A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Thumb Basal Joint Arthritis.

PURPOSE: Since the passage of the Agricultural Improvement Act of 2018, hand surgeons have increasingly encountered patients seeking counseling on over-the-counter, topical cannabidiol (CBD) for the treatment of pain. To this end, we designed a human clinical trial to investigate the therapeutic potential of CBD for the treatment of pain associated with thumb basal joint arthritis. METHODS: Following Food and Drug Administration and institutional approval, a phase 1 skin test was completed with 10 healthy participants monitored for 1 week after twice-daily application of 1 mL of topical CBD (6.2 mg/mL) with shea butter. After no adverse events were identified, we proceeded with a phase 2, double-blinded, randomized controlled trial. Eighteen participants with symptomatic thumb basal joint arthritis were randomized to 2 weeks of twice-daily treatment with CBD (6.2 mg/mL CBD with shea butter) or shea butter alone, followed by a 1-week washout period and then crossover for 2 weeks with the other treatment. Safety data and physical examination measurements were obtained at baseline and after completion of each treatment arm. RESULTS: Cannabidiol treatment resulted in improvements from baseline among patient-reported outcome measures, including Visual Analog Scale pain; Disabilities of the Arm, Shoulder, and Hand; and Single Assessment Numeric Evaluation scores, compared to the control arm during the study period. There were similar physical parameters identified with range of motion, grip, and pinch strength. CONCLUSIONS: In this single-center, randomized controlled trial, topical CBD treatment demonstrated significant improvements in thumb basal joint arthritis-related pain and disability without adverse events. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.

Cannabinoids and Pain for the Plastic Surgeon: What Is the Evidence?

BACKGROUND: Since the passage of the 2018 Farm Bill, practitioners have encountered more patients self-treating pain with over-the-counter topical cannabidiol (CBD) derived from hemp-Cannabis sativa with less than 0.3% delta-9-tetrahydrocannabinol-with reported improvements in pain control and activities of daily living. Cannabidiol has been touted for its capacity to improve inflammatory, arthritic, and neuropathic pain conditions, and increasing numbers of patients are exploring its use as potential replacement for opioids. However, limited rigorous clinical trials have been performed evaluating the safety and efficacy of cannabinoids for the treatment of pain. METHODS: A systematic search of PubMed was performed using the Medical Subject Headings (MeSH) terms "cannabinoid" or "CBD" or "cannabidiol" or "cannabis" or "medical marijuana" and "pain." It yielded 340 article titles. Twelve full-text primary studies of oral or topical CBD for chronic pain were selected for review, including 6 animal (2 randomized clinical trial and 4 prospective trials) and 6 human (4 randomized clinical trial and 2 prospective trials) studies. RESULTS: With respect to the safety and efficacy of oral and topical CBD for treating pain, animal and human studies have shown early positive results with limited minor side effects. However, all human studies may be underpowered with small sample sizes. CONCLUSIONS: With respect to the safety and efficacy of oral and topical CBD for treating pain, the evidence remains inconclusive in that we have a paucity of data to share with our patients who are considering the use of these products, which may be associated with significant costs.

All hands on deck: Hand replantation versus transplantation.

OBJECTIVES: Our hands play a remarkable role in our activities of daily living and the make-up of our identities. In the United States, an estimated 41,000 individuals live with upper limb loss. Our expanding experience in limb transplantation-including operative techniques, rehabilitation, and expected outcomes-has often been based on our past experience with replantation. Here, we undertake a systematic review of replantation with transplantation in an attempt to better understand the determinants of outcome for each and to provide a summary of the data to this point. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted PubMed searches from 1964 to 2013 for articles in English. In total, 53 primary and secondary source articles were found to involve surgical repair (either replantation or transplantation) for complete amputations at the wrist and forearm levels. All were read and analyzed. RESULTS: Hand replantations and transplantations were compared with respect to pre-operative considerations, surgical techniques, post-operative considerations and outcomes, including motor, sensation, cosmesis, patient satisfaction/quality of life, adverse events/side effects, financial costs, and overall function. While comparison of data is limited by heterogeneity, these data support our belief that good outcomes depend on patient expectations and commitment. CONCLUSION: When possible, hand replantation remains the primary option after acute amputation. However, when replantation fails or is not possible, hand transplantation appears to provide at least equal outcomes. Patient commitment, realistic expectations, and physician competence must coincide to achieve the best possible outcomes for both hand replantation and transplantation.

