Qualitative study on shared decision making in cystitis management in general practice.

BACKGROUND: Cystitis are commonly treated with antibiotics, although non-antibiotic options could be considered for healthy non-pregnant women. Shared decision making (SDM) can be used in cystitis management to discuss the various treatment options but is not frequently applied in general practice. AIM: Identifying barriers and facilitators for applying SDM in cystitis management in general practice. DESIGN & SETTING: Qualitative explorative research in general practice with healthcare professionals (HCPs; general practitioners (GPs) and GP assistants) and healthy non-pregnant women with a recent history of cystitis (patients). METHOD: Individual semi-structured interviews were conducted between May and October 2022. We applied a combination of thematic and framework analysis. RESULTS: Ten GPs, seven GP assistants, and fifteen patients were interviewed. We identified three main barriers and one key facilitator: 1) applying SDM is deemed inefficient; 2) HCPs presume that patients expect antibiotic treatment and some HCPs consider non-antibiotic treatment inferior; 3) Patients are largely unaware of the various non-antibiotic treatment options for cystitis; 4) HCPs recognise some benefits of applying SDM in cystitis management, including reduced antibiotic use and improved patient empowerment, and patients appreciate involvement in treatment decisions, but preferences for SDM vary. CONCLUSION: SDM is infrequently applied in cystitis treatment in general practice due to the current efficient cystitis management, HCPs' perceptions, and patient unawareness. Nevertheless, both HCPs and patients recognise the long-term benefits of applying SDM in cystitis management. Our findings facilitate the development of tailored interventions to increase the application of SDM which should be co-created with HCPs and patients and fit into the current efficient cystitis management.

Differences in help-seeking behaviour between males and females with multiple pelvic floor symptoms: A qualitative study.

Background: Pelvic floor symptoms (PFS) are common and frequently co-occur, but few patients seek help despite negative effects on their quality of life. Moreover, most studies assessing help-seeking behaviour have only focused on a single PFS. Aim: We aimed to explore the barriers to and facilitators of help-seeking behaviour in males and females with at least two PFS. Design and Setting: This interview-based study included participants by age and symptoms (number and type) from a larger group taking part in a survey on PFS in the general population. Method: Two researchers independently encoded and analyzed the semi-structured interviews, which continued to saturation for both the male and female cohorts. Results: Of the 25 participants (13 male and 12 female), 9 sought help for all PFS, 10 did not seek help for any PFS, and 6 sought help for some PFS. We identified themes in domains related to the patient, healthcare professional, environment, and symptoms. Although most themes applied to both sexes, some had greater sex specificity. Conclusion: Males and females have more similarities than differences in help-seeking behaviour. Healthcare providers should know that patients who seek help for one symptom probably have multiple PFS that the patient has not reported.

Sex differences in the association between (sexual) abuse and lower urinary tract symptoms.

OBJECTIVES: To study the possible association between (sexual) abuse and lower urinary tract symptoms (LUTS) in men and women. To study the differences in this association between men and women, and between the timing of the abuse. SUBJECTS AND METHODS: A Dutch observational population-based cross-sectional study was used, based on self-administered questionnaires. Respondents were included if they had answered all questions about abuse and LUTS. Logistic regression was used to analyse the data. RESULTS: Included were 558 men and 790 women, of whom 29% and 37%, respectively, reported a history of one of more types of abuse. Abuse was significantly associated with LUTS in both men (odds ratio [OR] 1.7; 1.2-2.5) and women (OR 1.4; 1.1-2.1). This association, testing by two-way interaction, was significantly stronger in men. No association was found between childhood abuse or adulthood abuse and LUTS, in men or women. The association of sexual abuse with LUTS was significant in both men (2.7; 1.4-5.2) and in women (1.5; 1.1-2.2), and this association (testing by two-way interaction) was significantly much stronger in men. CONCLUSION: In men more than in women, a history of any type of abuse is associated with LUTS, regardless of whether the abuse occurred during childhood or adulthood. In both sexes, a history of sexual abuse is also associated with experiencing LUTS, with a much stronger association in men than in women. Patients, in particular male patients, presenting with LUTS should therefore be asked about sexual abuse in the past.

