Abstract This international study aimed to test the measurement properties of the updated European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal ...cancer, the QLQ-CR29. The QLQ-CR29 was administered with the QLQ-C30, core questionnaire, to 351 patients from seven countries. Questionnaire scaling and reliability were established and clinical and psychometric validity examined. Patient acceptability and understanding were assessed with a debriefing questionnaire. Multi-trait scaling analyses and face validity refined the module to four scales assessing urinary frequency, faecal seepage, stool consistency and body image and single items assessing other common problems following treatment for colorectal cancer. Scales distinguished between clinically distinct groups of patients and did not correlate with QLQ-C30 scales, demonstrating construct validity. The QLQ-CR29 scores were reproducible over time in stable health. The EORTC QLQ-CR29 demonstrates sufficient validity and reliability to support its use to supplement the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Aim
Patient‐reported outcome (PRO) measures (PROMs) are standard measures in the assessment of colorectal cancer (CRC) treatment, but the range and complexity of available PROMs may be hindering the ...synthesis of evidence. This systematic review aimed to: (i) summarize PROMs in studies of CRC surgery and (ii) categorize PRO content to inform the future development of an agreed minimum ‘core’ outcome set to be measured in all trials.
Method
All PROMs were identified from a systematic review of prospective CRC surgical studies. The type and frequency of PROMs in each study were summarized, and the number of items documented. All items were extracted and independently categorized by content by two researchers into ‘health domains’, and discrepancies were discussed with a patient and expert. Domain popularity and the distribution of items were summarized.
Results
Fifty‐eight different PROMs were identified from the 104 included studies. There were 23 generic, four cancer‐specific, 11 disease‐specific and 16 symptom‐specific questionnaires, and three ad hoc measures. The most frequently used PROM was the EORTC QLQ‐C30 (50 studies), and most PROMs (n = 40, 69%) were used in only one study. Detailed examination of the 50 available measures identified 917 items, which were categorized into 51 domains. The domains comprising the most items were ‘anxiety’ (n = 85, 9.2%), ‘fatigue’ (n = 67, 7.3%) and ‘physical function’ (n = 63, 6.9%). No domains were included in all PROMs.
Conclusion
There is major heterogeneity of PRO measurement and a wide variation in content assessed in the PROMs available for CRC. A core outcome set will improve PRO outcome measurement and reporting in CRC trials.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for ...evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery.
The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival).
This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Aim
Evaluation of surgery for colorectal cancer (CRC) is necessary to inform clinical decision‐making and healthcare policy. The standards of outcome reporting after CRC surgery have not previously ...been considered.
Method
Systematic literature searches identified randomized and nonrandomized prospective studies reporting clinical outcomes of CRC surgery. Outcomes were listed verbatim, categorized into broad groups (outcome domains) and examined for a definition (an appropriate textual explanation or a supporting citation). Outcome reporting was considered inconsistent if results of the outcome specified in the methods were not reported. Outcome reporting was compared between randomized and nonrandomized studies.
Results
Of 5644 s, 194 articles (34 randomized and 160 nonrandomized studies) were included reporting 766 different clinical outcomes, categorized into seven domains. A mean of 14 ± 8 individual outcomes were reported per study. ‘Anastomotic leak’, ‘overall survival’ and ‘wound infection’ were the three most frequently reported outcomes in 72, 60 and 44 (37.1%, 30.9% and 22.7%) studies, respectively, and no single outcome was reported in every publication. Outcome definitions were significantly more often provided in randomized studies than in nonrandomized studies (19.0% vs 14.9%, P = 0.015). One‐hundred and twenty‐seven (65.5%) papers reported results of all outcomes specified in the methods (randomized studies, n = 21, 61.5%; nonrandomized studies, n = 106, 66.2%; P = 0.617).
