Challenges In Performing An Individual Participant-level Data Meta-analysis.

Individual participant-data meta-analysis (IPDMA) uses data at the participant level to synthesize evidence on clinical decision-making. We discuss the differences from aggregate-data meta-analysis and the advantages and challenges of IPDMA. IPDMA provides an opportunity to study effect modifiers at the participant level and can reduce bias in comparison to aggregate-data meta-analysis. A challenge with IPDMA is that it often requires considerable effort to obtain all the data, and an inability to obtain data for all the studies can lead to availability bias. PATIENT SUMMARY: Systematic reviews of the literature are performed to summarize available evidence regarding clinical decisions. Here we explain the differences between reviews that use aggregated data from published studies and reviews that use the participant-level data from those studies.

Impact of digital interdisciplinary consultation on secondary care referrals by general practitioners: a protocol for a stepped-wedge cluster randomised controlled trial.

INTRODUCTION: Optimal collaboration between general practice and hospital care is crucial to maintain affordable and sustainable access to healthcare for the entire population. General practitioners (GPs) are the gatekeepers to specialist care and patients will visit hospitals mostly only after referral. However, a substantial part of these referrals may be inappropriate, as communication between GPs and medical specialists can be challenging and referring patients may be the most obvious action for a GP to perform.A new digital platform (Prisma) connects GPs and specialists in interdisciplinary groups and facilitates asynchronous, accessible and fast teleconsultation within the group. No previous research has been done to evaluate the impact of this new platform on the referral rates to the hospital. METHODS AND ANALYSIS: A stepped-wedge randomised controlled trial (RCT) will be performed in Zwolle region in the Netherlands to analyse the effect of introduction of the platform on rate of inappropriate referrals to orthopaedic surgery. In four steps, GPs in the region will be given access to the platform. GPs will be part of the control condition until randomisation to the intervention. According to our sample size calculation, we need to include 18 practices with 1008 patients presenting with hip and knee symptoms. Routine care data of hospital registrations will be analysed to calculate the rate of inappropriate referrals (primary outcome). Secondary outcome are costs, primary and secondary care workload, posted cases and user satisfaction. Alongside this quantitative analysis, we will evaluate patient experience, facilitators and barriers for use of the platform. ETHICS AND DISSEMINATION: The medical ethics review board of University Medical Center Groningen (UMCG), the Netherlands (METc-number: 2021/288) has confirmed that the Medical Research Involving Human Subjects Act (WMO) does not apply to the process evaluation because the study does not involve randomisation of patients or different medical treatments (letter number: M21.275351). TRIAL REGISTRATION NUMBER: NL9704.

Effectiveness and costs of a new framework for selecting absorbent urinary incontinence products compared with current practice: a cohort study.

OBJECTIVES: To improve continence care in the Netherlands, a new framework has been developed in which a shift has been made from incontinence severity as the sole criterion for selecting incontinence products to a focus on patient need for daily life activities. The impact of the framework on daily care has not been assessed. We aimed to compare treatment effectiveness and costs between participants who did and did not undergo re-evaluation according to the new framework. DESIGN: Cohort study SETTING: Twelve pharmacies in the Netherlands PARTICIPANTS: Existing users of absorbent incontinence materials for urinary incontinence. INTERVENTIONS: Participants were offered the option to have their incontinence products re-evaluated within the new framework at their pharmacy. PRIMARY AND SECONDARY OUTCOME MEASURES: Effectiveness and cost outcomes were assessed at 3 and 6 months through questionnaires. These questionnaires included the International Consultation on Incontinence Questionnaire (ICIQ) Lower Urinary Tract Symptoms Quality of Life Module, ICIQ Urinary Incontinence Short Form, ICIQ Absorbent Pads, questions about satisfaction and the iPCQ and iMCQ. RESULTS: 303 users consented and 279 completed the baseline questionnaire. Of these participants, 72 agreed to a re-evaluation of their incontinence materials. There was a small improvement at 3 months in the re-evaluation group compared with the other group on most outcomes. However, these improvements were not clinically relevant. Moreover, these differences did not change much from 3 to 6 months. Small differences were also observed in the changes in costs, but with very wide CIs on both sides of zero (€99.38; 95% CI -633.48 to 832.23). CONCLUSIONS: The current study showed no clinically relevant effect of a newly implemented framework for selecting incontinence materials in pharmacies when compared with an existing method. Given that the study also showed no differences in effectiveness and costs, introducing the new framework in pharmacies may not lead to better incontinence care.

