Functional Assessment Of Chronic Illness Research Articles

Linguistic Validation of the Functional Assessment of Chronic Illness Therapy-Spiritual-Well-being-Expanded Version 4 Tool into Malayalam Language and its Feasibility in Advanced Cancer Patients Receiving Palliative Care

Objective: The objective of this study was to validate the ‘Functional Assessment of Chronic Illness Therapy-Spiritual-Well-being-Expanded(FACIT-SpEx) Version 4’ tool in Malayalam and assess its feasibility among advanced cancer patients receiving palliative care. Materials and Methods: The study was carried out at the outpatient Department of Cancer Palliative Medicine of Malabar Cancer Centre between November 2022 and June 2023. Initially, the FACIT-Sp-Ex version 4 tool with 23 items was translated into the Malayalam language with a forward-backward translation procedure. This was followed by pilot testing in 10 advanced adult cancer patients receiving palliative care who could read and comprehend the Malayalam language. After answering the draft version of the validated tool, patients responded to questions from a Malayalam-translated cognitive debriefing script. Results: The process of translation and cross-cultural adaptation went on smoothly with very few hurdles. The Malayalam terms used in three items Sp7, Sp9 and Sp23 when back translated were found to be different from the source. These issues were resolved with the use of the most suitable translations and closest equivalents available in Malayalam. In the pilot testing, the majority (70%) of the patients were female. The mean age of patients was 45.90 (standard deviation [SD] = 7.62) years. Carcinoma breast (50%) was the most common type of cancer. All the patients knew their diagnosis, while only 80% knew the prognosis. Almost 90% of the patients were receiving some form of palliative anticancer treatment. All patients completed the draft version of the validated tool. The mean spiritual well-being score measured using this validated tool was 71.20 (SD = 15.10). Analysis of the debriefing interviews revealed that the Malayalam version was easy to complete, relevant, and appropriate. Conclusion: Linguistic validation and cognitive debriefing produced the Malayalam translated FACIT-Sp-Ex version 4 tool conceptually equivalent to the original FACIT-Sp-Ex version 4 tool, and it is feasible for its use.

The chain mediating effect of spiritual well‐being and anticipatory grief between benefit finding and meaning in life of patients with advanced lung cancer: Empirical research quantitative

AbstractAimThis study aimed to explore the chain mediating effect of spiritual well‐being and anticipatory grief between benefit finding and meaning in life of patients with advanced lung cancer.DesignThis was a cross‐sectional study.MethodsThe research included 400 patients with advanced lung cancer who attended REDACTE from December 2022 to August 2023 as the research subjects. Data were collected using a questionnaire including socio‐demographic and clinical characteristics, the Functional Assessment of Chronic Illness Therapy‐Spiritual Well‐Being scale (FACIT‐Sp‐12), the Benefit Finding Scale (BFS), the Preparatory Grief in Advanced Cancer Patients Scale (PGAC), and the Meaning of Life Questionnaire (MLQ). The structural equation model (SEM) was used to analyse the relationship between benefit finding, spiritual well‐being, anticipatory grief and meaning in life.ResultsThere was a significant correlation between benefit finding, spiritual well‐being, anticipatory grief, and meaning in life. Benefit finding could have a direct positive impact on meaning in life of patients with advanced lung cancer, but it could also indirectly affect meaning in life of patients with advanced lung cancer through three pathways: the mediating effect of spiritual well‐being, the mediating effect of anticipatory grief and the chain mediating effect of spiritual well‐being and anticipatory grief. Nursing staff should develop an integrated program of interventions to enhance the meaning in life of patients with advanced lung cancer.

Reappraising personal values in cancer: Meaning-in-life adaptation, meaningfulness, and quality of life.

