Essink-Bot, M.L.E.

Informed decision-making in colorectal cancer screening using colonoscopy or CT-colonography (Article)

2013-06-01T00:00:00Z

Objective: To evaluate the level of informed decision making in a randomized controlled trial comparing colonoscopy and CT-colonography for colorectal cancer screening. Methods: 8844 citizens aged 50-75 were randomly invited to colonoscopy (. n=. 5924) or CT-colonography (. n=. 2920) screening. All invitees received an information leaflet. Screenees received a questionnaire within 4 weeks before the planned examination, non-screenees 4 weeks after the invitation. A decision was categorized as informed when characterized by sufficient decision-relevant knowledge and consistent with personal attitudes toward participation in screening. Results: Knowledge and attitude items were completed by 1032/1276 colonoscopy screenees (81%), by 698/4648 colonoscopy non-screenees (15%), by 824/982 CT-colonography screenees (84%) and by 192/1938 CT-colonography non-screenees (10%). 1027 colonoscopy screenees (>99%) and 815 CT-colonography screenees (99%) had adequate knowledge; 915 (89%) and 742 (90%) had a positive attitude. 675 non-screenees invited to colonoscopy (97%) and 182 invited to CT-colonography (95%) had adequate knowledge; 344 (49%) and 94 (49%) expressed a negative attitude. Conclusion: A large majority of screenees made an informed decision on participation. Almost half of responding non-screenees, made an uninformed decision, suggesting additional barriers to participation. Practice implications: Efforts to understand the additional barriers will create opportunities to facilitate informed participation to colorectal cancer screening.

Men's preferences for prostate cancer screening: a discrete choice experiment (Article)

2013-01-29T00:00:00Z

Background:Screening for prostate cancer (PC) may save lives, but overdiagnosis and overtreatment are serious drawbacks. We aimed to determine men's preferences for PC screening, and to elicit the trade-offs they make. Methods:A discrete choice experiment (DCE) was conducted among a population-based random sample of 1000 elderly men (55-75-years-old). Trade-offs were quantified with a panel latent class model between five PC screening aspects: risk reduction of PC-related death, screening interval, risk of unnecessary biopsies, risk of unnecessary treatments, and out-of-pocket costs. Results:The response rate was 46% (459/1000). Men were willing to trade-off 2.0% (CI: 1.6%-2.4%) or 1.8% (CI: 1.3%-2.3%) risk reduction of PC-related death to decrease their risk of unnecessary treatment or biopsy with 10%, respectively. They were willing to pay \[euro]188 per year (CI: \[euro]141-\[euro]258) to reduce their relative risk of PC-related death with 10%. Preference heterogeneity was substantial, with men with higher educational levels having a lower probability to opt for PC screening than men with lower educational levels. Conclusion:Men were willing to trade-off some risk reduction of PC-related death to be relieved of the burden of biopsies or unnecessary treatments. Increasing knowledge on overdiagnosis and overtreatment, especially for men with lower educational levels, is warranted to prevent unrealistic expectations from PC screening.British Journal of Cancer advance online publication, 29 January 2013; doi:10.1038/bjc.2013.5 www.bjcancer.com.

Burden of colonoscopy compared to non-cathartic CT-colonography in a colorectal cancer screening programme: Randomised controlled trial (Article)

2012-11-01T00:00:00Z

Objective: CT-colonography has been suggested to be less burdensome for primary colorectal cancer (CRC) screening than colonoscopy. To compare the expected and perceived burden of both in a randomised trial. Design: 8844 Dutch citizens aged 50-74 years were randomly invited for CRC screening with colonoscopy (n=5924) or CT-colonography (n=2920). Colonoscopy was performed after full colon lavage, or CT-colonography after limited bowel preparation (non-cathartic). All invitees were asked to complete the expected burden questionnaire before the procedure. All participants were invited to complete the perceived burden questionnaire 14 days later. Mean scores were calculated on 5-point scales. Results: Expected burden: 2111 (36%) colonoscopy and 1199 (41%) CT-colonography invitees completed the expected burden questionnaire. Colonoscopy invitees expected the bowel preparation and screening procedure to be more burdensome than CT-colonography invitees: mean scores 3.0±1.1 vs 2.3±0.9 (p<0.001) and 3.1±1.1 vs 2.2±0.9 (p<0.001). Perceived burden: 1009/1276 (79%) colonoscopy and 801/982 (82%) CT-colonography participants completed the perceived burden questionnaire. The full screening procedure was reported as more burdensome in CT-colonography than in colonoscopy: 1.8±0.9 vs 2.0±0.9 (p<0.001). Drinking the bowel preparation resulted in a higher burden score in colonoscopy (3.0±1.3 vs 1.7±1.0, p<0.001) while related bowel movements were scored more burdensome in CT-colonography (2.0±1.0 vs 2.2±1.1, p<0.001). Most participants would probably or definitely take part in a next screening round: 96% for colonoscopy and 93% for CT-colonography (p=0.99). Conclusion: In a CRC screening programme, colonoscopy invitees expected the screening procedure and bowel preparation to be more burdensome than CT-colonography invitees. In participants, CT-colonography was scored as more burdensome than colonoscopy. Intended participation in a next screening round was comparable.

Quality-of-life effects of prostate-specific antigen screening (Article)

2012-08-16T00:00:00Z

Background: After 11 years of follow-up, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported a 29% reduction in prostate-cancer mortality among men who underwent screening for prostate-specific antigen (PSA) levels. However, the extent to which harms to quality of life resulting from overdiagnosis and treatment counterbalance this benefit is uncertain. Methods: On the basis of ERSPC follow-up data, we used Microsimulation Screening Analysis (MISCAN) to predict the number of prostate cancers, treatments, deaths, and quality-adjusted life-years (QALYs) gained after the introduction of PSA screening. Various screening strategies, efficacies, and quality-of-life assumptions were modeled. Results: Per 1000 men of all ages who were followed for their entire life span, we predicted that annual screening of men between the ages of 55 and 69 years would result in nine fewer deaths from prostate cancer (28% reduction), 14 fewer men receiving palliative therapy (35% reduction), and a total of 73 life-years gained (average, 8.4 years per prostate-cancer death avoided). The number of QALYs that were gained was 56 (range, -21 to 97), a reduction of 23% from unadjusted life-years gained. To prevent one prostate-cancer death, 98 men would need to be screened and 5 cancers would need to be detected. Screening of all men between the ages of 55 and 74 would result in more life-years gained (82) but the same number of QALYs (56). Conclusions: The benefit of PSA screening was diminished by loss of QALYs owing to postdiagnosis long-term effects. Longer follow-up data from both the ERSPC and quality-of-life analyses are essential before universal recommendations regarding screening can be made. (Funded by the Netherlands Organization for Health Research and Development and others.) Copyright

Informing on prenatal screening for Down syndrome prior to conception. An empirical and ethical perspective (Article)

2012-03-01T00:00:00Z

In most Western countries, information on prenatal screening for Down syndrome is provided in the first-trimester of pregnancy. The purpose of this study was to examine whether this information should additionally be provided before pregnancy to improve the informed decision-making process. In an empirical study, we obtained data from pregnant women with respect to their preferences regarding information on prenatal screening preconceptionally. Questionnaire data (n=510) showed that 55.7% of responding women considered participating in prenatal screening for Down syndrome before pregnancy. 28.0% of women possessed information on prenatal screening preconceptionally. 84.6% preferred not to receive information preconceptionally in retrospect. In an ethical analysis, we elaborated on these preferences by weighing pros and cons. We considered two arguments against the provision of information on prenatal screening preconceptionally: women's preference to receive information in a step-by-step manner, and the risk of providing a directive message. We identified three reasons supporting its provision preconceptionally: the likelihood of making an informed decision could, firstly, be increased by "unchaining" the initial information from possible subsequent decisions, and, secondly, by providing women sufficient time to deliberate. Thirdly, the probability of equal access to prenatal screening may increase. To conclude with, we propose to incorporate an information offer on prenatal screening for Down syndrome in preconception care consultations. By offering information, instead of providing information, prospective parents are enabled to either accept or decline the information, which respects both their right to know and their right not-to-know.

Sexual function with localized prostate cancer: Active surveillance vs radical therapy (Article)

2012-01-20T00:00:00Z

Objective: To compare sexual function of men with localized prostate cancer (PCa) on active surveillance (AS) with similar patients who received radical therapy. Patients And Methods: Two groups of men with screening-detected localized PCa were compared. The first were men on AS within the prospective protocol-based Prostate Cancer Research International: Active Surveillance study. The second were men participating in the European Randomized Study of Screening for Prostate Cancer study who had received radical prostatectomy (RP) or radiation therapy (RT). Questionnaires were completed at two different timepoints after diagnosis or treatment (6 and 12-18 months). These contained 10 items on sexual function, the mental and physical component summary from the Short-Form 12-item health survey, the Center for Epidemiologic Studies Depression scale depression measure and the State Trait Anxiety Inventory general anxiety measure. Sexual function was compared between groups, and determinants were analysed in multivariable analysis, adjusting for baseline differences. Results: A total of 65-68% of men on AS, 35-36% of those who underwent RP, 36-37% of those who underwent RT and 36% of men in the RP and RT groups combined (combined Tx) were sexually active. A total of 20-30% of men in the AS group, 86-91% of men in the RP group, 56-60% of men in the RT group and 71-76% of men in the combined Tx group were sexually inactive as a result of erectile dysfunction. A total of 44-51% of men in the AS group, 96% of men in the RP group, 73-76% of men in the RT group and 84-85% of men in the combined Tx group who were sexually active had problems getting or keeping an erection. In multivariable analysis these differences were significant, except for AS vs RT. Conclusions: Men with localized PCa on AS were more often sexually active than similar men who received radical therapy, especially RP. If not sexually active, this was less often attributable to erectile dysfunction for those on AS. If sexually active, this was less often associated with problems getting or keeping an erection for those on AS. The study was non-randomized; the latest advances in RP and RT might impact results. © 2012 THE AUTHORS. BJU INTERNATIONAL

Authors' response to letter from Bond et al. the role of ad-hoc interpreters in teaching communication skills with ethnic minorities (Article)

2012-01-01T00:00:00Z

Perceived discrimination outside health care settings and health care utilization of Turkish and Moroccan GP patients in the Netherlands (Article)

2012-01-01T00:00:00Z

Background: Problematic interethnic relationships, expressed by feelings of discrimination, may contribute to ethnic variations in health and health care utilization. The impact of daily perceived discrimination on (mental) health has been shown. Less is known about the effect of everyday discrimination on the health care utilization. We examined the relationship between perceived discrimination of Turkish and Moroccan patients on GP health care utilization in the Netherlands and on health services use in the home country. Methods: Cohort study within the second Dutch National Survey of General Practice (2001). Interviews were conducted with 416 Turkish and 381 Moroccan respondents, and repeated in 2005 among respectively 118 and 102 participants. Linear, logistic and zero-inflated binomial regression models were used for the analyses. Results: Perceived discrimination was associated with non-attendance to the GP. Perceived quality of GP care was not a mediator in this relationship. No evidence was found for substitution of health care utilization in the home country to health care in the host country. GP attenders had higher odds of using health care in the home country than non-attenders. Over time, a lasting discrimination feeling was related to persistent non-attendance at the GP practice. Conclusion: Ethnic minority patients who feel discriminated may avoid GP health care. Further research is warranted on magnitude and health effects of such potential underutilization. Information on perceived discrimination within health care settings would increase insight into the profile of non-attenders, and on possible measures to better target interventions at a group at risk of underutilization.

Informed choice on Pap smear still limited by lack of knowledge on the meaning of false-positive or false-negative test results (Article)

2011-11-01T00:00:00Z

Objective: Screening for cervical cancer may have favourable or unfavourable effects at the individual level. This study assesses whether invitees in the Netherlands made an informed choice about screen uptake. Methods: Attached to the invitation letter and the information leaflet, screen invitees were sent a questionnaire. An informed decision was defined as based on decision-relevant knowledge, while the woman's attitude was consistent with her actual screening behaviour. Results: Of all cervical screen participants, 60% (924/1551) responded to the questionnaire. Decision-relevant knowledge was sufficient in 595 women. Especially knowledge about false-positive and false-negative test results was limited. The attitude towards cervical screening was mainly positive (99%). Requirements for informed decision making were met in 571 (68%) women and in 91% when an alternative cut-off point of sufficient decision-relevant knowledge was applied. Most frequently reported main reasons to attend were early detection of abnormalities (67%) and reassurance in case of a normal smear (22%). Conclusion: Insufficient decision-relevant knowledge was the main cause of uninformed attendance. Practice implication: Adequate strategies to provide invitees with sufficient decision-relevant information are still needed, especially regarding false-positive and false-negative test results.

Teaching communication with ethnic minority patients: Ten recommendations (Article)

2011-10-01T00:00:00Z

Introduction: Culturally competent communication is indispensable for medical practice in an ethnically diverse society. This article offers recommendations to teach such communication skills based on the experiences of members of a Dutch NMVO Special Interest Group on 'Diversity'. Method: A questionnaire with three open-ended questions on recommendations for training in culturally competent communication was sent to all members (n=35). Returned questionnaires (n=23) were analysed qualitatively with a thematic coding framework based on educational themes emerging from the data. Recommendations: All students need to be educated in culturally competent communication. Teachers should stimulate awareness of personal biases and an open attitude. Teach the three core communication skills, listening, exploring and checking, and offer practice with a professional interpreter. Knowledge content should focus on mechanisms relevant to various ethnic groups. Offer students a variety of experiences in a safe environment. All involved should be aware that stereotyping is a pitfall. Discussion: Training in communication skills for consultation with ethnic minority patients cannot be separated from teaching issues of awareness and knowledge. The shared views on the content of these communication trainings are in line with general patient-centred approaches. The development of proper training in this field demands specific efforts of those involved.

Quality of life after burns in childhood (5-15 years): Children experience substantial problems (Article)

2011-09-01T00:00:00Z

The aim of our study was to assess prevalence and correlates related to sub optimal outcome after pediatric burns and to make a comparison with pediatric injuries not related to burns. We conducted a cross-sectional study on quality of life (QOL) after burns in a sample (n = 138; median 24 months post-burn) of Dutch and Flemish children (5-15 years) with an admission to a burn center. QOL was assessed with the Burn Outcomes Questionnaire (BOQ). The generic EuroQol-5D was used to allow for a comparison with children after injuries not related to burns. More than half of the children had long-term limitations. According to the BOQ, children frequently (>50%) experienced sub optimal functioning on 5 out of 12 dimensions, concerning 'appearance', 'parental concern', 'itch', 'emotional health' and 'satisfaction with current state'. Children with a high total burned surface area (TBSA ≥10%) showed significantly more sub optimal functioning on 'upper extremity function' (OR = 5.3; ≥20% TBSA), 'appearance' (OR = 5.5; ≥10-20% TBSA), 'satisfaction with current state' (OR = 3.4; ≥10-20% TBSA) and 'parental concern' (OR = 3.4; ≥10-20% TBSA), compared to children with less than 10% TBSA. Burn victims at 9 months post-injury appeared to be worse off at several health dimensions. After 24 months generic quality of life of in pediatric burns was more comparable to pediatric injuries not related to burns. Children after burns experience substantial problems, mainly on itch and appearance and several psychosocial dimensions. More extensive burns are related to sub optimal functioning. These problems are in part specific for burns and not picked up by generic measures.

The Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship registry: Scope, rationale and design of an infrastructure for the study of physical and psychosocial outcomes in cancer survivorship cohorts (Article)

2011-09-01T00:00:00Z

'Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES)' is a registry for the study of the physical and psychosocial impact of cancer and its treatment from a dynamic, growing population-based cohort of both short and long-term cancer survivors. PROFILES contains a large web-based component and are linked directly to clinical data from the population-based Eindhoven cancer registry. This paper describes the rationale and design of PROFILES. The primary aims of studies that use the PROFILES registry are: (1) psychosocial risk and outcome assessment to identify patients at high risk for poor physical and mental health outcomes, (2) to analyse mediating mechanisms to better understand the biological and behavioural factors associated with cancer treatment outcomes, and (3) to evaluate physical and psychosocial care needs of cancer survivors. PROFILES is a tool that enables data collection management; from inviting patients to participation in studies, to collecting patient-reported outcomes data via web-based or mailed questionnaires and linking these data with clinical data. The availability of a control cohort of approximately 2000 persons from the general population who complete the same basic questionnaire annually will provide the opportunity to estimate the unique impact of cancer, beyond that of normal ageing and comorbidities. Raw data from the PROFILES registry will be available for non-commercial scientific research, subject to study question, privacy and confidentiality restrictions, and registration (www. profilesregistry.nl).

Informed decision-making in prenatal screening for Down's syndrome: What knowledge is relevant? (Article)

2011-08-01T00:00:00Z

Objective: To determine the content of decision-relevant knowledge needed for informed decision-making about (non-) participation in prenatal screening for Down's syndrome (DS), in order to develop a knowledge questionnaire for routine application in large-scale programme evaluations. Methods: A generic list of content domains for knowledge about screening was extracted from the literature. Items reflecting specific knowledge domains were constructed. An expert group of professionals and pregnant women expressed whether domains and items represented decision-relevant information. Results: All presented domains were scored as (very) important. Options when receiving an 'increased probability for DS' test result, the meaning of this result, the aim of the screening, and voluntary nature of the test were scored as most important. The condition being screened for, prevalence, and the screening procedure were scored as relatively less important, with a high amount of expert consensus. Conclusion: A knowledge measure for prenatal screening for DS was developed, based on domains and items acquired by expert consensus. Practice implications: This measure of decision-relevant knowledge can be used in routine, large-scale evaluations of the procedure for offering information about prenatal screening for DS.

Medium-term cost analysis of breast reconstructions in a single Dutch centre: A comparison of implants, implants preceded by tissue expansion, LD transpositions and DIEP flaps (Article)

2011-08-01T00:00:00Z

Background: Free flap breast reconstruction (BR) is generally believed to be more expensive than implant BR, but costs were previously shown to level out over time due to complications and re-operations. The aim of this study was to assess the economic implications of four BR techniques: silicone prosthesis (SP), implant preceded by tissue expansion (TE/SP), latissimus dorsi transposition with or without implant (LD ± SP) and deep inferior epigastric perforator (DIEP) flap. Methods: A prospective historic cohort study was performed to evaluate intramural medical costs in 427 patients, who had undergone BR between 2002 and 2009. Short- and medium-term complications were incorporated. In addition, 58 patients, who had recently undergone BR, participated in a questionnaire study to prospectively evaluate extramural medical and non-medical costs. Estimates of mean short- and medium-term costs are presented per patient. Results: Intramural medical costs for BR and short-term complications for unilateral DIEP flaps (12,848) and TE/SP reconstructions (12,400) were significantly higher than those for LD ± SP reconstructions (5804), which, in turn, were more expensive than SP reconstructions (4731). In bilateral cases, costs of TE/SP (12,723) and LD ± SP (10,760) reconstructions were comparable, while DIEP flaps (15,747) were significantly more expensive and SP reconstructions were significantly cheaper (6784). Overall, the medium-term costs for complications and additional operations were not significantly different (3017-4503). Extramural medical costs and non-medical costs were approximately 9300 per stage, regardless of technique. Conclusions: Differences in short-term costs between techniques did not level out during follow-up and SP reconstructions remained least expensive. Single-stage SP reconstructions, however, are not suitable for all patients due to high complication rates. Definite implant placement is therefore increasingly preceded by tissue expansion at more comparable costs to autologous BR. Incorporation of non-medical costs into the cost analysis would render two-stage procedures more costly than autologous BR. To achieve the optimal result, careful patient selection is critical. Only in select cases where two options are equally applicable, cost comparison becomes a valid argument for treatment selection.

Long-term effects of lung cancer computed tomography screening on health-related quality of life: The NELSON trial (Article)

2011-07-01T00:00:00Z

The long-term effects of lung cancer computed tomography (CT) screening on health-related quality of life (HRQoL) have not yet been investigated. In the Dutch-Belgian Randomised Lung Cancer Screening Trial (NELSON trial), 1,466 participants received questionnaires before randomisation (T0), 2 months after baseline screening (screen group only; T1) and at 2-yr follow-up (T2). HRQoL was measured as generic HRQoL (12-item short-form questionnaire and EuroQoL questionnaire), anxiety (Spielberger State-Trait Anxiety Inventory) and lung cancer-specific distress (impact of event scale (IES)). Repeated measures of ANOVA were used to analyse differences between the screen and control groups, and between indeterminate (requiring a follow-up CT) and negative screening result groups. At T0 and T2 there were no significant differences in HRQoL scores over time between the screen and control groups, or between the indeterminate or negative second-round screening result group. There was a temporary increase in IES scores after an indeterminate baseline result (T0: mean 4.0 (95% CI 2.8-5.3); T1: mean 7.8 (95% CI 6.5-9.0); T2: mean 4.5 (95% CI 3.3-5.8)). At 2-yr follow-up, the HRQoL of screened subjects was similar to that of control subjects, the unfavourable short-term effects of an indeterminate baseline screening result had resolved and an indeterminate result at the second screening round had no impact on HRQoL. Copyright

Informed decision-making about the fetal anomaly scan: What knowledge is relevant? (Article)

2011-06-01T00:00:00Z

Objectives This study had two objectives. The first was to determine the contents of relevant knowledge needed for informed decision-making (IDM) in second-trimester ultrasound screening for fetal anomalies, with the goal of developing a knowledge measure for use in large-scale program evaluations. The second was to compare the contents of decision-relevant knowledge for second-trimester ultrasound screening with those for first-trimester screening for Down syndrome using the combined test. Methods A generic list of content domains for knowledge about screening was extracted from the literature. Items reflecting specific knowledge domains for second-trimester ultrasound screening were constructed. An expert group of professionals and pregnant women expressed whether domains and items represented decision-relevant knowledge. Results Regarding second-trimester ultrasound screening, the experts scored all knowledge domains as (very) important. The meaning of an abnormal test result, the disorders being screened for, and the purpose of the screening were rated as very important for IDM, along with the voluntary nature of the test. All knowledge domains were included in the final measure. Importance ratings of knowledge domains for first-trimester Down syndrome screening and for second-trimester ultrasound screening were highly correlated (Pearson's r = 0.71). The domain 'consequences of a positive test result' was considered more important in first-trimester Down syndrome screening than in second-trimester ultrasound screening. Conclusions We have developed a knowledge measure for second-trimester ultrasound screening for fetal anomalies for use in routine, large-scale program evaluations.

Patients' preferences for breast reconstruction: A discrete choice experiment (Article)

2011-01-01T00:00:00Z

Background: Patients' preferences are important determinants in the decision for a specific type of breast reconstruction (BR). Understanding their considerations in the decision for a specific type of BR can contribute to further improvement in patient counselling. We explored patients' preferences for three BR modalities in a discrete choice experiment (DCE). Methods: We approached 386 patients who had previously undergone a therapeutic (n = 309) or prophylactic (n = 79) mastectomy, of whom 247 had also undergone a BR. These women were asked to choose between hypothetical BR profiles that were characterised by six treatment attributes: (1) material used for reconstruction, (2) number and duration of operations, (3) short-term complication rate, (4) long-term complication rate, (5) aesthetic result and (6) waiting time. The relative importance of attributes and trade-offs that the patients were willing to make among them were analysed using a multinomial logit regression model. Results: The overall response rate was 71%. All treatment characteristics proved important for patients to make their choices. Respondents generally expressed a preference for autologous material and an excellent aesthetic result, which had the biggest positive effect on preferences. Complication rates of 20-30% had a similar negative effect. In this DCE, autologous free flap BR fitted in best with patients' preferences. Conclusions: Our study provides insight into the relative weight patients place on various aspects of BR and trade-offs they make among BR characteristics. In addition to understanding patients' considerations, professional assessment of the technical feasibility, acceptable risks and obtainable aesthetic result of different techniques will always remain crucial in deciding which technique is best suited for an individual patient.

Well being of obstetric patients on minimal blood transfusions (WOMB trial) (Article)

2010-12-16T00:00:00Z

Background: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands.Methods/Design: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs.The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%).Discussion: This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.Trial registration: ClinicalTrials.gov NCT00335023, Nederlands Trial Register NTR335.

Informed decision making does not affect health-related quality of life in lung cancer screening (NELSON trial) (Article)

2010-12-01T00:00:00Z

Background: It is believed that making an informed decision about (screening) participation is associated with better health-related quality of life (HRQoL) outcomes. This is the first study in cancer screening to explore this association in subjects participating in a lung cancer computed tomography (CT) screening trial. Methods: Participants that made either an informed decision to participate (n = 155) or not (n = 133) were selected for this study. Differences in HRQoL, measured as generic HRQoL (Short Form 12 [SF-12] and EuroQol questionnaire [EQ-5D]), anxiety/distress (State-Trait Anxiety Inventory [STAI-6], Impact of Event Scale [IES] and Consequences of Screening-Lung Cancer [COS-LC]), were tested with Mann-Whitney U tests and ANOVA at three assessment points (when deciding about participation, before trial randomisation and 2 months after receiving the CT result). Results: Subjects who made an informed decision to participate had no better scores than those who did not make an informed decision for 23 out of 24 HRQoL comparisons, except for a better mean score for mental health (Mental Component Summary (MCS) = 53.9 ± 9.2 versus 51.0 ± 10.1, p = 0.003) before randomisation. For subjects with an indeterminate CT result (n = 64), no significant differences were found between subjects with (n = 35) or without (n = 29) an informed decision. Conclusion: Subjects who did not make an informed decision to participate in lung cancer CT screening trial did not experience worse HRQoL during screening than subjects who did make an informed decision, either in general or after receiving an indeterminate result.

Deciding on PSA-screening - Quality of current consumer information on the Internet (Article)

2010-11-01T00:00:00Z

Purpose of the study: Given that screening for prostate cancer has the potential to reduce prostate cancer mortality at the expense of considerable overdiagnosis and overtreatment, the availability of core consumer information - correct, balanced and supportive of autonomous decision-making - is a must. We assessed the quality of consumer information available through the Internet per November 2009 and its possible contribution to informed decision-making by potential screenees. Methods: Consumer information on PSA-screening was sought through the Internet in November 2009. Materials had to be targeted at potential consumers, offered by not-for-profit organisations, released in 2005 or after, in English or Dutch. Per material 2 of the authors assessed independently from each other whether standardised pre-defined topics were addressed, whether the content was correct and which approach was taken towards the decision-making process about uptake. Results: Twenty-three materials were included, of which 11 were released (shortly) after the results of 2 large randomized-controlled trials (RCTs) that evaluated the effectiveness of screening for prostate cancer had been published in March 2009. That a PSA-test result can be abnormal because of non-cancerous conditions (false positive) and that it may miss prostate cancer (false negative) was not addressed in 2/23 and 8/23 materials, respectively. The risk of overdiagnosis and overtreatment was not mentioned in 6 out of 23. PSA-screening was presented as a usual thing to do in some materials, whereas other materials emphasised the voluntary nature of PSA-screening ('it is your decision'). The content of 19/23 materials was considered sufficiently informative according to the pre-defined criteria, 12/23 materials were considered supportive of informed decision-making by men. Conclusions: Most materials of not-for-profit organizations supplied adequate information about PSA-screening, whilst the degree of persuasion towards uptake reflected variations in opinions on men's autonomy regarding their own health.

Ethnic differences in participation in prenatal screening for Down syndrome: A register-based study (Article)

2010-10-01T00:00:00Z

Objective: To assess ethnic differences in participation in prenatal screening for Down syndrome in the Netherlands. Methods: Participation in prenatal screening was assessed for the period 1 January 2009 to 1 July 2009 in a defined postal code area in the southwest of the Netherlands. Data on ethnic origin, socio-economic background and age of participants in prenatal screening were obtained from the Medical Diagnostic Centre and the Department of Clinical Genetics. Population data were obtained from Statistics Netherlands. Logistic regression models were used to assess ethnic differences in participation, adjusted for socio-economic and age differences. Results: The overall participation in prenatal screening was 3865 out of 15 093 (26%). Participation was 28% among Dutch women, 15% among those from Turkish ethnic origin, 8% among those from North-African origin, 15% among those from Aruban/Antillean origin and 26% among women from Surinamese origin. Conclusions: Compared to Dutch women, those from Turkish, North-African, Aruban/Antillean and other non-Western ethnic origin were less likely to participate in screening. It was unexpected that women from Surinamese origin equally participated. It should be further investigated to what extent participation and non-participation in these various ethnic groups was based on informed decision-making.

Ethnic and socio-economic differences in uptake of prenatal diagnostic tests for Down's syndrome (Article)

2010-08-01T00:00:00Z

Objective: The objective of this study was to assess ethnic and socio-economic differences in the uptake of maternal age-based prenatal diagnostic testing for Down's syndrome by amniocentesis or chorionic villus sampling. Study design: The study population consisted of 12,340 women aged 36 years or over, who lived in a geographically defined region in the Southwest of The Netherlands and who gave birth to a live born infant in the period 2000-2004. Data were obtained from the Department of Clinical Genetics Erasmus MC and Statistics Netherlands. Logistic regression analyses were done to assess ethnic and socio-economic differences in uptake. Results: The overall uptake of prenatal diagnostic tests was 28.5%. Women of Turkish and Caribbean origin participated in prenatal diagnostic tests equally or more often than Dutch women. Women of North-African origin and women from low socio-economic background had a lower uptake than others. Ethnic differences in uptake could not be attributed to differences in socio-economic background. Conclusions: Uptake of prenatal diagnostic tests for Down's syndrome in The Netherlands was low and varied among ethnic and socio-economic groups of advanced maternal age. The finding that women of Turkish and Caribbean origin participated in prenatal diagnostic tests equally or more often than Dutch women was unexpected. The low uptake among Dutch women may be related to the Dutch pregnancy culture. The finding that women of North-African origin and women from low socio-economic background had a lower uptake may be related to barriers in access to prenatal diagnostic tests.

