Risk factors for osteoporotic hip fracture among community-dwelling older adults: a real-world evidence study

Abstract Background Hip fractures in the older adults lead to increased morbidity and mortality. Although a low bone mineral density is considered the leading risk factor, it is essential to recognize other factors that could affect the risk of hip fractures. This study aims to evaluate the contribution of clinical characteristics, patient-reported outcomes, and muscle and aerobic capacity for hip fractures in community-dwelling older adults. Methods This is a retrospective cohort study with real world-data from subjects ≥ 60 years old attending an outpatient clinic in Minas Gerais, Brazil, from May 1, 2019, to August 22, 2022. Data about clinical characteristics (multimorbidity, medications of long-term use, sedative and or tricyclic medications, number of falls), patient-reported outcomes (self-perception of health, self-report of difficulty walking, self-report of vision problems, and self-report of falls) and muscle and aerobic capacity (calf circumference, body mass index, and gait speed) were retrieved from an electronic health record. The association of each potential risk factor and hip fracture was investigated by a multivariable logistic regression analysis adjusted for age and sex. Results A total of 7,836 older adults were included with a median age of 80 years (IQR 72-86) and 5,702 (72.7%) were female. Hip fractures occurred in 121 (1.54%) patients. Multimorbidity was associated with an increased risk of hip fracture (OR = 1.12, 95%CI 1.06-1.18) and each episode of fall increased the chance of hip fracture by 1.7-fold (OR = 1.69, 95%CI 1.52-1.80). Patient-reported outcomes associated with increased fracture risk were regular or poor self-perception of health (OR = 1.59, 95%CI 1.06-2.37), self-report of walking difficulty (OR = 3.06, 95%CI 1.93-4.84), and self-report of falls (OR = 2.23, 95%CI 1.47-3.40). Body mass index and calf circumference were inversely associated with hip fractures (OR = 0.91, 95%CI 0.87-0.96 and OR = 0.93, 95%CI 0.88-0.97, respectively), while slow gait speed increased the chance of hip fractures by almost two-fold (OR = 1.80, 95%CI 1.22-2.66). Conclusion Our study reinforces the importance of identified risk factors for hip fracture in community-dwelling older adults beyond bone mineral density and available fracture risk assessment tools. Data obtained in primary care can help physicians, other health professionals, and public health policies to identify patients at increased risk of hip fractures.

Papel de la persona navegadora del paciente en el cáncer de pulmón / The Role of the Navigator Person for a Patient with Lung Cancer

Introducción: la medicina basada en el valor ha logrado mejorar la calidad de atención del paciente y/o la satisfacción de las personas, reduciendo costos y obteniendo mejores resultados. Se apoya sobre tres pilares básicos: la medicina basada en la evidencia, la atención centralizada en el paciente, y la sustentabilidad. Sin embargo, existen pocas publicaciones sobre la estrategia de personas navegadoras para pacientes con cáncer de pulmón, que podrían ser una herramienta clave para brindar apoyo, asegurando que tengan acceso al conocimiento y los recursos necesarios a fin de completar la vía de atención clínica recomendada. Estado del arte: se trata de una intervención en salud cuyo objetivo principal es lograr vencer las barreras relacionadas con la atención (p. ej., logísticas, burocrático-administrativas, de comunicación y financieras) para poder mejorar la calidad y el acceso a la salud en el marco de la atención del cáncer. Estas personas cumplen un papel de guía para pacientes durante el proceso de diagnóstico y tratamiento activo. Su labor consiste en vincular al paciente con los proveedores clínicos, brindar un sistema de apoyo, asegurar un acompañamiento individualizado, garantizar que tengan acceso al conocimiento y a los recursos necesarios para completar el seguimiento y/o tratamiento adecuado. Discusión/Conclusión: indudablemente, es un elemento cada vez más reconocido en los programas de cáncer, centrado en el paciente y de alta calidad. Su implementación será de especial interés en la Unidad de Práctica Integrada para personas con cáncer de pulmón. (AU)

