Health and Quality of Life Outcomes

Due to an improving prognosis, and increased knowledge of intervention effects over time, long-term well-being among prostate cancer (PC) survivors has gained increasing attention. Yet, despite a variety of available PC interventions, experts currently disagree on optimal intervention course based on survival rates. In January 2017, we searched multiple databases to identify relevant articles. Studies were required to assess at least two different dimensions of health-related quality of life (HRQoL) in PC survivors ≥5 years past diagnosis with validated measures. Identified studies (n = 13) were mainly observational cohort studies (n = 10), conducted in developed countries with a sample size below 100 per study arm (n = 6). External-beam radiation therapy was the most common intervention (n = 12), whereas only three studies included patients on active surveillance or on watchful waiting. Studies were largely heterogeneous in cancer stage at diagnosis, intervention groups and instruments. All identified studies either used the EORTC QLQ-C30 (n = 5) or the SF-36 (n = 7) to assess generic HRQoL, yet 11 different instruments were employed to assess PC specific urinary, bowel and sexual symptoms. Overall, no consistent pattern between intervention and HRQoL was observed. Results from two randomized-controlled-trials (RCTs) and one observational study, comparing HRQoL by primary intervention in localized PC survivors suggest that long-term HRQoL does not differ by intervention. However, observational studies that included a combination of localized and locally advanced stage PC survivors identified HRQoL differences for various scales including physical well-being, social and role function, vitality, and role emotional. This review reveals the number of publications comparing HRQoL by primary intervention in long-term PC survivors is currently limited. Robust data from two RCTs and one observational study suggest that HRQoL does not seem to differ by intervention. However, the heterogeneity of studies’ methodologies and results hindered our ability to draw a clear conclusion. Therefore, in order to answer the question of which primary intervention is superior with respect to long-term HRQoL in PC patients, more high-quality, large-scale prospective cohort studies, or RCTs with repeated HRQoL assessments, are urgently needed.

Relative validity (RV), a ratio of ANOVA F-statistics, is often used to compare the validity of patient-reported outcome (PRO) measures. We used the bootstrap to establish the statistical significance of the RV and to identify key factors affecting its significance. Based on responses from 453 chronic kidney disease (CKD) patients to 16 CKD-specific and generic PRO measures, RVs were computed to determine how well each measure discriminated across clinically-defined groups of patients compared to the most discriminating (reference) measure. Statistical significance of RV was quantified by the 95% bootstrap confidence interval. Simulations examined the effects of sample size, denominator F-statistic, correlation between comparator and reference measures, and number of bootstrap replicates. The statistical significance of the RV increased as the magnitude of denominator F-statistic increased or as the correlation between comparator and reference measures increased. A denominator F-statistic of 57 conveyed sufficient power (80%) to detect an RV of 0.6 for two measures correlated at r = 0.7. Larger denominator F-statistics or higher correlations provided greater power. Larger sample size with a fixed denominator F-statistic or more bootstrap replicates (beyond 500) had minimal impact. The bootstrap is valuable for establishing the statistical significance of RV estimates. A reasonably large denominator F-statistic (F > 57) is required for adequate power when using the RV to compare the validity of measures with small or moderate correlations (r < 0.7). Substantially greater power can be achieved when comparing measures of a very high correlation (r > 0.9).

The QUALIOST® was designed for use with the SF-36 to measure established osteoporosis-specific quality of life (QoL). The reliability (internal consistency and test-retest) and validity of the questionnaire were established in a stand-alone psychometric validation study. The objective of this paper is to provide additional information on the instrument's responsiveness using clinical trial data, along with the reliability and validity of translated versions. The Spinal Osteoporosis Therapeutic Intervention (SOTI) was an international clinical trial comparing strontium ranelate to placebo on the occurrence of new vertebral fracture in patients with postmenopausal osteoporosis. QoL was a secondary endpoint, assessed using the SF-36 and QUALIOST® at baseline and every six months, with the main analysis at 3-year follow-up. Questionnaire acceptability, analysis of the hypothesised structure, internal consistency reliability and responsiveness to clinical change over time were assessed at the 3-year follow up. 1592 patients from 11 countries completed at least one QoL questionnaire. The psychometric properties of the questionnaires were assessed on cross-sectional (N = 1486) and longitudinal (N = 1288) data. Item discriminant validity of the QUALIOST® was excellent, as was item convergent validity, with 100% of item-scale correlations being above the 0.40 level. Internal consistency reliability was also extremely good, with high Cronbach's alpha scores above the 0.70 benchmark. Responsiveness results were consistent for all QUALIOST® scores, indicating that greater decreases in QoL corresponded to greater numbers of fractures experienced. QUALIOST® scores also differed according to the type of fracture suffered. This was demonstrated by increased effect sizes for more severe vertebral fractures (clinical vertebral and painful vertebral). In comparing responsiveness, the QUALIOST® scores were generally more consistent than those of the SF-36. Most notably, the QUALIOST® was more responsive with regard to painful vertebral fractures than the SF-36. The QUALIOST® is a reliable and valid tool for measuring QoL in postmenopausal osteoporotic women. Being available in several validated language versions, it is ready to be used in a variety of settings, including international clinical trials.

