Improvement In Subjective Outcomes Research Articles

Student advanced trauma management and skills (SATMAS): a validation study

IntroductionDespite trauma accounting 9% of global mortality, it has been demonstrated that undergraduate trauma teaching is inadequate nationally and worldwide. With COVID-19 exacerbating this situation, a scalable, accessible, and cost-effective undergraduate trauma teaching is required.MethodsOur Continual Professional Development United Kingdom (CPUDK)-accredited University Hospitals Birmingham (UHB) Major Trauma Service (MTS) affiliated programme consisted of seven biweekly pre-recorded sessions that were delivered online through the Moodle educational platform to University of Birmingham students. Pre- and post-randomised session-specific multiple-choice questions (MCQs) and anonymous feedback forms were administered.ResultsThere were 489 student responses, with 63 students completing all seven sessions. On an 8-point scale, students’ objective knowledge scores increased by a mean of 1.2 (p < 0.001). Using a 5-point Likert scale, students also showed improvement in subjective outcomes including their confidence in assessing trauma patient (absolute difference (AD) 1.38, p < 0.001), advising initial investigations and formulating initial management plans (AD 1.78, p < 0.001) and thereby their confidence to manage a trauma patient overall (AD 1.98, p < 0.001). A total of 410 student responses endorsed the online delivery of SATMAS through Moodle and recommended SATMAS to future medical students.ConclusionSATMAS has demonstrated positive student feedback and extensive recruitment from only one centre, demonstrating that our programme can be an indispensable low-cost learning resource that prepares undergraduate medical students for their trauma exams and informs the implementation of clinical skills required by all doctors. We publish our pilot study findings to encourage similar teaching programmes to be adopted at other universities nationally and internationally, to synergistically benefit students, tutors, and ultimately patients, on a larger scale.

Placebo effect in randomized controlled trials for Meniere's disease: A meta-analysis

PurposeMeniere's Disease is a condition known for its recurrent vertigo, fluctuating sensorineural hearing loss, aural fullness, and tinnitus. Previous studies have demonstrated significant influence of placebo treatments. Our objective was to quantify the magnitude of the placebo effect in randomized controlled trials for Meniere's Disease. Materials and methodsA systematic review was performed by searching PubMed, SCOPUS, CINAHL, and Cochrane databases from inception through September 27, 2022. Data extraction, quality rating, and risk of bias assessment were performed by two independent reviewers. A meta-analysis of mean differences with 95 % confidence interval, weighted summary proportions, and proportion differences were calculated using random and fixed effects models. ResultsA total of 15 studies (N = 892) were included in the review. Significant improvement was seen in the functional level scores of the pooled placebo groups, with a mean difference of −0.6 points, (95%CI: −1.2 to −0.1). There was no difference in pure tone audiometry, speech discrimination score, or vertigo frequency at 1 and 3 months for the placebo group. Patient-reported vertigo episodes were improved in 52.5 % (95%CI: 39.2 to 65.5) of the placebo group and was significantly less than the pooled experimental group (90.1 %, 95%CI: 39.2 to 65.5, p < 0.001). ConclusionsThe placebo effect in Meniere's Disease trials is associated with some symptomatic improvement in subjective outcomes, such as patient reported vertigo episodes. However, the clinical significance is questionable across other outcomes measures, especially when analyzing objective data. The extent and strength of the placebo effect continues to be a hurdle in the search for better treatment options.

Outcomes of Therapy and Ulnar Nerve Transposition for Elbow Stiffness After Pediatric Medial Epicondyle Fractures

