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BACKGROUND: Patient-reported outcome measures (PROMs) have become crucial in assessing cataract surgery, especially with increasing patient expectations. The RayPro database offers a platform for tracking PROMs after surgery. The purpose of this study is to investigate determinants of patient satisfaction following cataract surgery by analysing PROMs. METHODS: A multicentre, retrospective, observational study was conducted analysing the PROMs recorded in the RayPro database (Rayner, Worthing, UK) from May 2019 to February 2024. Inclusion criteria were age ≥ 18 years, uneventful cataract surgery, valid consent to the study, and at least 1 questionnaire response. Email questionnaires were sent at 1 week, 3 months, and 12 months postoperatively, in which patients scored their outcome satisfaction, surgeon and hospital satisfaction, spectacle independence, and dysphotopsia on a 0-10 scale. Correlations of PROMs with outcome satisfaction were determined for the overall cohort and for eyes categorized by type of implanted intraocular lens (IOL). RESULTS: 2589 patients (2589 eyes) from 119 hospitals (26 countries) were included. Outcome satisfaction showed strong to moderate negative correlation with daytime and nighttime dysphotopsia at 3 months (r=-0.522, p < 0.001; r=-0.430; p < 0.001, respectively), strengthening at 12 months (r=-0.609, p < 0.001; r=-0.541; p < 0.001, respectively). Outcome satisfaction showed weak to no correlation with spectacle independence for distance, intermediate, and near vision at 3 months (r = 0.209, p < 0.001; r = 0.160, p < 0.001; r = 0.071, p = 0.007, respectively). Similar correlations between outcome satisfaction and dysphotopsia and between outcome satisfaction and spectacle independence were observed in monofocal as well as presbyopia-correcting IOLs. In the overall cohort, surgeon and hospital satisfaction at 1 week were strongly correlated with each other (r = 0.592, p < 0.001), while both were moderately correlated with outcome satisfaction at 3 months (r = 0.344, p < 0.001; r = 0.339, p < 0.001, respectively) and 12 months (r = 0.307, p < 0.001; r = 0.314; p < 0.001, respectively). CONCLUSION: Dysphotopsia was strongly correlated with patient dissatisfaction, and the correlation strengthened over time. Outcome satisfaction was weakly correlated with spectacle independence, and moderately correlated with surgeon and hospital satisfaction. Thus, postoperative visual quality and quality of care provided by surgeon and hospital can influence patient satisfaction.
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Extração de Catarata , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Acuidade Visual , Humanos , Masculino , Feminino , Estudos Retrospectivos , Idoso , Acuidade Visual/fisiologia , Pessoa de Meia-Idade , Inquéritos e Questionários , Bases de Dados Factuais , Idoso de 80 Anos ou mais , Qualidade de VidaRESUMO
BACKGROUND: Shoulder stabilization surgery has evolved over time, and bony augmentation procedures on the glenoid side are being performed more often. The Latarjet procedure modifies subscapularis anatomy because the conjoined tendon divides the subscapularis muscle fibers through a split/takedown, which has structural and functional implications. Arthroscopic anatomic glenoid reconstruction (AAGR) re-creates anatomy. This technique uses the Halifax portal to deploy and fix a distal tibial allograft (DTA) through the rotator interval, thus preserving the subscapularis anatomy. PURPOSE/HYPOTHESIS: The purpose was to analyze the radiographic properties of the subscapularis muscle after AAGR. It was hypothesized that the subscapularis muscle structure remains preserved postoperatively. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A retrospective review was performed comprising a consecutive series of patients treated with AAGR with DTA between November 2012 and April 2021 for traumatic anterior shoulder instability with glenoid bone loss. Patients were excluded if they had posterior instability, glenoid fracture, missing pre- or postoperative computed tomography (CT) scans, or only CT arthrogram available. Radiographic variables measured on CT scans included estimates of subscapularis muscle volume, subscapularis/infraspinatus muscle ratio, and fatty infiltration according to the Goutallier classification. Pre- and postoperative Western Ontario Shoulder Instability index scores were collected as a secondary outcome of this study. RESULTS: Ninety-three patients were included in the study with a clinical follow-up of 2.3 ± 1.5 years (mean ± SD). The subscapularis volume increased from 185.91 ± 45.85 mL preoperatively to 194.1 ± 49.0 mL postoperatively (P = .006). The subscapularis to infraspinatus muscle ratio showed a significant increase from 0.96 ± 0.27 to 1.05 ± 0.30 after surgery (P = .002). All patients had a Goutallier stage of 0 before and after surgery. The Western Ontario Shoulder Instability scores showed a significant improvement from 64.8 ± 15.5 preoperatively to 28.2 ± 24.0 postoperatively (P < .001). CONCLUSION: Patients who undergo AAGR with DTA for traumatic shoulder instability with glenoid bone loss have a preserved subscapularis muscle volume with no fatty infiltration, while showing a significant improvement in clinical outcomes.
