Health-related Quality Of Life Data Collection Research Articles

Health-related quality of life in men with oligometastatic prostate cancer following metastases-directed stereotactic body radiotherapy: Real-world data from the E2-RADIatE OligoCare cohort

ObjectiveTo evaluate the impact of metastases-directed stereotactic body radiotherapy (SBRT) on health-related quality of life (HRQoL) in men with oligometastatic prostate cancer (PCa) using real-world data from the OligoCare cohort. Materials and methodsOligoCare is a pragmatic, observational cohort designed to assess the impact of metastases-directed SBRT on patients with oligometastatic disease (OMD). We report an interim analyses of the secondary endpoint HRQoL, assessed using the EORTC QLQ-C30, within six months of metastases-directed SBRT for oligometastatic disease in men with PCa among the first 1600 registered patients. HRQoL data collection was optional within the OligoCare cohort. To compare HRQoL between baseline and first follow-up assessment, a Wilcoxon signed-rank test was used. A multiple linear regression model was used to explore the HRQoL associations with predefined factors. ResultsOut of the 1600 registered patients, 658 were treated for oligometastatic PCa, of which 233 had baseline QoL data and 132 patients had both baseline and follow-up HRQoL data. At baseline, most patients had a WHO performance status of 0 or 1 (87 %), were de-novo oligometastatic (79 %), had one metastasis (90 %), and had a good overall global health status (mean 80.81, SD16.11, IQR 75–92). 51 % received hormonal therapy as concomitant systemic treatment. Patients with comorbidities as assessed by the Charlson Comorbidity index had a worse global health status at baseline (-4.88, 95 % CI:-9.35, −0.42). No clinically meaningful significant difference in global health status was observed at first assessment following SBRT (median 3.0 months) compared with baseline (mean difference 2.27, 95 % CI:-1.54, 6.08). Upon evaluating the proportions, meaningful clinically important differences (a 10-point or more difference) was observed in, 17 % and 11 % of the patients reporting deterioration and improvement of global health status, respectively. ConclusionMetastases-directed stereotactic body radiotherapy had no negative impact on global HRQoL within the first six months after treatment.

Feasibility of Symptom monitoring WIth Feedback Trial (SWIFT) for adults on hemodialysis: a registry-based cluster randomized pilot trial

BackgroundPatients with kidney failure on hemodialysis (HD) experience considerable symptom burden and poor health-related quality of life (HRQoL). There is limited use of patient reported outcome measures (PROMs) in facility HD units to direct immediate care, with response rates in other studies between 36 to 70%. The aim of this pilot study was to evaluate feasibility of electronic PROMs (e-PROMs) in HD participants, with feedback 3-monthly to the participants’ treating team, for severe or worsening symptoms as identified by the Integrated Palliative Outcome Scale (IPOS-Renal), with linkage to the Australian and New Zealand Dialysis and Transplant (ANZDATA) registry, compared with usual care.MethodsThis is a registry-based cluster-randomized controlled pilot trial involving all adults receiving HD in 4 satellite units in Australia over a 6-month period. HD units were cluster randomized 1:1 to the control (HRQoL data collection only) or intervention arm (symptom monitoring with feedback to treating team every 3 months). Feasibility was assessed by participant response rate (percentage of eligible HD participants, including new incident participants, who completed the questionnaire at each time point); retention rate (percentage of participants who completed the baseline questionnaire and all subsequent measures); and completion time. HRQoL and symptom burden scores are described.ResultsThere were 226 unique participants who completed the e-PROMs (mean age 62 years, 69% males, 78% White-European, median dialysis vintage 1.62 years). At 6 months, response rate and retention rate for the intervention arm were 54% and 68%, respectively, and 89% and 97% in the control arm. Median time to complete IPOS-Renal was 6.6 min (5.3, 10.1) at 3 months, and when combined with the outcome measure (EQ-5D-5L), the median time was 9.4 min (6.9, 13.6) at 6 months.ConclusionsElectronic symptom monitoring among HD participants with feedback to clinicians is feasible. Variations in response and retention rates could be potentially explained by the lengthier questionnaire, and higher frequency of data collection time points for participants in the intervention arm. A definitive national RCT is underway.Trial registrationACTRN12618001976279 (07/12/2018).

