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BACKGROUND: As with many other chronic diseases, systemic lupus erythematosus (SLE) and lupus nephritis (LN) have significant impacts on the health-related quality of life (HRQoL). Medication non-adherence is a significant challenge in the management of SLE, with consistently up to 75% of patients being non-adherent with their SLE medications. There is a need to assess the patient's perspective using patient-reported outcomes (PROs) to better understand the current impact of LN on HRQoL and treatment adherence in our region. The aim of this study was to explore the relationship between HRQoL and treatment adherence in patients with LN from the Colombian Caribbean. METHODS: A cross-sectional study was conducted from June to December 2022, including patients with biopsy-proven LN. HRQoL and treatment adherence were assessed using the Lupus Quality of Life (LupusQoL) and the Compliance Questionnaire in Rheumatology 19 (CQR19) instruments, respectively. Patients were categorized as adherent or non-adherent based on medication intake (defined as >80% correct dosage). Principal component analysis (PCA) was employed to identify principal components between adherent and non-adherent patients. RESULTS: A total of 42 patients with LN were included. Of these, 38 (90%) were female, and the mean age was 31 ± 10 years. Proliferative class IV was the predominant histopathological profile (90%). Twenty-five (60%) patients were categorized as non-adherent. Across all LupusQoL domains, a comprehensive range of responses was observed. Pain, planning, and intimate relationships domains remained unaffected, while burden to others domain had the lowest score. Poorer planning score correlated with older age (r = -0.72; p < .05) and longer disease duration (r = -0.74; p < .05). SLEDAI-2 K correlated with the pain domain (r = -0.78; p < .05). Non-adherent patients exhibited significantly worse pain domain scores compared to adherent counterparts (p < .05). PCA showed strong interactions between planning and pain, as well as between physical health and body image domains. CONCLUSIONS: LupusQoL pain domain scores were significantly worse in non-adherent patients compared to adherent patients. Effective pain management could be a determinant in HRQoL and treatment adherence rates in our population.
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Nefritis Lúpica , Cumplimiento de la Medicación , Calidad de Vida , Humanos , Nefritis Lúpica/tratamiento farmacológico , Nefritis Lúpica/psicología , Femenino , Estudios Transversales , Adulto , Colombia , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Adulto Joven , Encuestas y Cuestionarios , Medición de Resultados Informados por el Paciente , Persona de Mediana EdadRESUMEN
AIM: Patient-reported outcomes (PROs) hold significant potential in guiding clinical decision making, yet their utilization in periodontal trials has been limited. This systematic review aimed to critically synthesize and analyse qualitative studies that evaluated the knowledge and impact of periodontitis and its treatment on patients' lives, as well as their motivations, expectations and experiences in seeking treatment. MATERIALS AND METHODS: Six databases were searched up to March 2024 for qualitative studies on periodontitis patients. Studies were quality-assessed using the JBI Critical Appraisal and ConQual tools. Two authors independently extracted the findings, with discrepancies resolved by a third reviewer. RESULTS: Thirteen studies from 2006 to 2023 across four continents, involving 215 participants, identified five themes related to periodontitis: (i) knowledge about periodontitis and its treatment; (ii) impact of periodontitis on patients' lives; (iii) motivation and treatment expectations; (iv) obstacles to treatment; and (v) treatment impact on patients' lives. CONCLUSION: Significant physical and psychosocial impacts of periodontitis on patients' lives were identified, along with critical gaps in knowledge and awareness, emphasizing the important role of dentists in patient education. Specific PROs for use in validated instruments tailored to periodontitis were identified. These results can enhance patient-centred care by guiding future studies in accurately assessing patient perspectives on their condition and treatment.