Systematic Reviews and Meta-analyses of the Procedure-specific Risks of Thrombosis and Bleeding in General Abdominal, Colorectal, Upper Gastrointestinal, and Hepatopancreatobiliary Surgery.

OBJECTIVE: To provide procedure-specific estimates of symptomatic venous thromboembolism (VTE) and major bleeding after abdominal surgery. BACKGROUND: The use of pharmacological thromboprophylaxis represents a trade-off that depends on VTE and bleeding risks that vary between procedures; their magnitude remains uncertain. METHODS: We identified observational studies reporting procedure-specific risks of symptomatic VTE or major bleeding after abdominal surgery, adjusted the reported estimates for thromboprophylaxis and length of follow-up, and estimated cumulative incidence at 4 weeks postsurgery, stratified by VTE risk groups, and rated evidence certainty. RESULTS: After eligibility screening, 285 studies (8,048,635 patients) reporting on 40 general abdominal, 36 colorectal, 15 upper gastrointestinal, and 24 hepatopancreatobiliary surgery procedures proved eligible. Evidence certainty proved generally moderate or low for VTE and low or very low for bleeding requiring reintervention. The risk of VTE varied substantially among procedures: in general abdominal surgery from a median of <0.1% in laparoscopic cholecystectomy to a median of 3.7% in open small bowel resection, in colorectal from 0.3% in minimally invasive sigmoid colectomy to 10.0% in emergency open total proctocolectomy, and in upper gastrointestinal/hepatopancreatobiliary from 0.2% in laparoscopic sleeve gastrectomy to 6.8% in open distal pancreatectomy for cancer. CONCLUSIONS: VTE thromboprophylaxis provides net benefit through VTE reduction with a small increase in bleeding in some procedures (eg, open colectomy and open pancreaticoduodenectomy), whereas the opposite is true in others (eg, laparoscopic cholecystectomy and elective groin hernia repairs). In many procedures, thromboembolism and bleeding risks are similar, and decisions depend on individual risk prediction and values and preferences regarding VTE and bleeding.

Depressive feelings as mediator in the relation between adverse childhood events and lower urinary tract symptoms in males and females.

BACKGROUND: Adverse childhood events (ACEs) are prevalent and lead to well-established adverse health sequelae in adulthood. Recent literature has claimed that exposure to trauma in early life may worsen lower urinary tract symptoms (LUTS) because emotion can alter the perception of bodily distress in the brain. Specifically, depressive symptoms might influence the association between ACEs and LUTS. We aimed to describe the associations between ACEs and LUTS among males and females and to determine whether depressive symptoms mediated these associations. METHODS: This study was a secondary analysis of the Coevorden observational cohort study (n = 1691, age ≥16 years). For this observational study participants filled in the male or female modules of the International Consultation on Incontinence Questionnaire for LUTS (ICIQ-MLUTS and ICIQ-FLUTS, respectively), the NEMESIS Childhood Trauma Questionnaire (emotional neglect, psychological abuse, physical abuse, and sexual abuse within the family), and the Patient Health Questionnaire (PHQ-9) for depression. RESULTS: Overall, 564 males and 811 females answered all required items related to LUTS and ACEs. A series of regression models were then estimated to test for mediation: LUTS on ACEs, depression on ACEs, and LUTS on both ACEs and depression. The models were also adjusted for the following covariates: age, body mass index, diabetes mellitus, current smokers, educational level, and vaginal delivery (if female). Depressive symptoms were shown to mediate the association between ACEs and LUTS in both males and females. CONCLUSION: Childhood adversity and depression are areas of interest during the clinical assessment of patients with LUTS. Early detection of these conditions might help to manage risk, aid in the prevention of LUTS, and facilitate trauma-informed care.