Following medial epicondyle fractures, a subset of pediatric patients has persistent limitations in elbow motion. This study soughted to understand the patient characteristics of this group and to assess the effectiveness of intensive therapy and ulnar nerve transposition in improving elbow range of motion and patient-reported outcomes. A cohort of 31 pediatric patients with stiffness after elbow trauma was narrowed to 8 pediatric patients (7 female) ranging in age from 9 to 14 years, who were diagnosed with medial epicondyle fractures and underwent intensive therapy and ulnar nerve transposition with or without elbow joint release. We collected demographic and objective data as well as subjective data including Patient-Reported Outcome Measurement Information System (PROMIS) scores before and after ulnar nerve transposition. Following initial intensive therapy, elbow range of motion improved by an average of 56°, and 7 of the 8 patients reached a functional motion arc of 100°. Subsequently, following ulnar nerve surgery with or without elbow release, motion improved by an average of 22°, and 5 of the 8 patients demonstrated improvement from this intervention. Surgery led to improvements in subjective outcomes with an improvement in PROMIS mobility scores by an average of 9 points, pain interference by 6 points, and upper extremity scores by 3 points. Based on a previously determined minimally important difference of three points, these indicate significant clinical improvements. A subset of pediatric patients with persistent stiffness following medial epicondyle fractures may benefit from additional interventions, including intensive therapy, transposition of the ulnar nerve, and open capsular release. However, not all patients were improved after ulnar nerve surgery, and the identification and treatment of ulnar nerve irritability may not fully resolve preoperative symptoms in all patients. Therapeutic IV.

Outcomes of Gender-Affirming Voice and Communication Modification for Transgender Individuals.

Transgender individuals' voices are closely related to gender identity. A primary goal of gender-affirming voice modification is to help individuals alter their voices to improve gender congruence; however, there is a paucity of research to support this approach. This study aimed to evaluate the outcomes of a 12-week gender-affirming voice and communication modification program. Retrospective cohort study. A retrospective consecutive case series of transgender women enrolled in a voice and communication modification program was performed. Demographics, Trans Woman Voice Questionnaire (TWVQ), fundamental frequency (F0 ), and frequency range were collected before and after the program. A Wilcoxon signed-rank test assessed changes in outcomes. Spearman's rank-order correlation coefficients quantified associations between self-reported outcomes and acoustic measures. A total of 16 trans women individuals were enrolled. The mean age was 31.5 years. After program completion, TWVQ improved 20.4 points, F0 increased 26.5Hz (spontaneous speech) and 25.7Hz (reading), and the range increased 24.7Hz (spontaneous speech) and 0.1Hz (reading). None of the changes in acoustic measures significantly correlated with improvement in TWVQ scores in the cohort. Trans women experience improvements in self-reported outcomes and changes in acoustic measures after completing a gender-affirming voice and communication modification program. Individuals may experience significant improvement in subjective outcomes despite small changes in acoustic measures and vice versa. 4 (case series) Laryngoscope, 132:1615-1621, 2022.

Clinical Characteristics and Outcomes After Primary ACL Reconstruction and Meniscus Ramp Repair

Background:Satisfactory outcomes have been reported after all-inside meniscus ramp repair with combined anterior cruciate ligament reconstruction (ACLR). However, clinical outcomes after ACLR with inside-out meniscus ramp repair are limited.Purpose/Hypothesis:The purpose of this study was to evaluate patient-reported outcomes for patients who underwent ACLR and medial meniscus ramp repair compared with those who underwent isolated ACLR; patients in the 2 groups were matched for age, sex, and sport/activity. The null hypothesis was that there would be no significant differences in clinical outcomes between groups at a minimum of 2 years postoperatively.Study Design:Cohort study; Level of evidence 3.Methods:Patients who underwent primary ACLR with bone–patellar tendon–bone (BPTB) autograft by a single surgeon were retrospectively identified. A subgroup of patients with combined ACLR and meniscus ramp repair with a minimum 2-year postoperative follow-up were matched to a cohort who underwent isolated ACLR. Subjective patient-reported questionnaires, knee stability, and return to level of activity/sport were collected.Results:There were 851 patients who underwent primary ACLR; of these, 158 (18.6%) had medial meniscus ramp lesions confirmed at arthroscopy. The most common clinical characteristics in patients with ramp lesions were chronic injuries (68.4%), contact mechanism (88%), concomitant lateral meniscus tears (63.2%), and concomitant lateral meniscus posterior root tears (22.2%). Further, 50 patients who underwent combined ACLR and meniscus ramp repair with minimum 2-year follow-up were matched to patients who underwent isolated ACLR. Both groups reported significant improvements in subjective outcomes from preoperative to postoperative assessments (P < .001). No significant differences were found in postoperative outcomes for combined ACLR with ramp repair versus isolated ACLR (P > .05). Patients with meniscus ramp repair had increased preoperative knee laxity demonstrated by grade 3 Lachman (44% vs 6%) and pivot-shift (38% vs 12%) test results compared with patients who underwent isolated ACLR (P ≤ .005 for both).Conclusion:This study demonstrates similar clinical outcomes, knee stability on postoperative physical examination, and return-to-sport rates for patients who underwent combined ACLR with BPTB autograft and inside-out meniscus ramp repair versus a matched cohort who underwent isolated ACLR. Clinicians should have a high index of suspicion for the presence of ramp lesions in patients with ACL tears who have a contact mechanism of injury, grade 3 Lachman test result, and concomitant lateral meniscal abnormality.