Screening for colorectal cancer: Comparison of perceived test burden of guaiac-based faecal occult blood test, faecal immunochemical test and flexible sigmoidoscopy (Article)

2010-07-01T00:00:00Z

Background: Perceived burden of colorectal cancer (CRC) screening is an important determinant of participation in subsequent screening rounds and therefore crucial for the effectiveness of a screening programme. This study determined differences in perceived burden and willingness to return for a second screening round among participants of a randomised population-based trial comparing a guaiac-based faecal occult blood test (gFOBT), a faecal immunochemical test (FIT) and flexible sigmoidoscopy (FS) screening. Methods: A representative sample of the Dutch population (aged 50-74 years) was randomised to be invited for gFOBT, FIT and FS screening. A random sample of participants of each group was asked to complete a questionnaire about test burden and willingness to return for CRC screening. Results: In total 402/481 (84%) gFOBT, 530/659 (80%) FIT and 852/1124 (76%) FS screenees returned the questionnaire. The test was reported as burdensome by 2.5% of gFOBT, 1.4% of FIT and 12.9% of FS screenees (comparing gFOBT versus FIT p = 0.05; versus FS p < 0.001). In total 94.1% of gFOBT, 94.0% of FIT and 83.8% of FS screenees were willing to attend successive screening rounds (comparing gFOBT versus FIT p = 0.84; versus FS p < 0.001). Women reported more burden during FS screening than men (18.2% versus 7.7%; p < 0.001). Conclusions: FIT slightly outperforms gFOBT with a lower level of reported discomfort and overall burden. Both FOBTs are better accepted than FS screening. All three tests have a high level of acceptance, which may affect uptake of subsequent screening rounds and should be taken into consideration before implementing a CRC screening programme.

Social time preferences for health and money elicited with a choice experiment (Article)

2010-06-01T00:00:00Z

Objectives: In economic evaluations future health and monetary outcomes are commonly discounted at equal and constant rates. The theoretical foundation of this practice is being debated and appropriate discount rates for costs and health effects are sought. Here, we have derived social discount rates for health, money, and environmental benefits by means of a choice experiment. Methods: All choices were framed from a social perspective. We investigated differences in time preference by domain (health, monetary benefits, environmental benefits), time delay (5, 10, and 40 years), and respondent characteristics. Respondents were 173 health-care professionals and 34 health policymakers. Choice titration was used to determine when the respondent was indifferent between future and present benefits. Results: At least two-thirds of respondents preferred an intervention with immediate benefits to delayed benefits in the different domains. The median (mean) yearly discount rates for health benefits were 2.7% (10.7%), 1.3% (3.5%), and 1.1% (2.3%) assuming a 5, 10, and 40 years delay, respectively. Social time preference for monetary benefits was significantly stronger, with median (mean) yearly discount rates of 6.6% (18.7%) and 4.8% (11.2%) assuming a 5 and 10 years delay, respectively. The social time preference with regard to environmental benefits was similar to the monetary benefits. Social time preference for the different domains was significantly correlated at the individual level. Conclusions: The empirically derived social time preference is in line with current theoretical arguments for a lower discount rate for health benefits than for monetary benefits. Moreover, the implied median discount rates for health were lower than those commonly used or advocated in guidelines.

Study protocol: Population screening for colorectal cancer by colonoscopy or CT colonography: A randomized controlled trial (Article)

2010-05-19T00:00:00Z

Background: Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. Early detection and removal of CRC or its precursor lesions by population screening can reduce mortality. Colonoscopy and computed tomography colonography (CT colonography) are highly accurate exams and screening options that examine the entire colon. The success of screening depends on the participation rate. We designed a randomized trial to compare the uptake, yield and costs of direct colonoscopy population screening, using either a telephone consultation or a consultation at the outpatient clinic, versus CT colonography first, with colonoscopy in CT colonography positives.Methods and design: 7,500 persons between 50 and 75 years will be randomly selected from the electronic database of the municipal administration registration and will receive an invitation to participate in either CT colonography (2,500 persons) or colonoscopy (5,000 persons) screening. Those invited for colonoscopy screening will be randomized to a prior consultation either by telephone or a visit at the outpatient clinic. All CT colonography invitees will have a prior consultation by telephone. Invitees are instructed to consult their general practitioner and not to participate in screening if they have symptoms suggestive for CRC. After providing informed consent, participants will be scheduled for the screening procedure. The primary outcome measure of this study is the participation rate. Secondary outcomes are the diagnostic yield, the expected and perceived burden of the screening test, level of informed choice and cost-effectiveness of both screening methods.Discussion: This study will provide further evidence to enable decision making in population screening for colorectal cancer.Trial registration: Dutch trial register: NTR1829.

Do Anxiety and Distress Increase During Active Surveillance for Low Risk Prostate Cancer? (Article)

2010-05-01T00:00:00Z

Purpose: Anxiety and distress may be present in patients with low risk prostate cancer who are on active surveillance. This may be a reason to discontinue active surveillance. Materials and Methods: A total of 150 Dutch patients with prostate cancer on active surveillance in a prospective active surveillance study received questionnaires at study inclusion and 9 months after diagnosis. We assessed changes in scores on decisional conflict with the decisional conflict scale, depression with the Center for Epidemiologic Studies Depression Scale, generic anxiety with the State Trait Anxiety Inventory, prostate cancer specific anxiety with the Memorial Anxiety Scale for Prostate Cancer and the self-estimated risk of progression. We explored scores 9 months after diagnosis vs those at study inclusion for physical health (SF-12® physical component summary), personality (Eysenck Personality Questionnaire), shared decision making, prostate cancer knowledge, demographics, medical parameters and prostate specific antigen doubling time during followup. Results: Questionnaires at study inclusion and 9 months after diagnosis were completed by 129 of 150 (86%) and 108 of 120 participants (90%) a median of 2.4 and 9.2 months after diagnosis, respectively. Anxiety and distress at study inclusion were previously found to be generally favorable. Significant but clinically irrelevant decreases were seen in mean scores of the State Trait Anxiety Inventory (p = 0.016), Memorial Anxiety Scale for Prostate Cancer fear of progression subscale (p = 0.005) and the self-estimated risk of progression (p = 0.049). Anxiety and distress 9 months after diagnosis were mainly predicted by scores at study inclusion. Higher Eysenck Personality Questionnaire neuroticism score and an important role of the physician in the treatment decision had additionally unfavorable effects. Good physical health, palpable disease and older age had favorable effects. No association was seen for prostate specific antigen doubling time. Nine men discontinued active surveillance, including 2 due to nonmedical reasons. Conclusions: Anxiety and distress generally remain favorably low during the first 9 months of surveillance.

Preferences for colorectal cancer screening strategies: a discrete choice experiment (Article)

2010-03-01T00:00:00Z

Background:Guidelines underline the role of individual preferences in the selection of a screening test, as insufficient evidence is available to recommend one screening test over another. We conducted a study to determine the preferences of individuals and to predict uptake for colorectal cancer (CRC) screening programmes using various screening tests. Methods:A discrete choice experiment (DCE) questionnaire was distributed among naive subjects, yet to be screened, and previously screened subjects, aged 50-75 years. Subjects were asked to choose between scenarios on the basis of faecal occult blood test (FOBT), flexible sigmoidoscopy (FS), total colonoscopy (TC) with various test-specific screening intervals and mortality reductions, and no screening (opt-out). Results:In total, 489 out of 1498 (33%) screening-naïve subjects (52% male; mean age±s.d. 61±7 years) and 545 out of 769 (71%) previously screened subjects (52% male; mean age±s.d. 61±6 years) returned the questionnaire. The type of screening test, screening interval, and risk reduction of CRC-related mortality influenced subjects' preferences (all P<0.05). Screening-naive and previously screened subjects equally preferred 5-yearly FS and 10-yearly TC (P=0.24; P=0.11), but favoured both strategies to annual FOBT screening (all P-values <0.001) if, based on the literature, realistic risk reduction of CRC-related mortality was applied. Screening-naive and previously screened subjects were willing to undergo a 10-yearly TC instead of a 5-yearly FS to obtain an additional risk reduction of CRC-related mortality of 45% (P<0.001). Conclusion:These data provide insight into the extent by which interval and risk reduction of CRC-related mortality affect preferences for CRC screening tests. Assuming realistic test characteristics, subjects in the target population preferred endoscopic screening over FOBT screening, partly, due to the more favourable risk reduction of CRC-related mortality by endoscopy screening. Increasing the knowledge of potential screenees regarding risk reduction by different screening strategies is, therefore, warranted to prevent unrealistic expectations and to optimise informed choice.British Journal of Cancer advance online publication, 2 March 2010; doi:10.1038/sj.bjc.6605566 www.bjcancer.com.

Labeled versus unlabeled discrete choice experiments in health economics: An application to colorectal cancer screening (Article)

2010-03-01T00:00:00Z

Objectives: Discrete choice experiments (DCEs) in health economics commonly present choice sets in an unlabeled form. Labeled choice sets are less abstract and may increase the validity of the results. We empirically compared the feasibility, respondents' trading behavior, and convergent validity between a labeled and an unlabeled DCE for colorectal cancer (CRC) screening programs in The Netherlands. Methods: A labeled DCE version presented CRC screening test alternatives as "fecal occult blood test," "sigmoidoscopy," and "colonoscopy," whereas the unlabeled DCE version presented them as "screening test A" and "screening test B." Questionnaires were sent to participants and nonparticipants in CRC screening. Results: Total response rate was 276 (39%) out of 712 and 1033 (46%) out of 2267 for unlabeled and labeled DCEs, respectively (P < 0.001). The labels played a significant role in individual choices; approximately 22% of subjects had dominant preferences for screening test labels. The convergent validity was modest to low (participants in CRC screening: r = 0.54; P = 0.01; nonparticipants: r = 0.17; P = 0.45) largely because of different preferences for screening frequency. Conclusion: This study provides important insights in the feasibility and difference in results from labeled and unlabeled DCEs. The inclusion of labels appeared to play a significant role in individual choices but reduced the attention respondents give to the attributes. As a result, unlabeled DCEs may be more suitable to investigate trade-offs between attributes and for respondents who do not have familiarity with the alternative labels, whereas labeled DCEs may be more suitable to explain real-life choices such as uptake of cancer screening.

Ethnic differences in informed decision-making about prenatal screening for Down's syndrome (Article)

2010-03-01T00:00:00Z

Background: The aim of this study was to assess ethnic variations in informed decision-making about prenatal screening for Down's syndrome and to examine the contribution of background and decision-making variables. Methods: Pregnant women of Dutch, Turkish and Surinamese origin were recruited between 2006 and 2008 from community midwifery or obstetrical practices in The Netherlands. Each woman was personally interviewed 3 weeks (mean) after booking for prenatal care. Knowledge, attitude and participation in prenatal screening were assessed following the 'Multidimensional Measure of Informed Choice' that has been developed and applied in the UK. Results: In total, 71% of the Dutch women were classified as informed decision-makers, compared with 5% of the Turkish and 26% of the Surinamese women. Differences between Surinamese and Dutch women could largely be attributed to differences in educational level and age. Differences between Dutch and Turkish women could mainly be attributed to differences in language skills and gender emancipation. Conclusion: Women from ethnic minority groups less often made an informed decision whether or not to participate in prenatal screening. Interventions to decrease these ethnic differences should first of all be aimed at overcoming language barriers and increasing comprehension among women with a low education level. To further develop diversity-sensitive strategies for counselling, it should be investigated how women from different ethnic backgrounds value informed decisionmaking in prenatal screening, what decision-relevant knowledge they need and what they take into account when considering participation in prenatal screening.

Informed decision making on PSA testing for the detection of prostate cancer: An evaluation of a leaflet with risk indicator (Article)

2010-02-01T00:00:00Z

Background: Population-based screening for prostate cancer (PCa) remains controversial. To help men making informed decisions about prostate specific antigen (PSA) screening a risk indicator (www.uroweb.org) was developed. This risk indicator is embedded in a leaflet that informs men about the pros and cons of PCa screening and enables calculation of the individual risk of having a biopsy detectable PCa. Aim: To assess the effect of providing a leaflet including individualized risk estimation on informed decision making of men, i.e. knowledge about PCa and PSA screening, attitude towards undergoing a PSA test and intention to have a PSA test. Methods: An intervention study among 2000 men, aged 55-65 years, randomly selected from the population registry of the city of Dordrecht, the Netherlands, in 2008. Men were sent a questionnaire on knowledge of PCa, attitude and intention to have a PSA test. Men without a history of (screening for) PCa were sent the leaflet and Questionnaire 2 within 2 weeks after returning Questionnaire 1. Validated health and anxiety measures were used. Results: One thousand and twenty seven of 2000 men completed Questionnaire 1 (51%), of whom 298 were excluded due to a history of (screening for) PCa. Of the 729 remaining men, 601 completed Questionnaire 2 as well. At the second assessment significantly more men met the requirements of informed decision making (15% versus 33%, p < 0.001), more men had relevant knowledge (284/601, 50% versus 420/601, 77%, p < 0.001) and the intention to have a PSA test had increased (p < 0.001). Conclusions: Providing information on PCa screening combined with individualized risk estimation enhanced informed decision making and may be used for shared decision making on PSA screening of physicians and patients.

Disease insight and treatment perception of men on active surveillance for early prostate cancer (Article)

2010-02-01T00:00:00Z

Objective: To investigate the levels of knowledge of prostate cancer and the perception of active surveillance (AS) in men on AS, as AS for early prostate cancer instead of radical treatment might partly solve the over-treatment dilemma in this disease, but might be experienced as a complex and contradictory strategy by patients. PATIENTS AND METHODS In all, 150 Dutch men recently diagnosed with early prostate cancer participating in a prospective protocol-based AS programme (PRIAS study) received questionnaires, including a 15-item measure on their general knowledge of prostate cancer, and open-ended questions on the most important disadvantages and advantages of AS, and on the specific perception of AS. We assessed knowledge scores and explored potentially associated factors, the stated (dis)advantages and specific perceptions. Results: The questionnaire response rate was 86% (129/150). Participants provided correct answers to a median (interquartile range) of 13 (12-14) of 15 (87%) knowledge items. Younger and higher educated men had higher knowledge scores. In line with a priori hypotheses, the most frequently reported advantage and disadvantage of AS were the delay of side-effects and the risk of disease progression, respectively. Specific negative experiences included the feeling of losing control over treatment decisions, distress at follow-up visits, and the desire for a more active participation in disease management. No conceptually wrong understandings or expectations of AS were identified. Conclusions: We found adequate knowledge of prostate cancer levels and realistic perceptions of the AS strategy in patients with early prostate cancer and on AS. These findings suggest adequate counselling by the physician or patient self-education.

