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Biomedical subjects

Peep F M Stalmeier

Publications and source records attributed to Peep F M Stalmeier.

16 recordsLinked to original sources

Do patients with localized prostate cancer treatment really want more aggressive treatment?

PURPOSE: Examine whether patients with prostate cancer choose the more aggressive of two radiotherapeutic options, whether this choice is reasoned, and what the determinants of the choice are. PATIENTS AND METHODS: One hundred fifty patients with primary prostate cancer (T(1-3)N(0)M(0)) were informed by means of a decision aid of two treatment options: radiotherapy with 70 Gy versus 74 Gy. The latter treatment is associated with more cure and more toxicity. The patients were asked whether they wanted to choose, and if so which treatment they preferred. They also assigned importance weights to the probability of various outcomes, such as survival, cure and adverse effects. Patients who wanted to choose their own treatment (n = 119) are described here. RESULTS: The majority of these patients (75%) chose the lower radiation dose. Their choice was highly consistent (P < or = .001), with the importance weights assigned to the probability of survival, cure (odds ratio [OR] = 6.7 and 6.9) and late GI and genitourinary adverse effects (OR = 0.1 and 0.2). The lower dose was chosen more often by the older patients, low-risk patients, patients without hormone treatment, and patients with a low anxiety or depression score. CONCLUSION: Most patients with localized prostate cancer prefer the lower radiation dose. Our findings indicate that many patients attach more weight to specific quality-of-life aspects (eg, GI toxicity) than to improving survival. Treatment preferences of patients with localized prostate cancer can and should be involved in radiotherapy decision making.

Aged↗

Testing the interval-level measurement property of multi-item visual analogue scales.

BACKGROUND: Conditions were studied that may invalidate health-state values derived from the visual analogue scale (VAS). METHODS: Respondents were asked to place cards with descriptions of EQ-5D health states on a 20 cm EuroQol VAS and modified versions of it, positioning them such that the distances between the states reflect their valuation for these states. Anchor-point bias was examined using the standard EuroQol VAS (n = 212) and a modified version (n = 97) with a different lower anchor. Context bias was examined in another group of respondents (n = 112) who valued three different sets of EQ-5D health states. Marker bias was studied in yet another group of respondents (n = 100) who placed the same EQ-5D states on the standard EuroQol VAS and on a modified VAS without anchors, categories, or measurement markers. RESULTS: No indication for the existence of the anchor-point and the marker bias was found. However, the VAS valuations were significantly affected by the context of the set of health states in the scaling task. CONCLUSION: Advanced methodologies should be incorporated in VAS valuation studies to deal with the context bias.

Adolescent↗

Do prostate cancer patients want to choose their own radiation treatment?

PURPOSE: The aims of this study were to investigate whether prostate cancer patients want to be involved in the choice of the radiation dose, and which patients want to be involved. METHODS AND MATERIALS: This prospective study involved 150 patients with localized prostate cancer treated with three-dimensional conformal radiotherapy. A decision aid was used to explain the effects of two alternative radiation doses (70 and 74 Gy) in terms of cure and side effects. Patients were then asked whether they wanted to choose their treatment (accept choice), or leave the decision to the physician (decline choice). The treatment preference was carried out. RESULTS: Even in this older population (mean age, 70 years), most patients (79%) accepted the option to choose. A lower score on the designations Pre-existent bowel morbidity, Anxiety, Depression, Hopelessness and a higher score on Autonomy and Numeracy were associated with an increase in choice acceptance, of which only Hopelessness held up in multiple regression (p < 0.03). The uninformed participation preference at baseline was not significantly related to choice acceptance (p = 0.10). CONCLUSION: Uninformed participation preference does not predict choice behavior. However, once the decision aid is provided, most patients want to choose their treatment. It should, therefore, be considered to inform patients first and ask participation preferences afterwards.

Aged↗

Prospective patient and physician preferences for stimulation or no stimulation in IVF.