This study explores the reappraisal of personal values among people with cancer post-diagnosis and its connections to meaningfulness, encompassing personal meaning and sense of meaning, and various dimensions of quality of life. A total of 144 patients with diverse cancer types and a control group comprising 158 healthy adults with similar demographic characteristics completed the Valued Living Questionnaire-Perceived Change, the Personal Meaning Profile-Brief, the Portrait Values Questionnaire, and the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being. Cancer patients displayed a substantial values reappraisal compared to healthy adults. They reported an increased significance of social areas and self-transcendental values, including close relationships (family, partner, and friends), spirituality, citizenship, and universalism, as well as an increased importance of self-care and self in general. Conversely, cancer patients assigned less importance to work and self-enhancement values such as stimulation, power, and achievement. Cluster analysis revealed that patients who reappraised their values exhibited higher meaningfulness and better indicators of quality of life, including spiritual and physical well-being, compared to patients who did not modify their value system. These findings underscore the importance of assessing and promoting meaning-in-life adaptability among people with cancer, with potential applications in meaning-centered therapies and interventions aimed at enhancing psychological flexibility.

Multimodal prehabilitation service for patients with colorectal cancer: the challenges of implementation

Prehabilitation has been shown to improve outcomes for patients undergoing major surgery; benefits include reductions in length of hospital stay and postoperative complications. Multimodal prehabilitation programmes lead to improved patient...

Patient-reported outcomes provide prognostic information for survival in patients with diffuse large B-cell lymphoma: Analysis of 1239 patients from the GOYA study.

PurposeWe investigated the prognostic value of pretreatment patient‐reported outcomes (PROs) in patients with diffuse large B‐cell lymphoma (DLBCL) receiving obinutuzumab/rituximab plus chemotherapy in the GOYA phase III study.MethodsPatients completed the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ‐C30) and the Functional assessment of chronic illness therapy‐Lymphoma (FACT–Lym) lymphoma subscale (LYMS) during the study. PRO scales with high prognostic value were identified through Cox regression analyses of overall survival (OS) and progression‐free survival (PFS). These scales were evaluated in terms of their additional prognostic value beyond the International Prognostic Index (IPI). A preliminary assessment was performed to evaluate whether the scales provided improved patient‐risk stratification beyond IPI.ResultsOne thousand two hundred and fifty‐nine patients with valid pretreatment PRO scales were included in the analyses, and complete pretreatment data were available for 1239/1414 patients (87.6%). Four PRO scales with high prognostic value were identified: FACT–Lym LYMS and EORTC QLQ‐C30 physical functioning, global health status/quality of life (QoL), and fatigue. All four scales retained significant prognostic value for OS and PFS after IPI adjustment (all p < 0.05). After adjusting for multiple clinical variables (IPI, cell of origin, BCL2 status, and total metabolic tumor volume), all four scales retained significant prognostic value (all p < 0.05) for OS. Only the EORTC QLQ‐C30 physical functioning scale was significant (p < 0.05) for PFS after adjustment for multiple clinical variables.ConclusionsIn this large population of patients with DLBCL, pretreatment PROs provided prognostic information for OS and PFS beyond the well‐established IPI.

Hyperbaric oxygen therapy ameliorates pain in overweight or obese patients diagnosed with fibromyalgia

Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain, fatigue, poor sleep quality, allodynia and paresthesia. Therapy for this syndrome consists of pharmacological and non‑pharmacological approaches focused on controlling pain and fatigue to improve the quality of life of those affected. The present study aimed to determine whether hyperbaric oxygen therapy (HBOT) can be considered a useful adjuvant of pre‑existing pharmacological treatment to reduce pain and improve the quality of life of patients with fibromyalgia. Patients diagnosed with fibromyalgia were enrolled in the present study following a clinical evaluation. All participants received 20 sessions of HBOT (five sessions/week, Monday‑Friday). The sessions consisted of breathing for 60 min with 100% oxygen at a 2.0 atmospheric absolute pressure. Pain, fatigue, quality of life and the number of drugs used were measured to assess the effectiveness of HBOT. Prior to HBOT, the patients presented with an average visual analog scale score of 8.06±0.475, which was reduced to 3.86±0.748 following treatment. In addition, the functional assessment of chronic illness therapy‑fatigue score indicated amelioration of this symptom by HBOT, reducing the mean score from 44.86±2.19 to 21.6±1.09. Furthermore, the quantification of the quality of life using the fibromyalgia impact questionnaire reduced the score from 76.66±4.11 to 47.6±2.67. As regards the number of drugs administered to the patients, this decreased from 3.13±0.764 to 1.53±0.85. Taken together, the results of the present study suggest that HBOT may be used as an effective adjuvant in the treatment of fibromyalgia, reducing both pain and fatigue. In addition, this treatment improves the quality of life of those affected and may be used to avoid polypharmacy.

