加载中

    Reliability and validity of a cold-heat pattern questionnaire for traditional Chinese medicine. Ryu Hyunhee,Lee Haejung,Kim Honggie,Kim Jongyeol Journal of alternative and complementary medicine (New York, N.Y.) OBJECTIVE:The aim of this study was to develop and evaluate a questionnaire for Cold and Heat pathologic pattern identification in the context of Traditional Chinese Medicine (TCM). This questionnaire was intended to classify subjects into Cold or Heat pattern groups, a distinction that is useful in clinical trials of both herbal and acupuncture treatments. METHODS:A questionnaire that had been developed in a previous study was completed by 63 patients (Group A) and 64 patients (Group B) from TCM hospitals. Each patient was diagnosed by a TCM doctor as one of three patterns: Cold, Heat, and Complex. The questionnaire results were analyzed for internal reliability and validity based on the doctor's diagnosis. RESULTS:Cronbach's alpha coefficients were 0.579 for the 10 Cold items and 0.718 for the 10 Heat items. There were significant differences in the mean questionnaire scores between the Cold and Heat groups. The classification accuracy of this questionnaire for Group A was 94.9%, and for Group B it was 92.3%. CONCLUSIONS:Our results suggest that the questionnaire meets certain basic and fundamental requirements and that it may be useful as an adjunct diagnostic tool. Further studies using a greater number and variety of patients will be needed to evaluate its usefulness in clinical trials and in basic physiologic research. 10.1089/acm.2009.0331
    Construction of a traditional Chinese medicine syndrome-specific outcome measure: the Kidney Deficiency Syndrome Questionnaire (KDSQ). Chen Run Qiu,Wong Chit Ming,Lam Tai Hing BMC complementary and alternative medicine BACKGROUND:Development of Traditional Chinese Medicine (TCM) syndrome-specific outcome measures is needed for the evaluation of TCM syndrome-specific therapies. We constructed a Kidney Deficiency Syndrome Questionnaire (KDSQ) for the evaluation of the common TCM syndromes Kidney-Yin Deficiency Syndrome (KDS-Yin) and Kidney-Yang Deficiency Syndrome (KDS-Yang) in middle-aged women with menopausal symptoms. METHODS:KDS-Yin and KDS-Yang were traditionally defined by expert opinion were validated by exploratory factor analysis (EFA) and structural equation modeling (SEM). Content validity was tested by EFA on a sample of 236 women from a seminar and SEM on another sample of 321 women from a postal survey. Other psychometric properties were tested on 292 women from the seminar at baseline and two systematically selected sub-samples: 54 who reported no changes in discomforts 11-12 days after the baseline and 31 who reported changes in discomforts 67-74 days after the baseline. All participants completed the KDSQ, the Greene Climacteric Scale and the standard 12-item Short Form Health Survey. RESULTS:The EFA and SEM established the measurement models of KDS-Yin and KDS-Yang supporting content validity of the KDSQ. Internal consistency was good (Cronbach's Alpha >0.70). Construct validity was supported by theoretically-derived levels of correlation with the established external measures. Test-retest reliability was strong (ICC(agreement): KDS-Yin, 0.94; KDS-Yang, 0.93). The KDSQ was responsive to changes over time as tested by effect size and longitudinal validity. CONCLUSIONS:The KDSQ was a valid and reliable measure for KDS-Yin and KDS-Yang in Hong Kong Chinese middle-aged women with menopausal symptoms. 10.1186/1472-6882-12-73
    Development and evaluation of a traditional Chinese medicine syndrome questionnaire for measuring sub-optimal health status in China. Zhao Hui,Xiong Wei-hong,Zhao Xin,Wang Li-min,Chen Jia-xu Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan OBJECTIVE:Sub-optimal health status (SHS), in which a person's mind and body exists in a low-quality state of being between disease and health, has become a public health problem that cannot be ignored in China. SHS measurement presents a challenge to the academic fields. We developed and evaluated a questionnaire from the perspective of traditional Chinese medicine (TCM) that embodies the features of TCM syndrome diagnosis for measuring SHS in China. METHODS:The construction of the theoretical framework of the questionnaire was based on a literature review, an expert questionnaire survey and group interviews. The subscales and questionnaire items were screened through a pilot study using statistical means and qualitative analysis. Reliability tests that were used included test-retest reliability, Cronbach's a coefficient, split-half reliability; validity tests included content validity, criterion validity, discrimination validity and construct validity. RESULTS:The final questionnaire, the SHSQ-50, included 50 five-class quantifiable items that encompassed nine subscales: liver stagnation syndrome, liver-Qi deficiency syndrome, spleen-Qi deficiency syndrome, liver-fire syndrome, heart-fire syndrome, stomach-fire syndrome, heart-Qi deficiency syndrome, lung-Qi deficiency