Oral health in an urban slum, Nigeria: residents' perceptions, practices and care-seeking experiences.

BACKGROUND/INTRODUCTION: One of the key recommendations for the new WHO global strategy for oral health is inclusion of disadvantaged populations and their engagement in policy dialogues such that their needs and views are addressed in policy decisions. OBJECTIVES: This study explored oral health perceptions, practices and care-seeking experiences of slum residents in Ibadan, Nigeria. METHOD: Focus group discussions (FGD) were conducted with family health-decision makers in an urban slum site. Oral health perceptions, practices, and care-seeking experiences were discussed. FGDs were recorded, transcribed, and translated. ATLAS.ti qualitative research software was deployed for analysis using thematic analysis. RESULTS: Six FGD sessions, divided by gender and age, were conducted between September-October 2019, (N = total 58 participants, aged 25 to 59 years). Common dental ailments mentioned were dental pain, tooth sensitivity, bleeding gums, tooth decay, mouth odor, gum disease, and tooth fracture. Perceived causes of dental conditions included poor dental hygiene and habits, sugary diets, ignorance, and supernatural forces. Mouth cleaning was mostly done once daily using toothbrush and paste. Other cleaning tools were ground glass, wood ash, charcoal, "epa Ijebu" (a dentrifice), and "orin ata" (a type of chewing stick). Remedies for relieving dental pain included over-the-counter medicines, warm salted water, gin, tobacco (snuff/powdered), cow urine/dung, battery fluid, and various mixtures/ concoctions. Visits to the dentists were mentioned by a few but this was usually as last resort. Main barriers to accessing care from dental care facilities were unaffordability of service charges and fear of extreme treatment measures (extraction). Suggested measures to improve timely access to dental health care included reducing/subsidizing costs of treatments and medications, offering non-extraction treatment options, and oral health education programmes. CONCLUSION: The slum residents experience various forms of dental ailments mostly pain-related. The residents perceived formal dental clinics as unaffordable, thereby engaging in self-care remedies and harmful oral health practices before seeking professional help. Policymakers and decision-makers may leverage this empirical evidence for the people's education on early dental care and address challenges to affordable, available, and acceptable oral healthcare services among slum residents to improve access to care facilities.

Development of a video-observation method for examining doctors' clinical and interpersonal skills in a hospital outpatient clinic in Ibadan, Oyo State, Nigeria.

BACKGROUND: Improving the quality of primary healthcare provision is a key goal in low-and middle-income countries (LMICs). However, to develop effective quality improvement interventions, we first need to be able to accurately measure the quality of care. The methods most commonly used to measure the technical quality of care all have some key limitations in LMICs settings. Video-observation is appealing but has not yet been used in this context. We examine preliminary feasibility and acceptability of video-observation for assessing physician quality in a hospital outpatients' department in Nigeria. We also develop measurement procedures and examine measurement characteristics. METHODS: Cross-sectional study at a large tertiary care hospital in Ibadan, Nigeria. Consecutive physician-patient consultations with adults and children under five seeking outpatient care were video-recorded. We also conducted brief interviews with participating physicians to gain feedback on our approach. Video-recordings were double-coded by two medically trained researchers, independent of the study team and each other, using an explicit checklist of key processes of care that we developed, from which we derived a process quality score. We also elicited a global quality rating from reviewers. RESULTS: We analysed 142 physician-patient consultations. The median process score given by both coders was 100 %. The modal overall rating category was 'above standard' (or 4 on a scale of 1-5). Coders agreed on which rating to assign only 44 % of the time (weighted Cohen's kappa = 0.26). We found in three-level hierarchical modelling that the majority of variance in process scores was explained by coder disagreement. A very high correlation of 0.90 was found between the global quality rating and process quality score across all encounters. Participating physicians liked our approach, despite initial reservations about being observed. CONCLUSIONS: Video-observation is feasible and acceptable in this setting, and the quality of consultations was high. However, we found that rater agreement is low but comparable to other modalities that involve expert clinician judgements about quality of care including in-person direct observation and case note review. We suggest ways to improve scoring consistency including careful rater selection and improved design of the measurement procedure for the process score.