Study protocol for a nationwide implementation of internet-based vestibular rehabilitation for patients with chronic vestibular symptoms (I-RECOVER).

BACKGROUND: Vestibular rehabilitation is a safe and effective exercise-based treatment for patients with chronic vestibular symptoms. However, it is underused in general practice. Internet-based vestibular rehabilitation (Vertigo Training), which has proven to be effective as well, was developed to increase uptake. We now aim to improve the quality of care for patients with vestibular symptoms by carrying out a nationwide implementation of Vertigo Training. We will evaluate the effect of this implementation on primary care. METHODS: Our implementation study consists of three successive phases: 1) We will perform a retrospective observational cohort study and a qualitative interview study to evaluate the current management of patients with vestibular symptoms in primary care, in particular anti-vertigo drug prescriptions, and identify areas for improvement. We will use the results of this phase to tailor our implementation strategy to the needs of general practitioners (GPs) and patients. 2) This phase entails the implementation of Vertigo Training using a multicomponent implementation strategy, containing: guideline adaptations; marketing strategy; pharmacotherapeutic audit and feedback meetings; education; clinical decision support; and local champions. 3) In this phase, we will evaluate the effect of the implementation in three ways. a. Interrupted time series. We will use routine primary care data from adult patients with vestibular symptoms to compare the number of GP consultations for vestibular symptoms, referrals for vestibular rehabilitation, prescriptions for anti-vertigo drugs, and referrals to physiotherapy and secondary care before and after implementation. b. Prospective observational cohort study. We will extract data from Vertigo Training to investigate the usage and the characteristics of participants. We will also determine whether these characteristics are associated with successful treatment. c. Qualitative interview study. We will conduct interviews with GPs to explore their experiences with the implementation. DISCUSSION: This is one of the first studies to evaluate the effect of a nationwide implementation of an innovative treatment on Dutch primary care. Implementation strategies have been researched before, but it remains unclear which ones are the most effective and under what conditions. We therefore expect to gain relevant insights for future projects that aim to implement innovations in primary care.

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.

Reporting of costs and economic impacts in randomized trials of de-implementation interventions for low-value care: a systematic scoping review.

BACKGROUND: De-implementation of low-value care can increase health care sustainability. We evaluated the reporting of direct costs of de-implementation and subsequent change (increase or decrease) in health care costs in randomized trials of de-implementation research. METHODS: We searched MEDLINE and Scopus databases without any language restrictions up to May 2021. We conducted study screening and data extraction independently and in duplicate. We extracted information related to study characteristics, types and characteristics of interventions, de-implementation costs, and impacts on health care costs. We assessed risk of bias using a modified Cochrane risk-of-bias tool. RESULTS: We screened 10,733 articles, with 227 studies meeting the inclusion criteria, of which 50 included information on direct cost of de-implementation or impact of de-implementation on health care costs. Studies were mostly conducted in North America (36%) or Europe (32%) and in the primary care context (70%). The most common practice of interest was reduction in the use of antibiotics or other medications (74%). Most studies used education strategies (meetings, materials) (64%). Studies used either a single strategy (52%) or were multifaceted (48%). Of the 227 eligible studies, 18 (8%) reported on direct costs of the used de-implementation strategy; of which, 13 reported total costs, and 12 reported per unit costs (7 reported both). The costs of de-implementation strategies varied considerably. Of the 227 eligible studies, 43 (19%) reported on impact of de-implementation on health care costs. Health care costs decreased in 27 studies (63%), increased in 2 (5%), and were unchanged in 14 (33%). CONCLUSION: De-implementation randomized controlled trials typically did not report direct costs of the de-implementation strategies (92%) or the impacts of de-implementation on health care costs (81%). Lack of cost information may limit the value of de-implementation trials to decision-makers. TRIAL REGISTRATION: OSF (Open Science Framework): https://osf.io/ueq32 .

