Madeleine King

Nursing staffing, nursing workload, the work environment and patient outcomes

Nurse staffing (fewer RNs), increased workload, and unstable nursing unit environments were linked to negative patient outcomes including falls and medication errors on medical/surgical units in a mixed method study combining longitudinal data (5 years) and primary data collection.

Evidence-Based Guidelines for Determination of Sample Size and Interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30

UNLABELLED PURPOSE; To use published literature to estimate large, medium, and small differences in quality of life (QOL) data from 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 estimate large, medium, and small differences for QLQ-C30 scores. Published mean data were identified from the literature. Differences (contrasts) between groups (eg, between treatment groups, age groups, and performance status groups) were reviewed by 34 experts in QOL measurement and cancer treatment. The experts, blinded to actual QOL results, were asked to predict these differences. A large difference was defined as one representing unequivocal clinical relevance. A medium difference was defined as likely to be clinically relevant but to a lesser extent. A small difference was one believed to be subtle but nevertheless clinically relevant. A trivial difference was used to describe circumstances unlikely to have any clinical relevance. Actual QOL results were combined using meta-analytic techniques to estimate differences corresponding to small, medium, or large effects. RESULTS Nine hundred eleven articles were identified, leading to 152 relevant articles (2,217 contrasts) being reviewed by at least two experts. Resulting estimates from the meta-analysis varied depending on the subscale. Thus, the recommended minimum to detect medium differences ranges from 9 (cognitive functioning) to 19 points (role functioning). CONCLUSION Guidelines for the size of effects are provided for the QLQ-C30 subscales. These guidelines can be used for sample size calculations for clinical trials and can also be used to aid interpretation of differences in QLQ-C30 scores.

A point of minimal important difference (MID): a critique of terminology and methods

The minimal important difference (MID) is a phrase with instant appeal in a field struggling to interpret health-related quality of life and other patient-reported outcomes. The terminology can be confusing, with several terms differing only slightly in definition (e.g., minimal clinically important difference, clinically important difference, minimally detectable difference, the subjectively significant difference), and others that seem similar despite having quite different meanings (minimally detectable difference versus minimum detectable change). Often, nuances of definition are of little consequence in the way that these quantities are estimated and used. Four methods are commonly employed to estimate MIDs: patient rating of change (global transition items); clinical anchors; standard error of measurement; and effect size. These are described and critiqued in this article. There is no universal MID, despite the appeal of the notion. Indeed, for a particular patient-reported outcome instrument or scale, the MID is not an immutable characteristic, but may vary by population and context. At both the group and individual level, the MID may depend on the clinical context and decision at hand, the baseline from which the patient starts, and whether they are improving or deteriorating. Specific estimates of MIDs should therefore not be overinterpreted. For a given health-related quality-of-life scale, all available MID estimates (and their confidence intervals) should be considered, amalgamated into general guidelines and applied judiciously to any particular clinical or research context.

Quality of life three years after diagnosis of localised prostate cancer: population based cohort study

Objective To quantify the risk and severity of negative effects of treatment for localised prostate cancer on long term quality of life. Design Population based, prospective cohort study with follow-up over three years. Setting New South Wales, Australia. Participants Men with localised prostate cancer were eligible if aged less than 70 years, diagnosed between October 2000 and October 2002, and notified to the New South Wales central cancer registry. Controls were randomly selected from the New South Wales electoral roll and matched to cases by age and postcode. Main outcome measures General health specific and disease specific function up to three years after diagnosis, according to the 12 item short form health survey and the University of California, Los Angeles prostate cancer index. Results 1642 (64%) cases and 495 (63%) eligible and contacted controls took part in the study. After adjustment for confounders, all active treatment groups had low odds of having better sexual function than controls, in particular men on androgen deprivation therapy (adjusted odds ratio (OR) 0.02, 95% CI 0.01 to 0.07). Men treated surgically reported the worst urinary function (adjusted OR 0.17, 95% CI 0.13 to 0.22). Bowel function was poorest in cases who had external beam radiotherapy (adjusted OR 0.44, 95% CI 0.30 to 0.64). General physical and mental health scores were similar across treatment groups, but poorest in men who had androgen deprivation therapy. Conclusions The various treatments for localised prostate cancer each have persistent effects on quality of life. Sexual dysfunction three years after diagnosis was common in all treatment groups, whereas poor urinary function was less common. Bowel function was most compromised in those who had external beam radiotherapy. Men with prostate cancer and the clinicians who treat them should be aware of the effects of treatment on quality of life, and weigh them up against the patient’s age and the risk of progression of prostate cancer if untreated to make informed decisions about treatment.

Randomized Controlled Trial of the Role of Positron Emission Tomography in the Management of Stage I and II Non-Small-Cell Lung Cancer

PURPOSE Positron emission tomography (PET) is a costly new technology with potential to improve preoperative evaluation for patients with non-small-cell lung cancer (NSCLC). There is increasing pressure for PET to be included in standard diagnostic work-up before decisions about surgical management of NSCLC. The resource implications of its widespread use in staging NSCLC are significant. METHODS A randomized controlled trial was conducted to investigate the impact of PET on clinical management and surgical outcomes for patients with stage I-II NSCLC. The primary hypothesis was that PET would reduce the proportion of patients with stage I-II NSCLC who underwent thoracotomy by at least 10% through identification of patients with inoperable disease. RESULTS One hundred eighty-four patients with stage I-II NSCLC were recruited and randomly assigned; 92% had stage I disease. Following exclusion of one ineligible patient, 92 patients were assigned to no PET and 91 to PET. Compared with conventional staging, PET upstaged 22 patients, confirmed staging in 61 and staged two patients as benign. Stage IV disease was rarely detected (two patients). PET led to further investigation or a change in clinical management in 13% of patients and provided information that could have affected management in a further 13% of patients. There was no significant difference between the trial arms in the number of thoracotomies avoided (P =.2). CONCLUSION For patients who are carefully and appropriately staged as having stage I-II disease, PET provides potential for more appropriate stage-specific therapy but may not lead to a significant reduction in the number of thoracotomies avoided.

