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Informal supporters (friends, family, colleagues, and community members) play a crucial role in societal-wide responses to victim-survivors of domestic violence and abuse. Familial and social networks, however, report a sense of helplessness and difficulties in knowing how to respond. This mixed method systematic review examines the effectiveness, and perceived effectiveness, of training informal supporters to improve their responses to victim-survivors. A novel conceptual framework was developed to underpin the review. A systematic search of four electronic databases, specialist repositories, and websites were used to identify empirical research (in academic or gray literature). Eleven included studies examined educational interventions that aimed to improve responses from informal supporters. Quality appraisal was undertaken, and studies were judged to be "good enough" for synthesis. The studies in the review indicated that informal supporters recognized the value of training for building understanding and equipping them with the skills to respond to victim-survivors. The synthesis identified statistically significant improvements in the knowledge and attitudes of informal supporters in the immediate and short-term following training. Using a behavior change model to frame the evidence, the review found that training/educational activities prime informal supporters to respond to victim-survivors, as well as enhancing their capacity and motivation to do so. This increases the likelihood that informal supporters will take action to support victim-survivors of abuse. We don't know, however, what type of support they will provide and/or whether it would be judged to be helpful by victim-survivors.
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Violência Doméstica , Humanos , Violência Doméstica/prevenção & controle , Atitude , Amigos , Sobreviventes , Pesquisa EmpíricaRESUMO
Purpose: Systematic reviews have an important, and growing, role to play in the global evidence eco-system of domestic violence and abuse. Alongside substantive contributions to knowledge, such reviews stimulate debates about ethical reviewing practices and the importance of tailoring methods to the nuances of the field. This paper aims to pinpoint a set of ethical and methodological priorities to guide and enhance review practices specifically in the field of domestic abuse. Method: The five Pillars of the Research Integrity Framework (ethical guidelines for domestic abuse research) are used to interrogate the systematic review process. To do so, the Framework is retrospectively applied to a recently completed systematic review in domestic abuse. The review included a rapid systematic map and in-depth analysis of interventions aimed at creating or enhancing informal support and social networks for victim-survivors of abuse. Results: Ethical and methodological priorities for systematic reviews in domestic abuse include (1) Safety and wellbeing: maintaining the wellbeing of researchers and stakeholders, and appraising the ethics of included studies, (2) Transparency/ accountability: transparent reporting of research funding, aims and methods together with explicit consideration of authorship of outputs, (3) Equality, human rights and social justice: developing diverse review teams/ Advisory groups, and review methods that aim to search for, and report, diverse perspectives. Considering researcher positionality/ reflexivity in the review, (4) Engagement: collaboration with non-academic stakeholders and individuals with lived experience throughout the review process, (5) Research Ethics: independent ethical scrutiny of systematic review proposals with input from researchers with expertise in systematic reviews and domestic abuse. Conclusion: Additional research is required to comprehensively examine the ethics of each stage of the review process. In the meantime, attention should be given to the underpinning ethical framework for our systematic review practices and the wider research infrastructure that governs reviews.
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This is the protocol for a Campbell Evidence Gap Map. The main objectives of the EGM are: establish the nature and extent of the primary empirical evidence on informal social support interventions, identify interventions and clusters of evidence suitable for systematic review/evidence synthesis and identify gaps in the evidence on informal social support interventions.
