Colorectal cancer screening with fecal immunochemical testing or primary colonoscopy: An analysis of health equity based on a randomised trial.

Background: We have addressed health equity attained by fecal immunochemical testing (FIT) and primary colonoscopy (PCOL), respectively, in the randomised controlled screening trial SCREESCO conducted in Sweden. Methods: We analysed data on the individuals recruited between March 2014, and March 2020, within the study registered with ClinicalTrials.gov, NCT02078804. Swedish population registry data on educational level, household income, country of birth, and marital status were linked to each 60-year-old man and woman who had been randomised to two rounds of FIT 2 years apart (n = 60,123) or once-only PCOL (n = 30,390). Furthermore, we geo-coded each study individual to his/her residential area and assessed neighbourhood-level data on deprivation, proportion of non-Western immigrants, population density, and average distance to healthcare center for colonoscopy. We estimated adjusted associations of each covariate with the colonoscopy attendance proportion out of all invited to respective arms; ie, the preferred outcome for addressing health equity. In the FIT arm, the test uptake and the colonoscopy uptake among the test positives were considered as the secondary outcomes. Findings: We found a marked socioeconomic gradient in the colonoscopy attendance proportion in the PCOL arm (adjusted odds ratio [95% credibility interval] between the groups categorised in the highest vs. lowest national quartile for household income: 2·20 [2·01-2·42]) in parallel with the gradient in the test uptake of the FIT × 2 screening (2·08 [1·96-2·20]). The corresponding gradient in the colonoscopy attendance proportion out of all invited to FIT was less pronounced (1·29 [1·16-1·42]), due to higher proportions of FIT positives in socioeconomically disadvantaged groups. Interpretation: The unintended risk of exacerbating inequalities in health by organised colorectal cancer screening may be higher with a PCOL strategy than a FIT strategy, despite parallel socioeconomic gradients in uptake. Funding: This work was supported by the Swedish Cancer Society under Grant 20 0719. CB and US provided economic support from the Swedish Research Council for Health, Working life, and Welfare under Grant 2020-00962.

Modelling the lifetime cost-effectiveness of radical prostatectomy, radiotherapy and active monitoring for men with clinically localised prostate cancer from median 10-year outcomes in the ProtecT randomised trial.

BACKGROUND: Optimal management strategies for clinically localised prostate cancer are debated. Using median 10-year data from the largest randomised controlled trial to date (ProtecT), the lifetime cost-effectiveness of three major treatments (radical radiotherapy, radical prostatectomy and active monitoring) was explored according to age and risk subgroups. METHODS: A decision-analytic (Markov) model was developed and informed by clinical input. The economic evaluation adopted a UK NHS perspective and the outcome was cost per Quality-Adjusted Life Year (QALY) gained (reported in UK£), estimated using EQ-5D-3L. RESULTS: Costs and QALYs extrapolated over the lifetime were mostly similar between the three randomised strategies and their subgroups, but with some important differences. Across all analyses, active monitoring was associated with higher costs, probably associated with higher rates of metastatic disease and changes to radical treatments. When comparing the value of the strategies (QALY gains and costs) in monetary terms, for both low-risk prostate cancer subgroups, radiotherapy generated the greatest net monetary benefit (£293,446 [95% CI £282,811 to £299,451] by D'Amico and £292,736 [95% CI £284,074 to £297,719] by Grade group 1). However, the sensitivity analysis highlighted uncertainty in the finding when stratified by Grade group, as radiotherapy had 53% probability of cost-effectiveness and prostatectomy had 43%. In intermediate/high risk groups, using D'Amico and Grade group > = 2, prostatectomy generated the greatest net monetary benefit (£275,977 [95% CI £258,630 to £285,474] by D'Amico and £271,933 [95% CI £237,864 to £287,784] by Grade group). This finding was supported by the sensitivity analysis. Prostatectomy had the greatest net benefit (£290,487 [95% CI £280,781 to £296,281]) for men younger than 65 and radical radiotherapy (£201,311 [95% CI £195,161 to £205,049]) for men older than 65, but sensitivity analysis showed considerable uncertainty in both findings. CONCLUSION: Over the lifetime, extrapolating from the ProtecT trial, radical radiotherapy and prostatectomy appeared to be cost-effective for low risk prostate cancer, and radical prostatectomy for intermediate/high risk prostate cancer, but there was uncertainty in some estimates. Longer ProtecT trial follow-up is required to reduce uncertainty in the model. TRIAL REGISTRATION: Current Controlled Trials number, ISRCTN20141297: http://isrctn.org (14/10/2002); ClinicalTrials.gov number, NCT02044172: http://www.clinicaltrials.gov (23/01/2014).

