Pharmacologic Treatments of Acute Episodic Migraine Headache in Outpatient Settings: A Clinical Guideline From the American College of Physicians

Description: The American College of Physicians (ACP) developed this guideline based on the best available evidence on the comparative benefits and harms of pharmacologic treatments of acute episodic migraine headache, patients’ values and preferences, and economic evidence about these pharmacologic treatments. Methods: This guideline is based on a systematic review and network meta-analysis of the comparative benefits and harms of pharmacologic treatments of acute episodic migraine headaches, as well as systematic reviews of patients’ values and preferences and comparative cost-effectiveness analyses. The Clinical Guidelines Committee evaluated the following clinical outcomes using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach: pain freedom and pain relief at 2 hours; sustained pain freedom and sustained pain relief up to 48 hours; need for rescue medication within 24 hours; nausea, vomiting, and restored physical function at 2 hours; and overall and serious adverse events (AEs). Additional data on AEs were captured through U.S. Food and Drug Administration medication labels. Audience and Population: The audience for this clinical guideline is physicians and other clinicians. The population is adults with acute episodic migraine headache (defined as 1 to 14 headache days per month) managed in outpatient settings. Recommendation 1: ACP recommends that clinicians add a triptan to a nonsteroidal anti-inflammatory drug to treat moderate to severe acute episodic migraine headache in outpatient settings for nonpregnant adults who do not respond adequately to a nonsteroidal anti-inflammatory drug (strong recommendation; moderate-certainty evidence). Recommendation 2: ACP suggests that clinicians add a triptan to acetaminophen to treat moderate to severe acute episodic migraine headache in outpatient settings for nonpregnant adults who do not respond adequately to acetaminophen (conditional recommendation; low-certainty evidence).

In knee OA, intraarticular triamcinolone increased cartilage loss and did not differ from saline for knee pain

Source Citation McAlindon TE, LaValley MP, Harvey WF, et al. Effect of intra-articular triamcinolone vs saline on knee cartilage volume and pain in patients with knee osteoarthritis: a randomized clinical trial. JAMA. 2017;317:1967-75. 28510679

How Would You Treat This Patient With Acute and Chronic Pain From Sickle Cell Disease?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 175, No 4

Sickle cell disease is prevalent in large numbers of patients in the United States and has a significant global impact. Its complications span numerous organs and lead to reduced life expectancy. Acute and chronic sickle cell pain is a common cause of patient suffering. The American Society of Hematology published updated guidelines on management of acute and chronic pain from sickle cell disease in 2019. Several of the recommendations are conditional and leave specific decisions to the treating physician. These include conditional recommendations about the use of ketamine for acute pain and the initiation and discontinuation of long-term opioid therapy for chronic pain. Here, 2 hematologists discuss these guidelines and make contrasting recommendations for the management of acute and chronic pain for a patient with sickle cell disease.

Cannabis or Cannabinoids for the Management of Chronic Noncancer Pain: Best Practice Advice From the American College of Physicians

Description: The American College of Physicians’ Population Health and Medical Science Committee (PHMSC) developed this best practice advice to inform clinicians about what is currently known about the benefits and harms of cannabis or cannabinoids in the management of chronic noncancer pain and to provide advice for clinicians counseling patients seeking this therapy. Methods: The PHMSC considers areas where evidence is uncertain or emerging or practice does not follow the evidence to provide clinical advice based on a review and assessment of scientific work, including systematic reviews and individual studies. Sources of evidence included a living systematic review on cannabis and cannabinoid treatments for chronic noncancer pain and a series of living systematic reviews and primary studies. Best Practice Advice 1a: Clinicians should counsel patients about the benefits and harms of cannabis or cannabinoids when patients are considering whether to start or continue to use cannabis or cannabinoids to manage their chronic noncancer pain. Best Practice Advice 1b: Clinicians should counsel the following subgroups of patients that the harms of cannabis or cannabinoid use for chronic noncancer pain are likely to outweigh the benefits: young adult and adolescent patients, patients with current or past substance use disorder, patients with serious mental illness, and frail patients and those at risk for falling. Best Practice Advice 2: Clinicians should advise against starting or continuing to use cannabis or cannabinoids to manage chronic noncancer pain in patients who are pregnant or breastfeeding or actively trying to conceive. Best Practice Advice 3: Clinicians should advise patients against the use of inhaled cannabis to manage chronic noncancer pain.

