Salivary SIgA responses to acute moderate-vigorous exercise in monophasic oral contraceptive users

The purpose of this study was to examine the effect of oral contraceptive (OC) use on salivary secretory immunoglobulin A (SIgA) levels at rest and in response to an acute bout of moderate-vigorous exercise during two phases of the 4 week OC cycle corresponding to different phases of the synthetic menstrual cycle. Ten healthy active females completed a cycling at 70% V(・)O2peak for 45 min at two time points of an OC cycle: during the equivalent in time to the mid-follicular phase (day 8 ± 2) and the mid-luteal phase (day 20 ± 2). Timed unstimulated saliva samples were obtained before, immediately post exercise and 1 h post exercise and analyzed for salivary SIgA. Salivary SIgA secretion rate was 26 % (95% Confidence limits, CI, 6-46) lower at post-exercise compared with pre-exercise during the synthetic follicular phase (p = 0.019) but no differences were observed during the synthetic luteal trial. Saliva flow rate was 11% (95% CI, 8-30) lower at post-exercise compared with pre-exercise (main effect for time; p = 0.025). In conclusion, the pattern of salivary SIgA secretion rate response to moderate-vigorous exercise varies across the early and late phases of a monophasic OC cycle, with a transient reduction in salivary SIgA responses during the synthetic follicular phase. These findings indicate that monophasic OC use should be considered when assessing mucosal immune responses to acute exercise

Unsupervised machine learning of integrated health and social care data from the Macmillan Improving the Cancer Journey service in Glasgow

Background: Improving the Cancer Journey (ICJ) was launched in 2014 by Glasgow City Council and Macmillan Cancer Support. As part of routine service, data is collected on ICJ users including demographic and health information, results from holistic needs assessments and quality of life scores as measured by EQ-5D health status. There is also data on the number and type of referrals made and feedback from users on the overall service. By applying artificial intelligence and interactive visualization technologies to this data, we seek to improve service provision and optimize resource allocation.Method: An unsupervised machine-learning algorithm was deployed to cluster the data. The classical k-means algorithm was extended with the k-modes technique for categorical data, and the gap heuristic automatically identified the number of clusters. The resulting clusters are used to summarize complex data sets and produce three-dimensional visualizations of the data landscape. Furthermore, the traits of new ICJ clients are predicted by approximately matching their details to the nearest existing cluster center.Results: Cross-validation showed the model’s effectiveness over a wide range of traits. For example, the model can predict marital status, employment status and housing type with an accuracy between 2.4 to 4.8 times greater than random selection. One of the most interesting preliminary findings is that area deprivation (measured through Scottish Index of Multiple Deprivation-SIMD) is a better predictor of an ICJ client’s needs than primary diagnosis (cancer type).Conclusion: A key strength of this system is its ability to rapidly ingest new data on its own and derive new predictions from those data. This means the model can guide service provision by forecasting demand based on actual or hypothesized data. The aim is to provide intelligent person-centered recommendations. The machine-learning model described here is part of a prototype software tool currently under development for use by the cancer support community.Disclosure: Funded by Macmillan Cancer Support</p

A pilot cluster randomised trial to assess the effect of a structured communication approach on quality of life in secure mental health settings: the Comquol study

Background There is a lack of research in forensic settings examining therapeutic relationships. A structured communication approach, placing patients’ perspectives at the heart of discussions about their care, was used to improve patients’ quality of life in secure settings. The objectives were to: • Establish the feasibility of the trial design • Determine the variability of the outcomes of interest • Estimate the costs of the intervention • If necessary, refine the intervention Methods A pilot cluster randomised controlled trial was conducted. Data was collected from July 2012 to January 2015 from participants in 6 medium secure in–patient services in London and Southern England. 55 patients and 47 nurses were in the intervention group with 57 patients and 45 nurses in the control group. The intervention comprised 6 nurse-patient meetings over a 6 month period. Patients rated their satisfaction with a range of domains followed by discussions on improving patient identified problems. Assessments took place at baseline, 6 months, and 12 months. Participants were not blind to their allocated group. The primary outcome was self-reported quality of life collected by a researcher blind to participants’ allocation status. Results The randomisation procedures and intervention approach functioned well. The measures used were understood by the participants and gave relevant outcome information. The response rates were good with low patient withdrawal rates. The quality of life estimated treatment effect was 0.2 (95% CI: -0.4 to 0.8) at 6 months and 0.4 (95% CI: -0.3 to 1.1) indicating the likely extreme boundaries of effect in the main trial. The estimated treatment effect of the primary outcome is clinically important, and a positive effect of the intervention is not ruled out. The estimate of the ICC for the primary outcome at 6 and 12 months was 0.04 (0.00 to 0.17) and 0.05 (0.00 to 0.18). The cost of the intervention was £529 per patient. Conclusions The trial design was viable as the basis for a full-scale trial. A full trial is justified to estimate the effect of the intervention with greater certainty. The variability of the outcomes could be used to calculate numbers needed for a full-scale trial. Ratings of need for therapeutic security may be useful in any future study