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Institutos de Câncer , Neoplasias , Centros Médicos Acadêmicos , Objetivos , Humanos , Motivação , Neoplasias/terapia , Estados UnidosRESUMO
BACKGROUND: Existing research explores Parole Board decision-making, but not specifically for perpetrators of intimate partner violence (IPV), a special case due to the gendered and secretive nature of IPV and the role of control in predicting reoffending. AIM: To identify associations between case variables in England and Wales Parole Board decisions regarding perpetrators of IPV and explore how these variables help construct the decision. METHODS: Logistic regressions regarding decisions in a sample of all 137 male prisoners who had abused women and applied for release or progression to open conditions in England and Wales from April 2018 to September 2019, developed into latent class analyses. Thematic analyses of six interviews with Parole Board members about decision-making in IPV cases. RESULTS: Release decisions were strongly predicted by the recommendations of offender managers, offender supervisors and psychologists, mediated by the Parole Board's confidence in their ability. Decisions were also significantly associated with custodial behaviour and attendance on courses, mediated by the Board's confidence in the prisoner's insight and honesty. Thematic analysis was both consistent with these findings and provided a context in which the associations could be understood. CONCLUSIONS: The findings have implications for understanding the dynamics between professional decisions and the Parole Board's decision; for the importance of offender managers demonstrating their expertise and ability to manage risk; for Parole Board members' reflection and development; for academic research into IPV; and for those who have experienced IPV and are looking to understand parole decisions about their abuser.
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Tomada de Decisões , Violência por Parceiro Íntimo/psicologia , Prisioneiros/psicologia , Prisões/organização & administração , Adulto , Inglaterra , Feminino , Humanos , Modelos Logísticos , Masculino , Transtornos Relacionados ao Uso de Substâncias , País de GalesRESUMO
BACKGROUND: Prearrest diversion strategies are being adopted across the Western world, enabling the police to identify and divert people suspected of having mental disorder towards health and community services rather than the criminal justice system. AIMS: To quantify longer-term criminal justice and mental health outcomes after prearrest diversion of people with suspected mental disorder and consider economic correlates. METHODS: A systematic review of published literature on longer term outcomes after prearrest diversion. RESULTS: Only two quasi-experimental studies, with four independent samples, could be included. Findings for criminal and mental health outcomes were inconclusive, but potential for adverse outcomes was identified. Ten studies with cost data suggested that prearrest diversion can lead to overall cost savings. CONCLUSIONS: There is still inadequate evidence on which to base prearrest diversion programmes. Although some benefits have been identified by the review, so have possible harms. Future research and funding strategies must build in high-quality, systematic evaluation of outcomes before implementing a theoretically attractive strategy more widely.
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Serviços Comunitários de Saúde Mental/organização & administração , Crime , Criminosos/psicologia , Transtornos Mentais/psicologia , Polícia , Direito Penal , Humanos , Saúde Mental , Transtornos PsicóticosRESUMO
INTRODUCTION: Many clinicians have suggested that a history of bladder and bowel dysfunction (BBD) in childhood predisposes to the development of interstitial cystitis/bladder pain syndrome (IC/BPS) or irritable bowel syndrome (IBS) in adulthood. We hypothesized that BBD symptoms in childhood would predict the IBS-associated phenotype in adult IC/BPS patients. METHODS: Consecutive female patients (n=190) with a diagnosis of IC/BPS were administered a modified form of a clinical BBD questionnaire (BBDQ) to capture childhood BBD-like symptoms, as well as Interstitial Cystitis Symptoms Index (ICSI), Interstitial Cystitis Problem Index (ICPI), Pelvic Pain and Urgency/Frequency (PUF) questionnaires and UPOINT categorization. Patients were stratified to IBS-positive or IBS-negative according to clinical assessment of IBS-like symptoms. RESULTS: The 127 patients (67%) identified with IBS-like symptoms recalled significantly higher BBDQ scores than the 63 patients (33%) who were IBS-negative (2.8 vs. 2.3; p=0.05). The IBS-positive patients also reported a higher number of UPOINT domains than their non-IBS counterparts (3.8 vs. 2.9; p=0.0001), while their PUF total scores were significantly higher (13.6 vs. 12.3; p=0.04). IBS-positive patients more often recalled that in childhood they did not have a daily bowel movement (BM) (p=0.04) and had "to push for a BM" (p=0.009). In childhood, they "urinated only once or twice per day" (p=0.03) and recalled "painful urination" more than those without IBS (p=0.03). There were no significant differences between the groups in answers to the other five questions of the BBDQ. CONCLUSIONS: Our symptom recollection survey was able to predict the IBS phenotype of IC/BPS based on a childhood BBDQ. Further prospective studies are needed to further evaluate these novel findings.