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Artroscopia , Instabilidade Articular , Medidas de Resultados Relatados pelo Paciente , Articulação do Ombro , Tíbia , Humanos , Estudos Retrospectivos , Artroscopia/métodos , Masculino , Adulto , Feminino , Tíbia/cirurgia , Tíbia/diagnóstico por imagem , Articulação do Ombro/cirurgia , Articulação do Ombro/diagnóstico por imagem , Instabilidade Articular/cirurgia , Instabilidade Articular/diagnóstico por imagem , Adulto Jovem , Músculo Esquelético/diagnóstico por imagem , Músculo Esquelético/cirurgia , Músculo Esquelético/anatomia & histologia , Aloenxertos , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X , AdolescenteRESUMO
OBJECTIVE: The optimum number of screws in a volar locking plate (VLP) for distal radial fractures (DRF) fixation has not been established. We conducted a retrospective observational study aimed to evaluate the relationship between the number of used screws and the post-operative results provided by the patient-rated wrist evaluation (PRWE) questionnaire. METHOD: A total number of 62 surgically treated participants for DRF were included in the study between July 2019 and September 2022. Information was gathered regarding the number and arrangement of screws by examining X-ray images and using health records. We were looking at five variables: the total number of screws, the number of proximal fragment screws, the number of distal fragment screws, the number of locking screws, and finally number of cortical screws. RESULTS: Our data suggests that the number of screws in VLP for DRF fixation is a weak predictor of post-operative results and is therefore unlikely to influence the PRWE score. CONCLUSIONS: The ability to predict outcome by knowing the number of screws turned out to be an unreliable prognostic sign.
OBJETIVO: El número óptimo de tornillos en la placa volar de bloqueo para la fijación de fracturas distales del radio no ha sido establecido. Realizamos un estudio observacional retrospectivo con el objetivo de evaluar la relación entre el número de tornillos utilizados y los resultados posoperatorios proporcionados por el cuestionario de Evaluación de la Muñeca Calificada por el Paciente (PRWE, Patient-Rated Wrist Evaluation). MÉTODO: Se incluyeron en el estudio 62 participantes tratados quirúrgicamente por fractura distal del radio entre julio de 2019 y septiembre de 2022. Se recopiló información sobre el número y la disposición de los tornillos mediante la revisión de imágenes de rayos X y el uso de registros médicos. Se analizaron cinco variables: número total de tornillos, número de tornillos en el fragmento proximal, número de tornillos en el fragmento distal, número de tornillos de bloqueo y número de tornillos corticales. RESULTADOS: Nuestros datos sugieren que el número de tornillos en la placa volar de bloqueo para la fijación de fracturas distales del radio es un predictor débil de los resultados postoperatorios, y por lo tanto es poco probable que influya en la puntuación de la PRWE. CONCLUSIONES: La capacidad de predecir el resultado mediante el conocimiento del número de tornillos resultó ser un signo pronóstico poco fiable.
