scholarly journals The Newcastle ENDOPREM™: a validated patient reported experience measure for gastrointestinal endoscopy

2021 ◽  
Vol 8 (1) ◽  
pp. e000653
Author(s):  
Laura J Neilson ◽  
Linda Sharp ◽  
Joanne M Patterson ◽  
Christian von Wagner ◽  
Paul Hewitson ◽  
...  

ObjectivesMeasuring patient experience of gastrointestinal (GI) procedures is a key component of evaluation of quality of care. Current measures of patient experience within GI endoscopy are largely clinician derived and measured; however, these do not fully represent the experiences of patients themselves. It is important to measure the entirety of experience and not just experience directly during the procedure. We aimed to develop a patient-reported experience measure (PREM) for GI procedures.DesignPhase 1: semi-structured interviews were conducted in patients who had recently undergone GI endoscopy or CT colonography (CTC) (included as a comparator). Thematic analysis identified the aspects of experience important to patients. Phase 2: a question bank was developed from phase 1 findings, and iteratively refined through rounds of cognitive interviews with patients who had undergone GI procedures, resulting in a pilot PREM. Phase 3: patients who had attended for GI endoscopy or CTC were invited to complete the PREM. Psychometric properties were investigated. Phase 4 involved item reduction and refinement.ResultsPhase 1: interviews with 35 patients identified six overarching themes: anxiety, expectations, information & communication, embarrassment & dignity, choice & control and comfort. Phase 2: cognitive interviews refined questionnaire items and response options. Phase 3: the PREM was distributed to 1650 patients with 799 completing (48%). Psychometric properties were found to be robust. Phase 4: final questionnaire refined including 54 questions assessing patient experience across five temporal procedural stages.ConclusionThis manuscript gives an overview of the development and validation of the Newcastle ENDOPREM™, which assesses all aspects of the GI procedure experience from the patient perspective. It may be used to measure patient experience in clinical care and, in research, to compare patients’ experiences of different endoscopic interventions.

10.2196/18439 ◽  
2020 ◽  
Vol 8 (12) ◽  
pp. e18439
Author(s):  
Amanda Newton ◽  
Alexa Bagnell ◽  
Rhonda Rosychuk ◽  
Janelle Duguay ◽  
Lori Wozney ◽  
...  

Background Mobile device–based tools to help adolescents practice skills outside of cognitive behavioral therapy (CBT) sessions for treating an anxiety disorder may lead to greater treatment gains. Objective This study aimed to develop, design, and test the acceptability, learnability, heuristics, and usability of MindClimb, a smartphone-based app for adolescents with anxiety to use between CBT sessions to plan and complete exposure activities using skills (cognitive, relaxation, exposure practice, and reward) learned in treatment. Methods This 3-phase study took place from August 2015 to December 2018. In phase 1, the app was designed and developed in consultation with young people and CBT therapists to identify desired functions and content. Feedback was subjected to thematic analysis using a general inductive approach. In phase 2, we conducted 2 high-fidelity testing sessions using the think-aloud approach (acceptability, learnability, usability) and 10-item System Usability Scale with 10 adolescents receiving CBT. The high-fidelity MindClimb app was evaluated by 5 app developers based on Nielsen’s usability heuristics and 5-point severity ranking scale. In phase 3, a total of 8 adolescents and 3 therapists assessed the usability of MindClimb during CBT sessions by recording the frequency of skills practice, use of MindClimb features, satisfaction with the app, and barriers and facilitators to app use during treatment. Results Feedback from phase 1 consultations indicated that the app should (1) be responsive to user needs and preferences, (2) be easy to use and navigate, (3) have relevant content to the practice of CBT for anxiety, and (4) be aesthetically appealing. Using this feedback as a guide, a fully functional app prototype for usability testing and heuristic evaluation was developed. In phase 2, think-aloud and usability data resulted in minor revisions to the app, including refinement of exposure activities. The average system usability score was 77 in both testing cycles, indicating acceptable usability. The heuristic evaluation by app developers identified only minor errors (eg, loading speed of app content, with a score of 1 on the severity ranking scale). In phase 3, adolescents considered app features for completing exposure (6.2/10) and relaxation (6.4/10) modestly helpful. Both adolescents (average score 11.3/15, SD 1.6) and therapists (average score 10.0/12, 2.6 SD) reported being satisfied with the app. Conclusions The user-centered approach to developing and testing MindClimb resulted in a mobile health app that can be used by adolescents during CBT for anxiety. Evaluation of the use of this app in a clinical practice setting demonstrated that adolescents and therapists generally felt it was helpful for CBT practice outside of therapy sessions. Implementation studies with larger youth samples are necessary to evaluate how to optimize the use of technology in clinical care and examine the impact of the app plus CBT on clinical care processes and patient outcomes.