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PURPOSE: Identifying Hunner lesions in patients with interstitial cystitis/bladder pain syndrome presents an opportunity for objective classification into Hunner lesion interstitial cystitis/bladder pain syndrome (classic interstitial cystitis) and nonHunner lesion bladder pain syndrome. While currently the former diagnosis requires cystoscopy, limited data suggest that these subtypes can be distinguished without endoscopy based on the degree of bladder focused centricity and the infrequent association with generalized pain conditions. MATERIALS AND METHODS: Patients in a prospective, single center database of interstitial cystitis/bladder pain syndrome who had documented cystoscopic findings were categorized with Hunner lesion interstitial cystitis/bladder pain syndrome or nonHunner lesion bladder pain syndrome. Demographics, pain and symptom scores, voiding symptoms, irritable bowel syndrome and clinical UPOINT (urinary, psychosocial, organ specific, infection, neurological and tenderness) scoring were comparatively analyzed. RESULTS: We reviewed the records of 469 patients, including 359 with documented local anesthetic cystoscopic findings, 44 (12.3%) with Hunner lesion interstitial cystitis/bladder pain syndrome and 315 (87.7%) with nonHunner bladder pain syndrome. Patients with Hunner lesions were older (p = 0.004) and had greater urinary frequency (p = 0.013), more nocturia (p = 0.0004) and higher ICSI (Interstitial Cystitis Symptom Index) scores (p = 0.017). Hunner lesion prevalence was significantly lower in those younger than 50 years vs those 50 years old or older (7.8% vs 14.9%, p = 0.0095). There was no difference in the number of UPOINT phenotype domains reported, overall UPOINT scores or the prevalence of irritable bowel syndrome between the groups. CONCLUSIONS: A subtype of interstitial cystitis with Hunner lesions has worse bladder centric symptoms but did not show a distinct bladder centric phenotype. Given the management implications of distinguishing classic interstitial cystitis from nonHunner lesion bladder pain syndrome, we recommend cystoscopy with local anesthesia in patients diagnosed with interstitial cystitis/bladder pain syndrome.
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Cistite Intersticial/diagnóstico , Cistoscopia/métodos , Medição da Dor/métodos , Dor/etiologia , Bexiga Urinária/diagnóstico por imagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Cistite Intersticial/complicações , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Dor/diagnóstico , Fenótipo , Estudos Prospectivos , Síndrome , Bexiga Urinária/fisiopatologiaRESUMO
To ensure success in a partnership agreement, healthcare organizations should create a funds flow framework. An effective funds flow framework will address not only the partner organizations' current challenges but also potential changes within the organizations. Funds flow frameworks are unique to the organizations and partnerships that use them.
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Comportamento Cooperativo , Prestação Integrada de Cuidados de Saúde/economia , Alocação de Recursos para a Atenção à Saúde , Modelos Organizacionais , Estados UnidosRESUMO
INTRODUCTION: Phenotypic differentiation of patients with interstitial cystitis/bladder pain syndrome (IC/BPS) may improve our understanding of the condition, as well as the development of patient-specific treatment strategies. We identified a distinct subgroup of IC/BPS patients with a multiple sensitivity phenotype. METHODS: We defined patients with this IC/BPS associated multiple sensitivity syndrome as having at least 3 confirmed allergies/sensitivities to medications and/or environmental factors and a diagnosis of IC/BPS. These IC/BPS patients identified with a multiple sensitivity phenotype (cases) were compared to age-matched IC/BPS patients with few or no allergies (controls) at a 1:2 ratio. Comparisons were undertaken using standardized case assessment parameters (age, duration of symptoms, medical history, Interstitial Cystitis Symptoms Index [ICSI] and pelvic pain and urinary urgency/frequency [PUF] symptom scores, and urinary, psychosocial, organ specific, infection, neurologic/systemic, tenderness [UPOINT] categorization). RESULTS: The study consisted of 17 cases and 34 age-matched controls; the mean age was 55 and 56 years, respectively. There was statistically more medication and environmental allergies in the cases versus controls. Cases reported more concomitant illnesses (9.6 vs. 6.2, p < 0.001) and number of bodily systems affected (6.0 vs. 3.8, p ≤ 0.001). The prevalence of irritable bowel syndrome and fibromyalgia was higher in the case group (p = 0.028, p ≤ 0.001, respectively). Additionally, there were more reported psychiatric diseases (p = 0.019), allergic/immune diseases (p = 0.003), and pulmonary diseases (p < 0.001) in the case group. UPOINT classification