Cost-effectiveness of 2 Models of Pessary Care for Pelvic Organ Prolapse: Findings From the TOPSY Randomized Controlled Trial.

OBJECTIVES: Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation. METHODS: A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. RESULTS: There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%. CONCLUSIONS: Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.

Women's Experiences of Urinary Tract Infections and Impact on Life: An Exploratory Qualitative Study.

IMPORTANCE: Despite high incidences of urinary tract infections (UTIs), little is known about how bothersome symptoms are and the effects on women's life and sexual activity, leaving a gap in our understanding of the physical and emotional effects of UTIs on women. OBJECTIVES: This initial exploratory and descriptive study analyzes women's experiences of UTI and their perceived impact on quality of life. STUDY DESIGN: Qualitative interviews were undertaken with 23 women who had experienced at least 1 UTI, recruited from different settings-primary care, general gynecology clinics, urogynecology clinics, and online via social media. Data were analyzed thematically. RESULTS: Three themes described women's experiences of UTI: Women in all groups reported a wide range of physical symptoms and described the financial and psychological effects of UTIs. These effects seemed worse in women recruited via social media who also reported experiencing strong emotions and worries about close family members. Urinary tract infection support groups were considered useful, with women being grateful for consultations with alternative health practitioners and presuming safety of natural products. CONCLUSIONS: Having a UTI appeared to affect women in a variety of ways, ranging from having different physical symptoms to being psychologically affected by these symptoms, which affected their quality of life in different ways. This research contributes to the growing evidence on how UTIs affect women, specifically further expanding on the impact on women in a range of settings-in the community and different health care settings.

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.

Background: Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Methods: Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Findings: The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate. Funding: National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).

Total trans-obturator tape (TOT) removal; a case series including pain and urinary continence outcomes.

INTRODUCTION AND HYPOTHESIS: For many years, mid-urethral mesh tape (MUT) was the gold-standard procedure for management of stress urinary incontinence (SUI). However, significant concerns were raised over its safety. We present a case series of total trans-obturator tape (TOT) removals, performed in a tertiary unit over a 3-year period. We aim to evaluate improvement of pain and change in urinary continence symptoms following mesh explantation. METHODS: This is a retrospective case series of the outcomes of total TOT removal. Primary outcome is the change in pain scores following total removal, assessed preoperatively, at discharge and follow-up. Secondary outcomes were perioperative complications, including return to theatre, re-admission rates and incidence of worsening SUI and overactive bladder symptoms (OAB) postoperatively. Statistical analyses were performed using SPSS 27.0 package (IBM, Chicago, IL) and the GraphPad Prism 9 statistical packages. RESULTS: Nineteen women were identified. Mean age was 52 years and mean BMI was 31. Indications for mesh removal were: chronic pain (95%), vaginal exposure (37%) and pelvic sepsis (5%). No patients had return to theatre. Median intraoperative blood loss was 200 ml (interquartile range [IQR]: 150-288). Mean length of mesh excised was 22 cm. Mean postoperative hospital stay was 2 days. At follow-up, most patients (72%) reported "improvement" of their mesh-related pain at follow-up, while 6% reported "worsening" of pain. Eighty-three per cent of patients reported worsening SUI, and 50% reported worsening OAB symptoms. CONCLUSIONS: In the absence of sepsis, significant intraoperative complications are rare during total TOT removals. While 72% of patients reported improvement of their mesh-related pain, 6% still reported worsening pain after total mesh excision.

Impact of covid-19 on subspecialty training in obstetrics and gynaecology.

