Defining High-Quality Integrated Head and Neck Cancer Care Through a Composite Outcome Measure: Textbook Outcome.

OBJECTIVES/HYPOTHESIS: To further improve the quality of head and neck cancer (HNC) care, we developed a composite measure defined as "textbook outcome" (TO). METHODS: We analyzed a retrospective cohort of patients after curvative-intent primary surgery, radiotherapy (RT), or chemoradiation (CRT) for HNC between 2015 and 2018 at the Netherlands Cancer Institute. TO was defined as 1) the start of treatment within 30 days, 2a) satisfactory pathologic outcomes, without 30-day postoperative complications, for the surgically treated group, and 2b), for RT and CRT patients, no unexpected or prolonged hospitalization and toxicity after the completion of treatment as planned. RESULTS: In total, 392 patients with HNC were included. An overall TO was achieved in 9.6% of patients after surgery, 20.6% after RT, and 2.2% after CRT. Two indicators (margins >5 mm and start treatment <30 days) reduced TO radically for both groups. CONCLUSION: TO can aid the evaluation of the quality of care for HNC patients and guide improvement processes. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:78-87, 2022.

A Critical Review to Identify the Domains Used to Measure the Effect and Outcome of Adaptogenic Herbal Medicines.

Background: Phytoadaptogens are considered to be herbal medicines with a multi-target effect that strengthen organ systems compromised by stress. Although animal and laboratory studies have identified numerous molecular targets associated with adaptogenic activity, the non-specific characteristic of these herbal medicines has meant there is no known methods to accurately determine efficacy of adaptogens in humans. This critical review of the evidence aims to identify domains which have been used to measure the effect of adaptogens in humans, in order to create pathways for translating laboratory, animal, and clinical studies on adaptogens into practical applications in the future. Methods: EMBASE, AMED, PubMed, Cochrane Library, and WHO ICTRP databases were searched for randomized trials which examined known physiological actions of adaptogens. Results: Twenty-four studies were identified and critically appraised using the Jadad scale. The findings identified three broad categories of outcome measures, including cognitive, mood and biological measures. Conclusions: There was a great heterogeneity in data making it difficult to draw conclusions as to the most effective measurement tools to capture the holistic activity in humans. Cognitive measures hold promise as a reliable measurement tool when used in conjunction with other relevant tools. Further investigation is necessary to determine the most appropriate and diverse tools to measure the complex multi-target action of adaptogens.

Establishing a Foundation for Optimal Feeding Outcomes in the NICU.

Many infants in the NICU experience difficulties with oral feeding, which contribute to prolonged length of stay. Oral feeding is a complex task involving sensorimotor functioning of the face, mouth, and larynx, as well as coordination of sucking, swallowing, and breathing. The care provided in the NICU starting at birth sets the stage for future oral feeding. The purpose of this article is to describe strategies that will establish a positive foundation to support optimal oral feeding. Nurses can use these strategies to protect newborns from noxious stimuli and promote positive auditory, tactile, gustatory, and olfactory experiences to optimize neurodevelopment for the complex task of feeding.

The effects of hands on and hands off/poised techniques on maternal outcomes: A systematic review and meta-analysis.

