Aspects Of Health-related Quality Of Life Research Articles

Health-Related Quality of Life and Sleep Quality after 12 Months of Treatment in Nonsevere Obstructive Sleep Apnea: A Randomized Clinical Trial with Continuous Positive Airway Pressure and Mandibular Advancement Splints.

In this randomized controlled trial, patients with nonsevere obstructive sleep apnea (OSA) were treated with continuous positive airway pressure (CPAP) or a twin block mandibular advancement splint (MAS). The primary objective was to compare how CPAP and MAS treatments change the health-related quality of life (HRQoL) and self-reported sleep quality of patients after 12 months of treatment. In total, 104 patients were recruited: 55 were allocated to the CPAP treatment group and 49 to the MAS treatment group. We used the SF36 questionnaire to evaluate HRQoL and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. All patients were included in the intention-to-treat analyses. These analyses showed improvements in the SF36 physical component score (from 48.8 ± 7.6 at baseline to 50.5 ± 8.0 at follow-up, p=0.03) in the CPAP treatment group and in the mental component score (from 44.9 ± 12.1 to 49.3 ± 9.2, p=0.009) in the MAS treatment group. The PSQI global score improved in both the CPAP (from 7.7 ± 3.5 to 6.6 ± 2.9, p=0.006) and the MAS (8.0 ± 3.1 to 6.1 ± 2.6, p < 0.001) treatment groups. No difference was found between the treatment groups in any of the SF36 scores or PSQI global score at the final follow-up (p > 0.05) in any analysis. The improvement in the SF36 vitality domain moderately correlated to the improvement in the PSQI global score in both groups (CPAP: |r|=0.47, p < 0.001; MAS: |r|=0.36, p=0.01). In the MAS treatment group, we also found a weak correlation between improvements in the SF36 mental component score and PSQI global score (|r|=0.28, p=0.05). In conclusion, CPAP and MAS treatments lead to similar improvements in the HRQoL and self-reported sleep quality in nonsevere OSA. Improvements in aspects of HRQoL seem to be moderately correlated to the self-reported sleep quality in both CPAP and MAS treatments.

Health-related quality of life and health utility score of patients with gastric cancer: A multi-centre cross-sectional survey in China.

To evaluate the health-related quality of life (HRQoL) and health state utility scores of gastric cancer patients in daily life at different clinical stages after treatment, and to explore influencing factors associated with HRQoL. Gastric cancer patients discharged from hospitals and healthy controls identified by screening were recruited. The three-level EQ-5D was employed to assess HRQoL and was scored using two Chinese-specific tariffs published in 2014 and 2018. A total of 1,399 patients and 2,179 healthy controls were recruited. The likelihood of reporting problems in the five dimensions for patients was 4.0-23.8 times higher than controls. Based on the 2014/2018 tariff, the mean EQ-5D utility score was 0.321/0.163 lower than controls, and the mean utility scores of each patient subgroup were 0.077/0.039 (high-grade intraepithelial neoplasia/carcinoma in situ), 0.254/0.121 (Stage I), 0.249/0.123 (Stage II), 0.353/0.182 (Stage III) and 0.591/0.309 (Stage IV) lower than controls (all statistically significant). Age, occupation, duration of illness, other chronic disease status and therapeutic regimen had a significant impact upon different aspects of HRQoL in patients. Gastric cancer significantly impaired patients' HRQoL in daily life after treatment. More advanced cancer stages were associated with larger decrements on health state utility.

Male-female differences in quality of life and coping style in patients with Marfan syndrome and hereditary thoracic aortic diseases.