2020 ◽  
Author(s):  
Amanda Newton ◽  
Alexa Bagnell ◽  
Rhonda Rosychuk ◽  
Janelle Duguay ◽  
Lori Wozney ◽  
...  

BACKGROUND Mobile device–based tools to help adolescents practice skills outside of cognitive behavioral therapy (CBT) sessions for treating an anxiety disorder may lead to greater treatment gains. OBJECTIVE This study aimed to develop, design, and test the acceptability, learnability, heuristics, and usability of MindClimb, a smartphone-based app for adolescents with anxiety to use between CBT sessions to plan and complete exposure activities using skills (cognitive, relaxation, exposure practice, and reward) learned in treatment. METHODS This 3-phase study took place from August 2015 to December 2018. In phase 1, the app was designed and developed in consultation with young people and CBT therapists to identify desired functions and content. Feedback was subjected to thematic analysis using a general inductive approach. In phase 2, we conducted 2 high-fidelity testing sessions using the think-aloud approach (acceptability, learnability, usability) and 10-item System Usability Scale with 10 adolescents receiving CBT. The high-fidelity MindClimb app was evaluated by 5 app developers based on Nielsen’s usability heuristics and 5-point severity ranking scale. In phase 3, a total of 8 adolescents and 3 therapists assessed the usability of MindClimb during CBT sessions by recording the frequency of skills practice, use of MindClimb features, satisfaction with the app, and barriers and facilitators to app use during treatment. RESULTS Feedback from phase 1 consultations indicated that the app should (1) be responsive to user needs and preferences, (2) be easy to use and navigate, (3) have relevant content to the practice of CBT for anxiety, and (4) be aesthetically appealing. Using this feedback as a guide, a fully functional app prototype for usability testing and heuristic evaluation was developed. In phase 2, think-aloud and usability data resulted in minor revisions to the app, including refinement of exposure activities. The average system usability score was 77 in both testing cycles, indicating acceptable usability. The heuristic evaluation by app developers identified only minor errors (eg, loading speed of app content, with a score of 1 on the severity ranking scale). In phase 3, adolescents considered app features for completing exposure (6.2/10) and relaxation (6.4/10) modestly helpful. Both adolescents (average score 11.3/15, SD 1.6) and therapists (average score 10.0/12, 2.6 SD) reported being satisfied with the app. CONCLUSIONS The user-centered approach to developing and testing MindClimb resulted in a mobile health app that can be used by adolescents during CBT for anxiety. Evaluation of the use of this app in a clinical practice setting demonstrated that adolescents and therapists generally felt it was helpful for CBT practice outside of therapy sessions. Implementation studies with larger youth samples are necessary to evaluate how to optimize the use of technology in clinical care and examine the impact of the app plus CBT on clinical care processes and patient outcomes.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 164-164
Author(s):  
Michael Borean ◽  
Kishan Shani ◽  
M. Catherine Brown ◽  
Judy Chen ◽  
Mindy Liang ◽  
...  

