Do physical symptoms predict psychological issues in patients with cancer?: the Memorial Symptom Assessment Scale-Short Form.

OBJECTIVES: This study aimed to determine if individual physical symptoms were predictive of psychological disorders. METHODS: This study was a secondary analysis of data from two studies which used the Memorial Symptom Assessment Scale-Short Form (MSAS-SF) to assess both physical and psychological symptoms. Correlation between individual symptoms and the validated psychological subscale (MSAS-PSYCH) were performed using Spearman's coefficient. Linear regression analysis was performed to assess whether correlated symptoms predicted the presence of psychological disorders. RESULTS: 1507 patients' data were analysed. The physical symptoms of pain, lack of energy, drowsiness, dizziness, constipation, 'feeling bloated' and 'I don't look like myself' were correlated with MSAS-PSYCH. Other physical symptoms existed independently to psychological symptoms. None of these physical symptoms were independently predictive of a mood disorder. CONCLUSIONS: This study presents a large data set evaluating psychological symptom correlations. There are certain physical symptoms which correlate with mood disorders, but these are not independently predictive. It is not known whether the correlative data are cause or effect. Comprehensive assessment remains essential to assess all problems. TRIAL REGISTRATION NUMBER: The trial registered was at National Institute for Health Research Clinical Research Network Portfolio (Central Portfolio Management System (CPMS) ID 30723) Integrated Research Application System Identification (IRAS) ID 198753.

The Oral Symptom Assessment Scale (OSAS): criterion validation with the EORTC QLQ-OH15 and reliability testing.

PURPOSE: The aim of this study was to investigate the criterion validity and reliability of the Oral Symptom Assessment Scale (OSAS) in patients with advanced cancer receiving specialist palliative care. METHODS: To examine criterion validity, participants completed the OSAS, EORTC QLQ-C30 and EORTC QLQ-OH15. Twenty-four hours later participants repeated the OSAS to investigate test-retest reliability. RESULTS: 54 participants were recruited (median age 70; range: 35- 93 years). 51 complete datasets were obtained. Cohen's kappa test was used to evaluate the agreement for the presence / absence of symptoms on the OSAS on the first and second days (test-retest reliability). This analysis showed values of moderate and higher for agreement for all symptoms. All kappa values were statistically significant. The test-retest reliability for symptom severity, frequency and distress was assessed using Intraclass Correlation Coefficient. Spearman's rank correlation coefficients were used to evaluate agreement between similar questions on the OSAS from day one and the EORTC QLQ-OH15 also on day one to examine criterion validity. CONCLUSION: This study supports the validity of the OSAS, and provides evidence for the reliability of this novel oral symptom assessment tool, in patients with advanced cancer. Further research is needed to corroborate the findings of this study. TRIAL REGISTRATION: CancerTrials.gov registry registration no.: PM202166.

International e-Delphi Consensus Recommendations for the Assessment and Diagnosis of Circadian rest-Activity Rhythm Disorders (CARDs) in Patients with Cancer.

PURPOSE: Circadian rest-Activity Rhythm Disorders (CARDs) are common in patients with cancer, particularly in advanced disease. CARDs are associated with increased symptom burden, poorer quality of life, and shorter survival. Research and reporting practices lack standardization, and formal diagnostic criteria do not exist. This electronic Delphi (e-Delphi) study aimed to formulate international recommendations for the assessment and diagnosis of CARDs in patients with cancer. METHODS: An international e-Delphi was performed using an online platform (Welphi). Round 1 developed statements regarding circadian rest-activity rhythms, diagnostic criteria, and assessment techniques. Rounds 2 and 3 involved participants rating their level of agreement with the statements and providing comments until consensus (defined internally as 67%) and stability between rounds were achieved. Recommendations were then created and distributed to participants for comments before being finalized. RESULTS: Sixteen participants from nine different clinical specialties and seven different countries, with 5-35 years of relevant research experience, were recruited, and thirteen participants completed all three rounds. Of the 164 generated statements, 66% achieved consensus, and responses were stable between the final two rounds. CONCLUSIONS: The e-Delphi resulted in international recommendations for assessing and diagnosing CARDs in patients with cancer. These recommendations should ensure standardized research and reporting practices in future studies.

