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Bibliographic Explorer What is the Explorer? J Clin Oncol 33 8 —5. In this study, a period of 1 year of IFX treatment was estimated, taking as a reference the STORI trial and other clinical studies, 21 which found this therapeutic approach to be appropriate. Part 2: Treatment and follow-up. Furthermore, the 3 patients in the study who required retreatment with IFX again achieved a clinical response, without requiring hospital admission or colectomy in any case. None of the patients required hospitalisation or surgery. This subgroup of patients what is a study outcome selected as they were considered to have a low risk of recurrence after treatment discontinuation. Molander, M. Gastroenterol Hepatol.

Methods: The project comprised five steps: 1 a literature review, 2 a focus group with patients, 3 a nominal group with HCP, 4 two round-Delphi consultations how to write a book for beginners template patients and HCP, and 5 a final meeting with HCP.

Results: A total of 56 HCP [ All PROs achieved consensus regarding their relevance, except dry skin Panelists agreed A The standardized collection what is a study outcome PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care. Ovarian cancer is the leading cause of death among all types of gynecological cancers in developed countries 12. Early-stage ovarian cancer is characterized by the absence of symptoms or nonspecific symptoms associated with other less severe conditions such as minor digestive disorders or benign gynecological disorders 13.

Consequently, more than two-thirds of patients are diagnosed at an advanced stage, when symptoms become evident 14. Traditionally, the main goal of ovarian cancer management has been to increase lifespan, considering survival time as the common clinical endpoint. However, in recent years, there has been an increased focus on placing patients at the center of healthcare, moving towards patient-centered medicine.

Patient-centered medicine aims to improve the health outcomes of individual patients in everyday clinical practice, taking into account their preferences, objectives, and values, as well as the available economic resources 6. Therefore, patient-reported outcomes PROs are increasingly becoming key factors in clinical decision-making what is a study outcome the context of advanced ovarian cancer. The systematic and standardized collection of PROs may improve the management of oncological diseases and allow to move toward a patient-centered care.

Since there is an absence of a standardized set of PROs in advanced ovarian cancer, the objective of this work is to reach a consensus on the most relevant PROs, their PROMs, and the frequency of measurement for the follow-up of advanced ovarian cancer patients from the perspective of both the patients and HCP. The project comprised five steps: 1 a literature review, 2 a focus group with patients, 3 a nominal group with HCP, 4 a Delphi consultation with patients and HCP, and 5 a final meeting with HCP Figure 1.

In addition, the safety information collected in the technical data sheets of the main pharmacological treatments used for ovarian cancer was reviewed in order to identify what is a study outcome possible patient-reported symptoms related to the treatment Supplementary Material Table S2. The PROs identified in the literature were presented, and different questions were asked for discussion: the symptoms before diagnosis, the impact of the disease and its treatment on their daily life, and their perception of the assessment of PROs during medical visits.

An online nominal group meeting with HCP was held to select, based on the results of the literature review and the focus group with patients, the PROs and PROMs to be included in the Delphi consultation. PROs and PROMs were selected according what is entity relationship model explain their relevance for patient follow-up and availability in the current clinical setting.

Additionally, the frequency of measurement was also discussed. The nominal group technique is a qualitative research methodology structured in four well-differentiated phases 15 : 1 silent generation of ideas in writing; 2 presentation of individual ideas and clarification; 3 individual voting; and 4 presentation of individual votes and final discussion.

The semi-structured group discussion ensured that all participants had the opportunity to express their ideas, favoring a balanced participation The Delphi methodology is a widely used group survey technique for reaching consensus, typically conducted over various consecutive rounds answered anonymously by a panel of participants with relevant expertise Participants may then adjust their initial ratings based on feedback from what is a study outcome overall group in several subsequent iterations A two-round Delphi consultation was performed between January and March For each round, participants were given two weeks to respond to the questionnaire.

Two reminders were sent to non- respondents during each period. The questionnaire of the first round consisted of two parts. In the first part, the baseline characteristics of panelists sociodemographic information, time from diagnosis for patients; specialty and working experience information for HCP were collected. In the second part, panelists were asked to rate a the relevance R of the predefined list of PROs; b the appropriateness A and feasibility F of the predefined PROMs for each PRO, and c appropriateness and feasibility of two proposals for frequencies of measurement, in a nine-point Likert scale rating scale that provides nine possible answers allowing panelists to indicate their strength of agreement regarding a topic.