Seeking consultation for urinary incontinence: Behaviours and barriers among Jordanian women.

INTRODUCTION: The rates of seeking consultation for urinary incontinence (UI) and the barriers against consultations vary among countries and study populations and are influenced by various factors such as embarrassment, perception of illness, resources and culture. OBJECTIVES: To study healthcare-seeking behaviours and barriers among Jordanian women. METHODS: Between 1 March 2020 and 15 April 2020, we conducted a cross-sectional online survey among women 18 years of age or more who have UI and have access to the internet. We collected women's characteristics, UI types, severity, bother, seeking consultation behaviours and barriers. Logistic regression analyses were used to study the variables associated with seeking consultation. RESULTS: The data of 1454 women with a mean age (SD) of 41.5 (11.5) years were analysed. Mixed UI was the most common type (56.3%), while 43.8% of the participants sought consultation, and 33.8% waited 1 year before seeking consultation. The most common barriers were embarrassment (52.2%), considering UI as a normal occurrence with ageing (41.5%), and limited expectations of improvement from treatment (42.0%). The most common barriers vary according to UI type. Embarrassment was the most commonly reported barrier by women with mixed UI (29.4%), UI as normal with ageing was mostly considered by women with stress UI (11.5%) and treatment for UI is going to be expensive was expressed by women with mixed UI (19.4%). Seeking consultation decreased among women with more educational achievement (adjusted odds ratio [aOR]: 0.62; 95% confidence interval [CI]: 0.44-0.87) with university graduates doing so less than women with high school or less educational achievement. Additionally, seeking consultation was more among women who were aware of a family member with UI (aOR: 1.44; 95% CI: 1.03-2.01) compared to women who were not. Also, multiparous women (aOR: 1.8; 95% CI: 1.19-2.77) sought consultation more than nulliparous women. Seeking a consultation was more among women who were bothered by the impact of UI on various daily activities, namely, household activities (aOR: 1.42; 95% CI: 0.85-2.37), prayers (aOR: 1.7; 95% CI: 1.07-2.71) and sex life (aOR: 2.48; 95% CI: 1.45-4.21) compared to women who were not bothered. Seeking a consultation was less among women who reported embarrassment as a barrier (aOR: 0.534; 95% CI: 0.34-0.84) compared to women who were not embarrassed. CONCLUSION: Four in 10 women with UI sought care, but with a considerable delay between the onset of symptoms and actual care seeking. These outcomes could be explained by the impact of various barriers. Additionally, barriers might vary in different cultures and countries, so culture-sensitive questionnaires should be considered when healthcare-seeking consultations and barriers are studied.

Managing children with daytime urinary incontinence: a survey of Dutch general practitioners.

BACKGROUND: In the Netherlands, parents of children with daytime urinary incontinence (UI) first consult general practitioners (GPs). However, GPs need more specific guidelines for daytime UI management, resulting in care and referral decisions being made without clear guidance. OBJECTIVES: We aimed to identify Dutch GP considerations when treating and referring a child with daytime UI. METHODS: We invited GPs who referred at least one child aged 4-18 years with daytime UI to secondary care. They were asked to complete a questionnaire about the referred child and the management of daytime UI in general. RESULTS: Of 244 distributed questionnaires, 118 (48.4%) were returned by 94 GPs. Most reported taking a history and performing basic diagnostic tests like urine tests (61.0%) and physical examinations (49.2%) before referral. Treatment mostly involved lifestyle advice, with only 17.8% starting medication. Referrals were usually at the explicit wish of the child/parent (44.9%) or because of symptom persistence despite treatment (39.0%). GPs usually referred children to a paediatrician (n = 99, 83.9%), only referring to a urologist in specific situations. Almost half (41.4%) of the GPs did not feel competent to treat children with daytime UI and more than half (55.7%) wanted a clinical practice guideline. In the discussion, we explore the generalisability of our findings to other countries. CONCLUSION: GPs usually refer children with daytime UI to a paediatrician after a basic diagnostic assessment, usually without offering treatment. Parental or child demand is the primary stimulus for referral.