164 Background: Dysphagia as a cancer symptom can be associated with significant morbidity. We developed dysphagia screener tools for use in observational studies (Phase 1) and routine symptom monitoring in clinical care (Phase 2). Methods: Various dysphagia or odynophagia screening questions, selected after an expert panel reviewed content, criterion, and construct validity, were compared to either FACT-E Swallowing Index Cut-Off Values (SICV) or to questions adapted from the Patient Reported Outcomes for Common Terminology Criteria for Adverse Events (PRO-CTCAE). Sensitivity, specificity and patient acceptability were assessed. Results: In developing a tool for observational studies (Phase 1; n = 178 esophageal cancer patients), the screening question, “How are you currently eating?” had the highest sensitivities and specificities against various SICV cut-offs, with the best optimal cut-off associated with the clinical outcome of weight loss (80% sensitivity, 75% specificity). When developing a rapid screening tool for routine symptom monitoring (Phase 2; 255 head and neck, gastro-esophageal, and patients undergoing thoracic radiation), a single question screener (“Do you experience any difficulty or pain upon swallowing?”) versus a PRO-CTCAE-like gold standard generated sensitivities between 86-94% and specificities between 93-100%. The screening question (+/- follow-up questions where indicated) had a median completion time of under 2 minutes, and > 90% of patients were happy to complete the survey on an electronic tablet, did not feel that survey completion made their clinic visit more difficult, and did not find the questions upsetting or distressful. Conclusions: Two screener tools (for prospective observational studies “How are you currently eating?”, and for routine clinical monitoring “Do you experience any difficulty or pain upon swallowing?”) can effectively screen dysphagia symptoms without increasing cancer outpatient clinic burden.


Author(s):  
Nayna Manga ◽  
Richard Harding ◽  
Angela De Sa ◽  
Kathleen Murie ◽  
Mosedi K. Namane ◽  
...  

Background: There is a global increase in the prevalence of non-communicable diseases and a growing understanding that patients need to be involved in their care. Patient experience should be assessed and the information used to improve on the planning and delivery of health services.Aim: This study described the development and validation of a patient-reported experience measure (PREM) tool which is appropriate for the South African context, to assess self-reported patient experience of chronic care.Setting: The study was conducted at four primary health care facilities in the Cape Town Metropole.Methods: This was a validity and reliability study with multiple phases to develop and determine the psychometric properties of a novel tool. It consisted of three phases, namely: Phase 1 – Consensus Validity; Phase 2 – Face Validity; Phase 3 – Reliability. Phase 1 consisted of an expert panel reaching consensus on a draft tool. Phase 2a consisted of qualitative semi-structured interviews and cognitive interviews. Phase 3 tested the internal consistency of the tool, the time necessary to complete, as well as floor and ceiling effects with 200 questionnaires.Results: The process described resulted in a final questionnaire with n = 10 items in three languages that was easily understood by patients. Internal consistency was determined with the overall Cronbach’s alpha 0.86. This PREM has been named Chronic Care Assessment of Patient Experience.Conclusion: Using best practice guidance in tool construction and validation, we delivered a PREM with the potential to improve the quality of care from the perspective of patients. Implementation studies are now required to determine how best to use this tool in routine practice.


2020 ◽  
Vol 8 (13) ◽  
pp. 1-170 ◽  
Author(s):  
Louise Locock ◽  
Chris Graham ◽  
Jenny King ◽  
Stephen Parkin ◽  
Alison Chisholm ◽  
...  