Introduction: Value-based medicine has succeeded in improving the quality of patient care and or patient satisfaction, reducing costs, and obtaining better outcomes. It rests on three fundamental pillars: evidence-based medicine, patient-centered care, and sustainability. However, there are few publications on the people navigator strategy for lung cancer patients, which could be a crucial tool for providing support, ensuring that they have access to the knowledge and resources needed to complete the recommended clinical care pathway. State of the art: It is a health intervention whose main objective is to overcome care-related barriers (e.g., logistical, bureaucratic-administrative, communication, and financial) to improve quality and access to health in the context of cancer care. These individuals play a guiding role for patients during the diagnostic and active treatment process. Their job is to link the patient with clinical providers, provide a support system, ensure individualized accompaniment, and guarantee that they get access to the knowledge and resources necessary to complete the appropriate follow-up and, or treatment. Discussion/Conclusion: Undoubtedly, patient navigators represent an increasingly recognized element of high-quality, patient-centered cancer programs. Its implementation will be of specific interest in the Integrated Practice Unit for people with lung cancer. (AU)

A survey of symptoms after thoracoscopic lung cancer resection based on patient-reported outcomes / 中国胸心血管外科临床杂志

@#Objective     To analyze the changes of perioperative symptoms of lung cancer patients by using patient-reported outcomes at different time points. Methods    A total of 109 patients who underwent thoracoscopic lung cancer resection in the department of thoracic surgery of our hospital from March to April 2021 were selected, including 55 (50.46%) males and 54 (49.54%) females. The mean age was 55.19±12.12 years. The postoperative symptom scale for lung cancer patients was used to investigate the changes of symptoms before surgery, 1 day after surgery, the day of discharge, and 30 days after surgery. Results     The mean hospital stay was 6.89±2.25 days. None of the patients reported any clinical symptoms related to lung cancer before surgery. The most prominent symptoms 1 day after surgery were pain (3.33±0.96 points), nausea (2.81±1.18 points), dizziness (2.00±0.85 points), fatigue (1.89±0.79 points) and shortness of breath (1.79±1.37 points). The patients with dizziness, nausea, fatigue and other symptoms gradually decreased, and the symptoms were relieved significantly (P<0.05). However, the symptoms of conscious pain, cough and shortness of breath lasted for a long time. At 30 days after surgery, 70.64%, 64.22% and 33.03% of patients felt pain, cough and shortness of breath, respectively, and the degree of cough was aggravated (P<0.001). Conclusion     Pain, cough, dizziness, shortness of breath and fatigue are the core postoperative symptoms of lung cancer patients. Most postoperative adverse symptoms can be effectively controlled in a short period of time, but pain, cough and shortness of breath still present persistent characteristics, which deserve further study.

Research progress and clinical application of the visual functioning index / 国际眼科杂志(Guoji Yanke Zazhi)

Cataract surgery has moved from the era of anti-blindness surgery to the era of refractive surgery, and vision-related quality of life has become an important prognostic indicator for cataract surgery. Since indicators like visual acuity are difficult to describe the visual quality of patients in a panoramic view, the evaluation of visual function based on subjective experience has received attention in clinical and scientific research. The visual functioning index(VF-14)is the first scale applied to assess the visual function in cataract surgery, and is widely used internationally so far. This review presented the research history of VF-14, scrutinized its clinical applicability, and summarized the research and application of VF-14 in the assessment of visual function, evaluation of surgical efficacy, and postoperative follow-up from three groups of people with cataract, refractive discomforts, and other common ophthalmic diseases, aiming to provide a reference for the clinical application of the VF-14.