The test-retest reproducibility of the multiple array probe Leiden in men with lower urinary tract symptoms.

BACKGROUND: We aimed to study the test-retest reliability of the Multiple Array Probe Leiden (MAPLe), a multiple electrode probe designed to acquire and discriminate electromyography signals in the pelvic floor muscles, in men with lower urinary tract symptoms (LUTS). METHODS: Adult male patients with LUTS with sufficient knowledge of Dutch language, but without complications (e.g., urinary tract infection), or previous urologic cancer and/or urologic surgery were enrolled. In the initial study, next to physical examination and uroflowmetry, all men underwent MAPLe assessment at baseline and after 6 weeks. Second, participants were reinvited for a new assessment using a stricter protocol. A time interval of 2 h (M2) and 1 week (M3) after baseline (M1) allowed the calculation of the intraday agreement (M1 vs. M2), and the interday agreement (M1 vs. M3) for all 13 MAPLe variables. RESULTS: The outcomes of the initial study in 21 men suggested a poor test-retest reliability. The second study in 23 men showed a good test-retest reliability with intraclass correlations ranging from 0.61 (0.12-0.86) to 0.91 (0.81-0.96). The agreement was generally higher for the intraday determinations than for the interday determinations. CONCLUSIONS: This study revealed a good test-retest reliability of the MAPLe device in men with LUTS, when using a strict protocol. With a less strict protocol, the test-retest reliability of MAPLe was poor in this sample. To make valid interpretations of this device in a clinical or research setting, a strict protocol is needed.

Timing of symptomatic venous thromboembolism after surgery: meta-analysis.

BACKGROUND: The timing at which venous thromboembolism (VTE) occurs after major surgery has major implications for the optimal duration of thromboprophylaxis. The aim of this study was to perform a systematic review and meta-analysis of the timing of postoperative VTE up to 4 weeks after surgery. METHODS: A systematic search of MEDLINE, Scopus, and CINAHL databases was performed between 1 January 2009 and 1 April 2022. Prospective studies that recruited patients who underwent a surgical procedure and reported at least 20 symptomatic, postoperative VTE events by time were included. Two reviewers independently selected studies according to the eligibility criteria, extracted data, and evaluated risk of bias. Data were analysed with a Poisson regression model, and the GRADE approach was used to rate the certainty of evidence. RESULTS: Some 6258 studies were evaluated, of which 22 (11 general, 5 urological, 4 mixed, and 2 orthopaedic postoperative surgical populations; total 1 864 875 patients and 24 927 VTE events) were eligible. Pooled evidence of moderate certainty showed that 47.1 per cent of the VTE events occurred during the first, 26.9 per cent during the second, 15.8 per cent during the third, and 10.1 per cent during the fourth week after surgery. The timing of VTE was consistent between individual studies. CONCLUSION: Although nearly half of symptomatic VTE events in first 4 weeks occur during the first postoperative week, a substantial number of events occur several weeks after surgery. These data will inform clinicians and guideline developers about the duration of postoperative thromboprophylaxis.

Hundreds of millions of surgical procedures are performed annually worldwide. Blood clots in legs and lungs represent serious, and sometimes fatal, complications of surgery. To prevent these complications, clinicians often give blood thinners to patients. To optimize the starting time and duration of use of blood thinners, it is crucial to know when blood clots occur after surgery. This study summarized the timing of blood clots after surgery based on a systematic review and meta-analysis of 22 prospective studies including thousands of patients with blood clots from various surgical fields. Of blood clots occurring within 4 weeks after surgery, 47 per cent occurred by the first, 74 per cent by the second, and 90 per cent by the third week after surgery. These research results are useful for patients, clinicians, and guideline developers to guide the starting time and duration of use of blood thinners after surgery.