Background and aim The NHS collects a large number of data on patient experience, but there are concerns that it does not use this information to improve care. This study explored whether or not and how front-line staff use patient experience data for service improvement. Methods Phase 1 – secondary analysis of existing national survey data, and a new survey of NHS trust patient experience leads. Phase 2 – case studies in six medical wards using ethnographic observations and interviews. A baseline and a follow-up patient experience survey were conducted on each ward, supplemented by in-depth interviews. Following an initial learning community to discuss approaches to learning from and improving patient experience, teams developed and implemented their own interventions. Emerging findings from the ethnographic research were shared formatively. Phase 3 – dissemination, including an online guide for NHS staff. Key findings Phase 1 – an analysis of staff and inpatient survey results for all 153 acute trusts in England was undertaken, and 57 completed surveys were obtained from patient experience leads. The most commonly cited barrier to using patient experience data was a lack of staff time to examine the data (75%), followed by cost (35%), lack of staff interest/support (21%) and too many data (21%). Trusts were grouped in a matrix of high, medium and low performance across several indices to inform case study selection. Phase 2 – in every site, staff undertook quality improvement projects using a range of data sources. The number and scale of these varied, as did the extent to which they drew directly on patient experience data, and the extent of involvement of patients. Before-and-after surveys of patient experience showed little statistically significant change. Making sense of patient experience ‘data’ Staff were engaged in a process of sense-making from a range of formal and informal sources of intelligence. Survey data remain the most commonly recognised and used form of data. ‘Soft’ intelligence, such as patient stories, informal comments and daily ward experiences of staff, patients and family, also fed into staff’s improvement plans, but they and the wider organisation may not recognise these as ‘data’. Staff may lack confidence in using them for improvement. Staff could not always point to a specific source of patient experience ‘data’ that led to a particular project, and sometimes reported acting on what they felt they already knew needed changing. Staff experience as a route to improving patient experience Some sites focused on staff motivation and experience on the assumption that this would improve patient experience through indirect cultural and attitudinal change, and by making staff feel empowered and supported. Staff participants identified several potential interlinked mechanisms: (1) motivated staff provide better care, (2) staff who feel taken seriously are more likely to be motivated, (3) involvement in quality improvement is itself motivating and (4) improving patient experience can directly improve staff experience. ‘Team-based capital’ in NHS settings We propose ‘team-based capital’ in NHS settings as a key mechanism between the contexts in our case studies and observed outcomes. ‘Capital’ is the extent to which staff command varied practical, organisational and social resources that enable them to set agendas, drive process and implement change. These include not just material or economic resources, but also status, time, space, relational networks and influence. Teams involving a range of clinical and non-clinical staff from multiple disciplines and levels of seniority could assemble a greater range of capital; progress was generally greater when the team included individuals from the patient experience office. Phase 3 – an online guide for NHS staff was produced in collaboration with The Point of Care Foundation. Limitations This was an ethnographic study of how and why NHS front-line staff do or do not use patient experience data for quality improvement. It was not designed to demonstrate whether particular types of patient experience data or quality improvement approaches are more effective than others. Future research Developing and testing interventions focused specifically on staff but with patient experience as the outcome, with a health economics component. Studies focusing on the effect of team composition and diversity on the impact and scope of patient-centred quality improvement. Research into using unstructured feedback and soft intelligence. Funding The National Institute for Health Research Health Services and Delivery Research programme.


2013 ◽  
Vol 5 (1) ◽  
Author(s):  
Abdul Hasan Saragih

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.


2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?


2019 ◽  
Vol 8 (4) ◽  
pp. 555 ◽  
Author(s):  
Cátia Caneiras ◽  
Cristina Jácome ◽  
Sagrario Mayoralas-Alises ◽  
José Ramon Calvo ◽  
João Almeida Fonseca ◽  
...  

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.


2020 ◽  
Vol 98 (Supplement_3) ◽  
pp. 196-197
Author(s):  
Woo Jung Seok ◽  
Je min Ahn ◽  
Jing Hu ◽  
Dexin Dang ◽  
Yanjiao Li ◽  
...  