Value-based health care in heart failure: Quality of life and cost analysis

Abstract Objectives: To measure Quality of Life (QoL) and costs of Heart Failure (HF) outpatients in Brazil as an introduction to the Value-Based Health Care (VBHC) concept. Materials and methods: Cross-sectional study, patients with HF, with ejection fraction <50%, were recruited from three hospitals in Brazil. Two QoL (36-Item Short Form Survey [SF-36] and Minnesota Living with Heart Failure Questionnaire [MLHFQ]) and two anxiety/depression questionnaires were applied. SF-36 scores were stratified by domains. Treatment costs were calculated using the Time-Driven Activity-Based Costing (TDABC) method. Results were stratified by NYHA functional class and sex. Results: From October 2018 to January 2021, 198 patients were recruited, and the median MLHFQ (49.5 [IQR 21.0, 69.0]) and SF-36 scores demonstrated poor QoL, worse at higher NYHA classes. A third of patients had moderate/severe depression and anxiety symptoms, and women had higher anxiety scores. Mean costs of outpatient follow-up were US$ 215 ± 238 for NYHA I patients, US$ 296 ± 399 for NYHA II and US$ 667 ± 1012 for NYHA III/IV. Lab/exam costs represented 30% of the costs in NYHA I, and 74% in NYHA III/IV (US $ 63.26 vs. US$ 491.05). Conclusion: Patients with HF in Brazil have poor QoL and high treatment costs; both worsen as the NYHA classification increases. It seems that HF has a greater impact on the mental health of women. Costs increase mostly related to lab/exams. Accurate and crossed information about QoL and costs is essential to drive care and reimbursement strategies based on value.

Comparison of Outcomes Between All-Inside SingleBundle and Double-Bundle Anterior Cruciate Ligament Reconstruction: A Retrospective Study

@#Introduction: ACL rupture is the most common type of knee injury. The All-inside ACL reconstruction procedure features some distinguished components including closed-socket tunnels with less bone expulsion, double suspensory fixation, and smaller incisions. We aimed to compare the outcomes between the All-inside Single-bundle and the Double-bundle ACL reconstruction techniques. Materials and methods: This study was a retrospective study which analysed the patient-reported and the clinical outcomes on patients who underwent ACL reconstruction between January and December 2020 at Dr Kariadi General Hospital Semarang, Indonesia. We compared the patientreported and the clinical outcomes at 6- and 12-month follow-ups between the All-inside Single-bundle and the Double-bundle groups. The patient-reported outcomes were determined using the IKDC and Tegner-Lysholm scores while the clinical outcomes included the measurement of Thigh Circumference, Single Hop test, Anterior Drawer test, Lachman test, Range of motion, and the patient’s level of return to sport. Results: A total of 24 subjects were divided into two groups, namely the All-inside Single-bundle and the Double-bundle groups, consisting of 12 subjects in each group. Most of the subjects were male in both groups, including 9 (75%) subjects in the All-inside Single-bundle group, and 11 (91.67%) subjects in the Double-bundle group. The mean age of the subjects were 25.75±7.57 years old in the Allinside Single-bundle group, and 24.5±6.87 years old in the Double-bundle group. In terms of the side of the knee that suffered the most injuries in both groups were the right knees. The result of the patient-reported outcomes using IKDC and Tegner-Lysholm scores showed no statistically significant differences in both groups at 6- and 12-month follow-ups (p=0.864; p=0.293 and p=0.589; p=0.233, respectively). The results of clinical assessments at 6- and 12-month follow-ups also showed no statistically significant differences in both groups. Conclusion: Our study showed no significant differences in the patient-reported and the clinical outcomes between the All-inside Single-bundle and the Double-bundle ACL reconstruction techniques at 6- and 12-month follow-ups.

Consistency analysis of perioperative self-reported pain scores and clinical records in patients with lung cancer / 中国胸心血管外科临床杂志

@#Objective     To analyse the consistency of perioperative self-reported pain scores of lung cancer patients with clinical records to provide a basis for optimal pain management. Methods    The patients with lung cancer who underwent surgical treatment in the Department of Thoracic Surgery, Sichuan Cancer Hospital from November 2017 to January 2020 were selected. They were divided into two groups based on the source of pain data. The self-report group used a questionnaire in which patients self-reported their pain scores, and the pain scores for the clinical record group were extracted from the electronic medical record system. Kappa test was used to compare the concordance of pain scores between the two groups preoperatively, on postoperative 1-6 days and on the day of discharge. McNemar's paired χ2 test was used to compare the differences in pain intensity levels between the two groups. Binary logistic multi-factor regression was used to analyse the factors influencing the concordance of severe pain (7-10 points) between the two groups. Results     Totally 354 patients were collected, including 191 males and 163 females, with an average age of 55.64± 10.34 years. The median postoperative hospital stay was 6 days. The consistency of pain scores between the two groups was poor (Kappa=–0.035 to 0.262, P<0.05), and the distribution of pain levels at each time point was inconsistent and statistically significant (P<0.001). The percentage of inconsistent severe pain assessment ranged from 0.28% to 35.56%, with the highest percentage of inconsistent severe pain assessment on postoperative day 1 (35.56%). Single-port thoracoscopic surgical access was an influencing factor for inconsistent assessment of severe pain on postoperative day 3 (OR=2.571, P=0.005). Conclusion     Self-reported perioperative pain scores of lung cancer patients are poorly aligned with clinical records. Clinical measures are needed to improve the accuracy of patient pain data reporting by choosing the correct assessment method, increasing education, and developing effective quality control measures.