OBJECTIVE: The aim is to explore the preferences of female patients and physicians for IVF in three natural cycles compared to one stimulated cycle and to investigate which factors predict these preferences. STUDY DESIGN: A questionnaire about IVF preference was administered initially to 105 patients between 36 and 42 years, who were on the waiting list for their first or second IVF attempt. In addition a questionnaire was sent to 56 physicians of Dutch IVF centres. The participants were asked for their preferences at different success rates based on treatment trade-off scenarios. Finally, information on demographic, psychological and other predictors for treatment choice were collected. RESULTS: Complete data were obtained in 69 female patients (67%) and 27 physicians (49%). At a success rate for a life birth of 17% for both treatments, IVF in three natural cycles is preferred by 78% of the patients and physicians. Half of the patients and physicians still preferred natural cycle treatment at a success rate of 13%. Anxiety for hormone injections was the only significant predictor for patients' preferences. CONCLUSION: There seems to be a latent demand for IVF in the natural cycle related to anxiety for hormone injections.

Adult↗

Systematic review of the effect of radiation dose on tumor control and morbidity in the treatment of prostate cancer by 3D-CRT.

PURPOSE: A higher radiation dose is believed to result in a larger probability of tumor control and a higher risk of side effects. To make an evidence-based choice of dose, the relation between dose and outcome needs to be known. This study focuses on the dose-response relation for prostate cancer. METHODS AND MATERIALS: A systematic review was carried out on the literature from 1990 to 2003. From the selected studies, the radiation dose, the associated 5-year survival, 5-year bNED (biochemical no evidence of disease), acute and late gastrointestinal (GI) and genitourinary (GU) morbidity Grade 2 or more, and sexual dysfunction were extracted. With logistic regression models, the relation between dose and outcome was described. RESULTS: Thirty-eight studies met our criteria, describing 87 subgroups and involving up to 3000 patients per outcome measure. Between the (equivalent) dose of 70 and 80 Gy, various models estimated an increase in 5-year survival (ranging from 10% to 11%), 5-year bNED for low-risk patients (5-7%), late GI complications (12-16%), late GU complications (8-10%), and erectile dysfunction (19-24%). Only for the overall 5-year bNED, results were inconclusive (range, 0-18%). CONCLUSIONS: The data suggest a relationship between dose and outcome measures, including survival. However, the strength of these conclusions is limited by the sometimes small number of studies, the incompleteness of the data, and above all, the correlational nature of the data. Unambiguous proof for the dose-response relationships can, therefore, only be obtained by conducting randomized trials.

Dose-Response Relationship, Radiation↗

The gap effect: discontinuities of preferences around dead.

BACKGROUND: The assessment of health states considered to be worse than dead is a controversial issue. OBJECTIVE: To investigate how health states are valued when they are close to dead. Differences between adjacent states are compared with the differences between the first positive/first negative state with death. METHODS: A secondary analysis of the EuroQol EQ-5D data of the measurement of valuation and health (MVH) study was made. Visual analog scale (VAS) and time trade-off (TTO) preferences for 43 health states were obtained. Various subsets of 13 states were valued by 3395 respondents. States were rank ordered by their VAS and TTO values. Differences between adjacent states were calculated for the VAS and the positive and negative TTO values. RESULTS: Complete data were obtained in 2997 respondents. The differences between the ordered VAS values were equally large. In contrast, significant gaps around dead were found for the positive as well as the negative TTO values. DISCUSSION: These results are interpreted in light of a descriptive QALY model. This model was expanded to include utilities worse than dead. The VAS task does not pick up that bad states become intolerable, i.e. worse than dead, when they last too long, but the TTO task does. The current QALY model seems to lack descriptive validity for states valued worse than dead and for states with a maimal endurable time.

Attitude to Death↗

The decision evaluation scales.