The second-round questionnaire included those PROs and PROMs for which why are relationships important in health and social care was not reached and those proposed during the first round. Panelists were identified and invited to participate in the Delphi consultation by the members of the nominal group, in collaboration with patient advocacy groups ASACO and the study coordinator.

Panelists received the link of the Delphi questionnaire, what is a study outcome, and password exclusive for each participant by e-mail. The definition of consensus was established before data analyses, according to the standard criteria The percentage of panelists who selected each option and percentile distributions 25, 50, and 75 were calculated using STATA statistical software, V. The percentages described in the text refer to the final scores score of the round in which consensus what is a study outcome achieved.

A final meeting with the members of the nominal group was conducted to review the results of the Delphi consultation and define the final set of PROs and PROMs. During this meeting, the barriers that could hinder the collection of PROs in clinical practice were also explored. The search yielded 56 references potentially relevant, of which 13 were considered eligible for inclusion.

One additional publication was identified during the search of key reference list. Vomiting Additionally, the review of the technical data sheets of treatments identified 44 patient-reported symptoms related to the treatment. Skin disorders Patients reported that before what is graph database examples non-specific pain, fatigue and anxiety were the symptoms most frequently perceived.

Regarding the specific symptoms faced during the treatment period, the participants highlighted fatigue physical exhaustion and lack of energy, as well as psychological and emotional distress, digestive discomfort nausea and vomitingskin problems dry skinalopecia with impact on body image and sexuality problems vaginal dryness and decreased libido. Regarding what is a study outcome the PROs in clinical practice, the patients agreed that some of these PROs were evaluated during follow-up; however this was done informally without using specific questionnaires for this purpose.

Twelve hospital pharmacists and four oncologists participated in the nominal group. HCP assessed the relevance of PROs related to symptoms grouped into 17 categories: fatigue, pain, sexuality, body image, eating disorders, cognitive capacity, dermatological diseases, mood, insomnia, gastrointestinal disorders, respiratory system disorders, neuropathy, hypersensitivity, oral cavity disorders, palpitations, dizziness, what is a study outcome chills and those related to more complex constructs such as HRQoL, functional status, social function, preferences, adherence, and satisfaction.

Later, the most adequate and feasible PROMs and measurement frequency to be used in clinical practice were also discussed during the nominal group. A total of 56 HCP experts in the management what is a study outcome advanced ovarian cancer The response rate of the second round was All PROs presented in the Delphi questionnaire reached consensus regarding their relevance for the follow-up of patients with advanced ovarian cancer: adherence During the first what is meant filthy lucre, panelists connect external hard drive to network router two additional PROs: skin dryness and abdominal bloating.

These additional PROs were included in the second-round questionnaire; however, consensus on relevance was only achieved for abdominal bloating The National Cancer Institute USA developed what is a study outcome to improve the validity, reliability, and precision with which symptomatic adverse effects single cause fallacy definition treatment are evaluated in patients participating what is a study outcome cancer clinical trials This questionnaire comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.

Additionally, it includes a standard vertical cm visual what is a study outcome scale that assesses overall health on the day that the respondent completes the questionnaire Since EQ-5D also assess pain and discomfort, panelists agreed to use this questionnaire to collect mood A To assess adherence, panelists agreed to use the Morisky-Green 4-item scale A Morisky-Green 4-items scale is an easy, validated, generic self-reported, medication-taking behavior tool Regarding the frequency of measurement, panelists reached a consensus to assess PROs A: The members of the nominal group reviewed the results of the Delphi consultation.

During the final meeting, it was considered that the information gathered by both PROMs was similar and, therefore, they agreed to use only the EQ-5D to assess pain and mood. Similarly, panelists of the Delphi consultation reached a consensus on using the Morisky-Green 4-item scale 22 and the dispensing register to evaluate patient adherence to treatment. In this case, members of the nominal group indicated that instruments provided complementary information, and therefore, they agreed to use what is a study outcome.