The Covid-19 pandemic brought substantial changes in clinical practice in Obstetrics and Gynaecology (O and G). Redeployment of staff and restrictions in elective services raised training concerns. We sought to assess the impact on subspecialty training, to identify issues to help mitigate the impact. We conducted cross-sectional anonymous electronic surveys of UK subspecialty trainees at three time points: June 2020, February 2021, September 2021. Surveys were analysed by descriptive statistics and thematic analysis of free-text responses. Response rates ranged from 30% to 40%, with higher response rates from urogynaecology trainees. Up to 72% reported an impact on training, most notable in gynaecological subspecialties, and particularly urogynaecology, which persisted over time. More than a third anticipated needing extra time to complete training. This raises serious future workforce and patient care concerns. Clinical recovery should consider training needs as essential when re-establishing services. Subspecialty trainees may need additional time to achieve competencies required of future consultants.IMPACT STATEMENTWhat is already known on the subject? Covid-19 led to dramatic changes in clinical practice in Obstetrics and Gynaecology. Previous studies on training in O and G during the pandemic in the UK and internationally highlighted issues from redeployment, trainee absence, and changes in service provision, that had potential to severely impact training.What do the results of this study add? Subspecialty training in Obstetrics and Gynaecology has been affected by the pandemic. Urogynaecology was worst affected and continues to be affected over the course of the pandemic.What are the implications of these findings for clinical practice and/or further research? Covid-19 recovery plans need to incorporate training requirements. Extended training due to the pandemic may affect consultant workforce numbers and thus service provision in tertiary care.

Neurobiología del trastorno depresivo mayor / Neurobiology of major depressive disorder / Neurobiologia do transtorno depressivo maior

La depresión es una de las patologías más abordadas actualmente, la presencia de síntomas característicos provoca gran precaución y requiere de alto cuidado personal, además, el padecimiento de esta enfermedad se enlaza directamente a los aspectos neurobiológicos que explica los procesos dentro del sistema nervioso central. Objetivo. El objetivo del presente estudio es describir las siguientes teorías de la neurología de la depresión mayor: teoría de la monoaminas, teoría neurotrófica y teoría inflamatoria junto con su relación con la depresión. Metodología. Se realizó una revisión bibliográfica de la literatura científica relacionados a la neurobiología de la depresión mayor, incluyendo estudios; experimentales, originales, metaanálisis y paginas oficiales. Se utilizó la base de datos PubMed, y Google scholar, cuyos documentos fueron publicados entre 2015 a 2022 en idioma español e inglés; se utilizaron los términos MESH y DeCs: "depresión" "inflamación" "neurobiología" "monoaminas biogénicas". Conclusión: Se concluye que, a pesar de los nuevos descubrimientos en cuanto a diferentes mecanismos de la neurobiología de la depresión, aún existen vacíos por descubrir que impiden desarrollar una teoría unificada de la etiología.

Depression is currently one of the most frequently addressed pathologies, the presence of characteristic symptoms causes great caution and requires high personal care, in addition, the suffering of this disease is directly linked to the neurobiological aspects that explain the processes within the central nervous system. Objective. The aim of the present study is to describe the following theories of the neurology of major depression: monoamine theory, neurotrophic theory and inflammatory theory together with their relation to depression. Methodology. A bibliographic review of the scientific literature related to the neurobiology of major depression was carried out, including experimental studies, original studies, meta-analysis and official pages. The PubMed database was used, and Google scholar, whose documents were published between 2015 to 2022 in Spanish and English language; the terms MESH and DeCs were used: "depression" "inflammation" "neurobiology" "biogenic monoamines". Conclusion: It is concluded that, despite new discoveries regarding different mechanisms of the neurobiology of depression, there are still undiscovered gaps that prevent the development of a unified theory of etiology.

A depressão é uma das patologias mais freqüentemente abordadas atualmente, a presença de sintomas característicos causa grande cautela e requer um alto cuidado pessoal, além disso, o sofrimento desta doença está diretamente ligado aos aspectos neurobiológicos que explicam os processos dentro do sistema nervoso central. Objetivo. O objetivo do presente estudo é descrever as seguintes teorias da neurologia da depressão grave: teoria monoamina, teoria neurotrófica e teoria inflamatória, juntamente com sua relação com a depressão. Metodologia. Foi realizada uma revisão bibliográfica da literatura científica relacionada à neurobiologia da depressão grave, incluindo estudos experimentais, estudos originais, meta-análises e páginas oficiais. Utilizamos o banco de dados PubMed e Google scholar, cujos documentos foram publicados entre 2015 e 2022 em espanhol e inglês; usamos os termos MESH e DeCs: "depressão" "inflamação" "neurobiologia" "monoaminas biogênicas". Conclusão: Conclui-se que, apesar das novas descobertas sobre diferentes mecanismos da neurobiologia da depressão, ainda existem lacunas ainda não descobertas que impedem o desenvolvimento de uma teoria unificada da etiologia.

Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse.

BACKGROUND: Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention. METHODS: The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura's social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition. RESULTS: The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team. CONCLUSIONS: The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

Methenamine hippurate compared with antibiotic prophylaxis to prevent recurrent urinary tract infections in women: the ALTAR non-inferiority RCT.

BACKGROUND: Daily, low-dose antibiotic prophylaxis is the current standard care for women with recurrent urinary tract infection. Emerging antimicrobial resistance is a global health concern, prompting research interest in non-antibiotic agents such as methenamine hippurate, but comparative data on their efficacy and safety are lacking. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of methenamine hippurate (Hiprex®; Mylan NV, Canonsburg, PA, USA) compared with current standard care (antibiotic prophylaxis) for recurrent urinary tract infection prevention in adult women. DESIGN: Multicentre, pragmatic, open-label, randomised, non-inferiority trial of 12 months' treatment with the allocated intervention, including an early, embedded qualitative study and a 6-month post-treatment observation phase. The predefined non-inferiority margin was one urinary tract infection per person-year. SETTING: Eight UK NHS secondary care sites. PARTICIPANTS: A total of 240 adult women with recurrent urinary tract infection requiring preventative treatment participated in the trial. INTERVENTIONS: A central randomisation system allocated participants 1 : 1 to the experimental (methenamine hippurate: 1 g twice daily) or control (once-daily low-dose antibiotics: 50/100 mg of nitrofurantoin, 100 mg of trimethoprim or 250 mg of cefalexin) arm. Crossover between treatment arms was permitted. MAIN OUTCOME MEASURES: The primary clinical outcome was incidence of symptomatic antibiotic-treated urinary tract infection during the 12-month treatment period. Cost-effectiveness was assessed by incremental cost per quality-adjusted life-year gained, extrapolated over the patient's expected lifetime using a Markov cohort model. Secondary outcomes included post-treatment urinary tract infections, total antibiotic use, microbiologically proven urinary tract infections, antimicrobial resistance, bacteriuria, hospitalisations and treatment satisfaction. RESULTS: Primary modified intention-to-treat analysis comprised 205 (85%) randomised participants [102/120 (85%) participants in the antibiotics arm and 103/120 (86%) participants in the methenamine hippurate arm] with at least 6 months' data available. During treatment, the incidence rate of symptomatic, antibiotic-treated urinary tract infections decreased substantially in both arms to 1.38 episodes per person-year (95% confidence interval 1.05 to 1.72 episodes per person-year) for methenamine hippurate and 0.89 episodes per person year (95% confidence interval 0.65 to 1.12 episodes per person-year) for antibiotics (absolute difference 0.49; 90% confidence interval 0.15 to 0.84). This absolute difference did not exceed the predefined, strict, non-inferiority limit of one urinary tract infection per person-year. On average, methenamine hippurate was less costly and more effective than antibiotics in terms of quality-adjusted life-years gained; however, this finding was not consistent over the longer term. The urinary tract infection incidence rate 6 months after treatment completion was 1.72 episodes per year in the methenamine hippurate arm and 1.19 in the antibiotics arm. During treatment, 52% of urine samples taken during symptomatic urinary tract infections were microbiologically confirmed and higher proportions of participants taking daily antibiotics (46/64; 72%) demonstrated antibiotic resistance in Escherichia coli cultured from perineal swabs than participants in the methenamine hippurate arm (39/70; 56%) (p-value = 0.05). Urine cultures revealed that during treatment higher proportions of participants and samples from the antibiotic arm grew E. coli resistant to trimethoprim/co-trimoxazole and cephalosporins, respectively. Conversely, post treatment, higher proportions of participants in the methenamine hippurate arm (9/45; 20%) demonstrated multidrug resistance in E. coli isolated from perineal swabs than participants in the antibiotic arm (2/39; 5%) (p = 0.06). All other secondary outcomes and adverse events were similar in both arms. LIMITATIONS: This trial could not define whether or not one particular antibiotic was more beneficial, and progressive data loss hampered economic evaluation. CONCLUSIONS: This large, randomised, pragmatic trial in a routine NHS setting has clearly shown that methenamine hippurate is not inferior to current standard care (daily low-dose antibiotics) in preventing recurrent urinary tract infections in women. The results suggest that antimicrobial resistance is proportionally higher in women taking prophylactic antibiotics. RECOMMENDATIONS FOR RESEARCH: Future research should include evaluation of other non-antibiotic preventative treatments in well-defined homogeneous patient groups, preferably with the comparator of daily antibiotics. TRIAL REGISTRATION: This trial is registered as ISRCTN70219762 and EudraCT 2015-003487-36. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 23. See the NIHR Journals Library website for further project information.