Association of Supply Source with Continence Product and Care Satisfaction in Patients with Urinary Incontinence.

Purpose: We aimed to examine how supply source affects satisfaction with continence products and care among individuals with urinary incontinence (UI). Supply source was compared among pharmacies, national suppliers, and shops. The secondary aim was to compare participant characteristics between the three groups. Patients and Methods: A survey questionnaire was distributed via social media between April and June 2020. This included the international consultation on incontinence questionnaire (ICIQ) UI short form (ICIQ-UI-SF), the ICIQ-PadPROM, and the ICIQ-LUTSqol, together with questions about respondent characteristics and satisfaction with continence products. Results: Of the 1045 respondents, 706 fully completed and 339 partially completed the survey. Among these, 322 (45.6%), 199 (28.1%), and 185 (26.2%) made purchases from shops, national suppliers, and pharmacies, respectively. The mean ICIQ-UI-SF sum scores were comparable for the pharmacy (13.3 ± 3.7) and national supplier (13.8 ± 3.5) groups, but were significantly lower for the shop group (12.0 ± 3.3). Mean sum scores for satisfaction with continence products and satisfaction with continence care were also significantly lower in the shop group (7.9 ± 2.6 and 6.4 ± 2.7, respectively) compared with the pharmacy (9.1 ± 2.7 and 7.9 ± 2.6, respectively) and national supplier (9.3 ± 2.6 and 8.1 ± 3.0, respectively) groups. There were no statistically significant differences in the ICIQ-PadPROM and ICIQ-LUTSqol scores. Respondents' characteristics were similar, apart from the significantly lower number of males in the shop group. Conclusion: Satisfaction with continence products and continence care is lower for people with UI who purchase materials from a shop than from a pharmacy or national supplier.

Prediction model study focusing on eHealth in the management of urinary incontinence: the Personalised Advantage Index as a decision-making aid.

OBJECTIVE: To develop a prediction model and illustrate the practical potential of personalisation of treatment decisions between app-based treatment and care as usual for urinary incontinence (UI). DESIGN: A prediction model study using data from a pragmatic, randomised controlled, non-inferiority trial. SETTING: Dutch primary care from 2015, with social media included from 2017. Enrolment ended on July 2018. PARTICIPANTS: Adult women were eligible if they had ≥2 episodes of UI per week, access to mobile apps and wanted treatment. Of the 350 screened women, 262 were eligible and randomised to app-based treatment or care as usual; 195 (74%) attended follow-up. PREDICTORS: Literature review and expert opinion identified 13 candidate predictors, categorised into two groups: Prognostic factors (independent of treatment type), such as UI severity, postmenopausal state, vaginal births, general physical health status, pelvic floor muscle function and body mass index; and modifiers (dependent on treatment type), such as age, UI type and duration, impact on quality of life, previous physical therapy, recruitment method and educational level. MAIN OUTCOME MEASURE: Primary outcome was symptom severity after a 4-month follow-up period, measured by the International Consultation on Incontinence Questionnaire the Urinary Incontinence Short Form. Prognostic factors and modifiers were combined into a final prediction model. For each participant, we then predicted treatment outcomes and calculated a Personalised Advantage Index (PAI). RESULTS: Baseline UI severity (prognostic) and age, educational level and impact on quality of life (modifiers) independently affected treatment effect of eHealth. The mean PAI was 0.99±0.79 points, being of clinical relevance in 21% of individuals. Applying the PAI also significantly improved treatment outcomes at the group level. CONCLUSIONS: Personalising treatment choice can support treatment decision making between eHealth and care as usual through the practical application of prediction modelling. Concerning eHealth for UI, this could facilitate the choice between app-based treatment and care as usual. TRIAL REGISTRATION NUMBER: NL4948t.

Cost-effectiveness of an app-based treatment for urinary incontinence in comparison with care-as-usual in Dutch general practice: a pragmatic randomised controlled trial over 12 months.

