Defining outcome measures of hospitalization for assessment in the Japanese forensic mental health scheme: a Delphi study.
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SUBMITTER: Shiina A
PROVIDER: S-EPMC4328080 | biostudies-other | 2015
REPOSITORIES: biostudies-other
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Defining outcome measures of hospitalization for assessment in the Japanese forensic mental health scheme: a Delphi study.
Shiina Akihiro A Iyo Masaomi M Igarashi Yoshito Y
International journal of mental health systems 20150128
<h4>Background</h4>A new legislation concerning forensic mental health was established by the Japanese Government in 2005, the "Act on Medical Care and Treatment for the Persons Who Had Caused Serious Cases under the Condition of Insanity," or the Medical Treatment and Supervision (MTS) Act. Since it was passed, however, there has been broad controversy over Hospitalization for Assessment (HfA), the first stage of the MTS scheme.<h4>Methods</h4>Following a comprehensive literature search to asse ...[more]
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Project description:BackgroundMeasurement of outcomes in forensic mental health services is essential to ensure that these services are delivering good quality care and treatment. Instruments for outcome measurement should cover all important domains, be easy to implement in a routine clinical context and facilitate transfer of relevant information between clinicians as the patient progresses along a recovery and rehabilitation pathway.AimsWe sought the views of clinicians on 10 common instruments used as outcome measures in forensic mental health services, especially on their perceived comprehensiveness and ease of use.MethodsAn online survey was used to gather the views of clinicians from a range of professional backgrounds working in forensic mental health services in the United Kingdom. The selected instruments were identified from a previous systematic review of instruments for measuring outcomes in this context. Questions covered comprehensiveness, ease of use, patient involvement, relevance and use for progressing tracking and care planning.ResultsComplete responses were received from 229 individuals. The range of respondents either agreeing or strongly agreeing that individual instruments were comprehensive was 6-39%; easy to use 19%-69%; relevant 31%-78%; useful to measure progress 7-70%; and useful for care planning 33-81%. Respondents reported that, for each of the 10 instruments, full involvement of patients varied between 3% and 22%; partial involvement 12-45%, patients informed, but not involved 11%-28%; and patients not involved or informed 21%-64%.ConclusionsThe Health of the Nation Outcome Scale Secure, the only instrument designed as an outcome measure, is not regarded by clinicians as useful in that respect and the majority of clinicians do not inform patients they are using it. Clinicians appear most familiar with the Historical Clinical Risk 20 (HCR-20), which some respondents considered potentially useful as a progress measure but with limited patient involvement. Most respondents did not think that the HCR-20 is comprehensive. There is a need for outcome measures that are comprehensive, easy to use and have adequate patient involvement in their development and rating.
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Project description:ObjectiveTo define a standard set of outcomes and the most appropriate instruments to measure them for managing newly diagnosed patients with multiple myeloma (MM).MethodsA literature review and five discussion groups facilitated the design of two-round Delphi questionnaire. Delphi panellists (haematologists, hospital pharmacists and patients) were identified by the scientific committee, the Spanish Program of Haematology Treatments Foundation, the Spanish Society of Hospital Pharmacies and the Spanish Community of Patients with MM. Panellist's perception about outcomes' suitability and feasibility of use was assessed on a seven-point Likert scale. Consensus was reached when at least 75% of the respondents reached agreement or disagreement. A scientific committee led the project.ResultsFifty-one and 45 panellists participated in the first and second Delphi rounds, respectively. Consensus was reached to use overall survival, progression-free survival, minimal residual disease and treatment response to assess survival and disease control. Panellists agreed to measure health-related quality of life, pain, performance status, fatigue, psychosocial status, symptoms, self-perception on body image, sexuality and preferences/satisfaction. However, panellist did not reach consensus about the feasibility of assessing in routine practice psychosocial status, symptoms, self-perception on body image and sexuality. Consensus was reached to collect patient-reported outcomes through the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core questionnaire 30 (C30), three items from EORTC-QLQ-Multiple Myeloma (MY20) and EORTC-QLQ-Breast Cancer (BR23), pain Visual Analogue Scale, Morisky-Green and ad hoc questions about patients' preferences/satisfaction.ConclusionsA consensual standard set of outcomes for managing newly diagnosed patients with MM has been defined. The feasibility of its implementation in routine practice will be assessed in a future pilot study.
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Project description:BACKGROUND:A core outcome set (COS) represents the agreed minimum set of domains and measurement instruments that should be measured and reported in any clinical trial for a given condition. In BMS randomized controlled trials (RCTs), the outcomes identified in the existing literature regarding the efficacy of therapeutic interventions are numerous and diverse. Although the standardized IMMPACT core outcome domains has been developed for measurement of outcomes in chronic pain RCTs, no BMS-specific COS have been adopted and validated. With the evolving landscape of BMS management end points and the development of new therapies, a consensus on a COS for use in future BMS trials is paramount to reduce heterogeneity in outcome reporting. The aim of this study was to reach a consensus for adopting the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) outcome domains, and their tools of assessment, for burning mouth syndrome (BMS) clinical trials and clinical practice. METHODS:A BMS-specific COS will be developed using the method recommended by the Core Outcome Measures in Effective Trials (COMET) initiative (Registration: http://www.comet-initiative.org/studies/details/1357 ). Selection of questionnaire outcome measures was informed by the IMMPACT consensus and previous systematic review of RCTs in BMS conducted by the consortium. An international group of clinicians and researchers will be invited to participate in several rounds of a Delphi survey. A consensus meeting will be held with the objective of ratifying the outcomes for inclusion in the COS. A finalized COS explanatory document will be drafted, including all outcomes and measurements as determined by the Delphi rounds and consensus meeting. DISCUSSION:A COS for the management of BMS will improve the quality of future RCTs, reduce outcome reporting heterogeneity, and facilitate more vigorous data synthesis of management interventions for systematic reviews and meta-analysis. This would ensure enhanced quality evidence for clinical management of the condition.