Understanding and Measuring Key Symptoms and Health-Related Quality of Life in Patients with Chronic Immune Thrombocytopenia

Introduction Immune thrombocytopenia (ITP) is a rare autoimmune disorder in which there is an increase in platelet destruction and a decrease in platelet production, resulting in low platelet count, high bleeding risk and impact on quality of life (QoL). A critical appraisal of the literature was conducted to understand the patient experience with ITP and its treatment, and to assess which clinical outcome assessment (COA) instruments can best capture the ITP patient experience and changes due to disease management. Methods A focused PubMed search was performed for qualitative studies describing patient experience with ITP published prior to June 2019. The search paired population terms (ITP) with qualitative study design terms ("qualitative", "focus group/s", "interview/s", "blog"). Grey literature (congresses, patient advocacy group websites) was also consulted. Key patient-reported concepts of interest for measurement in clinical trials were identified. A second review was conducted to identify COA instruments used in ITP to measure the key concepts using PROQOLID (no limits; prior to November 2019), Clinicaltrials.gov (Phase 2 and 3; November 2009-2019), and PubMed (October 2009-2019). COA instruments were critically appraised based on their published psychometric properties and use in regulatory labels and health technology assessment (HTA) appraisal decisions. Results Of the 52 articles screened in the initial search, 2 relevant articles were identified. One reported the development of ITP-patient assessment questionnaire (ITP-PAQ), a disease-specific measure of health-related QoL (HRQoL) in adults with ITP (Mathias et al. Health and Quality of Life Outcomes 2007); the second introduced a conceptual model informed by literature, clinical expertise and qualitative research to describe the impact of ITP and its treatment on patients' HRQoL (Mathias et al. Health and Quality of Life Outcomes 2008). This conceptual model proposed 1 biological variable (low platelet count), 2 main determinants of HRQoL (symptoms of ITP, treatment side-effects) and 5 conceptual domains of HRQoL (emotional health, functional health, social and leisure, reproductive health, work). Fatigue and bleeding/bruising symptoms were considered the main determinants of HRQoL change for patients with ITP. However, the literature supporting this conceptual model was over 15 years old, from one country (US) and conducted in one clinical setting (tertiary care). A third recent publication reporting an interim analysis from the ITP World Impact Survey in 1,400 patients was identified from grey literature (Cooper et al. EHA Library 2018; PF654). Fatigue and bleeding (including petechiae) were the most frequently reported symptoms, at diagnosis and at time of survey completion, and fatigue was reported as one of the most severe symptoms. Twenty-two COA instruments used in ITP were identified for assessments of bleeding/bruising, fatigue/tiredness, anxiety/fear, and/or avoidance of physical activity. From this search, 8 instruments were analysed in depth: ITP-PAQ; Functional Assessment of Cancer Therapy - Thrombocytopenia 6 (FACT-Th6); FACT-Th11/18; Functional Assessment of Chronic Illness - Fatigue (FACIT-F); WHO Bleeding Score; ITP Bleeding Score; ITP-specific bleeding assessment tool (ITP-BAT); Short Form 36 (SF-36). The WHO Bleeding Scale is widely used in ITP and mentioned in at least one product label for ITP treatments (eltrombopag). The FACIT-F is the most widely-used fatigue instrument and was utilized in non-ITP related regulatory labels in the US and EU. It has also been considered by HTA agencies for ITP and its psychometric properties were validated in ITP. The ITP-PAQ was developed and validated in ITP for HRQoL evaluation; it was used for clinical development of romiplostim and was well considered by the National Institute for Health and Care Excellence (NICE). Conclusion The studies identified in these literature searches indicate that fatigue and bleeding are key determinants of HRQoL in patients with ITP. Three COA instruments (WHO Bleeding scale, FACIT-F and ITP-PAQ) were identified using evidence from the existing literature as potential valid tools to measure these concepts of interest in future ITP clinical trials. Disclosures Joly: Sanofi: Current Employment, Current equity holder in publicly-traded company. Reaney:IQVIA: Current Employment; Sanofi: Research Funding. Daak:Sanofi: Current Employment, Current equity holder in publicly-traded company. Venerus:Sanofi: Research Funding; IQVIA: Current Employment. Roborel de Climens:Sanofi: Current Employment, Current equity holder in publicly-traded company.