What determines individuals' preferences for colorectal cancer screening programmes? A discrete choice experiment. (Article)

2010-01-01T00:00:00Z

INTRODUCTION: In many countries uptake of colorectal cancer (CRC) screening remains low. AIM: To assess how procedural characteristics of CRC screening programmes determine preferences for participation and how individuals weigh these against the perceived benefits from participation in CRC screening. METHODS: A discrete choice experiment was conducted among subjects in the age group of 50-75 years, including both screening-naive subjects and participants of a CRC screening programme. Subjects were asked on their preferences for aspects of CRC screening programmes using scenarios based on pain, risk of complications, screening location, preparation, duration of procedure, screening interval and risk reduction of CRC-related death. RESULTS: The response was 31% (156/500) for screening-naive and 57% (124/210) for CRC screening participants. All aspects proved to significantly influence the respondents' preferences. For both groups combined, respondents required an additional relative risk reduction of CRC-related death by a screening programme of 1% for every additional 10 min of duration, 5% in order to expose themselves to a small risk of complications, 10% to accept mild pain, 10% to undergo preparation with an enema, 12% to use 0.75l of oral preparation combined with 12h fasting and 32% to use an extensive bowel preparation. Screening intervals shorter than 10 years were significantly preferred to a 10-year screening interval. CONCLUSION: This study shows that especially type of bowel preparation, risk reduction of CRC related death and length of screening interval influence CRC screening preferences. Furthermore, improving awareness on CRC mortality reduction by CRC screening may increase uptake.

What determines individuals' preferences for colorectal cancer screening programmes? A discrete choice experiment. (Article)

2010-01-01T00:00:00Z

Patients' preferences for scoliosis brace treatment: a discrete choice experiment (Article)

2010-01-01T00:00:00Z

Abstract STUDY DESIGN: Discrete choice experiment. OBJECTIVE: To investigate the reduction in the risk of surgery that scoliosis patients would require in order to consider brace treatment as acceptable, and to elicit the trade-offs individuals make between characteristics of brace treatment. SUMMARY OF BACKGROUND DATA: The effectiveness of brace treatment in idiopathic scoliosis patients has not been established in randomized controlled trials (RCTs). Treatment with a brace can be quite bothersome. Patients' preferences for brace treatment are unknown. Insight into patients' preferences for (characteristics of) brace treatment will be useful for future trials and for the development of braces that may optimize compliance with brace treatment. METHODS: A total of 197 patients who had completed treatment (brace and/or surgery) for scoliosis were approached for the study, of which 135 gave informed consent. A discrete choice experiment was designed in which patients had to choose between hypothetical brace treatment profiles that differed in following 4 treatment attributes: effectiveness, visibility, discomfort, and treatment duration. A multinomial logit model was used to analyze the relative importance of these attributes. Subgroup analyses were conducted for brace-only, brace-surgery, and surgery-only patients. RESULTS: The response rate was 86% (116/135). All treatment attributes proved to be important for patients' choices. All subgroups were prepared to initiate treatment with a Boston brace if the brace would reduce the need for surgery by 53%. Risk reductions in a range of 32% to 74% were required for acceptance of a treatment duration of 3 years. CONCLUSION: Scoliosis patients stated to be prepared to undergo brace treatment only if it provides sizeable reduction of the risk of surgery. Effectiveness and discomfort in wearing a brace were the most important determinants of the choices. These results are important if RCTs would conclusively establish that bracing is effective, and show directions for the further technical development of braces to increase the compliance with brace treatment.

Short-term health-related quality of life consequences in a lung cancer CT screening trial (NELSON) (Article)

2010-01-01T00:00:00Z

Background: In lung cancer CT screening, participants often have an indeterminate screening result at baseline requiring a follow-up CT. In subjects with either an indeterminate or a negative result after screening, we investigated whether health-related quality of life (HRQoL) changed over time and differed between groups in the short term.Methods: A total of 733 participants in the NELSON trial received four questionnaires: T0, before randomisation; T1, 1 week before the baseline screening; T2, 1 day after the screening; and T3, 2 months after the screening results but before the 3-month follow-up CT. HRQoL was measured as generic HRQoL (the 12-item Short Form, SF-12; the EuroQol questionnaire, EQ-5D), anxiety (the Spielberger State-Trait Anxiety Inventory, STAI-6), and lung-cancer-specific distress (the Impact of Event Scale, IES). For analyses, repeated-measures analysis of variance was used, adjusted for covariates.Results: Response to each questionnaire was 88% or higher. Scores on SF-12, EQ-5D, and STAI-6 showed no clinically relevant changes over time. At T3, IES scores that were clinically relevant increased after an indeterminate result, whereas these scores showed a significant decrease after a negative result. At T3, differences in IES scores between the two baseline result groups were both significant and clinically relevant (P<0.01).Conclusion: This longitudinal study among participants of a lung cancer screening programme showed that in the short term recipients of an indeterminate result experienced increased lung-cancer-specific distress, whereas the HRQoL changes after a negative baseline screening result may be interpreted as a relief.

Anxiety and borderline PAP smear results (Article)

2010-01-01T00:00:00Z

Purpose: Low-grade abnormalities after cervical cancer screening, i.e. borderline (Pap 2) or mildly (Pap 3a1) dyskaryotic (BMD) smear results, are found in considerable numbers of women annually. We compared quality of life and anxiety in women with BMD and a reference group of screening participants who were awaiting smear taking. Methods: Five hundred and fifty women with BMD in the preceding 6-24 months, identified through a regional screening organisation, were sent a questionnaire addressing generic quality of life (12-item Short-Form Health Survey [SF-12], EuroQol classification [EQ-5D]), generic anxiety (STAI-6) and screen-specific anxiety (Psychological Consequences Questionnaire [PCQ]). Results: After adjustment for differences in background characteristics, women with BMD (n = 270) reported more generic anxiety (44.4 versus 32.6) and screen-specific anxiety (5.0 versus 1.4) than the reference group (n = 352). The differences indicated statistical (p < 0.001) and clinical significance. High anxiety (STAI-6 > 44) was reported by 49% of the BMD group. Mental quality of life was worse in the BMD than in the reference group (44.2 versus 52.0, p < 0.001). The BMD group considered screening more often frightening (27% versus 10%) and reported 'fear for cervical cancer' more frequently as their reason for having a (repeat) smear taken (62/270, 23% versus 12/346, 4%). Conclusion/discussion: BMD smears were consistently associated with considerable excess anxiety in the period of 6-24 months after the original BMD Pap smears had been taken.

Ethnic differences in considerations whether or not to participate in prenatal screening for Down syndrome (Article)

2009-12-01T00:00:00Z

Objective: To evaluate ethnic differences in considerations whether or not to participate in prenatal screening for Down syndrome and to relate these to differences in participation. Method: The study population consisted of 270 pregnant women from Dutch, Turkish and Surinamese (African and South Asian) ethnic origin, attending midwifery or obstetrical practices in the Netherlands. Women were interviewed after booking for prenatal care. Considerations were assessed by one open-ended question and 18 statements that were derived from focus group interviews. Actual participation was assessed several months later. Results: Women from ethnic minorities were less likely to participate in prenatal screening, which could be attributed to differences in age and religious identity. They more often reported acceptance of 'what God gives', low risk of having a child with Down syndrome and costs of screening as considerations not to participate in prenatal screening. They also reported many considerations in favour of participation, which did not differ from those of Dutch women but were less often consistent with actual participation in screening. Conclusions: Women from ethnic minorities should not be stereotyped as being uninterested in prenatal screening, but should be better informed about the consequences of prenatal screening and Down syndrome. Copyright

Prostate cancer-specific anxiety in Dutch patients on active surveillance: Validation of the memorial anxiety scale for prostate cancer (Article)

2009-10-01T00:00:00Z

Purpose: Men with prostate cancer (PC) may show specific disease-related anxiety. We evaluated the psychometric properties of the Dutch adaptation of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC). Methods: The MAX-PC was translated using standardized forward-backward procedures. Patients (N = 150) on active surveillance, a strategy of initially withholding active therapy, for recently diagnosed early PC were mailed a questionnaire. Internal consistency was estimated using Cronbach's alpha. The scale structure was analyzed using confirmatory factor analysis (CFA). Construct validity was evaluated by Pearson's correlations between MAX-PC scores and scores on decisional conflict (DCS), generic anxiety (STAI), depression (CES-D), and general mental health (SF-12 MCS). Results: Data from 129 respondents were used (response rate 86%). Cronbach's alpha for the total score and the three subscales were 0.77, 0.91, 0.64, and 0.85, respectively. CFA largely confirmed the three-factor structure as used in the original publication (model fit: χ2 149, P = 0.051). The patterns of directions and sizes of the correlations (r = 0.36-0.66) between MAX-PC scale scores and the other variables were in accordance with a priori hypotheses, except for the prostate-specific antigen anxiety subscale. The relatively poor performance of this scale in the original version was replicated. Conclusions: The structure and validity of the MAX-PC to quantify PC-specific anxiety were largely confirmed in Dutch patients.

Anxiety and distress during active surveillance for early prostate cancer (Article)

2009-09-01T00:00:00Z

BACKGROUND: Patients on active surveillance (AS) for early prostate cancer (PC) may experience feelings of anxiety and distress while living with "untreated" cancer. In this study, these feelings were quantified, and their associations with various psychologic, medical, demographic, and decision-related factors were assessed. METHODS: Men with recently diagnosed PC who participated in a prospective protocol-based AS program (the Prostate Cancer Research International: Active Surveillance study [PRAIS]) received a questionnaire (N = 150). Scores concerning decisional conflict (the Decisional Conflict Scale), depression (the Center for Epidemiologic Studies Depression Scale), generic anxiety (the abridged State-Trait Anxiety Inventory), and PC-specific anxiety (the Memorial Anxiety Scale for Prostate Cancer) were compared with reference values and the literature. Associations with scores on physical health (the Medical Outcomes Study 12-item short-form Physical Component Summary), personality (the Eysenck Personality Questionnaire), shared decision-making, knowledge of PC, and demographic and medical parameters were determined with univariate and multivariate linear regression analyses. RESULTS: The questionnaire response rate was 86% (129 of 150 men). Of all respondents, 81%, 92%, 83%, and 93% scored better than reference values for clinically significant uncertainty regarding the treatment decision, depression, generic anxiety, and PC-specific anxiety, respectively. Scores were comparable to or more favorable than those of men (reported in literature) who underwent other treatments for localized PC. In multivariate analysis, the following associations emerged: a perceived important role of the physician in shared decision-making was associated with higher decisional conflict, better physical health was associated with lower depression, neurotic personality was associated with higher depression and with generic and PC-specific anxiety, and higher prostate-specific antigen level was associated with higher PC-specific anxiety. CONCLUSIONS: Men on protocol-based AS mainly reported favorable levels of anxiety and distress. A neurotic personality score was associated with unfavorable effects. These findings may help to optimize patient selection for AS or to select men for supportive measures.

Informed participation in a randomised controlled trial of computed tomography screening for lung cancer (Article)

2009-09-01T00:00:00Z

The actual lung cancer (screening) knowledge, attitudes, risk perceptions, reasons to participate in or decline participation, and informed decisions of subjects who decided to or decided not to participate in the Dutch-Belgian randomised controlled trial for lung cancer screening in high-risk subjects (the NELSON trial) were evaluated. A total of 2,500 high-risk subjects were asked to complete a questionnaire 3 weeks after they had received a brochure with information about the trial. Differences in knowledge, attitude and risk perception between participants and nonparticipants were analysed with logistic regression analyses adjusted for sex and smoking status. The questionnaire response of trial participants was 80% (n=889) whereas the response of nonparticipants was low (7%, n=97) and selective. Participants' responses to knowledge items on lung cancer as a disease were on average more often correct (mean±SD 68±17%) than items on lung cancer screening (49±29%). Participants had adequate knowledge on lung cancer screening (51%) more often than the nonparticipants (38%; p=0.009). Of the decisions regarding participation, 49% were uninformed, mainly due to insufficient knowledge. Most of the participants (99%) and 64% of the nonparticipants had a positive attitude towards lung cancer screening. Additional efforts are required to improve the knowledge and understanding of subjects who are in the process of decision-making regarding participation in a lung cancer screening trial. Copyright

Incidence of cervical cancer after several negative smear results by age 50: prospective observational study (Article)

2009-08-17T00:00:00Z

OBJECTIVE: To determine the incidence of cervical cancer after several negative cervical smear tests at different ages. DESIGN: Prospective observational study of incidence of cervical cancer after the third consecutive negative result based on individual level data in a national registry of histopathology and cytopathology (PALGA). SETTING: Netherlands, national data. Population 218,847 women aged 45-54 and 445,382 aged 30-44 at the time of the third negative smear test. MAIN OUTCOME MEASURES: 10 year cumulative incidence of interval cervical cancer. RESULTS: 105 women developed cervical cancer within 2 595,964 woman years at risk after the third negative result at age 30-44 and 42 within 1,278,532 woman years at risk after age 45-54. During follow-up, both age groups had similar levels of screening. After 10 years of follow-up, the cumulative incidence rate of cervical cancer was similar: 41/100,000 (95% confidence interval 33 to 51) in the younger group and 36/100,000 (24 to 52) in the older group (P=0.48). The cumulative incidence rate of cervical intraepithelial neoplasia grade I+ was twice as high in the younger than in the older group (P<0.001). CONCLUSIONS: The risk for cervical cancer after several negative smear results by age 50 is similar to the risk at younger ages. Even after several negative smear results, age is not a good discriminative factor for early cessation of cervical cancer screening.

