Abstract
Background
Heterogeneity exists in reported outcomes and outcome measurement instruments OMI from observational studies. A core outcome set COS for observational and real-world evidence RWE ...in inflammatory bowel disease IBD will facilitate pooling large datasets. This systematic review describes and classifies clinical and patient-reported outcomes, for COS development.
Methods
The systematic review of MEDLINE, EMBASE, and CINAHL databases identified observational studies published between 2000 and 2021 using the population exposure outcome PEO framework. Studies meeting eligibility criteria were included. After titles and abstracts screening, full-text articles were extracted by two independent reviewers. Primary and secondary outcomes with corresponding OMI were extracted and categorised in accordance with OMERACT Filter 2.1 framework. The frequency of outcomes and OMIs are described.
Results
From 5854 studies, 315 were included: 129 41% Crohn’s disease CD, 60 19% ulcerative colitis UC, and 126 40% inflammatory bowel disease IBD studies with 600 552 participants. Totals of 1632 outcomes and 1929 OMI were extracted mainly from medical therapy 181; 72%, surgical 34; 11%, and endoscopic 6; 2% studies. Clinical and medical therapy-related safety were frequent outcome domains recorded in 194 and 100 studies. Medical therapy-related adverse events n = 74 and need for surgery n = 71 were the commonest outcomes. The most frequently reported OMI were patient or event numbers n = 914, Harvey-Bradshaw Index n = 45, and Montreal classification n = 42.
Conclusions
There is substantial variability in outcomes reporting and OMI types. Categorised outcomes and OMI from this review will inform a Delphi consensus on a COS for future RWE in IBD. Data collection standardisation may enhance the quality of RWE applied to decision-making.
We document and provide photographic evidence of a group of spotted wrens (Campylorhynchus gularis), a Mexican endemic, obtaining Chrysomya carrion fly maggots inside of a sheep carcass in a ...disturbed xeric scrubland in the Barranca de Metztitlán Biosphere Reserve, Hidalgo, Mexico. We document for the first time the consumption of maggots that were inside a livestock carcass as food resource for the genus Campylorhynchus. This evidence indicates the potential of the genus Campylorhynchus for the use of ecological subsidies derived from human activity.
The COVID-19 pandemic has led to a change in healthcare models. The aim of this study was to evaluate patient acceptance of telehealth as an alternative to physical consultations, and to identify ...factors predicting higher satisfaction. This was an observational, cross-sectional, multi-center, international study. All consecutive patients for whom telehealth was used in consultations between April and July 2020 were considered for inclusion. The validated Telehealth Usability Questionnaire (TUQ) was used as a model to measure patient acceptance. Overall, 747 patients were observed, of whom 721 agreed to participate (96·5%). The TUQ showed that 86·9% of patients agreed that telehealth was useful; 85·2% supported the interface quality and 81·4% endorsed the interaction quality. Patients aged > 60 y were less likely to agree with the use of telehealth (p < 0·05). A web-based prediction tool was generated to calculate global satisfaction and to identify patients more likely to feel comfortable with telehealth. Telehealth is feasible and allows consultations that are satisfactory for patients. Technological advancements could ease safe implementation of telehealth into everyday practice. Adequate patient selection can be useful to ensure that the ideal strategy is used for each individual during and after the pandemic.
Health technology assessment (HTA) is intended to determine the value of health technologies and, once a technology is recommended for funding, bridge clinical research and practice. Understanding ...the values and beliefs expressed by patients and health professionals can help guide this knowledge transfer and work toward managing the expectations of end users. We gathered patient and patient group leader experiences to gain insights into the roles that patients and patient advocacy groups are playing. We argue that through partnerships and co-creation between HTA professionals, researchers and patient advocates we can strengthen the HTA process and better align with service delivery where person-centered care and shared decision making are key elements. Patient experiences and knowledge are important to the democratization of evidence and the legitimacy of HTAs. Patient preference studies are used to balance benefits with potential harms of technologies, and patient-reported outcomes (PROs) can measure what matters to patients over time. A change in culture in HTA bodies is occurring and with further transformative thinking patients can be involved in every step of the HTA process. Patients have a right to be involved in HTAs, with patients' values central to HTA deliberations on a technology and where patients can provide valuable insights to inform HTA decision-making; and in ensuring that HTA methodologies evolve. By evaluating the implementation of HTA recommendations we can determine how HTA benefits patients and their communities. Our shared commitment can positively effect the common good and provide benefits to individual patients and their communities.
Analgesics are widely used, but evidence regarding whether their use increases the risk of inflammatory bowel disease (IBD) flares or complications is unclear. Therefore, self-medication with ...analgesics in IBD is usually not recommended. The aim of this study was to explore the prevalence of self-medication with analgesics in a cohort of ulcerative colitis (UC) patients and to identify reasons and factors associated with self-medication.
This cross-sectional study included consecutive unselected adult patients with UC. Participants were asked to complete an anonymous web-based survey with multiple-choice questions and closed responses. No clinical data were collected.
