A case study on the implementation of quality and comprehensive indicators set in routine diabetes care.

INTRODUCTION: Type 2 diabetes is a major public health issue in Mexico due to its high prevalence and its projection for the coming years for this disease. Findings on multidisciplinary care related to chronic diseases have proven effective, based on measurement of patient-centered outcomes, The Center of Comprehensive Care for Patients with Diabetes (CAIPaDi) is a multidisciplinary program focused on reducing diabetes complications. This case study aims to illustrate the results of implementing health outcomes measurements and demonstrate the beneficial effects of establishing a comprehensive model of care through a patient-centered approach. METHODS: A descriptive analysis of the comprehensive care indicators of patients with type 2 diabetes treated in the CAIPaDi program between 2013 and 2023 was conducted. The results were structured according to the standard set of outcomes for diabetes proposed by the International Consortium for Health Outcomes Measurements (ICHOM). RESULTS: The baseline and prospective registration of consultations was completed for five years, complying with 25 of the 26 indicators of the ICHOM set. In diabetes control, 56.5% of patients had A1c ≤ 7%, 87.9% had BP ≤ 130/80 mmHg, 60.9% had LDL-cholesterol < 100 mg/dl, and obesity rates decreased from 42.19% to 30.6% during annual consultations. Fewer years of diagnosis before the first visit is key to overall improvement in program adherence (P = 0.02). In acute events, a hyperglycemic crisis occurred in only two cases and severe hypoglycemia episodes in 8 patients. For chronic complications, no lower limb amputations occurred. Cardiovascular outcomes occurred in < 1%. Periodontal disease was analyzed, and periodontitis decreased from 82.9% to 78.7%. Mortality reports were low, with COVID-19 being the main cause of death. Patient-reported outcomes demonstrated reductions in anxiety, depression, and diabetes distress during follow-up. CONCLUSION: Registering quality-of-care indicators is feasible in a comprehensive care program. It allows improving the medical, mental health, and lifestyle outcomes of patients with type 2 diabetes and provides relevant data for planning health programs. A quick diagnosis before program adherence is crucial for overall improvement in patients.

Cross-cultural adaptation and validation of the CFAbd-Score for gastrointestinal symptoms in patients with cystic fibrosis.

OBJECTIVE: Translating and cross-culturally adapting the CFAbd-Score, Cystic Fibrosis (CF) Abdominal Score, to use in Brazilian spoken Portuguese. The CFAbd-Score is a questionnaire for assessing CF-related abdominal symptoms and their influence on the quality of life (QoL). It comprises 28 questions on five domains: abdominal pain, bowel movements, eating and appetite, gastroesophageal reflux symptoms, and the impact of gastrointestinal (GI) symptoms on QoL. METHOD: Cross-cultural adaptation included assessment of conceptual and item equivalence, semantic, operational, and measurement equivalence. Content validity was assessed. The validation and psychometric analysis phase included 97 people with CF (pwCF), median age:14.58y (IQR 9/19), and 105 healthy individuals, 15.10y (IQR 9/20). Exploratory factor analysis (FA) identified retained factors. Internal consistency of the extracted domains was evaluated using Cronbach's α, and the Kaiser-Meyer-Olkin test (KMO) was used to check the sample adequacy. Bartlett's test tested the null hypothesis that the correlation matrix is an identity matrix. RESULTS: All items were considered relevant to the construct and good semantic equivalence of the version was recognized. FA showed the appropriate weight of all items and good internal consistency, with Cronbach's alpha 0.89. Bartlett's test significance level (p < 0.001) and KMO coefficient of 0.72 indicated good adequacy for structure. Internal consistency coefficients (Cronbach's alpha) were good for abdominal pain: 0.84; abdominal bloating: 0.73; flatulence: 0.76; heartburn: 0.81, and low for reflux: 0.54. CONCLUSION: The CFAbd-Score was adapted to the Brazilian spoken Portuguese and demonstrated content and semantic equivalence. The final version showed appropriate validity, and internal consistency, preserving the psychometric properties of the original version.

Patient-reported outcomes of treatment and adverse effects following acute lymphoblastic leukemia: a low- and middle-income country cross-sectional study.

