Does it matter how we evaluate HRQOL? Longitudinal comparison of the EORTC QLQ-C30/QLQ-OG25 and FACT-E.

PURPOSE: To determine whether EORTC QLQ-C30/QLQ-OG25 and FACT-E compared longitudinally provide similar reflections of health-related quality of life (HRQOL). METHODS: Eighty-six esophageal cancer patients treated with curative intent, scheduled to complete both questionnaires at baseline and post-treatment time points until 36 months. A generalized estimating equation model utilizing a Gaussian family compared instruments longitudinally. The two-one-sided-test (TOST) method assessed equivalence between the instruments. RESULTS: Trajectories for social domain and overall quality of life differed significantly between instruments. Also, FACT-G's functional well-being post-treatment returns to baseline 3-6 months earlier than the EORTC QLQ-C30's role functioning subscale, suggesting measurement of different components. Trajectories for physical and esophageal symptom subscales are similar and are deemed equivalent. Emotional domains are comparable and bear little resemblance to the physical domain trajectories indicating reflection of emotional experience rather than a physical proxy. EORTC QLQ-C30 subscales have a trajectory similar to its physical functioning scale except for the emotional and esophageal symptoms scales. Overall HRQOL in both instruments showed a consistent return to baseline/pre-treatment levels by 6 months post-treatment. CONCLUSIONS: Overall HRQOL recovers earlier after curative-intent treatment than previously reported despite persistence of physical symptoms, with a consistent return to pre-treatment levels by 6 months after treatment. This supports the concept that HRQOL is not primarily defined by physical function. Based on this longitudinal comparison, FACT-E provides a more multidimensional assessment of HRQOL. IMPLICATIONS FOR CANCER SURVIVORS: Curative intent treatment for esophageal cancer has adverse effects on HRQOL but despite intense treatment, overall HRQOL recovers within 6 months.

Health-related quality of life measure distinguishes between low and high clinical T stages in esophageal cancer.

BACKGROUND: Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life (HRQOL) instrument validated in patients with esophageal cancer. It is made up of both a general component and an esophageal cancer subscale (ECS). Our objective was to explore the relationship between baseline FACT-E, ECS and clinically determined T-stage in patients with stage II-IV cancer of the gastroesophageal junction or thoracic esophagus. METHODS: Data from four prospective studies in Canadian academic hospitals were combined. These were consecutive and eligible patients treated between 1996 and 2014 with clinical stage II-IV cancer of the gastroesophageal junction or thoracic esophagus. All patients completed pre-treatment FACT-E. Parametric (ANOVA) and non-parametric (Kruskal-Wallis) analyses were performed. RESULTS: Of the 135 patients that were deemed eligible, the T-stage distribution determined clinically was: 10 (7.4%) T1, 33 (24.4%) T2, 79 (58.5%) T3 and 13 (9.6%) T4. Parametric analysis showed no significant association between FACT-E & T-stage, although there was a trend towards significance (P=0.08). Non-parametric analysis showed a significant association between FACT-E and T-stage (P=0.05). Post-hoc tests identified that the most significant differences in FACT-E scores were between T1 and T3 patients. Both parametric (P=0.002) and non-parametric (P=0.003) analyses showed an association between ECS & T-stage. Post-hoc analyses showed significant differences in ECS scores between T1 and higher T-stages (P<0.01). CONCLUSIONS: Patient-reported HRQOL scores appear to be significantly different in patients with clinical T1 esophageal cancer as compared to those with higher clinical T stages. Since distinguishing T1 from T2/T3 lesions is important in guiding the most appropriate treatment modality and since EUS appears to have difficulties reliably making such T-stage distinctions, FACT-E and ECS scores may be helpful as an adjunct to guide decision-making.

Quality of life assessment in esophagectomy patients.

