Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

Pathological Conditions, Anatomical

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Psychotropic Drugs

Fentanyl

Midazolam

Propofol

All participants will undergo to colonoscopy examination performed by competent/junior or expert/senior endoscopists (\>150-400 or \>400 previous colonoscopies, respectively). Bowel preparation was performed using different solutions, according to the clinical discretion of the attending, who indicated colonoscopy. After deep sedation by intravenous propofol with or without fentanyl or midazolam administration, a water-assisted colonoscopy was performed using a high-definition (HD) scope with white light (WL). Colonoscope trademark differs among participant centres.

Diagnostic high-definition white-light (HDWL) colonoscopy

Colonoscopy completion by caecal intubation seldom represents a significant effort for the endoscopist. In this situation, additional techniques are necessary to achieve this goal: patients' manual abdominal compression, postural changes, and endoscopist relay. To date, no tool allows colonoscopy technical difficulty grading.

This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

Colonoscopy is the most performed digestive endoscopy procedure worldwide. It is indicated for colorectal cancer screening, pre-existence surveillance, diagnostic approach in symptomatic patients, and therapeutic purposes. Bowel preparation is the most crucial quality criterion that guarantees appropriate colonic mucosa assessment. Other colonoscopy quality criteria included a colonoscope withdrawal time above 6 to 10 minutes and colonoscopy completion by caecal intubation.

Besides bowel preparation, some situations limit caecal intubation: stenosis, diverticulitis, or haemodynamic instability. In the absence of one of those situations or similar, caecal intubation must be the goal to be achieved by every endoscopist. However, it sometimes represents a significant effort for the endoscopist. It can require additional techniques such as manual abdominal compression, postural changes, colonoscopy restart, and another endoscopist's new attempt. Also, this increases caecal intubation time by over 10 minutes, more anaesthesia and post-colonoscopy abdominal pain, with a higher risk of unnoticed lesions.

To the best of our knowledge, there is no standard definition for colonoscopy technical difficulty in terms of caecal intubation or any tool that grades it based on previously mentioned additional techniques. For the moment, developed tools such as the Difficult Colonoscopy Score (DCS) to consider patients' pre-colonoscopy factors such as age, body mass index (BMI), sleep quality, and endoscopist experience. Other tools are based on a qualitative appreciation of the technical difficulty.

A tool that documents those endpoints constitutes an additional objective quality criterion for colonic mucosa assessment, with critical change management during intra-colonoscopy and post-colonoscopy. Noticed a technically difficult colonoscopy deserves a more prolonged withdrawal time, more photo documentation, a more cautious discharge, more detailed patient instructions, and a personalised follow-up directed to adverse events warnings. A patient with a previous technically difficult colonoscopy will be planned for an earlier next colonoscopy, with a risk assessment independently on the age, pre-colonoscopy consulting with detailing of more potential adverse events, planned in a particular time and with a different anaesthesia planning, and even performed by a more experienced endoscopist or in a referral centre.

This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

The Argentina Brief Colonoscopy Difficulty Score (ABCD)

The Argentina Brief Colonoscopy Difficulty Score (ABCD): A Novel Tool to Estimate the Technical Difficulty of Colonoscopy With Caecal Intubation

Per each colonoscopy, there were documented:

1. The number of cases in which caecal intubation (CI) was or was not achieved.
2. Number of endoscopists who participated until caecal intubation, with the respective learning curve experience (expert/senior vs. non-expert/junior);
3. Requirement of restart colonoscopy (regardless of the responsible endoscopist);
4. Requirement of at least one postural change (from lateral to supine or vice versa);
5. Requirement of manual abdominal pressure.

ABCD score ranges from 0 to IV:

0: no difficulty. I: low difficulty. CI was issued after an effective abdominal compression. II: mild difficulty. CI was issued after a partial effective abdominal compression.

III: high difficulty. CI was issued after body rotation or change of endoscopist.

IV: very high difficulty. Declined cecal intubation after several attempts using additional techniques.

The caecal intubation time (CIT) is the time (mm:ss) from colonoscope insertion to the anal margin until caecal intubation (or its desertion after several attempts). Biopsy or therapeutic time will not be considered for this research.

The colonoscope withdrawal time (CWT) is the time (mm:ss) from caecal intubation (or its desertion after several attempts) until the returning to the anal margin after assessing the colonic mucosa thoroughly. Biopsy or therapeutic time will not be considered for this research.

