Defining the Longitudinal Risk of CIN 3+ for

OBJECTIVE: To determine the baseline and cumulative risk of cervical intraepithelial neoplasia (CIN)3 and invasive cervical cancer in participants referred to colposcopy with high-grade cytology and

Calculation of Stop Ages for Colorectal Cancer Screening Based on Comorbidities and Screening History.

BACKGROUND & AIMS: Routine screening for colorectal cancer typically is recommended until age 74 years. Although it has been proposed that a screening stop age could be determined based on sex and comorbidity, less is known about the impact of screening history. We investigated the effects of screening history on the selection of an optimal age to stop screening. METHODS: We used the Microsimulation Screening Analysis-Colon model to estimate the harms and benefits of screening with biennial fecal immunochemical tests by sex, comorbidity status, and screening history. The optimal screening stop age was determined based on the incremental number needed for 1 additional life-year per 1000 screened individuals compared with the threshold provided by stopping screening at 76 years in the average-health population with a perfect screening history (attended all required screening, diagnostic, and follow-up tests) to biennial fecal immunochemical testing from age 50 years. RESULTS: For persons age 76 years, 157 women and 108 men with a perfect screening history would need to be screened to gain 1 life-year per 1000 screened individuals. Previously unscreened women with no comorbid conditions and no history of screening could undergo an initial screening through 90 years, whereas unscreened men could undergo initial screening through 88 years, before this balance is reached. As screening adherence improved or as comorbidities increased, the optimal age to stop screening decreased to a point that, regardless of sex, individuals with severe comorbidities and a perfect screening history should stop screening at age 66 years or younger. CONCLUSIONS: Based on the harm-benefit balance, the optimal stop age for colorectal cancer screening ranges from 66 years for unhealthy individuals with a perfect screening history to 90 years for healthy individuals without prior screening. These findings can be used to assist patients and clinicians in making decisions about screening participation.

Reasons For Lack of Follow-up Colonoscopy Among Persons With A Positive Fecal Occult Blood Test Result: A Qualitative Study.

OBJECTIVES: Follow-up colonoscopy rates among persons with positive fecal occult blood test results (FOBT + ) remain suboptimal in many jurisdictions. In Ontario, Canada, primary care providers (PCPs) are responsible for arranging follow-up colonoscopies. The objectives were to understand the reasons for a lack of follow-up colonoscopy and any action plans to address follow-up. METHODS: Semi-structured interviews were conducted with 30 FOBT+ persons and 30 PCPs in Ontario. Eligible FOBT+ persons were identified through administrative databases and included those aged 50-74, with a 6-12 month old FOBT+, no follow-up colonoscopy, and no prior colorectal cancer diagnosis or colectomy. Eligible PCPs had ≥1 rostered FOBT+ person without follow-up colonoscopy. Transcripts were analyzed inductively using Nvivo 11 (QSR International Pty Ltd., 2015). RESULTS: Reasons for lack of follow-up colonoscopy were: person and/or provider believed the FOBT + was a false positive; person was afraid of colonoscopy; person had other health issues; and breakdown in communication of FOBT+ results or colonoscopy appointments. PCPs who initially recommended follow-up colonoscopy did not change the minds of the persons who dismissed the FOBT+ as a false positive and/or who were afraid of the procedure. These FOBT+ persons negotiated an alternative follow-up action plan including repeating the FOBT or not following-up. CONCLUSIONS: PCPs may not adequately counsel FOBT+ persons who believe the FOBT+ is a false positive and/or fear colonoscopy. PCPs may lack fail-safe systems to communicate FOBT+ results and colonoscopy appointments. Using navigators may help address these barriers and increase follow-up rates.

Risk of Advanced Adenoma, Colorectal Cancer, and Colorectal Cancer Mortality in People With Low-Risk Adenomas at Baseline Colonoscopy: A Systematic Review and Meta-Analysis.

OBJECTIVES: We conducted a systematic review and meta-analysis of the risk of advanced adenomas (AAs), colorectal cancer (CRC), and/or CRC-related death among individuals with low-risk adenomas (LRAs). METHODS: We searched PubMed and Embase for studies published between January 2006 and July 2015. Quality and strength of the evidence were rated using the Newcastle-Ottawa Scale (NOS) and the GRADE framework, respectively. RESULTS: Eleven observational studies (n=64,317) were included. A meta-analysis of eight cohort studies (n=10,139, 3 to 10 years' follow-up) showed a small but statistically significant increase in the incidence of AAs in individuals with LRAs compared with those with a normal baseline colonoscopy (RR 1.55 (95% CI 1.24-1.94); P=0.0001; I2=0%). The pooled 5-year cumulative incidence of AA was 3.28% (95% CI: 1.85-5.10%), 4.9% (95% CI: 3.18-6.97%), and 17.13% (95% CI: 11.97-23.0%) for the no adenoma, LRA, and AA baseline groups, respectively. Two studies, which could not be pooled, showed a reduction in the risk of CRC in individuals with LRAs compared with the general population (standardized incidence ratio 0.68 (95% CI 0.44-0.99) at a median follow-up of 7.7 years and OR 0.4 (95% CI 0.2-0.6) at 3-5 years). One large retrospective cohort study found a 25% reduction in CRC mortality in individuals with LRAs compared with the general population (SMR 0.75 (95% CI 0.63-0.88) at a median follow-up of 7.7 years). CONCLUSIONS: We observed a small but significant increase in the risk of AAs in people with LRAs compared with those with a normal baseline colonoscopy, but compared with the general population, people with LRAs have significantly lower risks of CRC and of CRC-related mortality.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk.