Publication and related biases in health services research: a systematic review of empirical evidence.

BACKGROUND: Publication and related biases (including publication bias, time-lag bias, outcome reporting bias and p-hacking) have been well documented in clinical research, but relatively little is known about their presence and extent in health services research (HSR). This paper aims to systematically review evidence concerning publication and related bias in quantitative HSR. METHODS: Databases including MEDLINE, EMBASE, HMIC, CINAHL, Web of Science, Health Systems Evidence, Cochrane EPOC Review Group and several websites were searched to July 2018. Information was obtained from: (1) Methodological studies that set out to investigate publication and related biases in HSR; (2) Systematic reviews of HSR topics which examined such biases as part of the review process. Relevant information was extracted from included studies by one reviewer and checked by another. Studies were appraised according to commonly accepted scientific principles due to lack of suitable checklists. Data were synthesised narratively. RESULTS: After screening 6155 citations, four methodological studies investigating publication bias in HSR and 184 systematic reviews of HSR topics (including three comparing published with unpublished evidence) were examined. Evidence suggestive of publication bias was reported in some of the methodological studies, but evidence presented was very weak, limited in both quality and scope. Reliable data on outcome reporting bias and p-hacking were scant. HSR systematic reviews in which published literature was compared with unpublished evidence found significant differences in the estimated intervention effects or association in some but not all cases. CONCLUSIONS: Methodological research on publication and related biases in HSR is sparse. Evidence from available literature suggests that such biases may exist in HSR but their scale and impact are difficult to estimate for various reasons discussed in this paper. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2016 CRD42016052333.

Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks.

In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to 'unethical research' and a 'government experimenting on its own people'. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.

Revising ethical guidance for the evaluation of programmes and interventions not initiated by researchers.

Public health and service delivery programmes, interventions and policies (collectively, 'programmes') are typically developed and implemented for the primary purpose of effecting change rather than generating knowledge. Nonetheless, evaluations of these programmes may produce valuable learning that helps determine effectiveness and costs as well as informing design and implementation of future programmes. Such studies might be termed 'opportunistic evaluations', since they are responsive to emergent opportunities rather than being studies of interventions that are initiated or designed by researchers. However, current ethical guidance and registration procedures make little allowance for scenarios where researchers have played no role in the development or implementation of a programme, but nevertheless plan to conduct a prospective evaluation. We explore the limitations of the guidance and procedures with respect to opportunistic evaluations, providing a number of examples. We propose that one key missing distinction in current guidance is moral responsibility: researchers can only be held accountable for those aspects of a study over which they have control. We argue that requiring researchers to justify an intervention, programme or policy that would occur regardless of their involvement prevents or hinders research in the public interest without providing any further protections to research participants. We recommend that trial consent and ethics procedures allow for a clear separation of responsibilities for the intervention and the evaluation.

Ranking Hospitals Based on Preventable Hospital Death Rates: A Systematic Review With Implications for Both Direct Measurement and Indirect Measurement Through Standardized Mortality Rates.