Conclusion
Outcome reporting in CRC surgery lacks consistency and method. Improved standards of outcome measurement are recommended to permit data synthesis and transparent cross‐study comparisons.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Aim. Self-expanding metal stents (SEMSs) are increasingly used for the palliation of metastatic colorectal cancer and as a bridge to surgery for obstructing tumours. This case series analyses the ...learning curve and changes in practice of colorectal stenting over a three year period. Methods. A study of 40 patients who underwent placement of SEMS for the management of colorectal cancer. Patients spanned the learning curve of a single surgeon endoscopist. Results. Technical success rates increased from 82% initially, using an average of 1.7 stents per procedure, to a 94% success rate where all patients were stented using a single stent. There has been a change in practice from elective palliative stenting toward emergency preoperative stenting. Conclusion. There is a steep learning curve for the use of SEMS in the management of malignant colorectal bowel obstruction. We suggest that at least 20 cases are required for an operator to be considered experienced.
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FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK
Purpose
Pandemic-related isolation may exacerbate loneliness among rural adults; we sought to characterize loneliness and associated factors among rural adults during the COVID-19 pandemic.
Design
...Cross-sectional observational study.
Setting
Remotely delivered self-management education (SME) workshops, rural upstate New York, May-December 2020.
Subjects
Rural SME workshop enrollees, aged 18+, n = 229
Measures
De Jong Gierveld 6-Item Loneliness Scale, sociodemographics, workshop type (chronic disease, chronic pain, diabetes), delivery mode (videoconference, phone, self-study); data collected via workshop process measures and enrollment surveys.
Analysis
Multivariable linear regression.
Results
Mean overall, emotional and social loneliness scores were 2.78 (SD = 1.91), 1.27 (SD = 1.02), and 1.52 (SD = 1.26). Being not married/partnered (β = .61) and self-reported depression/anxiety (β = .64) were associated with higher overall scores, and selection of videoconference (β = −.77) and self-study (β =-.85) modes with lower scores. Self-reported depression/anxiety (β = .51) was associated with increased emotional loneliness. Being not married/not partnered (β = .37) and selection of chronic pain workshops (β = .64) was were associated with increased social loneliness. Selection of videoconference (β = −.44) and self-study (β = −.51) delivery modes were protective of social loneliness.
Conclusion
In addition to marital status and depression/anxiety, experiencing chronic pain and selecting phone-based workshops were associated with higher degrees of loneliness among rural adults during the pandemic. The latter may be partly explained by insufficient internet access. Health educators should be prepared to address loneliness in rural areas during the pandemic.
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FSPLJ, NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
Introduction & Objective: Outcomes for people with diabetes in rural areas are worsening, widening disparities between urban and rural populations. The objectives of Diabetes on Track are to improve ...outcomes for people at risk for or living with pre-diabetes and type 2 diabetes in rural Nebraska. Methods: Investigators engaged health departments and primary care clinics in two rural communities. Community coalitions were developed with a focus on improving screening rates. Clinical interventions include a Project ECHO curriculum to disseminate evidence-based education via case-based learning, funding of RN health coach positions, and support for clinical pharmacy time. Individual provider dashboards were developed, along with a value-based incentive program tied to diabetes-related quality metrics (A1c monitoring and control; screening for dyslipidemia, nephropathy, and retinopathy). A patient pathway team aims to increase clinician awareness of community resources and improve referral workflows. Results: Project ECHO sessions have been regularly attended with good participation. Clinics are increasing use of team-based care for people with diabetes. Over 8 months, the enhanced team approach generated 18 referrals to pharmacy, 89 to Diabetes Education, and 134 to Health Coaching. A prediabetes registry was created and thus far, 225 patients have been contacted about their risk. All diabetes-related quality metrics have improved, primarily at the site where clinicians were given visibility to the incentive program. One location has joined an ACO. Conclusion: Improving diabetes at a community level requires a multi-pronged approach. Our model utilizes community interventions, healthcare team interventions, and a patient pathway to improve communication between health departments and local clinics. Understanding local relationships and developing trust takes time but is vital. The most impactful intervention to date has been the value-based incentive program. Disclosure L.A. Eiland: Advisory Panel; Provention Bio, Inc., Cecelia Health. S.M. Mohring: None. S. Keegan: Consultant; Tandem Diabetes Care, Inc. S. Nygaard: None. K. Pullyblank: None. C. Desouza: Advisory Panel; Novo Nordisk, Bayer Inc., Madrigal Pharmaceuticals, Inc. Other Relationship; ADA/ACC Diabetes by Heart Program. Advisory Panel; Asahi Kasei. Funding Private gift received through the University of Nebraska Foundation from the Diabetes Care Foundation.