"not one size fits all” The challenges of measuring paediatric health-related quality of life and the potential role of digital ecological momentary assessment: a qualitative study

PurposeTo explore the views of clinicians and researchers about the challenges of measuring health-related quality of life (HRQoL) in children (5–11 years) and to explore whether digital ecological momentary assessment (EMA) could enhance HRQoL measurement.MethodsSemi-structured qualitative interviews with 18 professionals (10 academics/researchers, four clinicians, four with both professional backgrounds) experienced in child HRQoL measurement. We analysed data thematically.ResultsTheme One describes the uncertainty around conceptualising HRQoL for children and which domains to include; the greater immediacy and sensitivity of children’s reflections on their HRQoL, leading to high variability of the construct; and the wide individual differences across childhood, incongruent with fixed HRQoL measures. Theme Two describes the challenges of proxy reporting, questioning whether proxies can meaningfully report a child’s HRQoL and reflecting on discrepancies between child and proxy reporting. Theme Three covers the challenge of interpreting change in HRQoL over time; does a change in HRQoL reflect a change in health, or does this reflect developmental changes in how children report HRQoL. Theme Four discusses digital EMA for HRQoL data capture. In-the-moment, repeated measurement could provide rich data and address challenges of recall, ecological validity and variability; passive data could provide objective markers to supplement subjective responses; and technology could enable personalisation and child-centred design. However, participants also raised methodological, practical and ethical challenges of digital approaches.ConclusionDigital EMA may address some of the challenges of HRQoL data collection with children. We conclude by discussing potential future research to explore and develop this approach.

Health-related quality of life in adolescents and young adults with cancer who received radiation therapy: a scoping review.

Radiation therapy (RT) is a critical component of treatment for adolescents and young adults (AYAs, age 15-39 years old) diagnosed with cancer. Limited prior studies have focused on AYAs receiving RT despite the potentially burdensome effects of RT. We reviewed the literature to assess health-related quality of life (HRQOL) in AYAs with cancer who received RT. The MEDLINE, EMBASE, and Web of Science databases were searched in January 2022 to identify studies that analyzed HRQOL measured by patient-reported outcomes in AYAs who received RT. After title (n = 286) and abstract (n = 58) screening and full-text review (n = 19), articles that met eligibility criteria were analyzed. Six studies were analyzed. Two studies included AYAs actively receiving treatment and all included patients in survivorship; time between diagnosis and HRQOL data collection ranged from 3 to > 20 years. Physical and mental health were commonly assessed (6/6 studies) with social health assessed in three studies. AYA-relevant HRQOL needs were rarely assessed: fertility (1/6 studies), financial hardship (1/6), body image (0/6), spirituality (0/6), and sexual health (0/6). No study compared HRQOL between patients actively receiving RT and those post-treatment. None of the studies collected HRQOL data longitudinally. HRQOL data in AYAs receiving RT is limited. Future studies examining longitudinal, clinician- vs. patient-reported, and AYA-relevant HRQOL are needed to better understand the unique needs in this population.

The impact of spontaneous intracranial hypotension on social life and health-related quality of life