Is age a barrier to chemotherapy? Rates of treatment in older patients with breast, colon or lung cancer in England in 2014: A national registry study

Background Survival from cancer in older patients is poorer in the UK than other countries with similar health systems and wealth possibly due to undertreatment and increased toxicities in this specific population. This population-based observational study describes factors affecting systemic anticancer treatment (SACT) use in older patients in England. Methods We identified patients aged ≥70 with stage II-III breast cancer, stage III colon cancer and stage IIIB-IV non-small cell lung cancer (NSCLC) diagnosed in 2014 from a dataset collected by the National Health Service in England. We used logistic regression to estimate factors affecting likelihood of receiving SACT and performed separate regression analyses for each disease, adjusting for age, gender, stage at diagnosis, pathological features, performance status, Charlson comorbidity index, ethnicity and socioeconomic group. We assessed 2-year overall survival (OS) using Kaplan-Meier method. Case mix adjusted treatment rates and workload volume were calculated at hospital level and presented using funnel plots, stratified by age groups (<70 and ≥70) to allow for assessment of variation between centres. Results 36892 patients were identified: 19879 with stage II-III breast cancer, 5292 with stage III colon cancer and 11721 with stage IIIB-IV NSCLC. Patients over 70 were less likely to receive SACT compared to those aged under 70: breast 11.7% vs 64.6%, p < 0.001; colon 37.4% vs 79%, p < 0.001; NSCLC 33.5% vs 60.2%, p < 0.001. 2-year OS for patients receiving SACT was similar for patients aged ≥70 and <70: breast 91.5% (95% CI: 89.3%-93.2%) vs 96.4% (95% CI: 95.9%-96.7%); colon 84.8% (95% CI: 82.6%-86.8%) vs 88.3% (95% CI: 86.7%-89.8%); NSCLC 16.7% (95% CI: 15.1%-18.4%) vs 19.8% (95%CI: 18.5%-21.1%). Patients receiving SACT had better OS than those untreated. SACT rates varied widely between hospitals after adjusting for case-mix across all ages. Conclusions Our study suggests that several factors affect the likelihood of receiving SACT but after adjusting for these, age remains determinant. Identifying hospitals with significantly lower SACT rates should prompt local review of multidisciplinary team practice

Opioid prescribing for chronic musculoskeletal pain in UK primary care: results from a cohort analysis of the COPERS trial

Objective To establish the level of opioid prescribing for patients with chronic musculoskeletal pain in a sample of patients from primary care and to estimate prescription costs. Design Secondary data analyses from a two-arm pragmatic randomised controlled trial (COPERS) testing the effectiveness of group self-management course and usual care against relaxation and usual care for patients with chronic musculoskeletal pain (ISRCTN 24426731). Setting 25 general practices and two community musculoskeletal services in the UK (London and Midlands). Participants 703 chronic pain participants; 81% white, 67% female, enrolled in the COPERS trial. Main outcome measures Anonymised prescribing data over 12 months extracted from GP electronic records. Results Of the 703 trial participants with chronic musculoskeletal pain, 413 (59%) patients were prescribed opioids. Among those prescribed an opioid, the number of opioid prescriptions varied from 1 to 52 per year. A total of 3319 opioid prescriptions were issued over the study period, of which 53% (1768/3319) were for strong opioids (tramadol, buprenorphine, morphine, oxycodone, fentanyl and tapentadol). The mean number of opioid prescriptions per patient prescribed any opioid was 8.0 (SD=7.9). A third of patients on opioids were prescribed more than one type of opioid; the most frequent combinations were: codeine plus tramadol and codeine plus morphine. The cost of opioid prescriptions per patient per year varied from £3 to £4844. The average annual prescription cost was £24 (SD=29) for patients prescribed weak opioids and £174 (SD=421) for patients prescribed strong opioids. Approximately 40% of patients received >3 prescriptions of strong opioids per year, with an annual cost of £236 per person. Conclusions Long-term prescribing of opioids for chronic musculoskeletal pain is common in primary care. For over a quarter of patients receiving strong opioids, these drugs may have been overprescribed according to national guidelines