syndrome and dampness syndrome. Questionnaires were completed by 268 of the 288 SHS subjects (93.0%) and by 86 of the 94 healthy subjects (91.5%). The Cronbach a coefficients, split-half coefficients and stability coefficients ranged from 0.70 to 0.95, 0.67 to 0.87 and 0.88 to 0.98, respectively, for the overall scores and subscales. The Wilcoxon rank test showed statistically significant differences in the subscales and overall scores between the SHS group and the healthy group (P < 0.01). Twelve factors with an eigenvalue greater than one were extracted by factor analysis and merged into nine factors, for which the cumulative contribution rate was 63.63%. The nine factors were corresponded to the overall structure of the questionnaire. CONCLUSION:The SHSQ-50 is a reliable and valid instrument for measuring TCM syndrome diagnosis of SHS in China. 10.1016/s0254-6272(13)60001-1
    Validation of the constitution in chinese medicine questionnaire: does the traditional chinese medicine concept of body constitution exist? Wong Wendy,Lam Cindy Lo Kuen,Wong Vivian Taam,Yang Zhi Min,Ziea Eric T C,Kwan Andrew Ka Lun Evidence-based complementary and alternative medicine : eCAM The study aims to adapt and validate the Constitution in Chinese Medicine Questionnaire (CCMQ) in Hong Kong Chinese people. 10 patients and 10 Chinese medicine practitioners (CMP) confirmed the content validity (CVI: 50%-100%) of CCMQ. 1084 HK subjects completed a cross-sectional study with 98.6% who could be classified into one or more BC types. Scaling success rates were 85.7%-100% for the 9 BC scales. Construct validity was supported by moderate correlations between CCMQ and SF-12v2 scores. The confirmatory factor analysis showed a reproducible structure as hypothesized. People with gentleness BC type had better health-related quality of life, HRQOL, than those with other (imbalanced) BC types. Internal consistency (reliability) (Cronbach's alpha  >  0.6) and test-retest reliability were also satisfactory (ICC > 0.6) for all scales. However, the sensitivity and specificity in predicting the BC types diagnosed by CMP were only fair, ranging from 42.7% to 82.7%. 27.6% of subjects had a change from the imbalanced BC types to gentleness BC type after 6 months. The CCMQ was adapted for HK Chinese people and proved to be valid, reliable, and responsive. People classified to have imbalanced BC types had significantly lower HRQOL than gentleness BC type, which supported the validity and importance of the TCM concept of the physiological BC type. 10.1155/2013/481491
    Development and initial validation of a Traditional Chinese Medicine symptom-specific outcome measure: a Zheng-related atopic dermatitis symptom questionnaire (ZRADSQ). Wu Darong,Huang Chujun,Mo Xiumei,Liu Junfeng,Cai Jianxiong,Liu Chi,Zhu Haili,Li Hongyi,Chen Dacan Health and quality of life outcomes BACKGROUND:Zheng represents pattern differentiation in Traditional Chinese Medicine (TCM), as the basic unit and a key concept in TCM therapeutic theory, is based on the physiology and pathology of TCM. None of the outcome measurements of atopic dermatitis (AD) are Zheng-specific. The effectiveness of TCM is likely to be underestimated without a Zheng-related symptom-specific instrument. The aim of this study was to develop an instrument for measuring the Zheng-related symptom-specific status of patients with AD. METHODS:We followed standard methodology to develop the instrument, including item generation and selection, item reduction and presentation, and pretesting, and recruited 188 patients with AD involved in a six-center randomized-controlled trial (ChiCTR-TRC-08000156) to validate the questionnaire. We conducted construct validity, reliability, and responsiveness analysis. The standardized effect size (SES) and standardized response mean (SRM) were used to calculate the responsiveness of additional items and the total score for the rating items. RESULTS:ZRADSQ has 15 items, with 12 rating items and 3 additional items. The 12 rating items fall within three domains: AD symptoms (n = 6 items); Heat (n = 4 items) and Mood (n = 2 items). Confirmatory factor analysis provided good support for a three-factor model (d.f. = 51, x2=97.11, RMSEA = 0.07, CFI = 0.96), and the Pearson's correlation coefficient between ZRADSQ and Severity Scoring of Atopic Dermatitis (SCORAD) was 0.40 (P < 0.001). The reliability was also good, with a Cronbach's alpha value for ZRADSQ of 0.84, a split-half coefficient of 0.75, and a test-retest reliability coefficient of 0.98. The standardized effect size and standardized response mean were close to or larger than 1, which indicated moderate to good responsiveness. CONCLUSIONS:The ZRADSQ demonstrates promising reliability, validity, and responsiveness. It can be used to determine whether Zheng-specific or symptom-specific treatments relieve the symptom that is most bothersome the patient. 10.1186/1477-7525-11-212