Methotrexate: Borrowed Hope for Persons With Knee Osteoarthritis?

Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 175, No 7

Background: The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported. Objective: To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia. Design: Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505) Setting: 46 U.S. and Canadian hospitals. Participants: Patients aged 50 years or older undergoing hip fracture surgery. Intervention: Spinal or general anesthesia. Measurements: Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care. Results: A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups. Limitation: Missing outcome data and multiple outcomes assessed. Conclusion: Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia. Primary Funding Source: Patient-Centered Outcomes Research Institute.

Self-management of Epilepsy: A Systematic Review: Annals of Internal Medicine: Vol 171, No 2

Background: Although self-management is recommended for persons with epilepsy, its optimal strategies and effects are uncertain. Purpose: To evaluate the components and efficacy of self-management interventions in the treatment of epilepsy in community-dwelling persons. Data Sources: English-language searches of MEDLINE, Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL in April 2018; the MEDLINE search was updated in March 2019. Study Selection: Randomized and nonrandomized comparative studies of self-management interventions for adults with epilepsy. Data Extraction: An investigator assessed study characteristics; intervention details, including 6 components of self-management; and outcomes, which were verified by a second reviewer. Risk of bias (ROB) was assessed independently by 2 investigators. Data Synthesis: 13 randomized and 2 nonrandomized studies (2514 patients) evaluated self-management interventions. Interventions were delivered primarily in group settings, used a median of 4 components, and followed 2 general strategies: 1 based on education and the other on psychosocial therapy. Education-based approaches improved self-management behaviors (standardized mean difference, 0.52 [95% CI, 0.0 to 1.04]), and psychosocial therapy–based approaches improved quality of life (mean difference, 6.64 [CI, 2.51 to 10.77]). Overall, self-management interventions did not reduce seizure rates, but 1 educational intervention decreased a composite of seizures, emergency department visits, and hospitalizations. Limitation: High ROB in most studies, incomplete intervention descriptions, and studies limited to English-language publications. Conclusion: There is limited evidence that self-management strategies modestly improve some patient outcomes that are important to persons with epilepsy. Overall, self-management research in epilepsy is limited by the range of interventions tested, the small number of studies using self-monitoring technology, and uncertainty about components and strategies associated with benefit. Primary Funding Source: U.S. Department of Veterans Affairs. (PROSPERO: CRD42018098604)

Target Trial Emulation for Evaluating Health Policy

Target trial emulation is an approach to designing rigorous nonexperimental studies by “emulating” key features of a clinical trial. Most commonly used outside of policy contexts, this approach is also valuable for policy evaluation as policies typically are not randomly assigned. In this article, we discuss the application of the target trial emulation framework in a policy evaluation context. The policy trial emulation framework includes 7 components: the units and eligibility criteria, definitions of the exposure and comparison conditions, assignment mechanism, baseline (“time zero”) and follow-up, outcomes, causal estimand, and statistical analysis and assumptions. Policy evaluations that emulate a randomized trial across these dimensions can yield estimates of the causal effects of the policy on outcomes. Using the policy trial emulation framework to conduct and report on research design and methods supports transparent assessment of threats to causal inference in nonexperimental studies intended to assess the effect of a health policy on clinical or population health outcomes.