Women with recurrent urine infections often require preventative treatment to reduce the frequency of infection episodes. Daily low-dose antibiotic medication is a guideline-recommended treatment option for these women. There is increasing concern globally regarding antibiotic-resistant infections, which has led researchers to look at alternative treatments. This trial was conducted to find out whether or not taking an alternative treatment that is not an antibiotic [i.e. methenamine hippurate (Hiprex^®; Mylan NV, Canonsburg, PA, USA)] was as effective as the standard daily low-dose antibiotics. A total of 240 women from across the UK took part in the trial. They were divided equally into two groups; half of the women were given methenamine hippurate and the other half were given standard low-dose antibiotics. Both treatments were prescribed to be taken every day for 1 year. To make a fair comparison, people were put into the two groups at random using a computer program. Aspects of the trial that could be improved were identified through telephone interviews with patients and recruiting staff. Feedback from these telephone interviews helped to ensure the successful conduct of the trial. Patients were followed up for 18 months, comprising the 12 months when they were taking treatment and a 6-month follow-up phase after they had finished treatment. We found that the non-antibiotic option of methenamine hippurate was no worse than the current standard treatment of daily antibiotics in preventing urinary tract infection episodes in adult women. For both treatments, patients expressed high levels of satisfaction. One advantage of the methenamine hippurate treatment was that infecting bacteria were slightly less likely to develop resistance to antibiotics. We also evaluated health-care costs of both treatments and found that methenamine hippurate seemed worthwhile to the NHS in the short term, but there was uncertainty over longer-term costs and benefits. These results will help patients with repeated urinary tract infections to decide on treatment options, particularly if they want to avoid prolonged courses of preventative antibiotics.

Use of Magnetic Resonance Imaging in women with suspected complications following insertion of implants for pelvic organ prolapse and stress urinary incontinence surgery.

OBJECTIVE: To evaluate the role of Magnetic Resonance Imaging (MRI) in women presenting with suspected implant complications following surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). STUDY DESIGN: Retrospective single-centre cohort study in a designated tertiary referral centre. All women with vaginally and/or abdominally placed implants for POP or SUI who were referred with suspected mesh complications, and investigated with an MRI scan, between January 2018-October 2020 were included in the study. RESULTS: 97 women were identified over this time-period with a total of 123 implants, a median age of 55 years (Range: 34-79) and an average insertion to presentation time of 84 months (Range: 2-300). 78% (74) had one implant in situ, with the remainder having at least 2 in situ. Transobturator tapes (TVT-O/TOT) were the most common implants [35% (43)]. Chronic Pelvic or abdominal pain was the most common clinical symptom [73.2% (71/112 primary complaints)] with provoked tenderness on examination being the most common clinical finding [27.8% (32/115 clinical findings)]. MRI was more likely to detect abdominally placed implants [100% (all 30)] and Retropubic Tapes [89% (16/18)] when compared to Transvaginal POP implants [87.5% (28/32)] and TVT-O/TOT [67% (29/43)]. MRI identified both cases of Sacrocolpopexy mesh rupture as well as all 11 cases of infection (100%). In 91% (10/11) of these cases, MRI revealed the infection to be more widespread than clinical findings initially suspected. Cohen's Kappa demonstrated excellent correlation between MRI and surgical findings in cases with implant related infection, rupture and normal findings (κ = 1; z = 4.58; p = 0.00000459). CONCLUSION(S): MRI can be a useful tool in assessment and management of patients with complications from implants. MRI can detect infection that may be more extensive that is initially clinically apparent in the outpatient setting. Abdominal implants appear to be easier to detect than transvaginal meshes and trans obturator tapes.

Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial.

OBJECTIVE: To test and compare the efficacy of methenamine hippurate for prevention of recurrent urinary tract infections with the current standard prophylaxis of daily low dose antibiotics. DESIGN: Multicentre, open label, randomised, non-inferiority trial. SETTING: Eight centres in the UK, recruiting from June 2016 to June 2018. PARTICIPANTS: Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment. INTERVENTIONS: Random assignment (1:1, using permuted blocks of variable length via a web based system) to receive antibiotic prophylaxis or methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed. MAIN OUTCOME MEASURE: Absolute difference in incidence of symptomatic, antibiotic treated, urinary tract infections during treatment. A patient and public involvement group predefined the non-inferiority margin as one episode of urinary tract infection per person year. Analyses performed in a modified intention-to-treat population comprised all participants observed for at least six months. RESULTS: Participants were randomly assigned to antibiotic prophylaxis (n=120) or methenamine hippurate (n=120). The modified intention-to-treat analysis comprised 205 (85%) participants (antibiotics, n=102 (85%); methenamine hippurate, n=103 (86%)). Incidence of antibiotic treated urinary tract infections during the 12 month treatment period was 0.89 episodes per person year (95% confidence interval 0.65 to 1.12) in the antibiotics group and 1.38 (1.05 to 1.72) in the methenamine hippurate group, with an absolute difference of 0.49 (90% confidence interval 0.15 to 0.84) confirming non-inferiority. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the methenamine group and most reactions were mild. CONCLUSION: Non-antibiotic prophylactic treatment with methenamine hippurate might be appropriate for women with a history of recurrent episodes of urinary tract infections, informed by patient preferences and antibiotic stewardship initiatives, given the demonstration of non-inferiority to daily antibiotic prophylaxis seen in this trial. TRIAL REGISTRATION: ISRCTN70219762.

Learning from the report of the independent medicines and medical devices safety review: "first do no harm".

This is a review of the learning points from the Independent Medicines and Medical Devices Safety Review,1 chaired by Baroness Julia Cumberlege CBE DL. This system-wide review was initiated by the then Secretary of State for Health and Social Care, following patient-led campaigns. It looked at how the "healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate".We aim to highlight the learning points for doctors in Obstetrics and Gynaecology as these are relevant to our current practice and future changes in our healthcare system. These are: Aims of the review: why it was initiated and how it was conductedOverarching themes and missed opportunities to prevent avoidable harmThree clinical scenarios: their histories, issues and adverse events associated with their use and the current response in Scotland The hormone pregnancy test - PrimodosThe anti-epileptic drug - sodium valproateSurgical mesh for prolapse & incontinenceThe recommendations made by the review and implementation guidanceResponses to the review, such as apologies issued by BSUG2/BAUS3/RCOG,4 and compensations schemes such as the Scottish scheme as recommended by the review.

Sistema de trazabilidad aplicado a la producción de semilla bajo el esquema de mínimos para cultivos semestrales en los valles interandinos / Traceability system applied to seed production under the minimum scheme for semi-annual crops in the inter-Andean valleys

RESUMEN La semilla es el insumo principal para el establecimiento de sistemas productivos agrícolas, por lo cual, durante la producción de semilla, una condición indispensable es que se mantenga la calidad del material en todo el proceso incremental. El Departamento de Semillas de la Corporación Colombiana de Investigación Agropecuaria-Agrosavia, comprometido con el cumplimiento de los requisitos establecidos en la Resolución ICA 3168 de 2015 y en el Decreto del MADR 931 de 2018, en todos sus procesos productivos, ha desarrollado e implementado un Sistema Interno de Trazabilidad (SIT) para la producción de semilla y, específicamente, en una de sus estrategias denominada Plan de Mínimos para cultivos semestrales soya, algodón, arroz, maíz y sorgo en los valles interandinos. Los resultados mostraron que esta herramienta tecnológica facilitó, en el proyecto, realizar el monitoreo y el seguimiento de las labores, el registro de eventos climáticos, el manejo eficiente de inventarios y el análisis de costos. Esta reflexión es un trabajo pionero en Colombia, que contribuye a la toma de decisiones, a mejorar la productividad y a fortalecer el Sistema Nacional de Semillas.