Esophagectomy is the mainstay of curative therapy for esophageal cancer; however, it is associated with significant morbidity and mortality, with subsequent major impact on quality of life. This paper reviews the evaluation of health-related quality of life (HRQOL) in esophageal cancer patients undergoing curative intent therapy, the relationship between postoperative HRQOL and survival as well the potential utility of pre-treatment HRQOL as a prognostic tool. HRQOL assessment is valuable in helping clinicians understand the impact on patients of esophageal cancer and the various treatments thereof. HRQOL is also valuable as an end-point in studies of esophageal cancer and esophageal cancer treatment. Given the morbidity and mortality associated with the various treatments for esophageal cancer, it could be argued that HRQOL is as important an endpoint as survival, if not more so. Patient-reported pre-treatment HRQOL assessment appears to predict survival better than clinician-derived performance status assessment period. HRQOL assessment also appears to be responsive to surgical and non-surgical therapy and thus could potentially be used in trials and in practice to serve that function. Thus, HRQOL assessment could be a potentially important adjunct in shared decision-making and guiding treatment planning as well as monitoring the progress of treatment.

Pretreatment quality-of-life score is a better discriminator of oesophageal cancer survival than performance status.

OBJECTIVES: Performance status [Eastern Cooperative Oncology Group (ECOG)] is a physician-assigned score indicating a patient's fitness for treatment. Functional assessment of cancer therapy-esophagus (FACT-E) is a patient-reported, health-related quality-of-life (HRQOL) instrument containing an oesophageal cancer subscale (ECS). Our objective was to assess the discriminative ability of pretreatment FACT-E and ECS when compared with performance status in predicting survival in patients with Stage II-III oesophageal cancer. METHODS: Patient data from four prospective studies were pooled together. These four studies included oesophageal patients who received chemoradiation either as neoadjuvant therapy or as definitive therapy. Three separate Cox regressions were performed considering FACT-E, ECS and ECOG as the main predictors, respectively. Receiver-operating characteristics analyses were performed. RESULTS: Of the 120 curative intent patients, 39.8% (n = 51), 58.6% (n = 75) and 1.6% (n = 2) had ECOG 0, 1 and 2, respectively. On Cox regression analysis, pretreatment FACT-E (P = 0.04) and ECS (P = 0.004) but not ECOG (P = 0.27) were independently associated with overall survival. ECOG could not discriminate between survivors and non-survivors (P = 0.28) with an area under the curve (AUC) of 0.56 [95% confidence interval (CI): 0.45-0.66], whereas FACT-E (P = 0.02) and ECS (P < 0.001) were discriminative with AUC = 0.63 (95% CI: 0.52-0.73) and AUC = 0.69 (95% CI: 0.60-0.79), respectively. CONCLUSIONS: In patients with Stage II-III oesophageal cancer being considered for curative therapy, pretreatment FACT-E and ECS have better discrimination for survival than does ECOG. The majority of patients were ECOG 0/1. Thus, these patient-derived scores were able to discriminate survivors from non-survivors even within this constrained range of clinician-assigned performance status. This highlights the potential utility of FACT-E and ECS as prognostic tools.

Longitudinal Evaluation of Trial Outcome Index Scores in Patients With Esophageal Cancer.

