Treatment Goal In Clinical Practice Research Articles

Consensus on the Definition of Control and Remission in Chronic Urticaria.

The terms control and remission and other key terms used in chronic urticaria (CU) such as flare-up, relapse, exacerbation, and recurrence have not been fully defined in the literature. Disease monitoring and treatment goals in clinical practice are not well established. After a qualitative appraisal of available evidence, we aimed to find a consensus definition of control and remission, clarify key terminology, provide guidance on how to monitor the disease, and establish treatment goals in clinical practice. A modified Delphi consensus approach was used. Based on a literature review, a scientific committee provided 137 statements addressing controversial definitions and terms, available patient-reported outcomes (PROs), and recommendations on how to measure therapeutic objectives in CU. The questionnaire was evaluated by 138 expert allergists and dermatologists. A consensus was reached on 105 out of the 137 proposed items (76.6%). The experts agreed that complete control and remission of CU could be defined as the absence of signs or symptoms while on treatment and in the absence of treatment, respectively. Consensus was not reached on the definition of other key terms such as flare-up, exacerbation, and recurrence. The panel agreed that the objective of therapy in CU should be to achieve complete control. PROs that define the degree of control (complete, good, partial, or absence) were established. An algorithm for disease assessment is provided. In conclusion, this work offers consensus definitions and tools that may be useful in the management of patients with CU.

Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial

BackgroundUlcerative colitis (UC) is an intestinal inflammatory disease characterized by inflammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients with moderately active UC, several therapies (e.g., aminosalicylates, corticosteroids, immunosuppressants, and biologics) are recommended for induction (or maintenance) of remission. Given the side effects and disease burden, it is difficult for most patients to achieve ideal treatment goals in clinical practice. Chinese herbal medicine (CHM), as a complementary therapy, has been widely used in the management of UC in China. Qing-Chang-Hua-Shi granule (QCHS) is a classical Chinese herbal formula. Our preliminary study suggested that the QCHS decoction has a significant effect on patients with moderately active UC. However, its effectiveness and safety has not been evaluated convincingly. Therefore, we designed this protocol to investigate the efficacy of QCHS granule for moderately active UC.MethodsThis is a multicenter, randomized, double-blind, placebo-controlled, superiority trial. A total of 120 patients with moderately active UC will be recruited from 10 hospitals in China. Each eligible participant will be randomly assigned to receive QCHS granule or placebo for 12 weeks. Both groups will be given basic treatment with mesalazine (4 g/day). The primary outcomes are the clinical response (remission) rate. The secondary outcomes are health-related quality of life, endoscopic response rate, mucosal healing rate, and inflammatory markers (e.g., fecal calprotectin and CRP). The whole study period will last 36 weeks, including 24 weeks follow-up time. According to the intention-to-treat principle, variables will be assessed at 2, 4, 6, 8, 10, and 12 weeks after study commencement.DiscussionThis is the first randomized controlled clinical study protocol regarding Chinese herbal extract granules in the management of moderately active UC. We aim to investigate the superiority of QCHS granules over placebo in terms of induction of remission. If the trial shows significant benefits of QCHS granules, it will help clinical practitioners, UC patients, and policymakers make more informed choices in the decision-making.Trial registrationChinese Clinical Trial Registry ChiCTR-IOR-14005554. Registered on 27 November 2014.

Consensus statements on pediatric atopic dermatitis from dermatology and pediatrics practitioners in Japan: Goals of treatment and topical therapy

BackgroundPediatric atopic dermatitis (PAD) is a pluricausal disease and is frequently seen in dermatological and pediatric practice. Therefore, it is important to find common views in clinical practice and to promote consensus among practitioners. Aiming to obtain common views among dermatologists and pediatricians and to disseminate them widely in clinical practice, we held the PAD Consensus Forums described herein. MethodsQuestionnaire surveys of treatment goals and drug therapy were conducted to prepare topics for discussion at the PAD Consensus Forums. Reaching consensus was defined as agreement among at least 70% of the participants. ResultsAs a result of discussion among 24 dermatologists and 25 pediatricians, consensus was obtained on 7 topics. These topics configure 3 consensus of treatment goals (Attainment targets were divided into the short/medium term and the long term. Attainment targets were associated with the primary evaluation domains of the Harmonising Outcome Measures for Eczema (HOME) roadmap, etc.) and 4 consensus of drug therapy (The number of applications of topical anti-inflammatory drugs in the acute phase and selection and ideal intervals between applications of topical anti-inflammatory drugs in proactive therapy, etc.). ConclusionsThe consensus is expected to help practitioners set appropriate treatment goals in clinical practice and facilitate the choice of drugs for treatment.

INVESTIGATION OF TREATMENT GOAL IN ALLERGEN IMMUNOTHERAPY FOR JAPANESE CEDAR POLLINOSIS

As few reports are available on treatment goal for Japanese cedar pollinosis treated with allergen immunotherapy, therapeutic effect has to be assessed based on subjective symptoms in clinical practice. This research was conducted to investigate the informative treatment goal in clinical practice by using the results of TO-194SL phase III clinical trial. In this investigation, correlation between total nasal symptom medication score (TNSMS), which was predefined as the primary endpoint, and secondary endpoints evaluated by severe symptom day, quality of life (QOL) score, and overall evaluation by subject, was firstly investigated. Based on the results, stratified analyses of the secondary endpoints to confirm relationships on the stratified results, TNSMS, and cedar season were performed. Correlation between TNSMS and evaluations which were severe symptom day, QOL score, and overall evaluation by subject was reasonably observed. TNSMS generally showed 3 or below (classified as mild) throughout the entire pollen season when these evaluations reached each threshold. The results of this investigation suggest that a few evaluation items would help patients to realize the therapeutic effects of allergen immunotherapy if they could be the treatment goal in clinical practice.