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Project description:BACKGROUND:Duchenne muscular dystrophy (DMD) is a progressive neuromuscular disease characterized by progressive muscle weakness, multiple system involvement and premature mortality. Effective treatments for DMD through clinical trials and natural history studies are currently underway. Clinical trials in DMD typically include several outcome measures of motor function. Research sites and studies have been found to have slightly different operational definitions for a given functional outcome resulting in different procedures and protocols for these measurements. OBJECTIVE:The goal of this study is to establish agreement among experts in the field around best practices in collecting functional outcome data in DMD providing researchers and clinicians with guidance on best practices. METHODS:A group of 30 experts in Duchenne Muscular Dystrophy (DMD) with experience in the development and/ or execution of lower extremity outcome measures for this population met face to face to identify incongruences in the collection of this data. This effort was based in the United States (US) and sponsored by Parent Project Muscular Dystrophy. Several discrepancies were categorized for each outcome which included: 6-minute walk test, 10-meter walk/run, supine to stand, ascend 4 stairs, sit to stand, and the NorthStar Ambulatory Assessment. Following this meeting an additional 32 experts in DMD (28 from the United States and 11 international participants) consented to participate in a Delphi Survey to reach consensus on the protocols and execution of lower extremity outcomes. RESULTS:Round one: 70 operationally defined questions were surveyed with 45 (64%) reaching >70% consensus. Round two: 27 questions were operational, with 20 (74%) reaching >70% consensus. Those questions that did not reach consensus appear minor. CONCLUSION:With minor modifications in the collection of data across sites, outcomes could potentially be normalized across research studies. This would reduce excessive training for evaluators in trials and produce minimal differences between protocols. Consistency in protocols will promote more efficient study start up, less errors between administration of items across studies, and ultimately improve quality and reliability of the functional outcomes. The authors strongly advocate for the establishment of a "research network library" that could be utilized by all those performing clinical assessments and trials in DMD.
| S-EPMC6698889 | biostudies-literature
Project description:INTRODUCTION:Value-based contracts (VBCs) that link drug payments to disease-related performance metrics aim to increase the value and lower the cost of medications by aligning incentives and sharing risk between payers and pharmaceutical manufacturers. This study sought to identify outcome measures that are meaningful to key stakeholders to inform VBCs for coronary artery disease (CAD) medications. METHODS:We administered a modified Delphi survey to gather expert opinion from a diverse panel of patients (n = 9), cardiologists (n = 4), primary care physicians (n = 5), payers (n = 2), pharmacy benefits managers (n = 3), and pharmaceutical company representatives (n = 2). A list of 16 CAD-associated clinical indicators was generated from the literature and expert consultation. Delphi participants rated the importance of each outcome on a five-point Likert scale, and selected the three most meaningful outcomes. We defined consensus as ≥ 75% agreement on the importance of an outcome (Likert scores 4 or 5 or selection of an outcome as most meaningful). RESULTS:Eleven of 13 outcomes reached consensus for importance on the Likert scale. "Preventing heart attacks" was selected as the most meaningful outcome (80%) while "preventing death" ranked second (76%). CONCLUSIONS:Our study results verify the utility of a widely used clinical CAD outcome measure, myocardial infarction events, for the purpose of pharmaceutical value-based contracting.
| S-EPMC6525225 | biostudies-literature
Project description:IntroductionRetrospective trauma scores are often used to categorise trauma, however, they have little utility in the prehospital or hyper-acute setting and do not define major trauma to non-specialists. This study employed a Delphi process in order to gauge degrees of consensus/disagreement amongst expert panel members to define major trauma.MethodA two round modified Delphi technique was used to explore subject-expert consensus and identify variables to define major trauma through systematically collating questionnaire responses. After initial descriptive analysis of variables, Kruskal-Wallis tests were used to determine statistically significant differences (p < 0.05) in response to the Delphi statements between professional groups. A hierarchical cluster analysis was undertaken to identify patterns of similarity/difference of response. A grounded theory approach to qualitative analysis of data allowed for potentially multiple iterations of the Delphi process to be influenced by identified themes.ResultsOf 55 expert panel members invited to participate, round 1 had 43 participants (Doctor n = 20, Paramedic n = 20, Nurse n = 5, other n = 2). No consistent patterns of opinion emerged with regards to professional group. Cluster analysis identified three patterns of similar responses and coded as trauma minimisers, the middle ground and the risk averse. Round 2 had 35 respondents with minimum change in opinion between rounds. Consensus of > 70% was achieved on many variables which included the identification of life/limb threatening injuries, deranged physiology, need for intensive care interventions and that extremes of age need special consideration. It was also acknowledged that retrospective injury severity scoring has a role to play but is not the only method of defining major trauma. Various factors had a majority of agreement/disagreement but did not meet the pre-set criteria of 70% agreement. These included the topics of burns, spinal immobilisation and whether a major trauma centre is the only place where major trauma can be managed.ConclusionBased upon the output of this Delphi study, major trauma may be defined as: "Significant injury or injuries that have potential to be life-threatening or life-changing sustained from either high energy mechanisms or low energy mechanisms in those rendered vulnerable by extremes of age".
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Project description:BackgroundContent validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's content validity and grading the quality of the evidence in systematic reviews of PROMs.MethodsAn online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales ('strongly disagree' to 'strongly agree'), and provided arguments for their ratings.ResultsDiscussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM.DiscussionThe consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.
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Project description:Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist's perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change.All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (?'s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions.The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned.
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