Validation of a French version of the Breakthrough Pain Assessment Tool in cancer patients: Factorial structure, reliability and responsiveness.

OBJECTIVE: Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). METHODS: First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. RESULTS: The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: "1-pain severity and impact" and "2-pain duration and medication". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. CONCLUSION: The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.

Oral symptom assessment tools in patients with advanced cancer: a scoping review.

PURPOSE: Oral symptoms are common in patients with advanced cancer. The aim of this scoping review was to identify oral symptom assessment tools that have been specifically utilised in patients with "advanced cancer". METHODS: The review was conducted/reported according to international guidelines for undertaking scoping reviews. PubMed, Embase, and CINAHL were searched for articles involving adult patients with advanced cancer, which involved assessment of ≥ 2 oral symptoms, and which involved patients with > 1 type of cancer. RESULTS: The review identified four validated symptom assessment scales, including one cancer-specific quality of life scale (EORTC QLQ OH-15), one generic tool for assessing the "social impact" of specific oral problems (OHIP), one cancer-specific generic symptom assessment scale (MSAS), and one cancer-specific oral symptom assessment scale (OSAS). CONCLUSION: Symptom assessment tools can facilitate good symptom control in clinical practice, and are an integral component of clinical research. The review identified four validated symptom assessment scales that could be utilised to assess oral symptoms in patients with advanced cancer.

Measured energy expenditure in mildly hypothermic critically ill patients with traumatic brain injury: A sub-study of a randomized controlled trial.

BACKGROUND & AIMS: Prophylactic hypothermia, often used in critically ill patients with traumatic brain injury, reduces energy expenditure and may affect energy delivered by nutrition therapy. The primary objective of this study was to measure energy expenditure in hypothermic patients over the first 3 days after traumatic brain injury (TBI). Secondary objectives included comparison of measured energy expenditure and nutrition delivery to day 7. METHODS: A prospective sub-study of a randomized controlled trial conducted in patients with severe TBI, investigating prophylactic hypothermia (33-35 °C) as a neuroprotective therapy. In two centers, indirect calorimetry was initiated within 24 h of randomization and repeated up to twice daily to day 7. Data are presented as n (%), mean (standard deviation (SD)), median [interquartile range (IQR)], and mean difference (95% confidence interval (CI)). RESULTS: Forty patients were included (20 in each group), with 17 patients in the hypothermic and 16 in the normothermic group having an indirect calorimetry measurement in the first 3 days. Over the first 3 days, the mean temperature in the hypothermic and normothermic groups was 33.5 (0.6) ºC (n = 17) and 37 (0.5) ºC (n = 16), p < 0.0001, and the mean measured energy expenditure, was 21 (5) and 27 (4) kcal/kg, p = 0.002, representing a mean difference of 5 (95% CI: 2-8) kcal/kg. Energy expenditure was 20% (95% CI: 9.5-29%) less in hypothermia patients compared to normothermia patients. Hypothermia patients also had higher gastric residual volumes across the 7 day study period (438 (237) mls vs 184 (103) mls, p < 0.0001) and higher use of metoclopramide and erythromycin as prokinetics. Despite enteral nutrition intolerance, hypothermia patients received 93% of measured energy expenditure over 7 days. CONCLUSION: In TBI patients, energy expenditure was 20% less when receiving prophylactic hypothermia compared to normothermia. Greater gastric residual volumes, use of prokinetics and energy delivery that approximated measured energy expenditure was also observed in hypothermia patients. TRIAL REGISTRY NUMBER: POLAR-RCT: clinicaltrials.gov Identifier: NCT00987688; Anzctr.org.au Identifier: ACTRN12609000764235. This sub-study was not registered separately.

Oral symptoms in patients with advanced cancer: an observational study using a novel oral symptom assessment scale.