Development and application of electronic patient-reported outcomes / 中华医院管理杂志

The rise of internet thinking, along with the growing acceptance of the " patient-centered" concept, has played a significant role in driving the development of electronic patient-reported outcomes (ePROs) in the field of clinical evaluation. While several large-scale and well-established ePROs evaluation systems have been widely adopted and implemented worldwide, China has lagged behind in ePROs research and electronic application. Therefore, the purpose of this paper is to comprehensively analyze and summarize the concepts, types, characteristics, state of development, and application of ePROs. Specifically, it focuses on analyzing the structure and content of ePROs evaluation network systems in the United States, France, and the United Kingdom. The ultimate objective is to provide insightful analysis and useful suggestions to aid in the development and evolution of ePROs in China.

Impacto Biopsicosocial de la Rehabilitación Oral Soportada por Implantes: Revisión Analítica de Instrumentos de Investigación

Este trabajo ha realizado una revisión narrativa de la literatura para analizar los instrumentos usados en la investigación clínica para los resultados centrados en el paciente en rehabilitación oral soportada por implantes. La búsqueda ha sido realizada en bases indexadoras de periódicos nacionales e internacionales, sin restricción temporal, en los idiomas portugués e inglés, utilizando las palabras-clave: implantes dentales, investigación clínica, resultados reportados por pacientes, cualidad de vida. Actualmente, los estudios clínicos deben incluir resultados obtenidos por relatos autorales de percepció n de los beneficios del tratamiento cuanto a los aspectos funcionales, sicológicos y sociales. La mayoría de los estudios utiliza instrumentos que añaden diferentes dimensiones de cualidad de vida, tales como GOHAI (Geriatric Oral Health Assessment Index), DIDL (Dental Impacton Daily Living), OHIP (Oral Health Impact Profile), OHQoL-UK (W), OIDP (Oral Impactson Daily Performances). En general, los ítems de estos cuestionarios han sido formulados de manera negativa, con el enfoque en los problemas, siendo el OHIP-14 lo más utilizado por ser sencillo, validado para varios idiomas y consolidado para las diferentes situaciones clínicas. Otros instrumentos de sicología positiva, como los cuestionarios de Rosenberg y McCullough, han sugestionado evaluar la percepción de la autoestima y de la gratitud, con el enfoque en el bienestar y en la satisfacción del pacien te a largo plazo. Estudios cualitativos o con métodos mistos pueden fornecer también más comprensión de los resultados centrados en los pacientes en rehabilitación soportada por implantes. Con base en la literatura observada se concluye que el estudio de resultados centrados en los pacientes puede ser enriquecido con el uso de diversos métodos para capturar la percepción del paciente de los beneficios de la rehabilitación soportada por implantes. Se sugestiona el uso del OHIP-14, aunque, su uso presente limitaciones que en parte pueden ser reprimidas por la aplicación de los cuestionarios relacionados a la sicología positiva como lo de la gratitud y lo de la autoestima, los cuales presentan dominios positivos.