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Placas Ósseas , Parafusos Ósseos , Fixação Interna de Fraturas , Fraturas do Rádio , Humanos , Fraturas do Rádio/cirurgia , Fraturas do Rádio/diagnóstico por imagem , Estudos Retrospectivos , Fixação Interna de Fraturas/instrumentação , Fixação Interna de Fraturas/métodos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Adulto , Medidas de Resultados Relatados pelo Paciente , Idoso de 80 Anos ou mais , Resultado do Tratamento , Fraturas do PunhoRESUMO
BACKGROUND: A task force from the US National Institute of Health aimed to establish parameters for surveys with patients with chronic low back pain (LBP) by recommending the use of the Patient-Reported Outcome Measurement Information System 29-item (PROMIS-29) questionnaire and the stratification according to the Impact Score. We aimed to assess the internal consistency, reliability, measurement error, construct validity and responsiveness of the Brazilian-Portuguese version of the PROMIS-29 questionnaire (version 2.1) and the Impact Score in patients with chronic LBP. METHODS: A prospective cohort study was carried out with patients with chronic LBP who were receiving physiotherapy treatment in clinics in São Paulo and Vitória cities, Brazil. The sample included 102 patients with chronic LBP, aged between 18 and 80 years, and with the ability to read and write in the Brazilian-Portuguese language. Exclusion criteria were patients with serious spinal conditions, cognitive impairment, pregnant women, and patients who had undergone lumbar surgery within the past six months. The PROMIS-29 questionnaire, the 12-item Short-Form Health Survey and the Roland-Morris Disability Questionnaire were applied. The PROMIS-29 questionnaire was reapplied after 24 hours and 4 weeks. RESULTS: The PROMIS-29 questionnaire showed Cronbach's Alpha values between 0.81 (anxiety) and 0.91 (depression). The ICC2.1 ranged from 0.85 (95% CI: 0.77 to 0.89) to 0,97 (CI 95%: 0.95 to 0.98). The SEM values ranged between 0.85 (physical function) and 2.62 (ability to participate in social roles and activities). The Impact Score showed Cronbach's Alpha, ICC2.1 and SEM values of 0.91, 0.97 (95% CI: 0.95 to 0.98) and 0.56, respectively. The PROMIS-29 questionnaire and the Impact Score showed sufficient construct validity. The PROMIS-29 questionnaire showed moderate responsiveness, while the Impact Score showed sufficient responsiveness. CONCLUSIONS: Both the Brazilian-Portuguese version of the PROMIS-29 questionnaire and the Impact Score showed sufficient internal consistency, reliability, construct validity and responsiveness in Brazilian patients with chronic LBP. The results support the US National Institutes of Health's recommendation to use the PROMIS-29 questionnaire and the Impact Score in patients with chronic LBP. We suggest that future studies evaluate the structural validity of the Brazilian-Portuguese version of the PROMIS-29 questionnaire. CLINICAL TRIAL NUMBER: Not applicable.
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Dor Crônica , Dor Lombar , Medidas de Resultados Relatados pelo Paciente , Humanos , Dor Lombar/diagnóstico , Dor Lombar/psicologia , Dor Lombar/terapia , Feminino , Brasil , Masculino , Adulto , Pessoa de Meia-Idade , Estudos Prospectivos , Dor Crônica/diagnóstico , Dor Crônica/psicologia , Reprodutibilidade dos Testes , Idoso , Inquéritos e Questionários/normas , Adulto Jovem , Adolescente , Idoso de 80 Anos ou mais , Avaliação da Deficiência , Medição da Dor/métodos , PsicometriaRESUMO
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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Nefrite Lúpica , Qualidade de Vida , Humanos , Nefrite Lúpica/tratamento farmacológico , Nefrite Lúpica/psicologia , Feminino , Estudos Transversais , Adulto , Colômbia , Masculino , Adulto Jovem , Inquéritos e Questionários , Medidas de Resultados Relatados pelo Paciente , Pessoa de Meia-IdadeRESUMO
Studies shows that 1%-2% of world population will develop chronic skin wound in their lifetime. Nowadays, the patient report outcome measure (PROM) questionnaires are used to evaluate the patient's quality of life. However, several PROM's questionnaires analyse specific chronic wounds. In this sense, WOUND-Q toll was designed to evaluate all types of wounds. Because of the WOUND-Q wide applicability, the use of WOUND-Q is helpful for other countries. This study aimed to translate and adapt WOUND-Q tool for Brazilian Portuguese language. Two independent translators translated the WOUND-Q questionnaire from English to Brazilian Portuguese. Then these translators build Version 1 (T1) and version 2 (T2). In a consensus meeting, a third senior author defined the final version. In the back translation process, an English proficient translator translated the Brazilian Portuguese version to the original version. After another consensus, a final version was defined. Then, our group performed a cognitive test to validate this version. After the first translation, the comparison of version T1 and T2 achieved an intraclass correlation coefficient of 77%. The back translation showed the need of few adjustments. For the cognitive test, the mean age was 44.1 ± 9.3 years. Only one question was changed to improve comprehensiveness. In the review phase, few adjustments were performed to the final Brazilian Portuguese version, mostly regarding verbal tense and prepositions. In conclusion, this study successfully translated and adapted the WOUND-Q questionnaire for a Brazilian Portuguese version.