INTRODUCTION: The scenario of adult patients with acute lymphoblastic leukemia treated in Brazil has not been well described yet. METHODS: Four hundred patients diagnosed with acute lymphoblastic leukemia from 1981 to 2019, registered in the Brazilian lymphoma and leukemia association (ABRALE) or their caregivers were interviewed by telephone to evaluate patient-reported perceptions of diagnosis, treatment and adverse effects. RESULTS: Overall, 203 were male with a mean age of 15.7 years and median follow-up of 6.2 years. Main presenting symptoms were fever (39 %), bleeding/ecchymosis (38 %), intense fatigue (30 %), and musculoskeletal pain (28 %). The proportion of patients diagnosed within one week of symptoms onset differed between public (17.9 %) and private healthcare (31.1 %; p-value = 0.019). Additionally, diagnostic difficulties were higher in public care: 35 % versus 22.6 % (p-value = 0.034). Only 36 patients were able to report their treatment protocols; from a list of eight reported protocols, the most common were the Brazilian Childhood Cooperative Group for Treatment of Acute Lymphoblastic Leukemia in Children (GBTLI - 10/27.8 %) and Berlin-Frankfurt-Münster (BFM - 8/22.2 %). Seventy patients (17.5 %) required treatment modification, 37.1 % due to severe adverse effects; 21.7 % received short treatment duration (≤6 months) and 16 % proceeded to allogeneic hematopoietic stem cell transplantation with 17/64 (27 %) reporting difficulties in this step, characterized as >3 months delay. Indication for transplantation was related to minimal residual disease and cranial radiotherapy; 41.7 % reported treatment-related adverse effects (range: 1-6), in particular: mood disorders (26.3 %), neurologic deficit (13.8 %), cognitive/memory impairment (12 %), and lung disease (15 %). Risk factors for adverse effects were age, indication of transplantation and living in a large city. Treatment disparities such as diagnostic and transplantation delays remain challenges in these patients. CONCLUSIONS: Urgent interventions are needed to optimize healthcare and reduce adverse effects, especially in adolescent and young adult patients.

Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes.

BACKGROUND: Low adherence to the number of insulin injections and glycemic variability are among the challenges of insulin therapy in type 1 diabetes (T1D). The TOP1 study investigated the effect of switching from twice-daily (BID) basal insulin to once daily (OD) insulin glargine 300 U/mL (Gla-300) on glycemic control and quality of life. METHODS: In this 28-week, phase 4 trial, people with T1D aged ≥ 18 years, who were treated with BID basal insulin in combination with prandial rapid-acting insulin for at least 1 year, and had HbA1c between 7.5% and 10.0%, were switched to Gla-300 OD as basal insulin. The present study aimed to evaluate the impact of this change on HbA1c, glycemic profile, treatment satisfaction and safety. The change in HbA1c from baseline to Week 24 was the primary endpoint. RESULTS: One hundred and twenty-three people with T1D (mean age 37 ± 11 years; 54.5% female) were studied. The disease duration was 20.0 ± 9.8 years, baseline HbA1c and fasting plasma glucose (FPG) were 8.6 ± 0.7% and 201 ± 80.3 mg/dL, respectively. After switching from BID to OD insulin regimen, no significant change in HbA1c was observed from baseline to Week 24 (p = 0.873). There were significant reductions in fasting self-monitoring blood glucose (SMBG) from baseline to Week 24 (175 ± 42 vs. 156 ± 38 mg/dL; p < 0.0001), and in glycemic profile (8-point SMBG) at several time points. There was a significant decrease in the proportion of patients with at least one hypoglycemic event (p = 0.025), in numbers of hypoglycemic events per patient-years of any type (p = 0.036), symptomatic (p = 0.007), and confirmed ≤ 70 mg/dL events (p = 0.049) from run-in to the last 4 weeks on treatment. There were significant improvements in treatment satisfaction (p < 0.0001), perceived hyperglycemia (p < 0.0001) scores and satisfaction with the number of injections between post-run-in and Week 24, and a significant decrease in fear of hypoglycemia. CONCLUSIONS: Switch from BID basal insulin to OD Gla-300 as part of basal bolus therapy in T1D resulted in similar glycemic control as measured by HbA1c, but provided significant improvements in SMBG, daily glucose profile, a lower incidence of hypoglycemia and increased patient satisfaction. TRIAL REGISTRATION: NCT03406000.

Dermatology-related quality-of-life outcomes in patients with RAS wild-type metastatic colorectal cancer treated with fluorouracil and folinic acid with or without panitumumab (Pmab) maintenance after FOLFOX + Pmab induction: a prespecified secondary analysis of the phase II randomized PanaMa (AIO KRK 0212) trial.