BACKGROUND: The purpose of this study was to use the Trial Outcome Index (TOI) to longitudinally assess the effects of treatment for esophageal cancer. METHODS: Patients with esophageal cancer treated with curative intent therapy (N = 84) were evaluated with Functional Assessment of Cancer Therapy-Esophageal Cancer subscale (FACT-E) questionnaires, which were scheduled at baseline and at 1, 3, 6, 9, 12, 18, 24, and 36 months after completion of treatment. Patients treated with preoperative therapy also completed questionnaires 6 to 8 weeks after starting treatment and after completion of induction treatment (12-14 weeks) just before the operative procedure. Physical and functional well-being subscales and the esophageal specific concerns that comprise the TOI were used for the analysis. A linear mixed-effects model with identity link function was used for longitudinal TOI scores. Tukey-Kramer adjustment for multiple comparisons was used for pairwise comparisons. RESULTS: TOI scores differed over time (p < 0.0001), with a significant decrease in TOI from baseline to 6 to 8 weeks after chemotherapy or chemoradiation (p < 0.0001; median, 95 versus 68). At 1 month after treatment (esophagectomy or definitive chemoradiation), median TOI scores were 79 (p = 0.0011 compared with baseline). However by 3 months after treatment, median scores were 90, not significantly different from baseline (p = 0.23). Beyond 3 months, TOI scores either increased or stabilized. Single patients have TOI scores 12 points lower than patients with partners (p = 0.0015). CONCLUSIONS: TOI is a useful tool to assess the physical and functional effects of treatment in patients with esophageal cancer and may provide an efficient index for the comparison of different types of treatment, particularly in the context of clinical trials.

Baseline measure of health-related quality of life (Functional Assessment of Cancer Therapy-Esophagus) is associated with overall survival in patients with esophageal cancer.

OBJECTIVE: Functional Assessment of Cancer Therapy-Esophagus is a health-related quality of life instrument validated in patients with esophageal cancer. It is composed of a general component and an esophageal cancer subscale. Our objective was to determine whether the baseline Functional Assessment of Cancer Therapy-Esophagus and esophageal cancer subscale scores are associated with survival in patients with stage II and III cancer of the gastroesophageal junction or thoracic esophagus. METHODS: Data from 4 prospective studies in Canadian academic hospitals were combined. These included consecutive patients with stage II and III esophageal cancer who received neoadjuvant therapy followed by surgery or chemoradiation/radiation alone. All patients completed baseline Functional Assessment of Cancer Therapy-Esophagus. Functional Assessment of Cancer Therapy-Esophagus and esophageal cancer subscale scores were dichotomized on the basis of median scores. Cox regression analyses were performed. RESULTS: There were 207 patients treated between 1996 and 2014. Mean age was 61 ± 10.6 years. Approximately 69.6% of patients (n = 144) had adenocarcinoma. All patients had more than 9 months of follow-up. In patients with stage II and III, 93 deaths were observed. When treated as continuous variables, baseline Functional Assessment of Cancer Therapy-Esophagus and esophageal cancer subscale were associated with survival with hazard ratios of 0.89 (95% confidence interval [CI], 0.81-0.96; P = .005) and 0.68 (95% CI, 0.56-0.82; P < .001), respectively. When dichotomized, they were also associated with survival with a hazard ratio of 0.58 (95% CI, 0.38-0.89; P = .01) and 0.43 (95% CI, 0.28-0.67; P < .001), respectively. CONCLUSIONS: In patients with stage II and III esophageal cancer being considered for therapy, higher baseline Functional Assessment of Cancer Therapy-Esophagus and esophageal cancer subscale were independently associated with longer survival, even after adjusting for age, stage, histology, and therapy received. Further study is needed, but Functional Assessment of Cancer Therapy-Esophagus may be useful as a prognostic tool to inform patient decision-making and patient selection criteria for studies.

Childhood Maltreatment Is Associated with Ulcerative Colitis but Not Crohn's Disease: Findings from a Population-based Study.