There are several instruments to assess how patients evaluate their medical treatment choice. These are used to evaluate decision aids. Our objective is to investigate which psychological factors play a role when patients evaluate their medical treatment choices. A pool of 36 items was constructed, covering concepts such as uncertainty about and satisfaction with the decision, informed choice, effective decision making, responsibility for the decision, perceived riskiness of the choice, and social support regarding the decision. This pool was presented to patients at high risk for breast and ovarian cancer, awaiting a genetic test result, and facing the choice between prophylactic surgery or screening. Additional measures were assessed for validation purposes. Factor and Rasch analyses were used for factor and item selection. Construct validity of emerging scales was assessed by relating them with the additional measures. Three factors summarised the psychological factors concerning decision evaluation: Satisfaction-Uncertainty, Informed Choice, and Decision Control. Reliabilities (Cronbach's alpha) of the three scales were 0.79, 0.85, and 0.75, respectively. Construct validity hypotheses were confirmed. The first two scales were similar to previously developed scales. Of these three scales, the Decision Control scale correlated most strongly with the well-being measures, was associated with partner's agreement and physician's preferences as perceived by patients, and with a negative emotional reaction to the information material. In conclusion, the Decision Control scale is a new scale to evaluate decision aids, and it appears to be rooted in health psychological theories.

Adult↗

Validity of utilities of patients with esophageal cancer.

OBJECTIVES: The convergent validity between utility assessment methods was assessed. METHODS: Investigated were patients with esophageal cancer treated surgically with curative intent. Patients were interviewed in a period from 3 to 12 months after surgical resection. Patients evaluated their actual health and seven other states. Visual analogue scale (VAS) and standard gamble (SG) utilities were obtained for the health states in an interview. Patients also indicated whether or not they preferred death to living in a health state (worse than dead [WTD] preferences). RESULTS: Fifty patients completed the interview. Convergent validity was excellent at the aggregate and individual level. However, the relation between VAS and SG differed strongly across individuals. On a scale from 0 (dead) to 100 (perfect health), SG scores were lower for patients with WTD preferences (mean difference d = 35; p = .002); however, VAS scores did not vary by WTD preferences. CONCLUSIONS: In general, there is good agreement between VAS and SG measures, although patients disagree about how the VAS and SG are related. The standard gamble varied by WTD preferences, however, the VAS did not.

Adaptation, Psychological↗

Patient preferences for expectant management vs. surgical evacuation in first-trimester uncomplicated miscarriage.

OBJECTIVE: Expectant and surgical management are widely accepted treatment options in case of a miscarriage. In the absence of differences in complications, the choice between both options can be based on patient preferences. STUDY DESIGN AND SETTING: We studied treatment preferences for future miscarriages in women with a miscarriage randomized to expectant or surgical treatment or managed according to their own choice. RESULTS: Data from 136 patients were analyzed. Women randomized either to expectant or surgical management opted for the allocated treatment in future in 55 and 74%, respectively. Of the women randomized to expectant management and with a successful spontaneous loss, 71% opted again for this treatment. Women who were managed according to their own treatment choice, held on to their initial treatment preference (expectant vs. surgical management; 84 and 88%, respectively). Preferences after treatment were strong. CONCLUSION: A strong treatment preference should be taken into account in the counseling process. Women without a preference should be well informed on all medical aspects of the two options in order to facilitate informed-shared decision-making.

Abortion, Spontaneous↗

Treatment of venous thromboembolism with vitamin K antagonists: patients' health state valuations and treatment preferences.

Determining the optimal duration of vitamin K antagonist (VKA) therapy for patients with venous thromboembolism (VTE) requires a weighting of the benefits and risks of treatment. The objectives of our study were to investigate patient variability in health state valuations associated with VKA therapy and treatment preferences, and to investigate the extent to which valuations and treatment preferences are associated with prior experience with these health states and other patient characteristics. Valuations of outcomes after VTE scaled from 0 (tantamount to death) to 1 (tantamount to perfect health) were elicited from 53 patients who had experienced VTE, 23 patients who had experienced major bleeding during treatment, and 48 patients with the post-thrombotic syndrome. In addition, patients' treatment preferences were evaluated using treatment trade-off questions. Median health state valuations ranged from 0.33 for 'non-fatal haemorrhagic stroke' to 0.96 for 'no VKA treatment'. Variability between patients was substantial. Patients' treatment preferences also varied: 25% of patients chose cessation of treatment, regardless of the probability of recurrent VTE presented, whereas 23% of patients were never willing to choose cessation of treatment. Differences in valuations and treatment preferences were not associated with type of event experienced. Due to the substantial and unpredictable variability in valuations and treatment preferences, recommendations regarding treatment duration should be tailored to patients' specific values and concerns.