    Validation of a new simple scale to measure symptoms in heart failure from traditional Chinese medicine view: a cross-sectional questionnaire study. Fu Tieh-Cheng,Lin Yi-Chung,Chang Ching-Mao,Chou Wei-Ling,Yuan Pei-Hsun,Liu Min-Hui,Wang Chao-Hung,Chen Juei-Chao,Chang Hen-Hong,Pan Tai-Long BMC complementary and alternative medicine BACKGROUND:Current clinical practices used to functionally classify heart failure (HF) are time-consuming, expensive, or require complex calculations. This study aimed to design an inquiry list from the perspective of traditional Chinese medicine (TCM) that could be used in routine clinical practice to resolve these problems. METHODS:The severity of documented HF in 115 patients was classified according to their performance in maximal exercise tests into New York Heart Association (NYHA) functional classification (FC) II or NYHA FC III. Concomitantly, the patients were assessed using the new TCM inquiry list and two validated quality of life questionnaires, namely, the Short Form 36 (SF-36) generic scale and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Factor analysis was applied to extract the core factors from the responses to the items in TCM inquiry list; logistic regression analysis was then used to predict the severity of HF according to the extracted factors. RESULTS:The TCM inquiry list showed moderate levels of correlation with the physical and emotional components of the SF-36 and the MLHFQ, and predicted the functional class of HF patients reliably using logistic regression analysis, with a correct prediction rate with 64.3 %. Factor analysis of the TCM inquiry list extracted five core factors, namely, Qi Depression, Heart Qi Vacuity and Blood Stasis, Heart Blood Vacuity, Dual Qi-Blood Vacuity, and Yang Vacuity, from the list, which aligned with the perspective of TCM as it relates to the pattern of HF. The correct prediction rate rose to 70.4 % when Dual Qi-Blood Vacuity was combined with the MLHFQ. The excessive false-negative rate is a problem associated with the TCM inquiry list. CONCLUSIONS:The TCM inquiry list is a simple scale and similar to patient-reported subjective measures of quality of life in HF, and may help to classify patients into NYHA FC II or NYHA FC III. Factor 4 addresses dizziness, dizzy vision and general weakness, which are critical parameters that distinguish between NYHA FC II and NYHA FC III. Incorporating these three items into the management of HF may help to classify patients from a functional perspective. 10.1186/s12906-016-1306-7
    Exploring potential biomarkers associated with health-related quality of life in patients with coronary artery disease and heart failure. Kazukauskiene Nijole,Burkauskas Julius,Macijauskiene Jurate,Mickuviene Narseta,Brozaitiene Julija European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology OBJECTIVE:There has been a lack of research examining associations between biomarkers and health-related quality of life (HRQoL) in patients with coronary artery disease and heart failure. In patients with coronary artery disease and heart failure, we aimed to explore potential associations between biomarkers of health such as serum levels of thyroid hormones, N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), inflammatory biomarkers and HRQoL. METHODS:In sum, 482 patients (75% male; mean age 58±10 years) with coronary artery disease and heart failure were evaluated for socio-demographic and clinical coronary artery disease risk factors. Blood samples were drawn to evaluate thyroid hormones, NT-pro-BNP, high-sensitivity C-reactive protein and interleukin-6 (IL-6). Additional data was collected on HRQoL (the Minnesota Living with Heart Failure Questionnaire), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), Type D personality (DS14 scale). RESULTS:In multivariable models, lower levels of high-sensitivity C-reactive protein and interleukin-6 were associated with worse results on the Minnesota Living with Heart Failure Questionnaire emotional subscale (β = -0.107, p = 0.003; β = -0.106, p = 0.004). Lower levels of interleukin-6 were associated with worse perceived global health (β = -0.101, p = 0.011). CONCLUSION:Even after controlling for socio-demographic and clinical risk factors including mental distress symptoms, lower levels of inflammatory biomarkers were associated with worse HRQoL. 10.1177/1474515118772828
    Adults with an epilepsy history fare significantly worse on positive mental and physical health than adults with other common chronic conditions-Estimates from the 2010 National Health Interview Survey and Patient Reported Outcome Measurement System (PROMIS) Global Health Scale. Kobau Rosemarie,Cui Wanjun,Zack Matthew M Epilepsy & behavior : E&B Healthy People 2020, a national health promotion initiative, calls for increasing the proportion of U.S. adults who self-report good or better health. The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale (GHS) was identified as a reliable and valid set of items of self-reported physical and mental health to monitor these two domains across the decade. The purpose of this study was to examine the percentage of adults with an epilepsy history who met the Healthy People 2020 target