BACKGROUND: Previous research suggests a link between childhood adversities and inflammatory bowel disease (IBD); however, study limitations prevent generalization of findings. To address this, the current study uses a Canadian population-based sample to investigate the relationship between 3 childhood adversities and 2 types of IBD while controlling for a range of factors. METHODS: Secondary data analysis of a subsample of the nationally representative 2012 Canadian Community Health Survey-Mental Health consisted of those with no missing data on any of the variables of interest (n = 21,852). The survey response rate was 68.9%. This study used logistic regression to estimate odds ratios of 3 types of childhood adversities (physical abuse, sexual abuse, and witnessing parental domestic violence) separately for ulcerative colitis and Crohn's disease, each compared with those without IBD. The final model controls for sociodemographics, health behaviors, and mental health. The exposure was assessed by retrospective self-report, and the outcome was by self-report of a health professional diagnosis. RESULTS: In a fully adjusted model, those who are physically (odds ratio = 2.28; confidence interval, 1.39-3.75) or sexually abused (odds ratio = 2.64; confidence interval, 1.61-4.33) during childhood had significantly higher odds of ulcerative colitis than their non-maltreated peers. No relationship is found between witnessing parental domestic violence and ulcerative colitis. None of the early adversities are significantly related to Crohn's disease. CONCLUSIONS: Childhood physical and sexual abuse are related to ulcerative colitis, but not Crohn's disease. Future research that can address epigenetic and neuroendocrine factors should investigate pathways through which early adversities may translate into one type of IBD but not another.

Robust Association Between Inflammatory Bowel Disease and Generalized Anxiety Disorder: Findings from a Nationally Representative Canadian Study.

BACKGROUND: Although the link between inflammatory bowel diseases (IBD) and depression is well accepted, less is known about the relationship between IBD and anxiety disorders and factors associated with anxiety among those with IBD. METHODS: Data were derived from the nationally representative 2012 Canadian Community Health Survey-Mental Health. The survey response rate was 68.9%. Two sets of analyses were undertaken. First, a series of logistic regression analyses were used to estimate the odd ratios of generalized anxiety disorder among those with IBD compared with those without (n = 22,522). The fully adjusted model controlled for sociodemographics, depression, substance abuse/dependence, pain, and adverse childhood experiences. Second, among those with IBD (n = 269), significant correlates of generalized anxiety disorder were identified using logistic regression. The presence of generalized anxiety disorder was determined using the WHO-CIDI lifetime criteria, and IBD was assessed by a self-reported health professional diagnosis. RESULTS: Individuals with IBD had over twice the odds of anxiety compared with those without IBD, even when controlling for a range of potential explanatory factors (odds ratio = 2.18; 95% confidence interval, 1.50-3.16). Controlling for chronic pain and childhood adversities attenuate the relationship the most. Among those with IBD, a history of childhood sexual abuse, female gender, and chronic pain are the strongest correlates of anxiety. Those with Crohn's and ulcerative colitis were equally vulnerable to generalized anxiety disorder. CONCLUSIONS: Our findings show that IBD is robustly related to generalized anxiety disorder. Health care professionals should be aware of the increased prevalence of generalized anxiety disorder among their patients with IBD, particularly women, those in chronic pain, and those with a history of childhood sexual abuse.

Long-term parental unemployment in childhood and subsequent chronic fatigue syndrome.

Objective. The association between long-term parental unemployment in childhood and chronic fatigue syndrome was examined in a population-based sample of women. Methods. A secondary analysis of data from a regionally representative sample of women (n = 7, 288) from the Canadian Community Health Survey (2005) was conducted using logistic regression. Age and race as well as the following clusters of factors were controlled for: (1) other childhood adversities, (2) adult health behaviors and hypertension, (3) adult stressors and socioeconomic status, and (4) adult mental health. Results. When adjusting for age and race only, the odds ratio of chronic fatigue syndrome among those reporting parental unemployment was 4.12 (95% CI: 2.60, 6.52) compared to those not reporting parental unemployment. When controlling for age and race plus all four clusters of factors the odds ratio for chronic fatigue syndrome dropped slightly to 3.05 (95% CI: 1.81, 5.14), but remained statistically significant. Conclusions. This study provides evidence for a significant association between long-term parental unemployment in childhood and chronic fatigue syndrome even after controlling for a wide range of potential risk factors.

Support like a walking stick: parent-buddy matching for language and culture in the NICU.