differed with more patients in the case group being categorized in the psychosocial and neuropathic/systemic domains (p = 0.045, p = 0.007, respectively). Total UPOINT classification (out of 6) was also higher in cases than controls (4.6 vs. 3.2, p = 0.001, respectively). CONCLUSIONS: We have characterized a distinct phenotypic group of patients with IC/BPS and multiple sensitivities. The limitations of our study include the retrospective case-control matching design, biases in phenotype definition, single centre patient recruitment, and the lack of follow-up. Nonetheless, the observation of this specific phenotype suggests that further research in this group may help develop targeted therapeutic strategies for patients with a concomitant multiple sensitivity syndrome and IC/BPS.
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BACKGROUND: Recent breast implant complications led to a UK government policy review of the evidence concerning cosmetic interventions. We synthesised cosmetic intervention research evidence covering psychosocial factors associated with requesting procedures and psychological outcomes, effects of procedures on psychological outcomes, preintervention assessments for identifying those at risk, alternative therapy effectiveness, and issues in achieving informed consent. METHODS: Undertaking a systematic rapid evidence assessment, six databases and three journals were searched. Included studies were systematic reviews or primary studies of participants requesting cosmetic procedures; published 2002-2012; containing either psychological or psychosocial measures, a psychological outcome, or evaluation of informed consent. Reviewers independently assessed study eligibility, extracted data, and assessed quality, undertaking narrative synthesis. RESULTS: Methodological quality of the included 13 systematic reviews and 179 primary studies was low, with wide variation in psychosocial measures. Findings suggest several psychosocial factors (e.g., intimate partner violence) may be associated with requesting cosmetic surgery. Multiple factors (e.g., unrealistic expectations) may predict poor psychological outcomes. Current psychological screening tools focus predominantly on body dysmorphic disorder (BDD) symptoms. Psychological and pharmacological interventions are effective alternative BDD treatments. Patients and doctors bring different needs to informed consent discussions, inconsistently matched to those required by professional ethics, litigation risk, and facilitating profit. CONCLUSIONS: Systematically reviewing this literature for UK policy has highlighted that some groups may be at risk of poor post-cosmetic procedure outcomes. Practitioners and patients must explore reasons for seeking cosmetic procedures and discuss all potential results and alternative solutions. Future research should employ more robust methodologies to identify effects in those at risk, led by consensus on a core set of psychological outcomes.
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Técnicas Cosméticas/psicologia , Consentimento Livre e Esclarecido , Humanos , Motivação , Qualidade de Vida , Autoimagem , Resultado do TratamentoRESUMO
OBJECTIVE: To assess a flexible therapeutic strategy for patients referred to a specialized interstitial cystitis/bladder pain syndrome (IC/BPS) clinic using an individualized phenotype-directed treatment plan based on clinically based urinary, psychosocial, organ-specific, infection, neurologic or nonbladder, and tenderness of pelvic floor (UPOINT) categorization, instead of the traditional algorithmic stepwise approach. METHODS: Consecutive patients referred to a specialized tertiary IC/BPS clinic with at least 1 follow-up posttreatment visit were categorized according to their UPOINT status and treated according to previously published individualized phenotype-based treatment plan. Patients were assessed at baseline and up to 2 years with validated symptom scores (interstitial cystitis symptom score [ICSI]; and pain urgency frequency questionnaire) as well as pain and voiding assessments. RESULTS: Follow-up visit data were available for 93 patients (mean age, 45.2 years; median age, 44 years; mean ICSI, 13.2±3.6). Patients reported a median of 4 UPOINT domains (mean, 3.7±0.94) with the following distribution: U=100%; P=31.2%; O=97.8%; I=45.2%; N=39.8%; and T=55.9%. The mean decrease in ICSI was 3.4 points. Significant clinical improvement (>30% decrease in ICSI) was observed in 46.2% compared with initial baseline visit. Pain urgency frequency, and pain and urgency scoring changes were comparable. No correlation between severity of symptoms and number of domains and ICSI decrease was observed. CONCLUSION: Almost 50% of patients referred to a tertiary IC/BPS clinic, regardless of the complexity or severity of condition, experienced clinically significant improvement using an individualized phenotype-directed therapeutic approach.