This study aimed to conduct a narrative review of the literatura to analyze the instruments used in clinical research for patient-reported outcomes measures in implant-supported oral rehabilitation. The search was conducted in index data bases of national and international journals without time restriction, in Portuguese and English, using the key words: dental implants, clinical research, patient-reported outcomes measures, quality of life. Currently, clinical studies should include results obtained through self- reporting of the perceived benefits of treatment in functional, psychological and social aspects. Most studies use instruments that add different dimensions of quality of life, such as GOHAI (Geriatric Oral Health Assessment Index), DIDL (Dental Impacton Daily Living), OHIP (Oral Health Impact Profile), OHQoL-UK (W), OIDP (Oral impacts in daily presentations). In general, the itens in these questionnaires were formulated in a negative way, with a focuson problens, with OHIP-14 being the most used because it is simple, validated for several languages and consolidated for different clinical situations. Other positive psychology tools, such as the Rosenberg and McCullough questionnaires, have been suggested to assess the perception of self-esteen and gratitude, with a focus on long-term well-being and patient satisfaction. Qualitative or mixed method studies can also provide a better understanding of the results centered on patients undergoing rehabilitation with implants. Based on the observed literature, it is concluded that the study of patient-centered results can be enriched with the use of various methods to capture the patient's perception of the benefits of implant-supported rehabilitation. It is suggested the use of the OHIP-14, however, their use has limitations that can be partially met by the application of questionnaires related to positive psychology, as gratitude and self-esteen, which have positive fields.

Validación de medidas de resultados informados por los pacientes en ortopedia y traumatología / Validation of patient-reported outcome measures in orthopedics and traumatology

En los últimos años, ha habido un aumento en la aplicación de cuestionarios diseñados para la medición de resultados (o desenlaces) clínicos en la práctica médica. Para aplicar un cuestionario en una población distinta a la cual fue originalmente creado y diseñado, es necesario llevar a cabo un proceso riguroso de adaptación, con una determinada metodología. El objetivo de esta guía metodológica es describir el proceso de traducción, adaptación transcultural y validación de medidas de resultados informados por los pacientes (MRIPs) en Ortopedia y Traumatología.

In recent years, there has been an increase in the use of questionnaires designed to measure outcomes in the medical practice. To use a questionnaire in a population different from the one for which it was originally created and designed, it is necessary to carry out a rigorous adaptation process, with a certain methodology. The objective of the present methodological guide is to describe the process of translation, crosscultural adaptation, and validation of patient-reported outcome measures in Orthopedics and Traumatology

Research status of patient-reported outcome in esophageal carcinoma surgery / 中国胸心血管外科临床杂志

@#Esophageal carcinoma is a malignant tumor with high morbidity and mortality worldwide, and surgery is the main treatment currently. With the development of patient-centered care, the effect of surgery should not be limited to the improvement of the incidence of postoperative complications, mortality and other indicators. It is also important to provide experience related to disease and surgery from the perspective of patients. Therefore, more and more attention is paid to patient-reported outcomes by scholars. This paper will provide an overview of the international widely used, reliable and effective scales and researches about patient-reported outcomes in esophageal carcinoma.

Ultrasound joint examination by an automated system versus by a rheumatologist: from a patient perspective

Abstract Background: The Arthritis Ultrasound Robot (ARTHUR) is an automated system for ultrasound scanning of the joints of both hands and wrists, with subsequent disease activity scoring using artificial intelligence. The objective was to describe the patient's perspective of being examined by ARTHUR, compared to an ultrasound examination by a rheumatologist. Further, to register any safety issues with the use of ARTHUR. Methods: Twenty-five patients with rheumatoid arthritis (RA) had both hands and wrists examined by ultrasound, first by a rheumatologist and subsequently by ARTHUR. Patient-reported outcomes (PROs) were obtained after the examination by the rheumatologist and by ARTHUR. PROs regarding pain, discomfort and overall experience were collected, including willingness to be examined again by ARTHUR as part of future clinical follow-up. All ARTHUR examinations were observed for safety issues. Results: There was no difference in pain or discomfort between the examination by a rheumatologist and by ARTHUR ( p =0.29 and p =0.20, respectively). The overall experience of ARTHUR was described as very good or good by 92% (n =23), with no difference compared to the examination by the rheumatologist ( p =0.50). All (n =25) patients were willing to be examined by ARTHUR again, and 92% (n =23) would accept ARTHUR as a regular part of their RA clinical follow up. No safety issues were registered. Conclusion: Joint ultrasound examination by ARTHUR was safe and well-received, with no difference in PRO components compared to ultrasound examination by a rheumatologist. Fully automated systems for RA disease activity assessment could be important in future strategies for managing RA patients. Trial registration: The study was evaluated by the regional ethics committee (ID: S-20200145), which ruled it was not a clinical trial necessary for their approval. It was a quality assessment project, as there was no intervention to the patient. The study was hereafter submitted and registered to Odense University Hospital, Region of Southern Denmark as a quality assessment project and approved (ID: 20/55294).