OBJECTIVE: To assess the cost-effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in Dutch primary care. DESIGN: A pragmatic, randomised controlled, superiority trial. SETTING: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. POPULATION: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. METHODS: The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. MAIN OUTCOME MEASURES: Costs and cost-effectiveness and -utility were assessed from a societal perspective, based on incontinence impact adjusted life years (IIALYs), quality adjusted life years (QALYs) and medical, non-medical and productivity costs. Information on costs was obtained with the iMCQ and iPCQ questionnaires (medical consumption and productivity cost questionnaires). RESULTS: In all, 262 women were andomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up, respectively. Costs were lower for app-based treatment with € -161 (95% confidence interval [CI -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger incremental cost-effectiveness ratios (ICER: -€3696) and incremental cost-utility ratios (ICUR: €6379). CONCLUSION: App-based treatment is a cost-effective alternative to care-as-usual for women with UI in Dutch primary care. TWEETABLE ABSTRACT: App-treatment for female urinary incontinence cost-effective compared to care-as-usual in general practice after 12 months.

Evaluation of the First Year(s) of Physicians Collaboration on an Interdisciplinary Electronic Consultation Platform in the Netherlands: Mixed Methods Observational Study.

BACKGROUND: Complexity of health problems and aging of the population create an ongoing burden on the health care system with the general practitioner (GP) being the gatekeeper in primary care. In GPs daily practice, collaboration with specialists and exchange of knowledge from the secondary care play a crucial role in this system. Communication between primary and secondary care has shortcomings for health care workers that want to practice sustainable patient-centered health care. Therefore, a new digital interactive platform was developed: Prisma. OBJECTIVE: This study aims to describe the development of a digital consultation platform (Prisma) to connect GPs with hospital specialists via the Siilo application and to evaluate the first year of use, including consultations, topic diversity, and number of participating physicians. METHODS: We conducted a mixed methods observational study, analyzing qualitative and quantitative data for cases posted on the platform between June 2018 and May 2020. Any GP can post questions to an interdisciplinary group of secondary care specialists, with the platform designed to facilitate discussion and knowledge exchange for all users. RESULTS: In total, 3674 cases were posted by 424 GPs across 16 specialisms. Most questions and answers concerned diagnosis, nonmedical treatment, and medication. Mean response time was 76 minutes (range 44-252). An average of 3 users engaged with each case (up to 7 specialists). Almost half of the internal medicine cases received responses from at least two specialisms in secondary care, contrasting with about one-fifth for dermatology. Of note, the growth in consultations was steepest for dermatology. CONCLUSIONS: Digital consultations offer the possibility for GPs to receive quick responses when seeking advice. The interdisciplinary approach of Prisma creates opportunities for digital patient-centered networking.

Primary care diagnostic and treatment pathways in Dutch women with urinary incontinence.

OBJECTIVE: To investigate how GPs manage women with urinary incontinence (UI) in the Netherlands and to assess whether this is in line with the relevant Dutch GP guideline. Because UI has been an underreported and undertreated problem for decades despite appropriate guidelines being created for general practitioners (GPs). DESIGN: Retrospective cohort study. SETTING: Routine primary care data for 2017 in the Netherlands. SUBJECTS: We included the primary care records of women aged 18-75 years with at least one contact registered for UI, and then extracted information about baseline characteristics, diagnosis, treatment, and referral to pelvic physiotherapy or secondary care. RESULTS: In total, 374 records were included for women aged 50.3 ± 15.1 years. GPs diagnosed 31.0%, 15.2%, and 15.0% women with stress, urgency, or mixed UI, respectively; no diagnosis of type was recorded in 40.4% of women. Urinalysis was the most frequently used diagnostic test (42.5%). Education was the most common treatment, offered by 17.9% of GPs; however, no treatment or referral was reported in 15.8% of cases. As many as 28.7% and 21.7% of women were referred to pelvic physiotherapy and secondary care, respectively. CONCLUSION: Female UI is most probably not managed in line with the relevant Dutch GP guideline. It is also notable that Dutch GPs often fail to report the type of UI, to use available diagnostic approaches, and to provide appropriate education. Moreover, GPs referred to specialists too often, especially for the management of urgency UI.Key pointsUrinary incontinence (UI) has been an underreported and undertreated problem for decades. Despite various guidelines, UI often lies outside the GPs comfort zone.•According to this study: general practitioners do not treat urinary incontinence according to guidelines.•The type of incontinence is frequently not reported and diagnostic approaches are not fully used.•We believe that increased awareness will help improve treatment and avoidable suffering.

