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As statistical reviewers and editors for BMJ Paediatrics Open (BMJPO), we frequently see methodological and statistical errors in articles submitted to our journal. To make a list of these common errors and propose suitable corrections, and inspired by similar efforts at other leading journals, we surveyed the statistical reviewers and editors at BMJPO to collect their 'pet peeves' and examples of best practices.(1, 2) We have divided these into seven sections: graphics; statistical significance and related issues; presentation, vocabulary, textual and tabular presentation; causality; model building, regression and choice of methods; meta-analysis; and miscellaneous. Here, we present the common errors, with brief explanations. We hope that the guidance provided here will help guide authors as they prepare their submissions to the journal, leading to higher quality and more robust research reporting.

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BACKGROUND: We sought to determine if lumpectomy patients who received perioperative opioid-sparing multimodal analgesia reported less pain when compared with those who received traditional opioid-based care. STUDY DESIGN: A prospective cohort of patients undergoing lumpectomy who received an opioid-sparing multimodal analgesia protocol [no opioids group (NOP)] was compared with a large cohort of patients who received traditional care [opioids group (OG)]. In-hospital and discharge opioids were compared using oral morphine equivalents (OMEs). Postoperative day one and week one pain scores were compared using the Kruskal-Wallis test. RESULTS: Overall, 1153 patients underwent lumpectomy: 634 patients received the protocol (NOP), and 519 patients did not (OG). Median pain scores were significantly lower in the NOP cohort when compared with the OG cohort the day after surgery (2 vs. 0, p < 0.001) and the week after surgery (1 vs. 0, p < 0.001). NOP patients were significantly less likely to report severe pain (7-10 on a 10-point scale) the day after surgery compared with OG patients (15.7% vs. 6.9%, p = 0.004). Patients in the NOP cohort were discharged with a median of zero OMEs (range 0-150), while patients in the OG were discharged with a median of 90 OMEs (range 0-360; p < 0.001). CONCLUSION: Implementation of an opioid-sparing multimodal analgesia protocol for lumpectomy patients resulted in superior pain control without a routine opioid prescription. Surgeons can improve their own patients' outcomes while addressing the larger societal issue of the opioid crisis by adopting similar protocols that decrease the quantity of opioids available for diversion.

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BACKGROUND: Obese patients are at increased risk of persistent pain and chronic opioid dependence after surgery. We sought to evaluate the impact of an Enhanced Recovery After Surgery (ERAS) protocol in breast surgery patients to determine whether multimodal analgesia was effective for both obese and non-obese patients. METHODS: A prospective cohort of patients undergoing breast surgery who received an opioid-sparing ERAS protocol was compared with patients who did not receive ERAS, including a historical cohort. Pain scores were compared with respect to body mass index (BMI). Obesity was defined as BMI ≥ 30, and moderate to severe pain was defined as 4-10 of a 10-point scale. Postoperative day one and week one pain scores were compared using the Kruskal-Wallis test. RESULTS: A combined contemporary and historical cohort of 1353 patients underwent lumpectomy and mastectomy without reconstruction. The present analysis comprises 622 patients with pain scores who did and did not receive ERAS between 2015 and 2018. The two groups were demographically similar. The day after surgery, those who received ERAS reported lower rates of moderate to severe pain, regardless of BMI (obese: 46.3% vs. 21.8%, p < 0.001; non-obese: 36.3% vs. 19.4%, p = 0.002). One week after surgery, obese patients who received ERAS had higher rates of persistent pain compared with non-obese patients (18.6% vs. 11.1%, p = 0.042). CONCLUSIONS: An opioid-sparing ERAS protocol utilizing multimodal analgesia significantly improved postoperative pain control for obese and non-obese patients. However, it appears that obese patients are still at relatively greater risk for persistent pain after surgery.