Hereditary thoracic aortic diseases (HTAD) such as Marfan syndrome (MFS) affect multiple organ systems and provide a risk of acute aortic dissection, which causes lifelong uncertainties. Although health‐related quality of life (HRQOL) was found to be reduced in HTAD patients, no studies have evaluated male–female‐specific aspects of HRQOL and coping in this population. This study aims to evaluate HRQOL in HTAD patients compared to the general population; assess male–female differences in HRQOL and factors associated with HRQOL; evaluate coping styles in male and female HTAD patients and identify factors associated with acceptance. All consecutive adult patients who visited the specialized HTAD outpatient clinic between 2013 and 2018 were asked to complete three HRQOL questionnaires: the Short Form 36 (SF‐36), the Hospital Anxiety and Depression Scale (HADS), and the Nijmegen Clinical Screening Instrument (NCSI). In total, 142 patients were included (mean age 42.1 years, 65 females, 123 MFS). Compared to the general population, HTAD patients scored significantly lower on multiple SF‐36 sub‐domains (males: General Health 54.5 ± 18.8 vs. 71.6 ± 20.6, p < .001; Vitality 58.3 ± 20.4 vs. 71.9 ± 18.3, p < .001; females: Physical Functioning 67.5 ± 23.8 vs. 80.4 ± 24.2, p = .003; Role Physical 58.3 ± 45.1 vs. 73.8 ± 38.5, p = .047; General Health 49.4 ± 24.3 vs. 69.9 ± 20.6, p < .001; Social Functioning 73.5 ± 22.0 vs. 82.0 ± 23.5, p = .027). Females scored significantly lower than males on the SF‐36 physical component score (41.6 [IQR 35.5–53.1] vs. 49.3 [IQR 42.3–54.6], p = .035). Males scored significantly higher on the coping style denial than females (2.75 [IQR 2.00–3.25] vs. 2.25 [IQR 1.75–3.25], p = .018). High scores on acceptance were found in 38 (26.8%) of HTAD patients, and these patients showed significantly better scores on the NCSI, SF‐36, and HADS, except on NCSI Satisfaction Relationships and SF‐36 Physical Functioning and Mental Health. Acceptance was associated with more medication use (beta blocker use, p = .008; angiotensin receptor blocker use, p = .003) and less hypertension (p = .001). In patients with MFS, employment was strongly associated with better scores on the NCSI. In conclusion, HTAD patients showed subnormal HRQOL, especially females. Interestingly, in both males and females factors such as employment, coping style, and disease acceptance seem more important for HRQOL than disease‐related factors. This highlights the importance of genetic counseling and guidance for HTAD patients, and offers valuable leads for HRQOL improvement.

Patient and clinician opinions of patient reported outcome measures (PROMs) in the management of patients with rare diseases: a qualitative study

BackgroundRare diseases may be life-threatening or chronically debilitating conditions. Patient care needs are often complex and challenging to coordinate and deliver effectively. Rare diseases and their clinical management may therefore substantially impact on patients’ health-related quality of life (HRQOL). The use of patient-reported outcome measures (PROMs) may complement clinical assessments by elucidating patients’ perspectives on their health status and care priorities. This study explored the opinions of patients and clinicians on the use of PROMs in the management of patients with rare diseases in routine clinical practice.MethodsA total of 15 semi-structured one-to-one interviews were conducted with four patients with primary sclerosing cholangitis (PSC); five renal transplant recipients; and six PSC doctors from University Hospitals Birmingham (UHB) NHS Foundation Trust. A focus group session was also conducted with 10 clinical staff members (doctors, nurses and other allied health professionals from UHB). The suitability and acceptability of the Chronic Liver Disease Questionnaire (CLDQ) and the Short Form 12 (SF12) were assessed by patients with PSC and their doctors while the Paediatric quality of life inventory Transplant Module (PedsQL-TM) and the EuroQoL-5 dimensions (EQ. 5D) were evaluated by the renal transplant recipients and their doctors. The discussions were audio recorded and transcribed verbatim. Coding of the transcripts was done using the Nvivo 11 Plus software. Thematic analysis was conducted to identify the main themes and subthemes.ResultsFour themes were identified, namely: (i) potential benefits of PROMs in the management of rare diseases; (ii) views on selected questionnaires; (iii) practical considerations for implementation; and (iv) potential facilitators and barriers of implementation. Patients and clinicians suggested that the use of ePROMs may facilitate patient-centred care by promoting patient-clinician communication, highlighting aspects of HRQOL that are important to patients and encouraging patient involvement in their care. They also felt that the disease-specific CLDQ and PedsQL-TM were more relevant than the generic SF12 and EQ-5D.ConclusionsPatients with rare diseases often experience impaired HRQOL. The use of an ePROM system may enhance the routine management of patients with rare diseases.

Quality of Life and Symptom Burden among Chronic Kidney Disease of Uncertain Etiology (CKDu) Patients in Girandurukotte, Sri Lanka.