BACKGROUND: The key endpoints for the assessment of the effect of maintenance therapy for metastatic colorectal cancer (mCRC) are survival and quality-of-life outcomes. We aimed to compare dermatology-related quality of life (DRQOL) in patients with RAS wild-type (wt) mCRC treated with fluorouracil and folinic acid (FU/FA) + panitumumab (Pmab) versus FU/FA alone as maintenance therapy after folinic acid, fluorouracil and oxaliplatin + Pmab induction. PATIENTS AND METHODS: The phase II randomized PanaMa (AIO KRK 0212; NCT01991873) trial included 387 patients at 70 community/academic sites in Germany. For this prespecified secondary analysis, DRQOL outcomes were assessed using the Functional Assessment of Cancer Therapy-epidermal growth factor receptor inhibitor (FACT-EGFRI), Dermatology Life Quality Index (DLQI), and Skindex-16 questionnaires at every second cycle of therapy until disease progression/death. RESULTS: At least one DRQOL questionnaire was completed by a total of 310/377 (82%) patients who received induction therapy, and by 216/248 (87%) patients who were randomized and received maintenance therapy. Patients who experienced skin toxicity according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) during induction therapy had significantly worse DRQOL according to all three measures, compared to those who did not [i.e. Skindex-16, mean difference at cycle 2 -12.87; 95% confidence interval (CI) -20.01 to -5.73; P < 0.001]. During maintenance therapy, significantly improved recovery was observed in all DRQOL measures for patients receiving FU/FA, compared to those receiving additional Pmab (i.e. Skindex-16, mean difference at cycle 6 -16.53; 95% CI -22.68 to -10.38; P < 0.001). CONCLUSIONS: In this secondary analysis of a phase II randomized clinical trial, patient-reported DRQOL outcomes correlated with skin toxicity according to NCI-CTCAE during induction therapy. Maintenance therapy with FU/FA + Pmab was associated with deteriorated DRQOL versus FU/FA alone in patients with RAS wt mCRC.

[Translated article] 4 Domain Sports PROM in Spanish: Cross-cultural adaptation in the Chilean population and reliability analysis.

BACKGROUND: Patient-Reported Outcome Measures (PROMs) are tools of increasing interest in the sports population. The purpose of this study was to perform the cross-cultural adaptation and reliability analysis of the 4 Domain Sports Patient-Reported Outcome Measure (4 DSP) into Spanish. METHODS: A six-stage cross-cultural adaptation protocol was executed to obtain the Spanish version of the 4 DSP (S-4DSP). Subsequently, the questionnaire was administered to a population of 108 postoperative athletes with ACL (Anterior Cruciate Ligament) injuries. The questionnaire was administered again after 30 days. Acceptability, floor and ceiling effects, internal consistency (Cronbach's alpha), and reproducibility (Intraclass Correlation) were evaluated. RESULTS: The S-4DSP was fully completed by 108 participants (mean age 34±10.75, 26% women), achieving 100% acceptability. No floor effect was detected. The statistical analysis yielded a global Cronbach's alpha for the questionnaire of 0.65, and domain-specific alphas of 0.88, 0.72, 0.27, and 0.68 for the first, second, third, and fourth domains, respectively. The Intraclass Correlation test reached a maximum of 0.94 and a minimum of 0.48 for the first and fifth questions, respectively. CONCLUSIONS: The S-4DSP is a reliable and useful tool for evaluating Spanish-speaking athletes after ACL reconstruction.

Mandibular overdenture retained by four one-piece titanium-zirconium mini implants: A 2-year RCT on patient-reported outcomes.

AIM: The positive impact of implant interventions on dental patient-reported outcomes is an essential parameter of treatment effectiveness. This study assessed the 2-year changes in patient satisfaction and oral health-related quality of life (OHRQoL) of edentulous patients treated with a four mini implant mandibular overdenture (IOD) METHODS: The study was planned as a 2 × 2 factorial randomized clinical trial that tested two surgical approaches (flapped or flapless) and two loading protocols (immediate and delayed) using a titanium-zirconium mini implant (Straumann Mini Implant System®) and a PEEK retentive system (Straumann® Optiloc® Retentive System). Outcome measures (OHIP-Edent scores and the McGill Denture Satisfaction questionnaire) were assessed before treatment and at the 3-, 6-, 12-, and 24-month follow-ups. The Friedman test and multiple regression using Generalized Estimating Equations (GEE) were used for data analysis, considering the per-protocol (PP) and intention-to-treat (ITT) approaches RESULTS: Seventy-four patients were randomized to the study groups. No implant failure occurred during the study period. Marked improvement in all post-treatment periods compared to baseline were observed for the two outcomes. No significant effect of patient's gender, age, and surgical protocol on the study outcomes. The effect of treatment provision was significant for the two outcomes in the PP and ITT approaches (p < 0.001). A barely significant positive effect of the immediate loading was observed for OHIP-Edent in the PP approach (p = 0.020) CONCLUSION: IOD treatment significantly improved patient-reported outcomes measures, with sustained benefits over the two years of overdenture use, and can be considered a promising treatment option in for the edentulous mandible.