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Purpose SPEAK OUT! and The LOUD Crowd is a standardized speech therapy program of 12 individual treatments combined with ongoing weekly group sessions for individuals with dysarthria due to Parkinson's disease (PD). The premise of this program is that individuals with PD must rely on goal-directed basal ganglia-cortical circuits to compensate for deficits in habitual, automatic control. The purpose of this study was to assess the outcome of this therapy program. Method Forty individuals with idiopathic PD received SPEAK OUT! in 12 individual 40-min sessions 3 times per week for 4 consecutive weeks and also participated in The LOUD Crowd. Assessments were conducted 3 times at baseline and then within 1 and 6 weeks after completion of the individual SPEAK OUT! sessions. Twenty-five adults without communication disorders were assessed on the same schedule. Acoustic outcome measures were mean intensity from reading and monologue, the prosody measures of standard deviation of intensity and frequency from reading and monologue, and the voice quality measure of cepstral peak prominence from reading. Patient perception of voice was also assessed with the Voice-Related Quality of Life. Results Posttherapy, mean intensity was greater and variation of frequency was larger in reading and monologue, while variation in intensity was larger in monologue but unchanged in reading. Cepstral peak prominence and Voice-Related Quality of Life scores were significantly higher (improved) after therapy. Conclusion These data contribute to evidence of the effectiveness of this program for hypokinetic dysarthria secondary to idiopathic PD and thus inform clinical practice in the selection among treatment options.

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BACKGROUND: Ibuprofen (Motrin; Johnson & Johnson) and acetaminophen (APAP, paracetamol) are the most commonly used analgesics in the pediatric emergency department (ED) for managing a variety of acute traumatic and nontraumatic painful conditions. The multimodal pain management of using a combination of ibuprofen plus acetaminophen has the potential to result in greater analgesia. OBJECTIVE: We compared the analgesic efficacy of a combination of oral ibuprofen plus acetaminophen with either analgesic alone for pediatric ED patients with acute pain. METHODS: We performed a randomized, double-blind superiority trial assessing and comparing the analgesic efficacy of a combination of oral ibuprofen (10 mg/kg dose) plus acetaminophen (15 mg/kg per dose) to either analgesic alone for the treatment of acute traumatic and nontraumatic pain in the pediatric ED. Primary outcomes included a difference in pain scores among the three groups at 60 min. RESULTS: We enrolled 90 patients (30 per group). The difference in mean pain scores at 60 min between acetaminophen and combination groups was 0.30 (95% confidence interval [CI] -0.84 to 1.83); between ibuprofen and combination groups was -0.33 (95% CI -1.47 to 0.80); and between acetaminophen and ibuprofen groups was 0.63 (95% CI -0.54 to 1.81). Reductions in pain scores from baseline to 60 min were similar for all patients in each of the three groups. No adverse events occurred in any group. CONCLUSIONS: We found similar analgesic efficacy of oral ibuprofen and acetaminophen in comparison with each analgesic alone for short-term treatment of acute pain in the pediatric ED, but the trial was underpowered to demonstrate the analgesic superiority of the combination of oral ibuprofen plus acetaminophen in comparison with each analgesic alone.

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STUDY OBJECTIVE: To compare analgesic efficacy and safety of intravenous lidocaine and ketorolac combination to each analgesic alone for ED patients with suspected renal colic. METHODS: We conducted a randomized, double-blind trial comparing analgesic efficacy of a combination of intravenous lidocaine (1.5 mg/kg) and ketorolac (30 mg), to ketorolac (30 mg), and to lidocaine (1.5 mg/kg) in patients aged 18-64 presenting to the ED with suspected renal colic. Primary outcome included difference in pain scores between the groups at 30 min. Secondary outcomes included a comparative reduction in pain scores in each group from baseline to 30 and 60 min as well as rates of adverse events and need for rescue analgesia at 30 and 60 min. RESULTS: We enrolled 150 subjects (50 per group). The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89 (95% CI: -4.39 to -1.39); between Ketorolac and Lidocaine/Ketorolac group was -0.92 (95% CI: -2.44 to 0.61); and between Ketorolac and Lidocaine was -1.98 (95% CI: -3.69 to -0.27). A comparative percentage of subjects in each group required rescue analgesia at 30 and 60 min. No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. Commonly reported adverse effects were dizziness, nausea, and headache. CONCLUSION: The administration of intravenous lidocaine/ketorolac combination to ED patients with suspected renal colic results in better analgesia in comparison to lidocaine alone but provides no analgesic advantages over ketorolac alone. Clinicaltrials.gov Registration: NCT02902770.