Symptom burden and health-related quality of life (HRQOL) are important predictors of how a disease affects patients’ lives, especially for endemic health problems such as chronic kidney disease of uncertain etiology (CKDu). Our study describes symptom burden, HRQOL, and associated demographic and clinical variables in CKDu patients in the Girandurukotte area, Sri Lanka. A cross-sectional study included 120 CKDu patients attending the renal clinic in the endemic area. The instruments applied were the Kidney Disease Quality of Life—Short Form (KDQOL-SFTM) version 1.3 and CKD Symptom Index—Sri Lanka. Socio-demographic, disease-related, and anthropometric variables were also investigated. The mean age of patients was 61.87 (SD 11.31), while 69.2% were male. The mean glomerular filtration rate was 28.17 (SD 14.03) mL/min/1.73 min2, and 70.8% were anemic. Bone/joint pain was the most experienced symptom while the median number of symptoms reported by patients was 5 (IQR 3–7). The mean symptom burden, physical component summary, mental component summary, and kidney-disease-specific component scores were 12.71 (SD 10.45), 68.63 (SD 19.58), 78.53 (SD 18.78), and 81.57 (SD 5.86), respectively. Age was found to be a significant predictor of HRQOL, while hemoglobin level and being a farmer were significant predictors of symptom burden. Our data indicate that CKDu patients in all stages experience at least one symptom affecting all aspects of HRQOL.

Health-Related Quality of Life in Patients after Repair of Esophageal Atresia: A Review of Current Literature.

Patients born with esophageal atresia (EA) require advanced reconstructive surgery and risk long-term digestive and respiratory morbidity. We describe the state of current literature on these patients' health-related quality of life (HRQoL) and give recommendations for future research. A literature search was conducted in PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and PsychINFO and included articles from 2015 to December 28, 2019. Criteria for selecting articles were predefined. Seventeen articles describing HRQoL among children, adolescents, and adults were found, two of which focused on adults only. Six studies included international samples and among 15 quantitative studies sample sizes varied from 17 to 928 (median: 46). Seven different HRQoL questionnaires were used for children, three of which were specially adjusted for EA, of which one was reported validity and reliability. Four questionnaires were used for adults, one of which was generic and three symptom-specific, referring to swallowing or to the gastrointestinal tract. Hence, HRQoL outcomes were described differently. However, several studies of pediatric patients with EA revealed associations between lower HRQoL and particular congenital and surgical characteristics, which reflected disease severity. In two out of three articles, pediatric patients with EA had lower overall scores than healthy children. Digestive symptoms consistently lowered HRQoL scores in children and adults. Prior to 2015, only 12 studies were published, which illustrate a recent expansion in this field. Various HRQoL aspects and heterogeneous samples are examined, and outcomes differently reported. Current literature suggests that clinical subgroups of children with EA present with impaired HRQoL and that digestive symptomology influence HRQoL negatively. Conclusions of studies focusing on adults with EA are difficult to draw. Additional research is required.

Efficacy of fenugreek seed extract on men's psychological and physical health: a randomized placebo-controlled double-blind clinical trial.

Limited research has examined the effects of fenugreek (Trigonella foenum-graecum L.) supplementation to improve healthy younger men's aging male symptoms. The study objective was to examine whether a fenugreek seed extract would improve healthy men's aging male symptoms, health-related quality of life (HRQoL), grip strength, and anxiety. Randomized double-blind placebo-controlled trial was employed, using a parallel design, with assessments at baseline, Day 30, and Day 60. Healthy male volunteers (n=57, mean age=26.1 years) were randomized to: fenugreek 400mg/d (n=19), fenugreek 500mg/d (n=19), or placebo group (n=19). The fenugreek groups reported significant improvements in aging male symptoms, anxiety levels, grip strength, and indicators of HRQoL compared to the placebo group, p's<0.05. No adverse events were reported. Fenugreek supplementation is an effective nutritional intervention for improving aging male symptoms, anxiety levels, grip strength, and aspects of HRQoL in healthy recreationally active men. Future researchers are encouraged to examine the health and ergogenic effects of fenugreek supplementation in hypogonadal and older populations. Clinicaltrials.gov identifier NCT03528538.

Improvements of health-related quality of life 5 years after gastric bypass. What is important besides weight loss? A study from Scandinavian Obesity Surgery Register.