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BACKGROUND: Patient management in rheumatoid arthritis (RA) has evolved to a "treat-to-target" (T2T) approach, which entails intensive treatment and regular follow-up with the goal of achieving low levels of disease activity or clinical remission. Even though a T2T approach is endorsed by professional organizations and yields superior outcomes, its implementation remains incomplete. EVEREST (EleVatE care in RhEumatoid arthritiS with Treat-to-target) is a quality-improvement initiative designed to improve the widespread implementation of a personalized T2T strategy and enable patients with RA to reach their full potential for remission. We describe the Brazilian results from the Global T2T Survey, first part of the EVEREST program. METHODS: Between June and September 2022, we conducted an online survey targeting rheumatologists in Brazil. Our objective was to evaluate the barriers and knowledge gaps hindering the effective implementation of T2T strategies. To achieve this, we employed a set of multiple-choice questions specifically crafted to elicit responses categorized in a structured order. RESULTS: 166 rheumatologists participated in the survey, 51% of them with more than 21 years of experience in rheumatology. Regarding the perceived challenges in the management of RA in clinical practice, the highest percentage of agreement/strong agreement among the participants was related to the contradictory results of disease activity measures (60%). In terms of the main barriers to assess the disease activity in clinical practice, the lack of adherence to treatment and contradictory assessments between patient-reported outcomes and composite measures were indicated by 75% and 59% of the participants, respectively, as a moderate/serious barrier. The most frequently knowledge and skill gaps related to the management of RA pointed out by the participants were on the difficulty to assess patients' health literacy (54% stated to have no more than intermediate knowledge on standardized methods to assess it and 43% no more than intermediate skills on determining the level of health literacy of the patients). In general, the use of tools to support the management of RA patients in clinical practice was indicated to be unusual by the participants. Self-reflection questionnaires, patient education materials and treatment consideration checklists were pointed out as the least frequently used tools (85%, 64% and 62% of the participants stated to use them never, rarely, or only sometimes, respectively). CONCLUSIONS: Our findings indicate a greater need for design, selection, and uptake of practical strategies to further improve communication between healthcare providers and patients with RA, as well as for promoting well-informed, collaborative decision-making in their care.
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Artritis Reumatoide , Reumatólogos , Artritis Reumatoide/tratamiento farmacológico , Humanos , Brasil , Antirreumáticos/uso terapéutico , Encuestas y Cuestionarios , Inducción de Remisión , Mejoramiento de la Calidad , MasculinoRESUMEN
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.
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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.
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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.
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Objective: To analyze patient-reported outcomes, cognitive function, and persistent symptoms in patients with neurologic post-acute sequelae of SARS-CoV-2 infection (Neuro-PASC) in Colombia. Methods: We recruited patients with laboratory-confirmed COVID-19 and PASC symptoms lasting more than 6 weeks at the CES University and CES Clinic (Medellín, Colombia). We included 50 post-hospitalization Neuro-PASC (PNP) and 50 non-hospitalized Neuro-PASC (NNP) patients. Long-COVID symptoms, cognitive (NIH Toolbox v2.1-Spanish for 18+), patient-reported (PROMIS) outcomes, and relevant medical history were evaluated. Statistical analyses were performed via generalized linear models. Results: Overall, brain fog (60%), myalgia (42%), and numbness or tingling (41%) were the most common neurological symptoms, while fatigue (74%), sleep problems (46%), and anxiety (44%) were the most common non-neurological symptoms. Compared to NNP, PNP patients showed a higher frequency of abnormal neurological exam findings (64% vs. 42%, p = 0.028). Both groups had impaired quality of life (QoL) in domains of cognition, fatigue, anxiety depression and sleep disturbance, and performed worse on processing speed and attention than a normative population. In addition, NNP patients performed worse on executive function than PNP patients (T-score 42.6 vs. 48.5, p = 0.012). PASC symptoms of anxiety and depression were associated with worse QoL and cognitive outcomes. Brain fog and fatigue remained persistent symptoms across all durations of Long COVID. Conclusion: Our findings highlight the high incidence and heterogeneity of the neurologic symptoms and impacts of Long COVID even more than 2 years from disease onset. Early detection, emotional support and targeted management of Neuro-PASC patients are warranted.
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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.
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Implantes Dentales , Prótesis Dental de Soporte Implantado , Prótesis de Recubrimiento , Arcada Edéntula , Mandíbula , Medición de Resultados Informados por el Paciente , Satisfacción del Paciente , Calidad de Vida , Titanio , Circonio , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Mandíbula/cirugía , Arcada Edéntula/rehabilitación , Arcada Edéntula/cirugía , Retención de Dentadura , Resultado del Tratamiento , Dentadura Completa Inferior , Diseño de Dentadura , Salud Bucal , Carga Inmediata del Implante DentalRESUMEN
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.
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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.
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Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Colorrectales , Fluorouracilo , Leucovorina , Panitumumab , Calidad de Vida , Humanos , Fluorouracilo/uso terapéutico , Fluorouracilo/farmacología , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Masculino , Femenino , Leucovorina/uso terapéutico , Leucovorina/farmacología , Leucovorina/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/farmacología , Panitumumab/uso terapéutico , Panitumumab/farmacología , Persona de Mediana Edad , Anciano , Adulto , Compuestos Organoplatinos/uso terapéutico , Compuestos Organoplatinos/farmacologíaRESUMEN
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.
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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.