A total of 546 patients (61.2% women, mean age 39.9 years) completed the survey. The prevalence of self-medication with analgesics was 49.8% (272/546). Paracetamol (45.2%) and metamizole (21.2%) were the most frequently used drugs; frequencies of self-medication were <5% for other analgesics (nonsteroidal anti-inflammatory drugs, opioids). The most frequent reasons for self-medication were the need for quick symptom relief and that it had been agreed with/prescribed by the treating physician. Multivariable analysis identified female sex (odds ratio OR=1.9), sick leave (OR=2.2), treatment with intravenous drugs (OR=2.9), and emergency room visit (OR=2.3) as variables associated with self-medication, whilst follow-up by a nurse was associated with less self-medication (OR=0.6).
The frequency of self-medication with analgesics in UC patients is high and appears to be associated with variables suggesting worse disease control. Closer follow-up, including a specialized nurse, could decrease self-medication. Strategies to improve disease control, including close monitoring of symptoms such as pain, are needed.
Los analgésicos son medicamentos ampliamente utilizados, pero las evidencias sobre si su uso aumenta el riesgo de brotes o complicaciones de la enfermedad inflamatoria intestinal (EII) no están claras; por lo tanto, en general, no se recomienda la automedicación con analgésicos en la EII. El objetivo de este estudio fue explorar la prevalencia de automedicación con analgésicos en una cohorte de pacientes con colitis ulcerosa (CU) e identificar los motivos y los factores asociados a la automedicación.
En este estudio transversal se incluyeron pacientes adultos con CU consecutivos y no seleccionados. Se pidió a los participantes que completasen una encuesta anónima por Internet con preguntas de elección múltiple y respuestas cerradas. No se recogieron datos clínicos.
Completaron la encuesta un total de 546 pacientes (61,2% mujeres; edad media 39,9 años). La prevalencia de automedicación con analgésicos fue del 49,8% (272/546). El paracetamol (45,2%) y metamizol (21,2%) fueron los fármacos utilizados con más frecuencia; la tasa de automedicación con otros analgésicos (antiinflamatorios no esteroideos, opioides) fue <5%. Los motivos más frecuentes para la automedicación fueron la necesidad de alivio sintomático rápido y que había sido acordado con/prescrito por el médico responsable del tratamiento. El análisis multivariante identificó el sexo femenino (odds ratio OR=1,9), la baja laboral (OR=2,2), el tratamiento con fármacos intravenosos (OR=2,9) y las visitas a urgencias (OR=2,3) como variables asociadas a la automedicación, mientras que el seguimiento por el personal de enfermería se asoció a menos automedicación (OR=0,6).
La frecuencia de automedicación con analgésicos en pacientes con CU es alta y parece estar asociada a variables que sugieren peor control de la enfermedad. Un seguimiento más estrecho, incluyendo personal de enfermería especializado, podría disminuir la automedicación. Se necesitan estrategias para mejorar el control de la enfermedad, incluyendo un seguimiento estrecho de síntomas como el dolor.
Background: Immune-mediated inflammatory diseases (IMID) are chronic and highly disabling diseases that share inflammatory sequences and immunological dysregulations. Considered as a disease in ...itself, the pre- valence of IMID is virtually unknown. The aim of this study was to assess the prevalence of 10 selected UDI, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, systemic lupus erythematosus, hidradenitis suppurativa, sarcoidosis and uvei- tis in Spain.
Methods: A cross-sectional epidemiological study of point prevalen- ce was made. This study was carried out through a series of computerized interviews in households chosen at random in 17 autonomous communities in Spain. A structured questionnaire was used to determine the frequency of diagnosis and the concurrence of 10 IMID in the respondents and other indi- viduals belonging to the same family nucleus. The point prevalence estimates were used and compared with the objective of determining the frequency of IMID by age, sex and communities. The data were processed using Excel 2016 (Microsoft, Redmond, WA, USA) and the SPSS V.019 system (IBM Corp. Armonk, NY, USA) for statistical analysis using the usual statistical tests in this type of studies.
Results: Of the 7,980 respondents, 510 were diagnosed with an IMID, representing a cross-sectional study of 6.39% (95% CI: 6.02-6.76). One, two, three or more members of the family were affected in 87.2%, 7.8% and 5% of positive relatives in IMID, respectively. The most recurrent diseases were psoriasis (2.69% 95% CI: 2.32-3.06) and rheumatic arthritis (1.07% 95% CI: 0.70-1.44). There were differences in prevalence due to sex (p = 0.004) and age (p = 0.000). No significant differences were identified related to geo- graphic location (p = 0.819). Attendance of at least 2 IMID was reported in
8.9% of respondents.
Conclusions: The overall prevalence was of the IMID studied was 6.39%, psoriasis being the most frequent with 2.69%. This study constitutes an initial step to consider IMID as an independent disease within the health system..
Fundamentos: Las enfermedades inflamatorias inmunomediadas (IMID) son enfermedades crónicas y altamente discapacitantes que comparten secuencias inflamatorias y desregulaciones inmunológicas. Considerada como una enfermedad en sí, la prevalencia de la IMID es prácticamente des- conocida. El objetivo de este trabajo fue valorar la prevalencia de 10 IMID seleccionadas, incluyendo artritis reumatoide, psoriasis, artritis psoriásica, espondilitis anquilosante, colitis ulcerosa, enfermedad de Crohn, lupus erite- matoso sistémico, hidrosadenitis supurativa, sarcoidosis y uveítis en España.
