Development of an Expectations Survey for Patients Undergoing Foot and Ankle Surgery

2016 ◽  
Vol 37 (12) ◽  
pp. 1277-1284 ◽  
Author(s):  
Elizabeth A. Cody ◽  
Carol A. Mancuso ◽  
Aoife MacMahon ◽  
Anca Marinescu ◽  
Jayme C. Burket ◽  
...  

Background: Many authors have reported on patient satisfaction from foot and ankle surgery, but rarely on expectations, which may vary widely between patients and strongly affect satisfaction. In this study, we aimed to develop a patient-derived survey on expectations from foot and ankle surgery. Methods: We developed and tested our survey using a 3-phase process. Patients with a wide spectrum of foot and ankle diagnoses were enrolled. In phase 1, patients were interviewed preoperatively with open-ended questions about their expectations from surgery. Major concepts were grouped into categories that were used to form a draft survey. In phase 2, the survey was administered to preoperative patients on 2 occasions to establish test-retest reliability. In phase 3, the final survey items were selected based on weighted kappa values for response concordance and clinical relevance. Results: In phase 1, 94 preoperative patients volunteered 655 expectations. Twenty-nine representative categories were discerned by qualitative analysis and became the draft survey. In phase 2, another 60 patients completed the draft survey twice preoperatively. In phase 3, 23 items were retained for the final survey. For retained items, the average weighted kappa value was 0.54. An overall score was calculated based on the amount of improvement expected for each item on the survey and ranged from zero to 100, with higher scores indicating more expectations. For patients in phase 2, mean scores for both administrations were 65 and 66 and approximated normal distributions. The intraclass correlation coefficient between scores was 0.78. Conclusion: We developed a patient-derived survey specific to foot and ankle surgery that is valid, reliable, applicable to diverse diagnoses, and includes physical and psychological expectations. The survey generates an overall score that is easy to calculate and interpret, and thus offers a practical and comprehensive way to record patients’ expectations. We believe this survey may be used preoperatively by surgeons to help guide patients’ expectations and facilitate shared decision making. Level of Evidence: Level II, cross-sectional study.

2017 ◽  
Vol 26 (6) ◽  
Author(s):  
Bryan L. Riemann ◽  
Kelsey Piersol ◽  
George J. Davies

Context: Single leg balance testing is a commonly used tool in sports medicine; however, there has been no consensus on trial duration needed to obtain reliable measures. Objective: This investigation sought to determine the minimum trial duration required to obtain the highest intrasession single and average trial reliability for single leg balance testing on stable and unstable surfaces using dominant and nondominant limbs. Design: Intrasession reliability.Setting:Biomechanics laboratory. Participants: 70 healthy (35 men, 35 women), physically active young adults aged 22.8 ± 2.8 y divided into 3 subgroups (n = 10, 30, 30) across a 3-phase study. Methods:3 phases of single leg balance testing were performed. For phase 1, the duration of time each participant could maintain posture on each limb/surface were computed. Phase 2 considered performance for 6 cumulative time intervals (5s, 10s, 15s, 20s, 25s, 30s). Phase 3 served to solidify results of phase 2 by computing reliability of 15s trials. Main outcome measures: Overall stability index of the center of pressure and platform tilt. Results: Intraclass correlation coefficients for phase 2 ranged from .74 (5s interval for nondominant limb on unstable surface) to .94 (20s interval for nondominant limb on stable surface). Phase 3 intraclass correlation coefficients ranged from .66 to .78 for single trial and .85 to .92 for 3 trial average with coefficients of variation ranging from 23.9% to 40.4% for single trial and 13.8% to 23.0% for 3 trial average. Conclusions:These results ultimately suggest 15s as the optimal trial duration to provide reliable measures while reducing compensatory event occurrence.


2017 ◽  
Vol 38 (5) ◽  
pp. 472-478 ◽  
Author(s):  
Elizabeth A. Cody ◽  
Carol A. Mancuso ◽  
Jayme C. Burket ◽  
Anca Marinescu ◽  
Aoife MacMahon ◽  
...  