BACKGROUND: Negative maternal outcomes such as perineal trauma and related perineal pain may cause both long-and short- term morbidities. Hands on and hands off/poised technique are two kinds of techniques to protect perineum during the second-stage of labor. Hands on technique has been the routine midwifery practice for a long time; nevertheless, the effects of hands on technique on protecting perineum has been doubted. Hands off/poised as a promising technique seems prevalent in clinical practice. However, there is no consensus on use of hands off/poised technique and hands on technique. The effects of these techniques on maternal outcomes have not been fully investigated. OBJECTIVE: To evaluate the effects of hands on hands off/poised technique on maternal outcomes during the second-stage of labor. DESIGN: Systematic review and meta-analysis of relevant quantitative studies. DATA SOURCES: Seven databases: PubMed, EMBASE, The Cochrane Library, CINAHL, WanFang Data, China National Knowledge Infrastructure (CKNI), SinoMed were systematically searched from inception to July 23,2018 for relevant quantitative studies comparing the effects of hands on and hands off/poised technique on maternal outcomes. REVIEW METHODS: Quantitative studies were retrieved for relevant studies. Two reviewers independently screened the studies, evaluated the methodological quality using JBI appraisal checklist tools and extracted the data. The included studies were divided into two groups for analysis according to study types. RESULTS: Nine RCTs with a total of 7112 participants and eight non-RCTs with 37,786 participants were included for meta-analysis. Based on the results from RCTs, this study did not find difference between hands on and hands off/poised technique regarding the risk of 2nd perineal tears, 3rd /4th degree perineal tears, duration of second-stage labor and incidence of postpartum hemorrhage (PPH>500 ml). The results from 9 non-RCTs were similar with that of RCTs, except for showing less 2nd degree perineal tears in hands off/poised technique than in hands on technique. CONCLUSION: Evidence in the present study indicated that hands off/poised technique may be a promising delivery technique to maintain intact perineum, and reduce perineal pain and episiotomy use among women with low-risk pregnancy undergoing vaginal delivery. In addition, hands off/poised technique might be safe to use as it did not increase the risk of severe perineal trauma, postpartum hemorrhage, and longer duration of second-stage labor when compared with hands on technique. More studies with stringent study design, especially large randomized controlled trial, should be conducted before strong recommendation of the hands off/poised technique.

SLEEP-GOAL: A multicenter success criteria outcome study on 302 obstructive sleep apnoea (OSA) patients.

OBJECTIVE: To demonstrate SLEEP-GOAL as a more holistic and comprehensive success criterion for Obstructive Sleep Apnoea (OSA) treatment. METHODS: A prospective 7-country clinical trial of 302 OSA patients, who met the selection criteria, and underwent nose, palate and/or tongue surgery. Pre- and post-operative data were recorded and analysed based on both the Sher criteria (apnoea hypopnea index, AHI reduction 50% and <20) and the SLEEP-GOAL. RESULTS: There were 229 males and 73 females, mean age of 42.4±17.3 years, mean BMI 27.9±4.2. The mean VAS score improved from 7.7±1.4 to 2.5±1.7 (p<0.05), mean Epworth score (ESS) improved from 12.2±4.6 to 4.9±2.8 (p<0.05), mean body mass index (BMI) decreased from 27.9±4.2 to 26.1±3.7 (p>0.05), gross weight decreased from 81.9±14.3kg to 76.6±13.3kg. The mean AHI decreased 33.4±18.9 to 14.6±11.0 (p<0.05), mean lowest oxygen saturation (LSAT) improved 79.4±9.2% to 86.9±5.9% (p<0.05), and mean duration of oxygen <90% decreased from 32.6±8.9 minutes to 7.3±2.1 minutes (p<0.05). The overall success rate (302 patients) based on the Sher criteria was 66.2%. Crosstabulation of respective major/minor criteria fulfilment, based on fulfilment of two major and two minor or better, the success rate (based on SLEEP-GOAL) was 69.8%. Based solely on the Sher criteria, 63 patients who had significant blood pressure reduction, 29 patients who had BMI reduction and 66 patients who had clinically significant decrease in duration of oxygen <90% would have been misclassified as "failures". CONCLUSION: AHI as a single parameter is unreliable. Assessing true success outcomes of OSA treatment, requires comprehensive and holistic parameters, reflecting true end-organ injury/function; the SLEEP-GOAL meets these requirements.

Validation of the Australian Treatment Outcomes Profile for use in clients with cannabis dependence.

INTRODUCTION AND AIMS: The Australian Treatment Outcomes Profile (ATOP) was developed as a clinical tool for monitoring the substance use, health and wellbeing of clients in alcohol and other drug treatment. This is the first psychometric validation of the ATOP in a cannabis-dependent treatment population. DESIGN AND METHODS: A total of 128 individuals with cannabis dependence enrolled in an outpatient randomised controlled trial were administered the ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline. Concurrent validity was assessed by testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS). Interrater reliability was tested by comparing clinician-administered ATOP items at the medical screening interview to the same ATOP items administered by researchers at baseline. RESULTS: ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67). The ATOP Quality of Life scale showed moderate agreement with the SDS and six-dimensional health state short form scales (r = 0.38-0.40). ATOP substance use, employment, education and child care items showed good to excellent interrater reliability (Krippendorff's α = 0.62-0.81), and tobacco use, Psychological Health, Physical Health and Quality of Life showed fair to moderate interrater reliability (Krippendorff's α = 0.42-0.53). DISCUSSION AND CONCLUSIONS: The ATOP appears to be valid and reliable when tested in a population with cannabis-dependence, justifying its widespread use in clinical settings.