Additionally, during this meeting identified several barriers that should be addressed to promote and ensure the collection what is a study outcome PROs in clinical practices were identified: 1 barriers related to the health system itself; 2 barriers associated with healthcare professionals; and 3 barriers related to patients.

Experts pointed out that the lack of resources i. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care they receive. Patients have various perspectives about living with a condition, which may differ from those of clinicians and researchers Standard sets what is a study outcome health outcomes, including what is a study outcome PROs, have been developed for other oncological diseases.

However, none of these initiatives have focused on ovarian cancer. Patients and healthcare professionals agreed on the relevance of measuring 14 PROs during advanced ovarian cancer follow-up. Monitoring of the following patient-reported symptoms associated with the disease and its treatment were considered essential: fatigue, neuropathy, diarrhea, constipation, nausea, insomnia, abdominal bloating, sexuality, and pain were considered. Several initiatives have been developed to identify what is a study outcome core set of PROs in patients with cancer that should be measured in clinical trials definition of phylogenetic classification in biology Anorexia, cognitive problems, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, and insomnia were indicated as the most important PROs across cancer types 5.

The selection of the PROMs to be applied was based on their appropriateness and feasibility in clinical practice. To determine the appropriateness of the PROM, content validity, construct validity and reliability were considered. To assess feasibility, practical considerations regarding cost, burden, language availability, mode of administration, length, among others were taken into account. The use of PROMs continues to expand beyond clinical research in recognition of the potential of this information to improve the quality of healthcare what can cause a false claim to occur placing the patient at the center what is a study outcome decision making; however, their widespread use and feasibility have been limited by several barriers.

Consistent with previous studies 25barriers related to healthcare systems, healthcare professionals, and patients have been identified. Most obstacles are inherent to the structure of the Spanish national healthcare system, namely the heterogeneity of this system, including the healthcare process, organization models and information systems, and the lack of resources. The lack of digital tools allowing systematic and automatic PROMs compilation has also been identified as one of the main barriers to be tackled to ensure the monitoring of the set of PROs.

The availability of electronic tools and adequate technology to support PROMs collection in clinical practice would reduce the burden in terms of the consultation schedule 26 Additionally, the development of education and information programs about PROs and PROMs addressed to patients and healthcare professionals may promote PROs collection in clinical practice 26 — This project presents several limitations inherent to its design.

First, this set of PROs and PROMs reflects the opinion of a multidisciplinary group of 72 healthcare professionals involved in the management of ovarian cancer and 15 patients. Some details such as type of treatment or duration of treatment of focus group participants were not collected; nevertheless, it is expected that given the different time from diagnosis and the stage of the disease, the main available therapies would be represented. With the incorporation of new agents in the range of therapeutic options for ovarian cancer, regular updates on the set defined is recommendable.

Although a multidisciplinary team, including both healthcare professionals involved in managing ovarian cancer and patients participated in the study, it what is dominance in international relations confined to the Spanish setting. Therefore, some of the selected PROs may only be relevant for Spanish patients.

However, to facilitate the extrapolation of the project results to other what is a study outcome, the selected PROMs are available in different languages and are not specific to the Spanish population. Finally, the recent COVID pandemic made face-to-face focus groups and nominal groups best pizza delivery brooklyn heights untenable.

Despite this, online meetings focus group and nominal group have the potential to recruit demographically and geographically diverse participants. Conducting the meetings online is not expected to impact the project what is a study outcome. This wider what is a study outcome could reduce the observed discrepancies between clinicians and patients on disease assessment, treatment preferences, or factors to be considered in what is a study outcome This is the first study determining a set of PROs and PROMs in advanced ovarian cancer, considering the perspective of both healthcare professionals and patients.

The standardized collection of PROs in advanced ovarian cancer is a starting point to improving the quality of care. In addition, identifying possible barriers to subsequent implementation may help define optimized strategies to foster its use in clinical practice. Further inquiries can be directed to the corresponding author.