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Cistite Intersticial/genética , Cistite Intersticial/terapia , Idoso , Cistite Intersticial/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Fenótipo , Estudos ProspectivosRESUMO
BACKGROUND: Unsafe abortion imposes heavy burdens on both individuals and society, particularly in low-income countries, many of which have restrictive abortion laws. Providing family planning counseling and services to women following an abortion has emerged as a key strategy to address this issue. STUDY DESIGN: This systematic review gathered, appraised and synthesized recent research evidence on the effects of postabortion family planning counseling and services on women in low-income countries. RESULTS: Of the 2965 potentially relevant records that were identified and screened, 15 studies satisfied the inclusion criteria. None provided evidence on the effectiveness of postabortion family planning counseling and services on maternal morbidity and mortality. One controlled study found that, compared to the group of nonbeneficiaries, women who received postabortion family planning counseling and services had significantly fewer unplanned pregnancies and fewer repeat abortions during the 12-month follow-up period. All 15 studies examined contraception-related outcomes. In the seven studies which used a comparative design, there was greater acceptance and/or use of modern contraceptives in women who had received postabortion family planning counseling and services relative to the no-program group. CONCLUSIONS: The current evidence on the use of postabortion family planning counseling and services in low-income countries to address the problem of unsafe abortion is inconclusive. Nevertheless, the increase in acceptance and/or use of contraceptives is encouraging and has the potential to be further explored. Adequate funding to support robust research in this area of reproductive health is urgently needed.
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Aborto Induzido , Comportamento Contraceptivo , Países em Desenvolvimento , Serviços de Planejamento Familiar , Aconselhamento , Feminino , Humanos , Aceitação pelo Paciente de Cuidados de Saúde , Gravidez , Gravidez não PlanejadaRESUMO
DNA molecules originating from animals and plants can be retrieved directly from sediments and have been used for reconstructing both contemporary and past ecosystems. However, the extent to which such 'dirt' DNA reflects taxonomic richness and structural diversity remains contentious. Here, we couple second generation high-throughput sequencing with 16S mitochondrial DNA (mtDNA) meta-barcoding, to explore the accuracy and sensitivity of 'dirt' DNA as an indicator of vertebrate diversity, from soil sampled at safari parks, zoological gardens and farms with known species compositions. PCR amplification was successful in the full pH range of the investigated soils (6.2 ± 0.2 to 8.3 ± 0.2), but inhibition was detected in extracts from soil of high organic content. DNA movement (leaching) through strata was evident in some sporadic cases and is influenced by soil texture and structure. We find that DNA from the soil surface reflects overall taxonomic richness and relative biomass of individual species. However, one species that was recently introduced was not detected. Furthermore, animal behaviour was shown to influence DNA deposition rates. The approach potentially provides a quick methodological alternative to classical ecological surveys of biodiversity, and most reliable results are obtained with spatial sample replicates, while relative amounts of soil processed per site is of less importance.