Health-related quality of life in cervical cancer survivors: a population-based survey (Article)

2009-07-30T00:00:00Z

PURPOSE: In a population-based sample of cervical cancer survivors, health-related quality of life (HRQoL) was assessed 2-10 years postdiagnosis. METHODS AND MATERIALS: All patients given a diagnosis of cervical cancer in 1995-2003 in the Eindhoven region, The Netherlands, and alive after Jan 2006 were identified through the cancer registry. Generic HRQoL (36-Item Short-Form Health Survey, EQ-5D), cervical cancer-specific HRQoL (European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire cervical cancer module), and anxiety (6-item State Trait Anxiety Inventory) were assessed and compared with a reference population (n = 349). Data for tumor characteristics at diagnosis and disease progression were available. RESULTS: A total of 291 women responded (69%), with a mean age of 53 +/- 13 (SD) years (range, 31-88 years). Treatment had consisted of surgery (n = 195) or a combination of therapies (n = 75); one woman had not been treated. Of all women, 85% were clinically disease free, 2% had a recurrence/metastasis, and in 13%, this was unknown. After controlling for background characteristics (age, education, job and marital status, having children, and country of birth), generic HRQoL scale scores were similar to the reference population, except for worse mental health in survivors. The most frequent symptoms were crampy pain in the abdomen or belly (17%), urinary leakage (15%), menopausal symptoms (18%), and problems with sexual activity. Compared with the 6-10-year survivors, more sexual worry and worse body image were reported by the 2-5-year survivors. Compared with surgery only, especially primary radiotherapy was associated with an increased frequency of treatment-related side effects, also after controlling for age and disease stage at diagnosis and follow-up. CONCLUSIONS: Most cervical cancer survivors were coping well, although their mental health was worse than in the reference population. Even after 2-10 years, radiotherapy was associated with an increased frequency of treatment-related side effects.

A labelled discrete choice experiment adds realism to the choices presented: preferences for surveillance tests for Barrett esophagus. (Article)

2009-07-02T00:00:00Z

BACKGROUND: Discrete choice experiments (DCEs) allow systematic assessment of preferences by asking respondents to choose between scenarios. We conducted a labelled discrete choice experiment with realistic choices to investigate patients' trade-offs between the expected health gains and the burden of testing in surveillance of Barrett esophagus (BE). METHODS: Fifteen choice scenarios were selected based on 2 attributes: 1) type of test (endoscopy and two less burdensome fictitious tests), 2) frequency of surveillance. Each test-frequency combination was associated with its own realistic decrease in risk of dying from esophageal adenocarcinoma. A conditional logit model was fitted. RESULTS: Of 297 eligible patients (155 BE and 142 with non-specific upper GI symptoms), 247 completed the questionnaire (84%). Patients preferred surveillance to no surveillance. Current surveillance schemes of once every 1-2 years were amongst the most preferred alternatives. Higher health gains were preferred over those with lower health gains, except when test frequencies exceeded once a year. For similar health gains, patients preferred video-capsule over saliva swab and least preferred endoscopy. CONCLUSION: This first example of a labelled DCE using realistic scenarios in a healthcare context shows that such experiments are feasible. A comparison of labelled and unlabelled designs taking into account setting and research question is recommended.

Sexual function of patients under surveillance for bladder cancer (Article)

2009-07-01T00:00:00Z

OBJECTIVE To describe the prevalence of sexual dysfunction and evaluate risk factors in patients just diagnosed with non-muscle-invasive bladder cancer (NMI UC), who have the prospect of an intensive surveillance scheme by cysto-urethroscopy to detect tumour recurrences. PATIENTS AND METHODS We conducted a cross-sectional survey on 150 patients just diagnosed with primary or recurrent NMI UC. Patients were participating in a randomized clinical multicentre trial (CEFuB), comparing two surveillance schemes. Patients were asked to complete questionnaires at study entry 3 months before the start of the study-surveillance scheme (demographic characteristics, a validated visual analogue scale, and validated subset of questions on sexual function and performance derived from QLQ-BLS-24). The results were compared with those from an age-and gender-matched healthy population. RESULTS The response rate was 95% (142/150); 61% (87/142) of the respondents were sexually active in the previous 4 weeks after diagnosis, 66% (70/105) of men and 46% (17/37) of women. Although libido was not negatively affected, 54% (47/87) of the patients had a sexual dysfunction, and 23% (17/73) were afraid to inflict harm on their partner by sexual contact. Sexually active patients perceived a higher state of general health (P = 0.03). CONCLUSIONS The prevalence of sexual dysfunction in patients with NMI UC is very high (54%) compared with an age- and gender-matched healthy population (20-45%). No predictors for sexual dysfunction were found. These patients and partners would benefit from proper sexual information in the outpatient clinic.

Preferences of GPs and patients for preventive osteoporosis drug treatment: A discrete-choice experiment (Article)

2009-04-22T00:00:00Z

Background: Osteoporotic fractures have a serious economic impact on society and on the quality of life of patients. Differences in opinions on the desirability of preventive treatment initiation may hamper the process and outcome of shared decision making between physician and patient. Objective: To evaluate and compare preferences of GPs and patients for preventive osteoporosis drug treatment. Methods: Discrete-choice experiment (DCE) involving 34 general practices in the area of Rotterdam, the Netherlands. Participants included 40 GPs and 120 women aged ≥60 years who participated in a study on osteoporosis case finding. We included any woman aged >60 years, with an over-representation of women with a high fracture risk (n = 60). Outcomes: (i) The relative weights that GPs and patients place on five treatment attributes of preventive osteoporosis drug treatment: effectiveness, nausea as an adverse effect, total treatment duration, route of drug administration and out-of-pocket costs; and (ii) the determinants of any differences in preferences between GPs and patients. Results: The response rate was 40/59 (68%) for GPs and 120/181 (66%) for patients. All treatment attributes proved to be important for preferences of GPs and patients. GPs had a significantly less favourable attitude towards preventive osteoporosis drug treatment than patients; they placed significantly higher values on effectiveness of preventive drug treatment and short total preventive treatment duration than patients. Conclusions: GPs and patients showed different preferences towards preventive osteoporosis drug treatment. Addressing each of these differences may have a positive effect on the process and outcomes of shared decision making regarding preventive treatment initiation.

Health-Related Quality of Life in Cervical Cancer Survivors: A Population-Based Survey (Article)

2009-04-01T00:00:00Z

Information about prenatal screening for Down syndrome Ethnic differences in knowledge. (Article)

2009-04-01T00:00:00Z

OBJECTIVE: To evaluate the provision of information about prenatal screening for Down syndrome to women of Dutch, Turkish and Surinamese origins, and to examine the effects of this provision on ethnic differences in knowledge about Down syndrome and prenatal screening. METHODS: The study population consisted of 105 Dutch, 100 Turkish and 65 Surinamese pregnant women attending midwifery or obstetrical practices in The Netherlands. Each woman was personally interviewed for 3 weeks (mean) after booking for prenatal care. RESULTS: Most women reported to have received oral and/or written information about prenatal screening by their midwife or obstetrician at booking for prenatal care. Turkish and Surinamese women less often read the information than Dutch women, more often reported difficulties in understanding the information, and had less knowledge about Down syndrome, prenatal screening and amniocentesis. Language skills and educational level contributed most to the explanation of these ethnic variations. CONCLUSION: Although most Dutch, Turkish and Surinamese women reported to have received information from their midwife or obstetrician, ethnic differences in knowledge about Down syndrome and prenatal screening are substantial. PRACTICE IMPLICATIONS: Interventions to improve the provision of information to women from ethnic minority groups should especially be aimed at overcoming language barriers, and targeting information to the women's abilities to comprehend the information about prenatal screening for Down syndrome.

Erectile dysfunction and mental health in a general population of older men (Article)

2009-02-09T00:00:00Z

Introduction. Erectile dysfunction (ED) is more prevalent with increasing age. Previous studies showed that ED was negatively associated with mental health (MH) in specific patient groups. Aim. To examine the association, and potential mediating factors, between ED and MH in healthy elderly men. Main Outcome Measures. ED was defined as (almost) always having problems in achieving or maintaining an erection if desired, or not being sexually active because of erectile problems. MH was assessed with 36-item Short-Form Health Survey scale MH5 with five items on, e.g., being happy or depressed (range 0-100). Potential mediators between ED and MH were satisfaction with and importance attached to sex life. Methods. The study population consisted of a consecutive sample of 3,810 participants from the European Randomized Study of Screening for Prostate Cancer, aged 57-78 years, who had screened negatively for prostate cancer. Associations between ED, potential mediating factors, and MH were tested by analysis of variance and analysis of covariance. Results. Covariance analysis, adjusted for age, comorbidity, and use of erectile aids, showed that men with ED had significantly lower MH scores (80.8 ± 1.2) than men without ED (83.7 ± 1.2; P < 0.001). ED was also associated with the potential mediator "satisfaction with sex life" but not with "importance attached to sex life." Men with ED were significantly more often dissatisfied with their sex lives (P < 0.001). Adjustment for satisfaction with sex life, but not for importance attached to sex life, reduced the strength of the association (β value) between ED and poor MH from 2.88 to -0.84. Conclusions. ED was associated with poorer MH. Satisfaction with sex life, but not importance attached to sex life, may play a mediating role in this association. These results suggest that if men with ED can be helped to be satisfied with their sex lives despite ED, MH can be preserved.

Reliability and Validity of the Dutch Translated Aberdeen Varicose Vein Questionnaire (Article)

2009-02-01T00:00:00Z

Objective: To evaluate reliability and validity of the Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) for measuring health related quality of life (HR-QOL) in patients with venous disease in the lower limb. Methods: The AVVQ consists of 13 questions related varicose veins. This study assessed feasibility, reliability and validity of the Dutch translated AVVQ in a sample of 145 patients with venous disease of the leg. Test and retest of the Dutch translated AVVQ were performed within a 2 week interval. Results: There was a high test (99%) and retest (97%) response. Feasibility; AVVQ showed few missing answers (0.6%) and non-unique answers (0.2%). Regarding internal consistency; Cronbach's α exceeded 0.7 indicating a high level of concordance between the AVVQ questions (α = 0.76). Test-retest reliability; Spearman's rho showed a significant strong association between test and retest scores (rho = 0.87). Discriminative validity; AVVQ score was able to differentiate between subgroups of patients with different severity of venous disease according to the CEAP classification (Mann-Whitney U test, p < 0.01). Conclusions: This study supports applications of the Dutch AVVQ in HR-QOL measurement in patients with venous disease in the Netherlands and the Flemish speaking part of Belgium.

Nurse-led follow-up of patients after oesophageal or gastric cardia cancer surgery: A randomised trial (Article)

2009-01-13T00:00:00Z

Between January 2004 and February 2006, 109 patients after intentionally curative surgery for oesophageal or gastric cardia cancer were randomised to standard follow-up of surgeons at the outpatient clinic (standard follow-up; n=55) or by regular home visits of a specialist nurse (nurse-led follow-up; n=54). Longitudinal data on generic (EuroQuol-5D, European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30) and disease-specific quality of life (EORTC QLQ-OES18), patient satisfaction and costs were collected at baseline and at 6 weeks and 4, 7 and 13 months afterwards. We found largely similar quality-of-life scores in the two follow-up groups over time. At 4 and 7 months, slightly more improvement on the EQ-VAS was noted in the nurse-led compared with the standard follow-up group (P=0.13 and 0.12, respectively). Small differences were also found in patient satisfaction between the two groups (P=0.14), with spouses being more satisfied with nurse-led follow-up (P=0.03). No differences were found in most medical outcomes. However, body weight of patients of the standard follow-up group deteriorated slightly (P=0.04), whereas body weight of patients of the nurse-led follow-up group remained stable. Medical costs were lower in the nurse-led follow-up group (\[euro]2600 vs \[euro]3800), however, due to the large variation between patients, this was not statistically significant (P=0.11). A cost effectiveness acceptability curve showed that the probability of being cost effective for costs per one point gain in general quality-of-life exceeded 90 and 75% after 4 and 13 months of follow-up, respectively. Nurse-led follow-up at home does not adversely affect quality of life or satisfaction of patients compared with standard follow-up by clinicians at the outpatient clinic. This type of care is very likely to be more cost effective than physician-led follow-up.

Bowel, Urinary, and Sexual Problems Among Long-Term Prostate Cancer Survivors: A Population-Based Study (Article)

2009-01-01T00:00:00Z

Purpose: To obtain insight into the long-term (5- to 10-year) effects of prostate cancer and treatment on bowel, urinary, and sexual function, we performed a population-based study. Prostate-specific function was compared with an age-matched normative population without prostate cancer. Methods and Materials: Through the population-based Eindhoven Cancer Registry, we selected all men diagnosed with prostate cancer between 1994 and 1998 in the southern Netherlands. In total, 964 patients, alive in November 2004, received questionnaire; 780 (81%) responded. Results: Urinary problems were most common after a prostatectomy; bowel problems were most common after radiotherapy. Compared with an age-matched normative population both urinary and bowel functioning and bother were significantly worse among survivors. Urinary incontinence was reported by 23-48% of survivors compared with 4% of the normative population. Bowel leakage occurred in 5-14% of patients compared with 2% of norms. Erection problems occurred in 40-74% of patients compared with 18% of norms. Conclusions: These results form an important contribution to the limited information available on prostate-specific problems in the growing group of long-term prostate cancer survivors. Bowel, urinary, and sexual problems occur more often among long-term survivors compared with a reference group and cannot be explained merely by age. Because these problems persist for many years, urologists should provide patients with adequate information before treatment. After treatment, there should be an appropriate focus on these problems.

Does diabetes mellitus as a comorbid condition affect the health-related quality of life in prostate cancer survivors? Results of a population-based observational study (Article)

2008-12-01T00:00:00Z

OBJECTIVE: To assess the health-related quality of life (HRQoL) of long-term, disease-free prostate cancer survivors and compare it with that of prostate cancer survivors with diabetes mellitus (DM), and a Dutch normative population, as comorbidity can have a major impact on HRQoL in cancer survivors. PATIENTS AND METHODS: The Eindhoven Cancer Registry was used to select all men diagnosed with prostate cancer from 1994 to 1998. Questionnaires on HRQoL (Short Form 36) and prostate specific problems (University of California, Los Angeles Expanded Prostate Cancer Index) were sent to 964 patients, and 780 (81%) responded. Excluding patients with disease progression, the sample comprised 525 with prostate cancer and 65 with both prostate cancer and DM. Survivors with DM were more likely to have other comorbid conditions at the time of survey besides DM than were those without DM (74% vs 60%, P = 0.05). At 5-10 years after diagnosis, patients with DM reported worse General Health Perceptions than patients without DM or the normative population (means 52, 61 and 63; P < 0.001). Patients with DM also reported worse Vitality scores (59 vs 63; P < 0.001) than the normative population. Regression analysis indicated that DM was negatively associated with General Health Perceptions (β = -0.13; P < 0.01) and Vitality (β = -0.12; P < 0.01). Survivors with DM did not report worse urinary and bowel function or bother, nor more sexual problems than those without DM. CONCLUSIONS: Except for general health perceptions and vitality, the HRQoL of prostate cancer survivors with or without DM was comparable to a normative population. Survivorship selection can possibly explain, in part, why patients with DM did not report worse generic or disease-specific HRQoL than those without DM, as had been expected.