ObjectiveSpontaneous intracranial hypotension (SIH), which is often caused by a spinal cerebrospinal fluid leak, is an important cause of disabling headaches. Many patients report devastating changes in their quality of life because of their symptoms. This study aimed to evaluate the impact of SIH on patients’ social/ working life and health-related quality of life (HRQoL).MethodsWe included consecutive patients with proven SIH treated at our institution from January 2013 to May 2020. Patients were contacted and asked to complete the 15D questionnaire for the collection of HRQoL data and to provide additional information on their social life status.ResultsOf 112 patients, 79 (70.5%) returned the questionnaire and were included in the analysis. Of those, 69 were treated surgically (87.3%), and 10 were managed non-operatively (12.7%). Twenty-five (31.6%) patients reported a severe impact on their partnership, 32 (41.5%) reported a moderate or severe impact on their social life. Forty (54.8%) patients reported sick leave for more than 3 months. The mean 15D score was 0.890 (± 0.114) and significantly impaired compared to an age- and sex-matched general population (p = 0.001), despite treatment. Patients with residual SIH-symptoms (36, 45.6%) had significantly impaired HRQoL compared to those without any residual symptoms (41, 51.9%) (p < 0.001).ConclusionSIH had a notable impact on the patients’ social life and HRQoL. It caused long periods of incapacity for work, and is therefore, associated with high economic costs. Although all patients were appropriately treated, reduced HRQoL persisted after treatment, underlining the chronic character of this disease.

Impact on Health-Related Quality of Life of Video-Assisted Thoracoscopic Surgery for Lung Cancer

BackgroundVideo-assisted thoracoscopic surgery (VATS) approaches are increasingly used in lung cancer surgery, but little is known about their impact on patients’ health-related quality of life (HRQL). This prospective study measured recovery and HRQL in the year after VATS for non-small cell lung cancer (NSCLC) and explored the feasibility of HRQL data collection in patients undergoing VATS or open lung resection.Patients and MethodsConsecutive patients referred for surgical assessment (VATS or open surgery) for proven/suspected NSCLC completed HRQL and fatigue assessments before and 1, 3, 6 and 12 months post-surgery. Mean HRQL scores were calculated for patients who underwent VATS (segmental, wedge or lobectomy resection). Paired t-tests compared mean HRQL between baseline and expected worst (1 month), early (3 months) and longer-term (12 months) recovery time points.ResultsA total of 92 patients received VATS, and 18 open surgery. Questionnaire response rates were high (pre-surgery 96–100%; follow-up 67–85%). Pre-surgery, VATS patients reported mostly high (good) functional health scores [(European Organisation for Research and Treatment of Cancer) EORTC function scores > 80] and low (mild) symptom scores (EORTC symptom scores < 20). One-month post-surgery, patients reported clinically and statistically significant deterioration in overall health and physical, role and social function (19–36 points), and increased fatigue, pain, dyspnoea, appetite loss and constipation [EORTC 12–26; multidimensional fatigue inventory (MFI-20) 3–5]. HRQL had not fully recovered 12 months post-surgery, with reduced physical, role and social function (10–14) and persistent fatigue and dyspnoea (EORTC 12–22; MFI-20 2.7–3.2).ConclusionsLung resection has a considerable detrimental impact on patients’ HRQL that is not fully resolved 12 months post-surgery, despite a VATS approach.Graphic

PCN481 METHODOLOGICAL ASPECTS OF HEALTH-RELATED QUALITY OF LIFE MEASUREMENT IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER IN CLINICAL TRIALS: A SYSTEMATIC REVIEW.

HER2-positive breast cancer is characterized by the overexpression of human epidermal growth factor receptor 2 (HER2) and is associated with poor prognosis. While there is no cure for HER2-positive metastatic breast cancer (MBC), survival outcomes have improved over the last decade due to the availability of novel agents. Health-related quality of life (HRQoL) data is becoming increasingly important to understand the long-term treatment impact on patients’ well-being. This systematic review aimed to identify the methodological aspects of HRQoL measurement among HER2+ MBC patients and critically appraise their strengths and weaknesses. A comprehensive search was conducted using PubMed, Embase, and Cochrane from database initiations to March 30, 2019, to identify publications of HER2+ MBC clinical trials that have reported HRQoL data in the English language. Following the PRISMA guideline, we screened 1566 articles and identified 14 studies that met our inclusion and exclusion criteria. Seven HRQoL instruments (EORTC QLQ-C30, FACT-G, FACT-B, FACT-B TOI, EORTC QLQ-BR23, FACT-Br, and EORTC QLQ-BN20) were identified, among which FACT-Br and EORTC QLQ-BN20 were used in breast cancer with brain metastasis. Five out of the fourteen studies used more than one instrument. Across the seven instruments, EORTC QLQ-C30 (9/14 studies) was most frequently used. All publications reported HRQoL as secondary endpoints. The literature demonstrates the complementary value of HRQoL when assessing clinical effectiveness and safety outcomes. However, significant diversity in the applied HRQoL instruments, the HRQoL assessment strategies, the timing of HRQoL data collection, and the data analysis methods was noted. Notably, non-response(NR) rates to HRQoL questionnaire as high as 26-38% were observed, but the impact of NR was not discussed in most of the studies. The development of standardized best practice guidelines in breast cancer HRQoL data collection and analysis is recommended to improve data quality to assist evidence-based clinical decision making.