PURPOSE: The aim of this study was to utilise a novel oral assessment tool (the Oral Symptom Assessment Scale/OSAS) to investigate oral symptoms in a cohort of advanced cancer patients receiving specialist palliative care. METHODS: Participants were asked to complete the OSAS, which asks about the presence of 20 oral symptoms in the previous week (and, if present, about the frequency, the severity, and the amount of distress caused by the symptoms). Patients were also asked to complete the Memorial Symptom Assessment Scale - Short Form, and to rate their performance status. RESULTS: Two hundred fifty participants completed the study, and 244 (97.5%) participants reported at least one oral symptom on the OSAS. The median number of oral symptoms reported was five (range, 1 to 18), with dry mouth being the most common symptom (83.5% participants). The total number of oral symptoms was higher in younger participants (p = 0.012), female participants (p = 0.048), and those with a worse performance status (p < 0.001). No other oral symptoms were reported by more than two participants. Statistical analysis identified a number of potential oral symptom clusters. CONCLUSIONS: Oral symptoms (and related oral problems) are common in patients with advanced cancer, and are associated with significant morbidity in this group of patients. TRIAL REGISTRATION: CancerTrials.gov registry reference number: NCT04404920.

Rhetoric or Reform? Changing Health and Social Care in Wales.

Throughout the United Kingdom, the National Health Service (NHS) struggles to meet demand and achieve performance targets. Services need to work with individuals and communities to reduce avoidable disease and dependence. All four UK nations have separately realised the need for change but 20 years' experience suggests that vision and rhetoric are not enough. Success requires reformed systems and changed leadership behaviour to enable frontline staff to break the status quo. Top down, target driven behaviour must be replaced with a real focus on improvement, championing those who have the knowledge to deliver it.

Type 2 diabetes remission: 2 year within-trial and lifetime-horizon cost-effectiveness of the Diabetes Remission Clinical Trial (DiRECT)/Counterweight-Plus weight management programme.

AIMS/HYPOTHESIS: Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT). METHODS: Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs. RESULTS: Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years. CONCLUSIONS/INTERPRETATION: Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention. TRIAL REGISTRATION: ISRCTN03267836 Graphical abstract.

Alcohol and drug use disorders in patients with cancer and caregivers: effects on caregiver burden.

BACKGROUND: The estimated prevalence of alcohol use disorders in patients with advanced cancer is reported as 4%-38%. There are limited data regarding alcohol and drug use disorders in caregivers of patients with cancer and the effects on other issues. AIM: To establish the prevalence of alcohol and drug use disorders in a large cohort of patients with advanced cancer and their caregivers.To evaluate the relationship between alcohol and drug use disorders and patient symptoms and caregiver burden. DESIGN: The patient with cancer and caregiver completed the Alcohol Use Disorders Identification Tool, CAGE questionnaire and Drug Abuse Screening Test. The patient completed the Memorial Symptom Assessment Scale-Short Form, and the caregiver completed the Zarit Burden Questionnaire.Statistical analysis compared cases and non-cases of alcohol and drug use disorders with symptom and burden score. SETTING/PARTICIPANTS: Patients with cancer, and their caregivers, were recruited from 11 UK sites, 6 hospices and 5 hospitals. RESULTS: Five hundred and seven patients and their caregivers were recruited. Twenty-seven patients (5%) and 44 caregivers (9%) screened positively for alcohol use disorders on the Alcohol Use Disorders Identification Tool. Thirty patients (6%), and 16 caregivers (3%), screened positively for drug abuse problems on the Drug Abuse Screening Test.There was a significantly higher carer burden score in caregivers screening positively for alcohol and drug abuse problems. CONCLUSIONS: The prevalence of alcohol use disorders in patients with cancer and caregivers was lower than reported in previous studies. Caregiver burden scores were significantly higher in carers screening positively for alcohol and drug use disorders. TRIAL REGISTRATION NUMBER: Trial registered National Institute for Health Research Clinical Research Network Portfolio (CPMS ID 30723) IRAS ID 198753.

Clinical nurse specialist prescribing in a cancer centre supportive and palliative care team.

OBJECTIVE: To provide insight into the prescribing practices of three independent nurse prescribers (INPs)/clinical nurse specialists (CNSs) working in a supportive and palliative care team (SPCT) in a district general hospital and a specialist tertiary cancer centre in the UK. METHODS: A prospective review of all consultations and the prescribing activity arising from the consultations (and reasons for non-prescribing following a consultation) of 3 INPs/CNSs between 1 August 2018 and 31 October 2018. RESULTS: Four hundred ninety-three consultations were undertaken on 186 individual patients. Two hundred forty-seven consultations representing 50% resulted in changes to a prescription, and 123 of those consultations representing 50% of prescriptions written resulted in the prescribing of an opioid for moderate-to-severe pain. CONCLUSIONS: This service evaluation demonstrates the potential for INPs in SPCTs to provide comprehensive symptom control while enabling CNSs to practice with a greater degree of autonomy leading to enhanced job satisfaction. On the basis of our experience, we would encourage all palliative care CNSs to undergo training to become INPs (if available).

