The modified Manchester Fothergill procedure compared with vaginal hysterectomy with low uterosacral ligament suspension in patients with pelvic organ prolapse: long-term outcome.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to compare the long-term outcome between vaginal hysterectomy with low uterosacral ligament suspension (VH) and the modified Manchester Fothergill procedure (MF) as surgical treatment in patients with pelvic organ prolapse (POP). We hypothesize that MF is non-inferior to VH in the long term. METHODS: In this single-center retrospective cohort study patients who underwent MF or VH for primary apical compartment prolapse between 2003 and 2009 were eligible for inclusion. The primary outcome was subjective recurrence of POP. Secondary outcomes included number and type of reinterventions, time to reintervention and the degree of complaints. RESULTS: One hundred sixty of 398 patients (53 MF, 107 VH) returned the questionnaires (40%). The mean follow-up was 12.97 years for MF and 13.24 years for VH (p = 0.38). There were similar rates of subjective POP recurrence (51% in both groups). The reintervention rate in the MF group was higher but reached no statistical significance [19/53 (36%) versus 29/107 (27%), p = 0.26]. Kaplan-Meier curve showed no statistically significant difference in risk of reintervention after MF at the maximum follow-up of 16.5 years [HR 1.830 (95% CI 0.934-3.586), p = 0.08]. The mean time to reintervention was 3 years shorter in the MF group (p = 0.03). CONCLUSIONS: The subjective recurrence after MF is similar to VH in treatment of POP at the long term. MF appears to be non-inferior to VH when comparing the risk of reintervention. However, the small sample size precludes a definitive conclusion of non-inferiority, and future studies are needed.

The effects of an online decision aid to support the reproductive decision-making process of genetically at risk couples-A pilot study.

Couples at risk of transmitting a genetic disease to their offspring may experience doubts about their reproductive options. This study examines the effects of an online decision aid (DA) on the (joint) reproductive decision-making process of couples (not pregnant at time of inclusion) at risk of transmitting a genetic disease to their offspring. The primary outcome is decisional conflict, and secondary outcomes are knowledge, realistic expectations, deliberation, joint informed decision-making, and decisional self-efficacy. These outcomes were measured with a pretest-posttest design: before use (T0), after use (T1), and 2 weeks after use (T2) of the decision aid (DA). Usability of the DA was assessed at T1. Paired sample t-tests were used to compute differences between baseline and subsequent measurements. The comparisons of T0-T1 and T0-T2 indicate a significant reduction in mean decisional conflict scores with stronger effects for participants with high baseline decisional conflict scores. Furthermore, use of the DA led to increased knowledge, improved realistic expectations, and increased levels of deliberation, with higher increase in participants with low baseline scores. Decision self-efficacy only improved for participants with lower baseline scores. Participants indicated that the information in the DA was comprehensible and clearly organized. These first results indicate that this online DA is an appropriate tool to support couples at risk of transmitting a genetic disease and a desire to have (a) child(ren) in their reproductive decision-making process.

Reproductive decision-making in the context of hereditary cancer: the effects of an online decision aid on informed decision-making.

Individuals having a genetic predisposition to cancer and their partners face challenging decisions regarding their wish to have children. This study aimed to determine the effects of an online decision aid to support couples in making an informed decision regarding their reproductive options. A nationwide pretest-posttest study was conducted in the Netherlands among 131 participants between November 2016 and May 2018. Couples were eligible for participation if one partner had a pathogenic variant predisposing for an autosomal dominant hereditary cancer syndrome. Participants completed a questionnaire before use (T0), and at 3 months (T3) after use of the decision aid to assess the primary outcome measure informed decision-making, and the secondary outcome measures decisional conflict, knowledge, realistic expectations, level of deliberation, and decision self-efficacy. T0-T3 comparisons show an overall positive effect for all outcome measures (all ps < 0.05; knowledge (ES = - 1.05), decisional conflict (ES = 0.99), participants' decision self-efficacy (ES = -0.55), level of deliberation (ES = - 0.50), and realistic expectations (ES = - 0.44). Informed decision-making increased over time and 58.0% of the participants made an informed reproductive decision at T3. The online decision aid seems to be an appropriate tool to complement standard reproductive counseling to support our target group in making an informed reproductive decision. Use of the decision aid may lessen the negative psychological impact of decision-making on couples' daily life and wellbeing.

Online decision support for persons having a genetic predisposition to cancer and their partners during reproductive decision-making.