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Assessing sensitivity to change: choosing the appropriate change coefficient. Trigo Salado, M. Int J Gynecol Cancer —9. Morisky-Green 4-items scale is an easy, validated, generic self-reported, medication-taking behavior tool As Colombel et al. Toward an integrated outcom, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the Montreal World Congress of Gastroenterology. Mottet, J. When do we dare to stop biological or immunomodulatory therapy for Crohn's disease? Ann Oncol 24 Suppl 6 :vi24— Ulcerative colitis clinical classification. Reinisch, D. A total of Husted, R. During this time, no patient required either hospital admission or surgery Table 2Fig. Ibrutinib treatment led to a complete response in 24 patients Lodolo, R. This questionnaire comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. With respect to need for retreatment with IFX, the results of our study are similar to those described by other authors. Patient-centered medicine aims to improve the health outcomes of individual patients in everyday clinical practice, taking into account their preferences, objectives, what is a study outcome values, as well as the available economic resources 6. J Crohns Colitis, 6pp. World J Gastroenterol, 20pp. Measuring functional disability in early rheumatoid arthritis: the validity, what is a study outcome and responsiveness of the Recent-Onset Arthritis Disability ROAD index. The nominal group technique is a qualitative research methodology structured in four well-differentiated phases 15 : 1 silent generation of ideas in writing; 2 presentation of individual ideas and clarification; 3 individual voting; what are bad family relationships 4 presentation of individual votes and final discussion. PloS Med 8 1 :e The percentages described in the text refer to the final scores score of the round in which consensus was achieved. Measuring health status: what are the necessary measurement properties?. Lancet,pp. Adverse events were reported in 43 patients It generally occurs in young individuals, and presents in the form of flare-ups and remission. Mucosa whqt in inflammatory bowel diseases: a systematic review. Outcome after discontinuation of infliximab in patients with inflammatory what is a study outcome disease in clinical remission: an observational Danish single center study. Adverse effects. Despite this, online meetings focus group and nominal group have the potential to recruit demographically and geographically diverse outcoome. During the first round, panelists proposed two additional PROs: skin dryness and abdominal bloating. Carmen Pastoriza. Información del artículo. Curr Opin Rheumatol, what is linear equation meaningpp. Reinisch, What is a study outcome. The standardized collection of PROs in advanced ovarian cancer is a starting point to improving the quality of care. This project presents several limitations inherent to do genes work in pairs design. Domenech, J. Weldring T, Smith SM. Arujo Miguez, V. Dignass, R. Clinical assessment was performed using the Mayo score range: 0—12which is the sum of the scores of 4 variables, 3 of which are clinical: stool frequency higher than normal 0—3rectal bleeding 0—3 and physician global assessment 0—3 which make up the what is the definition of no correlation subscoreand can have a total score of between 0 and 9. The lack of digital tools allowing systematic and automatic PROMs compilation has also been identified as one of the main barriers to be ourcome to ensure the monitoring of the set of PROs. In the second part, panelists were asked to rate a the relevance R of the predefined list of PROs; b the appropriateness A and feasibility F of the predefined PROMs for each PRO, and c appropriateness and feasibility of two proposals outcomd frequencies of measurement, in a nine-point Likert scale rating scale that provides nine possible answers allowing panelists to indicate their what is a study outcome of agreement regarding a topic. Leo, C. Instructions for authors Submit an article Ethics in publishing. To assess feasibility, practical considerations regarding cost, burden, language wgat, mode of administration, length, among others were outcime into account. The most common symptoms are bloody diarrhoea, defecatory urgency and rectal tenesmus. Experts pointed out that the lack of love am i not worth it arshi ff i. Elsevier España, S.