Micronutrient deficiencies and health-related quality of life: the case of children with vitamin D deficiency.

To explore the extent to which micronutrient deficiencies (MND) affect children's health-related quality of life (HRQoL), using vitamin D deficiency (VDD) as a case study. Proxy valuation study to estimate the impact of VDD on the HRQoL of younger (0-4 years) and older (>4 years) children. We used the Child Health Utility 9 Dimension (CHU9D) questionnaire to estimate HRQoL for children within six VDD-related health states: 'hypocalcaemic cardiomyopathy', 'hypocalcaemic seizures', 'active rickets', 'bone deformities', 'pain and muscle weakness' and 'subclinical VDD'. Sampling was not restricted to any particular setting and worldwide experts were recruited. Respondents were paediatric bone experts recruited through network sampling. Thirty-eight experts completed the survey. The health state with the largest detrimental impact (mean score (se)) on children's HRQoL was hypocalcaemic cardiomyopathy (0·47 (0·02)), followed by hypocalcaemic seizures (0·50 (0·02)) and active rickets (0·62 (0·02) in young children; 0·57 (0·02) in older children). Asymptomatic VDD had a modest but noticeable negative impact on HRQoL, attributed mostly to tiredness in both age groups and pain in the older paediatric population. Elicitation of HRQoL from clinical experts suggests a negative impact of VDD on HRQoL, even if there is no recognizable clinical manifestation. HRQoL data from populations of patients with MND will inform public health policy decisions. In some settings, routine collection of HRQoL data alongside national nutrition surveys may help capture the full burden of MND and prioritize resources towards effective prevention.

Methodological aspects of health-related quality of life measurement and analysis in patients with multiple myeloma.

Multiple myeloma (MM) is an incurable but treatment-sensitive cancer. For most patients, this means treatment with multiple lines of anti-myeloma therapy and a life with disease- and treatment-related symptoms and complications. Health-related quality of life (HRQoL) issues play an important role in treatment decision-making. Methodological challenges in longitudinal HRQoL measurements and analyses have been identified, including non-responses (NR) to scheduled questionnaires. Publications were identified for inclusion in a systematic review of longitudinal HRQoL studies in MM, focussing on methodological aspects of HRQoL measurement and analysis. Diversity in timing of HRQoL data collection and applied statistical methods were noted. We observed a high rate of NR, but the impact of NR was investigated in only 8/23 studies. Thus, evidence-based knowledge of HRQoL in patients with MM is compromised. To improve quality of HRQoL results and their implementation in daily practice, future studies should follow established guidelines.

Inclusion of health-related quality-of-life data in oncology drug reimbursement submissions in Canada: A review of submissions to the pan-Canadian Oncology Drug Review.