Validation of Catquest-9SF in Danish: developing a revised form of the Catquest-9SF - the Danish Catquest-7SF.

The primary goal was to validate a Danish translated version of the Catquest-9SF by Rasch analysis. The secondary goal was to investigate whether preoperative Catquest-9SF scores, best-corrected visual acuity, comorbidity, gender, age or corneal astigmatism could predict improvements in subjective outcome. In a prospective trial, 250 patients eligible for cataract surgery were included. Patients filled out the translated Catquest-9SF questionnaire before surgery and again 3months after surgery. Both preoperative and postoperative questionnaires were included in the Rasch analysis. A multiple reverse stepwise regression model was used to investigate the correlation between preoperative measurements and subjective improvement. The preliminary Rasch analysis showed misfit of items 4 and 6. These items were removed, and the remaining seven items demonstrated a measurement precision of 2.78, a person reliability coefficient of 0.89, ordered response categories, infit of 0.69-1.22, outfit of 0.73-1.14, observed raw variance explained by measures of 70.4% and an eigenvalue of 1.7. Item 7 showed a mild DIF for gender (0.54 logits), and person mean Rasch score targeting was -1.69 logits. Preoperative Catquest score was the only parameter with a significant correlation to a gain in subjective outcome (p<0.001). A preoperative Catquest-9SF score of 0.5 carried a 95% likelihood of an increase in subjective outcome. The Danish version of the Catquest-9SF fit the Rasch model. Only preoperative Catquest-9SF score was correlated to subjective improvement, and a cut-off value of 0.5 predicted an improvement in subjective outcome with 95% probability.

Use of Allogenic Mesenchymal Cellular Bone Matrix in Anterior and Posterior Cervical Spinal Fusion: A Case Series of 21 Patients.

Study DesignRetrospective case series.PurposeTo report our early experience using allogenic mesenchymal cellular bone matrix (CBM) products in cervical spine fusion.Overview of LiteratureMulti-level cervical fusions have historically yielded lower fusion rates than single level fusions, especially in patients with high risk medical comorbidities. At this time, significant literature in cervical fusion outcomes with this cellular allograft technology is lacking.MethodsTwenty-one patients underwent either multilevel (3 or 4 level) anterior cervical discectomy and fusion, anterior cervical corpectomy and fusion, or posterior cervical fusion. ViviGen (DePuy Synthes Spine, Raynham, MA, USA), an allogenic bone matrix product, was used in addition to standard instrumentation. Radiographic evaluation was performed at 2 weeks, 12 weeks, 24 weeks and 1 year postoperative. Visual analog scale (VAS) and neck disability index (NDI) scores along with return to work and leisure activity were recorded.ResultsAt 6 months postoperative, all patients had radiographic evidence of bone fusion regardless of age or medical comorbidities. All patients reported subjective improvement with a mean decrease in VAS from 8.3 to 1.5 and a mean decrease in NDI from 40.3% to 6.0% at 1 year. All patients also returned to work and/or regular leisure activity within 3 months.ConclusionsTwenty-one patients undergoing high-risk anterior and posterior cervical spine fusion, with the use of a commercially available mesenchymal CBM product, went on to radiographic fusion and all had improvement in subjective outcomes. While further effort and research is needed to validate its widespread use, this study shows favorable use of CBM in cervical fusion for high-risk cases.

Both isolated and multi-ligament posterior cruciate ligament reconstruction results in improved subjective outcome: results from the Danish Knee Ligament Reconstruction Registry.