Clinical outcomes after two-stage bicruciate knee ligament reconstruction / Resultado clínico após reconstrução ligamentar bicruzado do joelho, em dois tempos

ABSTRACT Objective: To correlate clinical and intraoperative findings with the postoperative evaluation of two-stage bicruciate knee ligament reconstruction. Methods: The study was conducted with 25 patients (20 men and 05 women) with mean age of 32.3 years, mean body mass index (BMI) of 26.2, and mean lesion duration of 18.3 months. The treatment consisted of an Inlay reconstruction of the posterior cruciate ligament (PCL) followed by the anterior cruciate ligament (ACL) reconstruction, at least 3 months after the first surgical procedure. Four patients required additional procedures: patellar tendon (02), medial collateral ligament (MCL) (02). Results: With an average follow-up of 24.8 months, 60% of the patients scored zero or + at the posterior drawer test, while 40% scored ++; 60% of patients were evaluated as good/excellent according to the Lysholm scale. Only one patient reached the pre-injury Tegner activity level. Injury duration had a negative influence on functional limitation, vitality, and mental health (SF-36). Conclusion: Although two-stage bicruciate knee ligament reconstruction improved knee stability and self-assessment, 96% of patients did not recover their pre-injury state. In the 36-item short form survey (SF-36), injury duration was inversely correlated with self-assessment of functional capacity, physical limitation, vitality, and mental health. Level of Evidence II, retrospective study.

RESUMO Objetivo: Correlacionar os achados clínicos e intraoperatórios com a avaliação pós-operatória da reconstrução ligamentar bicruzada do joelho em dois tempos. Métodos: 25 pacientes (20 homens e 05 mulheres), média de idade de 32,3 anos, IMC médio de 26,2, tempo médio da lesão de 18,3 meses. O tratamento foi iniciado com a reconstrução INLAY do LCP e, após o intervalo mínimo de 3 meses, foi realizada a reconstrução do LCA. Procedimentos adicionais em 04 pacientes - tendão patelar (02), LCM (02). Resultados: com seguimento médio de 24,8 meses, o teste de gaveta posterior foi classificado como zero ou + em 60% dos pacientes avaliados e 40% como ++. 60% dos pacientes avaliados como bons / excelentes (Lysholm). Apenas um paciente atingiu o nível de atividade Tegner pré-lesão. A tempo da lesão influenciou negativamente os parâmetros de limitação do funcionamento físico dos aspectos físicos, vitalidade e saúde mental (SF-36). Conclusão: a reconstrução bicruzado do joelho, em dois tempos, melhorou a estabilidade do joelho e a avaliação subjetiva, mas 96% dos pacientes não recuperaram o estado pré-lesão. O tempo de lesão apresentou correlação estatística inversa com a avaliação subjetiva da capacidade funcional, limitação dos aspectos físicos, vitalidade e saúde mental no escore S-36. Nível de Evidência II, Estudo retrospective.

Patient-Reported Outcomes in Subjects With A143T and R118C GLA Gene Variants

Abstract Background Fabry disease (FD) is caused by pathogenic variants in the GLA gene. A143T and R118C variants are considered not disease causing. Patient-reported outcomes provide information concerning the effects of their disease but should be carefully analyzed in rare diseases. Objectives To evaluate pain, depression, sleep disturbances, disability and quality of life in A143T or R118C Brazilian subjects and compare to data published for classic FD patients. Methods Nineteen subjects - 8:11 male:female - were evaluated and answered the questionnaires: Brief Pain Inventory (BPI), Hamilton Depression Rating Scale, Pittsburgh Sleep Quality Index, Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form Health Survey 36 (SF-36). Lyso-Gb3 and residual enzyme activity were obtained. Results Alpha-galactosidase A activity was low in males. Lyso-Gb3 levels were normal in all subjects. Comparing A143T/R118C subjects and FD patients, BPI severity, BPI interference, HAQ-DI values were not different (p>0.05) whereas raw scores for physical functioning (p=0.01) and general health perception (p<0.01) favored A143T/R118C. Depression and sleep disturbances were similar between groups. Conclusions A143T/R188C subjects had normal lyso-Gb3 levels. Depression, sleep disturbances and disability were frequent and under-recognized. However, findings depicted in this study are nonspecific and should not be considered as ground for diagnosing Fabry disease.

