"It ain't over till the fat lady sings" : A response to Cameron N. McIntosh, improving the evaluation of model fit in confirmatory factor analysis

Peer reviewedPublisher PD

Effects of mode of administration (MOA) on the measurement properties of the EORTC QLQ-C30: a randomized study

<p>Abstract</p> <p>Background</p> <p>While modern electronic data collection methods (e.g., computer touch-screen or web-based) hold much promise, most current studies continue to make use of more traditional data collection techniques, including paper-and-pencil administration and telephone interviews. The present randomized trial investigated the measurement properties of the EORTC QLQ-C30 under three different modes of administration (MOA's).</p> <p>Methods</p> <p>A heterogeneous sample of 314 cancer patients undergoing treatment at a specialized treatment center in Amsterdam were randomized to one of three MOA's for the QLQ-C30: paper-and-pencil at home via the mail, telephone interview, and paper-and-pencil at the hospital clinic. Group differences in internal consistency reliabilities (Cronbach's alpha coefficient) for the scale scores were compared. Differences in mean scale scores were also compared by means of ANOVA, with adjustment for potential confounders.</p> <p>Results</p> <p>Only one statistically significant, yet minor, difference in Cronbach's alpha between the MOA groups was observed for the Role Functioning scale (all 3 alphas >0.80). Significant differences in group means -after adjustment- were found for the Emotional Functioning (EF) scale. Patients completing the written questionnaire at home had significantly lower levels of EF as compared to those interviewed via the telephone; EF scores of those completing the questionnaire at the clinic fell in-between those of the other two groups. These differences, however, were small in magnitude.</p> <p>Conclusions</p> <p>MOA had little effect on the reliability or the mean scores of the EORTC QLQ-C30, with the possible exception of the EF scale.</p

Exceptions to the rule of informed consent for research with an intervention

Background In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. Methods Here, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy. Results We identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures. Conclusions The reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB

Feasibility of a home-based exercise intervention with remote guidance for patients with stable grade II and III gliomas:A pilot randomized controlled trial

Objective: In this pilot study, we investigated the feasibility of a home-based, remotely guided exercise intervention for patients with gliomas. Design: Pilot randomized controlled trial (RCT) with randomization (2:1) to exercise or control group. Subjects: Patients with stable grade II and III gliomas. Intervention: The six-month intervention included three home-based exercise sessions per week at 60%–85% of maximum heart rate. Participants wore heart rate monitors connected to an online platform to record activities that were monitored weekly by the physiotherapist. Main measures: Accrual, attrition, adherence, safety, satisfaction, patient-reported physical activity, VO2 peak (by maximal cardiopulmonary exercise testing) and body mass index (BMI) at baseline and at six-month follow-up. Results: In all, 34 of 136 eligible patients (25%) were randomized to exercise training (N = 23) or the control group (N = 11), of whom 19 and 9, respectively, underwent follow-up. Mean adherence to prescribed sessions was 79%. Patients’ experiences were positive. There were no adverse events. Compared to the control group, the exercise group showed larger improvements in absolute VO2 peak (+158.9 mL/min; 95% CI: −44.8 to 362.5) and BMI (−0.3 kg/m²; 95% CI: −0.9 to 0.2). The median increase in physical activity was 1489 metabolic equivalent of task (MET) minutes higher in the exercise group. The most reported reasons for non-participation were lack of motivation or time. Conclusion: This innovative and intensive home-based exercise intervention was feasible in a small subset of patients with stable gliomas who were interested in exercising. The observed effects suggest that the programme may improve cardiorespiratory fitness. These results support the need for large-scale trials of exercise interventions in brain tumour patients. Keywords: Glioma, brain tumour, exercise, physical training, physical fitnes

Cognitive behavioral therapy and physical exercise for climacteric symptoms in breast cancer patients experiencing treatment-induced menopause: design of a multicenter trial

<p>Abstract</p> <p>Background</p> <p>Premature menopause is a major concern of younger women undergoing adjuvant therapy for breast cancer. Hormone replacement therapy is contraindicated in women with a history of breast cancer. Non-hormonal medications show a range of bothersome side-effects. There is growing evidence that cognitive behavioral therapy (CBT) and physical exercise can have a positive impact on symptoms in naturally occurring menopause. The objective of this study is to investigate the efficacy of these interventions among women with breast cancer experiencing treatment-induced menopause.</p> <p>Methods/design</p> <p>In a randomized, controlled, multicenter trial, we are evaluating the effectiveness of CBT/relaxation, of physical exercise and of these two program elements combined, in reducing menopausal symptoms, improving sexual functioning, reducing emotional distress, and in improving the health-related quality of life of younger breast cancer patients who experience treatment-induced menopause. 325 breast cancer patients (aged < 50) are being recruited from hospitals in the Amsterdam region, and randomly allocated to one of the three treatment groups or a 'waiting list' control group. Self-administered questionnaires are completed by the patients at baseline, and at 12 weeks (T1) and 6 months (T2) post-study entry. Upon completion of the study, women assigned to the control group will be given the choice of undergoing either the CBT or physical exercise program.</p> <p>Discussion</p> <p>Cognitive behavioral therapy and physical exercise are potentially useful treatments among women with breast cancer undergoing treatment-induced, premature menopause. For these patients, hormonal and non-hormonal therapies are contraindicated or have a range of bothersome side-effects. Hence, research into these interventions is needed, before dissemination and implementation in the current health care system can take place.</p> <p>Trial registration</p> <p>The study is registered at the Netherlands Trial Register (NTR1165) and ClinicalTrials.gov (NCT00582244).</p