Review of Adherence-Related Issues in Adolescents and Young Adults With Cancer

PURPOSE This review aims to provide a broad overview of the issues and clinical challenges of nonadherence in adolescents and young adults (AYAs) with cancer. Nonadherence can reduce treatment efficacy, which places the patient at higher risk of relapse, adverse effects, and poor outcomes. DESIGN A review of the English-speaking literature between 1980 and 2008 was conducted to identify relevant publications, which were supplemented by reference and author searches. RESULTS Definition and measurement of adherence varies. Most studies have not clearly delineated an AYA age group (ie, 15-25 years) and have been dominated by leukemia and lymphoma samples. Estimates for nonadherence in this population range from 27% to 60%, with openness of family relationships and support found to predict adherence. Strategies to avoid, assess, and manage nonadherence are presented. CONCLUSION Overall, the evidence base for adherence and strategies to promote it in AYAs with cancer is woefully lacking. There is a need for high-quality studies that target clinically important questions, randomized controlled trials of theoretically based interventions, and development and evaluation of training programs for oncology staff in the special issues faced by AYAs with cancer.

Time Trade-Off Derived EQ-5D Weights for Australia

BACKGROUND Cost-utility analyses (CUAs) are increasingly common in Australia. The EuroQol five-dimensional (EQ-5D) questionnaire is one of the most widely used generic preference-based instruments for measuring health-related quality of life for the estimation of quality-adjusted life years within a CUA. There is evidence that valuations of health states vary across countries, but Australian weights have not previously been developed. METHODS Conventionally, weights are derived by applying the time trade-off elicitation method to a subset of the EQ-5D health states. Using a larger set of directly valued health states than in previous studies, time trade-off valuations were collected from a representative sample of the Australian general population (n = 417). A range of models were estimated and compared as a basis for generating an Australian algorithm. RESULTS The Australia-specific EQ-5D values generated were similar to those previously produced for a range of other countries, but the number of directly valued states allowed inclusion of more interaction effects, which increased the divergence between Australias algorithm and other algorithms in the literature. CONCLUSION This new algorithm will enable the Australian community values to be reflected in future economic evaluations.

Patient-reported outcomes in randomized clinical trials: Development of ISOQOL reporting standards

PurposeTo develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs.MethodsA Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance.ResultsForty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either ‘essential’ or ‘desirable’ when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors.ConclusionsISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.

Quality of Life and Survival in the 2 Years After Surgery for Non–Small-Cell Lung Cancer

PURPOSE Although surgery for early-stage non-small-cell lung cancer (NSCLC) is known to have a substantial impact on health-related quality of life (HRQOL), there are few published studies about HRQOL in the longer term. This article examines HRQOL and survival in the 2 years after surgery. PATIENTS AND METHODS Patients with clinical stage I or II NSCLC (n = 173) completed HRQOL questionnaires before surgery, at discharge, 1 month after surgery, and then every 4 months for 2 years. HRQOL was measured with a generic cancer questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30) and a lung cancer-specific questionnaire (EORTC QLQ-LC13). Data were analyzed to examine the impact of surgery and any subsequent therapy, and to describe the trajectories of those who remained disease free at 2 years and those with recurrent cancer diagnosed during follow-up. RESULTS Disease recurred within 2 years for 36% of patients and 2-year survival was 65%. Surgery substantially reduced HRQOL across all dimensions except emotional functioning. HRQOL improved in the 2 years after surgery for patients without disease recurrence, although approximately half continued to experience symptoms and functional limitations. For those with recurrence within 2 years, there was some early postoperative recovery in HRQOL, with subsequent deterioration across most dimensions. CONCLUSION Surgery had a substantial impact on HRQOL, and although many disease-free survivors experienced recovery, some lived with long-term HRQOL impairment. HRQOL generally worsened with disease recurrence. The study results are important for informed decision making and ongoing supportive care for patients with operable NSCLC.

Age, Health, and Education Determine Supportive Care Needs of Men Younger Than 70 Years With Prostate Cancer

PURPOSE It is important to meet the supportive care needs of cancer patients to ensure their satisfaction with their care. A population-wide sample of men younger than 70 years and newly diagnosed with prostate cancer was surveyed to determine their unmet needs in five domains and the factors predicting them. PATIENTS AND METHODS Eligible men were younger than 70 years and residents in New South Wales, Australia, with newly diagnosed histopathologically confirmed prostate cancer. Sixty-seven percent of eligible men diagnosed between October 2000 and October 2001 participated. Demographic, treatment, and self-reported health data were collected. Information on cancer stage, grade, and prostate-specific antigen was obtained from medical records. Logistic regression analyses determined patient and treatment variables that predicted higher unmet needs. RESULTS More than half (54%) of men with prostate cancer expressed some level of unmet psychological need, and 47% expressed unmet sexuality needs. Nearly one fourth expressed a moderate or high level of unmet need with respect to changes in sexuality. Sexuality needs were independently predicted by being younger, having had a secondary school education only, having had surgery, and being married, living as married, or divorced. Uncertainty about the future was also an important area of unmet need. CONCLUSION Attention should be given to sexual and psychological needs in the early months after diagnosis or treatment of prostate cancer, particularly in younger men, those with less education, and those having surgery. Research into better ways of meeting these needs will enable us to meet them with as much rigor as we meet clinical treatment needs.