Quality of Care Standards in Inflammatory Bowel Diseases: a European Crohn's and Colitis Organisation [ECCO] Position Paper.

The management of inflammatory bowel disease [IBD] is complex, and requires tight control of disease activity, close monitoring to avoid treatment side effects, health care professionals with expertise in IBD, and an interdisciplinary, holistic approach. Despite various efforts to standardise structures, processes, and outcomes,1-8 and due to the high variability at the local, national, and international levels, there are still no clear definitions or outcome measures available to establish quality of care standards for IBD patients which are applicable in all contexts and all countries. For this reason, the European Crohn's and Colitis Organisation [ECCO] supported the construction of a list of criteria summarising current standards of care in IBD. The list comprises 111 quality standard points grouped into three main domains [structure n = 31, process n = 42, outcomes n = 38] and is based on scientific evidence, interdisciplinary expert consensus, and patient-oriented perspectives. The list of proposed criteria is intended to represent the position of ECCO regarding the optimum quality of care that should be available to patients. Since health care systems and regulations vary considerably between countries, this list may require adaptation at local and national levels. It is recognised that not all these criteria that have been identified as optimal will be available in every unit. However, ECCO will continue its efforts to develop and coordinate projects and initiatives that will help to guarantee optimal quality of care for all IBD patients.

Defining Success in Measurement-Based Care for Depression: A Comparison of Common Metrics.

OBJECTIVE: The National Committee for Quality Assurance recommends response and remission as indicators of successful depression treatment for the Healthcare Effectiveness and Data Information Set. Effect size and severity-adjusted effect size (SAES) offer alternative metrics. This study compared measures and examined the relationship between baseline symptom severity and treatment success. METHODS: Electronic records from two large integrated health systems (Kaiser Permanente Colorado and Washington) were used to identify 5,554 new psychotherapy episodes with a baseline Patient Health Questionnaire (PHQ-9) score of ≥10 and a PHQ-9 follow-up score from 14-180 days after treatment initiation. Treatment success was defined for four measures: response (≥50% reduction in PHQ-9 score), remission (PHQ-9 score <5), effect size ≥0.8, and SAES ≥0.8. Descriptive analyses examined agreement of measures. Logistic regression estimated the association between baseline severity and success on each measure. Sensitivity analyses evaluated the impact of various outcome definitions and loss to follow-up. RESULTS: Effect size ≥0.8 was most frequently attained (72% across sites), followed by SAES ≥0.8 (66%), response (46%), and remission (22%). Response was the only measure not associated with baseline PHQ-9 score. Effect size ≥0.8 favored episodes with a higher baseline PHQ-9 score (odds ratio [OR]=2.3, p<0.001, for 10-point difference in baseline PHQ-9 score), whereas SAES ≥0.8 (OR=0.61, p<0.001) and remission (OR=0.43, p<0.001) favored episodes with lower baseline scores. CONCLUSIONS: Response is preferable for comparing treatment outcomes, because it does not favor more or less baseline symptom severity, indicates clinically meaningful improvement, and is transparent and easy to calculate.

A Pilot Study of the Effects of Chair Yoga and Chair-Based Exercise on Biopsychosocial Outcomes in Older Adults With Lower Extremity Osteoarthritis.

This pilot study examined whether chair yoga and chair-based exercise are effective in managing biopsychosocial outcomes for older adults with lower extremity osteoarthritis. Both interventions improved physical function and mobility over time, although no significant differences between the 2 interventions were identified.

Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 1 Self-Reported Outcomes.