94 Background: For health technologies, and cancer treatments specifically, economic evaluation is often used to assess the value of new treatments. The preferred approach to economic evaluation is often cost-utility analysis (CUA). In CUA, incremental costs and benefits of a new treatment and a standard of care are calculated with benefits quantified using the quality-adjusted life-year (QALY); the QALY attempts to account for the quantity and quality of life (using a utility weight). The utility weight often comes from a generic, preference-based measure of health-related quality of life (HRQoL), such as the 5-dimension EuroQol measure (EQ-5D). Many submissions for reimbursement by manufacturers, and indeed many clinical trials, still do not include HRQoL data which may result in lower quality submissions and thus, sub-optimal decisions. Methods: We reviewed submissions to the pan-Canadian Oncology Drug Review (pCODR), the body charged with making reimbursement recommendations in Canada. We reviewed submissions from those first recorded (August 2012) to the present (June 2018). Only submissions that were completed (status listed as 'Notification to Implement Issued') were included. Upon completion, three documents are produced by pCODR: the final recommendation from the pCODR Expert Review Committee, the final clinical guidance report, and the final economic guidance report. All three documents were searched for how HRQoL was incorporated into the economic evaluation. Results: In total, 135 submissions were made to pCODR over the period. Of these, 107 (79.3%) had been completed and met the criteria for inclusion. In most studies, the incremental gain in QALYs from the new technology was small (in 2017 submissions the mean QALY gain was 1.1 QALYs). In addition, few studies reported an original measure of HRQoL, with most citing previously completed studies of variable relevance and quality. Conclusions: Our results indicate that manufacturers should improve the collection of HRQoL data of patients alongside clinical trials. This would enhance the focus on patients and improve decision-making around reimbursement of treatments.

Systematic literature review of health-related quality of life in locally-advanced non-small cell lung cancer: Has it yet become state-of-the-art?

Lung cancer and its treatment have an important impact on the patients' health-related quality-of-life (HRQoL). A systematic literature review of prospective clinical studies published since 2005 and measuring HRQoL in patients with locally-advanced non-small cell lung cancer (LA- NSCLC) was performed. Besides reviewing the HRQoL impact of LA-NSCLC treatment, it critically examined the frequency, methodology and quality of HRQoL data collection and analysis in LA-NSCLC clinical studies. Out of 814 potentially eligible publications, only 27 (representing 19 individual studies) met the inclusion criteria. Eight studies documented an impact on HRQoL. Large variability in use of HRQoL instruments, statistical analysis and methodological quality was observed. Reporting of HRQoL data lacks standardization, but recent initiatives establishing recommendations to standardize the analysis and reporting of HRQoL in cancer trials are expected to address these issues. Overall, more research is needed to evaluate the treatment impact on HRQoL in both clinical trials and daily care.

Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life Using a Smartphone Application

Health-Related Quality of Life (HRQoL) is a construct of increasing importance in modern healthcare, and has typically been assessed using retrospective instruments. While such measures have been shown to have predictive utility for clinical outcomes, several cognitive biases associated with human recall and current mood state may undermine their validity and reliability. Retrospective tools can be further criticized for their lack of ecology, as individuals are usually assessed in less natural settings such as hospitals and health centers, and may be obliged to spend time and money traveling to receive assessment. Ecological momentary assessment (EMA) is an alternative, as mobile assessment using mobile health (mHealth) technology has the potential to minimize biases and overcome many of these limitations. Employing an EMA methodology, we will use a smartphone application to collect data on real-time HRQoL, with an adapted version of the widely used WHOQOL-BREF questionnaire. We aim to recruit a total of 450 healthy participants. Participants will be prompted by the application to report their real-time HRQoL over 2 weeks together with information on mood and current activities. At the end of 2 weeks, they will complete a retrospective assessment of their HRQoL and they will provide information about their sleep quality and perceived stress. The psychometric properties of real-time HRQoL will be assessed, including analysis of the factorial structure, reliability and validity of the measure, and compared with retrospective HRQoL responses for the same 2-week testing period. Further, we aim to identify factors associated with real-time HRQoL (e.g., mood, activities), the feasibility of the application, and within- and between-person variability in real-time HRQoL. We expect real-time HRQoL to have adequate validity and reliability, and positive responses on the feasibility of using a smartphone application for routine HRQoL assessment. The direct comparison of real-time and retrospective measures in this study will provide important novel insight into the efficacy of mHealth applications for HRQoL assessment. If shown to be valid, reliable and feasible for the collection of HRQoL data, mHealth applications may have future potential for facilitating clinical assessment, patient-physician communication, and monitoring individual HRQoL over course of treatment.