Factors related to spiritual health in Chinese haemodialysis patients: A multicentre cross-sectional study.

AimThis study aimed to investigate the current situation of the spiritual health of maintenance haemodialysis (MHD) patients in China and analyse the influencing factors.MethodsA total of 418 patients who underwent maintenance haemodialysis in three grade A tertiary hospitals were selected. The influencing factors were evaluated with demographic questionnaire, the Functional Assessment of Chronic Illness Therapy‐Spiritual Well‐Being (FACIT‐Sp‐12), Family APGAR Index, Herth Hope Index (HHI) and Acceptance of Illness Scale (AIS).ResultsSpiritual health was positively correlated with the HHI, Family APGAR and AIS scores. Nationality, HHI score, Family APGAR score and AIS score were independent influencing factors of spiritual health. MHD patients had a moderate level of spiritual health. Nationality, hope, family function and acceptance of illness were significant predictors of spiritual health. Patients who have higher hope levels, better family functioning and better illness acceptance may maintain better spiritual health.

Relationships between worry about dying in patients with advanced cancer and their illness understanding, treatment preferences, and advance care planning.

12080 Background: Patients with advanced cancer often worry about dying, yet little is known about the role their fears play regarding future care. We aimed to explore relationships between patients’ worry about dying and their illness understanding, treatment preference, and advance care planning. Methods: This cross-sectional study uses baseline data from a community-based, primary palliative care intervention trial. Patients had metastatic solid tumors, an Eastern Cooperative Oncology Group performance status of 0-2, and their oncologist “would not be surprised” if they died in the next year. Using patients’ response to “I worry about dying” (not at all, a little bit, somewhat, quite a bit, or very much) from the Functional Assessment of Chronic Illness - Palliative Care survey instrument, univariate and multivariate analyses assessed associations with illness understanding (report of being terminally ill or not), treatment preference (life-extending vs. symptom-focused), and advance care planning (completion of an advance directive or not). We also performed sensitivity analyses substituting “I feel scared about my future” (strongly disagree, disagree, agree, or strongly agree) from the Herth Hope Index for “I worry about dying.” Results: Of 672 patients, 54% were female, 94% white, and 69% currently receiving chemotherapy. 47% reported worrying about dying “not at all,” while 9.7% worried “quite a bit” or “very much.” In regression analysis, those who worried “quite a bit” or “very much” were more likely to describe themselves as terminally ill (adjusted odds ratio (AOR)=1.98, 95% CI=1.10-3.54, p=0.021) and more likely to prefer life-extending treatment over symptom-focused care (AOR=2.61, 95% CI=1.30-5.22, p=0.007) compared with patients who reported not worrying about dying. They also were less likely to have completed an advance directive (AOR=0.49, 95% CI=0.25-0.94, p=0.032). The same relationships were observed using patients’ response to “I feel scared about my future.” Conclusions: Patients with advanced cancer who worry more about dying can affirm they are terminally ill and are more likely to want life-extending treatment over symptom care while less likely to engage in advance care planning. Understanding these patients’ decision making is critical to ensuring that their values are known and understood near the end of life.

Peace of mind among adolescents and young adults with cancer.

Adolescents and young adults (AYAs) with cancer have high rates of psychological distress and unmet support needs. Peace of mind is an important construct among older cancer patients and parents of children with cancer but has not been explored in AYAs. We sought to evaluate the extent to which AYAs with cancer experience peace of mind and to identify factors associated with greater peace of mind. We surveyed 193 AYAs with cancer aged 15 to 29 years within 12 weeks of diagnosis; 137 patients completed the same measures again 4 and 12 months after diagnosis. Patients were asked to report peace of mind, measured using items from the Functional Assessment of Chronic Illness, Spiritual Well-being scale (FACIT-Sp); anxiety and depression, using the Hospital Anxiety and Depression Scale (HADS); and experiences surrounding medical communication and decision making. Mean scores for peace of mind were 3.59 at diagnosis (range 1-5, standard deviation 0.84), with similar scores at 4 (3.53, P = .34) and 12 (3.59, P = .94) months. In a multivariable model adjusted for age and gender, patients who reported receiving high-quality information about their cancer had greater peace of mind at diagnosis (β = .25, P = .03), whereas those who reported holding a passive role in treatment decision making (β = -.47, P < .0001) or who had anxiety (β = -.64, P = .0003) or depression (β = -.51, P = .04) had lower peace of mind. Peace of mind did not improve significantly over time for AYAs with cancer. While high-quality communication may be associated with heightened peace of mind, further study is needed to clarify relationships between peace of mind and other psychological variables.