Evaluation of the Concept of Value-Based Healthcare Applied to an Integrated Palliative Care Program in Colombia.

OBJECTIVE: This study aimed to evaluate the "Value-Based Healthcare" concept of an integrated palliative care (PC) program in Bogotá, Colombia, through the measurement of health outcomes and care costs in the last 3 months of life. METHODS: A multicenter, retrospective cohort study that included patients ≥18 years old who died in 2020 due to medical conditions amenable to PC. The measured health outcomes included pain, wellbeing, comfort, quality of life (QOL), and satisfaction. We analyzed the behavior of overall care costs during the last 3 months of the patients' lives and controlled for the effect of exposure to the program, considering the disease type and insurance coverage, using a linear regression model, nearest-neighbor matching, and sensitivity analysis. RESULTS: Among patients exposed to the program, the mean pain score was 2.1/10 (± 1.3) and wellbeing was rated at 3.5/10 (± 1.0), comfort at 1.6/24 (± 1.3), QOL at 3.6/5.0 (± 0.17), and satisfaction at 9.3/100 (± 0.15). The positive changes in these scores were greater for patients who remained in the program for over 3 months. Cost reduction was demonstrated in the last 90 days of life, with statistically significant and chronologically progressive savings during the last 30 days of life exceeding 5 million pesos per patient (P < .05). CONCLUSIONS: This study demonstrated the success of PC in reducing pain, improving wellbeing and QOL, providing comfort, and ensuring high levels of satisfaction. Moreover, PC is an effective value-based healthcare strategy and can significantly enhance the efficiency of healthcare services by reducing end-of-life healthcare costs.

The usefulness of patient-reported outcome measures in decision making in Chagas cardiomyopathy: a scoping review.

Chagas cardiomyopathy (ChC) presents many biopsychosocial complexities, highlighting the need to have patient self-report questions. This study demonstrates the scope of the use of patient-reported outcome measures (PROMs) in patients with ChC and highlights the main research gaps. This is a scoping review and the search strategy was performed in the Online Medical Literature Analysis and Retrieval System (MEDLINE), Excerpta Medica database (EMBASE), Accumulated Index of Nursing and Allied Health Literature (CINAHL), Cochrane Central, Latin American Literature and Caribbean in Health Sciences (LILACS) and Diagnostic Test Accuracy (DITA). The search identified 4484 studies and 20 studies met the inclusion criteria. The Short-Form of 36 items (SF-36) had potential prognostic value and the ability to identify systolic dysfunction. The Human Activity Profile was able to screen for functional impairment, and the New York Heart Association showed potential prognostic value. The SF-36 and Minnesota Living with Heart Failure Questionnaire were responsive to interventions. The pharmaceutical care affected adherence to treatment as assessed by the Morisky score and also for SF-36. Despite the increased use of PROMs, there are still a large number of gaps in the literature, and further studies using PROMs are needed.

Can a clinical assessment predict the functional status progression in patients with femoroacetabular impingement syndrome?

BACKGROUND: Femoroacetabular impingement syndrome (FAIS) is a hip joint motion-related clinical disorder with a triad of symptoms, clinical signs, and imaging findings. However, scientific evidence is still unclear regarding the best treatment for FAIS. OBJECTIVES: To assess the value of a physical therapy evaluation in predicting the progression of functional status over the subsequent years in patients with FAIS who are candidates for hip arthroscopy surgery. METHODS: In this case-series study, patients with FAIS, candidates for hip arthroscopy surgery, underwent a standard physical therapy evaluation. Baseline data were collected between 2013 and 2019. In 2020/2021, the patients' functional status was assessed through the International Hip Outcome Tool (iHOT-33). Functional status progression was calculated as the difference between the follow-up and baseline iHOT-33 scores. A multivariate forward stepwise regression analysis was conducted to explore the relationship between baseline characteristics and the functional status progression. RESULTS: From 353 patients who completed the baseline assessment, 145 completed the iHOT-33 follow-up. The mean (±SD) follow-up time was 58.7 (27.2) months (minimum 12 and maximum 103 months). The iHOT-33 scores increased 20.7 (21.8) points on average, ranging from -39.8 to 76.9 points. Among the 15 potential predictive factors assessed in this study, only baseline iHOT-33 score (ß -0.44; -0.061, -0.27), femoral version (ß 9.03; 1.36, 16.71), and body mass index (ß -0.99; -1.98, -0.01) had the ability to predict the functional status progression. CONCLUSION: Patients with a lower baseline iHOT-33 score, lower body mass index, and normal femoral version were more likely to increase their functional status after a minimum of one year of follow-up.