PURPOSE: To reduce chemotherapy-induced neuropathy (CIN)-a significant challenge among cancer patients following chemotherapy-we explored the effects of auricular point acupressure (APA), which involves needleless, acupuncture-like stimulation on specific ear points. DESIGN/METHOD: This pilot study examined the effects of a 4-week APA intervention in the management of CIN. Descriptive analysis was used to examine the changes in study outcomes. RESULTS: Fifteen participants were enrolled. Two participants dropped out because they developed new medical conditions. Thirteen participants completed the study (87% retention rate). Study participants had more severe symptoms in their lower extremities (i.e., toes, feet, soles) than in their upper extremities (i.e., fingers, wrists, elbows). After the 4-week APA intervention, the mean percentage change scores ranged from 38% (tingling) to 49% (numbness); compared to pre-intervention, the therapeutic effects of APA were sustained at the 1-month follow-up. Function in both upper and lower extremities improved after the APA intervention (≥28%) and continued to improve at the 1-month follow-up (≥36%). CONCLUSIONS: Preliminary results from this small sample provide initial evidence of the effectiveness of APA on CIN. Future studies should confirm these results using a larger sample, a comparative sham control, and an examination of the underlying physiological mechanisms of the anti-CIN effects of APA. CLINICAL IMPLICATIONS: APA may provide an inexpensive and effective complementary approach for the self-management of CIN. Once the seeds have been taped to the patient's ear by the provider, patients are empowered to self-manage their CIN in their own environment.

Nutritional supplementation of vitamin A and health-related outcomes in patients with multiple sclerosis: A protocol for a systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Multiple sclerosis (MS) is a chronic immune mediated disease which affects the central nervous system (CNS), having a substantial financial, functional, and quality of life (QOL) impact on these people. The vitamin A supplementation has been studied as a therapeutic possibility for in MS. Therefore, the objective of this protocol is to build an outline for a future systematic review, which will provide up-to-date available evidence about the clinical impact of nutritional supplementation of vitamin A in the outcomes related to the symptoms in patients with this pathology. METHODS: The search will be performed in the following databases: PubMed, Embase, Scopus, cinahl, Scielo, Web of Science, the Cochrane Library and Science Direct, randomized clinical trials published until May 2019 that evaluate the relationship of the supplementation of vitamin A and health-related outcomes in patients with MS will be included. Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) will be used to outline the protocol, and PRISMA to the systematic review. Undergraduate handbook of quality of evidence and strength of recommendations for decision making in health (GRADE) will be used to assess the quality of evidence and the strength of the recommendation, and the JADAD scale to assess the internal validity of selected studies. For the extraction of all the data found a database in Microsoft Excel will be created. For the summary of the findings the Cochrane Collaboration Handbook recommendations will be used, and for the meta-analysis standard statistical techniques the RevMan software will be used. RESULTS: In this study, we hope to find a considerable number of articles presenting evidence about the effectiveness of vitamin A supplementation in patients with MS. CONCLUSION: Currently, many lines of evidence have been produced when it comes to the use of food supplements. This systematic review proposal might provide recent, important, and trusted information for better treatment of patients. RECORD OF SYSTEMATIC REVIEW: This review was recorded in the International Register of Prospective Systematic Reviews (PROSPERO) on the January 30, 2019 (registration: CRD42019121757). Available at: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42019121757.

Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS & METHODS: The primary source of evidence for the original version of this guideline was the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report was supplemented with additional searches capturing literature published through December 2011. Following initial publication, this guideline underwent amendment in 2014 and 2018. The current document reflects relevant literature published through October 2018. RESULTS: When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low). Such statements are provided as Standards, Recommendations, or Options. In instances of insufficient evidence, additional guidance information is provided as Clinical Principles and Expert Opinions. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.

The next generation of mindfulness-based intervention research: what have we learned and where are we headed?

The previous two decades have seen an exponential increase in the number of published scientific investigations on the efficacy of mindfulness-based stress reduction (MBSR) training to improve function in a wide range of physical and psychological processes. The resulting body of work provides strong evidence that MBSR has salubrious effects. Yet, when compared directly to groups with training that matches MBSR in factors common to most legitimate interventions, such as learning new skills, expectation of benefit, social engagement and support, and attention from expert instructors, both groups tend to improve to a similar extent. This raises the question of whether there are benefits that are specific to training in mindfulness and if so, why are we not detecting them? Here, we discuss the factors that contribute to the general lack of differentiation between MBSR and active control groups, including the specificity of outcome measures and experimental design, random assignment, inclusion/exclusion criteria, and the time course and trajectory of change. In addition, we offer recommendations to address these factors in future research.

Evaluation frameworks in health services: An integrative review of use, attributes and elements.