One year effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in Dutch general practice: A pragmatic randomised controlled trial over 12 months.

OBJECTIVE: To assess the long-term effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in primary care. DESIGN: A pragmatic, randomised controlled, superiority trial. SETTING: Primary care in the Netherlands from 2015 to 2018, follow up at 12 months. POPULATION: Women with two or more UI episodes per week and access to mobile apps, wanting treatment. A total of 262 women were randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended 1 year follow up. INTERVENTIONS: The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual was delivered according to the Dutch GP guideline for UI. MAIN OUTCOME MEASURES: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTSqol) with linear regression on an intention-to-treat basis. RESULTS: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6) groups, with a non-significant mean difference of 0.903 (-0.66 to 1.871). CONCLUSION: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of effectiveness after 1 year. TWEETABLE ABSTRACT: App-based treatment for female urinary incontinence is a viable alternative to care-as-usual after 12 months.

Identifying women's preferences for treatment of urinary tract infection: a discrete choice experiment.

OBJECTIVE: To identify the preferences of women regarding management of urinary tract infections (UTIs). DESIGN: A discrete choice experiment of the preferences for certain treatment attributes was conducted by survey. Attributes included treatment duration, time to complaint resolution, complication risk, side effect risk and contribution to antimicrobial resistance. SETTING: General population in the Netherlands, recruited via social media. PARTICIPANTS: Women aged 18 years or older. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the relative importance of the attributes for treatment choice, using a conditional logit model. The secondary outcome was the heterogeneity in these preferences. RESULTS: The discrete choice experiment was completed by 833 women. Most attributes were important to decisions for UTI treatment. Women were willing to accept management with, for example, a higher chance of complications or longer time to resolution, if it could help avoid antimicrobial resistance. However, there was heterogeneity in the preferences. Women who had one previous UTI had a stronger preference for faster symptom resolution compared with those who had no previous UTI. Younger women also preferred faster symptom resolution. Finally, women with a low or middle education level gave less importance to preventing antimicrobial resistance than women with a high education level. CONCLUSIONS: The current study indicated that a considerable part of women valued alternatives to antimicrobial treatment and were prepared to tolerate management that was less optimal in certain respects to avoid antimicrobial treatment.

Evidence-based Urology: Understanding Heterogeneity in Systematic Reviews.

Variability in the results of randomized trials presents challenges to the interpretation and application of the evidence to patient care. Understanding how systematic reviews deal with this problem of "heterogeneity" will help clinicians in applying results in their patient management. This manuscript offers a review of heterogeneity from the clinical urological perspective. PATIENT SUMMARY: Systematic reviews of the literature are necessary to accurately summarize the available evidence to inform clinical decisions. In this mini-review, we explain how to understand and deal with the differences between studies-which we call heterogeneity-included in these types of reviews.

Barriers and Facilitators Associated With App-Based Treatment for Female Urinary Incontinence: Mixed Methods Evaluation.

