METHODS: A simulation-based approach contingent on all single-level transitions defined by the EQ-5D-5L descriptive system was used to estimate the MID for each algorithm.
RESULTS: The resulting mean (and standard deviation) instrument-defined MID estimates were Germany, 0.083 (0.022); Indonesia, 0.093 (0.012); Ireland, 0.098 (0.023); Malaysia, 0.072 (0.010); Poland, 0.080 (0.030); Portugal, 0.080 (0.018); Taiwan, 0.101 (0.010); and the United States, 0.078 (0.014).
CONCLUSIONS: These population preference-based MID estimates and accompanying evidence of how such values vary as a function of baseline index score can be used to aid interpretation of index score change. The marked consistency in the relationship between the calculated MID estimate and the range of the EQ-5D-5L index score, represented by a ratio of 1:20, might substantiate a rule of thumb allowing for MID approximation in EQ-5D-5L index score warranting further investigation.
METHODS AND ANALYSIS: We will conduct a scoping review according to the framework proposed by Arksey and O'Malley (2005). We will search MEDLINE, EMBASE, Web of Science and Google Scholar using a combination of terms such as "colorectal cancer", "screening" and "low-middle-income countries". Studies of CRC screening interventions/programmes conducted in the general adult population in LMICs as well as policy reviews (of interventions in LMICs) and commentaries on challenges and opportunities of delivering CRC screening in LMICs, published in the English language before February 2020 will be included in this review. The title and abstract screen will be conducted by one reviewer and two reviewers will screen full-texts and extract data from included papers, independently, into a data charting template that will include criteria from an adapted template for intervention description and replication checklist and implementation considerations. The presentation of the scoping review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews guidance.
ETHICS AND DISSEMINATION: There are no ethical concerns. The results will be used to inform colorectal screening interventions in LMICs. We will publish the findings in a peer-reviewed journal and present them at relevant conferences.
METHODS: We systematically followed a five-step scoping review framework to identify and review relevant literature about CRC screening in LMICs, written in the English language before February 2020. We searched Medline, Embase, Web of Science and Google Scholar for studies targeting the general, asymptomatic, at-risk adult population. The TIDieR tool and an implementation checklist were used to extract data from empirical studies; and we extracted data-informed insights from policy reviews and commentaries.
RESULTS: CRC screening interventions (n = 24 studies) were implemented in nine middle-income countries. Population-based screening programmes (n = 11) as well as small-scale screening interventions (n = 13) utilised various recruitment strategies. Interventions that recruited participants face-to-face (alone or in combination with other recruitment strategies) (10/15), opportunistic clinic-based screening interventions (5/6) and educational interventions combined with screening (3/4), seemed to be the strategies that consistently achieved an uptake of > 65% in LMICs. FOBT/FIT and colonoscopy uptake ranged between 14 and 100%. The most commonly reported implementation indicator was 'uptake/reach'. There was an absence of detail regarding implementation indicators and there is a need to improve reporting practice in order to disseminate learning about how to implement programmes.
CONCLUSION: Opportunities and challenges for the implementation of CRC screening programmes were related to the reporting of CRC cases and screening, cost-effective screening methods, knowledge about CRC and screening, staff resources and training, infrastructure of the health care system, financial resources, public health campaigns, policy commitment from governments, patient navigation, planning of screening programmes and quality assurance.
DESIGN: Budget impact analysis. Assumptions and costs in the opportunistic and novel CRC screening scenarios were derived from a previous evaluation of opportunistic CRC screening in community health clinics across Malaysia and the CRC-SIM research project, respectively.
SETTING: National level (with supplement analysis for district level). The BIA was conducted from the viewpoint of the federal government and estimated the annual financial impact over a period of 5 years.