A nationwide pretest-posttest study was conducted in all clinical genetic centres in the Netherlands, to evaluate the effects of an online decision aid to support persons who have a genetic predisposition to cancer and their partners in making an informed decision regarding reproductive options. Main outcomes (decisional conflict, knowledge, realistic expectations, level of deliberation, and decision self-efficacy) were measured before use (T0), immediately after use (T1), and at 2 weeks (T2) after use of the decision aid. Paired sample t tests were used to compute differences between the first and subsequent measurements. T0-T1 and T0-T2 comparisons indicate a significant reduction in mean decisional conflict scores with stronger effects for participants with high baseline decisional conflict. Furthermore, use of the decision aid resulted in increased knowledge levels and improved realistic expectations. Level of deliberation only increased for participants with lower baseline levels of deliberation. Decision self-efficacy increased for those with low baseline scores, whereas those with high baseline scores showed a reduction at T2. It can be concluded that use of the decision aid resulted in several positive outcomes indicative of informed decision-making. The decision aid is an appropriate and highly appreciated tool to be used in addition to reproductive counseling.

Exploring the preferences of involved health professionals regarding the implementation of an online decision aid to support couples during reproductive decision-making in hereditary cancer: a mixed methods approach.

To support persons having a genetic predisposition to cancer and their partners during reproductive decision-making, an online decision aid was developed and evaluated. To maximize the impact of the support tool, this mixed methods study aims at developing the optimal implementation strategy for the decision aid. A questionnaire to assess the critical determinants that may affect this implementation was completed by health professionals involved in oncogenetic counselling (N = 46). Subsequently, semi-structured focus groups (N = 19) and individual telephonic interviews (N = 15) were performed with a subset of health professionals. All health professionals indicated to be willing to refer couples to the decision aid, preferably at the moment of receiving the genetic test result. They agreed that the primary requirement for implementation in daily practice was ease of referring couples and preferably free online accessibility. Referral to the tool was able to be included in the standard report couples receive after consultation, thereby making the use of additional paper-based materials redundant (e.g. flyers). Furthermore, incorporating the link to the decision aid on patient organization websites was suggested. Health professionals agreed that implementation would benefit more from promoting awareness regarding the decision aid rather than the inclusion of the tool in official clinical guidelines. To foster implementation of the decision aid, the distribution of online newsletters and the designation of a contact person charged with continued implementation in each Clinical Genetic Center were suggested. Based on these preferences and recommendations, the implementation of the online decision aid will be nationally executed to optimize impact.

The development of an online decision aid to support persons having a genetic predisposition to cancer and their partners during reproductive decision-making: a usability and pilot study.

An online decision aid to support persons having a genetic predisposition to cancer and their partners during reproductive decision-making was developed. A two-phase usability test was conducted among 12 couples (N = 22; 2 persons participated without their partner) at risk for hereditary cancer and 15 health care providers. Couples and health care providers expressed similar suggestions for improvements, and evaluated the modified decision aid as acceptable, easy to use, and comprehensible. The final decision aid was pilot tested (N = 16) with paired sample t tests comparing main outcomes (decisional conflict, knowledge, realistic expectations regarding the reproductive options and decision self-efficacy) before (T0), immediately (T1) and 2 weeks after (T2) use of the decision aid. Pilot testing indicated decreased decisional conflict scores, increased knowledge, and improved realistic expectations regarding the reproductive options, at T1 and T2. No effect was found for couples' decision self-efficacy. The positive findings during usability testing were thus reflected in the pilot study. The decision aid will be further evaluated in a nationwide pretest-posttest study to facilitate implementation in the onco-genetic counselling setting. Ultimately, it is expected that the decision aid will enable end-users to make an informed decision.

Factors Associated with Acceptability, Consideration and Intention of Uptake of Direct-To-Consumer Genetic Testing: A Survey Study.

BACKGROUND: With interest in personalised health care growing, so is interest in personal genetic testing. This is now offered direct-to-consumer, thereby referred to as direct-to-consumer genetic testing (DTC-GT). Criticisms have been expressed on whether a truly informed decision to undergo testing is made with regard to these services. In order to provide relevant information to achieve this, knowing the characteristics of the expected user population is helpful. Therefore, the aim of this study is to identify characteristics of individuals who (1) find the concept of DTC-GT acceptable and (2) consider undergoing DTC-GT in the distant or near future. METHODS: This cross-sectional study investigated factors associated with acceptability, consideration and intention in the Dutch general population. Studied variables included awareness, principles and how-to knowledge, attitude, innovativeness, and multiple demographic characteristics. Generalised linear models were applied to identify associated variables. RESULTS: Full data was obtained for 836 respondents. Of those, 18.3% found DTC-GT somewhat or totally acceptable, whereas 12.6% considered and 5.5% intended to undergo DTC-GT in the distant or near future. Acceptability was greater with lower principles knowledge, and consideration and intention with lower how-to knowledge. A more positive attitude and greater innovativeness were associated with an increase in all 3 outcomes. CONCLUSION: Informed decision making may be hampered as individuals with lower how-to knowledge were found to be more interested in pursuing testing. The identified characteristics can be used in development and distribution of public and personalized information, in order to help consumers make a truly informed decision.