BACKGROUND: App-based treatment for urinary incontinence is a proven effective and cost-effective alternative to care as usual, but successful implementation requires that we identify and address the barriers and facilitators associated with app use. OBJECTIVE: The goal of the research was to explore the factors influencing app-based treatment for urinary incontinence and identify which barriers or facilitators are associated with treatment success or failure. METHODS: We used a sequential explanatory mixed methods design to connect the results of a randomized controlled trial with data from semistructured interviews. This previous RCT had shown the noninferiority of app-based treatment compared with care as usual for urinary incontinence over 4 months. Participants who reported success or failure with app-based treatment, as measured by the change in International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form symptom score, were selected for telephone interview by purposive sampling (n=17). This study reports mainly on the qualitative component of our mixed methods study. Qualitative analyses were conducted in two ways. First, we analyzed the qualitative data of all interviewed participants and discussed the relationships between the main themes. Second, the experiences between the success (n=9) and failure group (n=8) were compared and contrasted to explore factors that were positively or negatively associated with the quantitative effect of app-based treatment. These factors were then interpreted as barriers to and facilitators of successful app-based treatment. RESULTS: Four interrelated themes were identified as affecting the app based treatment effect: adherence, personal factors, app factors, and awareness. Qualitative analyses of the relationships between the themes showed that adherence-related factors directly influenced treatment effect in both a positive and negative matter. In turn, adherence was also positively and negatively influenced by the other 3 themes. Additionally, awareness was positively influenced by the treatment effect. Within these themes, several factors were identified that acted as barriers (eg, unrealistic expectation of time investment and interfering personal circumstances), facilitators (eg, strict integration of exercises and prior pelvic floor muscle therapy), or both (eg, personality traits and increased awareness of symptoms). CONCLUSIONS: This study shows that the effect of app-based treatment for urinary incontinence is mainly influenced by adherence, which in turn is affected by personal factors, app-based factors, and awareness. The identified factors could function as both facilitators and barriers depending on the user and interaction with other themes. Insight into these facilitators and barriers could lead to improved implementation and increased treatment effectiveness by targeting women most likely to benefit and through further development of the app. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1002/nau.23507.

Expectations and Perceptions of Dutch Pharmacy Staff Regarding a New Framework for Continence Care: A Focus Group Study.

Based on complaints that patients with urinary incontinence were not receiving the correct medical aids, the Dutch Ministry of Health, Wellbeing, and Sports requested further exploration. This resulted in a new framework based on considering individual activities of daily living when providing continence products. We aimed to explore the expectations of pharmacy staff regarding this new framework for continence care in the Netherlands and to establish the facilitators and barriers associated with that care. In total, 15 participants from 7 different pharmacies participated in 2 focus groups. Data analysis was by thematic content analysis. Pharmacy employees were positive about the idea of considering individual daily activities when providing continence products in the new framework, but they did have some reservations about the feasibility of implementation in daily practice. Barriers to optimal continence care included low reimbursement for patients with incontinence, especially with non-standard needs, and poor communication between the various stakeholders in continence care. Efforts must be extended to review the current reimbursement system and to change the policies and information provided by stakeholders in continence care, before the new framework will make a real impact in clinical practice.

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial.

PURPOSE: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting. METHODS: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis. RESULTS: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment. CONCLUSIONS: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.

User Experiences and Preferences Regarding an App for the Treatment of Urinary Incontinence in Adult Women: Qualitative Study.

BACKGROUND: Although several apps are available to support the treatment of urinary incontinence (UI), little has been reported about the experiences and preferences of their users. OBJECTIVE: The objective of this study was to explore the experiences and preferences of women using a mobile app for the treatment of UI and to identify potential improvements to the app. We developed this app for three types of UI: stress UI, urgency UI, and mixed UI. METHODS: The participants in this qualitative study were women with self-reported stress UI, urgency UI, or mixed UI who used an app-based treatment to manage their condition for at least six weeks. Following the intervention, semistructured interviews were conducted to explore the participants' experiences and preferences regarding the app. All interviews were audio-recorded, transcribed verbatim, and analyzed separately by two researchers. RESULTS: Data saturation was reached after interviewing 9 women (aged 32-68 years) with stress UI (n=1, 11%), urgency UI (n=3, 33%), or mixed UI (n=5, 56%). Accessibility, awareness, usability, and adherence emerged as the main themes. On the one hand, participants appreciated that the app increased their accessibility to care, preserved their privacy, increased their awareness of therapeutic options, was easy to use and useful, and supported treatment adherence. On the other hand, some participants reported that they wanted more contact with a care provider, and others reported that using the app increased their awareness of symptoms. CONCLUSIONS: This qualitative study indicates that women appreciate app-based treatment for UI because it can lower barriers to treatment and increase both awareness and adherence to treatment. However, the app does not offer the ability of face-to-face contact and can lead to a greater focus on symptoms.

Validity and reliability of a smartphone motion analysis app for lower limb kinematics during treadmill running.

