Evidence-based interpretation guidelines for quality of life measures

Aim: To use published literature to obtain estimates of large, medium and small differences in quality of life (QOL) data for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Methods: An innovative method combining systematic review of published studies, expert opinions and meta-analysis was used to obtain estimates of large, medium and small differences for QLQ-C30 scores. Published mean data were identified from the literature. Differences between groups of patients and over time within patients were reviewed by 34 experts in QOL measurement and cancer treatment. The experts, blinded to QOL results, were asked to predict these differences. Differences were combined using meta-analytic techniques to obtain estimates of small, medium and large effects. Qualitative interviews with patients and experts were used to assess the new methodology. Results: 911 articles were identified, with 211 relevant articles (3444 contrasts) for the analysis. Our systematic reviewof the randomised controlled trials (RCTs) showed that the clinical relevance of QOL differences was rarely discussed. Our meta-analysis estimates varied depending on the subscale and on whether QOL was improving or deteriorating. Thus, the recommended minimum to detect medium differences between groups ranges from 7 (diarrhoea) to 19 points (role functioning). When interpreting differences over time a minimum of 7 points represents a medium difference but for most subscales a larger difference is required for a medium deterioration compared with a medium improvement. Conclusion: Guidelines for interpreting the size of effects are provided for the QLQ- C30 subscales. These guidelines can be used for sample size calculations for clinical trials and to interpret differences in QLQ-C30 scores. The novel methodology was shown to be robust in sensitivity analyses but benefitted from a thorough quality assessment and using only the best quality evidence to derive the guidelines

Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial

Background: Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. Methods/design: A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period. The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience. The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. Methods: fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework. Discussion: This study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the ‘patient voice’ is critical if patient feedback is to be situated as an integral part of patient safety improvements

Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: Secondary outcomes of a randomised controlled trial.

INTRODUCTION AND AIM: In a randomised trial investigating the effects of regular use of health-related quality of life (HRQOL) in oncology practice, we previously reported an improvement in communication (objective analysis of recorded encounters) and patient well-being. The secondary aims of the trial were to measure any impact on patient satisfaction and patients' perspectives on continuity and coordination of their care. METHODS: In a prospective trial involving 28 oncologists, 286 cancer patients were randomised to: (1) intervention arm: regular touch-screen completion of HRQOL with feedback to physicians; (2) attention-control arm: completion of HRQOL without feedback; and (3) control arm: no HRQOL assessment. Secondary outcomes were patients' experience of continuity of care (Medical Care Questionnaire, MCQ) including 'Communication', 'Coordination' and 'Preferences to see usual doctor' subscales, patients' satisfaction, and patients' and physicians' evaluation of the intervention. Analysis employed mixed-effects modelling, multiple regression and descriptive statistics. RESULTS: Patients in the intervention arm rated their continuity of care as better than the control group for 'Communication' subscale (p=0.03). No significant effects were found for 'Coordination' or 'Preferences to see usual doctor'. Patients' evaluation of the intervention was positive. More patients in the intervention group rated the HRQOL assessment as useful compared to the attention-control group (86% versus 29%), and reported their doctors considered daily activities, emotions and quality of life. CONCLUSION: Regular use of HRQOL measures in oncology practice brought changes to doctor-patient communication of sufficient magnitude and importance to be reported by patients. HRQOL data may improve care through facilitating rapport and building inter-personal relationships

No evidence of association between interleukin-13 gene polymorphism in aspirin intolerant chronic urticaria

Aspirin-intolerant chronic urticaria (AICU) is a common condition among the chronic urticaria population, but the genetic mechanism is not yet understood. In this study, the genotypes and haplotypes of three interleukin (IL)-13 polymorphisms, -1510 A>C, -1055C>T, and Arg110Gln (110G>A), as well as their respective clinical phenotypes were examined to determine whether genetic variants of IL-13 play a role in AICU. Single-nucleotide polymorphism (SNP) genotyping was used to compare IL-13 genotype and allele frequencies among 135 patients with AICU, 146 with aspirin-tolerant chronic urticaria (ATCU), and 430 normal controls (NC). Relationships among the AICU phenotype, atopy, and total IgE level were also investigated. The results failed to show a significant difference in the allele or genotype frequencies between the AICU group and either the ATCU or NC group (P>0.05, respectively). Haplotype analysis confirmed that there was no significant difference among the three study groups (P>0.05), nor was there a significant difference in atopy or total IgE level according to the three genetic polymorphisms (P>0.05, respectively). Our data lead to the conclusion that there is no evidence supporting genetic polymorphisms in IL-13 as a genetic risk factor for the development of AICU

Quality of life with cediranib in relapsed ovarian cancer: The ICON6 phase 3 randomized clinical trial

BACKGROUND: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment. METHODS: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group. RESULTS: The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, –2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea. CONCLUSIONS: The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer

Characterisation of musk lime (Citrus microcarpa) seed oil

BACKGROUND: The seeds of musk lime (Citrus microcarpa) represent a substantial waste product of small‐scale citrus‐processing factories, as they constitute about 100.0 ± 3.2 g kg−1 of the whole fruit and contain a considerable amount of crude fat (338.0 ± 11.3 g kg−1). Thus the aim of the present study was to determine the physicochemical properties of this fat with a view to potential applications. RESULTS: The iodine and saponification values and unsaponifiable matter and free fatty acid contents of the freshly extracted oil were 118.0 g I2 per 100 g oil, 192.6 mg KOH g−1 oil, 22 mg g−1 oil and 18 mg oleic acid g−1 oil respectively. The oil had a Lovibond colour index of 33.1 Y + 1.1 B. Its fatty acid profile indicated that 73.6% of the fatty acids present were unsaturated. Linoleic (L, 31.8%), oleic (O, 29.6%) and palmitic (P, 21.4%) acids were the predominant fatty acids, existing mainly as the triacylglycerols POL (18.9%), PLL (13.7%) and OLL (11.9%). The melting and cooling points of the oil were 10.7 and − 45.2 °C respectively. Electronic nose qualitative analysis of the oil showed the presence of volatile (aroma) compounds, although the concentrations of the more volatile compounds were lower than those present in the seeds. CONCLUSION: Musk lime seeds are a rich source of oil, which is unusual in having linoleic, oleic and palmitic acids dominating the fatty acid composition. This property should make the oil both relatively stable to thermal oxidation owing to the combined presence of oleic and palmitic acids (61.0%) and highly nutritive owing to its high concentration of unsaturated fatty acids (73.6%)

Genome sequence of an Australian kangaroo, Macropus eugenii, provides insight into the evolution of mammalian reproduction and development.

BACKGROUND: We present the genome sequence of the tammar wallaby, Macropus eugenii, which is a member of the kangaroo family and the first representative of the iconic hopping mammals that symbolize Australia to be sequenced. The tammar has many unusual biological characteristics, including the longest period of embryonic diapause of any mammal, extremely synchronized seasonal breeding and prolonged and sophisticated lactation within a well-defined pouch. Like other marsupials, it gives birth to highly altricial young, and has a small number of very large chromosomes, making it a valuable model for genomics, reproduction and development. RESULTS: The genome has been sequenced to 2 × coverage using Sanger sequencing, enhanced with additional next generation sequencing and the integration of extensive physical and linkage maps to build the genome assembly. We also sequenced the tammar transcriptome across many tissues and developmental time points. Our analyses of these data shed light on mammalian reproduction, development and genome evolution: there is innovation in reproductive and lactational genes, rapid evolution of germ cell genes, and incomplete, locus-specific X inactivation. We also observe novel retrotransposons and a highly rearranged major histocompatibility complex, with many class I genes located outside the complex. Novel microRNAs in the tammar HOX clusters uncover new potential mammalian HOX regulatory elements. CONCLUSIONS: Analyses of these resources enhance our understanding of marsupial gene evolution, identify marsupial-specific conserved non-coding elements and critical genes across a range of biological systems, including reproduction, development and immunity, and provide new insight into marsupial and mammalian biology and genome evolution

An intervention to reassure patients about test results in rapid access chest pain clinic: a pilot randomised controlled trial

BACKGROUND: Most people referred to rapid access chest pain clinics have non-cardiac chest pain, and in those diagnosed with stable coronary heart disease, guidance recommends that first-line treatment is usually medication rather than revascularisation. Consequently, many patients are not reassured they have the correct diagnosis or treatment. A previous trial reported that, in people with non-cardiac chest pain, a brief discussion with a health psychologist before the tests about the meaning of potential results led to people being significantly more reassured. The aim of this pilot was to test study procedures and inform sample size for a future multi-centre trial and to gain initial estimates of effectiveness of the discussion intervention. METHODS: This was a two-arm pilot randomised controlled trial in outpatient rapid access chest pain clinic in 120 people undergoing investigation for new onset, non-urgent chest pain. Eligible participants were randomised to receive either: a discussion about the meaning and implication of test results, delivered by a nurse before tests in clinic, plus a pre-test pamphlet covering the same information (Discussion arm) or the pre-test pamphlet alone (Pamphlet arm). Main outcome measures were recruitment rate and feasibility for a future multi-centre trial, with an estimate of reassurance in the groups at month 1 and 6 using a 5-item patient-reported scale. RESULTS: Two hundred and seventy people attended rapid access chest pain clinic during recruitment and 120/270 participants (44%) were randomised, 60 to each arm. There was no evidence of a difference between the Discussion and Pamphlet arms in the mean reassurance score at month 1 (34.2 vs 33.7) or at month 6 (35.3 vs 35.9). Patient-reported chest pain and use of heart medications were also similar between the two arms. CONCLUSIONS: A larger trial of the discussion intervention in the UK would not be warranted. Patients reported high levels of reassurance which were similar in patients receiving the discussion with a nurse and in those receiving a pamphlet alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60618114 (assigned 27.05.2011). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1471-2261-14-138) contains supplementary material, which is available to authorized users