Volume 121, Issue 8

Context Considering the substantial increase in research funding in the field of urology, minimizing research waste should be a top priority. Systematic reviews (SRs) compile available evidence regarding a clinical question into a single critical resource. If properly utilized, SRs can help minimize redundant studies, focus attention to unsubstantiated treatments, and reduce research waste. Objectives To appraise the use of SRs as justification for conducting randomized controlled trials (RCTs) published in high impact urology journals, and to report the ways SRs were incorporated into RCT manuscripts published in the top four urology journals by h5 index. Methods On December 13, 2019, a PubMed search was conducted for RCTs published in the top four urology journals according to the Google Scholar h5-index: European Urology , BJU International , The Journal of Urology , and Urology . For an article to be eligible for inclusion in this study, it must have been a full length RCT, published between November 30, 2014, and November 30, 2019 in one of the identified journals, reported only human subjects, and been accessible in English. The following data points were extracted independently by select investigators from each included RCT: manuscript title, year of publication, journal title, type of intervention (drug, medical device, procedure, other), funding source (government, hospital/university, industry, mixed) type of trial (parallel groups, crossover, cluster), and total number of participants reported in each RCT. The included RCTs were searched for reference to an SR, which was then recorded as “yes – verbatim,” “yes – inferred,” or “not used as justification” and the location in the manuscript where the SR was cited was recorded. Results Of the 566 articles retrieved, 276 were included. Overall, 150 (54.3%) RCTs cited an SR as either verbatim (108; 39.1%) or inferred (42; 15.2%) trial justification, while 126 (45.7%) did not use an SR for RCT justification. Of those 126, 107 (84.9%) RCTs did not cite an SR to any extent. A significant association was noted between verbatim justification and type of intervention ( x 2 =20.23, p=0.017), with 18 of 31 (58.1%) “other” interventions (i.e. psychosocial intervention, exercise programs, and online therapy) having an SR cited as verbatim justification. Only 39 of 118 (33.1%) pharmaceutical trials referenced an SR as verbatim justification. Of 403 systematic review citations, 205 (50.8%) appeared in the Discussion section, while 15 (3.7%) were in the Methods section. Conclusions We found that RCTs published in four high impact urology journals inconsistently referenced an SR as justification and 39.1% of our entire sample did not reference an SR at all. These findings indicate that a divide exists between the instruction and implementation of evidence based medicine in the field of urology concerning RCTs published in the top four journals. Educating clinicians and researchers on the use of SR as justification for RCTs in urology may reduce research waste and increase the quality of RCTs in the field.

Context Many medical schools have a distributed model for clinical clerkship education, challenging our ability to determine student gaps during clinical education. With the graduating class of 2017, A.T. Still University’s School of Osteopathic Medicine in Arizona (ATSU-SOMA) began requiring additional online curricula for all clerkship courses. Objectives To determine whether third year and fourth year students receiving ATSU-SOMA’s online curricula during core clerkships performed better overall on national standardized examinations than students from previous years who had not received the curricula, and whether scores from online coursework correlated with outcomes on standardized examinations as possible early predictors of success. Methods This retrospective cohort study analyzed existing data (demographics and assessments) from ATSU-SOMA classes of 2017–2020 (curriculum group) and 2014–2016 (precurriculum group). The effect of the curriculum on national standardized examinations (Comprehensive Osteopathic Medical Achievement Test [COMAT] and Comprehensive Osteopathic Medical Licensing Examination of the United States [COMLEX-USA]) was estimated using augmented inverse probability weighting (AIPW). Correlations between assignment scores and national standardized examinations were estimated using linear regression models. Results The curriculum group had 405 students with a mean (standard deviation [SD]) age of 25.7 (±3.1) years. Two hundred and fifteen (53.1%) students in the curriculum group were female and 190 (46.9%) were male. The precurriculum group had 308 students (mean ± SD age, 26.4 ± 4.2 years; 157 [51.0%] male; 151 [49.0%] female). The online curriculum group had higher COMAT clinical subject exam scores in obstetrics and gynecology, osteopathic principles and practice (OPP), psychiatry, and surgery (all p≤0.04), as well as higher COMLEX-USA Level 2-Cognitive Evaluation (CE) family medicine and OPP subscores (both p≤0.03). The curriculum group had a 9.4 point increase in mean total COMLEX-USA Level 2-CE score (p=0.08). No effect was found for the curriculum overall on COMAT mean or COMLEX-USA Level 2-Performance Evaluation scores (all p≥0.11). Total coursework scores in each core clerkship, excluding pediatrics, were correlated with COMAT mean score (all adjusted p≤0.03). Mean scores for five of the seven assignment types in core clerkships, excluding evidence based medicine types, were positively correlated with COMAT mean scores (all adjusted p≤0.049). All assignment types correlated with COMLEX-USA Level 2-CE total score (all adjusted p≤0.04), except interprofessional education (IPE). Conclusions Results from this study of 713 students from ATSU-SOMA suggested that our online curriculum supplemented clinic based learning during clerkship courses and improved student outcomes on national standardized examinations.