Development of A Patient-reported Outcomes Scale for Post-stroke Aphasia Based on Traditional Chinese Medicine Holism / 中国康复理论与实践

Objective:To develop a patient-reported outcomes (PRO) scale for post-stroke aphasia based on the Traditional Chinese Medicine (TCM) holism. Methods:Referring to the TCM holism, the theoretical model was established following the standard process for the development of the PRO scale. An item pool was established and optimized with case review, patient interview, expert questionnaire survey and consensus conference. The PRO scale was established finally. Results:A pool of post-stroke aphasia items based on the holistic view of TCM was constructed in the physical, psychological and social model. The Expert Comment Form for the PRO Scale for Aphasia after Stroke was formed after sorting out the item pool. After expert surveys and meeting discussion, 40 items were finally selected to form the first version of Patient-reported Outcomes Scale for Post-stroke Aphasia-TCM. Conclusion:The first version of Patient-reported Outcomes Scale for Post-stroke Aphasia-TCM has been developed based on the TCM holism and the concept of PRO, which can be evaluated clinically.

Oncology patient preferences in reporting on symptoms

Background:Collecting patient reported outcomes (PROs) in oncology clinical trials is becoming increasingly important. However, there is limited consensus on the most appropriatefrequency of PRO administration in oncology trials. The aim of this preliminary study is to examine the perspective of participants with a cancer diagnosis on the importance of completing PROs and to identify at what frequency participants prefer to report on their cancer-related symptoms.Methods:166 participants with a self-reported cancer diagnosis completed a multiple-choice online survey regarding perceptions of symptom importance and reporting preferences.Results:When asked about the benefit of reporting oncology-related symptoms daily, 44% of participants indicated there would be “very much” a benefit, 29% indicated there would be “quite a bit” of benefit, and 17% indicated there would be “somewhat” of a benefit. When asked about how frequently they would prefer to report symptoms, 41% of participants preferred “as they occur,” 36% preferred “once a day,” 18% preferred “once a week,” 4% preferred “twice a day,” and 1% preferred “every 4 hours”. Conclusions: PROs in oncology clinical research are most often collected at weekly, monthly, or longer intervals; however, meaningful fluctuations in cancer-related symptoms can occur more frequently. While concerns regarding patient burden are often raised to support infrequent reporting, these data suggest that participants would like to report symptoms with greater frequency, as episodic and daily reporting options were most popular. Based on these data, more frequent PRO data capture is not only feasible but perceived as important by individuals with cancer

Measurement of equivalence using a patient-reported daily pain diary across three smartphone devices

Background:Patient-reported outcomesplay an essential role in evaluating the results of clinical trials. As technological advances are made throughout the industry, pharmaceutical sponsors’ ability to collect field-based patient data has greatly increased. Recently, many clinical trials areutilizing varying modes of data capture in order to enable maximum flexibility. Given the regulatory concern over the equivalence of mixed modes of administration, the need to research the use of varying devices is essential.Methods:This study reviewedthree handheld smartphone devices for conceptual equivalence and conducted usability for standard questions used in a daily pain diary. Out of ten participants, 7 were females and 3 were males with age ranging from27-70 years, diagnosed with chronic painor fibromyalgia, completed the same pain diary on three different smartphone devices.Results:Overall, participants reported no differences between these three smartphone devices and found the presentation of the diary content to be similar, if not identical, on all three devices. Conclusions: Device type had no impact on the presentation of the diary content or participants’ understanding of the diary questions