Abstract The objective of this study was to evaluate the effects of dietary supplementation of coated omega-3 fatty acid (n-3 CFA) by corn cob power silica on performance of weaning pigs. A total of 200 weaned pigs [(Landrace x Yorkshire) x Duroc, average initial body weight at 6.97 ± 1.22 kg] were randomly assigned to four experimental treatments in a 6-week experiment in 3 phases as follows: CON, basal diet; 2) 0.3CFA, CON + phase 1(0.3% n-3CFA), phase 2(0.2% n-3CFA), phase 3(0.1% n-3CFA); 3) 0.6CFA, CON + phase 1(0.6% n-3CFA), phase 2(0.4% n-3CFA), phase 3(0.2% n-3CFA); 4) 0.9CFA, CON + phase 1(0.9% n-3CFA), phase 2(0.6% n-3CFA), phase 3 (0.3% n-3CFA). Each treatment had 10 replicates with 5 pigs (three gilts and two barrows) per replicate. The data were analyzed using the GLM procedure of SAS as a randomized complete block design. Pen served as the experimental unit. Linear, quadratic and cubic polynomial contrasts were used to examine effect of dietary treatment with coated n-3FA in the basal diet. Variability in the data was expressed as the standard error of means and P< 0.05 was considered to statistically significant. Increasing the level of n-3CFA in the diet linearly increased ADG and G/F of pigs (Table 1). Increasing the level of n-3CFA showed a linear increment in the digestibility of DM (83.59, 84.38, 85.13, 85.89 %) whereas nitrogen digestibility (81.79, 82.38, 82.96, 83.64 %) showed a trend (linear effect, p=0.0594) at the end of experiment. The fecal lactobacillus count was increased (7.22, 7.27, 7.33, 7.35 log10cfu/g) with the increase in the supplemental level of n-3CFA (linear effect; p< 0.05). However, there were no differences in the concentration of serum haptoglobin, or fecal E. coli, Clostridium and Salmonella counts despite the increase in n-3CFA levels in the diet. Supplementation of the diet with coated n-3 fatty acids positively affected growth performance and digestibility of dry matter and nitrogen, and enhanced the count of lactobacillus in weaning pigs.


Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 759
Author(s):  
Vetriselvi Sampath ◽  
Dong Heon Baek ◽  
Sureshkumar Shanmugam ◽  
In Ho Kim

This experiment was performed to examine the hypothesis that blood plasma (BP) with yeast (Saccharomyces cerevisiae) supplement in the diet of weaning pigs could provoke the growth performance, nutrient digestibility, fecal microbial, and reduce harmful gas excretion. A total of one hundred and eighty healthy piglets were taken and assigned (complete random blocks) to three dietary treatments as: Phase 1: Treatment (TRT) 1-6% BP; TRT 2-3% BP + 3% yeast; TRT 3-6% yeast. Phase 2: TRT 1-3%; BP., TRT 2-1.5% BP + 1.5% yeast; TRT 3- 3% yeast. Phase 3: TRT 1- Control (CON) (Basal diet); TRT 2- CON; TRT 3- CON for six- weeks. Each treatment had twelve replicates and five (three gilts and two barrows) pigs per pen. Dietary inclusion of BP with yeast supplementation significantly increased the body weight of piglets during phase 2 (p = 0.003) and phase 3 (p = 0.032). In addition, TRT2 group piglets had a significant improvement in average daily gain at the end of each phase and overall (p = 0.047, 0.025, 0.018 and 0.012, respectively). At phase 3, TRT2 group piglets showed a significant improvement on nutrient digestibility of dry matter (p = 0.012) and nitrogen (p = 0.040). The fecal microbiota of TRT2 group piglets showed a tendency to increase the number of Lactobacillus counts at phase 1 (p = 0.07) and phase 2 (p = 0.06) as well as, a significant improvement at phase 3 (p = 0.021). In addition, TRT2 group piglets had trend to decrease NH3 (p = 0.074) and H2S (p = 0.069) during phase 2, and significantly reduced NH3 (p = 0.038) and H2S (p = 0.046) at phase 3. However, the fecal score of piglets remains unaffected during the entire trial. At the end of phase 1 piglets’ IgG (p = 0.008) was significantly increased with the inclusion of BP with yeast supplementation. Based on the positive effects on body weight, average daily gain, nutrient digestibility, Lactobacillus count, and reduced gas emission, we suggest that dietary supplement with BP and yeast in the diet of weaned piglet could serve as an excellent alternative to antibiotics growth promoters.


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