Reliability of the NICMAN Scale: An Instrument to Assess the Quality of Acupuncture Administered in Clinical Trials.
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SUBMITTER: Smith CA
PROVIDER: S-EPMC5485295 | biostudies-other | 2017
REPOSITORIES: biostudies-other
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Project description:BackgroundRegistration can help with transparency of acupuncture clinical trials (ACTs) by making protocol information and results available to the public. Recently, the number of registered ACTs has increased greatly, but only a few researchers have focused on the quality of ACTs registration. This review provides the first assessment of the registration quality of ACTs and the baseline information for future development.MethodsAll records of ACTs registered in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) were collected. Data was extracted and input to Excel spreadsheets. The current 20 items of the WHO Trial Registration Data Set (TRDS) and the special prepared items for acupuncture intervention details were used to assess the registration quality of ACTs.ResultsA total of 740 records, found in 11 registries, were examined. The number of registered ACTs increased rapidly and involved a number of different diseases. The completeness of 20 items was not too poor due to 16 of them had a higher reported percentage (>85%). The completeness of the 20 items was different among registries. For example, the average registration percentage of 20 items in Clinicaltrials.gov, ChiCTR, ISRCTN and ANZCTR were 89.6%, 92.2%, 82.4% and 91.6% respectively. Detailed information regarding acupuncture intervention was seriously insufficient. Among the 740 registration records, 89.2% lacked information on the style of acupuncture, 80.8% did not contain details regarding the needles used, 53.5% lacked information on the treatment regimen and 76.2% did not give details of other interventions administered with acupuncture.ConclusionsThe overall registration quality of ACTs is not high enough due to the serious lack of information on the specifics of acupuncture intervention. It is vital that a number of special items be set regarding acupuncture in order to develop a suitable system for the registration of ACTs.
| S-EPMC3610907 | biostudies-literature
Project description:Background: Several instruments that measure spirituality present overlaps with positive emotions, impacting the interpretation of their findings. In order to minimize these problems, we aimed to develop, assess the reliability and validate a new scale to evaluate spirituality. Methods: The instrument was designed using a theoretical framework minimizing tautological issues (i.e., Koenig's framework), a qualitative study investigating the definitions of spirituality, the development of the first version of instrument by experts' meetings and a qualitative cognitive debriefing. Then, the instrument was examined for its content validity by a multidisciplinary group of judges and was pilot-tested in two different groups - less religious (medical students - n = 85) and more religious (practicing religious members - n = 85). Finally, psychometric properties and validity were assessed. Results: The developed Attitudes Related to Spirituality Scale (ARES) is a self-report 11-item instrument using five-level Likert items. ARES presented appropriate psychometric properties revealing excellent internal consistency (alpha = 0.98) and temporal stability (ICC = 0.98). Likewise, ARES was strongly correlated with other validated R/S instruments (i.e., Duke Religion Index and Brief Multidimensional Measure of Religiousness/Spirituality) and was able to discriminate higher and lower religious groups. In the exploratory factor analysis, a unidimensional structure of the scale was described. Fit indices for the scale demonstrated good fit in the unidimensional model. Conclusion: The ARES is a reliable, valid and stable one-dimension instrument that is appropriate for use in the Portuguese-speaking population. Descriptors: Spirituality; Scale; Factorial Analysis; Instrument; Measure; Psychometrics.
| S-EPMC8600364 | biostudies-literature
Project description:BackgroundIn 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs).MethodsA standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy.Results and discussionThe monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency.ConclusionsSupplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.
| S-EPMC2806366 | biostudies-literature
Project description:IntroductionAcupuncture has been accepted in many Western countries and clinical trials have been increasing recently. However, the problems of insufficient and low-quality evidence remain, and substantially hinder the development of acupuncture clinical trials. We therefore aim to develop a guideline to strengthen the quality of acupuncture clinical trials, in accordance with WHO handbook for guideline development and the Reporting Items for practice Guidelines in HealThcare. The guideline will help to improve the quality of acupuncture clinical trials.Methods and analysisWe will search for studies on the quality of acupuncture clinical trials using PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database, The Cochrane Library, the WHO and Health Technology Assessment websites, and other sources. We will also check reference lists and contact experts in the field. We will systematically evaluate the quality of acupuncture clinical trials, and extract and summarise the quality problems and countermeasures of such trials. We will also systematically review clinical trial quality control manuals and systems and formulate research questions on quality control in acupuncture clinical trials. Finally, we will develop the guideline and establish a comprehensive quality control system to ensure high quality acupuncture clinical trials. We will also evaluate the guideline and will update the guideline to reflect new scientific evidence.Ethics and disseminationEthics committee approval and informed consent are not required for developing guideline because only published data will be used, however, we will interview the patients, the ethics committee approval has been got from West China Hospital of Sichuan Unversity (Number: 2021-1188). We will publish all manuscripts arising from this research and present the findings at conferences.Guideline registration numberIPGRP-2021CN093.