AIMS AND OBJECTIVE: To synthesise the evidence on the use of evaluation frameworks by nurses and midwives in research designed to improve healthcare services and practice. A secondary aim was to identify the attributes and elements of evaluation frameworks. BACKGROUND: Evaluation is an integral component of any initiative to improve outcomes or change clinical practice. Yet often an evaluation may not yield the information required to sustain or integrate an initiative into practice. Evaluation frameworks can support effective evaluations, but there is a lack of consensus regarding elements and attributes of frameworks that support use. METHODS: We undertook an integrative review to synthesise the use of evaluation frameworks in practice guided by the Preferred Reporting Items for Systematic review and Meta-Analysis flow diagram and checklist 2009 (Supporting Information File 4). The protocol was registered with PROSPERO (CRD42018087033). A broad range of electronic databases were systematically searched using keywords. FINDINGS: Twenty-five papers were included from a diverse range of clinical areas and across high-, middle- and low-income nations. Twenty of the research projects had used nine existing frameworks, and five had developed an evaluation specific to an initiative. Frameworks supported the processes of evaluation and made them more meaningful by simplifying a complex process (providing structure and guidance for the evaluation processes); identifying and including stakeholders; explaining reasons for outcomes; generating transferable lessons; and identifying the mechanisms driving or inhibiting change. CONCLUSION: Nurses and midwives reported that frameworks were useful in undertaking evaluations. Each framework had positive attributes and missing or confusing elements. When undertaking an evaluation, it is pertinent to review the elements and attributes of a framework to ensure it includes evaluation measures that are relevant to specific projects. RELEVANCE TO CLINICAL PRACTICE: Nurses are actively involved in evaluation of clinical practice. This review identifies important elements to consider when choosing a framework for evaluation.

Evaluating the quality of outcomes defined for children with Education Health and Care plans in England: A local picture with global implications.

Recently, the Children and Families Act 2014 was introduced in England to regulate provision for children with disabilities. According to this policy, statements of special educational needs were replaced with education, health and care plans, which should include high-quality, holistic and participation-focused outcomes to regulate provision; this change aligns with international recommendations regarding provision for children with disabilities. This study aimed to evaluate the outcomes defined for children with education, health and care plans in England. 236 Education Health and Care plans were included in the analysis, providing 2813 outcomes to be examined, which came from 11 local authorities and 42 schools and belong to 69 girls and 167 boys from 4 to 21 years of age. The outcomes were independently rated by two experienced researchers using a Goal Functionality Scale. Inter-rater agreement was calculated for 10% of the outcomes. Most outcomes were considered not to be functional or high-quality; differences in quality were found between local authorities, types of school, type of outcome, and the children's main need. There are important quality concerns regarding the outcomes that have been designed for children with disabilities in England, which should be addressed through standardised training and guidelines on procedures.

Toxicity-induced modification of treatment: what is in a name?

Severe treatment-induced toxicities can have clinical consequences such as hospitalisation or treatment modifications, which in turn may deteriorate the prognosis of patients with cancer. Identification of determinants of treatment-induced toxicities is essential to develop strategies that promote therapy compliance and enhance the quality of life. Whereas toxicities are systematically recorded and graded per protocol in most clinical trials, observational studies often depend on retrospective data collection from medical records collected as standard care. Existing population-based or patient cohorts are a valuable source of information, even when relying on retrospective data collection, but comparisons across studies are hampered by a lack of a uniform definition for toxicity outcomes. We propose a new standardised approach to summarise toxicities in observational studies that rely on medical records for outcome assessment. We recommend the term 'toxicity-induced modification of treatment' (TIMT) to cover all toxicities that are responsible for changes in a planned treatment schedule. We define a TIMT as (i) a dose reduction, (ii) temporary interruption, (iii) discontinuation of therapy or (iv) an unanticipated switch to another regimen, as a result of treatment-induced toxicities and not because of progressive disease. This definition will provide clinically relevant information, especially when data on specific adverse events and Common Terminology Criteria for Adverse Events (CTCAE) grades are not uniformly available. Implementation of this definition empowers comparisons across studies, facilitates communication between clinicians and researchers and will allow new research questions in this active field of research.

Workforce planning: How we think about the impact of organisations on outcomes.