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Biodiversidade , Código de Barras de DNA Taxonômico/métodos , DNA Mitocondrial/análise , Solo/análise , Vertebrados/genética , Animais , Sequenciamento de Nucleotídeos em Larga Escala , Plantas/classificação , Plantas/genética , Reação em Cadeia da Polimerase , RNA Ribossômico 16S/genética , Sensibilidade e Especificidade , Vertebrados/classificaçãoRESUMO
Within the systematic review process, the searching phase is critical to the final synthesis product, its use and value. Yet, relatively little is known about the utility of different search strategies for reviews of complex, inter-disciplinary evidence. This article used a recently completed programme of work on cultural and sporting engagement to conduct an empirical evaluation of a comprehensive search strategy. Ten different types of search source were evaluated, according to three dimensions: (i) effectiveness in identifying relevant studies; (ii) efficiency in identifying studies; and (iii) adding value by locating studies that were not identified by any other sources. The study found that general bibliographic databases and specialist databases ranked the highest on all three dimensions. Overall, websites and journals were the next most valuable types of source. For reviewers, these findings highlight that general and specialist databases should remain a core component of the comprehensive search strategy, supplemented with other types of sources that can efficiently identify unique or grey literature. For policy makers and other research commissioners, this study highlights the value of methodological analysis for improving the understanding of, and practice in, policy relevant, inter-disciplinary systematic reviews. Copyright © 2011 John Wiley & Sons, Ltd.
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OBJECTIVES: To determine the prevalence and clinical significance of documented bacteriuria and/or urinary tract infection in an interstitial cystitis/painful bladder syndrome (IC/PBS) population. METHODS: Urine cultures were obtained at the initial assessment (documentation of sterile urine mandatory at diagnosis) and during routine follow-up, at each active treatment visit, and during and after the presentation and treatment of symptom flares in consecutively assessed female patients with IC/PBS. At each visit, the following questionnaires were completed: the O'Leary-Sant IC Symptom and Problem Index, the Pain Urgency Frequency questionnaire, and pain, frequency, and urgency Likert scales (0-10). RESULTS: A total of 100 patients with IC were followed up for 2 years. Of these 100 patients, 31 (31%) had ≥ 1 documented positive urine culture with a traditional uropathogen (mean 1.8, range 1-5). No difference was seen in the patients identified with bacteriuria and those without bacteriuria in age, symptom duration, O'Leary-Sant IC Symptom and Problem Indexes, Pain Urgency Frequency questionnaire, or pain, frequency, and urgency Likert scales. No correlation was found between the number of bacteriuria episodes and any symptom index evaluated. No significant difference was seen in any of the symptom indexes evaluated at baseline, during the bacteriuria episodes, or after successful bacterial eradication in the group identified with bacteriuria. CONCLUSIONS: The presence of bacteriuria can be documented in an IC/PBS population of women whose urine has frequently been cultured; however, the patients with bacteriuria did not differ from those without evidence of bacteriuria, the bacteriuria episodes did not appear to be associated with the symptom flares, and antibiotic treatment of documented bacteriuria was not associated with significant IC/PBS-related symptom amelioration.
