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Validation of the German prostate-specific module
Abstract
Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.
... Beginning in 1996, Kuechler and co-workers developed a prostate-specific module (PSM) in a process similar to the guidelines for the development of tumour-and therapy-specific modules established by the EORTC Study Group on QoL. 5 The prostate cancer module consists of 36 items addressing therapy and prostate cancer-specific issues such as change of sexual problems, urinary problems or treatment strain leading to the scales 'urinary problems', 'incontinence', 'erectile dysfunction', 'sexual problems', 'problems with partner', 'pain', 'heat', 'nutrition' and 'psychic strain'. 6 Predominant symptoms in prostate cancer patients are erectile dysfunction and urinary problems. Within Europe and especially Germany, there is an ongoing debate on what symptoms are prostate cancer associated and what amount of symptoms is normal in men with increasing age. ...
... This sample consists of N ¼ 950 patients following either radical prostatectomy or radiation therapy. 6 The patients following radiotherapy were a little older than the prostatectomy patients; furthermore, they tend to have higher tumor stages. Therefore, in order to reduce this bias and to keep the groups (radiotherapy vs prostatectomy) comparable, the sample was restricted solely to a subsample of N ¼ 375 patients with low or intermediate risk according to international classification standards. ...
... The PSM was used in several (mainly historical cohort) studies in Germany and has been psychometrically tested using data from an empirical meta-analysis. 6 The PSM scales are scored according to the EORTC QLQ-C30 symptom scales ranging from 0 to 100, with high values representing a high level of symptomatology/ poor QoL. ...
Predominant symptoms in prostate cancer patients are erectile dysfunctions and urinary problems. As decreases of these functions can be attributed to disease and treatment but also to age-related decreases, we conducted a study on a German reference population measuring general quality of life (QoL) as well as prostate-specific symptoms. In cooperation with a German health insurance company, 3000 questionnaires were mailed to a randomly selected sample of men aged 45-75 years. Questionnaires used were the EORTC QLQ-C30 and a prostate-specific module (PSM). One thousand one hundred and fifty questionnaires were returned (response rate: 37.6%). QoL data from this reference population were compared to QoL data from a historical cohort study of prostate cancer patients following either prostatectomy or radiotherapy. In terms of general QoL, the reference population showed similar QoL scores as prostatectomy patients, but better scores than radiotherapy patients. On the PSM, the reference sample showed better overall QoL, but a surprisingly high extent of erectile dysfunction, urinary problems and psychic strain. Taking into account the sensitive topic of this study (sexuality and urinary problems), the response rate is more than satisfying. Older men in our randomly selected, population-based sample do not show perfect erectile and urinary function. These findings should be considered when interpreting QoL data of prostate cancer patients.
... Cancer-specific HRQOL, prostate-specific HRQOL, and sexual functioning were measured by validated questionnaires (see below). Urinary functioning, which is of interest as it is often compromised after RT, was measured by the best available instrument in German language at that time, the Prostate Specific Module (PSM) [22]. However, in our study cohort the PSM was found to have insufficient psychometric properties for some of the PSM scales and the data was, therefore, not considered in this analysis. ...
This study describes and compares health-related quality of life (HRQOL) of prostate cancer patients who received either radical prostatectomy (nerve-sparing, nsRP, or non-nerve-sparing, nnsRP) or radiotherapy (external RT, brachytherapy, or both combined) for treatment of localised prostate cancer.
The prospective, multicenter cohort study included 529 patients. Questionnaires included the IIEF, QLQ-C30, and PORPUS-P. Data were collected before (baseline), three, six, twelve, and twenty-four months after treatment. Differences between groups' baseline characteristics were assessed; changes over time were analysed with generalised estimating equations (GEE). Missing values were treated with multiple imputation. Further, scores at baseline and end of follow-up were compared to German reference data.
The typical time trend was a decrease of average HRQOL three months after treatment followed by (partial) recovery. RP patients experienced considerable impairment in sexual functioning. The covariate-adjusted GEE identified a significant - but not clinically relevant - treatment effect for diarrhoea (b = 7.0 for RT, p = 0.006) and PORPUS-P (b = 2.3 for nsRP, b = 2.2 for RT, p = 0.045) compared to the reference nnsRP. Most of the HRQOL scores were comparable to German norm values.