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Comparação Transcultural , Qualidade de Vida , Traduções , Humanos , Brasil , Inquéritos e Questionários , Masculino , Feminino , Adulto , Reprodutibilidade dos Testes , Medidas de Resultados Relatados pelo Paciente , Pessoa de Meia-Idade , Cicatrização , Ferimentos e Lesões , Doença Crônica , Idioma , Tradução , Psicometria/métodosRESUMO
AIMS: This study aimed to compare the effects of the combination of rivaroxaban and aspirin with aspirin alone on health-related quality of life in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial. METHODS and results: Health-related quality of life assessed using the EQ-5D-3L. The treatment effects on health utility and EQ visual analogue scale (EQ VAS) scores were compared between rivaroxaban plus aspirin and aspirin alone in terms of adjusted mean difference in change from baseline and odds ratio of having deterioration events. Nine thousand forty-nine (98.9%) and 6916 (75.5%) completed the EQ-5D-3L at baseline and at final visit, respectively. Nine thousand twenty-eight (98.9%) and 6887 (76.3%) completed the EQ-5D-3L at baseline and final visit, respectively. Mean (standard deviation) health utility and EQ VAS scores at baseline were 0.871 (0.141) and 76.0 (15.3), respectively, for the rivaroxaban plus aspirin group, compared with 0.873 (0.139) and 75.8 (15.1) for the aspirin group. Adjusted mean difference in change from baseline utility was -0.002 [95% confidence interval (CI), -0.006, 0.002, P = 0.30] between the combination therapy group and the aspirin group. The odds ratio (95% CI) of experiencing deterioration in health utility was 1.01 (95% CI, 0.93, 1.10, P = 0.81) between the two groups. Adjusted mean difference in change from baseline EQ VAS was 0.02 (95% CI, -0.43, 0.47, P = 0.93) between the two groups. CONCLUSION: This analysis of the COMPASS trial demonstrated that the quality of life of patients was similar between the rivaroxaban plus aspirin group and the aspirin alone group. REGISTRATION: Trial registration number: ClinicalTrials.gov number (NCT01776424). Trial protocol and statistical analysis plan: https://www.nejm.org/doi/full/10.1056/NEJMoa1709118#APPNEJMoa1709118PRO.
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Doenças Cardiovasculares , Aspirina , Estratégias de Saúde , Rivaroxabana , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Terapêutica , AnticoagulantesRESUMO
PURPOSE: To investigate the influence of different denture-bearing conditions on the masticatory function and patient-reported outcome measures (PROMs) of complete denture wearers. METHODS: Sixty edentulous patients were selected and allocated into two groups according to the American College of Prosthodontics' (ACP) classification: non-atrophic (NAT) (Classes I and II) (n = 24) and atrophic (AT) (Classes III and IV) (n = 36). All patients received new complete dentures (CDs). The objective variables (masticatory performance and swallowing threshold) were assessed as well as the PROMs (oral health-related quality of life (OHIP-EDENT), patient satisfaction) and quality of the prosthesis, at baseline (using the old CD) and after 4 months new prostheses use. Data were analyzed by Mann-Whitney test followed by the Generalized Equations Estimation (GEE), linear regression and Chi-square test. RESULTS: Higher masticatory performance was observed in the NAT group (p < .05) for both time points, baseline and after 4 months. However, compared to baseline, both groups showed significant masticatory improvement after 4 months (p < .05). Satisfaction and overall quality of life improved after 4 months with no difference between groups (p > .05). Regarding the quality of the CD, baseline results were significantly (p < .05) lower in the AT group, but after 4 months, no significant differences were found between groups and in intragroup analysis (p > .05). CONCLUSIONS: The denture-bearing conditions seems to impact masticatory function, but the PROMs are barely affected.
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Prótese Total , Mastigação , Boca Edêntula , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Qualidade de Vida , Humanos , Mastigação/fisiologia , Feminino , Masculino , Idoso , Boca Edêntula/fisiopatologia , Boca Edêntula/reabilitação , Pessoa de Meia-Idade , Deglutição/fisiologia , Saúde BucalRESUMO
PURPOSE: Inguinal hernias are highly prevalent worldwide and its surgical repair is one of the most common procedures in general surgery. The broad use of mesh has decreased the recurrence rates of inguinal hernia to acceptable levels, thus centering the attention on Quality of Life as a pivotal postoperative outcome. Carolinas Comfort Scale is a well-studied questionnaire designed to identify Quality of Life changes following hernia repair with mesh techniques. The aim of this study is to validate the CCS in Brazilian Portuguese for inguinal hernias. METHODS: The original CCS was translated into Brazilian Portuguese according to cross-cultural adaptation guidelines. We conducted a cross-sectional study in individuals aged 18 and above who had undergone inguinal laparo-endoscopic hernia repair for at least 6 months prior, between January 2019 and August 2022, at a Brazilian tertiary hospital. Participants answered an online survey containing the Brazilian CCS and the generic Patient-Reported Outcome Measure (PROM) Short-Form Health 36 (SF-36). Participants answered the same questionnaires in the follow-up after at least three weeks, with an additional question about satisfaction with surgery results. RESULTS: The survey was completed by 115 patients, of whom 78 (67%) responded to the follow-up questionnaire after 3 to 10 weeks. CCS showed excellent internal consistency, with Cronbach's α of 0.94. Intraclass correlation coefficient ranged from 0.60 to 0.82 in the test-retest analysis. Compared to SF-36, a strong correlation was observed in the physical functioning dimension, and a moderate correlation was found in role-physical and bodily pain (Pearson's Coefficient Correlation = 0.502, 0.338 and 0.332 respectively), for construct analysis. The mean CCS score was significantly lower (p < 0.001) among satisfied patients compared to the unsatisfied ones. CONCLUSION: The Brazilian version of CCS is a valid and reliable method to assess long-term quality of life after inguinal laparo-endoscopic hernia repair.