High affective risk perception is associated with more lung cancer-specific distress in CT screening for lung cancer (Article)

2008-12-01T00:00:00Z

Screening for cancer can cause distress. People who perceive their risk of cancer as high may be more vulnerable to distress. This study evaluated whether participants of a lung cancer Computed Tomography (CT) screening trial with a high affective risk perception of developing lung cancer had a higher level of lung cancer-specific distress during CT screening. Furthermore, we evaluated whether participants perceived their risk of developing lung cancer differently 6 months after screening compared with 1 day before screening. A total of 351 subsequent participants of the NELSON-trial (Dutch-Belgian randomized controlled trial for lung cancer screening in high-risk subjects), who were randomized to the screen arm, were asked to fill in questionnaires 1 day before and 6 months after screening. Lung cancer-specific distress (Impact of Event Scale (IES)), generic health-related quality of life (SF-12) and affective risk perception were assessed. One day before screening, the participants with a high affective risk perception (n = 47/321, 14.6%) had significantly higher (i.e., worse) median IES scores than participants with a low affective risk perception (11.5 vs. 2.0, p < 0.01). Although median IES scores were significantly lower 6 months after screening than 1 day before screening, participants with a high affective risk perception still showed significantly higher IES scores than participants with a low affective risk perception (6.5 vs. 1.0, p < 0.01). Six months after screening, significantly less participants (10.5%) felt that their risk of developing lung cancer was high than 1 day before screening (14.5%) (p < 0.01). Levels of distress were not severe, but were elevated compared to participants with a low affective risk perception, and therefore, attention for this group is recommended.

Does “Normal” Aging Imply Urinary, Bowel, and Erectile Dysfunction? A General Population Survey (Article)

2008-10-25T00:00:00Z

We assessed if urinary, bowel, and sexual dysfunction and associated bother were part of the “normal” aging process in the general male Dutch population. Methods Randomly selected participants of a screening trial were mailed a questionnaire on dysfunction and bother in the urinary, bowel, and sexual domains. A Dutch version of the Expanded Prostate Cancer Index Composite (EPIC) was used. Results Three thousand eight hundred ten (3810) men responded (81%), mean age 67 years, range 58 to 78. The prevalence of urinary dysfunction was low, and although the difference between younger versus older men was significant (P <0.001), it did not exceed the minimal important difference. Bowel dysfunction and bother were not related to age. Erectile dysfunction was reported by 19%, ranging from 12% in the youngest to 26% in the oldest group (P <0.001). The overall use of erectile aids was negatively associated with the satisfaction with sex life and positively with the importance attached to it (P <0.001), but not with age or sexual activity. Conclusions Urinary and bowel dysfunction were not part of the “normal” aging process. Erectile dysfunction was significantly more prevalent in older men. In men treated for localized prostate cancer, decreasing urinary or bowel function is thus not attributable to age, but may well be related to prior treatment. Decreasing erectile function, however, may be attributable to other causes as wellt. These data provide a benchmark for urologic functioning in men after treatment relative to age-related patterns, and will enable better interpretation of treatment outcomes.

Impact of computed tomography screening for lung cancer on participants in a randomized controlled trial (NELSON trial) (Article)

2008-07-15T00:00:00Z

BACKGROUND. Computed tomography (CT) screening is an important new tool for the early detection of lung cancer. In the current study, the authors assessed the discomfort associated with CT scanning and the subsequent wait for results and health-related quality of life (HRQoL) over time. METHODS. A total of 351 participants in the Dutch-Belgian randomized controlled trial for lung cancer screening in high-risk subjects (the NELSON trial) who had an appointment for a baseline CT scan were asked to complete questionnaires regarding their experienced discomfort and HRQoL before, 1 day after, and approximately 6 months after the CT scan. HRQoL was measured as generic HRQoL (12-item Short Form [SF-12] and EuroQol questionnaire [EQ-5D]), generic anxiety (State-Trait Anxiety Inventory [STAI-6]), and lung cancer-specific distress (Impact of Event Scale [IES]). Approximately 76.9% of the participants completed all 3 questionnaires. RESULTS. Approximately 87% to 99% of participants reported experiencing no discomfort related to the CT scan. The median SF-12, EQ-5D, STAI-6, and IES scores did not appear to change relevantly over time. Approximately 46.0% and 51.3%, respectively, of the participants reported discomfort in connection with having to wait for the results of the CT scan and dreading those results. These patients had relevantly higher STAI-6 and IES scores (P < .01) (unfavorable) at all 3 assessments. CONCLUSIONS. The current evaluation of the potential adverse effects of CT screening for lung cancer on HRQoL demonstrated no negative effects. However, waiting for the CT scan results was reported to be discomforting by approximately half of the participants. Minimizing the waiting time for the test results is merefore recommended.

Capsule endoscopy for the detection of oesophageal mucosal disorders: A comparison of two different ingestion protocols (Article)

2008-07-09T00:00:00Z

Objective. To assess the accuracy of a new ingestion protocol for capsule endoscopy (CE) in evaluating patients with gastro-oesophageal reflux disease (GORD). Methods. Oesophago-gastroduodenoscopy (OGD) was performed 1 week prior to CE. The first 28 subjects swallowed the capsule following the original ingestion protocol (OIP) and the subsequent 30 subjects following a simplified ingestion protocol (SIP). CE videos were reviewed by two independent investigators who were blinded to the OGD findings. Results. Of 48 patients included, 24 were diagnosed with reflux oesophagitis (67% male, mean age 49.5±13 years) and 24 with Barrett oesophagus (BO) (88% male, 55.6±10 years) by OGD. In addition, 10 asymptomatic healthy controls (50% male, 45.8±7.1 years) were included. Oesophageal transit time was faster in patients using the SIP compared to the OIP (126±26 s versus 214±33; p=0.04). Complete evaluation of the Z-line was possible in 19/28 (68%) of the OIPs compared to 28/30 (93%) of the SIPs (p=0.04). Sensitivity for detecting any oesophageal abnormality was higher in the SIP group than in the OIP group (97% versus 89%; p=0.11). Overall, CE detected oesophagitis in 22/24 patients (sensitivity, 92%; specificity, 88%) and BO in 23/24 patients (sensitivity, 96%; specificity, 91%). Furthermore, 41/44 (93%) preferred CE over OGD and experienced less discomfort and pain during CE. Conclusion. CE is an accurate method for detecting mucosal oesophageal abnormalities. The new ingestion protocol improves the visualization of the Z-line, which is likely to increase the diagnostic yield of CE.

Patients' preferences for osteoporosis drug treatment: A discrete choice experiment (Article)

2008-07-01T00:00:00Z

Summary: Active case finding for osteoporosis is used to identify patients at high fracture risk who may benefit from preventive drug treatment. We investigated the relative weight that women place on various aspects of preventive drugs in a discrete choice experiment. Our patients said they were prepared to take preventive drugs even if side effects were expected. Introduction: Active case finding for osteoporosis is used to identify patients who may benefit from preventive drugs. We aimed to elicit the relative weight that patients place on various aspects of preventive drug treatment for osteoporosis. Methods: We designed a discrete choice experiment, in which women had to choose between drug profiles that differed in five treatment attributes: effectiveness, side effects (nausea), total treatment duration, route of drug administration, and out-of-pocket costs. We included 120 women aged 60 years and older, identified by osteoporosis case finding in 34 general practices in the Netherlands. A conditional logit regression model was used to analyse the relative importance of treatment attributes, the trade-offs that women were willing to make between attributes, and their willingness to pay. Results: All treatment attributes proved to be important for women's choices. A reduction of the relative 10-year risk of hip fracture by 40% or more by the drug was considered to compensate for nausea as a side effect. Women were prepared to pay an out-of-pocket contribution for the currently available drug treatment (bisphosphonate) if the fracture risk reduction was at least 12%. Conclusions: Women identified by active osteoporosis case finding stated to be prepared to take preventive drugs, even if side effects were expected and some out-of-pocket contribution was required.

Women show mixed intentions regarding the uptake of HPV vaccinations in pre-adolescents: a questionnaire study. (Article)

2008-06-11T00:00:00Z

BACKGROUND: The general introduction of HPV vaccination, as the primary prevention of cervical cancer, is the subject of debate in the Netherlands. METHODS: We explored intentions towards HPV vaccinations for pre-adolescents in 1367 women; screen invitees, women with abnormal smears, cervical cancer survivors, and a reference group. RESULTS: 76% (screen invitees) to 81% (women with abnormal smears) said 'yes' to vaccinations, often motivated by 'prevention is better than cure'. Multivariate logistic regression showed that younger women were more positive than older women. Intentions were not related to education, job, marital status or having children. Both women who were pro and anti-HPV vaccinations expressed concerns about long-term effectiveness and side effects. Comments such as 'cervical cancer runs in the family' demonstrated confused knowledge. CONCLUSIONS: Most respondents had a positive intention towards HPV vaccinations, but intention was lower than actual childhood vaccination uptake in the current National Immunisation Programme (95%). Uncertainties about long-term effectiveness and side effects were the major causes of doubt.

Quality of Life During Neoadjuvant Treatment and After Surgery for Resectable Esophageal Carcinoma (Article)

2008-05-01T00:00:00Z

Purpose: Because of the trade-off between the potentially negative quality-of-life (QoL) effects and uncertain favorable survival effect of neoadjuvant chemoradiotherapy (CRT) in patients with resectable esophageal cancer, we assessed heath-related QoL (HRQoL) for up to 1 year postoperatively in these patients treated with preoperative CRT with a non-platinum-based outpatient regimen followed by esophagectomy. Methods and Materials: Patients undergoing neoadjuvant paclitaxel and carboplatin therapy concurrent with radiotherapy followed by surgery completed standardized HRQoL questionnaires before and after CRT and at regular times up to 1 year postoperatively. We analyzed differences in generic Qol core questionnaire [QLQ-C30] and condition-specific (esophageal site-specific [OES-18]) HRQoL scores over time by using a linear mixed-effects model. Results: Mean scores of most HRQoL scales deteriorated significantly during neoadjuvant CRT. The largest deterioration was observed for physical and role-functioning scales. All except two symptom scores worsened significantly. Postoperatively, most mean HRQoL scores improved until recovery to baseline level. Speed of improvement varied. Average taste score returned to baseline 3 months postoperatively, whereas it took 1 year for the average role-functioning score to restore. The emotional-functioning score showed a different pattern; it was worst at baseline and increased over time during CRT and postoperatively. Dysphagia and pain scores worsened considerably during CRT, restored to baseline 3 months postoperatively, and were even significantly better 1 year postoperatively. Conclusions: Preoperative CRT with paclitaxel and carboplatin for patients with resectable esophageal cancer had a considerable temporary negative effect on most aspects of HRQoL. Nonetheless, all HRQoL scores were restored or even improved 1 year postoperatively.

Patients' perceived burden of cystoscopic and urinary surveillance of bladder cancer: A randomized comparison (Article)

2008-05-01T00:00:00Z

OBJECTIVE: To compare, in patients with non-muscle-invasive low-grade (pTa/pT1, G1/G2) urothelial cell carcinoma of the urinary bladder, the perceived burden of flexible cystoscopy or surveillance by microsatellite analysis (MA) in voided urine, as such patients are normally recommended to adhere to regular cysto-urethroscopic surveillance (CUS). PATIENTS AND METHODS: In all, 220 participants of a randomized trial comparing CUS and surveillance by MA were asked to complete questionnaires 1 week after cystoscopy or urine sample collection. We assessed the discomfort and pain reported during CUS, experiences with MA, and physical symptoms, medical consumption and general functioning in the week after CUS/urine sampling. RESULTS: We analysed data from 732 questionnaires (197 patients) completed after CUS and 184 (67 patients) after collecting urine. The introduction of the cystoscope was reported to cause discomfort in 39% and pain in 35% of the responses to the questionnaires; the waiting time for the results of MA was reported as burdensome in 19%. Painful micturition was significantly more frequent in the week after CUS than after MA (30% and 12%, respectively). The frequency of fever (1% and 2%) and haematuria (7% and 6%) was similar in both groups. Older patients reported significantly less pain and discomfort from cystoscopy, and this was not related to having more previous cystoscopies. CONCLUSION: CUS caused pain and discomfort in about a third of patients. The burden of MA appeared fully attributable to the waiting time for the test result. The present results are a further motivation in the search for less invasive surveillance tests.

Response shift due to diagnosis and primary treatment of localized prostate cancer: a then-test and a vignette study (Article)

2007-12-01T00:00:00Z

Aim Whether a prostate cancer diagnosis induces response shift has not been established so far. Therefore, we assessed response shift in men who were diagnosed with localized prostate cancer. Patients and methods Out of 3,892 men who completed a questionnaire before screening, 82 were subsequently diagnosed with prostate cancer. Response shift was assessed in 52 (response 63%) by the then-test (EuroQol self-rating of health, Short-Form 36 mental health and vitality) and a novel method: rating of vignettes relating to side effects of prostate cancer treatment (urinary, bowel and erectile dysfunction). Three then-tests were conducted: two referencing pre-diagnosis (measured pre- and post-treatment), and one referencing pre-treatment (measured post-treatment). Results Then-test scores of pre-diagnosis health were significantly higher than original scores, indicating a more positive judgement in retrospect. Then-test scores of pre-treatment health were lower than original scores. Especially the vignette on erectile dysfunction was rated less bad after diagnosis versus before (P < 0.001, moderate effect size). Conclusions We found evidence for response shift in men who were diagnosed with prostate cancer. Men evaluated urinary, bowel, and erectile dysfunction as less bad after they had become patients who can expect to experience these side effects. The rating of vignettes is a promising additional technique to assess response shift.

Critical review of generic and dermatology-specific health-related quality of life instruments (Article)

2007-12-01T00:00:00Z

The measurement of health-related quality of life (HRQOL) is increasingly important in patients with skin diseases. Despite the availability of a variety of instruments and new psychometric techniques, there is no consensus as to which HRQOL instruments are to be preferred in dermatology. The objective of this review is to evaluate the generic HRQOL measures (i.e., health profiles) that have been used in dermatology (Short-Form-36 (SF-36) and -12, NHP, SIP, World Health Organization Quality of Life (WHOQOL)-100 and -BREF) and all dermatology-specific HRQOL measures (Dermatology Life Questionnaire Index, Skindex-29, -16, and -17, Dermatology Quality of Life Scales, and Dermatology-Specific Quality of Life). Criteria for evaluation were adapted from existing guidelines and included conceptual and measurement model, reliability, validity, responsiveness, item functioning, meaning of scores, administrative burden, respondent burden, the availability of alternative forms, and of cultural and language adaptations. Furthermore, an overview of skin diseases in which the included HRQOL tools have been used is presented. Although the selection of the appropriate HRQOL instrument remains a trade-off between various psychometric properties and research objectives, for now, we recommend the combination of SF-36 and Skindex-29 as the instruments of choice in dermatology. Promising new instruments for future research are the WHOQOL and the Skindex-17.