PURPOSE: (1) To explore the experience of non-English-speaking mothers with preterm, very low birth weight (VLBW) infants (,1,500 g); and (2) to examine mothers' assessment of a peer support program matching them with linguistically and culturally similar parent-buddies. DESIGN: An exploratory, qualitative analysis based on grounded theory. SAMPLE: A convenience sample of eight mothers from four of the most prevalent non-English-speaking cultures (Spanish, Portuguese, Chinese, and Tamil) in an urban Canadian-teaching hospital. MAIN OUTCOME VARIABLE: Non-Anglophone mothers' experience and support in the NICU. RESULTS: Study mothers experienced intense role disequilibrium during the unanticipated crisis of preterm birth of a VLBW infant; situational crises owing to the high-tech NI CU environment and their infant's condition; and developmental crises with feelings of loss, guilt, helplessness, and anxiety. Language barriers compounded the difficulties. Parent-buddies helped non-English-speaking mothers mobilize their strengths. Culture and language are important determinants of service satisfaction for non-English-speaking mothers. Linguistically congruent parent-to-parent matching increases access to service.

Health-related quality of life in esophageal cancer: effect of neoadjuvant chemoradiotherapy followed by surgical intervention.

OBJECTIVE: We sought to determine the effect of neoadjuvant chemoradiotherapy followed by surgical intervention on health-related quality of life in patients with esophageal cancer. METHODS: Health-related quality of life was evaluated in a prospective phase II study of neoadjuvant chemoradiotherapy followed by esophagectomy in 52 patients with carcinoma of the esophagus. Esophagectomy was performed 6 weeks after completion of induction. Functional Assessment of Cancer Therapy-Esophageal scoring was performed before treatment, 7 weeks after initiation of neoadjuvant therapy, before resection, and at 1, 3, and 6 months and 1 year after resection. RESULTS: Forty-three patients completed the entire treatment protocol. Functional Assessment of Cancer Therapy-Esophageal scores decreased significantly after chemoradiation at week 7 (120 vs 127 at baseline, P = .04) but returned to baseline levels before surgical intervention (127). Similarly, scores decreased significantly after surgical intervention (115 at 1 month, P = .02) but returned to baseline levels by 3 months postoperatively (127). At 1 year postoperatively, there was a statistically significant improvement in scores compared with those at baseline (139, P = .003). Functional Assessment of Cancer Therapy-Esophageal scores continued to increase over time for patients who were alive at least 1 year after the operation with or without disease but were observed to significantly decrease in those who died within 1 year after the operation (P = .0001). An increase in quality of life was associated with a significantly lower risk of death (P = .04). CONCLUSION: Neoadjuvant therapy has a significant effect on health-related quality of life, but this is transient, with recovery to baseline within 5 to 7 weeks after completion of induction therapy. Health-related quality of life decreases again after surgical intervention but returns to baseline levels within 3 months.

Do culturally sensitive services for Chinese in-patients make a difference?.

Hospitals in large cities provide services to an increasingly diverse linguistic and cultural clientele. Some strategies adopted to improve services to non-English speaking populations include the use of bilingual social workers, interpreters and printed translation tools. In order to identify gaps in culturally sensitive care in a Canadian teaching hospital, this study surveyed a consecutive sample of 279 Chinese in-patients to determine satisfaction with hospital experience, levels of information about hospital routines and awareness of on-site Chinese cultural services. Results were generally positive. However, satisfaction and information levels were significantly higher among those patients who were aware of culturally appropriate Chinese resources such as social workers, cultural interpreters, and culturally specific reference tools. Of particular interest are the 121 patients (44%) who were less comfortable with English, since awareness of culturally specific resources tended to make a greater difference to this sub-group. These results can potentially help health care providers improve services to patients and families from diverse cultural and linguistic groups.

Does difference matter? Diversity and human rights in a hospital workplace.