| S-EPMC8756270 | biostudies-literature
Project description:BackgroundChatGPT-4 is the latest release of a novel artificial intelligence (AI) chatbot able to answer freely formulated and complex questions. In the near future, ChatGPT could become the new standard for health care professionals and patients to access medical information. However, little is known about the quality of medical information provided by the AI.ObjectiveWe aimed to assess the reliability of medical information provided by ChatGPT.MethodsMedical information provided by ChatGPT-4 on the 5 hepato-pancreatico-biliary (HPB) conditions with the highest global disease burden was measured with the Ensuring Quality Information for Patients (EQIP) tool. The EQIP tool is used to measure the quality of internet-available information and consists of 36 items that are divided into 3 subsections. In addition, 5 guideline recommendations per analyzed condition were rephrased as questions and input to ChatGPT, and agreement between the guidelines and the AI answer was measured by 2 authors independently. All queries were repeated 3 times to measure the internal consistency of ChatGPT.ResultsFive conditions were identified (gallstone disease, pancreatitis, liver cirrhosis, pancreatic cancer, and hepatocellular carcinoma). The median EQIP score across all conditions was 16 (IQR 14.5-18) for the total of 36 items. Divided by subsection, median scores for content, identification, and structure data were 10 (IQR 9.5-12.5), 1 (IQR 1-1), and 4 (IQR 4-5), respectively. Agreement between guideline recommendations and answers provided by ChatGPT was 60% (15/25). Interrater agreement as measured by the Fleiss κ was 0.78 (P<.001), indicating substantial agreement. Internal consistency of the answers provided by ChatGPT was 100%.ConclusionsChatGPT provides medical information of comparable quality to available static internet information. Although currently of limited quality, large language models could become the future standard for patients and health care professionals to gather medical information.
| S-EPMC10365578 | biostudies-literature
Project description:ObjectiveAcupuncture systematic reviewers have increasingly searched Chinese databases and journals to identify eligible randomised clinical trials (RCTs). However, reviewers have infrequently searched for eligible RCTs in Korean databases and journals. This study aimed to identify difficult to locate acupuncture RCTs in Korean databases and journals and to assess the characteristics and quality of the identified RCTs.MethodsEleven electronic databases and seven journals were searched up to December 2012. All RCTs using needle acupuncture were considered for inclusion. Key study characteristics were extracted and risk of bias was assessed using the Cochrane Collaboration tool.ResultsOne hundred and forty-three publications met our inclusion criteria. Acupuncture RCTs in the Korean literature emerged in the mid-1990s and increased in the mid-2000s. Diverse methods of acupuncture were used, including some methods unique to Korea (eg, Saam acupuncture). The largest proportion of trials evaluated acupuncture for musculoskeletal conditions (27.3%). The mean sample size was 44.3±25.3 per trial. Random sequence generation methods were reported in 44.8% of the RCTs, whereas only 11.9% reported methods of allocation concealment. A low proportion of trials reported participant blinding (32.9%) and outcome assessment blinding (18.9%).ConclusionsKorean acupuncture trials, many of which evaluate acupuncture styles unique to Korea, are typically omitted from systematic reviews of acupuncture, resulting in the potential for language bias. The development of this database of difficult to locate Korean trials, which includes English language translations of abstracts, will enable these trials of varying quality to be assessed for inclusion in future acupuncture systematic reviews.
| S-EPMC3995291 | biostudies-literature
Project description:OBJECTIVE:There is debate on how the methodological quality of clinical trials should be assessed. We compared trials of physical therapy (PT) judged to be of adequate quality based on summary scores from the Physiotherapy Evidence Database (PEDro) scale with trials judged to be of adequate quality by Cochrane Risk of Bias criteria. DESIGN:Meta-epidemiological study within Cochrane Database of Systematic Reviews. METHODS:Meta-analyses of PT trials were identified in the Cochrane Database of Systematic Reviews. For each trial PeDro and Cochrane assessments were extracted from the PeDro and Cochrane databases. Adequate quality was defined as adequate generation of random sequence, concealment of allocation, and blinding of outcome assessors (Cochrane criteria) or as trials with a PEDro summary score ?5 or ?6 points. We combined trials of adequate quality using random-effects meta-analysis. RESULTS:Forty-one Cochrane reviews and 353 PT trials were included. All meta-analyses included trials with PEDro scores ?5, 37 (90.2%) included trials with PEDro scores ?6 and only 22 (53.7%) meta-analyses included trials of adequate quality according to the Cochrane criteria. Agreement between PeDro and Cochrane was poor for PeDro scores of ?5 points (kappa = 0.12; 95% CI 0.07 to 0.16) and slight for ?6 points (kappa 0.24; 95% CI 0.16-0.32). When combining effect sizes of trials deemed to be of adequate quality according to PEDro or Cochrane criteria, we found that a substantial difference in the combined effect size (?0.15) was evident in 9 (22%) out of the 41 meta-analyses for PEDro cutoff ?5 and 10 (24%) for cutoff ?6. CONCLUSIONS:The PeDro and Cochrane approaches lead to different sets of trials of adequate quality, and different combined treatment estimates from meta-analyses of these trials. A consistent approach to assessing RoB in trials of physical therapy should be adopted.