Adult↗

Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus.

BACKGROUND: Controversy exists about the best surgical treatment for esophageal carcinoma. METHODS: We randomly assigned 220 patients with adenocarcinoma of the mid-to-distal esophagus or adenocarcinoma of the gastric cardia involving the distal esophagus either to transhiatal esophagectomy or to transthoracic esophagectomy with extended en bloc lymphadenectomy. Principal end points were overall survival and disease-free survival. Early morbidity and mortality, the number of quality-adjusted life-years gained, and cost effectiveness were also determined. RESULTS: A total of 106 patients were assigned to undergo transhiatal esophagectomy, and 114 to undergo transthoracic esophagectomy. Demographic characteristics and characteristics of the tumor were similar in the two groups. Perioperative morbidity was higher after transthoracic esophagectomy, but there was no significant difference in in-hospital mortality (P=0.45). After a median follow-up of 4.7 years, 142 patients had died--74 (70 percent) after transhiatal resection and 68 (60 percent) after transthoracic resection (P=0.12). Although the difference in survival was not statistically significant, there was a trend toward a survival benefit with the extended approach at five years: disease-free survival was 27 percent in the transhiatal-esophagectomy group, as compared with 39 percent in the transthoracic-esophagectomy group (95 percent confidence interval for the difference, -1 to 24 percent [the negative value indicates better survival with transhiatal resection]), whereas overall survival was 29 percent as compared with 39 percent (95 percent confidence interval for the difference, -3 to 23 percent). CONCLUSIONS: Transhiatal esophagectomy was associated with lower morbidity than transthoracic esophagectomy with extended en bloc lymphadenectomy. Although median overall, disease-free, and quality-adjusted survival did not differ statistically between the groups, there was a trend toward improved long-term survival at five years with the extended transthoracic approach.

Adenocarcinoma↗

Decision analysis of prophylactic surgery or screening for BRCA1 mutation carriers: a more prominent role for oophorectomy.

PURPOSE: BRCA1 mutation carriers have a high risk of developing breast and ovarian cancer. Carriers may opt for prophylactic surgery and screening. Recent data suggesting that prophylactic oophorectomy reduces breast cancer risk have been incorporated in a decision analysis. METHODS: A Markov model was developed to compare LE and QALE following four strategies: (1) prophylactic mastectomy and prophylactic oophorectomy (PMPO), (2) screening for breast cancer and prophylactic oophorectomy (BSPO), (3) prophylactic mastectomy and screening for ovarian cancer (PMOS), and (4) screening for breast and ovarian cancer (BSOS). The analysis was performed for a high (85% breast cancer, 63% ovarian cancer) and medium (56% breast cancer, 16% ovarian cancer) risk level. Utilities for the health states after prophylactic surgery were obtained from mutation carriers. Other model parameter values were obtained from the literature. Sensitivity analyses were performed. RESULTS: When compared with BSOS, the average gain in LE for 30-year-old carriers in the high (medium) risk group was 11.7 (6.6) years for PMPO, 9.5 (5.3) years for BSPO, and 4.9 (4.4) years for PMOS. For 30-year-old carriers, BSPO had a QALE advantage when PO was performed before age 40. In the medium-risk group, there was a stronger advantage for BSPO when QALE was considered. CONCLUSION: PMPO is the most effective strategy to prolong life. However, if patient preferences were taken into account, BSPO tends to be a better strategy in most women at medium risk or in young women at high risk when PO was performed before age 40.

Adult↗

Discrepancies between chained and classic utilities induced by anchoring with occasional adjustments.