Obesity continues to increase in the world. It is strongly associated with morbidity, mortality, and decrease of health-related quality of life (HRQoL). Surgery is the most effective treatment for obesity, resulting in sustained weight loss and improvements of HRQoL. The aim of this study was to examine whether other factors, apart from weight loss, are associated with improvement in HRQoL scores between the preoperative visit and the 5-year follow-up. To examine whether there are factors besides weight loss that affect the improvement of HRQoL from before to 5 years after gastric bypass surgery. Large, nationwide, observational study with national quality and research registry. Patients operated with a primary gastric bypass in Sweden between January 2008 and December 2012 were identified in the Scandinavian Obesity Surgery Register. Patients with HRQoL data available at both baseline and 5 years after surgery were included. Two HRQoL instruments, the RAND Short form-36 and the obesity-related problems scale, were used in the study. The study sample comprised 6998 patients (21% men). Differences in HRQoL change according to sex were minor. Younger patients showed greater improvements in physical health scales. In general linear regression model analyses, age and weight loss correlated significantly with improvement in HRQoL after 5 years. Patients treated medically for depression preoperatively (13%) experienced less improvement in HRQoL than patients without such treatment. Patients with postoperative complications (26%) had significantly less improvements in all aspects of HRQoL compared with those without any form of postoperative complication. The study confirmed the importance of weight loss for improvement in HRQoL after bariatric surgery. Preoperative medication for depression and suffering a complication during the 5-year follow-up period were associated with less improvement in HRQoL.

Concepts of Health-Related Quality of Life of Australian Aboriginal and Torres Strait Islander Children: Parent Perceptions

Health-related quality of life (HR-QoL) is a valued patient-related outcome measure. HR-QoL is typically measured using a psychometric tool. Although there are a number of general and illness-specific HR-QoL measurement tools available globally, no tool has been validated for Australian Aboriginal and/or Torres Strait Islander children. The purpose of this study was to gather Australian Aboriginal and Torres Strait Islander parent/carer perspectives of HR-QoL in children in order to inform the development of a culturally appropriate tool. Yarning circles and face to face interviews were used to document the experiences of parents and carers of Aboriginal and Torres Strait Islander children who had experienced a chronic illness. Participants were recruited through word of mouth and via established social and professional networks in Queensland and the Northern Territory of Australia. Information collected was transcribed and analysed thematically and placed into a concept map. HR-QoL was defined as more than just physical, social and psychological wellbeing. Family and social support were valued aspects of HR-QoL, as was knowledge, communication and the relationship with the health system. Participants described the importance of being heard; their voice trusted and valued by health practitioners. Racism and prejudicial behaviour had negative impacts on HR-QoL. The concepts of HR-QoL identified in this study are not included in conventional HR-QoL measurement tools. Consideration should be given to concepts proposed by Australian Aboriginal and Torres Strait Islander populations in order to adequately capture perceived HR-QoL.

Exploring health state utility values of parents of children with a serious illness.

In cost-utility analysis, outcomes are usually measured in terms of quality-adjusted life years, where length of life is adjusted by levels of health-related quality of life (HRQoL) using a single value, known as a health state utility value (HSUV). This study explores the HSUVs of parents of children with a serious illness admitted within three hospital departments (cardiology, oncology and paediatric intensive care) across four time points, compares HSUVs with Australian population norms and examines predictors of parental HSUVs. Data were obtained from the Take a Breath study, where parental HSUVs were measured using the Assessment of Quality of Life-8 Dimensions (AQoL-8D). Descriptive statistics and t-tests compared the AQoL-8D scores with population norms, while repeated measures ANOVA was used to compare parental HSUVs of children treated across illness groups over time. Regression analysis was performed to determine predictors of parental HSUVs. Parental HSUVs were not significantly different from the general Australian population norms (p = 0.939), as measured by the AQoL-8D. However, statistically significant differences were observed in the psychosocial super-dimension (p < 0.01) and in all eight AQoL-8D dimensions, except for senses and self-worth. No significant differences were observed across illness groups. Parental HSUVs were associated with psychosocial risk factors of trait anxiety (p < 0.001), depression (p < 0.001) and family beliefs (p = 0.024). Having a child with a severe illness has an impact on the psychosocial aspects of parental HRQoL regardless of the type of illness. Psychosocial health factors of trait anxiety, depression and family beliefs were important predictors of parental HSUV.

A longitudinal analysis of the effect of anemia on health-related quality of life in children with mild-to-moderate chronic kidney disease.