Cost-effectiveness of roflumilast as an add-on to triple inhaled therapy vs triple inhaled therapy in patients with severe and very severe COPD associated with chronic bronchitis in the UK.

Purpose: Patients with severe COPD are at high risk of experiencing disease exacerbations, which require additional treatment and are associated with elevated mortality and increased risk of future exacerbations. Some patients continue to experience exacerbations despite receiving triple inhaled therapy (ICS plus LAMA plus LABA). Roflumilast is recommended by the Global Initiative for Chronic Obstructive Lung Disease as add-on treatment to triple inhaled therapy for these patients. This cost-effectiveness analysis compared costs and quality-adjusted life-years for roflumilast plus triple inhaled therapy vs triple inhaled therapy alone, using data from the REACT and RE2SPOND trials. Patients and methods: Patients included in the analysis had severe to very severe COPD, FEV1 <50% predicted, symptoms of chronic bronchitis and ≥2 exacerbations per year. Our model was adapted from a previously published and validated model, and the analyses conducted from a UK National Health Service perspective. A scenario analysis considered a subset of patients who had experienced at least one COPD-related hospitalization within the previous year. Results: Roflumilast as add-on to triple inhaled therapy was associated with non-significant reductions in rates of both moderate and severe exacerbations compared with triple inhaled therapy alone. The incremental cost-effectiveness ratio (ICER) for roflumilast as add-on to triple inhaled therapy was £24,976. In patients who had experienced previous hospitalization, roflumilast was associated with a non-significant reduction in the rate of moderate exacerbations, and a statistically significant reduction in the rate of severe exacerbations. The ICER for roflumilast in this population was £7,087. Conclusions: Roflumilast is a cost-effective treatment option for patients with severe or very severe COPD, chronic bronchitis, and a history of exacerbations. The availability of roflumilast as add-on treatment addresses an important unmet need in this patient population.

Homeless health care: meeting the challenges of providing primary care.

People experiencing homelessness have multiple complex health conditions yet are typically disengaged from primary health care services and place a significant burden on the acute health system. Barriers preventing people who are homeless from accessing primary care can be both personal and practical and include competing needs and priorities, illness and poor health, physical access to health services, difficulty in contacting services, medication security, and the affordability of health care. Differences in social status and perceptions of being judged can lead to relationship barriers to accessing primary care. Key solutions include prioritising access to stable housing, continuity of health care, specialised homeless general practice, hospital inreach, discharge planning and coordinated care, general practice outreach, and medical recovery centres.

Comprehensive assessment of patient image quality and radiation dose in latest generation cardiac x-ray equipment for percutaneous coronary interventions.

This study aimed to determine whether a reduction in radiation dose was found for percutaneous coronary interventional (PCI) patients using a cardiac interventional x-ray system with state-of-the-art image enhancement and x-ray optimization, compared to the current generation x-ray system, and to determine the corresponding impact on clinical image quality. Patient procedure dose area product (DAP) and fluoroscopy duration of 131 PCI patient cases from each x-ray system were compared using a Wilcoxon test on median values. Significant reductions in patient dose ([Formula: see text]) were found for the new system with no significant change in fluoroscopy duration ([Formula: see text]); procedure DAP reduced by 64%, fluoroscopy DAP by 51%, and "cine" acquisition DAP by 76%. The image quality of 15 patient angiograms from each x-ray system (30 total) was scored by 75 clinical professionals on a continuous scale for the ability to determine the presence and severity of stenotic lesions; image quality scores were analyzed using a two-sample [Formula: see text]-test. Image quality was reduced by 9% ([Formula: see text]) for the new x-ray system. This demonstrates a substantial reduction in patient dose, from acquisition more than fluoroscopy imaging, with slightly reduced image quality, for the new x-ray system compared to the current generation system.