RESULTS: The total annual cost of the current practice of opportunistic screening was RM1 584 321 (~I$1 099 460) of which 80% (RM1 274 690 or ~I$884 587) was expended on the provision of opportunistic CRC to adults who availed of the service. Regarding the implementation of national CRC screening programme, the net budget impact in the first year was estimated to be RM107 631 959 (~I$74 692 546) and to reach RM148 485 812 (~I$103 043 589) in the fifth year based on an assumed increased uptake of 5% annually. The costs were calculated to be sensitive to the probability of adults who were contactable, eligible and agreeable to participating in the programme.
CONCLUSIONS: Results from the BIA provided direct and explicit estimates of the budget changes to when implementing a population-based national CRC screening programme to aid decision making by health services planners and commissioners in Malaysia about whether such programme is affordable within given their budget constraint. The study also illustrates the use and value of the BIA approach in low-income and middle-income countries and resource-constrained settings.
METHODS: This quasi-experimental study was informed by the Implementation Research Logic Model and evaluated with the RE-AIM framework. Trained data collectors recruited by phone, randomly selected, asymptomatic adults aged 50-75 years from Segamat District, who previously completed a health census form for the South East Asia Community Observatory (SEACO). Participants were posted an iFOBT kit and asked to return a photo of the completed test for screening by health care professionals. A regression analysis of evaluation data was conducted to identify which variables were associated with the outcome indicators of 'study participation' and 'iFOBT completion' and the CRC-SIM was evaluated in terms of its appropriateness, feasibility and acceptability.
RESULTS: Seven hundred forty-seven eligible adults (52%) agreed to participate in this study and received an iFOBT kit. Participation was significantly lower amongst Chinese Malaysians (adjusted OR 0.45, 95% CI 0.35 - 0.59, p<0.001) compared to Malays and amongst participants from the rural sub-district (Gemereh) (adjusted OR 0.71, 95% CI 0.54 - 0.92, p=0.011) compared to the urban sub-district (Sungai Segamat). Less than half of participants (42%, n=311/747) completed the iFOBT. Test-kit completion was significantly higher amongst Chinese Malaysians (adjusted OR 3.15, 95% CI 2.11 - 4.69, p<0.001) and lower amongst participants with a monthly household income ≥RM 4,850 (adjusted OR 0.58, 95% CI 0.39 - 0.87, p=0.009) compared to participants with a lower household income. The main reported reason for non-participation was 'not interested' (58.6%) and main implementation challenges related to invalid photographs from participants and engaging iFOBT positive participants in further clinic consultations and procedures.
CONCLUSION: Home-testing for CRC (test completion) appeared to be acceptable to only around one-fifth of the target population in Malaysia. However, mindful of the challenging circumstances surrounding the pandemic, the CRC-SIM merits consideration by public health planners as a method of increasing screening in Malaysia, and other low- and middle-income countries.
METHODS AND ANALYSIS: The implementation research logic model guided the development of the study and implementation outcome measures were informed by the 'Reach, Effectiveness, Adoption, Implementation and Maintenance' (RE-AIM) framework. This CRC screening intervention for Malaysia uses home-testing and digital, small media, communication to improve CRC screening uptake. A sample of 780 people aged 50-75 years living in Segamat district, Malaysia, will be selected randomly from the South East Asia Community Observatory (SEACO) database. Participants will receive a screening pack as well as a WhatsApp video of a local doctor to undertake a stool test safely and to send a photo of the test result to a confidential mobile number. SEACO staff will inform participants of their result. Quantitative data about follow-up clinic attendance, subsequent hospital tests and outcomes will be collected. Logistic regression will be used to investigate variables that influence screening completion and we will conduct a budget impact-analysis of the intervention and its implementation. Qualitative data about intervention implementation from the perspective of participants and stakeholders will be analysed thematically.
ETHICS AND DISSEMINATION: Ethics approval has been granted by Monash University Human Research Ethics Committee (MUHREC ID: 29107) and the Medical Review and Ethics Committee (Reference: 21-02045-O7G(2)). Results will be disseminated through publications, conferences and community engagement activities.
TRIAL REGISTRATION NUMBER: National Medical Research Register Malaysia: 21-02045-O7G(2).