Policy Points The use of standardized mortality rates (SMRs) to profile hospitals presumes differences in preventable deaths, and at least one health system has suggested measuring preventable death rates of hospitals for comparison across time or in league tables. The influence of reliability on the optimal review number per case note or hospital for such a program has not been explored. Estimates for preventable death rates using implicit case note reviews by clinicians are quite low, suggesting that SMRs will not work well to rank hospitals, and any misspecification of the risk-adjustment models will produce a high risk of mislabelling outliers. Most studies achieve only fair to moderate reliability of the direct assessment of whether a death is preventable, and thus it is likely that substantial numbers of reviews of deaths would be required to distinguish preventable from nonpreventable deaths as part of learning from individual cases, or for profiling hospitals. Furthermore, population- and hospital system-specific data on the variation in preventable deaths or adverse events across the hospitals and providers to be compared are required in order to design a measurement procedure and the number of reviews needed to distinguish between the patients or hospitals. CONTEXT: There is interest in monitoring avoidable or preventable deaths measured directly or indirectly through standardized mortality rates (SMRs). While there have been numerous studies in recent years on adverse events, including preventable deaths, using implicit case note reviews by clinicians, no systematic reviews have aimed to summarize the estimates or the variations in methodologies used to derive these estimates. We reviewed studies that use implicit case note reviews to estimate the range of preventable death rates observed, the measurement characteristics of those estimates, and the measurement procedures used to generate them. We comment on the implications for monitoring SMRs and illustrate a way to calculate the number of reviews needed to establish a reliable estimate of the preventability of one death or the hospital preventable death rate. METHODS: We conducted a systematic review of the literature supplemented by a reanalysis of authors' previously published and unpublished data and measurement design calculations. We conducted initial searches in PubMed, MEDLINE (OvidSP), and ISI Web of Knowledge in June 2010 and updated them in June 2012 and December 2017. Eligibility criteria included studies of hospital-wide admissions from general and acute medical wards where preventable death rates are provided or can be estimated and that can provide interobserver variations. FINDINGS: Twenty-three studies were included from 1985 to 2017. Recent larger studies suggest consistently low rates of preventable deaths (interquartile range of 3.0%-6.0% since 2008). Reliability of a single review for distinguishing between individual cases with regard to the preventability of death had a Kappa statistic of 0.10-0.50 for deaths and 0.21-0.76 for adverse events. A Kappa of 0.35 would require an average of 8 to 17 reviews of a single case to be precise enough to have confidence in high-stakes decisions to change care procedures or impose sanctions within a hospital as a result. No study estimated the variation in preventable deaths across hospitals, although we were able to reanalyze one study to obtain an estimate. Based on this estimate, 200 to 300 total case note reviews per hospital could be required to reliably distinguish between hospitals. The studies displayed considerable heterogeneity: 13/23 studies defined preventable death with a threshold of greater than or equal to four in a six-category Likert scale and 11/24 involved a two-stage screening process with nurses at the first stage and physicians at the second. Fifteen studies provided expert clinical review support for reviewer disagreements, advice, and quality control. A "generalist/internist" was the modal physician specialty for reviewers and they received one to three days of generic tools orientation and case note review practice. Methods did not consider the influence of human or environmental factors. CONCLUSIONS: The literature provides limited information about the measurement characteristics of preventable deaths, suggesting that substantial numbers of reviews may be needed to create reliable estimates of preventable deaths at the individual or hospital level. Any operational program would require population-specific estimates of reliability. Preventable death rates are low, which is likely to make it difficult to use SMRs based on all deaths to validly profile hospitals. The literature provides little information to guide improvements in the measurement procedures.

Improving the health and welfare of people who live in slums.

In the first paper in this Series we assessed theoretical and empirical evidence and concluded that the health of people living in slums is a function not only of poverty but of intimately shared physical and social environments. In this paper we extend the theory of so-called neighbourhood effects. Slums offer high returns on investment because beneficial effects are shared across many people in densely populated neighbourhoods. Neighbourhood effects also help explain how and why the benefits of interventions vary between slum and non-slum spaces and between slums. We build on this spatial concept of slums to argue that, in all low-income and-middle-income countries, census tracts should henceforth be designated slum or non-slum both to inform local policy and as the basis for research surveys that build on censuses. We argue that slum health should be promoted as a topic of enquiry alongside poverty and health.

The history, geography, and sociology of slums and the health problems of people who live in slums.

Massive slums have become major features of cities in many low-income and middle-income countries. Here, in the first in a Series of two papers, we discuss why slums are unhealthy places with especially high risks of infection and injury. We show that children are especially vulnerable, and that the combination of malnutrition and recurrent diarrhoea leads to stunted growth and longer-term effects on cognitive development. We find that the scientific literature on slum health is underdeveloped in comparison to urban health, and poverty and health. This shortcoming is important because health is affected by factors arising from the shared physical and social environment, which have effects beyond those of poverty alone. In the second paper we will consider what can be done to improve health and make recommendations for the development of slum health as a field of study.