Endoscopic Severity Predicts Long-Term Prognosis in Crohn's Disease Patients with Clinical Remission

Introduction: Mucosal healing has emerged as a desirable treatment goal in clinical practice for patients with Crohn's disease (CD). The aim of this study was to assess the relationship between endoscopic activity and the long-term prognosis of CD using simple endoscopic score for Crohn's disease (SESCD) and Rutgeerts' score. Methods: We conducted a cohort study in clinical practice at a single center. Among CD patients who underwent colonoscopy between July 2008 and June 2011 at our hospital, 131 patients with clinical remission were selected, and the patients were divided into 2 groups: a non-surgical group (n = 84) and a surgical group (n = 47). The primary endpoint of this study was to assess the associations between variables and clinical relapse after endoscopic procedures. The cut-off levels of SESCD or Rutgeerts' score for the prediction of relapse were also assessed in patients with clinical remission. Results: In the non-surgical group, SESCD and C-reactive protein at baseline were significantly higher in patients who had clinical recurrence than in patients who maintained remission. A factor of SESCD ≤2 was independently associated with sustained remission, even in patients with clinical remission. In the surgical group, patients with Rutgeerts' scores ≤1 had significantly prolonged clinical remission compared to patients with Rutgeerts' scores ≥3. Conclusion: A cut-off value of SESCD ≤2 and a Rutgeerts' score ≤1 enabled the prediction of long-term prognosis. These cut-off values could be used in clinical trials of endoscopic remission from the point of view of the clinical outcomes of CD.

Relevance of therapy goals in outpatient cognitive-behavioral and psychodynamic psychotherapy

Objective: Against a background of sparse research and contradictory findings, the present study investigates determinants of psychotherapy goals and predictive value for therapy success in outpatient psychotherapy. Method: The sample consisted of 473 patients from a university-based polyclinic and their corresponding 103 therapists. Goals were coded with the Bern Inventory of Treatment Goals (BIT-T). Results: The results show that goal congruence between therapists and patients is relatively small. Theoretical orientation had a significant influence on the complexity of goal structure and goal preferences. With regard to the prognostic validity, only patients' problem- and symptom-focused goals enabled the prediction of treatment success independent of basic therapeutic variables. Conclusions: These findings underline the importance of consideration of patients' individual treatment goals in clinical practice and underpin the relevance of therapy goals for future psychotherapy research.

Histologic Remission: The Ultimate Therapeutic Goal in Ulcerative Colitis?

Ulcerative colitis (UC) is a disease of the mucosal layer, and activity of the disease is assumed to be related to mucosal appearance. Mucosal healing has emerged as a major therapeutic goal in UC. Whether mucosal healing should be the ultimate therapeutic goal in these patients is unknown. Even when endoscopy suggests mucosal healing, evidence of histologic activity has been observed. Histologic healing requires complete recovery of the colonic mucosa, with absence of inflammation or structural changes. Histologic improvements have been linked with improved clinical outcomes, such as a reduced risk of relapse and need for surgery/hospitalization and a reduced risk of developing cancer. Hence, there is a rationale for aiming for histologic remission in UC. Numerous methods of classification of histologic activity in UC have been proposed, although only some of these are widely used. We review the current definitions of histologic remission, the range of scoring systems most commonly used, and the evidence of histologic improvement that is available from the latest therapies for UC. We also highlight questions that will require careful consideration if histologic remission is to become more widely used as an end point in clinical trials and a treatment goal in clinical practice.

Treatment Options for Helicobacter Pylori Infection in the Elderly

Helicobacter pylori infection plays a key role in dyspepsia, peptic ulcer disease and gastric cancer, thus the eradication of the infection has become an important treatment goal in clinical practice. The aim of this review is to present indications and therapies that are relevant for the management of H. pylori infection in elderly patients. Effective antimicrobial therapy is available, although there is still no ideal treatment, and indications for therapy continue to evolve. One-week proton pump inhibitor-based triple therapies are very effective in elderly patients; moreover, low doses of antibiotics (clarithromycin) and proton pump inhibitors are probably sufficient to obtain excellent cure rates, reducing side effects and improving compliance in elderly subjects. In some elderly patients, 10-day sequential treatment may be considered. Prolonging triple therapies to 10–14 days or using bismuth-based quadruple therapies require further studies in elderly patients. Low compliance and antibiotic resistance are the main factors related to treatment failure in old age. Therapy for treatment failure may be improved by assessing antimicrobial sensitivity. New drugs and forms of administration have been reported, although their efficacy requires confirmation.

Eradication of Helicobacter pylori: recent advances in treatment

Helicobacter pylori plays a key role in dyspepsia, peptic ulcer disease, and gastric neoplasia and eradication of the infection has become an important treatment goal in clinical practice. Seven-day proton-pump inhibitor-amoxicillin-clarithromycin triple therapy is the current first-line therapy for H. pylori but eradication rates are compromised by poor compliance and antibiotic resistance. Ten-day sequential treatment may emerge as an alternative first-line therapy. Bismuth-based quadruple therapy is the second-line regimen of choice. Antimicrobial sensitivity testing is not recommended in the routine management of H. pylori infection. Novel triple-therapy regimens containing rifabutin, levofloxacin, or furazolidone may be useful alternatives as second- or third-line therapy.