Eva Nagele

Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials

Breast cancer is the leading cause of cancer death among women worldwide, and increasingly, randomised controlled trials of this disease are measuring the health-related quality of life of these patients. In this systematic Review, we assess the adequacy of methods used to report health-related quality of life (HRQOL) from 49 eligible randomised controlled trials of advanced breast cancer. We compare our findings with those from the literature to investigate whether the standard of HRQOL reporting in this field has changed. We conclude that the overall reporting of HRQOL has improved, but some crucial aspects remain problematic, such as the absence of HRQOL research hypotheses and the overemphasis on statistical rather than clinical significance. Additionally, new challenges are arising with the emergence of novel treatments and the advent of personalised medicine, and improved HRQOL tools are required to cover the range of side-effects of newer therapies.

Clinical effectiveness of stress-reduction techniques in patients with hypertension: systematic review and meta-analysis.

Objective: A systematic review and meta-analysis focusing on patient-relevant outcomes and blood pressure was conducted to assess the clinical effectiveness of stress-reduction techniques in adults with essential hypertension. Methods: Systematic reviews and randomized controlled trials (RCTs) were identified as part of a systematic search in six electronic databases ending September 2012. RCTs comparing stress-reduction techniques versus no such techniques with a follow-up of at least 24 weeks and published in English or German were included. Outcomes of interest were death, cardiovascular morbidity/mortality, end-stage renal disease, health-related quality of life, adverse events, changes in blood pressure, and changes in antihypertensive medication. When appropriate, meta-analyses were used to combine data. Results: Seventeen RCTs analyzing different stress-reduction techniques such as biofeedback, relaxation or combined interventions were identified. Data were not reported for most of the patient-relevant outcomes, and meta-analyses could only be used to evaluate effects on blood pressure. The data indicated a blood pressure-lowering effect, but the studies had methodological shortcomings and heterogeneity between them was high. Mean group differences for DBP ranged from −10 to 1 mmHg and for SBP from −12 to 10 mmHg. In terms of antihypertensive medication, no favorable effects of stress-reduction techniques could be identified. Conclusions: The available RCTs on stress-reduction techniques used for at least 24 weeks appeared to indicate a blood pressure-lowering effect in patients with essential hypertension, but this should be interpreted with caution because of major methodological limitations. A benefit of specific stress-reduction techniques in hypertensive patients remains unproven.

The impact of resilience on psychological outcomes in women after preeclampsia: an observational cohort study

BackgroundPreeclampsia is a frequent obstetric complication which affects the mother`s and the fetus’s health and can be life threatening. It also has an impact on psychological outcomes. There may be protective variables such as resilience shielding against psychosocial distress in women experiencing these pregnancy complications. The aim of this study was to examine differences in resilience in terms of quality of life, depression and post-traumatic stress symptoms in women after preeclampsia.MethodsFour international validated questionnaires were used to measure the psychological outcomes (Medical Outcome Study Short-Form SF12, Edinburgh Postnatal Depression Scale EPDS, Resilience Scale RS13, Impact of Event Scale IES-R). Statistical analyses were performed using independent-samples t-test and chi-square test.Results67 women with previous preeclampsia returned the questionnaires. Women with high resilience showed significantly less depression (p = 0.001) and better mental quality of life (p = 0.002) compared to women with low resilience. No group differences were found on the medical and socio-demographic characteristics.ConclusionsResilience has an important impact on the psychological outcomes in women after preeclampsia. A screening for resilience, depression and quality of life may be appropriate to identify these women.

How to evaluate sexual health in cancer patients : Development of the EORTC sexual health questionnaire for cancer patients

Background The aim of the study is to describe the development of a comprehensive European Organisation for Research and Treatment of Cancer (EORTC) questionnaire to assess sexual health of female and male cancer patients and for cancer survivors. Methods According to the EORTC guidelines, the development of an EORTC sexual health questionnaire is typically organised in four phases. The first phases comprise a literature search following interviews with patient and health care professionals (HCPs) (phase 1) and the operationalization into items (phase 2). The translation process is formally conducted according to the EORTC QLG Translation guidelines with a rigorous forward-backward procedure supported by native speakers. Results Studies on sexuality in oncology patients which were identified by a literature search predominantly focused on issues of activity, experiences of sexual dysfunction, and satisfaction with sexual functioning. The literature review identified themes beyond these aspects. In total 53 potentially relevant issues were presented to 107 patients and 83 HCPs, different evaluations were found. Conclusions A questionnaire that includes physical, psychological, and social aspects of sexuality of cancer survivors will be needed. Pre-testing and validation of the questionnaire will be done in future (phases 3 and 4). Divergent ratings of patients and professionals should be further investigated.

Phase 1-3 of the cross-cultural development of an EORTC questionnaire for the assessment of sexual health in cancer patients: the EORTC SHQ-22

To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ‐22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in‐depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross‐cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbachs alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22‐item short questionnaire resulted in a change of wording in five items and two communication‐related items; no items were removed. Preliminary psychometric analysis revealed a two‐factor solution and 11 single items; both scales showed good reliability indicated by a Cronbachs alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross‐cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large‐scale, cross‐cultural field testing of the EORTC SHQ‐22, has commenced.