The predictive validity of the Living Goods selection tools for community health workers in Kenya: cohort study.

BACKGROUND: Ensuring that selection processes for Community Health Workers (CHWs) are effective is important due to the scale and scope of modern CHW programmes. However they are relatively understudied. While community involvement in selection should never be eliminated entirely, there are other complementary methods that could be used to help identify those most likely to be high-performing CHWs. This study evaluated the predictive validity of three written tests and two individual sections of a one-to-one interview used for selection into CHW posts in eight areas of Kenya. METHODS: A cohort study of CHWs working for Living Goods in eight local areas of Kenya was undertaken. Data on the selection scores, post-training assessment scores and subsequent on-the-job performance (number of household and pregnancy registrations, number of child assessments, proportion of on-time follow-ups and value of goods sold) were obtained for 547 CHWs. Kendall's tau-b correlations between each selection score and performance outcome were calculated. RESULTS: None of the correlations between selection scores and outcomes reached the 0.3 threshold of an "adequate" predictor of performance. Correlations were higher for the written components of the selection process compared to the interview components, with some small negative correlations found for the latter. CONCLUSIONS: If the measures of performance included in this study are considered critical, then further work to develop the CHW selection tools is required. This could include modifying the content of both tools or increasing the length of the written tests to make them more reliable, for if a test is not reliable then it cannot be valid. Other important outcomes not included in this study are retention in post and quality of care. Other CHW programme providers should consider evaluating their own selection tools in partnership with research teams.

Adaption, implementation and evaluation of collaborative service improvements in the testing and result communication process in primary care from patient and staff perspectives: a qualitative study.

BACKGROUND: Increasing numbers of blood tests are being ordered in primary care settings and the swift and accurate communication of test results is central to providing high quality care. The process of testing and result communication is complex and reliant on the coordinated actions of care providers, external groups in laboratory and hospital settings, and patients. This fragmentation leaves it vulnerable to error and the need to improve an apparently fallible system is apparent. However, primary care is complex and does not necessarily adopt change in a linear and prescribed manner influenced by a range of factors relating to practice staff, patients and organisational factors. To account for these competing perspectives, we worked in conjunction with both staff and patients to develop and implement strategies intended to improve patient satisfaction and increase efficiency of existing processes. METHODS: The study applied the principles of 'experience-based co-design' to identify key areas of weakness and source proposals for change from staff and patients. The study was undertaken within two primary practices situated in South Birmingham (UK) of contrasting size and socio-economic environment. Senior practice staff were involved in the refinement of the interventions for introduction. We conducted focus groups singly constituted of staff and patients at each practice to determine suitability, applicability and desirability alongside the practical implications of their introduction. RESULTS: At each practice four of the six proposals for change were implemented these were increased access to phlebotomy, improved receptionist training, proactive communication of results, and increased patient awareness of the tests ordered and the means of their communication. All were received favourably by both patients and staff. The remaining issues around the management of telephone calls and the introduction of electronic alerts for missing results were not addressed due to constraints of time and available resources. CONCLUSIONS: Approaches to tackling the same area of weakness differed at practices and was determined by individual staff attitudes and by organisational and patient characteristics. The long-term impact of the changes requires further quantitative evaluation.

HEADROOM BEYOND THE QUALITY- ADJUSTED LIFE-YEAR: THE CASE OF COMPLEX PEDIATRIC NEUROLOGY.