BACKGROUND: Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. METHODS: Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. RESULTS: While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. CONCLUSIONS: Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches.

Practice recommendations for the use of sedation in routine hospital-based colonoscopy.

Objective: Although sedation improves patient experience during colonoscopy, there is great jurisdictional variability in sedative practices. The objective of this study was to develop practice recommendations for the use of moderate and deep sedation in routine hospital-based colonoscopy to facilitate standardisation of practice. Design: We recruited 32 multidisciplinary panellists to participate in a modified Delphi process to establish consensus-based recommendations for the use of sedation in colonoscopy. Panel members participated in a values assessment survey followed by two rounds of anonymous online voting on preliminary practice recommendations. An inperson meeting was held between voting rounds to facilitate consensus-building. Consensus was defined as >60% agreement/disagreement with recommendation statements; >80% agreement/disagreement was considered indicative of strong consensus. Results: Twenty-nine panellists participated in the values assessment survey. Panellists ranked all factors presented as important to the development of practice recommendations. The factor considered most important was patient safety. Patient satisfaction, procedural efficiency, and cost were considered less important. Strong consensus was achieved for all nine practice recommendations presented to the panel. These recommendations included that all endoscopists be able to perform colonoscopy with moderate sedation, that an endoscopist and a single trained nurse are sufficient for performing colonoscopy with moderate sedation, and that anaesthesia-provided deep sedation be used for select patients. Conclusion: The recommendations presented in this study were agreed on by a multidisciplinary group and provide guidance for the use of sedation in routine hospital-based colonoscopy. Standardised sedation practices will promote safe, effective, and efficient colonoscopy for all patients.

A policy informing qualitative study to improve the process of blood product recalls and withdrawals.

BACKGROUND: Challenges associated with blood product recalls and/or withdrawals in Canada identified a need to understand the process and identify ways in which it could be improved. With the use of qualitative techniques and a modified grounded theory approach, the current process was mapped, issues were identified, and recommendations to improve the system were developed. STUDY DESIGN AND METHODS: Potential participants were identified using a sampling strategy that included key stakeholder groups. After consenting, participants were interviewed using a semistructured interview guide. Interviews were audiotaped, transcribed, and coded using a coding scheme developed from the content of the interviews. A team approach to analysis identified relevant emergent themes and led to the development of recommendations. Draft recommendations were presented at a consensus meeting, and feedback was incorporated into the final set of recommendations. RESULTS: Forty-five interviews were conducted. Major themes arising from the data were communication, timeliness of follow-up information, and challenges related to patient notification. The current recall and/or withdrawal process was described and a new model for the recall and/or withdrawal process was developed. Nineteen recommendations were formulated: 12 general and 7 hospital-specific. CONCLUSION: Large-scale recalls and/or withdrawals involving unknown or uncertain risks can be challenging both for hospitals and for the blood supplier. However, using a qualitative research approach, recommendations and a model for improving the system were developed. Key recommendations include the development of national guidelines for notification and the use of a group of resource experts to assess risk and assist with notification decision making.

Information for disasters, information disasters, and disastrous information.

Information is needed to support humanitarian responses in every phase of a disaster. Participants of a multilateral working group convened to examine how best to meet these information needs. Although information systems based on routine reporting of diseases are desirable because they have the potential to identify trends, these systems usually do not deliver on their promise due to inadequate organization and management to support them. To identify organizational and management characteristics likely to be associated with successful information systems in disaster settings, evaluations of the Integrated Disease Surveillance and Response (IDSR) programs in 12 participating countries were reviewed. Characteristics that were mentioned repeatedly in the evaluations as associated with success were grouped into nine categories: (1) human resources management and supervision; (2) political support; (3) strengthened laboratory capacity; (4) communication and feedback (through many mechanisms); (5) infrastructure and resources; (6) system design and capacity; (7) coordination and partnerships with stakeholders; (8) community input; and (9) evaluation. Selected characteristics and issues within each category are discussed. Based on the review of the IDSR evaluations and selected articles in the published literature, recommendations are provided for improving the short- and long-term organization and management of information systems in humanitarian responses associated with disasters. It is suggested that information systems that follow these recommendations are more likely to yield quality information and be sustainable even in disaster settings.

Colorectal Cancer Screening in Average Risk Populations: Evidence Summary.

Introduction. The objectives of this systematic review were to evaluate the evidence for different CRC screening tests and to determine the most appropriate ages of initiation and cessation for CRC screening and the most appropriate screening intervals for selected CRC screening tests in people at average risk for CRC. Methods. Electronic databases were searched for studies that addressed the research objectives. Meta-analyses were conducted with clinically homogenous trials. A working group reviewed the evidence to develop conclusions. Results. Thirty RCTs and 29 observational studies were included. Flexible sigmoidoscopy (FS) prevented CRC and led to the largest reduction in CRC mortality with a smaller but significant reduction in CRC mortality with the use of guaiac fecal occult blood tests (gFOBTs). There was insufficient or low quality evidence to support the use of other screening tests, including colonoscopy, as well as changing the ages of initiation and cessation for CRC screening with gFOBTs in Ontario. Either annual or biennial screening using gFOBT reduces CRC-related mortality. Conclusion. The evidentiary base supports the use of FS or FOBT (either annual or biennial) to screen patients at average risk for CRC. This work will guide the development of the provincial CRC screening program.