Context The Comprehensive Osteopathic Medical Licensing Examination of the United States of America (COMLEX-USA) is a three level examination used as a pathway to licensure for students in osteopathic medical education programs. COMLEX-USA Level 2 includes a written assessment of Fundamental Clinical Sciences for Osteopathic Medical Practice (Level 2-Cognitive Evaluation [L2-CE]) delivered in a computer based format and separate performance evaluation (Level 2-Performance Evaluation [L2-PE]) administered through live encounters with standardized patients. L2-PE was designed to augment L2-CE. It is expected that the two examinations measure related yet distinct constructs. Objectives To explore the concurrent validity of L2-CE with L2-PE. Methods First attempt test scores were obtained from the National Board of Osteopathic Medical Examiners database for 6,639 candidates who took L2-CE between June 2019 and May 2020 and matched to the students’ L2-PE scores. The sample represented all colleges of osteopathic medicine and 97.5% of candidates who took L2-CE during the complete 2019–2020 test cycle. We calculated disattenuated correlations between the total score for L2-CE, the L2-CE scores for the seven competency domains (CD1 through CD7), and the L2-PE scores for the Humanistic Domain (HM) and Biomedical/Biomechanical Domain (BM). All scores were on continuous scales. Results Pearson correlations ranged from 0.10 to 0.88 and were all statically significant (p<0.01). L2-CE total score was most strongly correlated with CD2 (0.88) and CD3 (0.85). Pearson correlations between the L2-CE competency domain subscores ranged from 0.17 to 0.70, and correlations which included either HM or BM ranged from 0.10 to 0.34 with the strongest of those correlations being between BM and L2-CE total score (0.34) as well as between HM and BM (0.28).The largest increase between corresponding Pearson and disattenuated correlations was for pairs of scores with lower reliabilities such as CD5 and CD6, which had a Pearson correlation of 0.17 and a disattenuated correlation of 0.68. The smallest increase in correlations was observed in pairs of scores with larger reliabilities such as L2-CE total score and HM, which had a Pearson correlation of 0.23 and a disattenuated correlation of 0.28. The reliability of L2-CE was 0.87, 0.81 for HM, and 0.73 for BM. The reliabilities for the L2-CE competency domain scores ranged from 0.22 to 0.74. The small to moderate correlations between the L2-CE total score and the two L2-PE support the expectation that these examinations measure related but distinct constructs. The correlations between L2-PE and L2-CE competency domain subscores reflect the distribution of items defined by the L2-PE blueprint, providing evidence that the examinations are performing as designed. Conclusions This study provides evidence supporting the validity of the blueprints for constructing COMLEX-USA Levels 2-CE and 2-PE examinations in concert with the purpose and nature of the examinations.