Findings from previous research were reproduced in a specific setting of a patient cohort in the German health care system. According to the principle of evidence-based medicine, this strengthens the messages regarding treatment in prostate cancer and its impacts on patients' health-related quality of life. After adjustment for baseline HRQOL and other covariates, RT patients reported increased symptoms of diarrhoea, and nnsRP patients decreased prostate-specific HRQOL. RP patients experienced considerable impairment in sexual functioning. These differences should be taken into account by physicians when choosing the best therapy for a patient.
... Several older versions of the PR25 came up in our literature search, 52,53 but they were not included in the current review because they are precursors to the PR25 and are no longer in use. The German prostate-specific module 25 is also designed as a module to accompany the QLQ-C30 to measure outcomes for patients with localized or advanced disease, and has been validated for prostate cancer patients in German speakers. The FACT-P 23 was designed to aid in the management of prostate cancer for use in clinical trials and clinical practice evaluation, and is available in 50 languages. ...
It is critical for prostate cancer researchers and clinicians to have access to comprehensive, sensitive and simple-to-use symptom measures that allow them to understand and quantify the subjective patient experience. The purpose of the current review is to provide a comprehensive review, detailed tool descriptions and objectively defined quality criteria to facilitate tool choices for patients with localized prostate cancer. Using a systematic web-based literature search, we found n=29 prostate symptom measures described in n=35 validation studies. To be recommended, tools needed to meet four criteria: broad domain coverage, ability to differentiate objective and subjective experience, good internal consistency and validation in at least two populations and/or having achieved two types of validations. Of the 29 tools reviewed, n=7 meet our criteria for recommendation, and three in particular (the EPIC-26 (Expanded Prostate Cancer Index Composite)-26, PC-QOL (Prostate Cancer-Quality of Life) and the UCLA-PCI (UCLA Prostate Cancer Index)) showed the strongest psychometrics. There is a reasonable number of measures to choose from that meet criteria for good psychometrics.Prostate Cancer and Prostatic Disease advance online publication, 5 February 2013; doi:10.1038/pcan.2013.1.
... Diese unerwünschten Therapiewirkungen nehmen Einfluss auf die gesundheitsbezogene Lebensqualität und sind möglicherweise für den Patienten entscheidend bei der Therapiewahl. Bis vor Kurzem existierte zur Erfassung der prostataspezifischen Lebensqualität bei Patienten mit PCa im deutschen Sprachraum nur ein validiertes, umfangreiches Messinstrument: das prostataspezifische Modul der Arbeitsgruppe Küchler (Referenzzentrum Lebensqualität in der Onkologie, UK-SH Campus Kiel) [7,8] Ein 10 Fragen umfassender Fragebogen zur Erhebung der prostataspezifischen Lebensqualität wurde von der kanadischen Arbeitsgruppe um Murray Krahn vorgelegt. Der PORPUS ("Patient Outcomes Record of Psychometric and Utility Self-Report" [10] oder auch "Patient-Oriented Prostate Utility Scale" [11]) kann in der englischen Version als "Utility Index" (PORPUS-U) oder als Profilinstrument (PORPUS-P) eingesetzt werden [10,11]. ...
In der Therapie maligner Erkrankungen sind Mechanismen zur Therapiesteuerung unerlässlich, um einerseits den Behandlungserfolg an der Veränderung der Tumormanifestationen beurteilen zu können und andererseits Beeinträchtigungen des Patienten durch das Nebenwirkungsspektrum der Medikation und den damit verbundenen Einfluss auf seine Lebensqualität frühzeitig zu erfassen. Die Instrumente zur Therapiesteuerung einer medikamentösen Tumortherapie sind vielfältig und unterliegen einem stetigen Wandel. Bei jeder Form der Behandlung einer Erkrankung sind Instrumente zur Beurteilung des Therapieerfolgs unabdingbar. Dieses trifft insbesondere für die Behandlung lokal fortgeschrittener und/oder metastasierter Malignome zu, da die Unkenntnis über die aktuelle Situation der Tumorerkrankung negative Auswirkungen für den Patienten in Bezug auf das Gesamtüberleben und auch die Lebensqualität haben kann. Die derzeit am häufigsten eingesetzten Messinstrumente in der Therapiesteuerung der medikamentösen Tumortherapie sind:Anamnese, klinische Untersuchung, konventionelle Laborparameter,konventionelle bildgebende Verfahren,Tumormarker.Eine zunehmende Bedeutung ist für folgende Verfahren anzunehmen:funktionelle und molekulare Bildgebung,zirkulierende Tumorzellen,Lebensqualitätsuntersuchungen. Anamnese, klinische Untersuchung, konventionelle Laborparameter, konventionelle bildgebende Verfahren, Tumormarker. funktionelle und molekulare Bildgebung, zirkulierende Tumorzellen, Lebensqualitätsuntersuchungen.