The efficacy of placebo for the treatment of cancer-related fatigue: a systematic review and meta-analysis.

Cancer-related fatigue (CRF) is a common symptom among patients with cancer. The efficacy of placebo, however, was never the main objective of any meta-analysis. Predicting the efficacy of placebo may facilitate researchers in designing future clinical trials for the treatment of CRF. We performed a systematic review searching for prospective clinical trials comparing any treatment versus placebo for the treatment of CRF. We included studies that enrolled patients with any primary site of neoplasia and any stage of cancer. We excluded all studies that assessed fatigue related to any treatment. The primary endpoint of this study is the mean effect of placebo on fatigue according to the Functional Assessment of Chronic Illness (FACIT-F) and Brief Fatigue Inventory (BFI) scales. The secondary endpoint was the proportion of patients who reported improvement in fatigue (response rate). We found 520 studies, and 29 studies with 3758 participants were included in the meta-analysis. Placebo had a mean effect of + 4.88 (95%CI + 2.45 to + 7.29) using the FACIT-F scale, although it was statistically worse than the interventions studied (p = 0.005). Using the BFI scale, placebo had an average effect of + 0.64 (95%CI + 0.02 to + 1.30), although it was also worse than the other interventions studied (p = 0.002). In terms of the response rate, 29% (95%CI 25-32%) of patients taking a placebo reported a significant improvement in CRF compared with 36% of patients treated with other interventions (p = 0.030). Placebo treatments had a significant effect on CRF, and predicting these effects may help design future studies for CRF.

The efficacy of placebo for the treatment of cancer-related fatigue: A systematic review and meta-analysis.

e23157 Background: Cancer-related fatigue (CRF) is a common symptom among patients with cancer. The efficacy of placebo, however, was never the main objective of any meta-analysis. Predicting the efficacy of placebo may facilitate researchers in designing future clinical trials for the treatment of CRF. Methods: We performed a systematic review searching for prospective clinical trials comparing any treatment versus placebo for the treatment of CRF. We included studies that enrolled patients with any primary site of neoplasia and any stage of cancer. We excluded all studies that assessed fatigue related to any treatment. The primary endpoint of this study is the mean effect of placebo on fatigue according to the Functional Assessment of Chronic Illness (FACIT-F) and Brief Fatigue Inventory (BFI) scales. The secondary endpoint was the proportion of patients who reported improvement in fatigue (response rate). Results: We found 520 studies, and 29 studies with 3,758 participants were included in the meta-analysis. Placebo had a mean effect of +4.88 (95%CI +2.45 to +7.29) using the FACIT-F scale, although it was statistically worse than the interventions studied (p = 0.005). Using the BFI scale, placebo had an average effect of +0.64 (95%CI +0.02 to +1.30), although it was also worse than the other interventions studied (p = 0.002). In terms of the response rate, 29% (95%CI 25%–32%) of patients taking a placebo reported a significant improvement in CRF compared to 36% of patients treated with other interventions (p = 0.030). Conclusions: Placebo treatments had a significant effect on CRF, and predicting these effects may help design future studies for CRF.

Research on the status and influencing factors of spiritual health in patients with gastrointestinal malignant tumors