Background: Few authors have investigated patients’ expectations from foot and ankle surgery. In this study, we aimed to examine relationships between patients’ preoperative expectations and their demographic and clinical characteristics. We hypothesized that patients with more disability and those with anxiety or depressive symptoms would have greater expectations. Methods: All adult patients scheduled for elective foot or ankle surgery by 1 of 6 orthopaedic foot and ankle surgeons were screened for inclusion over 8 months. Preoperatively, all patients completed the Hospital for Special Surgery Foot & Ankle Surgery Expectations Survey in addition to the Foot & Ankle Outcome Score (FAOS), Short Form (SF)–12, Patient Health Questionnaire (PHQ)–8, Generalized Anxiety Disorder 7-item scale (GAD-7), and pain visual analog scale (VAS). The expectations survey contained 23 expectations categories, each with 5 answer choices ranging from “I do not have this expectation” to “complete improvement” expected. It was scored from 0 to 100, with higher scores indicating more expectations. Differences in expectations relating to numerous patient demographic and clinical variables were assessed. In total, 352 patients with an average age of 55 ± 15 (range, 18-86) years were enrolled. Results: Expectations scores were not related to age ( P = .36). On average, women expected to achieve complete improvement more often than men ( P = .011). Variables that were significantly associated with higher expectations scores ( P < .05) included nonwhite race, use of a cane or other assistive device, and greater medical comorbidity. Worse function and quality of life (as assessed by all FAOS subscales and the SF-12 physical and mental components), more depressive and anxiety symptoms, and higher pain VAS scores were associated with higher expectations scores and more expectations ( P < .01 for all). Conclusions: The results of this study may help inform surgeons’ preoperative discussions with their patients regarding realistic expectations from surgery. Generally, patients with worse function and more disability had higher expectations from surgery. Addressing these patients’ expectations preoperatively may help improve their ultimate satisfaction with surgery. Level of Evidence: Level II, cross sectional study.


Author(s):  
Muhammad Imran Nisar ◽  
Nadia Ansari ◽  
Farah Khalid ◽  
Mashal Amin ◽  
Hamna Shahbaz ◽  
...  

AbstractObjectiveTo determine population-based estimates of COVID-19 in a densely populated urban community of Karachi, Pakistan.MethodsThree cross-sectional surveys were conducted in April, June and August in low- and high-transmission neighborhoods of Karachi. Participants were randomly selected to provide blood for Elecsys® immunoassay for detection of anti-SARS-CoV-2 antibodies. Bayesian regression model was used to estimate seroprevalence after adjusting for the demographic characteristics of each district. Conditional Risk of Infection (CRI) with 95% confidence interval was calculated using a non-parametric bootstrap of households. Infection fatality rates (IFR) were estimated.ResultsWe enrolled 3005 participants from 623 households. In Phase 2, the adjusted seroprevalence was estimated as 8.7% (95% CI 5.1-13.1) and 15.1% (95% CI 9.4 -21.7) in low and high transmission areas respectively, compared to 0.2% (95% CI 0-0.7) and 0.4% (95% CI 0 - 1.3) in Phase 1. In Phase 3, it was 12.8% (95% CI 8.3 – 17.7) and 21.5% (95% CI 15.6-28) in low and high transmission areas, respectively. CRI was 0.31 (95% CI 0.16-0.47) and 0.41(95% CI 0.28-0.52) in low and high transmission neighborhoods respectively in Phase 2. Similar trends were observed in Phase 3. Only 5.4% of participants who tested positive for COVID-19 were symptomatic. IFR was 1.66% in phase 1, 0.37% in Phase 2 and 0.26% in Phase 3.ConclusionInitial rapid increase in seroprevalence was followed by a plateau in the later phase of the pandemic in Karachi. Continuing rounds of seroprevalence studies have the potential to fully characterize the pandemic in this geography.


2017 ◽  
Vol 55 (1) ◽  
pp. 35-44 ◽  
Author(s):  
Rebecka Ahl ◽  
Anne Harding-Bell

Background: Development of the speech audit tool Cleft Audit Protocol for Speech Augmented (CAPS-A) facilitated intercenter comparison of speech outcomes following cleft palate repair. The CAPS-A protocol recommends consensus listening by 3 speech and language therapists, 2 of whom must be CAPS-A trained. Allowing 15 minutes per sample, 15 to 20 samples can be assessed each day. Centers typically have resources to audit 15 to 75 samples per year but not to report speech outcomes of larger data sets for research. This 3-phased outcome study examines how the implementation of the CAPS-A protocol might be modified without compromising reliability. Methodology: In phase 1, 2 external listeners independently rated 42 speech samples; in phase 2, 2 external listeners consensus listened 25% of 140 samples before 1 listener independently rated the remainder; phase 3 compared 124 Great Ormond Street Speech Assessment (GOS.SP.ASS’98) records from live assessments with CAPS-A-rated video samples. Results: Hypernasality, nasal airflow, and passive cleft speech characteristics were rated to identify signs of velopharyngeal dysfunction across all phases. Phase 1 demonstrated suboptimal correlation, intraclass correlation coefficient (ICC) ranging between 0.39 and 0.72. However, the “modified” CAPS-A consensus listening process in phase 2 achieved a mean ICC of 0.91. Phase 3 revealed only moderate agreement between GOS.SP.ASS’98 and CAPS-A. Conclusion: A large data set of speech samples was successfully managed by establishing good interrater reliability on 25% of the data, which calibrated the listeners and validated a decision for only 1 of 2 listeners to rate the remaining speech samples. The recommended implementation of the CAPS-A protocol can therefore be modified for more efficient speech outcome reporting.