A longitudinal assessment of psychological distress after oesophageal cancer surgery.

BACKGROUND: Psychological distress is common among patients with oesophageal cancer. However, little is known about the course and predictors of psychological distress among patients treated with curative intent. Therefore, the aim of this study was to explore the prevalence, course and predictors of anxiety and depression in patients operated for oesophageal cancer, from prior to surgery to 12 months post-operatively. METHODS: A prospective cohort of patients with oesophageal cancer (n = 218) were recruited from one high-volume specialist oesophago-gastric treatment centre (St Thomas' Hospital, London, UK). Anxiety and depression were assessed prior to surgery, 6 and 12 months post-operatively. Mixed-effects modelling was performed to investigate changes over time and to estimate the association between clinical and socio-demographic predictor variables and anxiety and depression symptoms. RESULTS: The proportion of patients with anxiety was 33% prior to surgery, 28% at 6 months, and 37% at 12 months. Prior to surgery, 20% reported depression, 27% at 6 months, and 32% at 12-month follow-up. Anxiety symptoms remained stable over time whereas depression symptoms appeared to increase from pre-surgery to 6 months, levelling off between 6 and 12 months. Younger age, female sex, living alone and more severe self-reported dysphagia (i.e., difficulty swallowing) predicted higher anxiety symptoms. In-hospital complications, greater limitations in activity status and more severe self-reported dysphagia were predictive of higher depression. CONCLUSIONS: Many patients report psychological distress during the first year following oesophageal cancer surgery. Whether improving the experience of swallowing difficulties may also reduce distress among these patients warrants further study.

Analyzing Health-Related Quality of Life Data to Estimate Parameters for Cost-Effectiveness Models: An Example Using Longitudinal EQ-5D Data from the SHIFT Randomized Controlled Trial.

INTRODUCTION: The aim of this article is to discuss methods used to analyze health-related quality of life (HRQoL) data from randomized controlled trials (RCTs) for decision analytic models. The analysis presented in this paper was used to provide HRQoL data for the ivabradine health technology assessment (HTA) submission in chronic heart failure. METHODS: We have used a large, longitudinal EuroQol five-dimension questionnaire (EQ-5D) dataset from the Systolic Heart Failure Treatment with the I f Inhibitor Ivabradine Trial (SHIFT) (clinicaltrials.gov: NCT02441218) to illustrate issues and methods. HRQoL weights (utility values) were estimated from a mixed regression model developed using SHIFT EQ-5D data (n = 5313 patients). The regression model was used to predict HRQoL outcomes according to treatment, patient characteristics, and key clinical outcomes for patients with a heart rate ≥75 bpm. RESULTS: Ivabradine was associated with an HRQoL weight gain of 0.01. HRQoL weights differed according to New York Heart Association (NYHA) class (NYHA I-IV, no hospitalization: standard care 0.82-0.46; ivabradine 0.84-0.47). A reduction in HRQoL weight was associated with hospitalizations within 30 days of an HRQoL assessment visit, with this reduction varying by NYHA class [-0.07 (NYHA I) to -0.21 (NYHA IV)]. CONCLUSION: The mixed model explained variation in EQ-5D data according to key clinical outcomes and patient characteristics, providing essential information for long-term predictions of patient HRQoL in the cost-effectiveness model. This model was also used to estimate the loss in HRQoL associated with hospitalizations. In SHIFT many hospitalizations did not occur close to EQ-5D visits; hence, any temporary changes in HRQoL associated with such events would not be captured fully in observed RCT evidence, but could be predicted in our cost-effectiveness analysis using the mixed model. Given the large reduction in hospitalizations associated with ivabradine this was an important feature of the analysis. FUNDING: The Servier Research Group.

A Role for Tumor Volume Assessment in Resectable Esophageal Cancer.