To evaluate impact of anemia on health-related quality of life (HRQOL) over time in a large pediatric cohort with mild-to-moderate chronic kidney disease (CKD). Participants were enrolled in the Chronic Kidney Disease in Children Study (CKiD), a multicenter, longitudinal cohort. HRQOL was measured using the Pediatric Quality of Life Inventory (PedsQL). Anemia was defined as hemoglobin < 5th percentile for age, sex, and race. Two longitudinal analyses were conducted on consecutive visit pairs. Models examined effects of anemia status on both HRQOL score over time and change in HRQOL score between consecutive visits. The sample included 733 children with a median estimated GFR 54ml/min/1.73m2. Thirty percent of children had anemia at index visit. Analysis of HRQOL scores revealed the presence of anemia was associated with significantly lower overall HRQOL (β = - 2.90 (95% CI = - 7.74, - 0.21), p = 0.04) and physical functioning (β = - 5.72 (- 9.49, - 2.25), p = 0.001) according to children. On parent ratings, the development of anemia was associated with lower emotional functioning scores (β = - 4.87 (- 8.72, - 0.11), p = 0.045). In the second model, children who developed anemia were rated by caregivers as having more decreased physical functioning than children who remained anemia-free (β = - 3.30 per year (- 5.83, - 0.76), p = 0.01). Caregivers did not observe declines in their children's other PedsQL subscales in the presence of developed anemia. Children with resolved or persistence did not show improvement or decline in any aspect of HRQOL functioning relative to non-anemic subjects. In children with CKD, anemia has an adverse effect on HRQOL which persists over time but does not appear to be progressive.

Health-related quality of life in porphyria cutanea tarda: a cross-sectional registry based study

BackgroundPorphyria cutanea tarda (PCT) is a rare, photosensitive disease characterized by skin fragility and blistering on sun-exposed areas. There is little previous research on how this condition affects health-related quality of life (HRQoL) and to the best of our knowledge this is the largest sample of PCT patients surveyed about their HRQoL. The aims of this study were to describe HRQoL, symptoms, susceptibility factors, disease activity and treatment in patients with PCT, and investigate the associations between these factors.MethodsThis is a cross-sectional, retrospective study based on patient-reported outcome and laboratory data. The Norwegian Porphyria Centre diagnoses all patients with PCT in Norway, all of whom are invited to participate in the Norwegian Porphyria Registry. Between December 2013–2015, 111 patients received a postal questionnaire and invitation to participate.ResultsSixty-eight persons responded, with seven being excluded due to prolonged response time or missing information, resulting in 61 participants in the final analyses (55%). Median age was 60 years and 33 were female. We found a moderate negative relationship between the type and localisation of PCT symptoms and both mental (r = −.354 p < 0.01) and physical (r = −.441, p < 0.01) aspects of HRQoL. Participants who had started treatment when answering the questionnaire reported significantly better physical functioning and less bodily pain than those who had not started treatment. We did not observe an association between biochemical markers of disease activity and symptoms or HRQoL. Itching, a symptom that has received little attention in PCT was reported by 59% of the participants.ConclusionsOur results show that reduced HRQoL is associated with more symptoms and not having started treatment. PCT is a rare disease, and there is a need for the development of best-practice guidelines to facilitate good patient care.

Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial

BIG 3-07/TROG 07.01 is an international, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofractionation in patients with non-low-risk ductal carcinoma in situ following breast-conserving surgery and whole breast radiotherapy. Here, we report the effects of diagnosis and treatment on health-related quality of life (HRQOL) at 2 years. The BIG 3-07/TROG 07.01 trial is ongoing at 118 hospitals in 11 countries. Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ were randomly assigned, by use of a minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy using one of three randomisation categories. Category A was a 4-arm randomisation of tumour bed boost versus no boost following conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy (42·5 Gy in 16 fractions over 3·5 weeks). Category B was a 2-arm randomisation between tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy. Stratification factors were age at diagnosis, planned endocrine therapy, and treating centre. The primary endpoint, time to local recurrence, will be reported when participants have completed 5 years of follow-up. The HRQOL statistical analysis plan prespecified eight aspects of HRQOL, assessed by four questionnaires at baseline, end of treatment, and at 6, 12, and 24 months after radiotherapy: fatigue and physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question). For each of these measures, tumour bed boost was compared with no boost, and conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy, by use of generalised estimating equation models. Analyses were by intention to treat, with Hochberg adjustment for multiple testing. This trial is registered with ClinicalTrials.gov, NCT00470236. Between June 1, 2007, and Aug 14, 2013, 1208 women were enrolled and randomly assigned to receive no tumour bed boost (n=605) or tumour bed boost (n=603). 396 of 1208 women were assigned to category A: conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost (n=100). 447 were assigned to category B: conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost (n=224). 365 were assigned to category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost (n=183). All patients were followed up at 2 years for the HRQOL analysis. 1098 (91%) of 1208 patients received their allocated treatment, and most completed their scheduled HRQOL assessments (1147 [95%] of 1208 at baseline; 988 [87%] of 1141 at 2 years). Cosmetic status was worse with tumour bed boost than with no boost across all timepoints (difference 0·10 [95% CI 0·05-0·15], global p=0·00014, Hochberg-adjusted p=0·0016); at the end of treatment, the estimated difference between tumour bed boost and no boost was 0·13 (95% CI 0·06-0·20; p=0·00021), persisting at 24 months (0·13 [0·06-0·20]; p=0·00021). Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08 [95% CI 0·03-0·13], global p=0·0033, Hochberg adjusted p=0·045); the difference between tumour bed boost and no boost at the end of treatment was 0·08 (0·01 to 0·15, p=0·021), and did not persist at 24 months (0·04 [-0·03 to 0·11], p=0·29). None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. Conventional whole breast radiotherapy was associated with worse body image than hypofractionated whole breast radiotherapy at the end of treatment (difference -1·10 [95% CI -1·79 to -0·42], p=0·0016). No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy. Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending. National Health and Medical Research Council, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society.

The Influence of Comorbidity on Health-Related Quality of Life After Esophageal Cancer Surgery

BackgroundEsophageal cancer surgery reduces patients’ health-related quality of life (HRQoL). This study examined whether comorbidities influence HRQoL in these patients.MethodsThis prospective cohort study included esophageal cancer patients having undergone curatively intended esophagectomy at St Thomas’ Hospital London in 2011–2015. Clinical data were collected from patient reports and medical records. Well-validated cancer-specific and esophageal cancer-specific questionnaires (EORTC QLQ-C30 and QLQ-OG25) were used to assess HRQoL before and 6 months after esophagectomy. Number of comorbidities, American Society of Anesthesiologists physical status classification (ASA), and specific comorbidities were analyzed in relation to HRQoL aspects using multivariable linear regression models. Mean score differences with 95% confidence intervals were adjusted for potential confounders.ResultsAmong 136 patients, those with three or more comorbidities at the time of surgery had poorer global quality of life and physical function and more fatigue compared with those with no comorbidity. Patients with ASA III–IV reported more problems with the above HRQoL aspects and worse social function and pain compared with those with ASA I–II. Cardiac comorbidity was associated with worse global quality of life and dyspnea, while pulmonary comorbidities were related to coughing. Patients assessed both before and 6 months after surgery (n = 80) deteriorated in most HRQoL aspects regardless of comorbidity status, but patients with several comorbidities had worse physical function and fatigue and more trouble with coughing compared with those with fewer comorbidities.ConclusionComorbidity appears to negatively influence HRQoL before esophagectomy, but appears not to severely impact 6-month recovery of HRQoL.

What contributes to quality of life in Parkinson’s disease: a re-evaluation

Twenty years ago, we published a paper examining which of the clinical features of Parkinson’s disease (PD) were most closely associated with patients’ self-reported health-related quality of life (HR-QoL).1 In...

A value-based healthcare approach: Health-related quality of life and psychosocial functioning in women with Turner syndrome.