Novel three-day, community-based, nonpharmacological group intervention for chronic musculoskeletal pain (COPERS): a randomised clinical trial

Background Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain. Methods and Findings We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost–utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference −1.0, intervention versus control, 95% CI −4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (−0.7, 95% CI −1.2 to −0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US$214). The cost–utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95$277], 95% CI −£125 [−US$184] to £501 [US$738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US$8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components. Conclusions While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups. Trial registration ISRCTN Registry 2442673

Quality of life after bladder cancer: a prospective study comparing patient-related outcomes after radical surgery or radical radiotherapy for bladder cancer

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Systematic review of the effect of policies to restrict the marketing of foods and non-alcoholic beverages to which children are exposed

This systematic review examined the effectiveness of policies restricting the marketing of foods and/or non-alcoholic beverages to children to inform updated World Health Organization (WHO) guidelines. Databases were searched to March 2020. Inclusion criteria were primary studies of any design assessing implemented policies to restrict food marketing to children (0–19 years). Critical outcomes were exposure to and power of marketing, dietary intake, choice, preference, and purchasing. Important outcomes were purchase requests, dental caries, body weight, diet-related noncommunicable diseases, product change, and unintended consequences. Forty-four observational studies met inclusion criteria; most were moderate quality. Pooling was conducted using vote counting by direction of effect, and GRADE was used to judge evidence certainty. Evidence suggests food marketing policies may result in reduced purchases of unhealthy foods and in unintended consequences favorable for public health. Desirable or potentially desirable (for public health) effects of policies on food marketing exposure and power were also found. Evidence on diet and product change was very limited. The certainty of evidence was very low for four outcomes (exposure, power, dietary intake, and product change) and low for two (purchasing and unintended consequences). Policies can effectively limit food marketing to children; policymakers should prioritize mandatory approaches aligned with WHO recommendations

Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

<p>Abstract</p> <p>Background</p> <p>There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials.</p> <p>Methods</p> <p>A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis.</p> <p>Results</p> <p>Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP.</p> <p>Conclusion</p> <p>We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.</p

Association of Food and Nonalcoholic Beverage Marketing with Children and Adolescents' Eating Behaviors and Health: A Systematic Review and Meta-analysis

Importance: There is widespread interest in the effect of food marketing on children; however, the comprehensive global evidence reviews are now dated. Objective: To quantify the association of food and nonalcoholic beverage marketing with behavioral and health outcomes in children and adolescents to inform updated World Health Organization guidelines. Data Sources: Twenty-two databases were searched (including MEDLINE, CINAHL, Web of Science, Embase, and The Cochrane Library) with a publication date limit from January 2009 through March 2020. Study Selection: Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines were followed. Inclusion criteria were primary studies assessing the association of food marketing with specified outcomes in children and adolescents (aged 0-19 years). Exclusion criteria were qualitative studies or those on advertising of infant formula. Of 31063 articles identified, 96 articles were eligible for inclusion in the systematic review, and 80 articles in the meta-analysis (19372 participants). Data Extraction and Synthesis: Two reviewers independently extracted data. Random-effects models were used for meta-analyses; meta-regressions, sensitivity analyses, and P curve analyses were also performed. Where appropriate, pooling was conducted using combining P values and vote counting by direction of effect. Grading of Recommendations Assessment, Development, and Evaluation was used to judge certainty of evidence. Main Outcomes and Measures: Critical outcomes were intake, choice, preference, and purchasing. Important outcomes were purchase requests, dental caries, body weight, and diet-related noncommunicable diseases. Results: Participants totaled 19372 from 80 included articles. Food marketing was associated with significant increases in intake (standardized mean difference [SMD], 0.25; 95% CI, 0.15-0.35; P 76%) was unexplained by sensitivity or moderator analyses. The combination of P values for purchase requests was significant but no clear evidence was found for an association of marketing with purchasing. Data on dental health and body weight outcomes were scarce. The certainty of evidence was graded as very low to moderate for intake and choice, and very low for preference and purchasing. Conclusions and Relevance: In this systematic review and meta-analysis, food marketing was associated with increased intake, choice, preference, and purchase requests in children and adolescents. Implementation of policies to restrict children's exposure is expected to benefit child health