2013 ◽  
Vol 5 (1) ◽  
Author(s):  
Abdul Hasan Saragih

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.


2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?


2020 ◽  
Vol 98 (Supplement_3) ◽  
pp. 196-197
Author(s):  
Woo Jung Seok ◽  
Je min Ahn ◽  
Jing Hu ◽  
Dexin Dang ◽  
Yanjiao Li ◽  
...  

Abstract The objective of this study was to evaluate the effects of dietary supplementation of coated omega-3 fatty acid (n-3 CFA) by corn cob power silica on performance of weaning pigs. A total of 200 weaned pigs [(Landrace x Yorkshire) x Duroc, average initial body weight at 6.97 ± 1.22 kg] were randomly assigned to four experimental treatments in a 6-week experiment in 3 phases as follows: CON, basal diet; 2) 0.3CFA, CON + phase 1(0.3% n-3CFA), phase 2(0.2% n-3CFA), phase 3(0.1% n-3CFA); 3) 0.6CFA, CON + phase 1(0.6% n-3CFA), phase 2(0.4% n-3CFA), phase 3(0.2% n-3CFA); 4) 0.9CFA, CON + phase 1(0.9% n-3CFA), phase 2(0.6% n-3CFA), phase 3 (0.3% n-3CFA). Each treatment had 10 replicates with 5 pigs (three gilts and two barrows) per replicate. The data were analyzed using the GLM procedure of SAS as a randomized complete block design. Pen served as the experimental unit. Linear, quadratic and cubic polynomial contrasts were used to examine effect of dietary treatment with coated n-3FA in the basal diet. Variability in the data was expressed as the standard error of means and P&lt; 0.05 was considered to statistically significant. Increasing the level of n-3CFA in the diet linearly increased ADG and G/F of pigs (Table 1). Increasing the level of n-3CFA showed a linear increment in the digestibility of DM (83.59, 84.38, 85.13, 85.89 %) whereas nitrogen digestibility (81.79, 82.38, 82.96, 83.64 %) showed a trend (linear effect, p=0.0594) at the end of experiment. The fecal lactobacillus count was increased (7.22, 7.27, 7.33, 7.35 log10cfu/g) with the increase in the supplemental level of n-3CFA (linear effect; p&lt; 0.05). However, there were no differences in the concentration of serum haptoglobin, or fecal E. coli, Clostridium and Salmonella counts despite the increase in n-3CFA levels in the diet. Supplementation of the diet with coated n-3 fatty acids positively affected growth performance and digestibility of dry matter and nitrogen, and enhanced the count of lactobacillus in weaning pigs.


Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 759
Author(s):  
Vetriselvi Sampath ◽  
Dong Heon Baek ◽  
Sureshkumar Shanmugam ◽  
In Ho Kim

This experiment was performed to examine the hypothesis that blood plasma (BP) with yeast (Saccharomyces cerevisiae) supplement in the diet of weaning pigs could provoke the growth performance, nutrient digestibility, fecal microbial, and reduce harmful gas excretion. A total of one hundred and eighty healthy piglets were taken and assigned (complete random blocks) to three dietary treatments as: Phase 1: Treatment (TRT) 1-6% BP; TRT 2-3% BP + 3% yeast; TRT 3-6% yeast. Phase 2: TRT 1-3%; BP., TRT 2-1.5% BP + 1.5% yeast; TRT 3- 3% yeast. Phase 3: TRT 1- Control (CON) (Basal diet); TRT 2- CON; TRT 3- CON for six- weeks. Each treatment had twelve replicates and five (three gilts and two barrows) pigs per pen. Dietary inclusion of BP with yeast supplementation significantly increased the body weight of piglets during phase 2 (p = 0.003) and phase 3 (p = 0.032). In addition, TRT2 group piglets had a significant improvement in average daily gain at the end of each phase and overall (p = 0.047, 0.025, 0.018 and 0.012, respectively). At phase 3, TRT2 group piglets showed a significant improvement on nutrient digestibility of dry matter (p = 0.012) and nitrogen (p = 0.040). The fecal microbiota of TRT2 group piglets showed a tendency to increase the number of Lactobacillus counts at phase 1 (p = 0.07) and phase 2 (p = 0.06) as well as, a significant improvement at phase 3 (p = 0.021). In addition, TRT2 group piglets had trend to decrease NH3 (p = 0.074) and H2S (p = 0.069) during phase 2, and significantly reduced NH3 (p = 0.038) and H2S (p = 0.046) at phase 3. However, the fecal score of piglets remains unaffected during the entire trial. At the end of phase 1 piglets’ IgG (p = 0.008) was significantly increased with the inclusion of BP with yeast supplementation. Based on the positive effects on body weight, average daily gain, nutrient digestibility, Lactobacillus count, and reduced gas emission, we suggest that dietary supplement with BP and yeast in the diet of weaned piglet could serve as an excellent alternative to antibiotics growth promoters.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Hasan Banitalebi ◽  
Christian Owesen ◽  
Asbjørn Årøen ◽  
Hang Thi Tran ◽  
Tor Åge Myklebust ◽  
...  