ABSTRACT Seed is the main input for the establishment of agricultural production systems, so during seed production an indispensable condition is that the quality of the material is maintained throughout the incremental process. The Seed Department of Colombian Agricultural Research Corporation- Agrosavia, committed to complying with the requirements established in Resolution ICA 3168 of 2015 and Decree MADR 931 of 2018in all its production processes, has developed and implemented an Internal Traceability System (SIT) for the production of seed and specifically in one of its strategies called Minimum Plan for semi-annual crops of soybean, cotton, rice, corn and sorghum in the inter-Andean valleys. The results show that this technological tool facilitated in the project carried out the monitoring and tracing of the crops work, the registry of climatic events, the efficient management of inventories and the analysis of costs. This is a pioneering work in Colombia, which contributes to decision making, improve productivity and strengthen the National Seed System.

Self-management of overactive bladder at home using transcutaneous tibial nerve stimulation: a qualitative study of women's experiences.

BACKGROUND: Transcutaneous tibial nerve stimulation (TTNS) has been used to treat overactive bladder (OAB), however patient experiences and views of this treatment are lacking. The aim of this study was to explore women's experiences of OAB and TTNS treatment and the perceived factors influencing participation and adherence. METHODS: Semi-structured, individual interviews conducted as part of a mixed-methods, randomised, feasibility trial of self-managed versus HCP-led TTNS. Interviews were audio recorded and transcribed verbatim. Reflexive thematic analysis was undertaken using Booth et al. (Neurourol Urodynam. 2017;37:528-41) approach. RESULTS: 16 women were interviewed, 8 self-managing TTNS at home and 8 receiving TTNS in twice-weekly hospital clinic appointments. Women self-managing OAB considered TTNS easy to administer, flexible and favourably 'convenient', especially when the participant was bound by work and other life commitments. In contrast to OAB symptoms 'dominating life', self-managing bladder treatment was empowering and fitted around home life demands. Flexibility and control engendered by self-management, facilitated women's willingness to participate in TTNS. Women attending a hospital clinic for TTNS enjoyed the social aspects but found the routine appointments constrained their lives. Motivation to continue TTNS in the longer term was dependent on perception of benefit. CONCLUSIONS: This study provides novel insights into women's experiences of self-managing their OAB using TTNS compared to HCP-led management in the clinical setting. It highlights positive experiences self-managing TTNS at home and a willingness to continue in the longer term, facilitated by ease of use and convenience. Trial Registration 1/11/2018: ClinicalTrials.gov Identifier: NCT03727711.

Formative and Validation Human Factors studies of a new disposable autoinjector for subcutaneous delivery of chronic disease therapies.

BACKGROUND: Use-related risks related to autoinjector devices have been previously identified. To minimize these problems, the identification of potential use errors is a critical task during device development. METHODS: This article presents iterative human factor studies, which aim to assess user interaction with the tested push-on-skin BD Intevia™ 1 mL Disposable Autoinjector, across a wide range of indications, and a broad user population. RESULTS: Through the different human factor studies, use errors were recorded when the participants completed the critical tasks, but their occurrence continuously decreased. First, the incidence of use errors was reduced when the participants read the IFU. In addition, the IFU updates and design change implemented contributed to improve the usability performance. During the validation study, some use errors were still observed, mainly during the first uses. Nevertheless, providing a training to the participants almost fully eliminated the remaining use errors. CONCLUSION: Thus, these results demonstrated that this new autoinjector can be safely and efficiently used for its intended uses and under the expected use conditions by all tested user groups.

Attitudes of the Ecuadorian University Community Toward Genetically Modified Organisms.