Dose of propofol (mg) with or without fentanyl (mcg) or midazolam (mg) used during colonoscopy, following anaesthesia record.

Level of pain described by the patient one-hour post-colonoscopy. A general practitioner blind to the ABCD findings will ask the patient about pain from 1 (one) to 10 (ten), showing the Wong-Baker face pain rating scale, a type of visual analogue scale (VAS).

Austral University, Argentina

Hospital Nacional Profesor Alejandro Posadas

Institute of Gastroenterology and Advance Endoscopy

Principal investigator - Physician - GI Attending

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

* Professionals receive audit \& feedback
* Patients (and clinicians) have access to a website with information tailored to patients with an NHL. This website gives insight into the logistic processes of each diagnostic tool and into the patients' personal care pathway.
* Standardization of diagnostic and evaluative request forms and reports for clinicians.
* Supporting material for standardizing the procedure for multidisciplinary meetings.

Implementation tools

Standard intervention consists of audit\&feedback

Standard intervention

Rosella Hermens, PhD

Nelleke Ottevanger, MD, PhD

The main objective of the proposed study is to assess the effectiveness, feasibility and costs of a tailored strategy (developed in accordance with the barriers found and current practice) to improve care for patients with non-Hodgkin's lymphomas (NHL), compared to a common strategy of 'audit \& feedback'.

In a previous study among 22 Dutch hospitals many gaps in the care for patients with non-Hodgkin's lymphomas (NHL) were found, compared to best evidence as described in guidelines. In a problem analysis study, barriers and facilitators for good quality of NHL-care were assessed and a tailored implementation strategy was developed, based on these findings. The proposed study aims at the effectiveness, feasibility and costs of this tailored strategy to improve quality of care for patients with an NHL in a clustered randomized controlled trial in 19 Dutch hospitals.

Multilevel regression analyses will be performed to evaluate the effectiveness of both strategies. Exposure to and experiences with the strategy elements will be analysed descriptively.

Regarding the costs, the two strategies are compared with a health care perspective. The input of resources will be assessed by collecting volumes of consumed resources and multiplying these by the price of each resource unit; the implementation process and consequently costs will be estimated by an Activity Based Costing (ABC) approach. The output will be determined by the level of adherence to the NHL quality indicators.

PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care

Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma

The effect of our interventions will be measured by means of adherence to quality indicators for optimal NHL care. The effects of the audit and feedback strategy (9 hospitals) versus the tailored strategy (9 hospitals) will be evaluated using previously developed quality indicators. These indicators for optimal NHL care were developed on the basis of evidence based guidelines, literature and opinions of clinicians about NHL care in a previous study and were validated.

To study the feasibility of both strategies, a process evaluation has to give insight into the mechanisms and processes responsible for the result (= extent of adherence to the indicator set for optimal NHL care). The actual 'exposure' of the patients and professionals to the implementation elements, together with their experience with these elements may have influenced the final result (success or failure of adherence). Data about 'exposure' to the different interventions will be collected using questionnaires.

Non-adherence to the multidisciplinary NHL guideline may lead to unnecessary medical interventions and more complications, and subsequently to efficiency losses. This economic evaluation compares the two implementation strategies. The perspective of this economic evaluation will be a health care perspective. Both the costs of the implementation strategy and changes in health care consumption will be assessed. The outcome should facilitate local health care decision making on implementation.

Morbidity is an important outcome measure for the effect of the intervention strategy.

Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.

Radboud University Medical Center

Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania

Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania

Patients with an evaluation \& management claim attributed to a medical oncology pilot practice in southeastern Pennsylvania

Patients with an evaluation \& management claim attributed to a medical oncology comparison practice in southeastern Pennsylvania

Patients with a new diagnosis of cancer in the past two years

Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.

Pilot of Patient-Centered Oncology Care

Sarah H Scholle, DrPH, MPH

The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. The purpose of this project was to pilot and evaluate this model. Specific research questions were:

1. Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?

The demonstration occurred in oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices.

Background. Advances in cancer treatment mean that a growing number of Americans are living with cancer and experiencing it as a chronic, long-term condition. National panels led by consumers have identified the need for improved cancer care in the areas of communication between providers and patients and their families, care planning, attention to nonmedical needs, care coordination and provision of evidence-based treatment. The patient-centered medical home (PCMH) model of care is being widely adopted as a way to provide accessible, proactive, coordinated care and self-care through primary care practices. During active treatment for cancer, the oncology practice is often the primary setting supporting the patient and coordinating cancer treatment. By implementing the patient-centered medical home model, an innovative oncology practice in Pennsylvania has been able to improve access and reduce emergency department visits and hospitalizations for its patients.