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Cuidados Paliativos , Calidad de Vida , Humanos , Colombia , Cuidados Paliativos/métodos , Cuidados Paliativos/economía , Cuidados Paliativos/normas , Masculino , Femenino , Estudios Retrospectivos , Calidad de Vida/psicología , Persona de Mediana Edad , Anciano , Prestación Integrada de Atención de Salud/normas , Prestación Integrada de Atención de Salud/economía , Costos de la Atención en Salud/estadística & datos numéricos , Costos de la Atención en Salud/normas , Adulto , Satisfacción del Paciente , Atención Médica Basada en ValorRESUMEN
RESUMEN Objetivo: Reportar la sensibilidad al cambio e interpretabilidad de la versión argentina de la escala de catastrofización del dolor (PCS-Arg, por sus siglas en inglés) en una muestra de sujetos con dolor lumbar crónico (DLC). Materiales y métodos: Estudio prospectivo, observacional y longitudinal. Se reclutaron sujetos con DLC derivados a la unidad de kinesiología de un hospital público de la Ciudad Autónoma de Buenos Aires. Inicialmente, se registraron los datos demográficos y las puntuaciones de la PCS-Arg, así como la intensidad del dolor, discapacidad, calidad de vida y depresión mediante cuestionarios autoadministrados. En una segunda instancia, al mes o alta del tratamiento, se repitieron los cuestionarios junto con una escala global de cambio. La sensibilidad al cambio fue evaluada mediante la validez de constructo longitudinal. La interpretabilidad se calculó mediante el método basado en el ancla, y se reportaron la diferencia mínima clínicamente importante (DMCI) y el beneficio clínico sustancial (BCS). Resultados: Se incluyeron 102 sujetos en el estudio. La PCS-Arg demostró una sensibilidad al cambio aceptable. La DMCI fue de 10 puntos, con un área bajo la curva (AUC) de 0,65 y un intervalo de confianza del 95 % (IC 95 % 0,47-0,83). El BCS fue de 17 puntos, con un AUC de 0,66 (IC 95 % 0,55-0,77). Conclusión: La PCS-Arg es un instrumento sensible al cambio. La capacidad discriminativa de los valores para identificar la DMCI y el BCS fue pobre. Estos resultados permitirán interpretar el impacto de diferentes terapéuticas orientadas a modificar el catastrofismo, así como potenciar futuros ensayos clínicos que incluyan sujetos con DLC.
ABSTRACT Objective: To report the responsiveness and interpretability of the Argentine version of the Pain Catastrophizing Scale (PCS-Arg) in a sample of subjects with chronic low back pain (CLBP). Materials and methods: A prospective, observational, and longitudinal study was conducted. Subjects with CLBP referred to the physical therapy unit of a public hospital in the Autonomous City of Buenos Aires were recruited. At baseline, demographic data and PCS-Arg scores, as well as pain intensity, disability, quality of life, and depression were recorded through self-reported questionnaires. In a second instance, at one month or discharge, the same variables were collected, along with a Global Rating Of Change (GROC) scale. Responsiveness was assessed using longitudinal construct validity. Interpretability was calculated using the anchor-based method, and the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) were reported. Results: A total of 102 subjects were included in the study. The PCS-Arg showed acceptable responsiveness. The MCID score was 10 points, with an area under the curve (AUC) of 0.65 and a confidence interval of 95 % (95 % CI 0.47-0.83). The SCB score was 17 points, with an AUC of 0.66 (95 % CI 0.55-0.77). Conclusion: The PCS-Arg is a responsive instrument. The discriminative ability of the values to identify the MCID and SCB was poor. These results will allow for interpreting the impact of different treatments aimed at targeting catastrophizing, as well as enhancing future clinical trials on subjects with CLBP.
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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.
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Cardiomiopatía Chagásica , Medición de Resultados Informados por el Paciente , Humanos , Cardiomiopatía Chagásica/diagnóstico , Pronóstico , Calidad de Vida , Encuestas y Cuestionarios , Toma de DecisionesRESUMEN
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.
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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.
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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.
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Pinzamiento Femoroacetabular , Humanos , Pinzamiento Femoroacetabular/fisiopatología , Artroscopía , Articulación de la Cadera/fisiopatología , Modalidades de Fisioterapia , Rango del Movimiento Articular , Progresión de la EnfermedadRESUMEN
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.
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Dolor Musculoesquelético , Calidad de Vida , Humanos , Dolor Musculoesquelético/fisiopatología , Niño , Reproducibilidad de los Resultados , Dimensión del Dolor/métodos , Encuestas y Cuestionarios , Psicometría/métodosRESUMEN
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.
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Incontinencia Urinaria , Humanos , Femenino , Incontinencia Urinaria/diagnóstico , Incontinencia Urinaria/terapia , Encuestas y Cuestionarios , Medición de Resultados Informados por el PacienteRESUMEN
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.