for self-reported good or better health and to compare these percentages to adults with history of other common chronic conditions. Using the 2010 National Health Interview Survey, we compared and estimated the age-standardized prevalence of reporting good or better physical and mental health among adults with five selected chronic conditions including epilepsy, diabetes, heart disease, cancer, and hypertension. We examined response patterns for physical and mental health scale among adults with these five conditions. The percentages of adults with epilepsy who reported good or better physical health (52%) or mental health (54%) were significantly below the Healthy People 2020 target estimate of 80% for both outcomes. Significantly smaller percentages of adults with an epilepsy history reported good or better physical health than adults with heart disease, cancer, or hypertension. Significantly smaller percentages of adults with an epilepsy history reported good or better mental health than adults with all other four conditions. Health and social service providers can implement and enhance existing evidence-based clinical interventions and public health programs and strategies shown to improve outcomes in epilepsy. These estimates can be used to assess improvements in the Healthy People 2020 Health-Related Quality of Life and Well-Being Objective throughout the decade. 10.1016/j.yebeh.2017.04.047
    The internal logic of the Canadian Cardiovascular Society scale for grading angina pectoris: a first appraisal. Kong W H,Llewellyn-Thomas H,Naylor C D The Canadian journal of cardiology OBJECTIVE:To assess the internal logic (content validity) of the Canadian Cardiovascular Society (CCS) scale for grading angina pectoris. PATIENTS:Forty-one consenting patients with stable angina of at least two months duration, admitted to a tertiary centre for coronary angiography. METHODS:Patients completed a supervised questionnaire with closed-ended questions. Key questions included: usual numbers of blocks walked on the level or flights of stairs climbed before onset of chest pain; frequency with which chest pain occurred at the usual threshold distance; presence of rest pain; and influence of modifiers suggested for class II of the scale such as walking uphill and into the wind. RESULTS:Agreement of four questionnaire-defined 'stair-climbing grades' and 'walking grades' was statistically significant (P < 0.001) but only 37% better than expected by chance alone (weighted kappa). Frequency of angina at a patient's self-defined exercise threshold varied; only 22 of 41 patients (54%) had symptoms always or often. Higher classes of angina were more likely to be associated with frequent symptoms at threshold, eg, class I/II, six of 23 versus class III/IV, 16 of 17; 2P = 0.00002). Pain at rest was reported as 'definitely' present by 23 of 41 patients, and was similar in incidence across angina classes. All suggested modifiers reduced distances walked in a significant majority of patients (P values uniformly < 0.01) except for walking in the first few hours after awakening. However, the proportions of subjects for whom these factors were relevant were statistically similar for all angina grades, rather than for class II patients alone. CONCLUSIONS:These findings suggest that internal inconsistencies in the CCS scale are identifiable with simple validity checks. Further research appears warranted to improve this popular and useful clinical tool.
    A comparison of three quality of life instruments in subjects with angina pectoris: the Sickness Impact Profile, the Nottingham Health Profile, and the Quality of Well Being Scale. Visser M C,Fletcher A E,Parr G,Simpson A,Bulpitt C J Journal of clinical epidemiology Three instruments for the assessment of quality of life, the Quality of Well Being index (QWB), the Nottingham Health Profile (NHP) and the Sickness Impact Profile (SIP) were assessed in 59 patients with angina pectoris. The NHP showed increased statistically significant impairment with higher New York Heart Association (NYHA) class in 4 out of 6 subscales but not in single responses to questions on daily life. In the SIP 9 out of 11 dimensions increased with NYHA grade as did the physical and psychosocial subscores and the total score. There were statistically significant increases in six of the eleven dimensions. In the QWB an increase was observed only for two out of four categories employed in this instrument. The QWB was the most difficult to administer and thought likely to be insensitive to changes in anginal pain. There was a high level of agreement in similar dimensions of NHP and SIP. A psychological distress score was evaluated using the Symptom Rating Test and correlated with all summary dimensions of both instruments. The coefficients of variation were lower in SIP than in NHP categories. In conclusion quality of life instruments like NHP and SIP may be able to identify treatment effects in angina patients and so yield a useful addition to the traditional measures employed for the assessment of their condition.