| S-EPMC4498768 | biostudies-literature
Project description:BackgroundWithin the framework of a prospective cohort study of Swiss medical school graduates, a Career-Success Scale (CSS) was constructed in a sample of young physicians choosing different career paths in medicine. Furthermore the influence of personality factors, the participants' personal situation, and career related factors on their career success was investigated.Methods406 residents were assessed in terms of career aspired to, and their career progress. The Career-Success Scale, consisting of 7 items, was developed and validated, addressing objective criteria of academic career advancement. The influence of gender and career aspiration was investigated by a two-factorial analysis of variance, the relationships between personality factors, personal situation, career related factors and the Career-Success Scale by a multivariate linear regression analysis.ResultsThe unidimensional Career-Success Scale has an internal consistency of 0.76. It is significantly correlated at the bivariate level with gender, instrumentality, and all career related factors, particularly with academic career and received mentoring. In multiple regression, only gender, academic career, surgery as chosen specialty, and received mentoring are significant predictors. The highest values were observed in participants aspiring to an academic career, followed by those pursuing a hospital career and those wanting to run a private practice. Independent of the career aspired to, female residents have lower scores than their male colleagues.ConclusionThe Career-Success Scale proved to be a short, reliable and valid instrument to measure career achievements. As mentoring is an independent predictor of career success, mentoring programs could be an important instrument to specifically enhance careers of female physicians in academia.
| S-EPMC2442432 | biostudies-literature
Project description:BackgroundIn Mali and Senegal, over 1% of women die giving birth in hospital. At some hospitals, over a third of infants are stillborn. Many deaths are due to substandard medical practices. Criterion-based clinical audits (CBCA) are increasingly used to measure and improve obstetrical care in resource-limited settings, but their measurement properties have not been formally evaluated. In 2011, we published a systematic review of obstetrical CBCA highlighting insufficient considerations of validity and reliability. The objective of this study is to develop an obstetrical CBCA adapted to the West African context and assess its reliability and validity. This work was conducted as a sub-study within a cluster randomized trial known as QUARITE.MethodsCriteria were selected based on extensive literature review and expert opinion. Early 2010, two auditors applied the CBCA to identical samples at 8 sites in Mali and Senegal (n = 185) to evaluate inter-rater reliability. In 2010-11, we conducted CBCA at 32 hospitals to assess construct validity (n = 633 patients). We correlated hospital characteristics (resource availability, facility perinatal and maternal mortality) with mean hospital CBCA scores. We used generalized estimating equations to assess whether patient CBCA scores were associated with perinatal mortality.ResultsResults demonstrate substantial (ICC = 0.67, 95% CI 0.54; 0.76) to elevated inter-rater reliability (ICC = 0.84, 95% CI 0.77; 0.89) in Senegal and Mali, respectively. Resource availability positively correlated with mean hospital CBCA scores and maternal and perinatal mortality were inversely correlated with hospital CBCA scores. Poor CBCA scores, adjusted for hospital and patient characteristics, were significantly associated with perinatal mortality (OR 1.84, 95% CI 1.01-3.34).ConclusionOur CBCA has substantial inter-rater reliability and there is compelling evidence of its validity as the tool performs according to theory.Trial registrationCurrent Controlled Trials ISRCTN46950658.
| S-EPMC3514290 | biostudies-literature
Project description:Background and aim: 'Reasoning 4 Change' (R4C) is a newly developed instrument, including four domains (D1-D4), to assess clinical practitioners' and students' clinical reasoning with a focus on clients' behaviour change in a physiotherapy context. To establish its use in education and research, its psychometric properties needed to be evaluated. The aim of the study was to generate criterion scores and evaluate the reliability and construct validity of a web-based version of the R4C instrument. Methods: Fourteen physiotherapy experts and 39 final-year physiotherapy students completed the R4C instrument and the Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT). Twelve experts and 17 students completed the R4C instrument on a second occasion. The R4C instrument was evaluated with regard to: internal consistency (five subscales of D1); test-retest reliability (D1-D4); inter-rater reliability (D2-D4); and construct validity in terms of convergent validity (D1.4, D2, D4). Criterion scores were generated based on the experts' responses to identify the scores of qualified practitioners' clinical reasoning abilities. Results: For the expert and student samples, the analyses demonstrated satisfactory internal consistency (α range: 0.67-0.91), satisfactory test-retest reliability (ICC range: 0.46-0.94) except for D3 for the experts and D4 for the students. The inter-rater reliability demonstrated excellent agreement within the expert group (ICC range: 0.94-1.0). The correlations between the R4C instrument and PABS-PT (r range: 0.06-0.76) supported acceptable construct validity. Conclusions: The web-based R4C instrument shows satisfactory psychometric properties and could be useful in education and research. The use of the instrument may contribute to a deeper understanding of physiotherapists' and students' clinical reasoning, valuable for curriculum development and improvements of competencies in clinical reasoning related to clients' behavioural change.
| S-EPMC6141557 | biostudies-literature