Patient-Generated Actigraphy Data as a Novel Outcomes Instrument in Carpal Tunnel Syndrome.

BACKGROUND: Currently, we lack objective measures to quantify outcomes in carpal tunnel syndrome. Instead, surgeons rely on patient-reported outcomes measures (PROMs) to assess the effect of carpal tunnel release (CTR). We assessed the validity and reliability of wearable activity monitors to objectively characterize the functional and sleep impact of CTR. We hypothesized that actigraphy could detect changes in sleep and activity and would demonstrate short-term impairment due the operative procedure. METHODS: This pilot, prospective, cohort study compared validated PROMS with actigraphy data obtained via wearable activity monitors (ActiGraph Link; ActiGraph Corp, Pensacola, Fla). Subjects completed baseline questionnaires and wore their device for 1 week preoperatively as a baseline. Subjects then underwent open CTR, wearing actigraphy devices for 4 weeks and completing questionnaires at 2 and 4 weeks postoperatively. Preintervention and postintervention data were compared using paired-sample t test. The Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire data were analyzed in accordance with published PROMIS scoring manuals and raw scores were converted to standardized T scores. RESULTS: Twenty subjects (5 males, 15 females) with moderate or severe carpal tunnel syndrome were enrolled. The mean age was 57.7 years. The PROMIS 29 average cumulative T score was 42.9 with average change of -0.072 preoperatively versus postoperatively. Average sleep disturbance T score was 38.9 preoperatively and 41.4 postoperatively. There was no statistically significant difference in T score in any domain. The mean actigraphy activity data demonstrated near immediate return to baseline activity. Actigraphy sleep data demonstrate improvement in sleep fragmentation and decreased duration of awakenings. CONCLUSIONS: Overall, patient-generated data detected differences in sleep and activity preoperatively versus postoperatively and demonstrated only a short period of activity disruption after CTR, which may be used when counseling patients. These data support actigraphy as a viable adjunct to traditional PROMS to evaluate the impact of surgical intervention and therefore may be useful in the study of other diseases affecting the upper extremity.

Nutritional armor for the injured warfighter: omega-3 fatty acids in surgery, trauma, and intensive care.

Nutrients have traditionally been viewed as a means to provide basic energy for cellular homeostasis and amino acids for protein synthesis in all humans. Young, healthy men and women in the military today are presumed to be well nourished and mentally and physically fit to perform their duties in austere environments. Exposure to high-intensity projectiles, blast injuries, and other wounds of war, however, is an everyday occurrence during deployment that potentially challenges all homeostatic mechanisms. After sustaining such devastating injuries, critically ill, surgical, and trauma patients are in a constant dynamic state between the systemic inflammatory response syndrome (and compensatory anti-inflammatory response syndrome. Compelling evidence supports both immune and metabolic response modulation by specific nutrients, including omega-3 fatty acids, primarily eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). The concept of providing nutrients as therapeutic rather than supportive agents to meet the basic cellular caloric and metabolic demands requires a major paradigm shift. Although the exact route and dose of these metabolically active lipids has yet to be determined, data from large clinical studies of cellular ex-vivo experiments in patients support the liberal use of eicosapentaenoic acid and docosahexaenoic acid in the setting of trauma, surgery, and intensive care.

Towards evidence based emergency medicine: Best BETs from the Manchester Royal Infirmary. BET 1: An evaluation of the Alvarado score as a diagnostic tool for appendicitis in children.

A short-cut systematic review was carried out to establish whether the Alvarado score could be used to rule in or rule out a diagnosis of appendicitis in children. A literature search identified eight studies that were directly relevant to the question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of these papers are tabulated. The clinical bottom line is that the Alvarado score does effectively risk stratify children with suspected appendicitis. Children with an Alvarado score of less than 5 are unlikely to have acute appendicitis, although wide confidence intervals mean that more evidence is still needed before this alone can be used to exclude the diagnosis.

Fighting fire with fire: is it time to use probiotics to manage pathogenic bacterial diseases?