    [Questionnaire for the diagnosis of coronary heart disease]. Grüntzig A Schweizerische Rundschau fur Medizin Praxis = Revue suisse de medecine Praxis
    [Possibilities of the questionnaire method for detection of the symptoms of preclinical stages of coronary arteriosclerosis and ischemic heart disease]. Aronov D M,Kovaleva O F,Aleshin O I,Mazaev V P,Rozhnov A V,Danielov G E Kardiologiia A comprehensive study was made of 140 males aged 26-55 years who were divided into 3 groups: (1) 47 healthy individuals; (2) 67 subjects with early signs of coronary heart disease; and (3) 29 patients with coronary heart disease (Functional Class II). The pattern of chest pain was thoroughly analyzed by a specially developed questionnaire. The results were compared with the data obtained from an interview by Rose's questionnaire. The analysis demonstrated that neither Rose's questionnaire nor the detailed one specially developed by the authors identified subjects with preclinical coronary heart disease.
    A self-administered questionnaire for detection of unrecognised coronary heart disease. Cameron J D,Jennings G L,Kay S,Wahi S,Bennett K E,Reid C,Dart A M Australian and New Zealand journal of public health On an individual and a population basis, an increased incidence of coronary heart disease is associated with classical cardiovascular risk factors, but many cases occur in people not identified as at high risk. Conversely, many people at high statistical risk do not develop coronary disease. We used a questionnaire to identify unrecognised coronary heart disease in people attending large-scale health survey centres. Participants were required to report the presence and characteristics of any chest pain. Those returning responses consistent with myocardial ischaemia were offered treadmill exercise ECG tests. Over 18 months, 4070 questionnaires were returned. Of 475 respondents offered testing, 229 (198 male, 131 female) accepted. Thirty-two subjects (15 male, 17 female: a detection rate of 13.9 per cent of those assessed as likely on questionnaire, or 0.8 per cent of all respondents) had results consistent with significant coronary heart disease. Follow-up was available in 30 cases. There was no difference in classical risk-factor distribution (including multivariate risk percentiles: 42.4 (male) and 46.7 (female)) between those newly diagnosed with coronary heart disease and their community counterparts. More women than men were identified as suffering from unrecognised coronary heart disease, with a preponderance of younger women. Cost per case identified was A$1220. Screening by self-administered questionnaire is a useful and relatively cost-effective means of identifying unrecognised coronary heart disease.
    The coronary heart disease in-patient experience questionnaire (I-PEQ (CHD)): results from the survey of National Health Service patients. Jenkinson C,Coulter A,Bruster S,Richards N Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation OBJECTIVE:Analysis of data from the National Survey of Coronary Heart Disease patients to develop a core measure of patient experiences of health care. A secondary purpose was to determine whether a single summary index figure could be generated from the instrument. DESIGN:The data reported here comes from the survey of coronary heart disease (CHD) patients, which was the second in the programme of National Surveys of National Health Service (NHS) patients. It took place during 1999. After an in-patient episode for CHD, questionnaires were mailed out to patients with a covering letter and a pre-paid stamped addressed envelope. Those patients who did not reply within two weeks of the initial mailing were sent a reminder letter and, if this elicited no reply within two weeks, they were sent another copy of the questionnaire. SAMPLE:Of the 116,872 patients who were sent questionnaires, 3399 proved to be ineligible or out-of scope to the survey. Responses were gained from 84,310 (74.3% of eligible respondents). RESULTS:Reliability analysis supported the existence of seven dimensions which seem to be tapping distinct underlying phenomena: hospital environment, information and communication, patient involvement, coordination of care, discharge and transition, and pain. Higher order factor analysis indicated these dimensions constituted one factor and, consequently, can be summed to create an index figure. The construct validity of the measure was assessed, and it distinguished between groups as was hypothesised. CONCLUSIONS:The dimensions of the questionnaire have high internal reliability. Both the dimensions of the instrument and the index score were found to have high construct validity. The instrument provides a core set of issues that should be covered when assessing the quality of care for hospital patients with coronary heart disease. 10.1023/a:1020818500819
    Performance of WHO Angina Questionnaire in measuring burden of coronary heart disease in human isolate populations. Biloglav Zrinka,Ivanković Davor,Campbell Harry,Rudan Igor Collegium antropologicum Isolated human populations represent good candidates for studying genetic and environmental causes of common complex diseases because of their decreased genetic and environmental diversity. The possibility of inexpensive and reliable detection of disease prevalence in such populations is therefore of considerable importance, as comprehensive routine health data and disease registries are rarely available in these populations. In this study, we validated the performance of the WHO Rose Angina Questionnaire (RQ) in measuring the burden of coronary heart disease (CHD) in 9 settlements in these Croatian Adriatic islands. CHD was defined as myocardial infarction (MI) diagnosed by a specialist in the local general hospital, or angina pectoris (AP) by a local general practitioner (GP). The true prevalence of CHD in 1,001 adult persons was 10.5%. The results of the RQ screening based on the first 3, 5 and 6 questions were compared with medical record of CHD. Increasing the number of RQ questions from 3 to 6 resulted in decreasing test sensitivity (from 59.0% to 30.5%) and increasing test specificity (from 86.3% to 93.0%) in the prediction of true CHD status. CHD prevalence was overestimated by 76% when subset of the first 3 questions of RQ was used and by 25% when the first 5 questions were used. However, it was underestimated by 10% when the first 6 questions were used. We conclude that RQ is a useful screening method for measuring burden of CHD in isolate human populations, and that the result based on the first 6 questions is a good approximation of the true CHD prevalence in the population, although it should be considered a slight underestimate.