Lebensqualität (LQ) ist nach der Überlebenszeit das wichtigste Behandlungsziel für Krebspatienten. Dies gilt von der Diagnosestellung an für den gesamten Krankheits- und Behandlungsverlauf. Für Patienten mit nicht malignen bzw. nicht lebensbedrohlichen Erkrankungen sind Lebensqualität oder spezifische Aspekte davon zum Teil sogar primäre Therapieziele.
Context
Prostate cancer (PCa) is the second most common cancer among men worldwide. Urinary, bowel, and sexual function, as well as hormonal symptoms and health-related quality of life (HRQoL), were prioritised by patients and professionals as part of a core outcome set for localised PCa regardless of treatment type.
Objective
To systematically review the measurement properties of patient-reported outcome measures (PROMs) used in localised PCa and recommend PROMs for use in routine practice and research settings.
Evidence acquisition
The psychometric properties of PROMs measuring functional and HRQoL domains used in randomised controlled trials including patients with localised PCa were assessed according to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology. MEDLINE and Embase were searched to identify publications evaluating psychometric properties of the PROMs. The characteristics and methodological quality of the studies included were extracted, tabulated, and assessed according to the COSMIN criteria.
Evidence synthesis
Overall, 27 studies evaluating psychometric properties of the Expanded Prostate Cancer Index Composite (EPIC), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), European Organisation for Research and Treatment of Cancer (EORTC) quality of life core 30 (QLQ-C30) and prostate cancer 25 (QLQ-PR25) modules, International Index of Erectile Function (IIEF), and the 36-item (SF-36) and 12-item Short-Form health survey (SF-12) PROMs were identified and included in the systematic review. EPIC and EORTC QLQ-C30, a general module that assesses patients’ physical, psychological, and social functions, were characterised by high internal consistency (Cronbach’s α 0.46–0.96 and 0.68–0.94 respectively) but low content validity. EORTC QLQ-PR25, which is primarily designed to assess PCa-specific HRQoL, had moderate content validity and internal consistency (Cronbach’s α 0.39–0.87). UCLA-PCI was characterised by moderate content validity and high internal consistency (Cronbach’s α 0.21–0.94). However, it does not directly assess hormonal symptoms, whereas EORTC QLQ-PR25 does.
Conclusion
The tools with the best evidence for psychometric properties and feasibility for use in routine practice and research settings to assess PROMs in patients with localised PCa were EORTC QLQ-C30 and QLQ-PR25. Since EORTC QLQ-C30 is a general module that does not directly assess PCa-specific issues, it should be adopted in conjunction with the QLQ-PR25 module.
Patient summary
We reviewed and appraised the measurement properties of patient-reported outcome measure questionnaires used for patients with localised prostate cancer. We found good evidence to suggest that two questionnaires (EORTC QLQ-C30 and QLQ-PR25) can be used to measure urinary, bowel, and sexual functions and health-related quality of life.
Nicht nur in Hinblick auf die demographische Entwicklung deutet sich an, dass die Zahl der Lebensqualitätsstudien in der Uroonkologie weiter zunehmen wird. Nur wenn ein hoher wissenschaftlicher Standard aufrechterhalten wird, sind die Ergebnisse auch interpretierbar.