Socioeconomic position and suicidal behaviour in rural Sri Lanka: a prospective cohort study of 168,000+ people.

PURPOSE: Lower socioeconomic position (SEP) is associated with an increased risk of suicidal behaviour in high income countries, but this association is not established in low- and middle-income countries (LMIC). METHODS: We investigated the association of SEP with suicidal behaviour in a prospective cohort study of 168,771 Sri Lankans followed up for episodes of attempted suicide and suicide. SEP data were collected at baseline at the household and individual level at the start of the follow-up period. We used multilevel Poisson regression models to investigate the association of SEP at community, household and individual levels with attempted suicide/suicide. RESULTS: Lower levels of asset ownership [IRR (95% CI) suicide 1.74 (0.92, 3.28); attempted suicide 1.67 (1.40, 2.00)] and education [suicide 3.16 (1.06, 9.45); attempted suicide 2.51 (1.70, 3.72)] were associated with an increased risk of suicidal behaviour. The association of these measures of SEP and attempted suicide was stronger in men than women. Individuals living in deprived areas [1.42 (1.16, 1.73)] and in households with a young female head of household [1.41 (1.04, 1.93)] or a temporary foreign migrant [1.47 (1.28, 1.68)] had an elevated risk of attempted suicide. Farmers and daily wage labourers had nearly a doubling in risk of attempted suicide compared to other occupations. CONCLUSIONS: Improved employment opportunities, welfare and mental health support services, as well as problem-solving skills development, may help support individuals with poorer education, farmers, daily wage labourers, individuals in young female-headed households and temporary foreign migrant households.

Is socioeconomic position associated with risk of attempted suicide in rural Sri Lanka? A cross-sectional study of 165†000 individuals.

BACKGROUND: Lower socioeconomic position (SEP) is associated with an increased risk of suicidal behaviour in high-income countries, but this association is unclear in low-income and middle-income countries. METHODS: We investigated the association of SEP with attempted suicide in a cross-sectional survey of 165 233 Sri Lankans. SEP data were collected at the household (assets, social standing (highest occupation of a household member), foreign employment and young (≤40 years) female-headed households) and individual level (education and occupation). Respondent-reported data on suicide attempts in the past year were recorded. Random-effects logistic regression models, accounting for clustering, were used to investigate the association of SEP with attempted suicide. RESULTS: Households reported 398 attempted suicides in the preceding year (239 per 100 000). Fewer assets (OR 3.2, 95% CI 2.4 to 4.4) and having a daily wage labourer (ie, insecure/low-income job; OR 2.3, 95% CI 1.6 to 3.2) as the highest occupation increased the risk of an attempted suicide within households. At an individual level, daily wage labourers were at an increased risk of attempted suicide compared with farmers. The strongest associations were with low levels of education (OR 4.6, 95% CI 2.5 to 8.4), with a stronger association in men than women. CONCLUSIONS: We found that indicators of lower SEP are associated with increased risk of attempted suicide in rural Sri Lanka. Longitudinal studies with objective measures of suicide attempts are needed to confirm this association. TRIAL REGISTRATION NUMBER: NCT01146496; Pre-results.

Interventions to reduce the impact of unemployment and economic hardship on mental health in the general population: a systematic review.

BACKGROUND: Job loss, debt and financial difficulties are associated with increased risk of mental illness and suicide in the general population. Interventions targeting people in debt or unemployed might help reduce these effects. METHOD: We searched MEDLINE, Embase, The Cochrane Library, Web of Science, and PsycINFO (January 2016) for randomized controlled trials (RCTs) of interventions to reduce the effects of unemployment and debt on mental health in general population samples. We assessed papers for inclusion, extracted data and assessed risk of bias. RESULTS: Eleven RCTs (n = 5303 participants) met the inclusion criteria. All recruited participants were unemployed. Five RCTs assessed 'job-club' interventions, two cognitive behaviour therapy (CBT) and a single RCT assessed each of emotional competency training, expressive writing, guided imagery and debt advice. All studies were at high risk of bias. 'Job club' interventions led to improvements in levels of depression up to 2 years post-intervention; effects were strongest among those at increased risk of depression (improvements of up to 0.2-0.3 s.d. in depression scores). There was mixed evidence for effectiveness of group CBT on symptoms of depression. An RCT of debt advice found no effect but had poor uptake. Single trials of three other interventions showed no evidence of benefit. CONCLUSIONS: 'Job-club' interventions may be effective in reducing depressive symptoms in unemployed people, particularly those at high risk of depression. Evidence for CBT-type interventions is mixed; further trials are needed. However the studies are old and at high risk of bias. Future intervention studies should follow CONSORT guidelines and address issues of poor uptake.

Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

BACKGROUND: Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. METHODS: We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. RESULTS: The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. CONCLUSIONS: In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

Negligence claims following non-union and malunion of long bone fractures: An analysis of 15 years of data.

INTRODUCTION: Non-unions and malunions are recognised to be complications of the treatment of long bone fractures. No previous work has looked at the implications of these complications from a medicolegal perspective. METHODS: A complete database of litigation claims in Trauma and Orthopaedic Surgery was obtained from the NHS Litigation Authority. Two separate modalities of the treatment of long bone fractures were examined i) non-union and ii) acquired deformity. The type of complaint, whether defended or not, and costs were analysed. RESULTS: There were claims of which 97 related to non-union and 32 related to postoperative limb deformity. The total cost was £8.2 million over a 15-year period in England and Wales. Femoral and tibial non-unions were more expensive particularly if they resulted in amputation. Rotational deformity cost nearly twice as much as angulation deformities. CONCLUSIONS: The cosmetic appearances of rotational malalignment and amputation results in higher compensation; this reinforces an outward perception of outcome as being more important than harmful effects. Notwithstanding the limitations of this database, there are clinical lessons to be gained from these litigation claims.

Study protocol for an evaluation of the effectiveness of 'care bundles' as a means of improving hospital care and reducing hospital readmission for patients with chronic obstructive pulmonary disease (COPD).

BACKGROUND: Chronic Obstructive Pulmonary Disease is one of the commonest respiratory diseases in the United Kingdom, accounting for 10% of unplanned hospital admissions each year. Nearly a third of these admitted patients are re-admitted to hospital within 28 days of discharge. Whilst there is a move within the NHS to ensure that people with long-term conditions receive more co-ordinated care, there is little research evidence to support an optimum approach to this in COPD. This study aims to evaluate the effectiveness of introducing standardised packages of care i.e. care bundles, for patients with acute exacerbations of COPD as a means of improving hospital care and reducing re-admissions. METHODS / DESIGN: This mixed-methods evaluation will use a controlled before-and-after design to examine the effect of, and costs associated with, implementing care bundles for patients admitted to hospital with an acute exacerbation of COPD, compared with usual care. It will quantitatively measure a range of patient and organisational outcomes for two groups of hospitals - those who deliver care using COPD care bundles, and those who deliver care without the use of COPD care bundles. These care bundles may be provided for patients with COPD following admission, prior to discharge or at both points in the care pathway. The primary outcome will be re-admission to hospital within 28 days of discharge, although the study will additionally investigate a number of secondary outcomes including length of stay, total bed days, in-hospital mortality, costs of care and patient / carer experience. A series of nested qualitative case studies will explore in detail the context and process of care as well as the impact of COPD bundles on staff, patients and carers. DISCUSSION: The results of the study will provide information about the effectiveness of care bundles as a way of managing in-hospital care for patients with an acute exacerbation of COPD. Given the number of unplanned hospital admissions for this patient group and their rate of subsequent re-admission, it is hoped that this evaluation will make a timely contribution to the evidence on care provision, to the benefit of patients, clinicians, managers and policy-makers. TRIAL REGISTRATION: International Standard Randomised Controlled Trials - ISRCTN13022442 - 11 February 2015.

Readmission rates and financial penalties after ear, nose and throat surgery: how can we improve?

INTRODUCTION: Since April 2011, all patient readmissions within 30 days have resulted in a financial penalty to the hospital trust, and therefore the responsible department. These costs may be substantial and potentially preventable. METHODS: A service evaluation of readmissions within 30 days of discharge, over a 12-month period (January-December 2012), was performed in the ear, nose and throat department of a district general hospital, and findings were used as a basis to suggest areas for potential quality improvement. AIMS: To determine the number of readmissions, causes of readmission and resulting costs, and to explore how these readmissions may be prevented. RESULTS: The departmental 30-day readmission rate over the study period was 3.12% (81/2606). The commonest causes of readmission (33.3%) were complications following tonsillectomy (27/81) such as pain, infection or bleeding. Over a third of these patients (30/81) were readmitted for less than 24 hours, with the average length of stay being less than 2.5 days. Financial implications: In 2011 the trust had 7526 emergency readmissions which were eligible for penalty within the 30-day time frame. This resulted in a loss of income of more than £60 000 to the ear, nose and throat department. CONCLUSIONS: Optimizing postoperative care and improving patient understanding of common complications may reduce readmission rates, thus limiting the financial burden on the trust. These areas could serve as a basis for future quality improvement projects.