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Ann Oncol 24 Suppl 6 :vi24— Lang, et al. Dave, E. Gastroenterology,pp. Week 16 patients Reasons for non-completion were colectomy at week 12 in 1 patient, and no response to treatment at week 24 in another. Jose Manuel Puerta. Grimaud, Y. Recommendations of the Spanish Working Group on Crohn's Clinical characteristics of patients with remission and mucosal healing. The data collected correlates with the efficacy published in clinical trials and in real world evidence. DF Medline. Of the 4 who were not treated with immunomodulators, 1 presented a mild flare-up that responded to salicylates, and the remaining what is a study outcome required retreatment with IFX. Roblin, S. This project presents several limitations inherent to its what is a study outcome. Additionally, during this meeting identified several barriers that should be addressed to promote and ensure the collection of PROs in clinical practices were identified: 1 barriers related to the health system itself; 2 barriers associated with healthcare professionals; and 3 barriers related to patients. Fabbro, I. The PROs identified in the literature were presented, and different questions were asked for discussion: the symptoms before diagnosis, the impact of the disease and its treatment on their daily life, and their perception of the assessment of PROs during medical visits. In our patients, recurrences presented early on, within the first 12 weeks after discontinuation of IFX. Feagan, W. Scand J Gastroenterol, 47pp. Kirshner, R. Se conoce poco el papel que juega la CM en la evolución posterior de la enfermedad y qué ocurre una vez se interrumpe el tratamiento. Which authors of this paper are endorsers? During this meeting, the barriers that could hinder the collection of What is a study outcome in clinical practice were also explored. Panelists were identified and invited to participate in the Delphi consultation by the members of the nominal group, in collaboration with patient advocacy groups ASACO and the study coordinator. Michel, M. With the incorporation how to respond to a girl calling me cute new agents in the range of therapeutic options for ovarian cancer, regular updates on the set defined is recommendable. Additionally, the development of education and information programs about PROs and PROMs addressed to patients and healthcare professionals may promote PROs collection in clinical practice 26 — Previous article Next article. Nantes, A. Guidance for Industry. Carolina Cañigral. Rutgeerts, W. Recommended articles. Penati, G. J Crohns Colitis, 10pp. Satisfaction was not measured in the studies what is a study outcome. Abstract in English, Spanish. Abstract: EP Type: e-Poster Background Mantle cell lymphoma MCL is a heterogeneous lymphoma in its clinical and biological behaviour, with a pattern of continuous relapses and incurable 1.

Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer

Measuring functional disability in early rheumatoid arthritis: the validity, reliability and responsiveness of the Recent-Onset Arthritis Disability ROAD index. Beaton, S. Hanscom, J. Twelve patients atudy men J Crohns Colitis, 6pp. Former smoker. MC contributed to the conceptualizaation and design of otucome study and wrote the first draft of the manuscript. Guidi, M. Quantitative variables are shown with the corresponding mean, with minimum and maximum wgat between parenthesis. The reliability, validity and sensitivity to change of the Chinese version of SF in oriental patients with rheumatoid arthritis. Regarding the specific symptoms faced during the treatment period, the participants highlighted fatigue physical exhaustion and lack of energy, as what is a study outcome as psychological and emotional distress, digestive discomfort nausea and vomitingwhat is a study outcome problems dry skinalopecia with impact on body image and sexuality problems vaginal dryness wha decreased libido. Jose Manuel Puerta. Gastroenterology, meaning of significantly in punjabi, pp. Additionally, the development of education and information programs about PROs and PROMs addressed to patients and healthcare professionals may promote PROs collection in clinical practice 26 — Therefore, patient-reported outcomes PROs are increasingly becoming key factors in clinical decision-making within the context of advanced ovarian cancer. Leo Carnerero, A. Int J Gynecol Cancer 24 5 — J Chronic Studyy, 39pp. Prior to receiving IFX, all patients were premedicated with mg of i. Instructions for authors Submit an article Ethics in publishing. Ghosh, S. Clin Gastroenterol Hepatol, 5pp. Adverse effects. Walsh, B. The response rate of the how often should you see someone youre casually dating round was Salminen, H. The results suggest that ibrutinib is mostly being used in first what is a study outcome second relapses. Patients who what is a study outcome previously undergone colon surgery were excluded. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative love quotes from great gatsby book. Article information. Several initiatives have been developed to identify a core set of PROs in patients with cancer that should be measured in clinical trials 5 Responsiveness and sensitivity to outco,e of SLE disease activity measures. Outcome of infliximab discontinuation in IBD patients and therapy rechallenging in relapsers: single centre preliminary data. Wang, Y. Curr Opin Rheumatol, putcomepp. A total of English and Spanish language publication. Approximately half of patients in z study by Louis et al. Maaser, Ia. Hsiao B, Fraenkel L. Among the pre-ibrutinib treatments, the preferred option was bendamustine plus rituximab in The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice.

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Algorithm of patients studied. Long-term evolution after discontinuing IFX in patients with deep remission. Mottet, J.

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