Für das Prostatakarzinom, teilweise auch für das Hodenkarzinom liegt bereits ein Fundus an „Lebensqualitätswissen“ vor, auf dem sich aufbauen lässt. Für das Nierenzellkarzinom und insbesondere das Blasenkarzinom wird dies in den nächsten Jahren geschehen. Es wird weiterhin darum gehen, Lebensqualitätsdaten nicht nur mit Mortalitäts- und Morbiditätsdaten zu verbinden, sondern diese Daten auch mit ökonomischen Daten zu verknüpfen sowie Langzeitüberlebende und deren gesundheitsbezogene Lebensqualität stärker in den Blick zu nehmen.
Am wichtigsten wird es jedoch sein, Lebensqualitätsmessungen in die Evaluation neuerer Therapieverfahren zu integrieren, sei es bei chirurgischen, onkologischen, radiologischen oder kombinierten (neo-)adjuvanten Therapieschemata. Denn nur auf diese Weise wird sich nachhaltig zeigen lassen, dass die Uroonkologie einen messbaren Beitrag zu einem echten Fortschritt bei Patienten mit potenziell lebensbedrohenden urologischen Erkrankungen leistet.
In der Therapie maligner Erkrankungen sind Mechanismen zur Therapiesteuerung unerlässlich, um einerseits den Behandlungserfolg an der Veränderung der Tumormanifestationen beurteilen zu können und andererseits Beeinträchtigungen des Patienten durch das Nebenwirkungsspektrum der Medikation und den damit verbundenen Einfluss auf seine Lebensqualität frühzeitig zu erfassen. Die Instrumente zur Therapiesteuerung einer medikamentösen Tumortherapie sind vielfältig und unterliegen einem stetigen Wandel.
Lebensqualität (LQ)ist nach der Überlebenszeit das wichtigste Behandlungsziel für Krebspatienten. Dies gilt von der Diagnosestellung an für den gesamten Krankheits- und Behandlungsverlauf.Für Patienten mit nicht malignen bzw.nicht lebensbedrohlichen Erkrankungen sind Lebensqualität oder spezifische Aspekte davon primäre Therapieziele. Gesundheitsbezogene Lebensqualität ist heute mit naturwissenschaftlichen Methoden zuverlässig messbar.Es lassen sich so Auswirkungen von Krankheit und Therapie systematisch darstellen und vergleichen. Dies gilt insbesondere für die Uroonkologie,aber auch für das Gesamtgebiet “Urologie„.
In der Therapie maligner Erkrankungen sind Mechanismen zur Therapiesteuerung unerlässlich, um einerseits den Behandlungserfolg an der Veränderung der Tumormanifestationen beurteilen zu können und andererseits Beeinträchtigungen des Patienten durch das Nebenwirkungsspektrum der Medikation und den damit verbundenen Einfluss auf seine Lebensqualität frühzeitig zu erfassen. Die Instrumente zur Therapiesteuerung einer medikamentösen Tumortherapie sind vielfältig und unterliegen einem stetigen Wandel.
Background and Objectives The PORPUS-P is a short questionnaire for measuring prostate-specific related quality of life. The aim of the present study was to test psychometric properties (reliability, concurrent validity) of the German version of this instrument when applied to the general population. Furthermore, discriminant validity was tested by application of this questionnaire to patients with erectile dysfunction, prostate cancer patients with radiotherapy or radical prostatectomy. Patients and Methods Data sets of three studies were combined (San BKK-study, ProCaSP-study, CHEDY-study). In total, the study sample consisted of 988 men from the general population, 87 prostate cancer patients with radiotherapy, 274 prostate cancer patients with radical prostatectomy, and 48 men with erectile dysfunction. All men were assessed with PORPUS-P, EQ-5D, and EORTC QLQ-C30. Psychometric properties were tested with between-subgroup-differences (Mann-Whitney U-test, Kruskal-Wallis H-test, binary logistic regression analysis), computing age adjusted means, cronbach's alpha, correlation coefficients, and estimating floor and ceiling effects. Results The study sample consists of 988 men from the general population (mean age: 56 yrs), 87 prostate cancer patients with radiotherapy (67 yrs), 274 prostate cancer patients with radical prostatectomy (63 yrs), and 48 men with erectile dysfunction (58 yrs). Our analyses indicate that PORPUS-P is a valid tool to assess prostate-specific quality of life: Full-scale correlations between the instruments (PORPUS-P vs. EORTC QLQ-C30 global health, EQ-5D VAS and EQ-5D index value; rs range= 0.518-0.630; p<0.001) indicate validity as do correlations of key subscales. PORPUS-P is able to discriminate between different health status, age groups and categories of sociodemographic variables. Floor effects were seen regarding the answering scheme of some of the PORPUSitems. Conclusion Our data give evidence of the construct, discriminant, and concurrent validity as well as internal consistency. However, some PORPUS-items showed floor effects. In general, floor effects were more strongly pronounced in reference men than in erectile dysfunction or prostate cancer patients. We recommend the use of PORPUS-P in cases of study situations in combination with other generic questionnaires such as EORTC QLQC30. In cases of clinical routine PORPUS-P can be used as a "stand-alone solution".