OBJECTIVES: The headroom method was introduced for the very early evaluation of the potential value of new technologies. It allows for establishing a ceiling price for technologies to still be cost-effective by combining the maximum effect a technology might yield, the maximum willingness-to-pay (WTP) for this effect, and potential downstream expenses and savings. Although the headroom method is QALY-based, not all innovations are expected to result in QALY gain. METHODS: This study explores the feasibility and usefulness of the headroom method in the evaluation of technologies that are unlikely to result in QALY gain. This will be illustrated with the diagnostic trajectory of complex pediatric neurology (CPN). RESULTS: Our headroom analysis showed a large room for improvement in the current diagnostic trajectory of CPN in terms of diagnostic yield. Combining this with a maximum WTP value for an additional diagnosis and the potential downstream expenses and savings, resulted in a total headroom of €15,028. This indicates that a new technology in this particular diagnostic trajectory, might be cost-effective as long as its costs do not exceed €15,028. CONCLUSIONS: The headroom method seems a useful tool in the very early evaluation of medical technologies, also in cases when immediate QALY gain is unlikely. It allows for allocating healthcare resources to those technologies that are most promising. It should be kept in mind, however, that the headroom assumes an optimistic scenario, and for that reason cannot guarantee future cost-effectiveness. It might be most useful for ruling out those technologies that are unlikely to be cost-effective.

A Systematic Review of the Prevalence and Types of Adverse Events in Interfacility Critical Care Transfers by Paramedics.

OBJECTIVE: The aim of this study was to investigate if paramedics can safely transfer interfacility critically ill adult patients and to determine the prevalence and types of adverse events when paramedics lead interfacility critical care transfers. METHODS: MEDLINE, Web of Science, Embase, and CINAHL databases were searched from 1990 up to February 2016. Eligibility criteria were adult patients (16 years and over), interfacility transfer (between two health care facilities), quantitative or qualitative description of adverse events, and a paramedic as the primary care provider or the sole health care provider. RESULTS: Seven publications had paramedics as the sole health care provider conducting interfacility critical care transfers. All seven studies were observational studies published in the English language. The study duration ranged from 14 months to 10 years. The frequency of adverse events seen by paramedics in interfacility transfers ranges from 5.1% to 18%. CONCLUSION: There is a gap in literature on the safety and adverse events in interfacility transfers by paramedics. The prevalence of in-transit adverse events is well established; however, because the published literature is lacking longitudinal monitoring of patients and only reporting in-transit events, we believe that further research in this area might provide the basis of paramedics safety in interfacility transfers.

Identification of Extracolonic Pathologies by Computed Tomographic Colonography in Colorectal Cancer Symptomatic Patients.

BACKGROUND & AIMS: Symptoms suggestive of colorectal cancer may originate outside the colorectum. Computed tomographic colonography (CTC) is used to examine the colorectum and abdominopelvic organs simultaneously. We performed a prospective randomized controlled trial to quantify the frequency, nature, and consequences of extracolonic findings. METHODS: We studied 5384 patients from 21 UK National Health Service hospitals referred by their family doctor for the investigation of colorectal cancer symptoms from March 2004 through December 2007. The patients were assigned randomly to groups that received the requested test (barium enema or colonoscopy, n = 3574) or CTC (n = 1810). We determined the frequency and nature of extracolonic findings, subsequent investigations, ultimate diagnosis, and extracolonic cancer diagnoses 1 and 3 years after testing patients without colorectal cancer. RESULTS: Extracolonic pathologies were detected in 959 patients by CTC (58.7%), in 42 patients by barium enema analysis (1.9%), and in no patients by colonoscopy. Extracolonic findings were investigated in 142 patients (14.2%) and a diagnosis was made for 126 patients (88.1%). Symptoms were explained by extracolonic findings in 4 patients analyzed by barium enema (0.2%) and in 33 patients analyzed by CTC (2.8%). CTC identified 72 extracolonic neoplasms, however, barium enema analysis found only 3 (colonoscopy found none). Overall, CTC diagnosed extracolonic neoplasms in 72 of 1634 patients (4.4%); 26 of these were malignant (1.6%). There were significantly more extracolonic malignancies detected than expected 1 year after examination, but these did not differ between patients evaluated by CTC (22.2/1000 person-years), barium enema (26.5/1000 person-years; P = .43), or colonoscopy (32.0/1000 person-years; P = .88). CONCLUSIONS: More than half of the patients with symptoms of colorectal cancer are found to have extracolonic pathologies by CTC analysis. However, the proportion of patients found to have extracolonic malignancies after 1 year of CTC examination is not significantly greater than after barium enema or colonoscopy examinations. International Standard Randomised Controlled Trials no: 95152621.isrctn.com.