Developing and assessing the measurement properties of an instrument to assess the impact of musculoskeletal pain in children aged 9 to 12-the pediatric musculoskeletal pain impact summary score.

BACKGROUND: Despite the high prevalence of musculoskeletal (MSK) pain in children, there is a lack of instruments to measure the impact of MSK pain on children's activity and participation. OBJECTIVE: To assess the reliability and construct validity of the Pediatric MSK Pain Impact summary score in school children (aged 9 to 12) with MSK pain. METHODS: We used a pragmatic approach in a reflective framework to assess internal consistency, structural validity, convergent validity, and discriminative validity in a sample of 615 children with MSK pain. RESULTS: The confirmatory factor analysis results indicate that the summary score has limited internal consistency and construct validity. The estimated Cronbach's alpha was 0.63, and most goodness of fit indices met the recommended thresholds (SRMR = 0.030; GFI = 0.993, CFI = 0.955, RMSEA 0.073), although they were close to the lower bounds of the thresholds. The convergent validity showed appropriate correlation of the summary score with quality of life (r = -0.33), care-seeking (r = 0.45), and medication intake (r = 0.37). Discriminative validity showed that the instrument can discriminate between the impact of pain on children with frequent and infrequent (2.93; 95% CI: 2.36 - 3.50) MSK pain. CONCLUSION: The Pediatric MSK Pain Impact summary showed limited internal consistency and construct validity; however, it can discriminate between children with frequent and infrequent pain. The results are promising for clinical and research practices as it is a short and convenient tool to be used in school-aged children.

The Relationship Between Disc Herniation Morphology and Patient-Reported Outcomes after Microdiscectomy.

OBJECTIVE: Determine if herniation morphology based on the Michigan State University Classification is associated with differences in (1) patient-reported outcome measures (or (2) surgical outcomes after a microdiscectomy. METHODS: Adult patients undergoing single-level microdiscectomy between 2014 and 2021 were identified. Demographics and surgical characteristics were collected through a query search and manual chart review. The Michigan State University classification, which assesses disc herniation laterality (zone A was central, zone B/C was lateral) and degree of extrusion into the central canal (grade 1 was up to 50% of the distance to the intra-facet line, grade >1 was beyond this line), was identified on preoperative MRIs. patient-reported outcome measures were collected at preoperative, 3-month, and 1-year postoperative time points. RESULTS: Of 233 patients, 84 had zone A versus 149 zone B/C herniations while 76 had grade 1 disc extrusion and 157 had >1 grade. There was no difference in surgical outcomes between groups (P > 0.05). Patients with extrusion grade >1 were found to have lower Physical Component Score at baseline. On bivariate and multivariable logistic regression analysis, extrusion grade >1 was a significant independent predictor of greater improvement in Physical Component Score at three months (estimate = 7.957; CI: 4.443-11.471, P < 0.001), but not at 1 year. CONCLUSIONS: Although all patients were found to improve after microdiscectomy, patients with disc herniations extending further posteriorly reported lower preoperative physical function but experienced significantly greater improvement three months after surgery. However, improvement in Visual Analog Scale Leg and back, ODI, and MCS at three and twelve months was unrelated to laterality or depth of disc herniation.

Development and validation of a Spanish version of the Obstetric Quality of Recovery-10 item score (ObsQoR-10-Spanish).

Background: Spanish is the second most spoken language globally with around 475 million native speakers. We aimed to validate a Spanish version of the Obstetric Quality of Recovery-10 item (ObsQoR-10) patient-reported outcome measure. Methods: ObsQoR-10-Spanish was developed using EuroQoL methodology. ObsQoR-10-Spanish was assessed in 100 Spanish-speaking patients undergoing elective Caesarean or vaginal delivery. Patients <38 weeks, undergoing an intrapartum Caesarean delivery, intrauterine death, or maternal admission to the intensive care unit (ICU) were excluded. Validity was assessed by evaluating (i) convergent validity-correlation with 24-h EuroQoL and global health visual analogue scale (GHVAS) scores (0-100); (ii) discriminant validity-difference in ObsQoR-10-Spanish score for patients with GHVAS scores >70 vs <70; (iii) hypothesis testing-correlation of ObsQoR score with maternal and neonatal factors; and (iv) cross-cultural validity assessed using differential item functioning analysis. Reliability was assessed by evaluating: (i) internal consistency; (ii) split-half reliability and (iii) test-retest reliability; and (iv) floor and ceiling effects. Results: One hundred patients were approached, recruited, and completed surveys. Validity: (i) convergent validity: the ObsQoR 24-h score correlated moderately with the 24-h EuroQoL (r=-0.632) and GHVAS scores (r=0.590); (ii) discriminant validity: the ObsQoR-10-Spanish 24-h scores were higher in women who delivered vaginally compared to via Caesarean delivery, (mean [standard deviation] scores were 89 [9] vs 81 [12]; P<0.001). The 24-h ObsQoR-Spanish scores were lower in patients experiencing a poor vs a good recovery (mean [standard deviation] scores were 76 [12.3] vs 87.1 [10.6]; P=0.001); (iii) hypothesis testing: the ObsQoR-10 score correlated negatively with age (r=-0.207) and positively with 5-min (r=0.204) and 10-min (r=0.243) Apgar scores. Remaining correlations were not significant; and (iv) differential item functioning analysis suggested no potential bias among the 10 items. Reliability: (i) internal consistency was good (Cronbach alpha=0.763); (ii) split-half reliability was good (Spearman-Brown prophesy reliability estimate of 0.866); (iii) test-retest reliability was excellent with an intra-class correlation coefficient of 0.90; and (iv) floor and ceiling effects: six patients scored a maximum total ObsQoR-10 score. Conclusions: The ObsQoR-10-Spanish patient-reported outcome measure is valid, reliable, and clinically feasible, and should be considered for use in Spanish-speaking women to assess quality of inpatient postpartum recovery.