Objective To investigate the status and its influencing factors of spiritual health of patients with gastrointestinal malignant tumors. Methods Totally 147 advanced cancer patients from three tertiary hospitals in Tianjin (Tianjin Hospital of ITCWM Nankai Hospital, Tianjin Medical University Cancer Institute and Therapy, The Second Hospital of Tianjin Medical University) were enrolled through convenience sampling methods. The status of spiritual health and quality of life were analyzed by the Functional Assessment of Chronic Illness Therapy-Spiritual Well Being Scale (FACIT-Sp-12) and the World Health Organization's Quality of Life Questionnaire-Brief Version Scale(WHOQOL-BREF). Results The overall scores of the FACIT-Sp-12 were (25.64 ± 2.84) points, at a lower-middle level,the overall scores of the WHOQOL-BREF were (11.24±2.85) points,at a lower level. Multiple linear-regression analysis showed that the age,religious belief and educational level were influencing factors of spiritual health(P<0.05). Conclusions The level of spiritual health of advanced cancer patients is at lower-middle level. With different age,religious belief, educational level the status of spiritual health is different. Nurses should carry out targeted nursing intervention according to individual conditions of patients with gastrointestinal malignant tumors to improve their quality of life. Key words: Quality of life; Gastrointestinal malignant tumors patients; Spritual health; Influencing factors

Analysis of influencing factors on spiritual health of postoperative patients with gastric neuroendocrine neoplasm

Objective To explore the influencing factors on spiritual health of postoperative patients with gastric neuroendocrine neoplasm (gNEN) . Methods A total of 108 patients with gNEN who undertook operation in the First Affiliated Hospital of Zhengzhou University from July 2013 to July 2016 were recruited by purposive sampling method. All the research subjects were investigated with a general information questionnaire, the Chinese Version of Functional Assessment of Chronic Illness Therapy-Spiritual-12 (FACIT-Sp-12) , Herth Hope Index (HHI) and Social Dysfunction Screening Scale (SDSS) . Results Multivariate linear regression analysis showed that age, educational level, religious belief, SDSS and HHI were the influencing factors of spiritual health in patients with gNEN (P<0.01) . Conclusions Age, educational level, religious belief, social function and hope level were the influencing factors of spiritual health in patients with gNEN. Nursing staff need to construct a scientific and effective spiritual health care model according to the characteristics of patients. Key words: Neoplasms; Gastric neuroendocrine neoplasms; Spiritual health; Hope level; Social function

Abstract TMP38: Comorbidities Drive Chronic Post-Stroke Fatigue

Introduction: Post-stroke fatigue (PSF) is a debilitating part of stroke recovery with long-term effects. Risk factors contributing to PSF, whether they are modifiable, and if they change over time remain understudied. In this study, we determine factors associated with PSF and how they evolve from the subacute to chronic phase of recovery. Methods: A consecutive series of patients presenting to our urban tertiary referral comprehensive stroke center with acute ischemic stroke were seen in follow-up 2-3 months post-event and given the Functional Assessment of Chronic Illness (FACIT) to evaluate for PSF. It was re-administered via telephone 1-2 years post-infarct. Demographics, stroke characteristics (NIH Stroke Scale (NIHSS), size and location of infarct), medical comorbidities, and outcomes (modified Rankin scale (mRS)) were also evaluated. Regression analyses were used to determine factors associated with PSF at each time point. Results: 108 patients were seen in follow-up a mean 2 months post-stroke, 59 of whom were reached by phone a mean 21 months post-event. The characteristics of those reached were similar to those not reached. Stroke attributes such as follow-up NIHSS (p=.035) and mRS (p&lt;.001) were associated with lower FACIT scores in the subacute setting, while comorbid medical conditions including chronic obstructive pulmonary disease (COPD, p=.038) and body mass index (p=.020) were associated with chronic PSF. Anxiety was associated with PSF both subacutely (p&lt;.001) and chronically (p=.002). Conclusions: PSF in the subacute period appears to be due to stroke characteristics (most notably stroke severity), while chronic fatigue occurs in the setting of other comorbid medical conditions such as obesity and COPD. This has significant clinical implications when considering both patients at risk for PSF and potential treatments, which appear to differ significantly between different recovery time points.

The impact of pain on spiritual well-being in people with a spinal cord injury.