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Hérnia Inguinal , Herniorrafia , Qualidade de Vida , Humanos , Hérnia Inguinal/cirurgia , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Transversais , Brasil , Adulto , Idoso , Traduções , Comparação Transcultural , Inquéritos e Questionários , Telas Cirúrgicas , Reprodutibilidade dos Testes , Medidas de Resultados Relatados pelo PacienteRESUMO
OBJECTIVE: To analyze the psychometric properties of the cross-culturally adapted version of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) Compact Form Brazil. METHODS: A methodological study was conducted with 281 adult Primary Health Care users. Data collection took place online. Confirmatory Factor Analysis (CFA) was used to evaluate the psychometric properties of the PREOS-PC after the process of cross-cultural adaptation to the Brazilian context. Internal consistency was evaluated through Cronbach's alpha coefficient (α) and McDonald's omega coefficient (ω). RESULTS: The sample consisted of 73.3% women. The mean age was 36.1 years (SD = 12.2). Of the 23 items of the PREOS-PC that were eligible for CFA, a model with four correlated domains and 16 items presented satisfactory fit indexes. The domains were Practice Activation (PrA) (four items), Patient Activation (PaA) (two items), Experiences of patient safety events (EPaS) (five items) and Outcomes of patient safety (OPaS) (six items). One domain (GPeS) presented one question with a 0 to 10 response scale and two open questions, which cannot be inserted in the CPA due to the nature of the items, but can be included in the application of the scale, being evaluated individually. In this factorial model, five items (EPaS2, EPaS3, EPaS4, EPaS5, EPaS6 and EPaS8) presented factor loadings ≤ 0.30. The α and ω values demonstrated good internal consistency for all domains of the PREOS-PC. CONCLUSIONS: The Brazilian version of the PREOS-PC Compact Form Brazil composed of four domains (PrA, PA, EPaS and OPaS) and 16 items presented evidence of validation of its psychometric properties and can be used to evaluate the experiences and results of patient safety in Primary Health Care in the Brazilian context.
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Segurança do Paciente , Atenção Primária à Saúde , Psicometria , Humanos , Feminino , Brasil , Adulto , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Inquéritos e Questionários , Análise Fatorial , Adulto JovemRESUMO
BACKGROUND: We assessed the effectiveness, safety and patient-reported outcomes (PROs) of dimethyl fumarate (DMF) in real-world clinical practice in patients with multiple sclerosis (PwMS) from Argentina. METHODS: We conducted a multicenter ambispective cohort study in Argentina between September 2020 and March 2023. Changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, magnetic resonance imaging (MRI), no evidence of disease activity (NEDA), PROs (depression, anxiety, fatigue, burden of treatment and quality of life), and safety data were collected at clinical visits performed every 6 months for at least 24 months. RESULTS: We included 161 PwMS (64% female). DMF treatment was associated with a significant reduction in ARR from baseline after 24 months of treatment (from 0.87 to 0.23, p < 0.001). Disability progression was observed in 27.9% vs. 9.3% pre- and post-DMF, and disability improvement was found in 13% of patients from baseline to month 24. MRI activity was significantly reduced compared with baseline. Fatigue, depression, and quality of life scores were significantly improved from baseline to 24 months. Flushing was the most frequent adverse event reported in 19.2%. No significant reduction was observed in the hospitalization rate pre- and post-DMF (19.8% vs. 5.6%, p = 0.32). During follow-up, 135 (83%) patients were relapse-free, 110 (68.3%) were MRI free activity (Gad + lesion) and 108 (67%) reached NEDA. CONCLUSIONS: DMF significantly reduced disease activity in PwMS from Argentina with a good safety profile in real-world settings. A significant impact on the quality of life during follow-up was found.