BACKGROUND: Healthcare workforce availability and planning is of fundamental importance to patients, clinicians, operational managers and strategic leaders alike. Despite much attention and development of plans and policy, a definitive answer remains elusive. OBJECTIVE: The aim of this article is to encourage colleagues to make explicit their underlying assumed models when undertaking workforce planning. DISCUSSION: It is posited that, akin to making a holistic diagnosis in medicine, understanding workforce issues by uncovering the prisms of presupposition and assumption that we hold about organisations is critical to generating fruitful new insights. Morgan's organisational metaphors are described as one example of a management conceptual model that might help us to illuminate these prisms. Examples are given of how each metaphor alters the way in which we might address our workforce needs and priorities.

Do Hospitals Performing Frequent Neuraxial Anesthesia for Hip and Knee Replacements Have Better Outcomes?

BACKGROUND: Neuraxial anesthesia is increasingly recommended for hip/knee replacements as some studies show improved outcomes on the individual level. With hospital-level studies lacking, we assessed the relationship between hospital-level neuraxial anesthesia utilization and outcomes. METHODS: National data on 808,237 total knee and 371,607 hip replacements were included (Premier Healthcare 2006 to 2014; 550 hospitals). Multivariable associations were measured between hospital-level neuraxial anesthesia volume (subgrouped into quartiles) and outcomes (respiratory/cardiac complications, blood transfusion/intensive care unit need, opioid utilization, and length/cost of hospitalization). Odds ratios (or percent change) and 95% CI are reported. Volume-outcome relationships were additionally assessed by plotting hospital-level neuraxial anesthesia volume against predicted hospital-specific outcomes; trend tests were applied with trendlines' R statistics reported. RESULTS: Annual hospital-specific neuraxial anesthesia volume varied greatly: interquartile range, 3 to 78 for hips and 6 to 163 for knees. Increasing frequency of neuraxial anesthesia was not associated with reliable improvements in any of the study's clinical outcomes. However, significant reductions of up to -14.1% (95% CI, -20.9% to -6.6%) and -15.6% (95% CI, -22.8% to -7.7%) were seen for hospitalization cost in knee and hip replacements, respectively, both in the third quartile of neuraxial volume. This coincided with significant volume effects for hospitalization cost; test for trend P < 0.001 for both procedures, R 0.13 and 0.41 for hip and knee replacements, respectively. CONCLUSIONS: Increased hospital-level use of neuraxial anesthesia is associated with lower hospitalization cost for lower joint replacements. However, additional studies are needed to elucidate all drivers of differences found before considering hospital-level neuraxial anesthesia use as a potential marker of quality.

Establishment of Comprehensive Indicators in TCM Pectoral-qi Case Report Based on Experts Diagnosis and Self-test Technology.

RATIONALE: To establish TCM Pectoral-qi comprehensive indicators and highlight the inner structure among different variables in an objective way, the article uses Partial Least Square Second-order Latent Variable Model (PLS-SLVM) and accomplishes 3 different comprehensive indicators based on both experts diagnosis and self-test data. SLVM includes a measurement model that defines the relationship between observed variables and latent variables and a structure model that imputes relationships between latent variables. The article focuses on PLS as the estimation method. Without normal distribution and independence assumptions, PLS uses objective weighting methods based on the data. Bootstrap method (B = 200) is used to calculate the mean value and standard errors of the PLS estimates. The article chooses the percentile interval to obtain the confidence interval of PLS parameters. PATIENT CONCERNS: The patients were diagnosed by the means of experts diagnosis and self-test technology. On the one hand, the patients want to know the effect of self-test by wearing a kind of instrument. On the other hand, we want to establish TCM Pectoral-qi comprehensive indicators and highlight the inner structure among different variables in an objective way. DIAGNOSES: The group of 59 subjects are the same no matter whether they were diagnosed through TCM Pectoral-qi Assessment Questionnaire of self-test technology. INTERVENTIONS: The same group of 59 subjects keep wearing the instrument for hours and get the self-test data consequently. OUTCOMES: As one of comprehensive indicator establishing methods, PLS-SLVM highlights the structure state among variables and improves the evaluation efficiency. Furthermore, it provides a new tool and method in TCM diseases prevention and health security. LESSONS: As expected, PLS-SLVM is a useful tool due to its nonassumption of normal distribution and independence with consideration of correlation among different variables. Thus PLS-SLVM can be applied in ordinal data from assessment questionnaire and continuous data about physicochemical indexes for the same group of people. It displays that PLS-SLVM builds a connection between TCM experts diagnosis and the self-testing technology.