    Possible angina detected by the WHO angina questionnaire in apparently healthy men with a normal exercise ECG: coronary heart disease or not? A 26 year follow up study. Bodegard J,Erikssen G,Bjornholt J V,Thelle D,Erikssen J Heart (British Cardiac Society) OBJECTIVE:To determine whether men with possible angina (from their responses to the World Health Organization angina questionnaire) but a normal exercise ECG differ in long term rates of coronary heart disease events from men with no symptoms of angina. DESIGN:During 1972-75, 2014 apparently healthy men aged 40-59 years underwent an examination programme including case history, clinical examination, exercise ECG to exhaustion, and various other tests. All men completed the WHO angina questionnaire. SUBJECTS:Of 2014 men, 68 had possible angina, 1831 had no symptoms of angina, and 115 were excluded because they had definite angina or pathological exercise ECGs. All 68+1831 had normal exercise ECGs and none developed chest pain during the exercise test. RESULTS:At 26 years, men with possible angina had a coronary heart disease mortality of 25.0% (17/68) v 13.8% (252/1831) among men with no symptoms of angina (p < 0.013). They also had a higher incidence of coronary artery bypass grafting (CABG) (p < 0.0004) and acute myocardial infarction (p < 0.026). The excess coronary heart disease mortality among men with possible angina only started after 15 years, whereas differences in CABG/acute myocardial infarction started early. Multivariate analysis including well recognised coronary heart disease risk factors showed that possible angina was an independent risk factor (relative risk 1.79, 95% confidence interval 1.26 to 2.10). CONCLUSIONS:Men with possible angina, even with a normal exercise test, have a greater risk of dying from coronary heart disease, having an acute myocardial infarct, or needing a CABG than age matched counterparts with no symptoms of angina. 10.1136/hrt.2003.012542
    Development and validation of a very brief questionnaire measure of physical activity in adults with coronary heart disease. Orrell Alison,Doherty Patrick,Miles Jeremy,Lewin Robert European journal of cardiovascular prevention and rehabilitation : official journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology BACKGROUND:The aim of this study was to validate the Total Activity Measure, a brief questionnaire, to measure physical activity in an older adult population with heart disease. METHODS:Two versions of the Total Activity Measure were administered twice, 7 days apart. The Total Activity Measure 1 asked respondents for the frequency and average duration of bouts of physical activity at three different intensity levels per week, whereas the Total Activity Measure 2 asked respondents for the total time spent in activity at each activity level per week. Questionnaire accuracy was studied in 62 men and 15 women aged 47-84 years, by repeatability and comparison of both administrations of the Total Activity Measure 1 and Total Activity Measure 2 with 7-day RT3 accelerometer data. RESULTS:Seventy-three adults (58 men, 15 women) were used for all statistical analyses. Intraclass correlation coefficients for the Total Activity Measure 1 and Total Activity Measure 2 total activity scores (metabolic equivalent per minute) were r=0.73 (95% confidence intervals, 0.56-0.83) and r=0.82 (95% confidence intervals, 0.71-0.88), respectively. Correlations between the Total Activity Measure 1 and RT3 accelerometer for total activity score (metabolic equivalent per minute) were significant, r=0.26 at time 1 and r=0.27 at time 2 for moderate intensity activities. Correlations between the Total Activity Measure 2 and RT3 accelerometer for total activity score (metabolic equivalent per minute) were also significant, r=0.38 at time 1 and r=0.36 at time 2, r=0.31 at time 2 for strenuous intensity activities and r=0.29 at time 1 and r=0.25 at time 2 for moderate intensity activities. Participants overestimated the amount of physical activity on both questionnaires as compared with the RT3 accelerometer. CONCLUSIONS:The Total Activity Measure 2 was reasonably accurate in assessing total and moderate intensity activity over a 7-day period and demonstrated good test-retest reliability. The Total Activity Measure 1 was less accurate. The Total Activity Measure 2 is a suitable measure of total or moderate intensity physical activity for surveys and audits in an adult cardiac population. 10.1097/HJR.0b013e3280ecfd56