Salt intakes in sub-Saharan Africa: a systematic review and meta-regression.

BACKGROUND: High sodium intake increases the risk of hypertension and cardiovascular diseases. For this reason the World Health Organization recommends a maximum intake of 2 g per day and a 30 % reduction in population sodium intake by 2025. However, in global reviews, data on sodium intake in sub-Saharan Africa have been limited. METHODS: A systematic review was conducted to identify studies reporting sodium intake in sub-Saharan African populations. Meta-regression analyses were used to test the effect of year of data collection and method of data collection (urinary/dietary), as well as any association between sex, urban/rural status or a country's economic development, and population sodium intake. RESULTS: We identified 42 papers reporting 67 estimates of adult population sodium intakes and 12 estimates of child population sodium intakes since 1967. Of the 67 adult populations, 54 (81 %) consumed more than 2 g sodium/day, as did four of the 12 (33 %) child populations. Sixty-five adult estimates were included in the meta-regression, which found that urban populations consumed higher amounts of salt than rural populations and that urine collection gave lower estimates of sodium intake than dietary data. CONCLUSIONS: Sodium intake in much of sub-Saharan Africa is above the World Health Organization's recommended maximum intake and may be set to increase as the continent undergoes considerable urbanization. Few identified studies used stringent measurement criteria or representative population samples. High quality studies will be required to identify where and with whom to intervene, in order to meet the World Health Organization's target of a 30 % reduction in population sodium intake and to demonstrate progress towards this target.

The systemic immune response to trauma: an overview of pathophysiology and treatment.

Improvements in the control of haemorrhage after trauma have resulted in the survival of many people who would otherwise have died from the initial loss of blood. However, the danger is not over once bleeding has been arrested and blood pressure restored. Two-thirds of patients who die following major trauma now do so as a result of causes other than exsanguination. Trauma evokes a systemic reaction that includes an acute, non-specific, immune response associated, paradoxically, with reduced resistance to infection. The result is damage to multiple organs caused by the initial cascade of inflammation aggravated by subsequent sepsis to which the body has become susceptible. This Series examines the biological mechanisms and clinical implications of the cascade of events caused by large-scale trauma that leads to multiorgan failure and death, despite the stemming of blood loss. Furthermore, the stark and robust epidemiological finding--namely, that age has a profound influence on the chances of surviving trauma irrespective of the nature and severity of the injury--will be explored. Advances in our understanding of the inflammatory response to trauma, the impact of ageing on this response, and how this information has led to new and emerging treatments aimed at combating immune dysregulation and reduced immunity after injury will also be discussed.

An approach to prioritization of medical devices in low-income countries: an example based on the Republic of South Sudan.

BACKGROUND: Efficient and evidence-based medical device and equipment prioritization is of particular importance in low-income countries due to constraints in financing capacity, physical infrastructure and human resource capabilities. METHODS: This paper outlines a medical device prioritization method developed in first instance for the Republic of South Sudan. The simple algorithm offered here is a starting point for procurement and selection of medical devices and can be regarded as a screening test for those that require more labour intensive health economic modelling. CONCLUSIONS: A heuristic method, such as the one presented here, is appropriate for reaching many medical device prioritization decisions in low-income settings. Further investment and purchasing decisions that cannot be reached so simply require more complex health economic modelling approaches.

Computed tomographic colonography versus barium enema for diagnosis of colorectal cancer or large polyps in symptomatic patients (SIGGAR): a multicentre randomised trial.