OBJECTIVE: To investigate the validity and reliability of a smartphone application for selected lower-limb kinematics during treadmill running. DESIGN: Validity and reliability study. SETTING: Biomechanics laboratory. PARTICIPANTS: Twenty healthy female runners. MAIN OUTCOME MEASURE(S): Sagittal-plane hip, knee, and ankle angle and rearfoot eversion were assessed using the Coach's Eye Smartphone application and a 3D motion capture system. Paired t-test and intraclass correlation coefficients (ICC) established criterion validity of Coach's Eye; ICC determined test-retest and intrarater/interrater reliability. Standard error of measurement (SEM) and minimal detectable change (MDC) were also reported. RESULTS: Significant differences were found between Coach's Eye and 3D measurements for ankle angle at touchdown and knee angle at toe-off (p < 0.05). ICCs for validity of Coach's Eye were excellent for rearfoot eversion at touchdown (ICC = 0.79) and fair-to-good for the other kinematics (range 0.51-0.74), except for hip at touchdown, which was poor (ICC = 0.36). Test-retest (range 0.80-0.92), intrarater (range 0.95-0.99) and interrater (range 0.87-0.94) ICC results were excellent for all selected kinematics. CONCLUSION: Coach's Eye can be used as a surrogate for 3D measures of knee and rearfoot in/eversion at touchdown, and hip, ankle, and rearfoot in/eversion at toe-off, but not for hip and ankle at touchdown or knee at toe-off. Reliable running kinematics were obtained using Coach's Eye, making it suitable for repeated measures.

Recruitment through media and general practitioners resulted in comparable samples in an RCT on incontinence.

OBJECTIVES: The objective of the study was to assess the impact of recruitment strategy on the baseline characteristics of patients recruited in a randomized controlled trial for treating women with urinary incontinence. STUDY DESIGN AND SETTING: We conducted a cross-sectional analysis of baseline data from an earlier trial. Women were recruited through the media (including social media) or from participating general practices. Baseline characteristics were compared by univariate testing. Logistic regression analysis was performed to study the association between recruitment type and multiple baseline characteristics. RESULTS: The only differences between recruitment methods were in patient age, with those recruited through the media being significantly older than those recruited through general practice. The mean age difference was 5.0 years (95% confidence interval: 2.2-7.9). CONCLUSION: Samples recruited through the media and through case identification were largely comparable. Therefore, recruitment through the media may be a viable alternative to recruitment through primary care. This may be especially relevant for research on eHealth treatment for conditions with which patients experience barriers when seeking health care.

Determining the minimal important differences in the International Prostate Symptom Score and Overactive Bladder Questionnaire: results from an observational cohort study in Dutch primary care.

OBJECTIVES: To determine the minimal important difference (MID) of the International Prostate Symptom Score (IPSS) and the Overactive Bladder Questionnaire short form (OAB-q SF) assessed in primary care among patients treated for lower urinary tract symptoms (LUTS). DESIGN: Single-arm, open-label observational cohort study with a 6-week follow-up. SETTING: Twenty-two pharmacies in the Netherlands. PARTICIPANTS: We enrolled Dutch men with uncomplicated LUTS who received a new alpha-blocker prescription from their general practitioner or urologist. PRIMARY AND SECONDARY OUTCOMES: The IPSS and OAB-q SF were completed before and after 6 weeks of therapy. At 6 weeks, men also completed the Patient Global Impression of Improvement (PGI-I). The mean change scores of the IPSS and OAB-q SF were calculated for each PGI-I outcome category, with the category 'a little better' used to determine the MID. The SE of measurement (SEM) was calculated for each questionnaire. RESULTS: In total, 165 men completed follow-up. The MID was 5.2 points (95% CI 3.9 to 6.4; SEM 3.6) for the IPSS and 11.0 points (95% CI 7.1 to 14.9; SEM 9.7) for the OAB-q SF. For both questionnaires, CIs showed an overlap with the no-change categories. However, the MID for the IPSS was higher in men with severe baseline symptoms (7.1; 95% CI 5.3 to 9.0) than in men with moderate baseline symptoms (3.2; 95% CI 1.7 to 4.8). CONCLUSION: In this study, the MID for the IPSS was considerably higher than the MID of 3.1 reported in the only other study on this topic, but may be due to methodological differences. Interpretation of the MID for the OAB-q SF is hampered by the overlap with the SEM. Future studies are needed to confirm our results because correlations between the PGI-I and symptom questionnaires were suboptimal.