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STUDY OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are used extensively for the management of acute pain, with ibuprofen being one of the most frequently used oral analgesics in the emergency department (ED). We compare the analgesic efficacy of oral ibuprofen at 3 different doses for adult ED patients with acute pain. METHODS: This was a randomized, double-blind trial comparing analgesic efficacy of 3 doses of oral ibuprofen (400, 600, and 800 mg) in adult ED patients with acute painful conditions. Primary outcome included difference in pain scores between the 3 groups at 60 minutes. RESULTS: We enrolled 225 subjects (75 per group). The difference in mean pain scores at 60 minutes between the 400- and 600-mg groups was -0.14 (95% confidence interval [CI] -0.67 to 0.39); between the 400- and 800-mg groups, 0.14 (95% CI -0.65 to 0.37); and between the 600- and 800-mg groups, 0.00 (95% CI -0.47 to 0.47). Reductions in pain scores from baseline to 60 minutes were similar for all subjects in each of the 3 groups. No adverse events occurred in any group. CONCLUSION: Oral ibuprofen administered at doses of 400, 600, and 800 mg has similar analgesic efficacy for short-term pain relief in adult patients presenting to the ED with acute pain.

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BACKGROUND: The use of nonsteroidal anti-inflammatory drugs is an effective adjunct in managing perioperative pain. We sought to determine if the use of intraoperative ketorolac as part of a multimodal ERAS protocol increased the risk of bleeding complications in breast surgery. METHODS: A subset analysis of a prospective cohort study including patients undergoing lumpectomy and mastectomy compared two groups: those who received intraoperative ketorolac and those who did not. Bleeding complications were compared using Fisher's exact test or t test, and analyzed with respect to surgical modality. Patients undergoing immediate reconstruction were excluded. RESULTS: Seven hundred and fifty-eight breast surgeries were performed in a 13-month period: 157 lumpectomy patients and 57 mastectomy patients met inclusion criteria between July 2017 and August 2018. Two hundred and fourteen patients were included in the analysis: 115 received ketorolac and 99 did not. The two groups were similar with regards to sex, age, race, tobacco use, and comorbidities. When analyzed together, there was no difference in bleeding complications between the group that received intraoperative ketorolac and those who did not (2% vs. 2.6%, p = 1.00). No hematomas occurred in the lumpectomy patients, and three occurred in mastectomy patients: one of which received ketorolac, and two did not (5.9% vs. 5.0%, p = 0.575). The rates of seroma, infection, or dehiscence were not significantly different between the two groups, regardless of surgical modality. CONCLUSIONS: The use of intraoperative ketorolac is a useful adjunct in perioperative pain management in breast surgery and does not increase the risk of bleeding.

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BACKGROUND: A 10-step protocol employing multimodal analgesia was implemented in patients undergoing mastectomy to decrease the quantity of opioids prescribed at discharge. METHODS: Patients who received the Enhanced Recovery After Surgery (ERAS) protocol were compared to a control group. Inpatient and discharge prescription of opioids were compared using oral morphine equivalents (OMEs), along with postoperative pain scores. RESULTS: Between 2017 and 2018, fifty-seven patients were eligible for inclusion: 20 patients received ERAS and 37 received usual care (UC). The ERAS group received a mean of 2.4 (0-13) inpatient OMEs and the UC group received 13.7 (0-80) (p = 0.002). The ERAS group received 2.0 (0-40) OMEs at discharge and the UC group received 59.8 (0-120) (p < 0.001). Postoperative pain scores were significantly lower in the patients who received the ERAS protocol. CONCLUSIONS: Patients who received the ERAS protocol required less postoperative opioids and reported lower pain scores when compared to a control group.