Ethnic differences in determinants of participation and non-participation in prenatal screening for Down syndrome: A theoretical framework (Article)

2007-10-01T00:00:00Z

Objective: To develop a theoretical framework for analysing ethnic differences in determinants of participation and non-participation in prenatal screening for Down syndrome. Methods: We applied Weinstein's Precaution Adoption Process (PAP) Model to the decision of whether or not to participate in prenatal screening for Down syndrome. The prenatal screening stage model was specified by reviewing the empirical literature and by data from seven focus group interviews with Dutch, Turkish and Surinamese pregnant women in the Netherlands. Results: We identified 11 empirical studies on ethnic differences in determinants of participation and nonparticipation in prenatal screening for Down syndrome. The focus group interviews showed that almost all stages and determinants in the stage model were relevant in women's decision-making process. However, there were ethnic variations in the relevance of determinants, such as beliefs about personal consequences of having a child with Down syndrome or cultural and religious norms. Discussion: The prenatal screening stage model can be applied as a framework to describe the decision-making process of pregnant women from different ethnic backgrounds. It provides scope for developing culturally sensitive, tailored methods to guide pregnant women towards informed decision-making on participation or non-participation in prenatal screening for Down syndrome. Copyright

Different perceptions of the burden of upper GI endoscopy: An empirical study in three patient groups (Article)

2007-10-01T00:00:00Z

Background: Few studies have evaluated patients' perceived burden of cancer surveillance tests. Cancer screening and surveillance, however, require a large number of patients to undergo potentially burdensome tests with only some experiencing health gains from it. We investigated the determinants of patients' reported burden of upper gastrointestinal (GI) endoscopy by comparing data from three patient groups. Patients and methods: A total of 476 patients were included: 180 patients under regular surveillance for Barrett esophagus (BE), a premalignant disorder; 214 patients with non-specific upper GI symptoms (NS), and 82 patients recently diagnosed with upper GI cancer (CA). We assessed pain, discomfort and overall burden experienced during endoscopy, symptoms in the week afterwards and psychological distress over time (Hospital Anxiety and Depression scale and Impact of Event Scale). Results: Two-thirds (66%) of patients reported discomfort and overall burden of upper GI endoscopy. Only 23% reported any pain. BE patients reported significantly less discomfort, pain and overall burden than the other patients: those with NS reported more discomfort, CA patients more pain, and both more overall burden. These differences could be statistically explained by the number of previous endoscopies and whether sedation was provided or not, but not by patient characteristics. Conclusion: The perception of upper GI endoscopy varies by patient group, due to potential adaptation after multiple endoscopies and aspects of the procedure.

Psychometric evaluation of health-related quality of life measures in women after different types of delivery (Article)

2007-09-01T00:00:00Z

Objective: We examined the psychometric properties of three internationally established measures for health-related quality of life (HRQoL) in women after vaginal delivery (VD), elective cesarean section (CS), and emergency CS and the relationship of HRQoL scores with blood loss after delivery. Methods: This is a prospective longitudinal study. One hundred forty-one consecutive patients (71 after VD, 36 after elective CS, and 34 after emergency CS) were enrolled in two university hospitals and one general hospital from June 2003 to March 2004. Women completed the Multidimensional Fatigue Inventory (MFI) and the EQ-5D classification of own health between 12 and 24 h after VD or between 24 and 48 h after CS. Subsequent assessments, additionally including the Short Form 36 (SF-36), were made 1, 3, and 6 weeks after delivery. We analyzed feasibility (response, completion time, reported difficulties, item nonresponse), reliability (Cronbach's α), discriminative validity between groups by type of delivery, and responsiveness over time (Wilcoxon's signed rank tests and effect sizes). Results: The MFI, SF-36, and EQ-5D proved to be highly feasible and reliable (α>.7 for all scales of MFI and SF-36). The measures were able to discriminate between groups by mode of delivery and to detect moderate recovery in physical and small recovery in mental status over time in the first 6 weeks after delivery. The suboptimal total questionnaire response of 60% after 6 weeks was attributable to low response among women of non-Dutch ethnic origin. The significant correlation between Hb level and mean physical HRQoL scores found at T=0 disappeared 1 week postpartum. Conclusion: The combination of MFI, SF-36, and EQ-5D showed good psychometric performance and is a good choice to measure HRQoL after delivery in scientific studies. Development of a shorter set is needed for use in routine clinical practice.

Impact of External Beam Adjuvant Radiotherapy on Health-Related Quality of Life for Long-Term Survivors of Endometrial Adenocarcinoma: A Population-Based Study (Article)

2007-09-01T00:00:00Z

Purpose: To compare the health-related quality of life (HRQOL) among 5-10-year survivors of Stage I-II endometrial (adeno-)carcinoma (EC) treated with surgery alone or surgery with external beam adjuvant radiotherapy (EBRT) and an age-matched norm population. Methods and Materials: A population-based, cross-sectional survey was conducted by the Eindhoven Cancer Registry. All patients were included who had been diagnosed with EC between 1994 and 1998 (n = 462). Information from the questionnaires returned was linked to data from the Eindhoven Cancer Registry on patient, tumor, and treatment characteristics. Results: Responses were received from 75% of the patients. The analyses were restricted to women with Stage I-II disease at diagnosis, treated with either surgery alone or surgery with adjuvant EBRT, and without recurrent disease or new primary malignancies (n = 264). The patients who had received adjuvant EBRT (n = 80) had had a significantly higher tumor stage and grade at diagnosis (p < 0.0001) and a longer mean time since diagnosis (p = 0.04). Age, number of comorbid diseases, current marital status, nulliparity, education, and occupation were similar for both treatment groups. On multivariate analyses, adjuvant EBRT was independently and negatively associated with the vitality and physical and social well-being scale scores. The HRQOL scores of both treatment groups, however, were similar to those of an age-matched norm population. Conclusion: In general, the HRQOL of EC survivors is good. EC survivors treated with surgery alone had a better HRQOL than women treated with surgery and adjuvant EBRT, although for both groups, the HRQOL was in the range of the norm population.

Evidence-based guidelines, time-based health outcomes, and the Matthew effect (Article)

2007-09-01T00:00:00Z

Background: Cardiovascular risk management guidelines are 'risk based'; health economists' practice is 'time based'. The 'medical' risk-based allocation model maximises numbers of deaths prevented by targeting subjects at high risk, for example, elderly and smokers. The time-based model maximises numbers of life years gained by treating the young and non-smokers, or 'the one who has will be given more' (Matthew 25:29). We explored practical consequences of risk- or time-based allocation. Methods: We used epidemiological modelling to generate semi-quantitative scenarios comparing the distributional effects of allocating a fixed number of prescriptions of a (hypothetical) preventive cardiovascular drug ('CVStop') either to avert the maximum number of deaths (risk-based) or to save the maximum number of life years (time based) in the male Dutch population. We subsequently asked 123 Dutch guideline developers which distribution they preferred. Results: Time- and risk-based allocations resulted in different distributions of the drug across the population. There were also differences in absolute numbers of life years gained and deaths averted, and in the distribution of these across the population. For example, risk-based allocation of 'CVStop' resulted in preferential treatment of elderly, leading to more deaths averted (mostly among 70 and above) but fewer life years gained, if compared with time-based allocation. The guideline developers experienced the choice dilemmas as difficult. No priority choice was dominant among the respondents. Conclusion: In evidence-based resource allocation the choice to save time or to avert deaths may introduce moral choices because of the various origins of increased disease risk. Evidence-based guideline development inevitably has moral implications.

Individual differences in the use of the response scale determine valuations of hypothetical health states: An empirical study (Article)

2007-05-23T00:00:00Z

Background. The effects of socio-demographic characteristics of the respondent, including age, on valuation scores of hypothetical health states remain inconclusive. Therefore, we analyzed data from a study designed to discriminate between the effects of respondents' age and time preference on valuations of health states to gain insight in the contribution of individual response patterns to the variance in valuation scores. Methods. A total of 212 respondents from three age groups valued the same six hypothetical health states using three different methods: a Visual Analogue Scale (VAS) and two variants of the Time trade-off (TTO). Analyses included a generalizability study, principal components analysis, and cluster analysis. Results. Valuation scores differed significantly, but not systematically, between valuation methods. A total of 36.8% of variance was explained by health states, 1.6% by the elicitation method, and 0.2% by age group. Individual differences in the use of the response scales (e.g. a tendency to give either high or low TTO scores, or a high or low scoring tendency on the VAS) were the main source of remaining variance. These response patterns were not related to age or other identifiable respondent characteristics. Conclusion. Individual response patterns in this study were more important determinants of TTO or VAS valuations of health states than age or other respondent characteristics measured. Further valuation research should focus on explaining individual response patterns as a possible key to understanding the determinants of health state valuations.

New insights into fatigue and health-related quality of life after delivery (Article)

2007-05-07T00:00:00Z

Background. A delivery has a major impact on the health-related quality of life (HRQoL) of the new mother, especially on fatigue. A common complication during delivery that might have a relationship with maternal morbidity is blood loss. The objectives were to investigate fatigue and HRQoL in women after vaginal delivery (VD), elective caesarean section (CS) and emergency CS, and its relationship with postpartum hemoglobin (Hb) levels during the first 6 weeks postpartum. Methods. Some 141 patients (71 after VD, 36 after elective CS and 34 after emergency CS) completed the HRQoL questionnaires MFI and EQ-5D between 12 and 24 h after VD and 24-48 h after CS (t=0). At 1, 3 and 6 weeks postpartum these questionnaires were repeated, together with the SF36. Results. Patients after VD had higher mean physical HRQoL scores than after CS. The average period to reach full physical recovery was 3 weeks after VD, 6 weeks after elective CS, and >6 weeks after emergency CS. Mean mental HRQoL scores of the study groups were similar or even better compared to reference values. The significant correlation between Hb level and mean physical HRQoL scores found at t=0 had disappeared at 1 week postpartum. Conclusions. Results of this study provided insights into the natural course of fatigue and HRQoL postpartum. Important differences in fatigue and HRQoL scores were observed between the 3 modes of delivery. These HRQoL measures can be used in future clinical trials to assess the effects of interventions postpartum.

The structural equation modeling technique did not show a response shift, contrary to the results of the then test and the individualized approaches (Article)

2007-04-01T00:00:00Z

Reliability and validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) in a general population and respiratory disease sample (Article)

2007-04-01T00:00:00Z

Objective: To evaluate feasibility, internal consistency, test-retest reliability, and concurrent and discriminative validity of the Infant and Toddler Quality of Life Questionnaire (ITQOL) for parents of pre-school children with 12 scales (103-items) covering physical and psychosocial domains and impact of child health on parents, in comparison with the TNO-AZL Pre-school Children Quality of Life Questionnaire (TAPQOL). Methods: Parents of children from a random general population sample (2 months-4 years old; n = 500) and of an outpatient clinic sample of children with respiratory disease (5 months-51/2 years old; n = 217) were mailed ITQOL and TAPQOL questionnaires; a retest was sent after two weeks. Results: Feasibility: The response was ≥80% with few missing and non-unique ITQOL-answers (<2%) in both study populations. Some ITQOL-scales (3-4 scales) showed a ceiling effect (>25% at maximum score). Internal consistency: All Cronbach's α >0.70. Test-retest Intraclass Correlation Coefficients (ICCs) were moderate or adequate (≥0.50; p < 0.01) for 10 ITQOL-scales. Validity: ITQOL-scales, with a few exceptions, correlated better with predefined parallel TAPQOL scales than with non-parallel scales. Five to eight ITQOL-scales discriminated clearly between children with few and with many parent-reported chronic conditions, between children with and without doctor-diagnosed respiratory disease and with a low and a high parent-reported medical consumption (p < 0.05). Conclusions: This study supported the evidence that the ITQOL is a feasible instrument with adequate psychometric properties. The study provided reference ITQOL scores for gender/age subgroups. We recommend repeated evaluations of the ITQOL in varied populations, especially among very young children, including repeated assessments of test-retest characteristics and evaluations of responsiveness to change. We recommend developing and evaluating a shortened ITQOL version.

Side-effects of treatment for localized prostate cancer: Are they valued differently by patients and healthy controls? (Article)

2007-04-01T00:00:00Z

OBJECTIVES: To determine how men treated for localized prostate cancer and who had permanent side-effects, and healthy controls, would value five descriptions of health states associated with side-effects of treatment for localized prostate cancer, hypothesising that patients would value the health states as less detrimental than men with no prostate cancer. PATIENTS, SUBJECTS AND METHODS: In previous research, patients with prostate cancer reported high generic quality-of-life scores after primary treatment, despite side-effects; it was suggested that these patients accepted the side-effects, i.e. urinary, bowel and sexual dysfunction, as 'part of the bargain' because they felt they were saved from a life-threatening disease. Thus, we asked 54 men who had been treated for localized prostate cancer and had permanent side-effects, and 53 healthy controls, to value five descriptions of health states. All respondents valued all descriptions using two valuation methods, a visual analogue scale (VAS, range 0-100) and time trade-off (TTO, range 0-1). The respondent functioning was assessed using the EuroQol-5D, completed with items on urinary, bowel and sexual function. RESULTS: Patients and healthy controls had similar valuations for nine of the 10 comparisons (five health states by two methods). Valuations in both groups resulted in the same ranking order of states on the TTO and one exchange in rank order on the VAS. CONCLUSIONS: When asked to value five health states associated with side-effects of treatment for localized prostate cancer, there was no difference in the valuation of erectile, urinary and bowel dysfunction between patients with permanent side-effects after treatment and healthy controls. More likely explanations for the high generic quality-of-life scores after primary treatment for prostate cancer are a response shift and insensitivity of generic health-related quality-of-life measures.

Guidelines for the conduction of follow-up studies measuring injury-related disability (Article)

2007-02-01T00:00:00Z

BACKGROUND: Scientific knowledge on functional outcome after injury is limited. During the past decade, a variety of measures have been used at various moments in different study populations. Guidelines are needed to increase comparability between studies. METHODS: A working group of the European Consumer Safety Association conducted a literature review of empirical studies into injury-related disability (1995-2005). We included injury from all levels of severity and selected studies using generic health status measures with both short-term and long-term follow up. The results were used as input for a consensus procedure toward the development of guidelines for defining the study populations, selecting the health status measures, selecting the timings of the assessments, and data collection procedures. RESULTS: The group reached consensus on a common core of health status measures and assessment moments. The group advises to use a combination of EuroQol-5D and Health Utilities Mark III in all studies on injury-related disability. This combination covers all relevant health domains, is applicable in all kinds of injury populations and in widely different age ranges, provides a link with utility scores, and has several practical advantages (e.g., brevity, availability in different languages). For specific types of injury, the common core may be supplemented by injury-specific measures. The group advises a common core of assessments at 1, 2, 4, and 12 months after injury. CONCLUSIONS: Our guidelines should be tested and may lead to improved and more consistent epidemiologic data on the incidence, severity, and duration of injury-related disability.