Introduction: The acceptance of genetically modified organisms (GMOs) by the civilian population in Ecuador is a controversial issue, where beliefs and practices are determinant. In Ecuador, the use of GMOs for research or productive purposes has been banned since 2008; however, the current position of the population toward this technology is unknown. Objective: The aim of the study was to explain the attitude toward GMOs in the Ecuadorian university population based on sociodemographic variables, knowledge, beliefs, practices, and bioethical approach. Methods: A validated survey was applied to 719 students and teachers of the Catholic University of Cuenca through Google Forms. The collected data were processed using SPSS 23.0 software. Multivariate and linear regression analyses were used to explain the attitude toward GMOs based on the variables studied. Results: Partial approval of GMO use is research-oriented, with a rejection toward food. The linear regression model explained 65% of the variance of attitude toward GMOs from the beliefs, practices, knowledge, and bioethical approach variables. The sociodemographic variables were completely excluded from the model due to the absence of statistical significance. Conclusions: The incipient acceptance of GMOs in the academic sector corroborates a transformation in the thinking of Ecuadorian civil society. Considerations on the use of GMOs are supported by a bioethical approach that leans toward a pragmatic utilitarianism based on the immediate or mediate benefits of the technology.

Urethral bulking agents: a retrospective review of primary versus salvage procedure outcomes.

PURPOSE: Urethral bulking agents (UBA) have traditionally been offered as salvage procedures for recurrent stress urinary incontinence (SUI). We compare the success of UBA in patients that had undergone a previous procedure for SUI (Salvage-UBA) to the SUI surgery naïve (Primary-UBA). We hypothesised a positive effect in both Primary and Salvage-UBA with potentially poorer rates of response in the salvage group. METHODS: Retrospective case series of patients having their first UBA (2010-2018). Primary outcome was to assess any difference in patient reported success between groups. Patient-reported improvement was assessed on a 4-point scale: 'cured, improved, no change, worse' and treatment 'success' defined as 'cured' or 'improved'. A multivariate analysis, adjusting for plausible differences between groups, was undertaken in IBM SPSS Statistics (2016). RESULTS: 135 Primary-UBA and 38 Salvage-UBA were performed. Complete follow-up was obtained for 114 patients (66%): 86 Primary and 28 Salvage. Median follow-up time: 33 months. In 2012, 47% (8/17) of all UBA were Salvage-UBA, whilst in 2018, the majority were Primary-UBA (92%, 46/50). Success was not significantly different between Salvage-UBA 75% (21/28) versus Primary-UBA 67% (58/86) (Wald χ2 = 0.687, df = 1, p = 0.407). Top-up rates were similar: 14% (n = 4/28, Salvage-UBA) versus 15% (n = 13/86, Primary-UBA) (χ2 = 0.011, df = 1, p = 0.914). CONCLUSION: The number of women opting for UBA has increased substantially. No significant differences were noted for success with Salvage-UBA compared to Primary-UBA.

Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT.