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Bacteriúria/epidemiologia , Cistite Intersticial/epidemiologia , Infecções Urinárias/epidemiologia , Antibacterianos/uso terapêutico , Bacteriúria/tratamento farmacológico , Comorbidade , Cistite/epidemiologia , Cistite/microbiologia , Enterobacteriaceae/isolamento & purificação , Infecções por Enterobacteriaceae/tratamento farmacológico , Infecções por Enterobacteriaceae/epidemiologia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Dor/epidemiologia , Dor/etiologia , Prevalência , Inquéritos e Questionários , Infecções Urinárias/tratamento farmacológico , Urina/microbiologiaRESUMO
PURPOSE: We have proposed a clinical phenotype system (UPOINT) to classify patients with urological pelvic pain to improve the understanding of etiology and guide therapy. We examined the relationship between UPOINT and symptoms in patients with interstitial cystitis/painful bladder syndrome. MATERIALS AND METHODS: Patients with interstitial cystitis/painful bladder syndrome were classified in each domain of UPOINT, that is urinary, psychosocial, organ specific, infection, neurological/systemic and tenderness. Symptoms were assessed using the Interstitial Cystitis Symptom Index, Pain/Urgency/Frequency score and visual analogue scale for pain/urgency/frequency. Clinically relevant associations were calculated. RESULTS: The mean age of 100 consecutive patients with interstitial cystitis/painful bladder syndrome was 48 years, median symptom duration was 7 years and median Interstitial Cystitis Symptom Index score was 12.8. The percent positive for each domain was urinary 100%, psychosocial 34%, organ specific 96%, infection 38%, neurological/systemic 45% and tenderness 48%. All patients were included in at least 2 domains, with 2 domains for 13%, 3 domains--35%, 4 domains--34%, 5 domains--13% and 6 domains--5%. The number of domains was associated with greater symptom duration (p = 0.014) but not age. The number of domains was also associated with poorer general interstitial cystitis and pain symptoms (Interstitial Cystitis Symptom Index p = 0.012, pain p = 0.036) but not with frequency or urgency. The psychosocial domain was associated with increased pain, urgency and frequency, while tenderness was associated with increased Interstitial Cystitis Symptom Index score, pain/urgency/frequency score and urgency. The neurological/systemic domain was associated with increased Interstitial Cystitis Symptom Index score while the infection domain was not associated with any increased symptoms. CONCLUSIONS: The UPOINT phenotyping system can classify patients with interstitial cystitis according to clinically relevant domains. Increased symptom duration leads to a greater number of domains, and domains that function outside of the bladder (psychosocial, neurological, tenderness) predict a significant impact on symptoms. We hypothesize that the UPOINT system can direct multimodal therapy and improve outcomes.
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Cistite Intersticial/classificação , Cistite Intersticial/terapia , Transtornos Urinários/diagnóstico , Urologia/métodos , Fatores Etários , Idoso , Estudos de Coortes , Terapia Combinada , Cistite Intersticial/diagnóstico , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Medição da Dor , Probabilidade , Qualidade de Vida , Medição de Risco , Perfil de Impacto da Doença , Estresse Psicológico , Resultado do Tratamento , Transtornos Urinários/classificação , Transtornos Urinários/terapia , UrodinâmicaRESUMO
OBJECTIVE: To report a multicentre, community based open-label study designed to assess the efficacy and safety of intravesical sodium chondroitin sulphate in the treatment of patients with the clinical diagnosis of interstitial cystitis (IC). Chondroitin sulphate is a naturally occurring glycosaminoglycan (GAG) in the bladder mucus layer and changes in this GAG have been implicated in the pathogenesis of IC, and small single-centre studies have suggested that intravesical chondroitin sulphate may have efficacy in IC. PATIENTS AND METHODS: Patients with IC were treated with sodium chondroitin sulphate (Uracyst, Stellar Pharmaceuticals Inc., London ON, Canada) solution 2.0% via urinary catheter weekly for 6 weeks and then monthly for 16 weeks for a total of 10 treatments. The primary efficacy endpoint was the percentage of responders to treatment as indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale at week 10 (4 weeks after the initial six treatments) compared with baseline. A major secondary efficacy endpoint (durability) was the percentage of responders on the GRA scale after 10 treatments. Additional secondary efficacy objectives were differences from baseline in Patient Symptom/Problem Index scores over the course of the treatment compared with baseline. RESULTS: In all, 47% of the 53 enrolled patients with long standing moderately severe IC (mean [SD, range] diagnosis of IC 3.0 [3.4, 0.1-16] years; duration of symptoms 9.2 [9.2, 1-39] years; baseline symptom score 14.2 [3.2]) were responders at week 10. At 24 weeks, 60% were responders. There was a statistically and clinically significant decrease in the mean (SD) symptom and bother scores from baseline at 10 weeks and 24 weeks, at 9.0 (4.3) and 8.1 (5.0), respectively (P < 0.001). There were no significant safety issues during the study. CONCLUSIONS: This multicentre community based real-life clinical practice study suggests that intravesical chondroitin sulphate may have an important role in the treatment of IC and validates the rationale for a randomized placebo-controlled trial.