Métodos: Se hizo un estudio epidemiológico transversal de prevalencia puntual. Este estudio llevó a cabo a través de una serie de entrevistas informa- tizadas en hogares elegidos al azar en 17 comunidades autónomas en España. Mediante un cuestionario estructurado se determinó la frecuencia de diagnós- tico y las concurrencias de 10 IMID en los encuestados y otros individuos pertenecientes al mismo núcleo familiar. Las estimaciones de prevalencia pun- tual se utilizaron y compararon con el objetivo de determinar la frecuencia de IMID por edad, sexo y comunidades. Los datos fueron procesados utilizando el programa Excel 2016 (Microsoft, Redmond, WA, USA) y el sistema SPSS V.019 (IBM Corp. Armonk, NY, USA) para el análisis estadístico utilizando los test estadísticos habituales en este tipo de estudios.
Resultados: : De los 7.980 encuestados, 510 fueron diagnosticados con una IMID, lo que representa un estudio transversal de un 6,39% (95% ci:
6,02-6,76). Uno, dos, tres o más miembros de la familia estaban afectados en un 87,2%, 7,8% y 5% de familiares positivos en IMID, respectivamente. Las enfermedades más recurrentes fueron psoriasis (2,69% 95% ci: 2,32-3,06) y artritis reumática (1,07% 95% ci:0,70-1,44). Se observaron diferencias en la prevalencia debidas al sexo (p=0,004) y edad (p=0,000). No se identi- ficaron diferencias significativas relacionadas con la localización geográfica (p=0,819). Se reportó concurrencia de al menos 2 IMID en un 8,9% de en- cuestados.
Conclusiones: La prevalencia global fue de las IMID estudiadas fue del
6,39 % siendo las mas frecuentes la psoriasis con el 2,69%. Este estudio cons- tituye un paso inicial para considerar la IMID como una enfermedad indepen- diente dentro del sistema sanitario
Objective: To propose a theoretical model to measure and intertwine the human food activities that affect the loss or achievement of ecosystem balance.
Methodology: Adocumentary review was made on ...the current eating pattern, its determinants, and the impact on planetary health.
Results: The transformation of the eating act, determined by different social, economic, and cultural factors, has given rise to unbalanced diets with high consumption of meat, which demand environmental systems. Parallel to this, rates of chronic non-communicable diseases have been increasing, creating a negative effect on planetary health.
Limitations: This study formulates a theoretical proposal that allows addressing the complexity of the diet and its effect on public and environmental welfare, serving as a guideline for applied analysis.
Conclusions: The MCS provides a broad and critical vi-sion for the analysis and intervention of socioecological difficultiessuch as food, providing scientific bases for health professionals, food production, decision-makers, and public policy developers.
Objetivo: proponer un modelo teórico para dimensionar y entrelazar las actividades alimentarias humanas que inciden en la pérdida u obtención del equilibrio ecosistémico.
Metodología: se efectuó revisión documental sobre el patrón alimentario actual, sus determinantes y el impacto en la salud planetaria.
Resultados: la transformación del acto alimentario, determinada por diferentes factores sociales, económicos y culturales, ha dado lugar a dietas desequilibradas con un alto consumo de carne, que exigen a los sistemas ambientales. Paralelo a esto, las tasas en enfermedades crónicas no transmisibles han ido aumentando, creando un efecto negativo en la salud planetaria.
Limitaciones: el presente estudio formula una propuesta teórica que permita abordar la complejidad de la dieta y su efecto en el bienestar público y ambiental, sirviendo como pauta para análisis aplicados.
Conclusiones: el MCS otorga una visión amplia y crítica para el análisis e intervención de dificultades socioecológicos como lo es la alimentación, dando bases científicas para profesionales de la salud, producción de alimentos, tomadores de decisiones y desarrolladores de políticas públicas.
Objetivo: proponer un modelo teórico para dimensionar y entrelazar las actividades alimentarias humanas que inciden en la pérdida u obtención del equilibrio ecosistémico. Metodología: se efectuó ...revisión documental sobre el patrón alimentario actual, sus determinantes y el impacto en la salud planetaria. Resultados: la transformación del acto alimentario, determinada por diferentes factores sociales, económicos y culturales, ha dado lugar a dietas desequilibradas con un alto consumo de carne, que exigen a los sistemas ambientales. Paralelo a esto, las tasas en enfermedades crónicas no transmisibles han ido aumentando, creando un efecto negativo en la salud planetaria. Limitaciones: el presente estudio formula una propuesta teórica que permita abordar la complejidad de la dieta y su efecto en el bienestar público y ambiental, sirviendo como pauta para análisis aplicados. Conclusiones: el MCS otorga una visión amplia y crítica para el análisis e intervención de dificultades socioecológicos como lo es la alimentación, dando bases científicas para profesionales de la salud, producción de alimentos, tomadores de decisiones y desarrolladores de políticas públicas
PDF