Objectives. Building on these recommendations and experience, the National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. We sought PCORI support to pilot and evaluate this model. Specific research questions were:

1. Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?

Methods. The demonstration occurred in 5 oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices. Patients, clinicians, and health plan leaders helped design the project, and disseminate results. The project used Patient Centered Outcomes Research Institute (PCORI) resources efficiently by building on ongoing efforts. Our evaluation consisted of a retrospective, pre-post study design with a concurrent non-randomized control group of 18 local practices for the utilization and patient experience outcomes. We used difference-in-difference regression models that accounted for practice-level clustering and used functional forms appropriate to the dependent variables. For quality, we compared baseline and follow-up pilot practice performance to national and regional benchmark performance data.

Patient Outcomes. People with cancer are seeking high quality, coordinated and supportive care. The Patient-Centered Oncology Model has the potential to address current gaps in cancer care.

Evaluating the Impact of Patient-Centered Oncology Care

Patient experience survey composite scores were evaluated in the pilot practice group and in the comparison practice group during the intervention period and the follow-up period using a modified version of the cancer CAHPS patient survey.

We calculated survey composite scores on a 0-100 scale using proportional scoring and the summated rating method based on the CAHPS macro.This method calculates the mean responses to each survey item in the composite, after transforming each response to a 0-100 scale (100 representing the most positive response on any given item response scale; 0 representing the least positive). For example, on a Yes/No response scale, if "Yes" represents the most positive response, then Yes= 100 and No = 0; on an Always/Usually/Sometimes/Never response scale, if "Always" represents the most positive response, then Always = 100, Usually = 67, Sometimes = 33 and Never = 0. A higher score means that practices were rated more positively for care on that item.

Quality measure performance rates were evaluated in the pilot practice group during the baseline period and the follow-up period. Data were abstracted from medical records for a sample of patients diagnosed with an invasive malignancy within previous 2 years and with at least 2 visits to the practice in the previous six months at baseline and at 36 months follow-up.

Per member per month hospitalizations, emergency department visits, primary care visits and specialist visits were evaluated in the pilot group and in the comparison group using insurance claims data during the baseline, start-up, intervention and follow-up periods.

American Society of Clinical Oncology

Independence Blue Cross

National Coalition for Cancer Survivorship

Oncology Management Services

RAND

National Committee for Quality Assurance

All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed

Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania

Intervention:

Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.

Pilot Practices Patient Survey Cohort

Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania

Intervention:

No intervention/Usual care

Comparison Practices Patient Survey Cohort

Pilot Practices Utilization Cohort

Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania

Intervention: No intervention/Usual care

Comparison Practices Utilization Cohort

Patients with a new diagnosis of cancer in the past two years

Intervention:

Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.

Pilot Practices Quality Measures Cohort

Total

18-24

25-54

55-64

65-74

75 and older

Unknown

Age, Customized

Female

Male

Sex/Gender, Customized

White

Black/African-American

Asian

American Indian/Alaska Native

Native Hawaiian/Pacific Islander

Other

Hispanic/Latino

Race/Ethnicity, Customized

United States

Region of Enrollment

Sarah Hudson Scholle

To estimate exposure to the intervention on the Access composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Affective Communication composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Shared Decision-Making composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Patient Self-Management composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Exchanging Information composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

To estimate exposure to the intervention on the Overall Rating of Treatment Team composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).

Affective Communication Composite-Start-Up

Affective Communication Composite-Follow-Up

Access Composite-Start-Up

Access Composite-Follow-Up

Exchanging Information Composite-Start-Up

Exchanging Information Composite-Follow-Up

Patient Self-Management Composite-Start-Up

Patient Self-Management Composite-Follow-Up

Shared Decision-Making Composite-Start-Up

Shared Decision-Making Composite-Follow-Up

Overall Rating-Start-Up

Overall Rating-Follow-Up

Only the Pilot Practices Patient Survey Cohort and Comparison Practices Patient Survey Cohort were pre-specified to be assessed for this Primary Outcome.