Individual differences in the use of the response scale determine valuations of hypothetical health states: an empirical study (Article)

2007-01-01T00:00:00Z

ABSTRACT: BACKGROUND: The literature remains inconclusive about the effects of socio-demographic characteristics of the respondent, including age, on valuation scores of hypothetical health states. We analyzed data from a study designed to discriminate between the effects of respondents age and time preference on valuations of health states to get insight in the contribution of individual response patterns to the variance in valuation scores. METHODS: 212 respondents from different age groups valued six hypothetical health states with three methods: a Visual Analogue Scale (VAS) and two variants of the Time trade-off (TTO). Analyses included a generalizability study, principal components analysis and cluster analysis. RESULTS: Valuation scores differed significantly but not systematically between valuation methods. A total of 36.8% of variance was explained by health states, 1.6% by elicitation method and 0.2% by age group. Individual differences in the use of the response scales, e.g. a tendency to give either high or low TTO-scores, or a high or low scoring tendency on the VAS were the main source of remaining variance. These response patterns were not related to age or other identifiable respondent characteristics. CONCLUSIONS: We conclude that individual response patterns were more important determinants of TTO or VAS valuations of health states than age or other measured respondent characteristics. Further valuation research should focus on explaining individual response patterns as a possible key to understanding the determinants of health state valuations.

Patients with Barrett's esophagus perceive their risk of developing esophageal adenocarcinoma as low (Article)

2007-01-01T00:00:00Z

Background: The risk of developing esophageal adenocarcinoma (EAC) for patients with Barrett's esophagus (BE) is approximately 0.5% per year. Objective: To investigate how patients with BE estimate and perceive their risk of developing EAC. Design: Questionnaire study. Setting: Patients with BE who were undergoing surveillance endoscopy based on histologic and flow cytometric results. Patients: A total of 192 patients with BE were included. Main Outcome Measurements: Individual patients were asked to estimate the numerical risk to develop EAC for patients with BE in general and for themselves. How patients perceived their own risk was measured on a scale from "very small" to "very large.". Results: At least 1 question was filled out by 169 patients (88% response). Sixty percent of respondents underestimated the numerical risk for patients with BE, in general, to develop EAC, while even more patients (69%) underestimated their own risk. Most respondents perceived their own risk as very small or small (63%). Limitations: Risk estimations may depend on the response scale used. Conclusions: Most patients with BE underestimated the numerical risk and perceived their risk of developing EAC as (very) low. Despite a low perceived risk, all patients in this group adhered to endoscopic surveillance.

Functional outcome at 2.5, 5, 9, and 24 months after injury in the Netherlands (Article)

2007-01-01T00:00:00Z

BACKGROUND: The collection of empirical data on the frequency, severity, and duration of functioning is a prerequisite to identify patient groups with long term or permanent disability. METHODS: We fielded postal questionnaires in a stratified sample of 8,564 injury patients aged 15 years and older, who had visited an emergency department in the Netherlands. Measurements were at 2.5, 5, 9, and 24 months after the injury and included a generic health status classification (EQ-5D), socio-demographic, and medical information. We analyzed determinants of long-term functional outcome by multivariate regression analysis. RESULTS: Five months after the injury health status of nonhospitalized injury patients was comparable to the general population's health (EQ-5D summary measure 0.87). Health status of patients admitted for 3 days or less improved until 9 months (0.82). For those admitted more than 3 days health status improved until 24 months (0.48 toward 0.67), but remained below population norms. Hospitalization, age and sex (females), type of injury (spinal cord injury, hip fracture, and lower extremity injury), and comorbidity were significant predictors of poor functioning in the long term. CONCLUSIONS: Recovery patterns vary widely between nonhospitalized, shortly, and long hospitalized injury patients. Nonhospitalized injury patients recover within 5 months from an injury whereas a considerable group of hospitalized injury patients suffer from persistent health problems. Our study indicates the importance of health monitoring with an adapted longitudinal design for injury patients. The time intervals used should match the various stages of the recovery process, which depends on the severity of the injury studied.

Health-related quality of life in preschool children with wheezing and dyspnea: Preliminary results from a random general population sample (Article)

2005-10-01T00:00:00Z

Respiratory symptoms have a high prevalence among preschool children (5-20%). This study evaluated the impact of parent-reported respiratory symptoms on health-related quality of life (HRQOL) using the TNO-AZL Preschool Children Quality of Life (TAPQOL) questionnaire. A random general population sample of 500 parents of 3-46-month old children was mailed a questionnaire containing the TAPQOL and questions on the prevalence of respiratory symptoms. The impact of respiratory symptoms on HRQOL was analysed using the Mann-Whitney test and linear regression analysis. Response rate was 83%. The prevalence of combined 'wheezing and dyspnea' during the past 4 weeks was 10%. For the sleeping, appetite, lung problems, skin problems, communication, and positive mood TAPQOL scales, HRQOL was significantly lower in the subgroup with 'wheezing and dyspnea' (n = 41) than in the subgroup without symptoms (n = 321); large effect sizes were observed for lung problems (2.06) and sleeping (0.80). In multivariate analysis, adjusted for age and gender of the child, 'wheezing and dyspnea' were associated with the scales sleeping, appetite, lung problems, communication, and positive mood (p < 0.05). In conclusion, decreases in HRQOL among preschoolers with parent-reported respiratory symptoms are measurable with the TAPQOL. We recommend studying the impact of doctor-diagnosed respiratory symptoms on HRQOL in future studies.

Reliability and validity of the short form of the child health questionnaire for parents (CHQ-PF28) in large random school based and general population samples (Article)

2005-01-01T00:00:00Z

STUDY OBJECTIVES: This study assessed the feasibility, reliability, and validity of the 28 item short child health questionnaire parent form (CHQ-PF28) containing the same 13 scales, but only a subset of the items in the widely used 50 item CHQ-PF50. DESIGN: Questionnaires were sent to a random regional sample of 2040 parents of schoolchildren (4-13 years); in a random subgroup test-retest reliability was assessed (n = 234). Additionally, the study assessed CHQ-PF28 score distributions and internal consistencies in a nationwide general population sample of (parents of) children aged 4-11 (n = 2474) from Statistics Netherlands. MAIN RESULTS: Response was 70%. In the school and general population samples seven scales showed ceiling effects. Both CHQ summary measures and one multi-item scale showed adequate internal consistency in both samples (Cronbach's alpha>0.70). One summary measure and one scale showed excellent test-retest reliability (intraclass correlation coefficient >0.70); seven scales showed moderate test-retest reliability (intraclass correlation coefficient 0.50-0.70). The CHQ could discriminate between a subgroup with no parent reported chronic conditions (n = 954) and subgroups with asthma (n = 134), frequent headaches (n = 42), and with problems with hearing (n = 38) (Cohen's effect sizes 0.12-0.92; p<0.05 for 39 of 42 comparisons). CONCLUSIONS: This study showed that the CHQ-PF28 resulted in score distributions, and discriminative validity that are comparable to its longer counterpart, but that the internal consistency of most individual scales was low. In community health applications, the CHQ-PF28 may be an acceptable alternative for the longer CHQ-PF50 if the summary measures suffice and reliable estimates of each separate CHQ scale are not required.

Reliability and validity of health status measurement by the TAPQOL (Article)

2005-01-01T00:00:00Z

BACKGROUND: In addition to clinical measures in the evaluation of paediatric interventions, health related quality of life (HRQoL) is an important outcome. The TAPQOL (TNO-AZL Preschool children Quality of Life) was developed to measure HRQoL in preschool children. It is a generic instrument consisting of 12 scales that cover the domains physical, social, cognitive, and emotional functioning. AIMS: To evaluate the feasibility, score distribution, internal consistency, test-retest reliability, and discriminative and concurrent validity of the TAPQOL multi-item scales in preschool children, aged 2-48 months. Also to evaluate the feasibility, reliability, and validity separately for infants (2-12 months old) and toddlers (12-48 months old). METHODS: Parents of a random general population sample of 500 preschool children were sent a questionnaire by mail. A random subgroup of 159 parents who participated received a retest after two weeks. RESULTS: The response rate was 83% at the test and 75% at the retest. There were few missing answers. Six scales showed ceiling effects. Nine scales had Cronbach's alphas >0.70. In general, score distributions and Cronbach's alphas were comparable for infants and toddlers. Test-retest showed no significant differences in mean scale scores; two scales had intra-class correlations <0.50. Five scales showed significant differences between children with no conditions versus children with two or more parent reported chronic conditions. CONCLUSION: Results showed that the TAPQOL is a feasible instrument to measure HRQoL and support the reliability and discriminative validity of the majority of its scales for infants as well as toddlers.

Measuring disease specific quality of life in localized prostate cancer: The Dutch experience (Article)

2003-06-01T00:00:00Z

Objective: We aimed at developing and testing a Dutch health-related quality of life measure for localized prostate cancer patients. Methods: Scales on urinary and bowel function and bother from the UCLA Prostate Cancer Index (PCI) underwent formal linguistic and cultural translation. PCI sexual scales were replaced by an existing Dutch sexual activities module (SAc). After qualitative pilot testing 389 patients with localized prostate cancer (mean age 67 ± 7 years) completed the measure before and at 2 time points after primary treatment. Psychometric properties (feasibility, score distribution, reliability, construct validity and responsiveness to change) of the new instrument were analyzed. Results: Response rates ranged from 93% at baseline to 87% after treatment. Urinary and bowel function scales showed Cronbach's αs >0.7. Urinary function and bother, and bowel function and bother were significantly correlated. Pre- vs. post-prostatectomy effect sizes were >0.9 only for urinary scales; while pre- vs. post-radiotherapy effect sizes were >0.75 only for bowel scales. Six months after baseline erectile dysfunction was reported by 64% of respondents, either as a problem in sexual activity or as a reason for not being sexually active. Conclusion: The Dutch PCI and SAc performed well in men treated for early stage prostate cancer.

Manual Health and Labour Questionnaire (Research Paper)

2000-01-01T00:00:00Z

When the indirect costs form a part of an economical evaluation, a standardised method for measuring production losses, as a result of illness, is required. Standardisation will increase the comparability and transparency of the results. The Health and Labour Questionnaire (HLQ) is designed to collect quantitative data on the relation between illness and treatment and work performance. The HLQ data permits the estimation of production losses (costs) of paid and unpaid labour. It contains also an indicator for impediments for paid and unpaid labour, one of the indicators for quality of life. The HLQ is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labour production and impediments to paid and unpaid labour. The modular structure permits the omission of questions that are not applicable to the study population. The questionnaire is suitable for self-assessment. This manual is a user guide for the HLQ. The scoring- and valuing methods are presented. Furthermore a survey of norm-scores for several groups of respondents is given. The manual contains also information with regard to feasibility and validity of the HLQ. Finally, the procedural aspects for using the questionnaire are given. Currently we are working on a short form version of the HLQ.

Manual Health and Labour Questionnaire (in Dutch) (Research Paper)

1999-01-01T00:00:00Z

Indien indirecte kosten deel uit maken van een economische evaluatie dan is een gestandaardiseerde methode om de productieverliezen als gevolg van ziekte te meten een vereiste. Standaardisatie zal de vergelijkbaarheid en transparantie van de resultaten vergroten. De Vragenlijst over Ziekte en Werk is ontwikkeld om kwantitatieve data te verzamelen over de relatie tussen ziekte, behandeling en werkprestaties. Met de data uit de Vragenlijst over Ziekte en Werk kunnen schattingen van de productieverliezen (indirecte kosten) bij betaald en onbetaald werk gemaakt worden. Daarnaast bevat de vragenlijst een indicator voor hinder die ziekte oplevert om betaald en onbetaald werk te verrichten. Dit kan men zien als één aspect van kwaliteit van leven. De vragenlijst bestaat uit 4 modulen om data te verzamelen over verzuim van betaald werk, productieverliezen zonder verzuim bij betaald werk, productieverliezen bij onbetaald werk en hinder bij het uitoefenen van betaald en onbetaald werk. De modulaire opbouw biedt de mogelijkheid om, afhankelijk van de onderzoekspopulatie, een niet-relevante module achterwege te laten. De vragenlijst kan schriftelijk worden afgenomen en is geschikt voor invulling door de respondent zelf. Deze handleiding vormt een toelichting op de achtergrond van de vragenlijst. Tevens worden de scorings- en waarderingsmethoden uiteengezet. Voorts wordt een overzicht gegeven van de normscores voor verschillende groepen respondenten. De handleiding bevat daarnaast informatie met betrekking tot haalbaarheid, betrouwbaarheid en validiteit van de Vragenlijst over Ziekte en Werk. Tenslotte worden de procedurele aspecten bij het gebruik van de vragenlijst beschreven.

Health status as a measure of outcome of disease and treatment (Doctoral Thesis)

1995-12-13T00:00:00Z

This thesis addresses a number of related topics in health status measurement in the evaluation of the effects of disease and of medical care. Its main objectives are: I. To provide a general overview of the field of descriptive health status measurement. 2. To compare the contents and the relative performance of a number of currently available measures for descriptive health status measurement, to demonstrate applications of descriptive health status measurement and to discuss the importance of standardization of research methods in health status measurement. 3. To provide an overview of the current state of affairs in evaluative health status measurement, and to demonstrate empirical studies addressing the feasibility of collecting valuation data by self-assessment questionnaire.

Societal consequences of migraine in The Netherlands (in Dutch) (Research Paper)

1995-01-01T00:00:00Z

De studie geeft een overzicht van de maatschappelijke gevolgen van migraine. Wij onderzochten medische consumptie, de kosten van verzuim en produktieverlies zonder verzuim en de kwaliteit van leven. Het iMTA ontwikkelde een screeningsvragenlijst op grond van de IHS-criteria voor de selectie van migraine patiënten. Op grond hiervan zijn 846 migraine patiënten en een controle groep van 834 personen geselecteerd uit de gemiddelde populatie. De prevalentie van migraine bedraagt 9%, 5% voor mannen en 12% voor vrouwen. Voor het bepalen van produktie verliezen met en zonder verzuim is de 'Ziekte & Werk' vragenlijst van het iMTA vragenlijst gebruikt. Hieraan zijn vier gestandaardiseerde generieke kwaliteit van leven vragenlijsten toegevoegd. De totale kosten voor migraine bedragen volgens deze voorzichtige schatting 675 miljoen gulden per jaar. Hiervan zijn de directe kosten 134 miljoen gulden per jaar, de kosten van verzuim varieerde afhankelijk van de recall periode van 264 tot 473 miljoen gulden per jaar. De conservatieve schatting van de kosten van produktieverlies zonder verzuim op basis van de 'Ziekte & Werk' methode is 277 miljoen gulden per jaar. Schatting op grond van twee alternatieve methode voor het meten van productieverliezen zonder verzuim komen hoger uit, respectievelijk 968 en 1455 miljoen per jaar. Op grond van generieke vragenlijsten bleek dat de kwaliteit van leven van migraine patiënten ook buiten de aanvallen significant lager is dan van de controle groep.