Introduction: In German-speaking countries only one validated questionnaire asking for prostate-specific quality of life existed until summer 2009 (PSM; but since then the German version of EORTC QLQ-PR25 was available). After a translation of the English version of PORPUS into German we wanted to show psychometric properties of the translated questionnaire. Materials and Methods: Sensitivity to change and validity were proven with data from the San-BKK- (general population, one questioning), the CHEDY- (men with erectile dysfunction, one questioning) and the ProCaSP-study (men with localized prostate cancer [PCa]), initial questioning and 4 follow-up surveys within 2 years). Each study focused on quality of life as a primary endpoint. Quality of life was measured with multiple questionnaires, e. g. EORTC QLQC30, EQ-5D, and PORPUS-P. Results: Data were derived from 988 men of the general population (mean age 56 years), 87 PCa-patients with radiotherapy (67 years), 274 PCa-patients with radical prostate ectomy (63 years), and 48 men with erectile dysfunction (58 years). Different quality of life-scales correlated with each other and proved convergence validity (PORPUS-P vs. EORTC QLQ-C30 global health, EQ-5D VAS and EQ-5D index value; range rs = 0.518-0.630; each p < 0.001). Furthermore, PORPUS-P differed between age groups, health status, and social subgroups. The distribution of answers in the general population indicated sensitivity to change as well as the changes of answering patterns and changes of PORPUS-P in men with PCa (follow up for 2 years). Approximately 3.5 minutes are needed to complete PORPUS (10 items). Conclusion: PORPUS is another valid German questionnaire to evaluate prostate-specific quality of life. The advantage of PORPUS is its briefness, which allows a good acceptance and fits in busy clinical routines.
Reports on the quality of care aim at health and patient-reported outcomes in routine clinical care. To achieve meaningful information the study designs must be robust against bias through highly selected patient populations or health care providers but also allow for adequate control of confounding. The article describes the potential and pitfalls of administrative claims data and surveys of beneficiaries. The large potential of using both sources is illustrated in the primary inpatient treatment for prostate cancer. However, linking claims data and patient survey data still leaves some problems to be addressed in the final section. Linking claims data and beneficiary survey information on patient reported outcomes overcomes sectoral barriers and allows for an integrated evaluation of pathways of care in the short-, mid- and long-term. It is economical and well suited for a variety, but not all health care problems. Future efforts might be directed towards more collaboration among sickness funds.
© Georg Thieme Verlag KG Stuttgart · New York.
Background
The HAROW project was founded by the Stiftung Männergesundheit to have a closer look at the situation of patients who suffer from prostate cancer, especially focusing on their situation regarding supply and services.
Methods
In the current study 504 members of support groups were asked about their health-related quality of life (QOL). Standardized questionnaires were used to ensure the validation. Both the diagnosis and initial therapy dated back at least 12 months. The EORTC QLQ-C30 as well as the prostate-specific module (PSM) were used as questionnaires.
Results
Various forms of therapies proved to have different impacts on QOL. Patients with a combined hormonal therapy and radiation therapy evaluated their QOL worse than others with different forms of therapies. Patients with cured tumors reported significantly better data than those in the middle of therapy or the uncured.
Conclusion
The data even indicate that their QOL is similar to people living under normal circumstances and health situations. Particular characteristics however exist on specific scales. Patients attending support groups show surprisingly high values for QOL.