Introduction & Objective: Outcomes for people with diabetes in rural areas are worsening, widening rural disparities. The goal of Diabetes On Track is to improve outcomes for people living with ...pre-diabetes and type 2 diabetes in rural Nebraska. One intervention has been a value-based incentive model for primary care providers (PCPs) in two communities, with aims to improve diabetes-related quality metrics and encourage health systems to recognize benefits of joining value-based contracts and achieving shared savings. Methods: Two rural communities were identified, and primary care clinic leadership was engaged in each community. Individual provider dashboards were created for diabetes-related metrics, allowing PCPs to monitor progress. Baseline data was collected for each site, and target and stretch goals were created for 6-month periods over 2 years. Data were collected on a1c monitoring and control (A1c <9%), as well as screening for dyslipidemia, nephropathy, and retinopathy over a rolling 12-month period. Results: Clinic A incentivized PCPs directly; Clinic B did not. After 6 months, Clinic B showed small improvements in nephropathy and retinopathy screening, while other metrics remained stable. Clinic A showed improvement in all metrics and is on track to achieve stretch goals set for the entire 2-year program. Some of this improvement is due to resolving lab mapping issues and purchasing a retinal camera. Clinic A improved both A1c completion and control by 6% from baseline (ending at 94% and 84%, respectively). Nephropathy and retinopathy screening improved by 270% and 38%, respectively. Lipid monitoring increased by 25%. Clinic A is joining an accountable care organization in 2024. Conclusion: Providing real-time patient panel data and incentivizing PCPs contributed to improved diabetes-related quality metrics. This pilot is a critical component of a comprehensive diabetes program, allowing rural health systems to recognize the importance of the shift towards value-based care. Disclosure L.A. Eiland: Advisory Panel; Provention Bio, Inc., Cecelia Health. S.M. Mohring: None. S. Keegan: Consultant; Tandem Diabetes Care, Inc. S. Nygaard: None. K. Pullyblank: None. C. Desouza: Advisory Panel; Novo Nordisk, Bayer Inc., Madrigal Pharmaceuticals, Inc. Other Relationship; ADA/ACC Diabetes by Heart Program. Advisory Panel; Asahi Kasei. Funding Private gift received through the University of Nebraska Foundation from the Diabetes Care Foundation.
Objectives
We intended to assess changes in pain-related outcomes among rural adults who completed 6-week self-management programs offered remotely during the COVID-19 pandemic.
Methods
We offered ...the Chronic Pain Self-Management Program and Chronic Disease Self-Management Program between May 2020 and December 2021. Delivery mode options included 2½-hour weekly videoconference, mailed toolkit plus 1-hour weekly conference call, and mailed toolkit alone. We conducted pre- and post-workshop surveys including questions on patient activation, self-efficacy, depression and pain disability. We used paired t-tests to compare pre-post differences in outcomes among participants completing 4 or more sessions.
Results
Among 218 adults reporting chronic pain, mean age was 57; 83.6% were female; and 49.5% participated via videoconference, 23.4% by phone and 27.1% via mailed toolkit alone. Completion rates were higher among phone (88.2%) versus videoconference (60.2%) workshop participants. Among completers, patient activation (mean change = 3.61, p = 0.01) and self-efficacy (mean change = 3.72, p < 0.0001) increased while depression scores (mean change = -1.03, p = 0.01), pain disability (mean change = -0.93, p = 0.003) and pain symptoms (mean change = -0.61, p = 0.001) decreased over the 6-week period.
Discussion
Self-management programs offered remotely during the pandemic were successful in improving patient activation, self-efficacy, depression, pain disability, and pain symptoms among rural adults experiencing chronic pain.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
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