There are few descriptions of outcomes after posterior cruciate ligament (PCL) reconstruction in the literature due to the rarity of this type of knee injury. Since 2005, the Danish Knee Ligament Reconstruction Registry (DKRR) has monitored outcomes of PCL reconstructions. This study describes the epidemiology of PCL reconstruction and subsequent outcomes in a Danish population. Of 23,253 knee ligament reconstructions performed in 2005-2015, 581 were registered as PCL reconstructions in the DKRR. The types of reconstruction were classified as isolated (n=237) or multi-ligament (n=344), and the cause of injury and concomitant meniscus and cartilage injury data were extracted. The outcome at 1-year follow-up was based on the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Tegner activity level. The outcome data were compared with data on 21.820 primary anterior cruciate ligament (ACL) reconstructions. Isolated PCL reconstruction was performed in 43% of cases. Meniscus lesions and cartilage lesions were seen in 19 and 15% of cases, respectively. The main causes of PCL injuries were sports (43%) and traffic accidents (33%). The KOOS improved from pre-operative to 1-year follow-up for both isolated PCL reconstructions and multi-ligament PCL reconstructions but did not reach the levels of those recorded in ACL reconstructions. Multi-ligament reconstructions showed the highest improvement in KOOS. The Tegner activity levels for isolated and multi-ligament PCL reconstructions were 4 (0-7) and 4 (0-8), respectively. PCL reconstructions represented only 2.6% of all knee ligament reconstructions in Denmark. Sports and traffic accidents were the main causes of injury. Meniscus and cartilage injuries were less frequent in PCL injuries as compared to ACL injuries. Isolated PCL and multi-ligament PCL reconstructions showed significant improvements in subjective outcomes but did not reach those observed in ACL reconstructions. Patients should be counselled about expected outcomes after PCL reconstruction. III.

Sham surgical procedures for pain intervention result in significant improvements in pain: systematic review and meta-analysis

ObjectiveTo perform a systematic review and meta-analysis to study the magnitude of the placebo effect associated with sham surgery procedures. Study Design and SettingWe conducted a systematic search for randomized controlled clinical trials comparing any type of surgery to a corresponding sham placebo group and compared improvements in the sham treatment arms in subjective, objective, categorical, and continuous outcomes, as well as complication rates and mortality. Effect sizes were reported as standardized mean differences (SMDs). This is a systematic review and meta-analysis. ResultsThe overall effect size for pain improvement after sham surgery was SMD = 0.22 (95% confidence interval [CI] = 0.08–0.35) with improvement most marked at 1 month (SMD = 0.34, 95% CI = 0.26–0.43). There was a higher rate of improvement in subjective outcomes compared to objective outcomes for both dichotomized (number of patients with improvement) (42.8% compared to 27.1%) and continuous outcomes (SMD = 0.12, 95% CI = −0.05, 0.30 vs. SMD = −0.01, 95% CI = −0.05, 0.03). There were no deaths in the sham treatment arms and major complications were very rare (0.2%, 95% CI = 0.0–0.6%). ConclusionSham surgery is associated with a large improvement in pain and other subjective patient-reported outcomes but with relatively small effect on objective outcomes. Sham surgeries are overwhelmingly safe. The magnitude of this effect should be used when planning future sham-controlled surgery trials.

Fat Grafting for Neuropathic Pain After Severe Burns.

Chronic neuropathic pain after burn injury is a significant problem that affects up to 29% of burn patients. Neuropathic burn scar pain is a challenge for plastic and burn surgeons, who have limited solutions. Fat grafting, with its mechanical and regenerative qualities, can improve neuropathic pain from various traumatic and postsurgical etiologies, but its effectiveness in neuropathic burn scar pain has yet to be demonstrated. In this study, the possible role of lipotransfer in treating neuropathic burn scar pain is explored, focusing on safety, graft take, and short-term efficacy. We performed an institutional review board-approved, retrospective case review of 7 patients with chronic, refractory neuropathic pain, who underwent fat grafting to burn scars. These patients had failed conventional therapy, which included pharmacologic, medical, and laser treatment of the burn scars. Each patient had 2 sessions of fat grafting, spaced 2 months apart. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to assess pain perception, with patients answering the questionnaire before and after fat grafting, to assess subjective outcomes. Six of 7 patients had improvement in neuropathic pain after fat grafting, permitting reduction in their neuropharmacologic regimen. Tinel sign, present in all patients preoperatively, was absent on examination in all patients at follow-up. Three of the 5 patients who completed PROMIS questionnaires had PROMIS scores indicating improvement in pain by 1-year follow-up. One patient had similar preoperative and postoperative PROMIS scores, and 1 patient had an increase in pain at follow-up; however, he had suffered an additional burn to the same extremity. Analysis of pooled mean PROMIS scores reflects a statistically significant improvement in subjective outcomes by 1-year follow-up. Donor-site seroma in 1 patient was the only complication, with no cases of infection, wound breakdown, or graft loss. Adipose tissue can be safely grafted into burn scars and may improve symptoms in patients with refractory neuropathic pain after burn injury. Further translational and clinical research is necessary to elucidate mechanisms of action, indications, optimal type of transfer, and long-term effectiveness.