Variation of Quality of Life Data Collection Across INTERMACS Sites

BackgroundGiven the importance of patients' health-related quality of life (HRQL) after mechanical circulatory support (MCS) device implantation, the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) collects the Kansas City Cardiomyopathy Questionnaire (KCCQ) before and after MCS. The success of data collection and potential implications of missing data on HRQL analyses are unknown. MethodsWe examined the frequency and reasons for not collecting baseline and 3-month KCCQ data across INTERMACS sites from May 2012 to December 2013. Hierarchical logistic regression was used to examine site variability (median odds ratios [MOR]) for not collecting KCCQ data to demonstrate the degree to which some sites can collect more complete data than others. ResultsAmong 3960 and 3523 patients participating in INTERMACS before and 3 months after left ventricular assist device implantation, the KCCQ was not collected in 43.1% at baseline (range across sites, 0–100%) and 40.9% (range, 0–100%) at follow-up. The most common reasons for incomplete KCCQ data at baseline were that the patient was too sick (13.9%) and consent to participate in research was not obtained (12.4%). Significant variation across sites was observed for missingness because of patient (MOR, 2.8; P < .001) and administrative (MOR, 4.8; P < .001) reasons. The most variable patient reasons were that the patients were too stressed (MOR, 7.2; P < .001) and too busy (MOR, 10.6; P < .001). The most variable administrative reasons were that the coordinator was too busy/forgot (MOR, 7.1; P < .001) and miscellaneous reasons (MOR, 8.7; P < .001). At 3 months, significant variation persisted for both patient (MOR, 2.7; P < .001) and administrative (MOR, 3.5; P < .001) reasons. The most variability across sites was that the patient was too busy (MOR, 6.0, P < .001) and that the coordinator was too busy/forgot (MOR, 5.8; P < .001). ConclusionsSites vary substantially in collecting KCCQ data, and many of these variations seem addressable. Improving the consistency of HRQL data collection can improve the value of INTERMACS in defining the patient-centered benefits of MCS treatment.

Abstract 276: Variation of Quality of Life Data Collection Across INTERMACS Sites

Purpose: To capture health-related quality of life (HRQOL) benefits and[[Unable to Display Character: &amp;#8232;]] risks of mechanical circulatory support (MCS), the INTERMACS registry expanded collection of HRQOL data to include the Kansas City[[Unable to Display Character: &amp;#8232;]] Cardiomyopathy Questionnaire (KCCQ) prior to and after MCS (beginning[[Unable to Display Character: &amp;#8232;]] 6/12). To better understand reasons for incomplete data collection, we examined patient- and site-associated factors. Methods: Descriptive analyses and hierarchical logistic regression were used to examine the frequency &amp; site variability (median odds ratios [MOR]) for each reason for not collecting the KCCQ at baseline &amp; at three months. Results: The KCCQ was not collected in 43.4% (2031 of 4682) (range across sites: 0-[[Unable to Display Character: &amp;#8232;]]100%) &amp; 34.6% (1282 of 3702), (0-100%) of pts. at baseline and 3 months. The most common reason for incomplete KCCQ data at baseline was that the patient was too sick (14.4%) &amp; consent was not obtained (12.2%); at 3 months,[[Unable to Display Character: &amp;#8232;]] the key reason was that the coordinator was too busy/forgot (12.4%). Variations across sites, on a logistic scale, reveal no significant variation[[Unable to Display Character: &amp;#8232;]] in those who were too sick at baseline, but significant variation [[Unable to Display Character: &amp;#8232;]]in all other reasons (Fig 1). Similarly, administrative reasons for incomplete data at three months were much more variable than patient-centered[[Unable to Display Character: &amp;#8232;]] reasons. If a mechanism were created for assigning KCCQ values to the “too sick” patients then the completion rates would be 71.0% at baseline and 69.1% at three months.[[Unable to Display Character: &amp;#8232;]] Conclusion: Sites vary substantially in the completeness of KCCQ data due to both patients and administrative reasons. However, the sources of missing data need to be considered in analyses; most importantly, sites need to increase commitment to complete data collection.