Change in Patient Experience From Baseline to Follow up

Pain assessed, Baseline

Pain assessed, Follow-Up

Pain intensity quantified, Baseline

Pain intensity quantified, Follow-Up

Plan of care for moderate/severe pain, Baseline

Plan of care for moderate/severe pain, Follow-up

Pain addressed defect-free measure, Baseline

Pain addressed defect-free measure, Follow-up

Emotional well-being assessed, Baseline

Emotional well-being assessed, Follow-up

Emotional well-being addressed, Baseline

Emotional well-being addressed, Follow-up

Documented plan for chemotherapy, Baseline

Documented plan for chemotherapy, Follow-up

Chemotherapy intent documented, Baseline

Chemotherapy intent documented, Follow-up

Chemotherapy intent discussion w/ patient, Baselil

Chemotherapy intent discussion with patient, follo

Number of chemotherapy cycles documented, Baseline

Number of chemotherapy cycles documented, Follow-u

Chemotherapy planning defect-free measur, Baseline

Chemotherapy planning defect-free measu, Follow-up

Chemotherapy treatment summary completed, Baseline

Chemotherapy treatment summary completed, Follow-u

Chemotherapy treatment summary to patient, Baselin

Chemotherapy treatment summary to patient, Follow-

Chemotherapy treatment summary to provider, Basel

Chemotherapy treatment summary to provider, Follow

Chemotherapy treatment defect-free measur Baselin

Chemotherapy treatment defect-free measur Follow-u

Tobacco use documented, Baseline

Tobacco use documented, Follow-up

Tobacco use cessation recommended, Baseline

Tobacco use cessation recommended, Follow-up

Tobacco use cessation administered, Baseline

Tobacco use cessation administered, Follow-up

Tobacco defect-free measure, Baseline

Tobacco defect-free measure, Follow-up

Serotonin antagonist prescribed, Baseline

Serotonin antagonist prescribed, Follow-up

Sertonin antagonist/corticosteroids, Ba

Serotonin antagonist/corticosteroids, Follow-up

Aprepitant prescribed, Baseline

Aprepitant prescribed, Follow-up

Anti-emetics defect-free measure, Baseline

Anti-emetics defect-free measure, Follow-up

Infertility risks discussed, Baseline

Infertility risks discussed, Follow-up

Fertility preservation options discussed, Baseline

Fertility preservation options discussed, Follow-u

Patients with a new diagnosis of cancer in the past two years

Patient-Centered Oncology Care: Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.

The pilot practices quality measures cohort were pre-specified to be assessed for this outcome. The pilot practices pulled a sample of patient charts at baseline and follow-up (total of 657 patients). Some patients were eligible for specific measures below and some were not.

Change in Quality of Care From Baseline to Follow up: Percentage of Patients Receiving Recommended Care

To estimate exposure to the intervention on Per Member Per Month Hospitalizations, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Hospitalizations. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).

To estimate exposure to the intervention on Per Member Per Month Emergency Department (ED) Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month ED Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).

To estimate exposure to the intervention on Per Member Per Month Primary Care Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Primary Care Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).

To estimate exposure to the intervention on Per Member Per Month Specialist Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Specialist Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).

All-cause hospitalizations, Baseline

All-cause hospitalizations, Start-up

All-cause hospitalizations, Intervention

All-cause hospitalizations, Follow-up

All-cause ED visits, Baseline

All-cause ED visits, Start-up

All-cause ED visits, Intervention

All-cause ED Visits, Follow-up

PCP Office Visits, Baseline

PCP Office Visits, Start-Up

PCP Office Visits, Intervention

PCP Office Visits, Follow-up

Specialist Office Visits, Baseline

Specialist Office Visits, Start-Up

Only the Pilot Practices Utilization Cohort and Comparison Practices Utilization Cohort were pre-specified to be assessed for this outcome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Argentina Brief Colonoscopy Difficulty Score (ABCD)	NCT05422820	Colorectal Canc... Diagnoses Disea... Polyp of Colon Adenoma Colon	Diagnostic high...	18 Years - 79 Years	Institute of Gastroenterology and Advance Endoscopy
PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care	NCT01562509	Non-Hodgkin Lym...	Implementation ... Standard interv...	18 Years -	Radboud University Medical Center
Evaluating the Impact of Patient-Centered Oncology Care	NCT02110758	Neoplasms	Pilot of Patien...	18 Years -	National Committee for Quality Assurance
Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.	NCT02205853	Cancer Fatigue	The patient-dir... The multi-facet...	18 Years -	Radboud University Medical Center
Observatory of the Quality of Surgical Procedures for Digestive Cancers	NCT03681600	Digestive Syste... Surgery Surgery--Compli... Quality of Heal... Medical Audit		16 Years -	Moroccan Society of Surgery

Spots Global Cancer Trial Database for quality of health care