The study uses a cross-sectional, group comparison, questionnaire-based design. To determine whether spinal cord injury and pain have an impact on spiritual well-being and whether there is an association between spiritual well-being and measures of pain and psychological function. University teaching hospital in Sydney, New South Wales, Australia. Questionnaires evaluating pain, psychological and spiritual well-being were administered to a group of people with a spinal cord injury (n=53) and a group without spinal cord injury (n=37). Spiritual well-being was assessed using the Functional Assessment of Chronic Illness and Therapy - Spirituality Extended Scale (FACIT-Sp-Ex). Pain and psychological function were also assessed using standard, validated measures of pain intensity, pain interference, mood and cognition. Levels of spiritual well-being in people with a spinal cord injury were significantly lower when compared with people without a spinal cord injury. In addition, there was a moderate but significant negative correlation between spiritual well-being and pain intensity. There was also a strong and significant negative correlation between depression and spiritual well-being and a strong and significant positive correlation between spiritual well-being and both pain self-efficacy and satisfaction with life. Consequences of a spinal cord injury include increased levels of spiritual distress, which is associated, with higher levels of pain and depression and lower levels of pain self-efficacy and satisfaction with life. These findings indicate the importance of addressing spiritual well-being as an important component in the long-term rehabilitation of any person following spinal cord injury. This study was supported by grant funding from the Australian and New Zealand College of Anaesthetists, and the National Health and Medical Research Council of Australia.

Validation of the Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F) in patients with inflammatory bowel disease

BACKGROUND Many patients with ulcerative colitis (UC) and Crohn's disease (CD) complain of significant fatigue. To date, no instrument to measure fatigue has been validated in a US inflammatory bowel disease (IBD) population. AIM To determine the reliability and validity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale in IBD. METHODS A total of 209 patients with IBD completed the 13 items of the FACIT-F, alongside laboratory testing and disease activity assessment. Internal consistency was measured by Cronbach's alpha; test-retest reliability by the intraclass correlation coefficient (ICC); validity by the correlation of the FACIT-F score with C-reactive protein (CRP) erythrocyte sedimentation rate (ESR), haematocrit (HCT) and disease activity as measured by the Harvey-Bradshaw Index (HBI; CD) and Simple Clinical Colitis Activity Index (SCCAI; UC). RESULTS The mean ± SD FACIT-F score was 38.9 ± 11.0 overall (CD 38.6 ± 11.3; UC 39.4 ± 10.6). Cronbach's alpha was 0.94. The ICC for first and repeat FACIT-F scores assessed within 180 days without change in disease state was 0.81 (CD 0.78; UC 0.87). FACIT-F scores were lower in patients with active symptoms (CD 4.6 points, 95% CI 2.4-6.9, P < 0.001; UC 8.5 points, 95% CI 5.5-11.4, P < 0.001). In UC, FACIT-F scores were correlated with ESR (-0.76, 95% CI -0.89 to -0.50), CRP (-0.72, 95% CI -0.88 to -0.43) and HCT (0.53, 95% CI 0.22-0.74). CONCLUSION The FACIT-F scale is a reliable and valid instrument for measuring fatigue in IBD.

Heath-related quality of life in thyroid cancer patients following radioiodine ablation

BackgroundThere is limited information about the medium to long-term health-related quality of life (QOL) in thyroid cancer patients after initial therapy and the existing studies suffer from limitations. The aim of the study was to assess the determinants of medium-term QOL after the initial therapy.MethodsFollowing a total thyroidectomy, 88 thyroid cancer patients received either rhTSH or hypothyroid-assisted radioiodine ablation (RRA) using 3.7 GBq (100 mCi) of radioiodine. QOL evaluation of the patients using the validated Functional Assessment of Chronic Illness & Therapy (FACIT) was performed at the time of inclusion (t0) and later at the 9-month post-RRA (t1).Results83 patients were eligible for the final evaluation. Medium-term FACIT scores were not statistically different between t0 and t1 patients. All but one domain of the QOL score was similar between t0 and t1. Using a multivariate analysis, only age and immediate postoperative QOL scores were found to be determinants of the overall medium term 9-month QOL scores. Analysis showed that 'high QOL levels' (baseline and 9-month) and 'no depression', 'low anxiety levels', were associated with '<45yrs', 'men', 'partner', and 'rhTSH stimulation'.ConclusionsThe use of radioiodine ablation does not seem to affect the medium term QOL scores of patients. Medium-term QOL is mainly determined by pre-ablation QOL. The assessment of baseline QOL might be interesting to evaluate in order to adapt the treatment protocols, the preventive strategies, and medical information to patients for potentially improving their outcomes.