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STUDY OBJECTIVE: We compare the analgesic efficacy and safety of subdissociative intravenous-dose ketamine (SDK) versus morphine in geriatric Emergency Department (ED) patients. METHODS: This was a prospective, randomized, double-blind trial evaluating ED patients aged 65 and older experiencing moderate to severe acute abdominal, flank, musculoskeletal, or malignant pain. Patients were randomized to receive SDK at 0.3 mg/kg or morphine at 0.1 mg/kg by short intravenous infusion over 15 min. Evaluations occurred at 15, 30, 60, 90, and 120 min. Primary outcome was reduction in pain at 30 min. Secondary outcomes included overall rates of adverse effects and incidence of rescue analgesia. RESULTS: Thirty patients per group were enrolled in the study. The primary change in mean pain scores was not significantly different in the ketamine and morphine groups: 9.0 versus 8.4 at baseline (mean difference 0.6; 95% CI -0.30 to 1.43) and 4.2 versus 4.4 at 30 min (mean difference -0.2; 95% CI -1.93 to1.46). Patients in the SDK group reported higher rates of psychoperceptual adverse effects at 15, 30, and 60 min post drug administration. Two patients in the ketamine group and one in the morphine group experienced brief desaturation episodes. There were no statistically significant differences with respect to changes in vital signs and need for rescue medication. CONCLUSION: SDK administered at 0.3 mg/kg over 15 min provides analgesic efficacy comparable to morphine for short-term treatment of acute pain in the geriatric ED patients but results in higher rates of psychoperceptual adverse effects. ClinicalTrials.gov Registration #: NCT02673372.

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OBJECTIVE: Our aim was to compare the outcomes of tuberculous aortic aneurysms treated with endovascular aortic repair (TEVAR) or open surgery. METHODS: An electronic search of the National Library of Medicine PubMed database for tuberculous aortic aneurysm was performed between January 1998 through December 2017. Cases were screened for completeness of information and outcomes were recorded and analyzed. RESULTS: A total of 56 studies were reviewed, with 61 (20 TEVAR, 41 open surgical repair) having adequate case details and follow-up. The in-hospital/30-day mortality was 0% (0 out of 20) in the TEVAR group and 7% (three out of 41) in the open surgery group (P = .54). Overall mortality was 5% (1/20) in the TEVAR group and 10% (4/41) in the open surgery group (P = .53). Two-year survival and freedom from aneurysm recurrence were comparable in the two groups, P = .45 and P = .94, respectively. One patient in the TEVAR group and one patient in the open surgery group died due to a rupture of a recurrent aortic aneurysm 16 and 28 months after surgery, respectively. CONCLUSIONS: TEVAR and anti-tuberculosis (TB) medications are reasonable initial treatment options for tuberculous aortic aneurysm especially in high-risk patients; however, careful follow-up is necessary.

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INTRODUCTION: We aimed to evaluate the patterns of analgesic prescribing for emergency department (ED) patients suffering from pain of renal colic before, during, and after implementation of an opioid reduction initiative. We hypothesized that this initiative based on the concept of channels/enzymes/receptors-targeted analgesia would result in overall decrease in opioid utilization in the ED and at discharge. METHODS: We performed a retrospective analysis of ED electronic medical record of patients presenting with renal colic who received analgesics in the ED and at discharge over a five-year period. Patients were divided into three groups based on the following periods: 2012-2014 (pre-implementation phase); 2014-2015 (implementation phase); and 2015-2017 (post-implementation). RESULTS: A total of 4,490 patients presented to the ED with renal colic over a five-year study period. Analgesics were administered to 3,793 ED patients of whom 1,704 received opioids and 2,675 received non-opioid analgesics. A total of 3,533 ED patients received a prescription for analgesic(s) upon discharge from the ED: 2,692 patients received opioids, and 2,228 received non-opioids. We observed a 12.7% overall decrease from the pre-implementation to post-implementation time period in opioid prescribing in the ED and a 25.5% decrease in opioid prescribing at discharge, which translated into 432 and 768 fewer patients receiving opioids, respectively. CONCLUSION: Implementation of an opioid-reduction initiative based on patient-specific, pain syndrome-targeted opioid alternative protocols resulted in a reduction in opioid administration in the ED by 12.7% and at prescriptions at discharge by 25.5%. Adoption of similar ED initiatives nationwide has the potential to foster effective non-opioid analgesic practices for ED patients presenting with renal colic and to reduce physicians' reliance on administering and prescribing opioids.

