Introduction
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBD). Each class and type of medication available for the treatment of IBD has distinct ...characteristics and long-term effects that a patient may consider. We present the results of qualitative research that aimed to develop a descriptive framework that outlines the most relevant disease and/or treatment attributes for IBD treatment decisions and focuses on the patient perspective.
Methods
This research employed a three-step approach: a literature review to identify a broad list of attributes, a focus group meeting including patients and clinicians to assess the relevance of the attributes, and two rounds of voting to name and define each attribute. The literature review was used to develop the initial list of attributes. Although the same attributes were defined for both UC and CD, the relative importance of each attribute to UC or CD was considered. The list of attributes was discussed and evaluated in the focus group meeting, which included eight patient representatives and nine gastroenterologists. Using feedback elicited from the focus group meeting, the research team developed a draft of the descriptive framework that grouped the attributes into domain subsets. All members of the focus group participated in two subsequent rounds of structured, online voting, which was used to refine the wording to name and define each attribute. Additionally, participants ranked all the attributes included in the descriptive framework to suggest which attributes were less relevant and could be omitted.
Results
Among 574 publications retrieved from the databases and registries, we identified 32 eligible publications, and an initial list of attributes was developed. This list was refined during the focus group meeting, resulting in a draft descriptive framework of attributes within subsets of domains. The final descriptive framework was developed based on structured rounds of online voting to further refine attribute names and definitions. In the final descriptive framework, a total of ten attributes were identified: abdominal pain, other disease-related pain, bowel urgency, fatigue, risk of cancer and serious infections within the next 10 years, risk of mild to moderate complications, aesthetic complications related to treatment, emotional status, sexual life, and social life and relationships. These attributes were distributed across three domains: efficacy, complications and risk, and health-related quality of life.
Conclusions
Through the identification of the ten most relevant attributes that influence patient decision making for IBD treatments, we developed a descriptive framework that should be considered by physicians when discussing IBD treatment options with their patients. The results of our qualitative research may also be helpful for the development of future IBD clinical studies and quantitative research.
Abstract
Background and Aims
As more therapeutic options with their own characteristics become available for inflammatory bowel disease IBD, drug development and individual treatment decision-making ...needs to be tailored towards patients’ preferences and needs. This study aimed to understand patient preferences among IBD patients, and their most important treatment outcomes and unmet needs.
Methods
This qualitative study consisted of 1 a scoping literature review, 2 two focus group discussions FGDs with IBD patients n = 11 using the nominal group technique, and 3 two expert panel discussions.
Results
IBD patients discussed a multitude of unmet needs regarding their symptoms, side-effects, and psychological and social issues for which they would welcome improved outcomes. In particular, IBD patients elaborated on the uncertainties and fears they experienced regarding the possible need for surgery or an ostomy, the effectiveness and onset of action of their medication, and the medication’s long-term effects. Furthermore, participants extensively discussed the mental impact of IBD and their need for more psychological guidance, support, and improved information and communication with healthcare workers regarding their disease and emotional wellbeing. The following five characteristics were identified during the attribute grading as most important: prevent surgery, long-term clinical remission, improved quality of life QoL, occurrence of urgency and improved labour rate.
Conclusions
This study suggests that IBD drug development and treatment decision-making are needed to improve IBD symptoms and adverse events that significantly impact IBD patients’ QoL. Furthermore, this study underlines patients’ need for a shared decision-making process in which their desired treatment outcomes and uncertainties are explicitly discussed and considered.