Comparing male and female pelvic floor muscle function by the number and type of pelvic floor symptoms.

AIMS: Pelvic floor symptoms (PFS), including lower urinary tract symptoms, defecation problems, sexual dysfunction, and pelvic pain, are common in males and females. Comparing pelvic floor musculature (PFM) function between sexes may reveal important differences relevant to clinical care. This study aimed to compare male and female PFM function and to assess the function of both sexes with the number and type of PFS. METHODS: We purposively enrolled males and females aged ≥ 21 years with 0-4 PFS based on questionnaire responses in an observational cohort study. Participants then underwent PFM assessment, and muscle function in the external anal sphincter (EAS) and puborectal muscle (PRM) were compared between sexes. The relationships between muscle function and the number and type of PFS were explored. RESULTS: Of the invited 400 males and 608 females, 199 and 187 underwent PFM assessment, respectively. Compared with females, males more often showed increased EAS and PRM tone during assessments. Compared with males, females more often showed weaker maximum voluntary contraction (MVC) of the EAS and dysfunctional endurance of both muscles; additionally, those with zero or one PFS, sexual dysfunction, and pelvic pain more often showed a weak MVC of the PRM. CONCLUSIONS: Despite a few similarities between males and, females we found differences in muscle tone, MVC, and endurance between male and female PFM function. These findings provide useful insights into the differences in PFM function between males and females.

Comparing Single-Incision Midurethral Sling with Bulking Agents for Female Stress Urinary Incontinence: Rationale for a Non-Randomized Controlled Trial.

OBJECTIVES: Midurethral slings are considered the gold standard for the surgical treatment of stress urinary incontinence (SUI), with an efficacy up to 80%. Another therapeutic option is the use of bulking agents, which create an artificial mass in the urethral submucosa, with an efficacy varying from 64% to 74%. Although bulking agents have a lower risk of complications than midurethral sling surgery, they are mainly used in case a midurethral sling is not an option or if midurethral sling surgery failed to cure stress urinary incontinence. In this study, we offer all patients with SUI in secondary care a choice between a single-incision midurethral sling procedure and treatment with a bulking agent. We want to examine patient preference and patient satisfaction for both procedures. We expect that offering both interventions in combination with standardized counselling will result in high patient satisfaction. DESIGN: In this non-randomized controlled trial, 266 patients will be objectively counselled for both interventions, after which all patients will choose between single-incision midurethral slings and polyacrylamide hydrogel (PAHG), followed by the standard care procedure for women with SUI. PARTICIPANTS/MATERIALS, SETTING, METHODS: From January 1, 2021, onward, all consecutive adult patients (between 18 and 80 years of age) attending the outpatient gynaecology department with objectively confirmed, moderate to severe SUI will be eligible for enrolment in this non-randomized study. The primary outcome is patient satisfaction at 1 year, measured by the Patient Global Impression of Improvement; secondary outcomes are patient satisfaction at 3 months, objective and subjective cure at 3 months and 1 year, adverse events, post-operative pain, and cost-effectiveness. Differences in outcome measures will be assessed through logistic and linear regression analyses, both unadjusted and adjusted with covariate adjustment using the propensity score. RESULTS: No results are available yet. LIMITATIONS: The major disadvantage of this study design is the potential confounding bias. We intend to eliminate this bias by applying propensity scoring. CONCLUSION: By designing a non-randomized patient preference trial, we not only expect to demonstrate high patient satisfaction with both interventions but also provide insight into the possible role of PAHG-injections in the treatment of female SUI as a first-choice non-conservative treatment.

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.

Magnetic Resonance Imaging-targeted Prostate Biopsy Compared with Systematic Prostate Biopsy in Biopsy-naïve Patients with Suspected Prostate Cancer.