Prevalence of Elevated Cardiovascular Risks in Young Adults: A Cross-sectional Analysis of National Health and Nutrition Examination Surveys

Background: The 2013 cholesterol management guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) recommend lipid screening in all adults older than 20 years to identify those at increased risk for atherosclerotic cardiovascular disease (ASCVD). Statins may be considered for patients with elevated 10-year risk (>5%) or a low-density lipoprotein cholesterol (LDL-C) level of 4.92 mmol/L (190 mg/dL) or greater. Objective: To describe the prevalence of elevated ASCVD risk among nondiabetic adults younger than 50 years. Design: Cross-sectional. Setting: NHANES (National Health and Nutrition Examination Survey), 1999 to 2000 through 2011 to 2012. Participants: Adults aged 30 to 49 years without known ASCVD or diabetes. Measurements: 10-year ASCVD risk was estimated by using the 2013 ACC/AHA ASCVD risk calculator. Participants were subdivided by age, sex, and history of smoking and hypertension. The percentages of adults in each subgroup with a 10-year ASCVD risk greater than 5% and of those with an LDL-C level of 4.92 mmol/L (190 mg/dL) or greater were estimated. Low-prevalence subgroups were defined as those in which a greater than 1% prevalence of elevated cardiovascular risk could be ruled out (that is, the upper 95% confidence bound for prevalence was ≤1%). Results: Overall, 9608 NHANES participants representing 67.9 million adults were included, with approximately half (47.12%, representing 32 million adults) in low-prevalence subgroups. In the absence of smoking or hypertension, 0.09% (95% CI, 0.02% to 0.35%) of adult men younger than 40 years and 0.04% (CI, 0.0% to 0.26%) of adult women younger than 50 years had an elevated risk. Among other subgroups, 0% to 75.9% of participants had an increased risk. Overall, 2.9% (CI, 2.3% to 3.5%) had an LDL-C level of 4.92 mmol/L (190 mg/dL) or greater. Limitation: No information was available regarding cardiovascular outcomes. Conclusion: In the absence of risk factors, the prevalence of increased ASCVD risk is low among women younger than 50 and men younger than 40 years. Primary Funding Source: None.

Unloading Shoes for Self-management of Knee Osteoarthritis: A Randomized Trial: Annals of Internal Medicine: Vol 165, No 6

Background: Appropriate footwear is recommended for self-management of knee osteoarthritis. Shoes that reduce harmful knee loads are available, but symptomatic effects are uncertain. Objective: To evaluate the efficacy of unloading shoes in alleviating knee osteoarthritis symptoms. Design: Participant- and assessor-blinded comparative effectiveness randomized, controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12613000851763) Setting: Community. Participants: 164 persons with medial knee osteoarthritis. Intervention: Walking shoes with triple-density, variable-stiffness midsoles and mild lateral-wedge insoles designed to unload the medial knee and worn daily (intervention) versus conventional walking shoes (comparator). Measurements: Primary outcomes were pain with walking (assessed on a numerical rating scale [NRS]) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) at 6 months. Secondary outcomes were knee pain and stiffness (WOMAC), average pain (NRS), intermittent and constant knee pain (Intermittent and Constant Osteoarthritis Pain questionnaire), quality of life (Assessment of Quality of Life instrument), physical activity (Physical Activity Scale for the Elderly), and global change in pain and function (Likert scales). Results: A total of 160 participants (98%) completed primary outcome measures at 6 months. Changes in pain (mean difference, 0.0 units [95% CI, −0.9 to 0.8 unit]) and function (mean difference, 0.3 unit [CI, −3.2 to 3.7 units]) did not differ between groups at 6 months, with both groups showing clinically relevant improvements in function and the intervention group showing clinically relevant improvements in pain. There were no differences in secondary outcomes. Pain was globally improved in 54% of participants, and function was globally improved in 44% to 48%. Unloading shoes were not associated with increased probability of improvement (odds ratios, 0.99 [CI, 0.53 to 1.86] for pain and 0.85 [CI, 0.45 to 1.61] for function). Limitation: Effects on joint structure were not evaluated. Conclusion: Shoes with modified midsoles to unload the medial knee conferred no additional benefit over conventional walking shoes. Both improved pain and function by clinically relevant amounts. Primary Funding Source: Australian National Health and Medical Research Council.