Lebensqualität (LQ) ist nach der Überlebenszeit das wichtigste Behandlungsziel für Krebspatienten. Dies gilt von der Diagnosestellung
an für den gesamten Krankheits- und Behandlungsverlauf. Für Patienten mit nicht malignen bzw. nicht lebensbedrohlichen Erkrankungen
sind Lebensqualität oder spezifische Aspekte davon primäre Therapieziele. Gesundheitsbezogene Lebensqualität ist heute mit naturwissenschaftlichen Methoden zuverlässig messbar. Es lassen sich so Auswirkungen von Krankheit und Therapie
systematisch darstellen und vergleichen. Dies gilt insbesondere für die Uroonkologie, aber auch für das Gesamtgebiet »Urologie«.
The HAROW project was founded by the Stiftung Männergesundheit to have a closer look at the situation of patients who suffer from prostate cancer, especially focusing on their situation regarding supply and services.
In the current study 504 members of support groups were asked about their health-related quality of life (QOL). Standardized questionnaires were used to ensure the validation. Both the diagnosis and initial therapy dated back at least 12 months. The EORTC QLQ-C30 as well as the prostate-specific module (PSM) were used as questionnaires.
Various forms of therapies proved to have different impacts on QOL. Patients with a combined hormonal therapy and radiation therapy evaluated their QOL worse than others with different forms of therapies. Patients with cured tumors reported significantly better data than those in the middle of therapy or the uncured.
The data even indicate that their QOL is similar to people living under normal circumstances and health situations. Particular characteristics however exist on specific scales. Patients attending support groups show surprisingly high values for QOL.
The EORTC Study Group on Quality of Life (the Study Group) has adopted a modular approach to quality of life (QOL) assessment in cancer clinical trials. A 'core' instrument-the QLQ-C30-has been designed to cover a range of QOL issues relevant to a broad spectrum of cancer patients. It is intended that this QLQ-C30 be supplemented by more specific subscales ('modules') to assess aspects of QOL of particular importance to specific subgroups of patients. Since individual members of the Study Group were to be involved in module development, guidelines were required to standardize the module development process in order to ensure uniformly high quality across modules. These guidelines are presented in this paper. The term 'module' is defined, the composition of modules is outlined, and the criteria used to develop modules are specified. The module development process, consisting of four phases (generation of relevant QOL issues, operationalization of the QOL issues into a set of items, pretesting the module questionnaire, and large-scale field-testing) is described in detail. Further, issues related to cross-cultural instrument development, and the need for monitoring the module development process from within the Study Group are discussed. Finally, experiences with developing two site-specific modules (i.e., for head and neck, and breast cancer), are presented and the extent to which the guidelines meet practical requirements is discussed. The guidelines appear to provide a practical tool for module construction, that can facilitate the development of a comprehensive system for assessing the QOL of cancer patients internationally.
In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials.
We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included.
The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity.
The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe.
These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
Quality of Life Assessment has progressed considerably since the publication of the first highly acclaimed edition of this book in 1998. Quality of life has now become an indispensable outcome measure in many randomised clinical trials and other studies. Thus, it is timely to provide not just an update, but a completely new edition that reviews the current state of art and also discusses topical issues including areas where active research is in progress. The first section discusses the development and evaluation of generic and disease-targeted questionnaires. Having decided the items to be included the thrust of the next section covers how to convert these into usable forms. Section 3 addressing analysis and the methods of analysing studies with missing data is followed by chapters on interpretation of results and exploring the role of single-item questions. The final section of the book looks beyond the individual clinical trial and how we can use clinical trial and other data to make macro-decisions. A strong international team of experts cover a wide range of topics, emphasizing new and innovative approaches that are of practical and clinical importance, reviewing the current state of the art and illustrating the benefits and potential of health related quality of life assessment in clinical trials.