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BACKGROUND: The evolving conceptualization of the management of surgical pain was a major contributor to the supply of narcotics that led to the opioid crisis. We designed and implemented a breast surgery-specific Enhanced Recovery After Surgery (ERAS) protocol using opioid-sparing techniques to eliminate narcotic prescription at discharge without sacrificing perioperative pain control. METHODS: A pilot observational study included patients with and without cancer undergoing lumpectomy. The convenience sample consisted of an ERAS group and a control usual care (UC) group who underwent surgery during the same time period. Discharge narcotic prescriptions were compared after converting to oral morphine milligram equivalents (MME's). Postoperative day one and week one pain scores were also compared between the two groups. RESULTS: Ninety ERAS and 67 UC patients were enrolled. Most lumpectomies were wire-localized, and half of the patients in each group had breast cancer. There were more obese patients in the ERAS group. UC lumpectomy patients were discharged with a median of 54.5 MMEs (range 0-120), while the ERAS lumpectomy patients were discharged with none (p < 0.001). Postoperative pain scores were not significantly different between groups, and there were few complications. CONCLUSION: A breast surgery-specific ERAS protocol employing opioid-sparing techniques successfully eliminated postoperative narcotic prescription without sacrificing perioperative pain control or increasing postoperative complications. By promoting the adoption of similar protocols, surgeons can continue to improve patient outcomes while decreasing the quantity of narcotics available for diversion within our patients' communities.

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Transplant education has been historically unstructured and inconsistent. The purpose of this study was to measure nursing students' knowledge and attitudes toward organ donation, allocation, and preparation for practice using a modified version of the Organ Donation Attitude Questionnaire II-Student Version. Scores were low, particularly regarding brain death and organ allocation. Preparedness for practice was related to knowledge of brain death (z = 2.05, p = .04); knowledge (t = 2.24, p = .03) and attitude (t = 7.55, p < .0001) were related to signing a driver's license. Results support including organ donation and transplant education in nursing curricula.

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TA-65 is a dietary supplement based on an improved formulation of a small molecule telomerase activator that was discovered in a systematic screening of natural product extracts from traditional Chinese medicines. This study summarizes the findings on telomere length (TL) changes from a randomized, double blind, placebo controlled study of TA-65 over a 1 year period. The study was conducted on 117 relatively healthy cytomegalovirus-positive subjects aged 53-87 years old. Subjects taking the low dose of TA-65 (250 U) significantly increased TL over the 12 months period (530 ± 180 bp; p = 0.005), whereas subjects in the placebo group significantly lost TL (290 ± 100 bp; p = 0.01). The high dose of TA-65 (1000 U) showed a trend of improvements in TL compared with that of the placebo group; however, the improvements did not reach statistical significance. TL changes in the low-dose group were similar for both median and 20th percentile TLs. The findings suggest that TA-65 can lengthen telomeres in a statistically and possibly clinically significant manner.

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OBJECTIVES: Disorders of behavioral dysregulation often involve more than one dsyregulated behavior (e.g., drug abuse and aggression, alcohol abuse and gambling). The high co-occurrence suggests the need of a transdiagnostic treatment that can be customized to target multiple specific behaviors. METHOD: The current pilot study compared a 20-week, individual transdiagnostic therapy (mindfulness and modification therapy [MMT]) versus treatment as usual (TAU) in targeting alcohol problems, drug use, physical aggression, and verbal aggression in self-referred women. Assessments were administered at baseline, post-intervention, and 2-month follow-up. RESULTS: Wilcoxon signed-ranked tests and multilevel modeling showed that MMT (n = 13) displayed (a) significant and large decreases in alcohol/drug use, physical aggression, and verbal aggression; (b) significantly greater decreases in alcohol/drug use and physical aggression than did TAU (n = 8); and (c) minimal-to-no deterioration of effects at follow-up. Both conditions showed significant decreases in verbal aggression, with no statistically significant difference between conditions. MMT also displayed greater improvements in mindfulness. CONCLUSIONS: Preliminary findings support the feasibility and efficacy of MMT in decreasing multiple dysregulated behaviors.