    Rose Angina Questionnaire: validation with cardiologists' diagnoses to detect coronary heart disease in Bangladesh. Rahman Muhammad Aziz,Spurrier Nicola,Mahmood Mohammad Afzal,Rahman Mahmudur,Choudhury Sohel Reza,Leeder Stephen Indian heart journal AIM/OBJECTIVES:The study aimed to validate the Rose Angina Questionnaire (RAQ) to detect coronary heart disease (CHD) by comparing with cardiologists' diagnoses in Bangladesh. METHODS:Patients aged 40-75 years attending to two cardiac hospitals were diagnosed as either CHD positive or CHD negative by cardiologists. The RAQ was used to reclassify them into CHD positive [RAQ] and CHD negative [RAQ]. FINDINGS:There were 302 CHD positive [cardiologists] and 302 CHD negative [cardiologists] individuals. The RAQ reclassified 194 individuals as CHD positive [RAQ] and 409 individuals as CHD negative [RAQ]. Therefore, the RAQ had 53% sensitivity and 89% specificity. There was no difference in sensitivity and specificity during subgroup analyzes by age and gender; the sensitivity was higher among people from lower socio-economic status. CONCLUSION:The RAQ, having moderate sensitivity but high specificity to detect CHD, can be used to screen individuals at risk of CHD in large-scale epidemiological surveys. 10.1016/j.ihj.2012.09.008
    Diagnostic accuracy of the Patient Health Questionnaire-9 for assessment of depression in type II diabetes mellitus and/or coronary heart disease in primary care. van der Zwaan G Lennart,van Dijk Susan E M,Adriaanse Marcel C,van Marwijk Harm W J,van Tulder Maurits W,Pols Alide D,Bosmans Judith E Journal of affective disorders BACKGROUND:Depression is common among type 2 diabetes mellitus (DM2)/coronary heart disease (CHD) patients and is associated with adverse health effects. A promising strategy to reduce burden of disease is to identify patients at risk for depression in order to offer indicated prevention. This study aims to assess the diagnostic accuracy of the Patient Health Questionnaire-9 (PHQ-9) to be used as a tool to identify high risk patients. METHODS:In this cross-sectional study, 586 consecutive DM2/CHD patients aged >18 were recruited through 23 general practices. PHQ-9 outcomes were compared to the Mini International Neuropsychiatric Interview (MINI), which was considered the reference standard. Diagnostic accuracy was evaluated for minor and major depression, comparing both sum- and algorithm based PHQ-9 scores. RESULTS:For minor depression, the optimal cut-off score was 8 (sensitivity 71%, specificity 71% and an AUC of 0.74). For major depression, the optimal cut-off score was 10 resulting in a sensitivity of 84%, a specificity of 82%, and an AUC of 0.88. The positive predictive value of the PHQ-9 algorithm for diagnosing minor and major depression was 25% and 33%, respectively. LIMITATIONS:Two main limitations apply. MINI Interviewers were not blinded for PHQ-9 scores and less than 10% of all invited patients could be included in the analyses. This could have resulted in biased outcomes. CONCLUSIONS:The PHQ-9 sum score performs well in identifying patients at high risk of minor and major depression. However, the PHQ-9 showed suboptimal results for diagnostic purposes. Therefore, it is recommended to combine the use of the PHQ-9 with further diagnostics to identify depression. 10.1016/j.jad.2015.09.045
    Validation of Veterans Specific Activity Questionnaire to assess exercise tolerance of Chinese elderly with coronary heart disease. Wang Yan,Shi Jing-Jing,Wang Bo-Zhong Journal of geriatric cardiology : JGC OBJECTIVE:The Veterans Specific Activity Questionnaire (VSAQ) has been used to assess exercise tolerance. Nevertheless, there is no validated Chinese version. The aim of this study is to determine whether a questionnaire-based method using the Chinese version of VSAQ (the modified VSAQ) is a practical tool to assess exercise tolerance of Chinese elderly with coronary heart disease. METHODS:One hundred thirty consecutive elderly patients who were diagnosed with coronary heart disease (CHD) (mean age 68.9 ± 6.0 years) referred for treadmill exercise testing (TET) for clinical reasons were included in the study. They were asked to complete a questionnaire for clinical characteristics information on age, sex, history, exercise habits, medications, the original VSAQ and the modified VSAQ. We investigated the