The need for accurate measures of health-related quality of life (HRQOL) in men treated for prostate cancer is of paramount importance because patients may survive for many years after their diagnosis. Hence, interest has increased in choosing treatments that optimize both the quality and quantity of life in patients with this disease. This study sought to develop and evaluate a self-administered, multiitem, disease-specific instrument to capture the health concerns central to the quality of life of men treated for early stage prostate cancer. After focus group analysis and pilot testing, the instrument was tested with a large retrospective, cross-sectional survey. Exploratory factor analysis and multitrait scaling analysis were used to facilitate the formation of six scales containing 20 disease-targeted items that address impairment in the urinary, bowel, and sexual domains. The psychometric properties of the new scales were assessed by measuring test-retest reliability, internal consistency reliability, and construct validity. Performance on the new scales was compared with scores on other established cancer-related health-related quality of life instruments. Two hundred fifty-five long-term survivors of prostate cancer treatment and 273 age-matched and ZIP code-matched comparison subjects without prostate cancer from a large managed care population in California were studied. Mean age was 72.7 years. In addition to the new scales, the RAND 36-Item Health Survey (SF-36) was used as a generic core measure, and a cancer-related health-related quality of life instrument (the Cancer Rehabilitation System-Short Form) was used to provide construct validity. For the new scales, test-retest reliability ranged from 0.66 to 0.93, and internal consistency ranged from 0.65 to 0.93. Disease-targeted measures of function and bother in the three domains correlated substantially with one another. Scale scores correlated well with related, established scales. Men undergoing prostatectomy or pelvic irradiation demonstrated the expected differences in performance on the disease-specific health-related quality of life scales when compared with each other or with comparison subjects. Age was inversely related to sexual and bowel function. The UCLA Prostate Cancer Index performed well in this population of older men with and without prostate cancer. It demonstrated good psychometric properties and appeared to be well understood and easily completed. The high response among patients suggests that these men especially are interested in addressing both the general and disease-specific concerns that impact their daily quality of life.
Explains how social scientists can evaluate the reliability and validity of empirical measurements, discussing the three basic types of validity: criterion related, content, and construct. In addition, the paper shows how reliability is assessed by the retest method, alternative-forms procedure, split-halves approach, and internal consistency method.
The EORTC Study Group on Quality of Life (the Study Group) has adopted a modular approach to quality of life (QOL) assessment in cancer clinical trials. A ‘core’ instrument—the QLQ-C30—has been designed to cover a range of QOL issues relevant to a broad spectrum of cancer patients. It is intended that this QLQ-C30 be supplemented by more specific subscales (‘modules’) to assess aspects of QOL of particular importance to specific subgroups of patients. Since individual members of the Study Group were to be involved in module development, guidelines were required to standardize the module development process in order to ensure uniformly high quality across modules. These guidelines are presented in this paper. The term ‘module’ is defined, the composition of modules is outlined, and the criteria used to develop modules are specified. The module development process, consisting of four phases (generation of relevant QOL issues, operationalization of the QOL issues into a set of items, pretesting the module questionnaire, and large-scale field-testing) is described in detail. Further, issues related to cross-cultural instrument development, and the need for monitoring the module development process from within the Study Group are discussed. Finally, experiences with developing two site-specific modules (i.e., for head and neck, and breast cancer), are presented and the extent to which the guidelines meet practical requirements is discussed. The guidelines appear to provide a practical tool for module construction, that can facilitate the development of a comprehensive system for assessing the QOL of cancer patients internationally.
Thesis (doctoral)--Christian-Albrechts-Universität zu Kiel, 2000.
To the Editor.
—I concur with Dr Catalona and colleagues1 regarding the goal of increasing the detection of prostate cancer and was interested in their use of a lower serum PSA level, 2.6 ng/mL, on which to base prostate biopsy. However, in our current economic climate, we must turn a critical eye toward all new diagnostic testing, especially those tests that are expensive. The authors of this study have not shown convincing evidence of the need for an additional test, that of free PSA. They indicate a positive predictive value of 22% by using the PSA alone in their study population of 317 men who had total PSA levels between 2.5 and 4.0 ng/mL and who underwent needle biopsy. They then state,Using a free PSA cutoff of 27% as a criterio for biopsy would have detected 90% of the cancers and avoided 18% of unnecessary biopsies, yielding a positive predictive value of 24% in the men who underwent biopsy. Therefore, percentage of free PSA would provide
The need for accurate measures of health-related quality of life (HRQOL) in men treated for prostate cancer is of paramount importance because patients may survive for many years after their diagnosis. Hence, interest has increased in choosing treatments that optimize both the quality and quantity of life in patients with this disease. This study sought to develop and evaluate a self-administered, multiitem, disease-specific instrument to capture the health concerns central to the quality of life of men treated for early stage prostate cancer.