BACKGROUND: Classic utility assessment uses death and perfect health as end points. Chained utility assessment uses other health states as endpoints. It has been previously noted that these 2 assessment procedures lead to different utilities. PURPOSE: The author attempts to explain these discrepancies between chained and classic assessments. METHOD: Previous data are plotted in a uniform way to facilitate comparison. Using time trade-off and paired-comparison data, the author estimates the extent to which respondents adjust their responses when end points are varied. Data were obtained in various samples: in healthy volunteers from the general public, in students, and in women at high risk for breast cancer seeking genetic counseling. RESULTS: The author obtained 741 valid data records from a total of 106 participants. The data replicate the pattern found previously. When compared to classic utilities, (1) chained utilities are smaller (larger) when the best (worst) endpoint varies and (2) the discrepancies become smaller for utilities near 0 and 1. The data reveal that there is a distinct failure to adjust responses when the end points are varied, as if the responses anchor on some master health scale. The latter finding explains the robust pattern of discrepancies. CONCLUSION: Decision analyses that use a mix of classic and chained utilities are not on firm ground. One should be wary of normative interpretations of new value assessment procedures. Alternative interpretations of the findings are discussed.

Adolescent↗

A comparison of 3 valuation methods for temporary health states in patients treated with oral anticoagulants.

BACKGROUND: The application of the time tradeoff (TTO) method in temporary health states may lead to less valid results because an unrealistic scenario is presented to patients. The chained TTO has been proposed to solve this problem. OBJECTIVES: To compare a chained TTO method with a conventional TTO method in the valuation of temporary health states, in terms of consistency and reliability. To compare both TTO methods with direct rating. PATIENTS AND METHODS: Eighty-four patients treated with oral anticoagulants were interviewed twice. During the 1st interview, values for 5 temporary health states were obtained with a rank ordering procedure, direct rating, and the chained TTO method. During the 2nd interview, either the 1st interview was repeated (n = 30) or health state values were obtained with the conventional TTO method (n = 54). Consistency was assessed by comparing the 3 valuation methods with the rank ordering procedure. Generalizability theory was used to assess reliability. RESULTS: The 3 methods produced significantly different valuations of health states. Chained TTO values were higher than values obtained with direct rating and the conventional TTO. Consistency and reliability did not differ across the 3 methods. CONCLUSION: The authors found no evidence for a difference in consistency and reliability between the chained TTO method and the conventional TTO method in the valuation of temporary health states. As direct rating is simpler to administer than both TTO methods, one could consider using direct ratings for the valuation of temporary health states. Biases associated with the conventional and the chained TTO method are discussed.

Administration, Oral↗

Inconsistencies in TTO and VAS values for EQ-5D health states.

BACKGROUND: Most EQ-5D health states can be ordered logically. When people assign values to different health states, they may violate this logical order, which can be seen as inconsistencies. OBJECTIVE: The aim of this study was to assess the effect of inconsistently valued EQ-5D health states on mean visual analog scale (VAS) and time trade-off (TTO) values. The authors also examined the effect of removing respondents with high numbers of inconsistent states on the estimation of tariffs, which is used to interpolate values to all possible EQ-5D states from the direct valuation of a subset of states. METHOD: Data from the Dutch EQ-5D valuation study were used. A representative sample of 309 Dutch adults valued 17 EQ-5D health states by VAS and TTO. A state was valued inconsistently when it had a higher value than at least 1 logically better state. Mean values of groups with various numbers of inconsistently valued states were compared. RESULTS: Of the respondents, 65% had inconsistencies for VAS and 89% for TTO. The mean VAS values of consistent respondents tend to be lower. For TTO, those with inconsistencies gave lower values. Removing data of respondents with the highest number of inconsistently valued states for VAS (13%) and TTO (9%) did not result in statistically significant different coefficients in the estimated tariff using all data. CONCLUSION: The majority of respondents valued at least 1 state inconsistently. For both VAS and TTO, the presence of these inconsistencies did not affect the estimated tariffs.

Adolescent↗