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Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women.

ABSTRACT: PURPOSE:To reassess the diagnostic values of the "draft" guidelines for the clinical diagnosis of acute uncomplicated cystitis (AC), recently proposed by US Food and Drug Administration (FDA) and European Medicines Agency (EMA). METHODS:The data of 517 female respondents (patients with acute cystitis and controls) derived from the e-USQOLAT database were analyzed and used for the validation of proposed "draft" guidelines of FDA and EMA, compared to the Acute Cystitis Symptom Score (ACSS) questionnaire. The diagnostic values of the proposals concerning signs, symptoms and their severity were assessed and compared. RESULTS:The six "typical" symptoms of the ACSS were strongly associated with the diagnosis of AC. The number of positive "typical" symptoms differed significantly between patients and controls: median 5 (IQR 4-6) vs 1 (IQR 0-3) respectively. Scored severity of "typical" symptoms also differed significantly between groups of patients and controls: median (IQR) 10 (7-13) vs 1 (0-4), respectively. The best balance between sensitivity and specificity is shown by the ACSS cut-off value of 6 scores and more of the "Typical" domain, followed by an approach proposed by FDA and EMA, justifying ACSS to be used as a diagnostic criterion for the clinical diagnosis of AC. CONCLUSIONS:Not only the presence but also the severity of the symptoms is important for an accurate diagnosis of AC. The ACSS, even without urinalysis is at least as favourable as the draft diagnostic proposals by FDA and EMA. The ACSS can be recommended for epidemiological and interventional studies, and allows women to establish self-diagnosis of AC, making the ACSS also cost-effective for healthcare.

SUBMITTER: Alidjanov JF

PROVIDER: S-EPMC6954149 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women.

Alidjanov Jakhongir F JF Naber Kurt G KG Pilatz Adrian A Radzhabov Abdukhamid A Zamuddinov Musluhuddin M Magyar András A Tenke Peter P Wagenlehner Florian M FM

World journal of urology 20190419 1

<h4>Purpose</h4>To reassess the diagnostic values of the "draft" guidelines for the clinical diagnosis of acute uncomplicated cystitis (AC), recently proposed by US Food and Drug Administration (FDA) and European Medicines Agency (EMA).<h4>Methods</h4>The data of 517 female respondents (patients with acute cystitis and controls) derived from the e-USQOLAT database were analyzed and used for the validation of proposed "draft" guidelines of FDA and EMA, compared to the Acute Cystitis Symptom Score ...[more]

PMID: 31004204

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Project description:AimsThe European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) produce guidelines for the design of pivotal psychiatric drug trials used in new drug applications. It is unknown who are involved in the guideline development and what specific trial design recommendations they give.MethodsCross-sectional study of EMA Clinical Efficacy and Safety Guidelines and FDA Guidance Documents. Study outcomes: (1) guideline committee members and declared conflicts of interest; (2) guideline development and organisation of commenting phases; (3) categorisation of stakeholders who comment on draft and final guidelines according to conflicts of interest ('industry', 'not-industry but with industry-related conflicts', 'independent', 'unclear'); and (4) trial design recommendations (trial duration, psychiatric comorbidity, 'enriched design', efficacy outcomes, comparator choice). Protocol registration https://doi.org/10.1101/2020.01.22.20018499 (27 January 2020).ResultsWe included 13 EMA and five FDA guidelines covering 15 psychiatric indications. Eleven months after submission, the EMA had not processed our request regarding committee member disclosures. FDA offices draft the Guidance Documents, but the Agency is not in possession of employee conflicts of interest declarations because FDA employees generally may not hold financial interests (although some employees may hold interests up to $15,000). The EMA and FDA guideline development phases are similar; drafts and final versions are publicly announced and everybody can submit comments. Seventy stakeholders commented on ten guidelines: 38 (54%) 'industry', 18 (26%) 'not-industry but with industry-related conflicts', six (9%) 'independent' and eight (11%) 'unclear'. They submitted 1014 comments: 640 (68%) 'industry', 243 (26%) 'not-industry but with industry-related conflicts', 44 (5%) 'independent' and 20 (2%) 'unclear' (67 could not be assigned to a specific stakeholder). The recommended designs were generally for trials of short duration; with restricted trial populations; allowing previous exposure to the drug; and often recommending rating scale efficacy outcomes. EMA mainly recommended three arm designs (both placebo and active comparators), whereas FDA mainly recommended placebo-controlled designs. There were also other important differences and FDA's recommendations regarding the exclusion of psychiatric comorbidity seemed less restrictive.ConclusionsThe EMA and FDA clinical research guidelines for psychiatric pivotal trials recommend designs that tend to have limited generalisability. Independent and non-conflicted stakeholders are underrepresented in the guideline development. It seems warranted with more active involvement of scientists and independent organisations without conflicts of interest in the guideline development process.