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Fumarato de Dimetilo , Imunossupressores , Humanos , Fumarato de Dimetilo/uso terapêutico , Fumarato de Dimetilo/efeitos adversos , Feminino , Argentina , Masculino , Adulto , Imunossupressores/uso terapêutico , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Estudos de Coortes , Resultado do Tratamento , Esclerose Múltipla/tratamento farmacológico , Qualidade de Vida , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagemRESUMO
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 Dentários , Prótese Dentária Fixada por Implante , Revestimento de Dentadura , Arcada Edêntula , Mandíbula , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Qualidade de Vida , Titânio , Zircônio , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Mandíbula/cirurgia , Arcada Edêntula/reabilitação , Arcada Edêntula/cirurgia , Retenção de Dentadura , Resultado do Tratamento , Prótese Total Inferior , Planejamento de Dentadura , Saúde Bucal , Carga Imediata em Implante DentárioRESUMO
OBJECTIVES: This study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico. DESIGN: We conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention's effect on patients' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention's benefits and barriers and understand its feasibility. PARTICIPANTS: 50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers. SETTING: Oncology services in three public hospitals of the Mexican Social Security Institute. INTERVENTION: The ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks. RESULTS: 50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms. CONCLUSIONS: This pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT05925257.
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Neoplasias da Mama , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Humanos , Feminino , Neoplasias da Mama/terapia , Projetos Piloto , Pessoa de Meia-Idade , México , Adulto , Idoso , Adulto Jovem , Intervenção Baseada em Internet , Estudos de ViabilidadeRESUMO
INTRODUCTION: Ventral hernia surgery (VHS) has the intent to promote a better quality of life (QoL). VHS results were evaluated by recurrence incidence in the past, however the concept of Patient-Reported Outcomes Measures has changed this scenario. SF-36 is a generic questionnaire with some limitations on the hernioplasty postoperative evaluation. Disease-specific surveys such Hernia-Related Quality of Life Survey (HerQLes) and Carolinas Comfort Scale (CCS) were developed to improve specificity. The aim of this study was to validate a Brazilian version of the CCS as a QoL questionnaire for patients undergoing VHS in Brazil. MATERIALS AND METHODS: The study consists of a retrospective cohort that reviewed the medical records of patients who underwent ventral hernia surgery for incisional hernias in the Hospital de Clínicas de Porto Alegre between January 2019 to December 2020. Participants answered both the HerQles questionnaire and the CCS, then we compared the patients' scores between scales. In-personal evaluations or surveys applied by telemedicine were performed. Intraclass correlation coefficient was utilized to assess the consistency of the agreement between the HerQLes and CCS scales. RESULTS: A sample of 80 patients were evaluated. Most were male (70%), mean age 61.11 years and BMI 28.4. The most common comorbidity was systemic arterial hypertension, one third were smokers and 77.5% of cases were ASA 2. The average HerQLes score was 30.40 and the CCS was 15.46 (SD: 21.81), with an intraclass coefficient of 0.68. CONCLUSION: This study suggests that CCS is a good and robust tool for assessing ventral hernia. Tools to measure QoL are increasingly used in the literature, as QoL seems to be important data to assess surgical success, since it shows the perception of the patient about the results of their surgery. Further studies with larger sample sizes should be performed to confirm our findings.
Assuntos
Hérnia Ventral , Herniorrafia , Qualidade de Vida , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Brasil , Estudos Retrospectivos , Inquéritos e Questionários/normas , Hérnia Ventral/cirurgia , Idoso , Reprodutibilidade dos Testes , Medidas de Resultados Relatados pelo PacienteRESUMO
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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Cardiomiopatia Chagásica , Medidas de Resultados Relatados pelo Paciente , Humanos , Cardiomiopatia Chagásica/diagnóstico , Prognóstico , Qualidade de Vida , Inquéritos e Questionários , Tomada de DecisõesRESUMO
We evaluated the effect of periosteal-releasing incisions on flap displacement in anterior maxillary sites following implant placement and simultaneously guided bone regeneration. Thirty patients, each requiring a single dental implant and guided bone regeneration in the maxillary esthetic zone, were recruited. After full-thickness flap elevation, the displacement of the flap was measured under a standardized tension of 1 Ncm. Then, a 2-step periosteal releasing incision was placed in the internal aspect of the flap, and the displacement was remeasured using the same standardized tension. Keratinized tissue width and mucosal thickness at the surgical site were recorded. Patient-reported outcomes were assessed at the 7- and 14-day recall visits. Flap displacement (primary outcome) was calculated before and after periosteal-releasing incisions. Multivariable linear regression models were used to evaluate the influence of mucosal thickness on flap displacement and adjusted for Keratinized tissue width. Primary wound closure was achieved in all patients. The mean difference in flap coronal displacement before and after the periosteal-releasing incisions was 8.2 mm (p < .0001). Adjusted regression models showed no association between mucosal thickness and keratinized tissue width with the amount of flap displacement (p = .770). Patient-reported outcome measures for pain, swelling, and bleeding amounted to 1.28 ± 1.93, 1.36 ± 1.87, and 0.0 ± 0.0 at 7 days and 0.11 ± 0.57, 0.56 ± 1.03, and 0.0 ± 0.0 at 14 days, respectively. Periosteal-releasing incisions using the 2-step procedure described here are a predictable technique to obtain coronal flap displacements >8 mm without increased surgical complications.