The use of a proactive dissemination strategy to optimize reach of an internet-delivered computer tailored lifestyle intervention.

BACKGROUND: The use of reactive strategies to disseminate effective Internet-delivered lifestyle interventions restricts their level of reach within the target population. This stresses the need to invest in proactive strategies to offer these interventions to the target population. The present study used a proactive strategy to increase reach of an Internet-delivered multi component computer tailored intervention, by embedding the intervention in an existing online health monitoring system of the Regional Public Health Services in the Netherlands. METHODS: The research population consisted of Dutch adults who were invited to participate in the Adult Health Monitor (N = 96,388) offered by the Regional Public Health Services. This Monitor consisted of an online or a written questionnaire. A prospective design was used to determine levels of reach, by focusing on actual participation in the lifestyle intervention. Furthermore, adequacy of reach among the target group was assessed by composing detailed profiles of intervention users. Participants' characteristics, like demographics, behavioral and mental health status and quality of life, were included in the model as predictors. RESULTS: A total of 41,155 (43%) people participated in the Adult Health Monitor, of which 41% (n = 16,940) filled out the online version. More than half of the online participants indicated their interest (n = 9169; 54%) in the computer tailored intervention and 5168 participants (31%) actually participated in the Internet-delivered computer tailored intervention. Males, older respondents and individuals with a higher educational degree were significantly more likely to participate in the intervention. Furthermore, results indicated that especially participants with a relatively healthier lifestyle and a healthy BMI were likely to participate. CONCLUSIONS: With one out of three online Adult Health Monitor participants actually participating in the computer tailored lifestyle intervention, the employed proactive dissemination strategy succeeded in ensuring relatively high levels of reach. Reach among at-risk individuals (e.g. low socioeconomic status and unhealthy lifestyle) was modest. It is therefore essential to further optimize reach by putting additional effort into increasing interest in the lifestyle intervention among at-risk individuals and to encourage them to actually use the intervention. TRIAL REGISTRATION: Dutch Trial Register (NTR1786) and Medical Ethics Committee of Maastricht University and the University Hospital Maastricht (NL2723506809/MEC0903016).

Program completion of a web-based tailored lifestyle intervention for adults: differences between a sequential and a simultaneous approach.

BACKGROUND: Unhealthy lifestyle behaviors often co-occur and are related to chronic diseases. One effective method to change multiple lifestyle behaviors is web-based computer tailoring. Dropout from Internet interventions, however, is rather high, and it is challenging to retain participants in web-based tailored programs, especially programs targeting multiple behaviors. To date, it is unknown how much information people can handle in one session while taking part in a multiple behavior change intervention, which could be presented either sequentially (one behavior at a time) or simultaneously (all behaviors at once). OBJECTIVES: The first objective was to compare dropout rates of 2 computer-tailored interventions: a sequential and a simultaneous strategy. The second objective was to assess which personal characteristics are associated with completion rates of the 2 interventions. METHODS: Using an RCT design, demographics, health status, physical activity, vegetable consumption, fruit consumption, alcohol intake, and smoking were self-assessed through web-based questionnaires among 3473 adults, recruited through Regional Health Authorities in the Netherlands in the autumn of 2009. First, a health risk appraisal was offered, indicating whether respondents were meeting the 5 national health guidelines. Second, psychosocial determinants of the lifestyle behaviors were assessed and personal advice was provided, about one or more lifestyle behaviors. RESULTS: Our findings indicate a high non-completion rate for both types of intervention (71.0%; n = 2167), with more incompletes in the simultaneous intervention (77.1%; n = 1169) than in the sequential intervention (65.0%; n = 998). In both conditions, discontinuation was predicted by a lower age (sequential condition: OR = 1.04; P < .001; CI = 1.02-1.05; simultaneous condition: OR = 1.04; P < .001; CI = 1.02-1.05) and an unhealthy lifestyle (sequential condition: OR = 0.86; P = .01; CI = 0.76-0.97; simultaneous condition: OR = 0.49; P < .001; CI = 0.42-0.58). In the sequential intervention, being male (OR = 1.27; P = .04; CI = 1.01-1.59) also predicted dropout. When respondents failed to adhere to at least 2 of the guidelines, those receiving the simultaneous intervention were more inclined to drop out than were those receiving the sequential intervention. CONCLUSION: Possible reasons for the higher dropout rate in our simultaneous intervention may be the amount of time required and information overload. Strategies to optimize program completion as well as continued use of computer-tailored interventions should be studied. TRIAL REGISTRATION: Dutch Trial Register NTR2168.