As impact of literature concerning this subject is scarce, the objectives of this study were to assess whether the Health Related Quality of Life (HRQoL) is decreased in patients with painful temporomandibular disorders as compared to the HRQoL in the general population, and to evaluate to what extent pain duration affects HRQoL. Data concerning physical and mental health were retrieved from patients with painful temporomandibular disorders. Assessment tools used were: the Mandibular Function Impairment Questionnaire (MFIQ), the Short-Form-36 (SF-36), the Hospital Anxiety and Depression Schedule (HADS), and the General Health Questionnaire (GHQ). In order to examine the influence of the duration of pain on HRQoL, the total sample was divided into three different subgroups. Subgroup 1 consisted of patients with complaints existing less than one year. Patients with complaints from 1 to 3 years were allocated to the second group. The 3rd subgroup included patients with complaints longer than 3 years. The total sample consisted of 95 patients (90 females and 5 males). On most physical and social functioning items, groups 2 and 3 scored significantly worse than the general population. On the other hand, none of the groups differed from the general population when comparing the mental items. Duration of pain was significantly correlated with SF-36 subscale physical functioning and the mandibular impairment. Patients with TMD pain less than one year score better than compared to the population norm. With a longer duration of pain, mental health scores and role limitations due to emotional problems do not appear to be seriously affected by reduced physical health, while social functioning appears to be considerably affected.

Patients diagnosed with inflammatory bowel disease (IBD) are required to deal with the unpredictability of this clinical condition, which is associated with poorer health-related quality of life (HRQoL) compared to other clinical conditions. Patient engagement is currently demonstrated to relate with chronic patients’ HRQoL, but few studies have been conducted among this population. A cross-sectional study was conducted among 1176 IBD patients. Data were collected on participants’ HRQoL (SIBD-Q) and patient engagement (PHE-s®). Regression analysis was used to examine the effects of patient engagement on HRQoL. About the half of the sample (47%) reported a low patient engagement level. 30% of the sample reported a low level of HRQoL. Psycho-emotional functioning resulted to be the aspect of HRQoL most impacted in the 37% of the sample. The regression model showed that PHE-s® is significantly related to the SIBD-Q total score (B = .585; p < .001; R squared = .343) and to the subscales’ scores—systemic symptoms (B = .572; p < .001; R squared = .327), bowel symptoms (B = .482; p < .001; R squared = .232), social (B = .485; p < .001; R squared = .234) and psycho-emotional (B = .607; p < .001; R squared = .369) functioning. Patients who are engaged in their IBD care pathway are more likely to report higher level of HRQoL, thus offering clues to potential therapeutic approaches to ameliorating IBD patients’ wellbeing. As this is a modifiable factor, screening for patient  health engagement levels, coupled with appropriate interventions, could improve care, and ultimately improve HRQoL outcomes among IBD patients.

As a precarious clinical condition and a public health problem, heart failure (HF) is associated with a significant burden of morbidity, mortality, and health care costs. As almost all of the published research has been conducted in Western countries, there is a need for culturally relevant studies in Saudi Arabia. This is the first study to investigate health-related quality of life (HRQoL) and its associated factors among Saudi patients with HF in the Qassim region. A cross-sectional study was conducted at the only tertiary care hospital in the Qassim region of Saudi Arabia during the period from November 2020 to July 2021. The participants were interviewed face-to-face by trained interviewers using the standard validated 36-item Short-Form Health Survey (SF-36) questionnaire for HRQoL assessment. The data were analyzed using STATA version 16. The participants included 246 HF patients whose mean (SD) age was 56.7 (10.9) years. A majority of the respondents (80%, n = 197) were male, and 49% (n = 121) had an education level of less than secondary school. The median scores were high for the domains of social functioning (100 points) and bodily pain (75 points) and low for role-physical functioning (25 points). In general, the median scores for the physical and mental component summaries were 58.1 and 63.7, respectively. Patients with an education level less than secondary school were more likely to have a low physical component summary score (aOR 3.00, 95% CI 1.46–6.17), while female patients were more likely to have a low mental component summary score (aOR 2.67, 95% CI 1.38–5.16). Health-related quality of life was found to be moderate among these HF patients. Periodic HRQoL assessment is recommended for HF patients to minimize their physical and psychological concerns, particularly for patients with low education levels and female patients.

The assessment of patient satisfaction during treatment is essential to provide patient-centered high-quality cancer care. Nevertheless, no German instrument assesses patient satisfaction with comprehensive cancer care, which not only includes oncological treatment, but also interpersonal quality of care as well as psychosocial support services. Based on the French REPERES-60, we developed the German Patient Satisfaction with Comprehensive Cancer Care (SCCC) questionnaire. The REPERES-60 was translated and the items were adapted to make it applicable to the German healthcare system and across different tumor entities. Scales of the resulting instrument were extracted via principal axis factoring (PAF). Subsequently, we investigated the reliability (Cronbach’s Alpha, CA), discriminatory power (corrected item-scale correlations) and convergent validity (pre-specified correlations of the SCCC with different outcomes). The SCCC consisted of 32 items which were subsequently tested among a sample of 333 patients across different tumor entities (response rate: 47%). Average age was 59 years (standard deviation: 14), 63% were male. PAF revealed four multi-item scales named Competence, Information, Access and Support accounting for 71% of the variance. Two single-items scales assess global satisfaction with medical and psychosocial care, respectively. CA across the multi-item scales ranged from .84 to .96. Discriminatory power was sufficiently high, with all r ≥ .5. Convergent validity was largely verified by negative associations of the four multi-item scales with depressive/anxious symptomatology (r ≥ − .18, p < .01) and fatigue/overall symptom burden (r ≥ − .14, p < .01). We developed a tool to assess patient satisfaction with comprehensive cancer care in Germany. The SCCC showed satisfactory psychometric properties. Further studies are needed to verify these preliminary findings.