessment. Each participant completed weekly phone interviews, was prompted to complete daily pain app assessments, and was asked to repeat the baseline questionnaires again after 6 weeks and 3 months. RESULTS: Sixty percent of the subjects were female, 77.9% were Caucasian, and the average age was 46.2 years. Significant reductions in pain intensity (P < 0.01) and activity interference (P < 0.025) and significant improvements in pain catastrophizing (P < 0.025) were noted in the experimental group compared with the control group. No group differences were found on depression, anxiety, or pain-related disability. Older subjects with a longer duration of pain tended to use the hfTENS more often. Subjects who showed greater sensitivity based on QST results revealed increased use of the hfTENS (P < 0.025) and tended to believe that the hfTENS was more helpful in reducing their back pain, but these findings did not reach significance (P = 0.09). CONCLUSION: These results suggest that hfTENS can have a moderate effect in reducing pain and improving quality of life in low back pain patients. Further trials designed to determine the mechanism of action of the hfTENS are needed.

Determining Pain Catastrophizing From Daily Pain App Assessment Data: Role of Computer-Based Classification.

This study compared persons with chronic pain who consistently reported that their pain was worsening with those who reported that their pain was improving or remaining the same per daily assessment data from a smartphone pain app. All participants completed baseline measures and were asked to record their progress every day by answering whether their overall condition had improved, remained the same, or gotten worse (perceived change) on a visual analogue scale. One hundred forty-four individuals with chronic pain who successfully entered daily assessments were included. Those persons who were classified as worse showed significantly higher pain intensity scores, greater activity interference, higher disability and mood disturbance scores, and higher scores on the Pain Catastrophizing Scale both at baseline and after 3 months (P < .001). Repeated measures analyses and multilevel modeling of perceived change data over different time intervals of 20 assessments over 40 days, 10 assessments over 20 days, and 5 assessments over 10 days were examined. These analyses demonstrated that group classification of better, same, and worse could be reliably determined, even with as few as 5 assessments. These results support the use of innovative mobile health technology to identify individuals who are prone to catastrophize about their pain. Perspective: This study demonstrated that daily assessment of overall perceived change with a smartphone pain app was positively correlated with the Pain Catastrophizing Scale and capturing short-term daily assessment trends data using computer-based classification methods might be a future way to help to identify individuals who tend to catastrophize about their pain.

Using Integrative Medicine in Pain Management: An Evaluation of Current Evidence.

Complementary medicine therapies are frequently used to treat pain conditions such as headaches and neck, back, and joint pain. Chronic pain, described as pain lasting longer than 3-6 months, can be a debilitating condition that has a significant socioeconomic impact. Pharmacologic approaches are often used for alleviating chronic pain, but recently there has been a reluctance to prescribe opioids for chronic noncancer pain because of concerns about tolerance, dependence, and addiction. As a result, there has been increased interest in integrative medicine strategies to help manage pain and to reduce reliance on prescription opioids to manage pain. This article offers a brief critical review of integrative medical therapies used to treat chronic pain, including nutritional supplements, yoga, relaxation, tai chi, massage, spinal manipulation, and acupuncture. The goal of this article is to identify those treatments that show evidence of efficacy and to identify gaps in the literature where additional studies and controlled trials are needed. An electronic search of the databases of PubMed, The Cochrane Library, EMBASE, PsycINFO, and Science Citation Index Expanded was conducted. Overall, weak positive evidence was found for yoga, relaxation, tai chi, massage, and manipulation. Strong evidence for acupuncture as a complementary treatment for chronic pain that has been shown to decrease the usage of opioids was found. Few studies were found in which integrative medicine approaches were used to address opioid misuse and abuse among chronic pain patients. Additional controlled trials to address the use of integrative medicine approaches in pain management are needed.