BACKGROUND: Esophageal cancer has a poor prognosis, and many patients undergoing surgery have a low chance of cure. Imaging studies suggest that tumor volume is prognostic. The study aimed to evaluate pathological tumor volume (PTV) as a prognostic variable in esophageal cancer. METHODS: This single-center cohort study included 283 patients who underwent esophageal cancer resections between 2000 and 2012. PTVs were obtained from pathological measurements using a validated volume formula. The prognostic value of PTV was analyzed using multivariable regression models, adjusting for age, tumor grade, tumor (T) stage, nodal stage, lymphovascular invasion, resection margin, resection type, and chemotherapy response, which provided hazard ratios (HRs) with 95 % confidence intervals (CIs). Primary outcomes were time to death and time to recurrence. Secondary outcomes were margin involvement and lymph node positivity. Correlation analysis was performed between imaging and PTVs. RESULTS: On unadjusted analysis, increasing PTV was associated with worse overall mortality (HR 2.30, 95 % CI 1.41-3.73) and disease recurrence (HR 1.87, 95 % CI 1.14-3.07). Adjusted analysis demonstrated worse overall mortality with increasing PTV but reached significance in only one subgroup (HR 1.70, 95 % CI 1.09-2.38). PTV was an independent predictor of margin involvement (OR 2.28, 95 % CI 1.02-5.13) and lymph node-positive status (OR 2.77, 95 % CI 1.23-6.28). Correlation analyses demonstrated significant positive correlation between computed tomography (CT) software and formula tumor volumes (r = 0.927, p < 0.0001), CT and positron emission tomography tumor volumes (r = 0.547, p < 0.0001), and CT and PTVs (r = 0.310, p < 0.001). CONCLUSIONS: Tumor volume may predict survival, margin status, and lymph node positivity after surgery for esophageal cancer.

Methods for the analysis of ordinal response data in medical image quality assessment.

The assessment of image quality in medical imaging often requires observers to rate images for some metric or detectability task. These subjective results are used in optimization, radiation dose reduction or system comparison studies and may be compared to objective measures from a computer vision algorithm performing the same task. One popular scoring approach is to use a Likert scale, then assign consecutive numbers to the categories. The mean of these response values is then taken and used for comparison with the objective or second subjective response. Agreement is often assessed using correlation coefficients. We highlight a number of weaknesses in this common approach, including inappropriate analyses of ordinal data and the inability to properly account for correlations caused by repeated images or observers. We suggest alternative data collection and analysis techniques such as amendments to the scale and multilevel proportional odds models. We detail the suitability of each approach depending upon the data structure and demonstrate each method using a medical imaging example. Whilst others have raised some of these issues, we evaluated the entire study from data collection to analysis, suggested sources for software and further reading, and provided a checklist plus flowchart for use with any ordinal data. We hope that raised awareness of the limitations of the current approaches will encourage greater method consideration and the utilization of a more appropriate analysis. More accurate comparisons between measures in medical imaging will lead to a more robust contribution to the imaging literature and ultimately improved patient care.

Consensus Recommendations on Initiating Prescription Therapies for Opioid-Induced Constipation.

OBJECTIVE: Aims of this consensus panel were to determine (1) an optimal symptom-based method for assessing opioid-induced constipation in clinical practice and (2) a threshold of symptom severity to prompt consideration of prescription therapy. METHODS: A multidisciplinary panel of 10 experts with extensive knowledge/experience with opioid-associated adverse events convened to discuss the literature on assessment methods used for opioid-induced constipation and reach consensus on each objective using the nominal group technique. RESULTS: Five validated assessment tools were evaluated: the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), Stool Symptom Screener (SSS), Bowel Function Index (BFI), and Bowel Function Diary (BF-Diary). The 3-item BFI and 4-item SSS, both clinician administered, are the shortest tools. In published trials, the BFI and 12-item PAC-SYM are most commonly used. The 11-item BF-Diary is highly relevant in opioid-induced constipation and was developed and validated in accordance with US Food and Drug Administration guidelines. However, the panel believes that the complex scoring for this tool and the SSS, PAC-SYM, and 28-item PAC-QOL may be unfeasible for clinical practice. The BFI is psychometrically validated and responsive to changes in symptom severity; scores range from 0 to 100, with higher scores indicating greater severity and scores >28.8 points indicating constipation. CONCLUSIONS: The BFI is a simple assessment tool with a validated threshold of clinically significant constipation. Prescription treatments for opioid-induced constipation should be considered for patients who have a BFI score of ≥30 points and an inadequate response to first-line interventions.