Abstract Purpose To evaluate the effect of imaging plane and experience of observers on the reliability of T2 mapping of native and repair cartilage tissue of the knee. Methods Fifteen consecutive patients from two randomised controlled trials (RCTs) were included in this cross-sectional study. Patients with an isolated knee cartilage lesion were randomised to receive either debridement or microfracture (RCT 1) or debridement or autologous chondrocyte implantation (RCT 2). T2 mapping was performed in coronal and sagittal planes two years postoperatively. A musculoskeletal radiologist, a resident of radiology and two orthopaedic surgeons measured the T2 values independently. Intraclass Correlation Coefficient (ICC) with 95% Confidence Intervals was used to calculate the inter- and intraobserver agreement. Results Mean age for the patients was 36.8 ± 11 years, 8 (53%) were men. The overall interobserver agreement varied from poor to good with ICCs in the range of 0.27– 0.76 for native cartilage and 0.00 – 0.90 for repair tissue. The lowest agreement was achieved for evaluations of repair cartilage tissue. The estimated ICCs suggested higher inter- and intraobserver agreement for radiologists. On medial femoral condyles, T2 values were higher for native cartilage on coronal images (p < 0.001) and for repair tissue on sagittal images (p < 0.001). Conclusions The reliability of T2 mapping of articular cartilage is influenced by the imaging plane and the experience of the observers. This influence may be more profound for repair cartilage tissue. This is important to consider when using T2 mapping to measure outcomes after cartilage repair surgery. Trial registration ClinicalTrials.gov, NCT02637505 and NCT02636881, registered December 2015. Level of evidence II, based on prospective data from two RCTs.


2018 ◽  
Vol 40 (1) ◽  
pp. 98-104 ◽  
Author(s):  
Johanna Marie Richey ◽  
Miranda Lucia Ritterman Weintraub ◽  
John M. Schuberth

Background: The incidence rate of venous thrombotic events (VTEs) following foot and ankle surgery is low. Currently, there is no consensus regarding postoperative prophylaxis or evidence to support risk stratification. Methods: A 2-part study assessing the incidence and factors for the development of VTE was conducted: (1) a retrospective observational cohort study of 22 486 adults to calculate the overall incidence following foot and/or ankle surgery from January 2008 to May 2011 and (2) a retrospective matched case-control study to identify risk factors for development of VTE postsurgery. One control per VTE case matched on age and sex was randomly selected from the remaining patients. Results: The overall incidence of VTE was 0.9%. Predictive risk factors in bivariate analyses included obesity, history of VTE, history of trauma, use of hormonal replacement or oral contraception therapy, anatomic location of surgery, procedure duration 60 minutes or more, general anesthesia, postoperative nonweightbearing immobilization greater than 2 weeks, and use of anticoagulation. When significant variables from bivariate analyses were placed into the multivariable regression model, 4 remained statistically significant: adjusted odds ratio (aOR) for obesity, 6.1; history of VTE, 15.7; use of hormone replacement therapy, 8.9; and postoperative nonweightbearing immobilization greater than 2 weeks, 9.0. The risk of VTE increased significantly with 3 or more risk factors ( P = .001). Conclusion: The overall low incidence of VTE following foot and ankle surgery does not support routine prophylaxis for all patients. Among patients with 3 or more risk factors, the use of chemoprophylaxis may be warranted. Level of Evidence: Level III, retrospective case series.


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