Background: It remains uncertain whether transrectal ultrasound (TRUS)-guided systematic biopsies can be omitted and rely solely on multiparametric magnetic resonance imaging-targeted biopsies (MRI-TBx) in biopsy-naïve men suspected of prostate cancer (PCa). Objective: To compare PCa detection in biopsy-naïve men between systematic biopsy and MRI-TBx. Design setting and participants: A prospective cohort study was conducted in a Dutch teaching hospital. Consecutive patients with suspected PCa, no history of biopsy, and no clinical suspicion of metastasis underwent both TRUS-guided systematic biopsies and MRI-TBx by multiparametric magnetic resonance imaging (mpMRI)-ultrasound fusion, including sham biopsies in case of negative mpMRI. Outcome measurements and statistical analysis: Clinically significant PCa (csPCa), defined as group ≥2 on the International Society of Urological Pathology grading, was detected. Results and limitations: The overall prevalence of csPCa, irrespective of biopsy technique, was 37.4% (132/353) in our population. MRI-TBx were performed in 263/353 (74.5%) patients with suspicious mpMRI (Prostate Imaging Reporting and Data System [PI-RADS] ≥3). The detection rates for csPCa were 39.5% for MRI-TBx and 42.9% for systematic biopsies. The added values, defined as the additional percentages of patients with csPCa detected by adding one biopsy technique, were 8.7% for the systematic biopsies and 5.3% for MRI-TBx. In patients with nonsuspicious mpMRI, five cases (6%) of csPCa were found by systematic biopsies. Conclusions: This study in biopsy-naïve patients suspected for PCa showed that systematic biopsies have added value to MRI-TBx alone in patients with mpMRI PI-RADS >2. Patient summary: We studied magnetic resonance imaging (MRI)-guided prostate biopsy for diagnosing prostate cancer and compared it with the standard method of prostate biopsy. Standard systematic biopsies cannot be omitted in patients with suspicious MRI, as they add to the detection of significant prostate cancer.

Randomized controlled trials in de-implementation research: a systematic scoping review.

BACKGROUND: Healthcare costs are rising, and a substantial proportion of medical care is of little value. De-implementation of low-value practices is important for improving overall health outcomes and reducing costs. We aimed to identify and synthesize randomized controlled trials (RCTs) on de-implementation interventions and to provide guidance to improve future research. METHODS: MEDLINE and Scopus up to May 24, 2021, for individual and cluster RCTs comparing de-implementation interventions to usual care, another intervention, or placebo. We applied independent duplicate assessment of eligibility, study characteristics, outcomes, intervention categories, implementation theories, and risk of bias. RESULTS: Of the 227 eligible trials, 145 (64%) were cluster randomized trials (median 24 clusters; median follow-up time 305 days), and 82 (36%) were individually randomized trials (median follow-up time 274 days). Of the trials, 118 (52%) were published after 2010, 149 (66%) were conducted in a primary care setting, 163 (72%) aimed to reduce the use of drug treatment, 194 (85%) measured the total volume of care, and 64 (28%) low-value care use as outcomes. Of the trials, 48 (21%) described a theoretical basis for the intervention, and 40 (18%) had the study tailored by context-specific factors. Of the de-implementation interventions, 193 (85%) were targeted at physicians, 115 (51%) tested educational sessions, and 152 (67%) multicomponent interventions. Missing data led to high risk of bias in 137 (60%) trials, followed by baseline imbalances in 99 (44%), and deficiencies in allocation concealment in 56 (25%). CONCLUSIONS: De-implementation trials were mainly conducted in primary care and typically aimed to reduce low-value drug treatments. Limitations of current de-implementation research may have led to unreliable effect estimates and decreased clinical applicability of studied de-implementation strategies. We identified potential research gaps, including de-implementation in secondary and tertiary care settings, and interventions targeted at other than physicians. Future trials could be improved by favoring simpler intervention designs, better control of potential confounders, larger number of clusters in cluster trials, considering context-specific factors when planning the intervention (tailoring), and using a theoretical basis in intervention design. REGISTRATION: OSF Open Science Framework hk4b2.