The Simplified Medication Adherence Questionnaire: validation of a Brazilian-Portuguese version in hypertensive adults.

Background: Self-reported adherence scales are widely used in research and practice because they are low in cost and easy to apply. A free version in Brazilian-Portuguese of the Simplified Medication Adherence Questionnaire (SMAQ) can be a useful alternative for determining the adherent behavior of hypertensive patients. Purpose: To translate and evaluate the psychometric properties of the Brazilian-Portuguese version of the SMAQ therapeutic adherence scale for patients with arterial hypertension. Patients and methods: A multicenter, cross-sectional study was conducted in five outpatient units in Maceió-AL and Aracaju-SE between January and July 2019. A total of 117 patients aged over 18 years using antihypertensive drugs were recruited. The cross-cultural adaptation followed international methodological recommendations. Internal consistency (Cronbach's alpha) was tested as a reliability parameter. Criterion and construct validity were verified by concurrent validation, exploratory factor analysis (EFA), and validation by known groups. Results: The participants had a mean age of 56.6 years (SD = 10.7 years); most were female (72.6%). The mean number of antihypertensives prescribed per patient was 1.87 (SD = 0.87). There were 79.5% (n = 86) of patients considered non-adherent. Internal consistency was satisfactory (Cronbach's alpha = 0.63). A satisfactory correlation coefficient was verified with the Morisky-Green-Levine test as an external criterion (r = 0.56, p < 0.001). The scale's sensitivity measured through known group validity was 75.3%, specificity 29.5%, positive predictive value 63.9%, and negative predictive value 41.9%. We identified two factors of the instrument's construct from EFA: specific medication-taking behaviors and barriers to adherence. The initial KMO measure of sampling adequacy was 0.691, and Bartlett's test of sphericity was significant (χ2 = 118.342, p < 0.001). Conclusion: The Brazilian-Portuguese version of the SMAQ scale proved valid and reliable for determining adherence to the pharmacotherapy in hypertensive patients. It showed more ability to detect non-adherent patients but with low specificity, possibly influenced by high social desirability.

eTEP Rives-Stoppa impact on abdominal contour: a retrospective observational and clinical quality improvement study using Ellipse 9 tool.

BACKGROUND: The eTEP Rives-Stoppa (RS) procedure, increasingly used for ventral hernia repair, has raised concerns about postoperative upper abdominal bulging. This study aims to objectively evaluate changes in the abdominal contour after eTEP RS and explore potential causes using a novel analytical tool, the Ellipse 9. METHODS: Thirty patients undergoing eTEP RS without posterior rectus sheath closure were assessed before and 3 months after surgery using CT scan images. Key measurements analyzed included the distance between linea semilunaris (X2), eccentricity over the Cord (c/a Cord), superior eccentricity (c/a Sup), Y2, and the superior perimeter of the abdomen. The Ellipse 9 tool, which provides graphical images and numerical representations, was utilized alongside patient-reported outcomes to assess perceived abdominal changes. RESULTS: The study group exhibited a trend toward a flatter abdomen with reduced distance between linea semilunaris(X2). However, 17% of patients developed upper abdominal bulging (5). Significant differences in c/a Cord, c/a Sup, Y2, and the superior perimeter of the abdomen, confirmed with Bonferroni corrections, were noted between bulging (5 patients) and non-bulging groups (25 patients). There was a notable disparity between patient perceptions and objective outcomes. CONCLUSION: The eTEP RS procedure improved abdominal contour in most patients from a selected cohort. The Ellipse 9 tool was valuable for the objective analysis of these changes. The cause of bulging post-eTEP RS is probably multifactorial. Notably, there was often a discrepancy between patient perceptions of bulging and objective clinical findings.