Context Studies have indicated that the muscle energy technique (MET) and the positional release technique (PRT) are effective in the management of piriformis syndrome (PS); however, evidence is scarce regarding the combination of these techniques in the form of an integrated neuromuscular inhibition technique (INIT) in the management of individuals with PS. Although a previous trial investigated the effect of INIT for PS, that study did not integrate Ruddy’s reciprocal antagonist facilitation (RRAF) method into the INIT protocol, nor did the authors diagnose PS according to established criteria. Objectives To examine the effects of INIT with integrated RRAF compared with PRT in the management of patients diagnosed with PS. Methods This study was designed as a single blind randomized clinical trial in which participants diagnosed with PS were randomly allocated into INIT and PRT groups. Each group attended two treatment sessions per week for 8 weeks. Patients in the INIT group received a protocol in which the patient’s tender point or trigger point was palpated in the belly of the piriformis approximately halfway between the inferior lateral angle of the sacrum and the greater trochanter, at which point the therapist applied an intermittent or sustained pressure and maintained the pressure for 20–60 seconds (depending on the participant’s response to pain reduction). For INIT patients, that protocol was also followed by RRAF, a method in which a patient introduces a series of tiny/miniature contractions or efforts (20 times per 10 seconds) against a therapist’s resistance. Patients in the PRT group were treated by palpating the same trigger point described in the INIT group, followed by application of light pressure at the location of the trigger point, which was maintained the pressure for 2 minutes or until the pain subsided (determined by asking the participant to report a pain score using a visual analog scale at 30 second intervals). For both groups, three repetitions of the INIT or PRT treatment were performed over 10 minutes at each clinical visit. Additionally, each group also received stretching exercises immediately after the INIT or PRT treatment session. Each participant was assessed at baseline, immediately posttreatment, and at 4 months posttreatment for pain, sciatica, functional mobility, quality of life, hip abduction, and internal rotation. A repeated measures analysis of variance (ANOVA) of within-between group interactions was used to analyze the treatment effect. Results Forty eight participants (age range, 25–47 years; mean age ± standard deviation, 32.81 ± 3.27 years) were randomized into the INIT and PRT groups, with 24 participants in each group. No significant between-group differences (p>0.05) were observed in the baseline demographic and clinical variables of the participants. A repeated-measures ANOVA indicated that there was a significant time effect for all outcomes, with a significant interaction between time and intervention (p<0.001). The Bonferroni post hoc analyses of time and intervention effects indicated that the INIT group improved significantly compared with the PRT group in all outcomes (p<0.05) immediately posttreatment and at the 4 months follow up period. Conclusions INIT was more effective than PRT in the management of individuals with PS. It should be noted the significant improvement achieved in both the groups may have also been contributed to by the stretching exercises that were used as adjunct therapies by both groups.

Context Tocilizumab (TCZ), an interleukin-6 (IL-6) receptor antagonist, has been approved for use in rheumatoid arthritis and cytokine storm syndrome (CSS) associated with chimeric antigen receptor T cells treatment. Although TCZ is currently utilized in the treatment of critically ill coronavirus 2019 (COVID-19) patients, data on survival impact is minimal. Objectives To assess the mortality rate of patients presenting with COVID-19 who received TCZ for suspected CSS. Methods This retrospective cohort study was conducted at Henry Ford Health System between March 10, 2020 and May 18, 2020. Data collection began in May 2020 and was completed in June 2020. Patients included in the study required hospital admission and had positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction on nasopharyngeal swab. Eligibility criteria to receive TCZ, per hospital protocol, included any of the following: persistent fever, defined as 38.0 °C for at least 6 hours; a diagnosis of the acute respiratory distress syndrome (ARDS); serum ferritin ≥1,000 (ng/mL) or doubling within 24 hours; D-Dimer ≥ 5 (mg/L); serum lactate dehydrogenase ≥500 (IU/L); or interlukin-6 level ≥5 times the upper limit of normal. Dosing was initially determined by weight, then changed to a fixed 400 mg per hospital protocol. A comparator cohort was created from patients with COVID-19 and ARDS who did not receive TCZ. Patient survival was analyzed using the Kaplan–Meier method and compared by log rank test. A multivariable cox regression was applied to evaluate the association between TCZ and mortality. Results One hundred and thirty patients were evaluated in the study, 54 (41.5%) of whom received TCZ. Patients who received TCZ were younger (mean age, 63.8 vs. 69.4 years; p=0.0083) and had higher body mass indices (mean, 33.9 vs. 30.4; p=0.005). Of the comorbid conditions evaluated, heart disease was more common in the comparator group than the TCZ group (27 patients [35.5%] vs. 10 patients [18.5%]; p=0.034). A Kaplan–Meier survival curve demonstrated no difference in survival between TCZ and comparator patients (log rank p=0.495). In the multivariable Cox regression model for mortality at 30 days, treatment with TCZ was not associated with decreased mortality (hazard ratio, 1.1; 95% confidence interval, 0.53–2.3; p=0.77). Lower mean C-reactive protein (CRP) levels were demonstrated within 48 hours of disposition in the TCZ group (mean TCZ, 4.9 vs. mean comparator, 13.0; p=<0.0001). Conclusions In this cohort study, no difference in survival was observed in critically ill patients treated with TCZ.