Probiotics, when considered in clinical practice, have traditionally been used for prophylaxis; however, there is growing data suggesting treatment benefits in numerous disease states. In this review, we focus on probiotics as treatment for and prevention of several acute and chronic infectious processes including Helicobacter pylori, Clostridium difficile, necrotizing enterocolitis, ventilator-associated pneumonia, vancomycin-resistant enterococci, and nonalcoholic fatty liver disease. It is inaccurate to generalize findings observed in a single probiotic species to all probiotics. This reasoning is due to the variability of colonizing abilities of native intestinal floras, probiotic or otherwise, secondary to different combinations, doses, and duration of treatments. Given these limitations, multiple animal and human studies have shown anti-inflammatory and selective antimicrobial effects of specific probiotics. Some studies suggest a role for probiotics as supplemental treatment, in combination with antibiotics, for the aforementioned disease processes. It is apparent from this review that the efficacy of probiotics is widely variable and multifaceted. More focused clinical and basic science research is necessary to better understand the treatment potential of various probiotics.

Deciphering the use and predictive value of "emergency medical services provider judgment" in out-of-hospital trauma triage: a multisite, mixed methods assessment.

BACKGROUND: "Emergency medical services (EMS) provider judgment" was recently added as a field triage criterion to the national guidelines, yet its predictive value and real world application remain unclear. We examine the use and independent predictive value of EMS provider judgment in identifying seriously injured persons. METHODS: We analyzed a population-based retrospective cohort, supplemented by qualitative analysis, of injured children and adults evaluated and transported by 47 EMS agencies to 94 hospitals in five regions across the Western United States from 2006 to 2008. We used logistic regression models to evaluate the independent predictive value of EMS provider judgment for Injury Severity Score ≥ 16. EMS narratives were analyzed using qualitative methods to assess and compare common themes for each step in the triage algorithm, plus EMS provider judgment. RESULTS: 213,869 injured patients were evaluated and transported by EMS over the 3-year period, of whom 41,191 (19.3%) met at least one of the field triage criteria. EMS provider judgment was the most commonly used triage criterion (40.0% of all triage-positive patients; sole criterion in 21.4%). After accounting for other triage criteria and confounders, the adjusted odds ratio of Injury Severity Score ≥ 16 for EMS provider judgment was 1.23 (95% confidence interval, 1.03-1.47), although there was variability in predictive value across sites. Patients meeting EMS provider judgment had concerning clinical presentations qualitatively similar to those meeting mechanistic and other special considerations criteria. CONCLUSIONS: Among this multisite cohort of trauma patients, EMS provider judgment was the most commonly used field trauma triage criterion, independently associated with serious injury, and useful in identifying high-risk patients missed by other criteria. However, there was variability in predictive value between sites.

Uninsured patient opinions about a reduced-fee retainer program at academic health center clinics.

BACKGROUND: Access Assured, an experimental program to deliver primary care to uninsured patients using a monthly retainer payment system, has been shown to provide a financially viable method of delivering primary care services to people without health insurance. This qualitative study was designed to assess patient attitudes and concerns about this program and to identify ways to improve it. METHODS: We conducted telephone interviews with 40 purposefully selected Access Assured members between May and June of 2009. This population was stratified to include a sample of 20 patients from those who had elected to renew enrollment in the program after their first 6-month enrollment period. The other 20 patients were selected from those enrollees who had not re-enrolled in the program after this initial period. The semistructured interviews were based on an original list of 19 standardized questions, which were asked of each participant. All interviews were audio taped. The interview tapes were transcribed verbatim and content analysis was conducted using immersion-crystallization methods. RESULTS: Content analysis identified 9 themes related to patient attitudes and concerns about this program. (1) Patients could not understand why they needed to remain enrolled if they were healthy. (2) Patients had variable levels of personal agency or responsibility for their own care. (3) Patients reported they had no choice and needed to enroll in the program to have access to care. (4) Patients liked that the program allowed them to choose their provider and see that provider with continuity from visit to visit. (5) Patients felt they were respected and treated the same as other patients. (6) Patients expressed appreciation for the program. (7) Patients had a range of comments about the quality of care and service they received. (8) Patients reported confusion about the rules of the program and often did not understand its terms and benefits. (9) Patients were under personal and family economic stress. Twenty of the subjects in our study had re-enrolled in Access Assured and 11 of the 20 patients who had not re-enrolled expressed an intention to do so. CONCLUSIONS: Our study population expressed gratitude and other positive opinions about the retainer-based program for uninsured patients in 2 academic family medicine clinics. Conversely, some were concerned about the perceived lack of choice related to enrollment. Significant gaps in patient understanding about the program were identified. Based on these results, we have made improvements to the program and plan to continue to offer this care model to uninsured patients in our practices.