Correlation between psychological status, revised Müller AO classification and patient-reported outcomes: a prospective cohort analysis.

INTRODUCTION: The impact of psychological status on clinical outcomes is valued in several medical conditions, but rare attention is given to it in orthopedic trauma. We aimed to assess the correlation between psychological status, fracture severity and patient-reported outcomes in fractured patients needing urgency surgical treatment. MATERIALS AND METHODS: We prospectively followed 139 consecutive patients undergoing urgency surgical treatment of a lower/upper limb fracture. Before surgery, all patients were divided into grades of fracture severity according to the Revised AO Müller Classification (AO grades). On the 15th and the 120th days after surgery, all patients underwent a psychological status assessment through the Hospital Anxiety and Depression Score (HADS), in addition to a pain evaluation through VAS. One year after surgery, patient-reported outcomes were obtained by using specific scales depending on the site of fracture. RESULTS: AO grades and VAS scores were significantly correlated to scores at HADS-A (anxiety component) and HADS-D (depression component), both on the 15th and the 120th. Patients presenting persistent HADS-A and HADS-D scores equal or greater than 8 points had a risk of more than 2.5 or 2.0 times of experiencing unsatisfactory surgical outcomes, respectively [HADS-A: RR = 2.8 (95% CI: 2.2-3.5)] [HADS-D: RR = 2.2 (95% CI: 1.7-3.1)]. AO grade C and the persistency of significant symptoms of anxiety or depression were independent predictors of unsatisfactory patient-reported outcomes (OR: 1.7, p = 0.03 // OR: 2.9, p < 0.01). Female gender, age, and BMI did not present any statistically significant utility in predicting unsatisfactory patient-reported outcomes. CONCLUSION: In fractured patients needing urgency surgical treatment, the risk of presenting unsatisfactory outcomes is more than twice as high in patients that present significant persistent changes in psychological status. Changes in psychological status are more frequent in patients presenting more severe pain and more severe fractures. AO grades and HADS scores are independent predictors of unsatisfactory outcomes in these patients.

The TRICK-TIP Rhinoplasty: Tip of the Nose Preservation Using the Combined Synergy of Open and Closed Approaches.

BACKGROUND: This study introduces and assesses the outcomes of a novel rhinoplasty technique, TRICK-TIP (Transcolumellar and Inter Cartilaginous Keystoning with Tip preservation), employing a combined open and closed approach with tip anatomy conservation and structured tip support. METHODS: The procedure involves a low stairstep columellar sectioning, followed by transmembranous and intercartilaginous incisions without skin dissection in the columella or tip. Elevating the entire mobile nose as a three-layered flap provides extensive access to the entire nasal pyramid and septum. Tip modifications, including retrograde cephalic cartilage resection and supratip skin thinning, are performed based on individual cases. A key columellar strut is frequently used, initially sutured in the interdomal space and then turned down for height adjustment and final fixation. Interdomal sutures, supratip sutures, and alar resection are implemented as needed. RESULTS: One hundred twenty patients participated, with high satisfaction and a low frequency of adverse effects reported using four FACE-Q™ questionnaires. One hundred and two independent raters evaluated pre and postoperative photographs, scoring "overall nose result" as 3.6 out of 5, with minimal or absent nostril deformities (1.84), soft triangle deformities (1.73), and columellar external scar deformity/visibility (1.35) where 1 is the absence of the deformity and 5 is disfigurement. Complications were absent, and revisions were infrequent. CONCLUSIONS: The combined benefits of the wide-open approach, shortened surgery duration, and nasal tip preservation contribute to outcome optimization. TRICK-TIP rhinoplasty is characterized by simplicity, enabling targeted modifications, preventing soft triangle and rim complications, and facilitating essential tip support while maintaining favorable results. Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The minimal important difference of patient-reported outcome measures related to female urinary incontinence: a systematic review.