La dieta desequilibrada impacta en el medioambiente a través de la agricultura, como un sector de alta emisión de gases de efecto invernadero (GEI) que usa el 70% de las reservas mundiales de agua. ...Además, existe una desigualdad en la distribución y uso de este recurso que se acrecentó durante el confinamiento por coronavirus. El objetivo de esta investigación fue identificar los cambios en la dieta y el cuidado del agua en la zona centro de México durante la pandemia de COVID-19. Encontrándose un aumento en el consumo de verduras (71.7%) y frutas (64.9%). En el cuidado del agua en casa la atención de fugas (58.4%) y regulación del tiempo de baño en regadera (54.5%) mostraron un incremento. Así mismo, se identificaron grupos caracterizados por acciones dirigidas a una alimentación adecuada y menos contaminante, un mejor cuidado del agua y la percepción de beneficios en la participación del cuidado del medio ambiente. La emisión de CO2 semanal de la dieta permitió identificar características del consumo de alimentos durante pandemia y una participación hacia mejorar el ecosistema. Dando bases para plantear estrategias que partan de las actividades que llevan a cabo las personas o que fomenten una mayor incidencia de estas.
Measuring quality of care (QoC) from a patient's perspective is becoming increasingly important in inflammatory bowel disease.
The objective of this study was to determine whether patients' ...evaluations of QoC correlate with better inflammatory bowel disease outcomes.
A survey including patients' characteristics, a decalogue of QoC indicators, and self-reported disease outcomes was completed by Spanish patients with inflammatory bowel disease. A QoC index (QoCI) was constructed with the sum of the "yes" answers in the decalogue. We evaluated the correlation of QoCI with outcomes. A sub-analysis comparing patients with high QoCI vs those with low QoCI was performed (QoCI = 10 or ≤ 7).
Seven hundred and eighty-eight questionnaires were analyzed. Mean age of participants was 43.4 years (63% women). Mean QoCI was 8.1 (± 2.4). The QoCI correlated significantly with activity of the disease, number of flares, emergency/unscheduled visits, and disease control. Patients scoring in the first QoCI quartile reported a decreased rate of moderate/severe disease (34.8% vs 55.3%, p < 0.001), fewer numbers of flares (p < 0.001), and fewer emergency/unscheduled visits (p < 0.001) compared with those in the lower QoCI quartile. The high QoC group also reported better disease control.
Patient-evaluated QoC correlates with better outcomes. Evaluation of QoC by patients may be useful to detect inadequate care and improve inflammatory bowel disease outcomes.
Information regarding patients' needs, fears and experiences/perceptions in the perioperative setting is limited. Through two focus groups, we explored the needs, fears and experiences of patients ...who had recently undergone, or were scheduled for, surgery under general anaesthesia, with regard to the entire perioperative process.
Adults were invited to participate in a focus group if they had (a) undergone abdominal or gynaecological surgery with general anaesthesia in the past 4 months (focus group 1) or (b) been indicated for abdominal or gynaecological surgery and were waiting for the assigned surgery date (focus group 2). Discussions were audio recorded and, through thematic analysis, patients' needs and experiences/perceptions regarding perioperative surgical stages were obtained/coded. Analysis of code co-occurrence was performed using a codes matrix.
Focus groups consisted of 13 females, 1 male (50% aged >45 years). The immediate postoperative period generated the highest number of co-occurrences, followed by the indication of surgery. The most frequent code was the need for information, especially at the indication of surgery, the pre-anaesthesia clinic and in the postoperative period. Fears were described particularly at the indication of surgery, the waiting period, the surgical room, anaesthesia induction and the postoperative period, particularly after hospital discharge; pain was cited most commonly in the postoperative period. Stress/anxiety and emotional impact were also cited in the postoperative period including home arrival.
Information collected in these patients' focus groups should inform future research and healthcare planning. Patients demand receiving more comprehensive and understandable information and more involvement in several steps; this could reduce fears and stress/anxiety described across the perioperative process. Importantly, findings also extend to the postoperative period and home arrival.