BACKGROUND: Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence. DESIGN: A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor. SETTING: This trial was set in UK community and outpatient care settings. PARTICIPANTS: Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or < 6 months postnatal, those with prolapse greater than stage II, those currently having treatment for pelvic cancer, those with cognitive impairment affecting capacity to give informed consent, those with neurological disease, those with a known nickel allergy or sensitivity and those currently participating in other research relating to their urinary incontinence. INTERVENTIONS: Both groups were offered six appointments over 16 weeks to receive biofeedback pelvic floor muscle training or basic pelvic floor muscle training. Home biofeedback units were provided to the biofeedback pelvic floor muscle training group. Behaviour change techniques were built in to both interventions. MAIN OUTCOME MEASURES: The primary outcome was urinary incontinence severity at 24 months (measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score, range 0-21, with a higher score indicating greater severity). The secondary outcomes were urinary incontinence cure/improvement, other urinary and pelvic floor symptoms, urinary incontinence-specific quality of life, self-efficacy for pelvic floor muscle training, global impression of improvement in urinary incontinence, adherence to the exercise, uptake of other urinary incontinence treatment and pelvic floor muscle function. The primary health economic outcome was incremental cost per quality-adjusted-life-year gained at 24 months. RESULTS: A total of 300 participants were randomised per group. The primary analysis included 225 and 235 participants (biofeedback and basic pelvic floor muscle training, respectively). The mean 24-month International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form score was 8.2 (standard deviation 5.1) for biofeedback pelvic floor muscle training and 8.5 (standard deviation 4.9) for basic pelvic floor muscle training (adjusted mean difference -0.09, 95% confidence interval -0.92 to 0.75; p = 0.84). A total of 48 participants had a non-serious adverse event (34 in the biofeedback pelvic floor muscle training group and 14 in the basic pelvic floor muscle training group), of whom 23 (21 in the biofeedback pelvic floor muscle training group and 2 in the basic pelvic floor muscle training group) had an event related/possibly related to the interventions. In addition, there were eight serious adverse events (six in the biofeedback pelvic floor muscle training group and two in the basic pelvic floor muscle training group), all unrelated to the interventions. At 24 months, biofeedback pelvic floor muscle training was not significantly more expensive than basic pelvic floor muscle training, but neither was it associated with significantly more quality-adjusted life-years. The probability that biofeedback pelvic floor muscle training would be cost-effective was 48% at a £20,000 willingness to pay for a quality-adjusted life-year threshold. The process evaluation confirmed that the biofeedback pelvic floor muscle training group received an intensified intervention and both groups received basic pelvic floor muscle training core components. Women were positive about both interventions, adherence to both interventions was similar and both interventions were facilitated by desire to improve their urinary incontinence and hindered by lack of time. LIMITATIONS: Women unable to contract their muscles were excluded, as biofeedback is recommended for these women. CONCLUSIONS: There was no evidence of a difference between biofeedback pelvic floor muscle training and basic pelvic floor muscle training. FUTURE WORK: Research should investigate other ways to intensify pelvic floor muscle training to improve continence outcomes. TRIAL REGISTRATION: Current Controlled Trial ISRCTN57746448. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 70. See the NIHR Journals Library website for further project information.

Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and 'biofeedback' equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over 16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women's urinary incontinence. Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman's ability to exercise. Notably, women viewed the therapists' input very positively. The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.

Implementing pelvic floor muscle training for women with pelvic organ prolapse: a realist evaluation of different delivery models.

BACKGROUND: Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. METHODS: Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18 month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. RESULTS: A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women's health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff's role and core work. CONCLUSION: Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women's health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.

BACKGROUND: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. METHODS: This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. DISCUSSION: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017.

The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation.

BACKGROUND: Process evaluations have become a valued component, alongside clinical trials, of the wider evaluation of complex health interventions. They support understanding of implementation, and fidelity, related to the intervention and provide valuable insights into what is effective in a practical setting by examining the context in which interventions are implemented. The TOPSY study consists of a large multi-centre randomised controlled trial comparing the effectiveness of pessary self-management with clinic-based care in improving women's condition-specific quality of life, and a nested process evaluation. The process evaluation aims to examine and maximise recruitment to the trial, describe intervention fidelity and explore participants' and healthcare professionals' experiences. METHODS: The trial will recruit 330 women from approximately 17 UK centres. The process evaluation uses a mixed-methods approach. Semi-structured interviews will be conducted with randomised women (18 per randomised group/n = 36), women who declined trial participation but agreed to interview (non-randomised women) (n = 20) and healthcare professionals recruiting to the trial (n ~ 17) and delivering self-management and clinic-based care (n ~ 17). The six internal pilot centres will be asked to record two to three recruitment discussions each (total n = 12-18). All participating centres will be asked to record one or two self-management teaching appointments (n = 30) and self-management 2-week follow-up telephone calls (n = 30). Process data (quantitative and qualitative) will be gathered in participant completed trial questionnaires. Interviews will be analysed thematically and recordings using an analytic grid to identify fidelity to the intervention. Quantitative analysis will be predefined within the process evaluation analysis plan. DISCUSSION: The wide variety of pessary care delivered across the UK for women with pelvic organ prolapse presents specific localised contexts in which the TOPSY interventions will be implemented. Understanding this contextual variance is central to understanding how and in what circumstances pessary self-management can be implemented (should it be effective). The inclusion of non-randomised women provides an innovative way of collecting indispensable information about eligible women who decline trial participation, allowing broader contextualisation and considerations of generalisability of trial findings. Methodological insights from examination of recruitment processes and mechanisms have the potential to inform recruitment mechanisms and future recruitment strategies and study designs. TRIAL REGISTRATION: ISRCTN62510577 . Registered on 6 October 2017.