Health care providers underestimate symptom intensities of cancer patients: A multicenter European study

<p>Abstract</p> <p>Background</p> <p>Many patients with advanced cancer depend upon health care providers for symptom assessment. The extent of agreement between patient and provider symptom assessments and the association of agreement with demographic- and disease-related factors was examined.</p> <p>Methods</p> <p>This cross-sectional study included 1933 patient-health care provider dyads, from 11 European countries. Patients reported symptoms by using the four-point scales of the European Organization of Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) version 3, and providers used corresponding four-point categorical scales. Level of agreement was addressed at the group level (Wilcoxon Signed-Rank test), by difference scores (provider score minus patient score), at the individual level (Intraclass Correlation Coefficients, ICCs) and visually by Bland-Altman plots. Absolute numbers and chi-square tests were used to investigate the relationship between agreement and demographic-, as well as disease-related factors.</p> <p>Results</p> <p>The prevalence of symptoms assessed as moderate or severe by patients and providers, respectively, were for pain (67 vs.47%), fatigue (71 vs. 54%), generalized weakness (65 vs. 47%), anorexia (47 vs. 25%), depression (31 vs. 17%), constipation (45 vs. 30%), poor sleep (32 vs. 21%), dyspnea (30 vs. 16%), nausea (27 vs. 14%), vomiting (14 vs. 6%) and diarrhea (14 vs. 6%). Symptom scores were identical or differed by only one response category in the majority of patient-provider assessment pairs (79-93%). Providers underestimated the symptom in approximately one of ten patients and overestimated in 1% of patients. Agreement at the individual level was moderate (ICC 0.38 to 0.59). Patients with low Karnofsky Performance Status, high Mini Mental State-score, hospitalized, recently diagnosed or undergoing opioid titration were at increased risk of symptom underestimation by providers (all p < 0.001). Also, the agreement was significantly associated with drug abuse (p = 0.024), provider profession (p < 0.001), cancer diagnosis (p < 0.001) and country (p < 0.001).</p> <p>Conclusions</p> <p>Considerable numbers of health care providers underestimated symptom intensities. Clinicians in cancer care should be aware of the factors characterizing patients at risk of symptom underestimation.</p

A 'short walk' is longer before radiotherapy than afterwards: a qualitative study questioning the baseline and follow-up design

<p>Abstract</p> <p>Background</p> <p>Numerous studies have indirectly demonstrated changes in the content of respondents' QoL appraisal process over time by revealing response-shift effects. This is the first known study to qualitatively examine the assumption of consistency in the content of the cognitive processes underlying QoL appraisal over time. Specific objectives are to examine whether the content of each distinct cognitive process underlying QoL appraisal is (dis)similar over time and whether patterns of (dis)similarity can be discerned across and within patients and/or items.</p> <p>Methods</p> <p>We conducted cognitive think-aloud interviews with 50 cancer patients prior to and following radiotherapy to elicit cognitive processes underlying the assessment of 7 EORTC QLQ-C30 items. Qualitative analysis of patients' responses at baseline and follow-up was independently carried out by 2 researchers by means of an analysis scheme based on the cognitive process models of Tourangeau et al. and Rapkin & Schwartz.</p> <p>Results</p> <p>The interviews yielded 342 comparisons of baseline and follow-up responses, which were analyzed according to the five cognitive processes underlying QoL appraisal. The content of comprehension/frame of reference changed in 188 comparisons; retrieval/sampling strategy in 246; standards of comparison in 152; judgment/combinatory algorithm in 113; and reporting and response selection in 141 comparisons. Overall, in 322 comparisons of responses (94%) the content of at least one cognitive component changed over time. We could not discern patterns of (dis)similarity since the content of each of the cognitive processes differed across and within patients and/or items. Additionally, differences found in the content of a cognitive process for one item was not found to influence dissimilarity in the content of that same cognitive process for the subsequent item.</p> <p>Conclusions</p> <p>The assumption of consistency in the content of the cognitive processes underlying QoL appraisal over time was not found to be in line with the cognitive processes described by the respondents. Additionally, we could not discern patterns of (dis)similarity across and within patients and/or items. In building on cognitive process models and the response shift literature, this study contributes to a better understanding of patient-reported QoL appraisal over time.</p

Minimally important differences for interpreting EORTC QLQ-C30 scores in patients with advanced breast cancer

Background We aimed to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in patients with advanced breast cancer. Patients and Methods Data were derived from two published EORTC trials. Clinical anchors, e.g. performance status, were selected using correlation strength and clinical plausibility of their association with a particular QLQ-C30 scale. Three change status groups were formed: deteriorated by one anchor category, improved by one anchor category and no change. Patients with greater anchor changes were excluded. The mean change method was used to estimate MIDs for within-group change and linear regression was used to estimate MIDs for between-group differences in change over time. For a given QLQ-C30 scale, MID estimates from multiple anchors were triangulated to a single value via a correlation-based weighted average. Results MIDs varied by QLQ-C30 scale, direction (improvement versus deterioration) and anchor. MIDs for within-group change ranged from 5 to 14 points (improvement) and –14 to –4 points (deterioration), and MIDs for between-group change over time ranged from 4 to 11 points and from –18 to –4 points. Correlation-weighted MIDs for most QLQ-C30 scales ranged from 4 to 10 points in absolute values. Conclusions Our findings aid interpretation of changes in EORTC QLQ-C30 scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in advanced breast cancer

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study)

Background. Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design. Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Discussion. The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction. Trial registration. Current Controlled Trials ISRCTN46462267

Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

Contains fulltext : 69534.pdf (publisher's version ) (Open Access)BACKGROUND: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. METHODS/DESIGN: The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. DISCUSSION: The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease. TRIAL REGISTRATION: Nederlands Trial Register NTR1150

High level of virological suppression among HIV-infected adults receiving combination antiretroviral therapy in Addis Ababa, Ethiopia

Plasma viral load (pVL) is a key indicator of therapeutic response in HIV-infected patients receiving combination antiretroviral therapy (cART), but is often unavailable in routine clinical care in resource-limited settings. Previous model-based simulation studies have suggested that the benefits of routine pVL monitoring among patients on first-line regimens in resource-limited settings are modest, but this needs corroboration in well-defined study populations. We investigated virological suppression levels and identified predictors of detectable viraemia among 870 randomly selected patients who started cART between May 2009 and April 2012 in 10 health-care facilities in Addis Ababa, Ethiopia. A total of 656 (75.4%) patients, who were alive, were retained in HIV care and receiving cART for at least 6 months provided a blood sample for pVL measurement. Predictors of detectable viraemia were identified in a multivariate logistic regression model. In on-treatment analysis, 94.5% (95% CI 92.5, 96.1) of the patients achieved virological suppression below 400 copies/ml after a median (IQR) of 26 (17-35) months on cART. When patients who were lost to follow-up, dead or stopped were assumed to have had detectable viraemia, the proportion of patients with virological suppression <400 copies/ml decreased to 74.6% (95% CI 71.5%, 77.4%). Younger age, lower educational status, <95% medication adherence, lower CD4(+) T-cell count at cART initiation and/or the diagnosis of immunological failure thereafter significantly predicted detectable viraemia. Virological suppression levels can be high in an established ART programme in a resource-limited setting, even without the availability of routine pVL monitoring. Efforts to improve treatment outcomes should focus on younger and illiterate patients, earlier detection of HIV-positive status and cART initiation before patients are severely immunocompromised, and improving retention in car