Impact of surgery on pain, disability, and quality of life of patients with degenerative lumbar disease: Brazilian data / Impacto da cirurgia na dor, incapacidade e qualidade de vida de portadores de doença degenerativa lombar: dados brasileiros

ABSTRACT Objective: To study the impact of surgery on pain, disability, quality of life, and patient satisfaction in a sample of patients with Degenerative Lumbar Disease (DLD). Methods: Retrospective analysis of prospectively collected data. Comparison between pre and postoperative (6 - 12 months) ODI and SF-36, plus postoperative Patient Satisfaction Index. Results: From a total of 216 patients included, improvement was observed in average scores of pain (201.2%), disability (39.7%), physical quality of life (42%), and mental quality of life (37.8%). Among these patients, 57.7% reached or surpassed the minimal clinically important difference (MCID) for ODI, 57.7% for the SF-36 pain component, 59.7% for the SF-36 physical component summary, and 50.5% achieved or surpassed the MCID for the SF-36 mental component summary. Conclusions: Surgery produced a significantly positive impact on pain, disability, and quality of life of patients. Overall, 82.5% of the patients were satisfied.

RESUMO Objetivo: Descrever o impacto da cirurgia na dor, incapacidade, qualidade de vida e a satisfação global do paciente numa amostra unificada de pacientes portadores de DDL. Métodos: Análise retrospectiva de dados colhidos prospectivamente em pacientes operados no período de janeiro de 2014 a março de 2017, que tivessem avaliação pré-operatória e pelo menos uma avaliação pós-operatória entre 6 e 12 meses com os questionários de ODI, SF-36 e o ISP. Resultados: Um total 216 pacientes preenchia os critérios de inclusão. Houve melhora no escore médio de dor (201,2%), incapacidade (39,7%), qualidade de vida física (42%) e mental (37,8%). Da amostra, 57,7% alcançaram o MCID de dor, 59,7% de ODI, 59,7% 50,5% de PCS e 50,5% de MCS; 82,5% dos pacientes se consideraram "Satisfeitos". Conclusões: O efeito da cirurgia foi amplamente favorável na dor, incapacidade e qualidade de vida dos pacientes portadores de DDL. Estes dados podem servir de guia para aconselhamento pré-operatório quanto às perspectivas de sucesso.

Evaluation Index of Enhanced Recovery After Surgery: Status and Progress of Patient Report Outcomes in Thoracic Surgery / 中国肺癌杂志

The good effect of enhanced recovery after surgery is reflected in reducing the incidence of perioperative complications and shortening the hospital stays. However, the concern for the management of perioperative patients and the quality of life of patients after surgery is not high enough. Evaluating clinical efficacy from the perspective of patient-reported data has received increasing attention. Combining the current domestic and foreign research results on the outcome of patient reports, this article systematically discusses the concept connotation, research significance, and clinical application of thoracic surgery for the outcome of patient reports with proposing a clinical outcome research model that draws on foreign patient reports to develop Chinese characteristics. Combine the related research of discipline characteristics, and summarize and analyze the existing literature reports.
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A practical guide to understanding, using and including patient reported outcomes in clinical trials in ovarian cancer / 부인종양

Health related quality of life (HRQOL) is a key priority for patients with ovarian cancer as there is significant morbidity associated with the disease and the treatment. It is therefore essential to include measures of HRQOL and patient reported outcomes (PROs) in all clinical trials and ideally report them in the initial manuscript. The results of these analyses help interpret the primary trial endpoints which are typically progression free survival and overall survival from the perspective of the patients, but can also assist with regulatory approval of new drugs and inform future patients regarding the potential benefits and downsides of the treatment as well as help support clinical recommendations. Including PROs in clinical trials allows patient-defined clinical benefits to be assessed in parallel to traditional survival outcomes to provide a more holistic overview and aid in the interpretation of the trial results. Given the importance of these instruments in clinical trials, greater effort is required to improve the appropriate inclusion, quality of analyses and reporting of PROs. It is also essential that all clinicians understand the intricacies of the selection, implementation and interpretation of these measures of HRQOL and PRO's and how important their contribution is to clinical trials as well as clinical practice. This review is a practical guide for clinicians to gain a better understanding of PROs and how they can be incorporated into ovarian cancer trials.