BACKGROUND: Barium enema (BE) is widely available for diagnosis of colorectal cancer despite concerns about its accuracy and acceptability. Computed tomographic colonography (CTC) might be a more sensitive and acceptable alternative. We aimed to compare CTC and BE for diagnosis of colorectal cancer or large polyps in symptomatic patients in clinical practice. METHODS: This pragmatic multicentre randomised trial recruited patients with symptoms suggestive of colorectal cancer from 21 UK hospitals. Eligible patients were aged 55 years or older and regarded by their referring clinician as suitable for radiological investigation of the colon. Patients were randomly assigned (2:1) to BE or CTC by computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome-diagnosis of colorectal cancer or large (≥10 mm) polyps-by intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621. FINDINGS: 3838 patients were randomly assigned to receive either BE (n=2553) or CTC (n=1285). 34 patients withdrew consent, leaving for analysis 2527 assigned to BE and 1277 assigned to CTC. The detection rate of colorectal cancer or large polyps was significantly higher in patients assigned to CTC than in those assigned to BE (93 [7.3%] of 1277 vs 141 [5.6%] of 2527, relative risk 1.31, 95% CI 1.01-1.68; p=0.0390). CTC missed three of 45 colorectal cancers and BE missed 12 of 85. The rate of additional colonic investigation was higher after CTC than after BE (283 [23.5%] of 1206 CTC patients had additional investigation vs 422 [18.3%] of 2300 BE patients; p=0.0003), due mainly to a higher polyp detection rate. Serious adverse events were rare. INTERPRETATION: CTC is a more sensitive test than BE. Our results suggest that CTC should be the preferred radiological test for patients with symptoms suggestive of colorectal cancer. FUNDING: NIHR Health Technology Assessment Programme, NIHR Biomedical Research Centres funding scheme, Cancer Research UK, EPSRC Multidisciplinary Assessment of Technology Centre for Healthcare, and NIHR Collaborations for Leadership in Applied Health Research and Care.

Computed tomographic colonography versus colonoscopy for investigation of patients with symptoms suggestive of colorectal cancer (SIGGAR): a multicentre randomised trial.

BACKGROUND: Colonoscopy is the gold-standard test for investigation of symptoms suggestive of colorectal cancer; computed tomographic colonography (CTC) is an alternative, less invasive test. However, additional investigation after CTC is needed to confirm suspected colonic lesions, and this is an important factor in establishing the feasibility of CTC as an alternative to colonoscopy. We aimed to compare rates of additional colonic investigation after CTC or colonoscopy for detection of colorectal cancer or large (≥10 mm) polyps in symptomatic patients in clinical practice. METHODS: This pragmatic multicentre randomised trial recruited patients with symptoms suggestive of colorectal cancer from 21 UK hospitals. Eligible patients were aged 55 years or older and regarded by their referring clinician as suitable for colonoscopy. Patients were randomly assigned (2:1) to colonoscopy or CTC by computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome-the rate of additional colonic investigation-by intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621. FINDINGS: 1610 patients were randomly assigned to receive either colonoscopy (n=1072) or CTC (n=538). 30 patients withdrew consent, leaving for analysis 1047 assigned to colonoscopy and 533 assigned to CTC. 160 (30.0%) patients in the CTC group had additional colonic investigation compared with 86 (8.2%) in the colonoscopy group (relative risk 3.65, 95% CI 2.87-4.65; p<0.0001). Almost half the referrals after CTC were for small (<10 mm) polyps or clinical uncertainty, with low predictive value for large polyps or cancer. Detection rates of colorectal cancer or large polyps in the trial cohort were 11% for both procedures. CTC missed 1 of 29 colorectal cancers and colonoscopy missed none (of 55). Serious adverse events were rare. INTERPRETATION: Guidelines are needed to reduce the referral rate after CTC. For most patients, however, CTC provides a similarly sensitive, less invasive alternative to colonoscopy. FUNDING: NIHR Health Technology Assessment Programme, NIHR Biomedical Research Centres funding scheme, Cancer Research UK, EPSRC Multidisciplinary Assessment of Technology Centre for Healthcare, and NIHR Collaborations for Leadership in Applied Health Research and Care.