After focus group analysis and pilot testing, the instrument was tested with a large retrospective, cross-sectional survey. Exploratory factor analysis and multitrait scaling analysis were used to facilitate the formation of six scales containing 20 disease-targeted items that address impairment in the urinary, bowel, and sexual domains. The psychometric properties of the new scales were assessed by measuring test-retest reliability, internal consistency reliability, and construct validity. Performance on the new scales was compared with scores on other established cancer-related health-related quality of life instruments. Two hundred fifty-five long-term survivors of prostate cancer treatment and 273 age-matched and ZIP code-matched comparison subjects without prostate cancer from a large managed care population in California were studied. Mean age was 72.7 years. In addition to the new scales, the RAND 36-Item Health Survey (SF-36) was used as a generic core measure, and a cancer-related health-related quality of life instrument (the Cancer Rehabilitation System-Short Form) was used to provide construct validity.
For the new scales, test-retest reliability ranged from 0.66 to 0.93, and internal consistency ranged from 0.65 to 0.93. Disease-targeted measures of function and bother in the three domains correlated substantially with one another. Scale scores correlated well with related, established scales. Men undergoing prostatectomy or pelvic irradiation demonstrated the expected differences in performance on the disease-specific health-related quality of life scales when compared with each other or with comparison subjects. Age was inversely related to sexual and bowel function.
The UCLA Prostate Cancer Index performed well in this population of older men with and without prostate cancer. It demonstrated good psychometric properties and appeared to be well understood and easily completed. The high response among patients suggests that these men especially are interested in addressing both the general and disease-specific concerns that impact their daily quality of life.
Brachytherapy with 103palladium (103Pd) is an increasingly administered treatment modality for localized prostate cancer. We compared general and disease specific health related quality of life after 103Pd treatment, radical prostatectomy and external beam radiation therapy given during the same time frame.
We performed a retrospective cross-sectional survey study of patients treated at a single community medical center between 1995 and 1999. We mailed 5 validated health related quality of life survey instruments to 269, 142 and 222 men who underwent radical prostatectomy, 103Pd treatment and external beam radiation therapy, respectively, with a response rate of greater than 80% in all groups.
General health related quality of life assessed by the SF-36 showed the same scores in patients who underwent prostatectomy and 103Pd treatment. The University of California-Los Angeles Prostate Cancer Index was used to assess bowel, urinary and sexual function/bothersomeness. External beam radiation therapy reported was associated with worse bowel function and greater bowel bothersomeness. Prostatectomy was associated with worse urinary function compared to 103Pd and external beam radiation therapy. Prostatectomy was associated with worse sexual function than 103Pd or external beam radiation therapy, although nerve sparing surgery and erectile aids minimized the difference. American Urological Association symptom scores were initially higher for 103Pd but became equal to those in the other groups in patients treated greater than 12 months from survey time. Disease-free men who underwent prostatectomy and 103Pd brachytherapy were equally confident that cancer would not recur in the future. Satisfaction rates were equivalent and biochemical failure significantly decreased satisfaction in all groups.
While general health related quality of life was mostly unaffected by the 3 most common treatments for prostate cancer, there were differences in bowel, urinary and sexual function. This information may aid patients in the decision making process.
Entwicklung eines prostata-spezifischen Moduls zu Messung von Lebensqualität nach radikaler Prostatektomie
- C W Biermann
- A Semjonow
- L Hertle
- T Küchler
Ku¨ Reference Center Quality of Life in Oncology
- Deutsche Krebshilfe
- B Bestmann
- Ae J.-U Siebmann
- Ae
QLQ-C30 core questionnaire. Supported by a grant from ''Deutsche Krebshilfe e.V.'' B. Bestmann AE J.-U. Siebmann AE T. Ku¨ Reference Center Quality of Life in Oncology, Department of General and Thoracic Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Germany V. Rohde (&) AE W. Weidner Department of Urology and Pediatric Urology, Justus Liebig University Gießen, Rudolf-Buchheim-Str. 7, 35392 Gießen, Germany E-mail: vrohde@gmx.de Tel.: +49-641-9944505