Arthroscopic partial shoulder resurfacing.

The purpose of this study was to report patients' clinical and subjective outcomes 2 years after arthroscopic-assisted partial resurfacing of the humeral head. In this prospective case series, 11 patients (4 females, 7 males; median age, 59 years; range 47-72) underwent arthroscopic-assisted partial shoulder resurfacing between April 2010 and March 2011. Clinical conditions and subjective assessments were evaluated before surgery and at 6 weeks, 3 and 6 months, and then annually after surgery using the Constant score (CS), active range of motion (ROM), the visual analogue scale (VAS) for pain, the American Shoulder and Elbow Surgeons scale (ASES), and the subjective shoulder value (SSV). Radiological outcomes and major complications were monitored. The mean CS improved significantly from 54.6 ± 13.6 preoperatively to 72.9 ± 17.2 points 6 weeks postoperatively (P = 0.009). At the 2-year follow-up, the mean CS had further increased to 86.5 ± 14.3 points (P < 0.001). Trends towards increasing ROMs were detected. VAS, ASES, and SSV significantly improved from baseline to the first follow-up and maintained improvement after 2 years. One patient required revision surgery owing to a technical failure and two patients because of rapidly progressive osteoarthritis. Ten of 11 patients (91 %) claimed that they would undergo arthroscopic partial shoulder resurfacing again. Arthroscopic-assisted partial humeral head resurfacing, which has the advantages of bone stock preservation and the maintenance of an intact subscapularis tendon, allowed immediate postoperative mobilization and provided significant improvements in subjective outcomes, especially for pain relief in active patients without severe glenoid cartilage wear. Therapeutic case series, Level IV.

Outcomes Using an Internal Osteotomy and Distraction Device for Corrective Osteotomy of Distal Radius Malunions Requiring Correction in Multiple Planes

Many different methods have been proposed for correction of distal radius malunions; however, precise correction of a severe malunion that requires simultaneous adjustment of displacement, angulation, and rotation in multiple planes is difficult. This prospective study measured radiographic and functional outcomes using an adjustable osteotomy, distraction, and fixation system for distal radius malunions that required correction in multiple planes. Five consecutive patients with symptomatic distal radius malunions requiring correction in multiple planes were recruited into this study. All patients had correction of the malunion with an adjustable osteotomy, distraction, and fixation device. Radiographic parameters and objective and subjective functional outcomes were measured before surgery and at 3 months, 6 months, and 1 year after surgery. All radiographic measurements improved after surgery. Grip strength, pinch strength, and the Jebsen-Taylor test showed only marginal improvement. Ulnar deviation of the wrist and forearm pronation-supination improved, but the wrist extension-flexion arc did not. The Michigan Hand Outcomes Questionnaire showed improvement in all domains, and significant improvement was seen in the overall, work, aesthetic, and satisfaction domains. The Michigan Hand Outcomes Questionnaire, however, also indicated a substantial amount of residual impairment in all domains, including activities of daily living and pain. Corrective osteotomy with the adjustable osteotomy, distraction, and fixation device resulted in improvement in distal radius anatomy and function. However, not all improvements were statistically significant, and anatomy and function did not returned to baseline levels. Despite residual disability, patients noted substantial improvement in subjective outcomes. This system is useful for improving anatomy and function in distal radius malunions that require correction in multiple planes, but patients should be informed that they cannot expect to regain normal anatomy or function. Therapeutic IV.