Project description:ObjectivesTo identify a set of signs and symptoms most likely to indicate uncomplicated cystitis in noncatheterized nursing home residents ≥65 years of age using consensus-based methods informed by a literature review.DesignLiterature review and modified Delphi survey with strict inclusion criteria.Setting and participantsExpert panel of 20 physicians certified in geriatric medicine and/or medical direction, actively practicing in post-acute and long-term care settings.MethodsThe authors performed a literature review to produce a comprehensive list of potential signs and symptoms of presumptive uncomplicated cystitis, including nonspecific "quality control" items deemed unlikely to indicate uncomplicated cystitis. The expert panel rated their agreement for each sign/symptom using a 5-point Likert-type scale (1 = strongly disagree to 5 = strongly agree). Agreed upon signs and symptoms were summarized using a diagnostic algorithm for easy clinical use.ResultsThe literature review identified 16 signs and symptoms that were evaluated in 3 Delphi survey rounds. The response rate was 100% for round 1 and 95% for the second 2 rounds. Consensus agreement for inclusion was achieved for dysuria on round 1 with exclusion of the 3 quality controls, and "offensive smelling urine." Consensus in the second round was reached for including 4 additional items (gross hematuria, suprapubic pain, urinary frequency, and urinary urgency). Round 3 evaluated dysuria alone and combinations of symptoms. Consensus that dysuria alone is sufficient for diagnosis of cystitis was not reached.Conclusions/implicationsThe panel identified 5 signs and symptoms likely indicative of uncomplicated cystitis in nursing home residents and developed a diagnostic algorithm that can be used to promote antibiotic stewardship in nursing homes. Given similarities in populations, the algorithm may also be applicable to the older adult and the broader post-acute/long-term care populations.

Project description:Early detection of cystitis in equine is essential to improve the prognosis and outcome of therapy. However, the conventional white light endoscopy is not sufficiently accurate for this purpose. Hence, this study evaluated chromoendoscopy as a recent diagnostic tool for cystitis in female donkeys. For this purpose, 5 apparently normal donkeys (control group) and 5 female donkeys with cystitis (diseased group) were used. Physical and rectal examinations, urine analysis, white light cystoscopy, methylene blue-based chromoendoscopy and histopathology were performed in all animals. Turbid urine exhibiting an alkaline pH and a significant (P = .02) increase in the numbers of RBCs and WBCs was observed in the diseased group compared to the control one. In the control group, white light cystoscopy showed a smooth pale pink glistening mucosa with two openings of the ureters and visible submucosal blood vessels. During chromocystoscopy, faint bluish discoloration of the mucosal surface with clearly visible submucosal blood vessels was detectable. These findings were correlated with the histopathological findings of the biopsies collected from the urinary bladder. In the diseased group, white-light cystoscopy showed clearly visible blood vessels, mildly hyperaemic mucosa in focal or diffuse forms and small vesicle formation. Chromocystoscopy revealed dark bluish oedematous and irregular mucosa either in a focal form or a diffuse form (marbled appearance) with deeply stained submucosal blood vessels. Histopathologically, the urothelium was hyperplastic with squamous metaplasia and the lamina propria was infiltrated with few leukocytes and congested blood vessels. Small bluish dots representing the absorbed methylene blue dye were seen in the inflamed areas against the lightly stained mucosa of the bladder. Severe diffuse necrotic cystitis was also seen with bacterial aggregations on the surface. Gram's staining revealed both gram positive bacilli and Gram positive coccobacilli. In conclusion, chromoendoscopy is a helpful tool for early diagnosis of cystitis in female donkeys and enables targeted biopsies, which improves the prognosis and outcome of therapy.

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Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women.

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Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women.

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