BACKGROUND: The minimal important difference is a valuable metric in ascertaining the clinical relevance of a treatment, offering valuable guidance in patient management. There is a lack of available evidence concerning this metric in the context of outcomes related to female urinary incontinence, which might negatively impact clinical decision-making. OBJECTIVES: To summarize the minimal important difference of patient-reported outcome measures associated with urinary incontinence, calculated according to both distribution- and anchor-based methods. METHODS: This is a systematic review conducted according to the PRISMA guidelines. The search strategy including the main terms for urinary incontinence and minimal important difference were used in five different databases (Medline, Embase, CINAHL, Web of Science, and Scopus) in 09 June 2021 and were updated in January 09, 2024 with no limits for date, language or publication status. Studies that provided minimal important difference (distribution- or anchor-based methods) for patient-reported outcome measures related to female urinary incontinence outcomes were included. The study selection and data extraction were performed independently by two different researchers. Only studies that reported the minimal important difference according to anchor-based methods were assessed by credibility and certainty of the evidence. When possible, absolute minimal important differences were calculated for each study separately according to the mean change of the group of participants that slightly improved. RESULTS: Twelve studies were included. Thirteen questionnaires with their respective minimal important differences reported according to distribution (effect size, standard error of measurement, standardized response mean) and anchor-based methods were found. Most of the measures for anchor methods did not consider the smallest difference identified by the participants to calculate the minimal important difference. All reports related to anchor-based methods presented low credibility and very low certainty of the evidence. We pooled 20 different estimates of minimal important differences using data from primary studies, considering different anchors and questionnaires. CONCLUSIONS: There is a high variability around the minimal important difference related to patient-reported outcome measures for urinary incontinence outcomes according to the method of analysis, questionnaires, and anchors used, however, the credibility and certainty of the evidence to support these is still limited.

New Dizziness Impact Measures of Positional, Functional, and Emotional Status Were Supported for Reliability, Validity, and Efficiency.

Objective: To calibrate the 25 items from the Dizziness Handicap Inventory (DHI) patient-reported outcome measure (PROM), using item response theory (IRT), into 1 or more item banks, and assess reliability, validity, and administration efficiency of scores derived from computerized adaptive test (CAT) or short form (SF) administration modes. Design: Retrospective cohort study. Setting: Outpatient rehabilitation clinics. Participants: Patients (N=28,815; women=69%; mean age [SD]=60 [18]) included in a large national dataset and assessed for dizziness-related conditions who responded to all DHI items at intake. Interventions: Not applicable. Main Outcome Measures: IRT model assumptions of unidimensionality, local item independence, item fit, and presence of differential item functioning (DIF) were evaluated. Generated scores were assessed for reliability, validity, and administration efficiency. Results: Patients were treated in 976 clinics from 49 US states for either vestibular-, brain injury-, or neck-related impairments. Three unidimensional item banks were calibrated, creating 3 distinct PROMs for Dizziness Functional Status (DFS, 13 items), Dizziness Positional Status (DPS, 4 items), and Dizziness Emotional Status (DES, 6 items). Two items did not fit into any domain. A DFS-CAT and a DFS 7-item SF were developed. Except for 2 items by age groups and 1 item by main impairment, no items were flagged for DIF; DIF impact was negligible. Median reliability estimates were 0.91, 0.72, and 0.79 for the DFS, DPS, and DES, respectively. Scores discriminated between patient groups in clinically logical ways and had a large effect size (>0.8), with acceptable floor and ceiling effects (<15%), except for a floor effect for DPS (20.4%). DFS-CAT scores were generated using a median of 8 items; they correlated highly with full-bank scores (r=0.99). Conclusion: The 3 dizziness impact PROMs demonstrated moderate to high reliability, were valid, and highly responsive to change; thus, they are suitable for research and routine clinical administration.

Burnt hand outcomes tool: Translation, adaptation and validation into Brazilian Portuguese.

INTRODUCTION: In burn trauma, hands are often injured due to defensive action or proximity to the causative agent, leading to significant morbidity during a patients work and social rehabilitation process. In this context, the use of patient-reported outcome measures is a first step in measuring and improving these outcomes. The Burned Hand Outcome Tool (BHOT) is a specific questionnaire for adults with burned hands aimed at quantifying outcomes related to this trauma. OBJECTIVE: To translate, culturally adapt, and validate the BHOT into Brazilian Portuguese. METHODS: Following established standards in the literature, the original English questionnaire was translated, back translated, and analyzed by a panel of experts in the field. Cultural adaptation of the translation was carried out with a sample of target patients. The questionnaire was validated concurrently with the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire translated into Portuguese, at three time points (0 h, 2 h, 48 h), with two different evaluators. RESULTS: The cultural adaptation was conducted on a sample of 30 adult patients with hand burns without the need for reassessment of the translated items. The questionnaire validation was carried out on a sample of 100 adult patients with hand burns. The Cronbach's Alpha found at the first time point was 0.936. The correlations between the questionnaires varied from 0.656 to 0.915. CONCLUSION: The Burned Hand Outcome Tool has been translated, culturally adapted, and validated for a target population in Brazilian Portuguese.