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Maxila , Periósteo , Humanos , Periósteo/cirurgia , Masculino , Feminino , Pessoa de Meia-Idade , Maxila/cirurgia , Regeneração Óssea , Implantação Dentária Endóssea/métodos , Regeneração Tecidual Guiada Periodontal/métodos , Retalhos Cirúrgicos/cirurgia , Adulto , Medidas de Resultados Relatados pelo Paciente , Idoso , Implantes Dentários para Um Único DenteRESUMO
OBJECTIVES: To investigate the current clinical practice regarding pre- and post-surgical rehabilitation and return to sport (RTS) criteria following anterior cruciate ligament reconstruction (ACLR). DESIGN: Cross-sectional design. Online survey. SETTING: Survey platform. PARTICIPANTS: Argentinian physical therapists (PTs). OUTCOME MEASURES: The survey consisted of a combination of 39 open- and closed-ended questions, divided across 3 sections: (1) demographic and professional information, (2) clinical practice and rehabilitation strategies, and (3) return-to-running (RTR) and RTS. RESULTS: A total of 619 PTs completed the survey. Considerable variability was observed in preoperative rehabilitation, criteria used for rehabilitation progression and RTS decision-making criteria used by PTs. From the total surveyed, 336 (54.3%) carried out RTS assessment in their clinical practice. Most of PTs (53.3%) use visual estimation to assess knee range of motion. Only 20% of the PTs reported incorporating patient-reported outcome measures in their decision-making. From PTs who use strength assessment as a criterion of RTS (68.8%), 16.6% extrapolate this from jump tests and 15.3% use manual muscle testing. Less than the 50% of the PTs recommended nine months or more to allow patients to RTS. CONCLUSIONS: Current rehabilitation practices of Argentinian PTs following ACLR are largely variable and not aligned with current evidence and scientific guidelines. To achieve better rehabilitation and RTS practices better knowledge dissemination and implementation are required.
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Lesões do Ligamento Cruzado Anterior , Reconstrução do Ligamento Cruzado Anterior , Fisioterapeutas , Volta ao Esporte , Humanos , Reconstrução do Ligamento Cruzado Anterior/reabilitação , Argentina , Estudos Transversais , Lesões do Ligamento Cruzado Anterior/cirurgia , Lesões do Ligamento Cruzado Anterior/reabilitação , Inquéritos e Questionários , Feminino , Masculino , Adulto , Amplitude de Movimento Articular , Medidas de Resultados Relatados pelo Paciente , Traumatismos em Atletas/reabilitação , Traumatismos em Atletas/cirurgiaRESUMO
Health research is the foundation of medical knowledge and healthcare system recommendations. Therefore, choosing appropriate outcomes in studies of therapeutic interventions is a fundamental step in producing evidence and, subsequently, for decision-making. In this article, we propose three key factors for the choice of outcomes: the inclusion of patient-reported outcomes, since they focus on the patient's perception of their health status and quality of life; the consideration of clinically relevant outcomes, which are direct measurements of the patient's health status and, therefore, will be decisive in decision-making; and the use of core outcome sets, a tool that standardizes the measurement and interpretation of outcomes, facilitating the production and synthesis of appropriate evidence for the evidence ecosystem. The correct choice of outcomes will help health decision-makers and clinicians deliver appropriate patient-centered care and optimize the use of resources in healthcare and clinical research.