Assessing Health-Related Quality of Life in Gynecologic Oncology

Researchers wishing to assess the health-related quality of life (HRQoL) of women with gynecologic cancers have a range of questionnaires to choose from. In general, disease-, treatment-, or symptom-specific questionnaires are assumed to be better able to identify between-group differences (sensitivity) and changes over time (responsiveness) than are cancer-specific or generic questionnaires. However, little work has tested this assumption in oncology. We set out to (a) identify all multidimensional HRQoL questionnaires used in studies with women with gynecologic cancer and (b) evaluate their track records in identifying minimal clinically important differences (MCIDs), with a view to making recommendations. We searched MEDLINE using the term quality of life and each gynecologic cancer type, as well as the names of identified questionnaires. We used 10% of the scale range as the threshold for an MCID. We identified 1 generic (SF-36/SF-12), 3 cancer-specific (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ] C30, Functional Assessment of Cancer Therapy-General [FACT-G], and short-form Cancer Rehabilitation Evaluation System [CARES-SF]), and 1 disease-specific (QOL-Ovarian Cancer Patient Version) HRQoL questionnaires and 5 disease-specific (QLQ-OV28, FACT-O for ovarian, QLQ-CX24, FACT-Cx for cervical and FACT-V for vulvar), 1 treatment-specific (FACT and Gynecologic Oncology Group-Ntx for neurotoxicity), and 2 symptom-specific (FACT-Anemia and Functional Assessment of Chronic Illness and Therapy [FACIT]-Fatigue) modules. Twenty-seven articles reported results from 26 studies in which an MCID had been identified. The FACIT's anemia and fatigue subscales were more sensitive, and the neurotoxicity subscale more sensitive and responsive than the FACT-G on at least 1 comparison. However, we found no evidence for superior performance by the FACT-G compared with the SF-36 or EORTC and FACIT disease-specific modules versus the QLQ-C30 and FACT-G. There was also little evidence to favor EORTC versus FACIT questionnaires or vice versa. The evidence we reviewed offered little support for the hypothesis that disease-, symptom-, or treatment-specific instruments are more sensitive and responsive than cancer-specific or generic questionnaires. However, conclusions were limited by the small number of head-to-head comparisons available. We summarize the clinical contexts in which each instrument identified an MCID to inform choice of questionnaire(s), sample size calculations, and interpretation of results in future studies.

Spirituality and religion in patients with HIV/AIDS

Spirituality and religion are often central issues for patients dealing with chronic illness. The purpose of this study is to characterize spirituality/religion in a large and diverse sample of patients with HIV/AIDS by using several measures of spirituality/religion, to examine associations between spirituality/religion and a number of demographic, clinical, and psychosocial variables, and to assess changes in levels of spirituality over 12 to 18 months. We interviewed 450 patients from 4 clinical sites. Spirituality/religion was assessed by using 8 measures: the Functional Assessment of Chronic Illness Therapy-Spirituality-Expanded scale (meaning/peace, faith, and overall spirituality); the Duke Religion Index (organized and nonorganized religious activities, and intrinsic religiosity); and the Brief RCOPE scale (positive and negative religious coping). Covariates included demographics and clinical characteristics, HIV symptoms, health status, social support, self-esteem, optimism, and depressive symptoms. The patients' mean (SD) age was 43.3 (8.4) years; 387 (86%) were male; 246 (55%) were minorities; and 358 (80%) indicated a specific religious preference. Ninety-five (23%) participants attended religious services weekly, and 143 (32%) engaged in prayer or meditation at least daily. Three hundred thirty-nine (75%) patients said that their illness had strengthened their faith at least a little, and patients used positive religious coping strategies (e.g., sought God's love and care) more often than negative ones (e.g., wondered whether God has abandoned me; P<.0001). In 8 multivariable models, factors associated with most facets of spirituality/religion included ethnic and racial minority status, greater optimism, less alcohol use, having a religion, greater self-esteem, greater life satisfaction, and lower overall functioning (R2=.16 to .74). Mean levels of spirituality did not change significantly over 12 to 18 months. Most patients with HIV/AIDS belonged to an organized religion and use their religion to cope with their illness. Patients with greater optimism, greater self-esteem, greater life satisfaction, minorities, and patients who drink less alcohol tend to be both more spiritual and religious. Spirituality levels remain stable over 12 to 18 months.