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OBJECTIVE: To characterize changes in bone mineral density (BMD) according to race among HIV-infected and uninfected women, and to evaluate the relationship between race and menopause-related bone loss. METHODS: Dual X-ray absorptiometry measured BMD on study entry and a minimum of 18 months later in 246 HIV-infected and 219 HIV-uninfected women in the Menopause Study. Linear regression analyses determined percent annual BMD change at the total hip (TH), femoral neck (FN), and lumbar spine (LS) after adjusting for potential confounders. Race-stratified and HIV-infected subgroup analyses were performed. RESULTS: At baseline, mean age was 45 years, 19% of women were postmenopausal. HIV-infected women were more likely to be black (58% vs. 38%), and had lower BMI and less cigarette exposure when compared to HIV-uninfected women. Women who were perimenopausal at baseline and postmenopausal at follow-up had the greatest TH bone loss (-1.68%/yr, p < .0001) followed by those postmenopausal throughout (-1.02%/yr, p = .007). We found a significant interaction between HIV status and race in multivariate analyses of BMD change at the FN and TH. In race-stratified analyses, HIV infection was associated with TH BMD loss in non-black women. Black women experienced greater menopause-associated decline in TH BMD compared with non-black women. CONCLUSIONS: The association of HIV and BMD differs strikingly by race, as do the effects of the menopausal transition on bone. Determining the extent to which the effect of HIV on fracture risk varies by race will be crucial to identify HIV-infected women at greatest risk for osteoporotic fracture, particularly as they enter menopause.

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A short average telomere length is associated with low telomerase activity and certain degenerative diseases. Studies in animals and with human cells confirm a causal mechanism for cell or tissue dysfunction triggered by critically short telomeres, suggesting that telomerase activation may be an approach to health maintenance. Previously, we reported on positive immune remodeling in humans taking a commercial health maintenance program, PattonProtocol-1, composed of TA-65® (a natural product-derived telomerase activator) and other dietary supplements. In over a 5-year period and an estimated 7000 person-years of use, no adverse events or effects have been attributed to TA-65 by physicians licensed to sell the product. Here we report on changes in metabolic markers measured at baseline (n=97-107 subjects) and every 3-6 months (n=27-59 subjects) during the first 12 months of study. Rates of change per year from baseline determined by a multi-level model were -3.72 mg/dL for fasting glucose (p=0.02), -1.32 mIU/mL for insulin (p=0.01), -13.2 and -11.8 mg/dL for total cholesterol and low-density lipoprotein cholesterol (LDL-C) (p=0.002, p=0.002, respectively), -17.3 and -4.2 mmHg for systolic and diastolic blood pressure (p=0.007 and 0.001, respectively), and -3.6 µmole/L homocysteine (p=0.001). In a subset of individuals with bone mineral density (BMD) measured at baseline and 12 months, density increased 2.0% in the spine (p=0.003). We conclude that in addition to apparent positive immune remodeling, PattonProtocol-1 may improve markers of metabolic, bone, and cardiovascular health.

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We aimed 1) to define risk factors for adverse outcome in urban African American patients, 2) to determine whether clinical variables as risk factors are congruent with previously published data, and 3) to identify the proportion of infants with different outcomes. The study included African American infants who were born and participated in neurodevelopmental follow-up. Infants with gestational age range of 23 to 41 weeks, and birth weight (BW) range of 495 to 3,965 g were classified by developmental outcome. Among the smallest infants, BW, gestational age, gender and respiratory distress syndrome were significantly (p<.05) associated with adverse outcome. No significant risk factors were identified for adverse outcome in the two other birth weight categories. Adverse outcomes were seen more frequently in infants with BW ≤1,500 g than in larger infants. The number of infants with severe outcome was found higher than previously reported and may be related to different racial/generational origin.

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