La investigación en salud es la base del conocimiento médico y de las recomendaciones en los sistemas de salud. Por ello, la elección de desenlaces apropiados en estudios de intervenciones terapéuticas es un paso fundamental en la producción de evidencia y, posteriormente, para la toma de decisiones. En este artículo proponemos tres factores clave para la elección de desenlaces: la inclusión de desenlaces reportados por pacientes, ya que ponen el foco del efecto de la intervención en la percepción que tienen los propios pacientes de su estado de salud y calidad de vida; la consideración de desenlaces clínicamente relevantes, los cuales son mediciones directas del estado de salud del paciente y, por ende serán determinantes en la toma de decisiones; y la utilización de herramienta que estandariza y permite la homogeneización en la medición e interpretación de desenlaces, facilitando la producción y posterior síntesis de evidencia apropiada para el ecosistema de evidencia. La correcta elección de los desenlaces permitirá que la evidencia generada de estos estudios ayude a los tomadores de decisiones en salud y los profesionales clínicos a entregar cuidados apropiados centrados en el paciente y a optimizar el uso de recursos en salud e investigación clínica.
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Ensaios Clínicos como Assunto , Tomada de Decisões , Nível de Saúde , Medidas de Resultados Relatados pelo Paciente , Assistência Centrada no Paciente , Qualidade de Vida , Humanos , Avaliação de Resultados em Cuidados de Saúde , Comportamento de Escolha , Pesquisa BiomédicaRESUMO
Objective: The purpose of this study was to compare postoperative pain between SF flap and serratus anterior muscle (SM) in direct-to-implant breast reconstruction. Methods: This is a prospective cohort study that included 53 women diagnosed with breast cancer who underwent mastectomy and one-stage implant-based breast reconstruction from January 2020 to March 2021. Twenty-nine patients (54.7%) had SF elevation, and 24 patients (45.3%) underwent SM elevation. We evaluated patient-reported early postoperative pain on the first day after surgery. Also, it was reported that all surgical complications in the first month and patient reported outcomes (PROs) were measured with the BRECON 23 questionnaire. Results: The serratus fascia group used implants with larger volumes, 407.6 ± 98.9 cc (p < 0.01). There was no significant difference between the fascial and muscular groups regarding the postoperative pain score reported by the patients (2 versus 3; p = 0.30). Also, there was no difference between the groups regarding early surgical complications and PROs after breast reconstruction. Conclusion: The use of SF seems to cause less morbidity, which makes the technique an alternative to be considered in breast reconstruction. Although there was no statistical difference in postoperative pain scores between the fascia and serratus muscle groups.
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Neoplasias da Mama , Mamoplastia , Mastectomia , Dor Pós-Operatória , Retalhos Cirúrgicos , Humanos , Feminino , Estudos Prospectivos , Mastectomia/efeitos adversos , Pessoa de Meia-Idade , Neoplasias da Mama/cirurgia , Mamoplastia/métodos , Mamoplastia/efeitos adversos , Adulto , Fáscia/transplante , Medidas de Resultados Relatados pelo Paciente , Resultado do Tratamento , Implante Mamário/métodosRESUMO
BACKGROUND: Dysmenorrhea, or menstrual pain, is a subjective experience, and can only be assessed by patient-reported outcomes. These instruments should be reliable, valid and responsive. AIM: To identify and critically appraise the available evidence for the measurement properties of specific patient-reported outcome measures used for dysmenorrhea. METHODS: The PRISMA statement was used to report this systematic review. Databases searched were PubMed, SCOPUS, CINAHL, Web of Science, ScienceDirect and Google Scholar (April 2021; updated on February 2023). Original studies with primary data collection, with no restriction on language and publication date that reported psychometric properties of one or more dysmenorrhea-related patient-reported outcome measure. The literature searches, selection of studies, data extraction and assessment of the risk of bias were performed independently by two reviewers and followed the COSMIN guidelines. RESULTS: Thirty studies were analysed in this review, and 19 patient-reported outcome measures were evaluated. The instruments varied in relation to the measured construct and measurement properties (validity, reliability and responsiveness). The methodological quality of the studies and the quality of evidence of the patient-reported outcome measures were variable. Among the 13 studies that reported the development of patient-reported outcome measures, most had inadequate methodological quality, and the overall rating was insufficient or inconsistent. CONCLUSIONS: The Dysmenorrhea Symptom Interference (DSI) scale was the only identified patient-reported outcome measure that has the potential to be recommended because of its sufficient rating combined with moderate quality of evidence for content validity. Future studies should further evaluate the measurement properties of the existing patient-reported outcome measures, or develop new patient-reported outcome measures following the COSMIN methodology. PATIENT OR PUBLIC CONTRIBUTION: Not applicable as this is a systematic review. TRIAL REGISTRATION: PROSPERO protocol: CRD42021244410. Registration on April 22, 2021.