The urban hospital workplace is a dynamic environment that mirrors the cultural and social diversity of the modern city. This paper explores the literature relating to diversity in the workplace and then describes an urban Canadian teaching hospital's comprehensive approach to the promotion of an equitable and inclusive diverse environment. With this goal, four years ago the hospital established an office of Diversity and Human Rights staffed by a social worker. The office provides education, training, policy development and complaints management. The administration also convened a hospital-wide committee to advise on the outcomes, and to plan a process for diversity and human rights organizational change. The committee worked with a social work research consultant to design a qualitative focus group study, currently ongoing, to explore the perspectives of hospital staff. The lessons learned from the process have the potential to increase overall cultural competency of staff that can translate into more sensitive work with patients.

Depression and inflammatory bowel disease: findings from two nationally representative Canadian surveys.

Most studies of depression and inflammatory bowel disease (IBD) have been drawn from clinical populations or from samples selected from the membership of Crohn's and ulcerative colitis community organizations. This study determined the prevalence and correlates of depression in people with IBD or a similar bowel disorder from 2 nationally representative Canadian surveys. In the Canadian Community Health Survey, conducted in 2000 through 2001, there were 3076 respondents who reported that they had "a bowel disorder such as Crohn's disease or colitis" that had lasted >or=6 months and had been diagnosed by a health professional. The National Population Health Survey, conducted from 1996 through 1997, had 1438 respondents who reported that they had such a condition. Within each subsample, bivariate analyses were conducted to compare the depressed and nondepressed individuals. Logistic regression analyses also were conducted using the Canadian Community Health Survey 1.1 data set. The 12-month period prevalence of depression among individuals with IBD and similar bowel disorders was comparable in the 2 data sets (16.3% and 14.7%). Depression rates were higher among female respondents, those without partners, younger respondents, those who reported greater pain, and those who had functional limitations. Seventeen percent of depressed respondents had considered suicide in the past 12 months; an additional 30% had considered suicide at an earlier time. Only 40% of depressed individuals were using antidepressants. Individuals with IBD and similar bowel disorders experience rates of depression that are triple those of the general population. It is important for clinicians to assess depression and suicidal ideation among their patients with active IBD symptoms, particularly among those reporting moderate to severe pain.

Validation of the functional assessment of cancer therapy esophageal cancer subscale.

BACKGROUND: To develop and validate a quality of life subscale for patients with esophageal cancer to be used with the Functional Assessment of Cancer Therapy-General (FACT-G). METHODS: Prospective cohort study of patients with esophageal cancer treated with surgery alone or neoadjuvant chemoradiotherapy and surgery evaluating the validity, internal consistency, and responsiveness to change of the FACT-Esophageal (FACT-E) when comparing it with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ 30) and esophageal (OES 24) as well as clinical factors. RESULTS: The FACT-E demonstrated very good convergent and divergent validity when compared with the EORTC QLQ30 and OES 24 and clinical variables. Internal consistency was also good with coefficient alpha > 0.70 for all subscales and individual items. Stability coefficients were > 0.80. Changes in clinical status were reflected in changes in FACT-E scores demonstrating responsiveness to change, particularly in patients receiving neoadjuvant chemoradiotherapy before surgery. CONCLUSIONS: The FACT-E met or exceeded all standards for validity, providing an option to measure health-related quality of life for different treatment strategies for esophageal cancer.

Social group work: building a professional collective of hospital social workers.

Deconstruction of traditional social work departments can isolate social workers from their primary source of professional affiliation, leaving them without the support to take stands on controversial patient care issues. This paper describes an alternative: the building of a powerful social work collective based on social group work theory that potentiates professional practice while transcending management forms. The model includes group supervision, but moves beyond it to utilize the social work group as a central organizing principle. At the heart of the collective are the elements of professional accountability, support, autonomy, and collaborative decision- making within democratic peer group structures. The authors highlight current management theory, distinctions that create an authentic social work value-based practice, and outcomes for social workers, their clients, and colleagues.