Litigation trends and costs in otorhinolaryngology.

BACKGROUND: Litigation in surgery is increasing and liabilities are becoming unsustainable. This study aimed to analyse trends in claims, and identify areas for potential risk reduction, improved patient safety and a reduction in the number, and cost, of future claims. METHODS: Ten years of retrospective data on claims in otorhinolaryngology (2003-2013) were obtained from the National Health Service Litigation Authority via a Freedom of Information request. Data were re-entered into a spreadsheet and coded for analysis. RESULTS: A total of 1031 claims were identified; of these, 604 were successful and 427 were unsuccessful. Successful claims cost a total of £41 000 000 (mean, £68 000). The most common areas for successful claims were: failure or delay in diagnosis (137 cases), intra-operative problems (116 cases), failure or delay in treatment (66 cases), failure to warn - informed consent issue (54 cases), and inappropriate treatment (47 cases). CONCLUSION: Over half of the claims in ENT relate to the five most common areas of liability. Recent policy changes by the National Health Service Litigation Authority, over the level of information divulged, limits our learning from claims.

Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

BACKGROUND: Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. METHODS: Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50-69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up. RESULTS: Among randomised practices, 271 (68%) in the intervention arm (198,114 men) and 302 (78%) in the control arm (221,929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices). CONCLUSIONS: The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.

Pathways to diagnosis for Black men and White men found to have prostate cancer: the PROCESS cohort study.

Black men in England have three times the age-adjusted incidence of diagnosed prostate cancer as compared with their White counterparts. This population-based retrospective cohort study is the first UK-based investigation of whether access to diagnostic services underlies the association between race and prostate cancer. Prostate cancer was ascertained using multiple sources including hospital records. Race and factors that may influence prostate cancer diagnosis were assessed by questionnaire and hospital records review. We found that Black men were diagnosed an average of 5.1 years younger as compared with White men (P<0.001). Men of both races were comparable in their knowledge of prostate cancer, in the delays reported before presentation, and in their experience of co-morbidity and symptoms. Black men were more likely to be referred for diagnostic investigation by a hospital department (P=0.013), although general practitioners referred the large majority of men. Prostate-specific antigen levels were comparable at diagnosis, although Black men had higher levels when compared with same-age White men (P<0.001). In conclusion, we found no evidence of Black men having poorer access to diagnostic services. Differences in the run-up to diagnosis are modest and seem insufficient to explain the higher rate of prostate cancer diagnosis in Black men.

Effects of hypertonic saline, alternate day and daily rhDNase on healthcare use, costs and outcomes in children with cystic fibrosis.

BACKGROUND: Daily recombinant human deoxyribonuclease (rhDNase) is an established but expensive treatment in cystic fibrosis (CF). An alternative lower cost therapy is hypertonic saline (HS), which has been shown to improve lung function in short term studies. This study compares the costs and consequences of daily rhDNase with alternate day rhDNase and HS in children with CF. METHODS: In an open, randomised, crossover trial, 48 children with CF were allocated consecutively to 12 weeks of once daily 2.5 mg rhDNase, alternate day 2.5 mg rhDNase, and twice daily 5 ml 7% HS. Outcomes assessed included forced expiratory volume in 1 second (FEV(1)) and quality of life. All healthcare resource use was prospectively recorded for each patient. Unit costs were collected and combined with resource use data to give the total health service costs per patient for each treatment strategy. RESULTS: Daily rhDNase resulted in a significantly greater increase in mean FEV(1) than HS (8%, 95% CI 2 to 14) but there was no significant difference in FEV(1) between daily and alternate day rhDNase (2%, 95% CI -4 to 9). Over a 12 week period the mean incremental costs of daily rhDNase compared with HS was pound 1409 (95% CI pound 440 to pound 2318), and the incremental cost of using daily rather than alternate day rhDNase was pound 513 (95% CI - pound 546 to pound 1510). CONCLUSIONS: Daily rhDNase is more effective than 5 ml 7% HS twice daily delivered by jet nebuliser, but significantly increases healthcare costs. Administering rhDNase on an alternate day rather than a daily basis is as effective, with a potential for cost savings.