Optimizing diffusion of an online computer tailored lifestyle program: a study protocol.

BACKGROUND: Although the Internet is a promising medium to offer lifestyle interventions to large amounts of people at relatively low costs and effort, actual exposure rates of these interventions fail to meet the high expectations. Since public health impact of interventions is determined by intervention efficacy and level of exposure to the intervention, it is imperative to put effort in optimal dissemination. The present project attempts to optimize the dissemination process of a new online computer tailored generic lifestyle program by carefully studying the adoption process and developing a strategy to achieve sustained use of the program. METHODS/DESIGN: A prospective study will be conducted to yield relevant information concerning the adoption process by studying the level of adoption of the program, determinants involved in adoption and characteristics of adopters and non-adopters as well as satisfied and unsatisfied users. Furthermore, a randomized control trial will be conducted to the test the effectiveness of a proactive strategy using periodic e-mail prompts in optimizing sustained use of the new program. DISCUSSION: Closely mapping the adoption process will gain insight in characteristics of adopters and non-adopters and satisfied and unsatisfied users. This insight can be used to further optimize the program by making it more suitable for a wider range of users, or to develop adjusted interventions to attract subgroups of users that are not reached or satisfied with the initial intervention. Furthermore, by studying the effect of a proactive strategy using period prompts compared to a reactive strategy to stimulate sustained use of the intervention and, possibly, behaviour change, specific recommendations on the use and the application of prompts in online lifestyle interventions can be developed. TRIAL REGISTRATION: Dutch Trial Register NTR1786 and Medical Ethics Committee of Maastricht University and the University Hospital Maastricht (NL2723506809/MEC0903016).

Some signals cannot wait: effects of a national campaign on early detection of cancer among Dutch adults (>55 years).

BACKGROUND: The present study examined the effects of the campaign "early detection of cancer" on knowledge, attitudes, awareness, and intention to perform passive detection and timely seeking medical help. Further, the campaign was evaluated on recall and recognition and the various campaign components were evaluated. METHODS: A longitudinal study using a Solomon four-group design among 784 Dutch adults aged 55 years and older was conducted. Data was gathered by means of telephone interviews. RESULTS: The results showed moderate levels of campaign awareness. After the campaign, solely respondents who received a pre-test questionnaire and were aware of the campaign had significant higher cancer knowledge levels regarding passive detection. Respondents who were only aware of the campaign were significantly more willing to perform passive detection behavior and to timely seek medical help in the future. Further, they were more aware that paying attention to cancer warning signs can lead to early detection of cancer. CONCLUSIONS: It can be concluded that solely the combination of the pre-test questionnaire and exposure to the campaign had a significant positive impact on respondents' cancer knowledge levels. The effects of the campaign on intention and awareness are indistinct and could be a consequence of (the results of) a self-selection bias. It seems that the dose, frequency, and duration of the campaign should be increased in order to substantiate the effects of the campaign.

Low thyroid-stimulating hormone as an independent risk factor for Alzheimer disease.

OBJECTIVE: To assess a possible relationship between thyroid-stimulating hormone (TSH) levels, vascular risk factors, and Alzheimer disease (AD). METHODS: TSH levels were measured in 178 AD patients (35 confirmed post mortem) and 291 cognitively screened control subjects who were all euthyroid (TSH: 0.5 to 6 mU/L). The risk of AD was determined in participants with lower levels of TSH, several cerebrovascular risk factors, and other potential confounds. RESULTS: AD patients had significantly lower levels of TSH than control subjects. Lowered TSH was associated with a more than twofold increased risk of AD (odds ratio = 2.36, 95% CI = 1.19 to 4.67), independent of other risk factors. CONCLUSION: Lowered TSH within the normal range is a risk factor for AD, independent of several cerebrovascular risk factors and confounding variables.