OP36 * CONCORDANCE OF PATIENT AND CLINICIAN REPORTED PRESENTING SYMPTOMS AT INITIAL NEURO-ONCOLOGY ASSESSMENT

INTRODUCTION: Health-related quality of life (HRQoL) is increasingly recognised as an important component of neuro-oncology assessment. The EORTC QLQ-C30 is a well-validated instrument for measuring global health domains and cancer-related symptoms. On this background we sought to evaluate questionnaire symptom reporting as compared to standard clinical assessment. METHOD: Patients presenting for initial assessment in neurosurgical oncology clinic were asked to complete the QLQ-C30 and BN20 brain cancer module questionnaires prior to their appointment. Clinician reported symptoms were determined retrospectively from outpatient clinic letters. Statistical significance was determined using paired t-test and Fisher's exact test. RESULTS: A total of 181 patients were included in the analysis (96 male, 86 female; median age 61). Commonest diagnoses included high-grade glioma (n = 63; 34.6%), metastatic disease (n = 33; 18.1%) and low-grade glioma (n = 29; 15.9%). A higher average number of symptoms was reported by patients (8.2 ± 0.3) compared to clinicians (2.1 ± 0.1; p < 0.0001). Reporting rate for all symptoms was significantly higher from the questionnaire (all p < 0.002) with the exception of seizures which had a higher reporting rate from clinician review (p < 0.0001). Positive symptoms showing the highest concordance included motor dysfunction (43.0%), communication deficit (30.4%) and visual disorder (29.5%). CONCLUSION: Measuring HRQoL with the QLQ-C30 and BN20 enabled detection of more presenting symptoms than by clinician review alone, with concordance highest for gross neurological deficits. Routine collection of HRQoL data thus adds a further dimension to clinical assessment that enhances and complements current practice.

Effectiveness and cost-effectiveness of traditional and new partner notification technologies for curable sexually transmitted infections: observational study, systematic reviews and mathematical modelling

Partner notification is essential to the comprehensive case management of sexually transmitted infections. Systematic reviews and mathematical modelling can be used to synthesise information about the effects of new interventions to enhance the outcomes of partner notification. To study the effectiveness and cost-effectiveness of traditional and new partner notification technologies for curable sexually transmitted infections (STIs). Secondary data analysis of clinical audit data; systematic reviews of randomised controlled trials (MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials) published from 1 January 1966 to 31 August 2012 and of studies of health-related quality of life (HRQL) [MEDLINE, EMBASE, ISI Web of Knowledge, NHS Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA)] published from 1 January 1980 to 31 December 2011; static models of clinical effectiveness and cost-effectiveness; and dynamic modelling studies to improve parameter estimation and examine effectiveness. General population and genitourinary medicine clinic attenders. Heterosexual women and men. Traditional partner notification by patient or provider referral, and new partner notification by expedited partner therapy (EPT) or its UK equivalent, accelerated partner therapy (APT). Population prevalence; index case reinfection; and partners treated per index case. Enhanced partner therapy reduced reinfection in index cases with curable STIs more than simple patient referral [risk ratio (RR) 0.71; 95% confidence interval (CI) 0.56 to 0.89]. There are no randomised trials of APT. The median number of partners treated for chlamydia per index case in UK clinics was 0.60. The number of partners needed to treat to interrupt transmission of chlamydia was lower for casual than for regular partners. In dynamic model simulations, >10% of partners are chlamydia positive with look-back periods of up to 18 months. In the presence of a chlamydia screening programme that reduces population prevalence, treatment of current partners achieves most of the additional reduction in prevalence attributable to partner notification. Dynamic model simulations show that cotesting and treatment for chlamydia and gonorrhoea reduce the prevalence of both STIs. APT has a limited additional effect on prevalence but reduces the rate of index case reinfection. Published quality-adjusted life-year (QALY) weights were of insufficient quality to be used in a cost-effectiveness study of partner notification in this project. Using an intermediate outcome of cost per infection diagnosed, doubling the efficacy of partner notification from 0.4 to 0.8 partners treated per index case was more cost-effective than increasing chlamydia screening coverage. There is evidence to support the improved clinical effectiveness of EPT in reducing index case reinfection. In a general heterosexual population, partner notification identifies new infected cases but the impact on chlamydia prevalence is limited. Partner notification to notify casual partners might have a greater impact than for regular partners in genitourinary clinic populations. Recommendations for future research are (1) to conduct randomised controlled trials using biological outcomes of the effectiveness of APT and of methods to increase testing for human immunodeficiency virus (HIV) and STIs after APT; (2) collection of HRQL data should be a priority to determine QALYs associated with the sequelae of curable STIs; and (3) standardised parameter sets for curable STIs should be developed for mathematical models of STI transmission that are used for policy-making. The National Institute for Health Research Health Technology Assessment programme.

Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists

Background Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. Methods And Findings We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Conclusions Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.

Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists

BackgroundPatient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem.Methods And FindingsWe undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden.ConclusionsOur findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.

Review of health-related quality of life data in multiple myeloma patients treated with novel agents.

In multiple myeloma (MM), health-related quality of life (HRQoL) data is becoming increasingly important, owing to improved survival outcomes and the impact of treatment-related toxicity on HRQoL. Researchers are more frequently including HRQoL assessments in clinical trials, but analysis and reporting of this data has not been consistent. A systematic literature review assessed the effect of novel agents (thalidomide, bortezomib and lenalidomide) on HRQoL in MM patients, and evaluated the subsequent reporting of these HRQoL results. A relatively small body of literature addresses HRQoL data in MM patients treated with novel MM therapeutic agents: 9 manuscripts and 15 conference proceedings. The literature demonstrates the complementary value of HRQoL when assessing clinical response, progression, overall survival and toxicity. However, weaknesses and inconsistencies in analysis and presentation of HRQoL data were observed, often complicating interpretation of the impact of treatment on HRQoL in MM. Further evaluation of HRQoL in MM patients treated with novel agents is required in larger cohorts, and ideally in head-to-head comparative studies. Additionally, the development of standardised MM-specific best practice guidelines in HRQoL data collection and analysis is recommended. These would ensure that future data are more useful in guiding predictive models and clinical decisions.

Use of Health-Related Quality-of-Life Measurements to Estimate Individuals’ Health on Screening

Objectives : to investigate the utility of assessing Health-Related Quality of Life (HRQoL) in a large group of subjects participating in a screening program for aneurysm and the relationship between HRQoL, diagnosis of aneurysm and related risk factors.Methods : subjects involved in this screening program were submitted the EQ-5D questionnaire to report their own HRQoL. HRQoL was reported also a second time by the subjects who were diagnosed with aneurysm during screening and who returned for a monitoring follow up visit a few months later. We evaluated compliance with HRQoL data collection and performed multiple regression analyses in order to investigate the possible relationship between demographic and clinical data with HRQoL.Results : 1,633 subjects screened (6.1% diagnosed with aneurysm) and 125 subjects diagnosed with aneurysm and attending a follow-up visit reported their HRQoL. Completion of the EQ-5D questionnaire was well accepted by both physicians and subjects undergoing screening. HRQoL was not significantly different between the screening and follow - up visits, on adjusting for age and sex. At the screening visit, HRQoL was associated with ASA class, heart condition, BMI and respiratory diseases. No associations were found at the follow-up visit.Conclusion : Assessing HRQoL in screening programs is feasible and well accepted and add useful information on health of large numbers of subjects from general population. This could be considered as a routine approach to optimizing the informative role of screening programs in guiding other investigations or interventions.