Health-related quality of life in adult patients with brain metastases after stereotactic radiosurgery:A systematic, narrative review

Purpose A growing number of patients with brain metastases (BM) are being treated with stereotactic radiosurgery (SRS), and the importance of evaluating the impact of SRS on the health-related quality of life (HRQoL) in these patients has been increasingly acknowledged. This systematic review summarizes the current knowledge about the HRQoL of patients with BM after SRS. Methods We searched EMBASE, Medline Ovid, Web-of-Science, the Cochrane Database, PsycINFO Ovid, and Google Scholar up to November 15, 2018. Studies in patients with BM in which HRQoL was assessed before and after SRS and analyzed over time were included. Studies including populations of several types of brain cancer and/or several types of treatments were included if the results for patients with BM and treatment with SRS alone were described separately. Results Out of 3638 published articles, 9 studies met the eligibility criteria and were included. In 4 out of 7 studies on group results, overall HRQoL of patients with BM remained stable after SRS. In small study samples of longer-term survivors, overall HRQoL remained stable up to 12 months post-SRS. Contradictory results were reported for physical and general/global HRQoL, which might be explained by the different questionnaires that were used. Conclusions In general, SRS does not have significant negative effects on patients’ overall HRQoL over time. Future research is needed to analyze different aspects of HRQoL, differences in individual changes in HRQoL after SRS, and factors that influence these changes. These studies should take into account several methodological issues as discussed in this review

Development of MijnAVL, an Interactive Portal to Empower Breast and Lung Cancer Survivors: An Iterative, Multi-Stakeholder Approach

Background: MijnAVL (MyAVL) is an interactive portal being developed to empower cancer survivors. Literature review and focus groups yielded the selection of features such as access to the electronic medical record (EMR), patient reported outcomes (PROs) and related feedback, and a physical activity support program. Objective: Our aim was to present a final design of MijnAVL based on (1) health professionals' evaluation of proposed features, (2) cancer survivors’ evaluation of a first draft, and (3) cancer survivors’ evaluation of a functional online prototype. Methods: Professionals from various disciplines gave input to the content of and procedures related to MijnAVL. Subsequently, 16 cancer survivors participated in an interview to evaluate content and graphic design of a first draft (shown with screenshots). Finally, 7 survivors participated in a usability test with a fully functional prototype. They performed predefined tasks (eg, logging in, finding a test result, completing a questionnaire) while thinking aloud. Descriptive statistics and simple content analysis were used to analyze the data of both the interviews and the usability tests. Results: Professionals supported access to the EMR (eg, histology reports, lab results, and their letters to general practitioners). They also informed the development of PROs and the physical activity support program. Based on the first draft, survivors selected the preferred graphic design, approved the features and provided suggestions for the content (eg, explanation of medical jargon, more concise texts, notification by emails). Usability tests revealed that it was relatively easy to navigate the website and use the different features. Recommendations included, among others, a frequently asked questions section and the use of hyperlinks between different parts of the website. Conclusions: The development of MijnAVL, an interactive portal to empower breast and lung cancer survivors, was performed iteratively and involved multiple groups of end-users. This approach resulted in a usable and understandable final version. Its effectiveness should be determined in further researc

Health-related quality of life around the time of diagnosis in patients with bladder cancer.

Objectives To quantify the health-related quality of life (HRQoL) of patients with bladder cancer around the time of diagnosis and to test the hypotheses of a two-factor model for the HRQoL questionnaire QLQ-C30.Methods From participants in the Bladder Cancer Prognoses Programme, a multicentre cohort study, sociodemographic data were collected using semi-structured face-to-face interviews. Answers to the QLQ-C30 were transformed into a scale from 0 to 100. HRQoL data were analysed in multivariate analyses. The hypothesized two-factor (Physical and Mental Health) domain structure of the QLQ-C30 was also tested with confirmatory factor analyses (CFA).Results A total of 1160 participants (78%) completed the questionnaire after initial visual diagnosis and before pathological confirmation. Despite non-muscle-invasive bladder cancer (NMIBC) being associated with a higher HRQoL than carcinoma invading bladder muscle, only the domain Role Functioning was clinically significantly better in patients with NMIBC. Age, gender, bladder cancer stage and comorbidity all had a significant influence on QLQ-C30 scores. The CFA showed an overall good fit of the hypothesized two-factor model.Conclusion This study identified a baseline reference value for HRQoL for patients with bladder cancer, which allows better evaluation of any changes in HRQoL as disease progresses or after treatment. In addition, a two-factor (Physical and Mental Health) model was developed for the QLQ-C30