ObjectiveAs part of the value‐based healthcare programme in our hospital, a set of patient‐reported outcome measures was developed together with patients and implemented in the dedicated Turner Syndrome (TS) outpatient clinic. This study aims to investigate different aspects of health‐related quality of life (HR‐QoL) and psychosocial functioning in women with TS in order to establish new possible targets for therapy.Design/ParticipantsA comprehensive set of questionnaires (EQ‐5D, PSS‐10, CIS‐20, Ferti‐QoL, FSFI) was developed and used to capture different aspects of HR‐QoL and psychosocial functioning in a large cohort of adult women with Turner syndrome. All consecutive women, ≥18 years, who visited the outpatient clinic of our tertiary centre were eligible for inclusion.ResultsOf the eligible 201 women who were invited to participate, 177 women (age 34 ± 12 years, mean ± SD) completed at least one of the validated questionnaires (88%). Women with TS reported a lower health‐related quality of life (EQ‐5D: 0.857 vs 0.892, P = .003), perceived more stress (PSS‐10:14.7 vs 13.3; P = .012) and experienced increased fatigue (CIS‐20: P < .001) compared to the general Dutch population. A relationship between noncardiac comorbidities (eg diabetes, orthopaedic complaints) and HR‐QoL was found (R = .508).ConclusionsWe showed that TS women suffer from impaired HR‐QoL, more perceived stress and increased fatigue compared to healthy controls. A relationship between noncardiac comorbidities and HR‐QoL was found. Especially perceived stress and increased fatigue can be considered targets for improvement of HR‐QoL in TS women.

Development and preliminary validation of the Adolescent Psoriasis Quality of Life instrument: a disease-specific measure of quality of life in adolescents with psoriasis.

SummaryBackgroundNo age‐appropriate and disease‐specific instrument currently exists to measure health‐related quality of life in adolescents with psoriasis (patients aged 12–17 years).ObjectivesTo develop and provide preliminary validation of the Adolescent Psoriasis Quality of Life instrument.MethodsQualitative interviews with adolescents with psoriasis, parents of adolescents with psoriasis, and healthcare professionals informed the development of an initial item pool for the instrument, which was subsequently refined through cognitive interviews. Finally, data from an independent sample of adolescents with psoriasis (n = 50) were used for item reduction, scale construction and initial validation, using a combination of techniques from classical test theory and Rasch modelling.ResultsRich qualitative data concerning health‐related quality of life in adolescents with psoriasis (from 18 adolescents, 14 parents and four healthcare professionals), combined with cognitive interview testing (n = 12), resulted in a 41‐item draft version. Item reduction led to the final version, a 17‐item instrument consisting of two subscales showing good fit to their respective Rasch models: psychosocial impact (12 items) and the impact of physical symptoms and treatment (five items). All a priori stated hypotheses regarding construct validity were supported. Both subscales and the total scale showed acceptable test–retest reliabilities (intraclass correlations 0·97, 0·89 and 0·96) and internal consistencies (Cronbach's α 0·94, 0·81 and 0·95).ConclusionsThe preliminary form of the Adolescent Psoriasis Quality of Life instrument shows promising psychometric properties. It can be used in daily clinical practice and research to support a patient‐centred approach and inform treatment planning. What's already known about this topic? Health‐related quality of life (HRQoL) instruments should be targeted towards narrowly defined age groups, as life contexts of children, adolescents and adults may differ substantially.Dermatology‐specific instruments have been used to measure HRQoL in adolescents with psoriasis, but it is not known whether these instruments accurately capture all relevant HRQoL aspects in adolescent psoriasis.Age‐appropriate and psoriasis‐specific instruments may be more sensitive for HRQoL issues experienced by this unique group. What does this study add? The Adolescent Psoriasis Quality of Life instrument represents the first age‐appropriate and disease‐specific instrument for measuring HRQoL in adolescents (12–17 years old) with psoriasis.It is intended for use in daily clinical practice to support dermatologists and other healthcare professionals in providing optimal care for adolescents with psoriasis.

Item generation for a proxy health related quality of life measure in very young children

Background and aimsVery young children have a relatively high prevalence of morbidity and mortality. Health care and supportive technology has improved but may require difficult choices and decisions regarding the allocation of these resources in this age group. Cost-effective analysis (CEA) can inform these decisions and thus measurement of Health-Related Quality of Life (HRQoL) is becoming increasingly important. However, the components of HRQoL are likely to be specific to infants and young children. This study aimed to develop a bank of items to inform the possible development of a new proxy report instrument.MethodsA review of the literature was done to define the concepts, generate items and identify measures that might be an appropriate starting point of reference. The items generated from the cognitive interviews and systematic review were subsequently pruned by experts in the field of HRQoL and paediatrics over two rounds of a Delphi study.ResultsBased on the input from the different sources, the greatest need for a new HRQoL measure was in the 0–3-year age group. The item pool identified from the literature consisted of 36 items which was increased to 53 items after the cognitive interviews. The ranking of items from the first round of the Delphi study pruned this pool to 28 items for consideration. The experts further reduced this pool to 15 items for consideration in the second round. The experts also recommended that items could be merged due to their similar nature or construct. This process allowed for further reduction of items to 11 items which showed content validity and no redundancy.ConclusionThe need for an instrument to measure appropriate aspects of HRQoL in infants and young children became apparent as items included in existing measures did not cover the required spectrum. The identification of the final items was based on a sound conceptual model, acceptability to stakeholders and consideration of the observability of the item selected. The pruned item bank of 11 items needs to be subject to further testing with the target population to ensure validity and reliability before a new measure can be developed.