El aumento del turismo emisor en China está relacionado con su desarrollo económico, social y el rápido crecimiento económico de ciertas zonas del país. Estos factores han cambiado el origen interno ...de la emisión de turistas. Los estudios realizados sobre el turismo emisor chino hasta ahora se han basado en el supuesto de que los mercados emisores nacionales y regionales eran homogéneos. El objetivo de este estudio es medir las variaciones en la interacción de las campañas en redes sociales por parte de una marca destino internacional (DMO) entre los diferentes niveles Tier de las ciudades chinas. Hemos aplicado un modelo de regresión Tobit para determinar las relaciones lineales entre el nivel Tier de la ciudad y el número de usuarios que interactúan en las campañas de la marca destino en Sina Weibo, la segunda red social más influyente de China. Los resultados confirman que, en términos de segmentación geográfica, las ciudades de nivel 2, 3 y 4 se asocian con una mayor interacción en las campañas de la marca destino en comparación con las ciudades de nivel 1. De acuerdo con los resultados de este estudio, la localización en ciudades de nivel inferior es un factor importante para lograr un mayor número de usuarios que interactúen en las campañas de las marcas destino y por tanto ofrece una oportunidad para conectar con un mayor número de visitantes potenciales. Estos resultados pueden ayudar a las marcas destino internacionales a desarrollar una segmentación geográfica efectiva en sus campañas de promoción a través de las redes sociales en China.
Abstract
Background and Aims
The utility of real-world data is dependent on the quality and homogeneity of reporting. We aimed to develop a core outcome set for real-world studies in adult patients ...with inflammatory bowel disease IBD.
Methods
Candidate outcomes and outcome measures were identified and categorised in a systematic review. An international panel including patients, dietitians, epidemiologists, gastroenterologists, nurses, pathologists, radiologists, and surgeons participated in a modified Delphi consensus process. A consensus meeting was held to ratify the final core outcome set.
Results
A total of 26 panellists from 13 countries participated in the consensus process. A total of 271 items 130 outcomes, 141 outcome measures in nine study domains were included in the first-round survey. Panellists agreed that real-world studies on disease activity should report clinical, endoscopic, and biomarker disease activity. A disease-specific clinical index Harvey–Bradshaw Index, Partial Mayo Score, Simple Clinical Colitis Activity Index should be used, rather than physician global assessment. In ulcerative colitis UC, either the UC Endoscopic Index of Severity or the Mayo Endoscopic Score can be used, but there was no consensus on an endoscopic index for Crohn’s disease, nor was there consensus on the use of the presence of ulcers. There was consensus on using faecal calprotectin and C-reactive protein. There was no consensus on the use of histology in real-world studies.
Conclusions
A core outcome set for real-world studies in IBD has been developed based on international multidisciplinary consensus. Its adoption will facilitate synthesis in the generation of real-world evidence.
Heterogeneity in demographic and outcomes data with corresponding measurement instruments (MI) creates barriers for data pooling and analysis. Several core outcome sets developed in inflammatory ...bowel disease (IBD) homogenise outcomes data. A parallel Minimum Data Set (MDS) for baseline characteristics is lacking. We conducted a systematic review to develop the first MDS.
A systematic review of observational studies from 3 databases (2000 to 2021). Titles and abstracts were screened; full-text articles reviewed, and data extracted by two reviewers. Baseline data were grouped into 10 domains: demographics, clinical features, disease behaviour/complications, biomarkers, endoscopy, histology, radiology, healthcare utilisation and patient-reported data. Frequency of baseline data and MI within respective domains are reported.
From 315 included studies (600,552 subjects), most originated from Europe (196; 62%), and North America (59; 19%), and were published between 2011 and 2021 (251; 80%). The most frequent domains were demographics (311; 98.7%) and clinical (289; 91.7%); 224 (71.1%) studies reported on the triad of sex (306; 97.1%), age (289; 91.7%) and disease phenotype (231; 73.3%). Few included baseline data for radiology 19; 6%), healthcare utilisation (19; 6%) and histology (17; 5.4%). Ethnicity (19; 6%), race (17; 5.4%) and alcohol/drug consumption (6; 1.9%) were least reported demographics. From 25 MI for clinical disease activity, Harvey Bradshaw Index (n=53) and Mayo score (n=37) were most frequently used.
Substantial variability exists in baseline population data reporting. These findings will inform a future consensus for MDS in IBD to enhance data harmonisation and credibility of real-world evidence.
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.
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