Relationship Between Pain Reduction and Improvement in Health-Related Quality of Life in Patients with Knee Pain Due to Osteoarthritis Receiving Duloxetine: Exploratory Post Hoc Analysis of a Japanese Phase 3 Randomized Study.

PurposeThis post hoc analysis of a Japanese phase 3 randomized study (ClinicalTrials.gov identifier: NCT02248480) investigated relationships between changes in pain severity and changes in health-related quality of life (HRQoL) in duloxetine-treated patients with knee osteoarthritis (OA).Patients and MethodsPatients with knee OA and Brief Pain Inventory (BPI) average pain score ≥4 received duloxetine 60 mg/day or placebo for 14 weeks. Spearman rank correlation coefficients were calculated for change in pain severity, as assessed by the BPI, and change in HRQoL, as assessed by the items of the (i) 36-item Short-Form Health Survey (SF-36; a generic measure of HRQoL) and (ii) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; an OA-specific measure of HRQoL).ResultsAfter 14 weeks of treatment, there was a significantly greater improvement (p<0.001) for duloxetine (n=177) vs placebo (n=176) in BPI average pain severity score and significantly greater improvements (p<0.01) for duloxetine vs placebo for 5 of the 8 SF-36 domains (including the Role-Physical, Bodily Pain, and Physical Functioning domains) and all 24 individual WOMAC items. The correlation between BPI change from baseline and SF-36 item change from baseline was statistically significant (p<0.05) for 2 of the 8 SF-36 items (Bodily Pain, Physical Functioning) in duloxetine-treated patients. The correlation between BPI change from baseline and WOMAC item change from baseline was statistically significant for 22 of the 24 WOMAC items in duloxetine-treated patients.ConclusionThis post hoc analysis suggested that the pain reduction observed in duloxetine-treated patients with knee OA was associated with improvements in OA-specific aspects of HRQoL, ie, pain and physical functioning.

Higher sensitivity for traumatic cerebral microbleeds at 7 T ultra-high field MRI: is it clinically significant for the acute state of the patients and later quality of life?

Background:The present study evaluates the possible prognostic benefits of 7 T susceptibility weighted imaging (SWI) of traumatic cerebral microbleeds (TMBs) over 3 T SWI to predict the acute clinical state and subjective impairments, including health-related quality of life (HRQOL), after closed head injury (CHI).Methods:The study group comprised 10 participants with known TMBs All subjects underwent 3 T magnetic resonance imaging (MRI) and 7 T MRI, respectively. Location and count of TMBs were independently evaluated by two neuroradiologists. The initial Glasgow Coma Scale (GCS), the duration of coma and further clinical data were taken from the patients records. HRQOL was assessed by means of a questionnaire. Memory complaints and neurological symptoms were inquired at the time of the MRI examinations.Results:SWI revealed a total of 485 TMBs at 3 T, 584 TMBs at 7 T with similar spatial resolution, and 684 TMBs at 7 T with a factor of 10 higher spatial resolution. The TMBs depicted by 7 T high-resolution SWI were correlated with the duration of coma (Spearman’s rho of 0.77). The corresponding association with TMBs in 3 T MRI SWI showed a Spearman’s rho of 0.71. The initial GCS score and TMBs correlated with a Spearman’s rho of −0.35 at 3 T SWI MRI and a rho of −0.33 at 7 T high-resolution SWI, respectively. The physical aspect of HRQOL correlated substantially with the count of TMBs (rho = 0.44 for 3 T SWI and rho = 0.35 for both 7 T SWI sequences, respectively).Conclusions:The number of TMBs showed a substantial association with indicators of the acute clinical state and chronic neurobehavioral parameters after CHI, but there was no additional advantage of 7 T MRI. These preliminary findings warrant a larger prospective study for the future.