relationship between exercise tolerance in metabolic equivalents (METs) estimated by VSAQ and that obtained by TET. RESULTS:The METs by the original VSAQ and the modified VSAQ did not difference significantly ( = 0.528). The modified VSAQ scores were significantly correlated with the METs obtained by TET ( = 0.819, 95% CI: 0.753-0.873, < 0.01), and the scores of original VSAQ also correlated with the METs by TET ( = 0.804, 95% CI: 0.745-0.854, < 0.01). The Bland-Altman graph analysis showed few values outside the limits of agreement, suggesting good precision between the METs estimated by questionnaire and the METs obtained by TET. CONCLUSIONS:The Chinese version of the VSAQ confirmed its validity and equivalence to the original version, especially when evaluating individuals with coronary heart disease and older adults. The results showed that the VSAQ is a valuable tool to assess the exercise tolerance. 10.11909/j.issn.1671-5411.2016.12.005
    Validation of the English Version of the HeartQoL Health-Related Quality of Life Questionnaire in Patients With Coronary Heart Disease. Oldridge Neil,Cho Chris,Thomas Randal,Low Murray,Höfer Stefan Journal of cardiopulmonary rehabilitation and prevention PURPOSE:The aim of this study was to validate the English version of the HeartQoL health-related quality of life questionnaire for use in patients with angina or myocardial infarction. METHODS:Patients living in the United States and referred, either for percutaneous coronary intervention or to cardiac rehabilitation, completed the HeartQoL, the Short Form-36 Health Survey, and the Hospital Anxiety and Depression Scale at baseline and 3-months later. The data were analyzed for validity, reliability, and responsiveness. RESULTS:Patients (n = 313 with angina and n = 97 with myocardial infarction) who were referred either for percutaneous coronary intervention (n = 164) or to cardiac rehabilitation (n = 246) completed baseline questionnaires. Patients with angina had significantly lower HeartQoL scores (poorer health-related quality of life) compared with patients with myocardial infarction. Exploratory factor analysis largely supported the 2-factor structure of the HeartQoL in both diagnoses, but further investigation is warranted. Internal consistency reliability was adequate, convergent validity correlations were significant, and discriminative validity was fully confirmed in patients with angina and largely confirmed in patients with myocardial infarction. Responsiveness was largely confirmed in patients who underwent percutaneous coronary intervention (n = 67) and those referred to cardiac rehabilitation (n = 167) with conventional statistical tests and clinically with the effect size, a standardized measure of change. CONCLUSIONS:The English HeartQoL health-related quality of life questionnaire is valid, reliable, and responsive in patients with angina and myocardial infarction allowing (1) assessment of baseline, (2) between-diagnosis comparisons, and (3) evaluation of change over time. 10.1097/HCR.0000000000000248
    Development of a Diagnostic Questionnaire for Damp Phlegm Pattern and Blood Stasis Pattern in Coronary Heart Disease Patients (CHD-DPBSPQ). Fang Ge,Zhang Ling-Lin,Ren Qi,Zhou Xiao-Wen,Wang Bin,Zhou Xuan,Liu Xiao-Qi,Peng Dan-Hong,Chen Xin-Lin,Li Xian-Tao Evidence-based complementary and alternative medicine : eCAM Background:The aim was to develop a diagnostic questionnaire for damp phlegm pattern and blood stasis pattern in coronary heart disease patients (CHD-DPBSPQ). Methods:The standard procedures of questionnaire development were carried out to develop and assess CHD-DPBSPQ. The patients were assessed using the CHD-DPBSPQ, CHD-DPPQ, and CHD-BSPQ. Four methods were used to select the items on the CHD-DPBSPQ in a pilot study based on data from a Guizhou tertiary grade A hospital. Cronbach's alpha and the split-half reliability, test-retest reliability, content validity, criterion validity, construct validity, and convergent validity were determined in a validation study using a nationwide sample. Results:After item selection, the CHD-DPBSPQ contained 15 items in two domains: the phlegm domain (9 items) and the blood stasis domain (6 items). For the CHD-DPBSPQ, the alpha coefficient was 0.88, the split-half coefficient was 0.90, and the intraclass correlation coefficient was 0.83. The range of the item-level content validity index (I-CVI) was 0.71 to 1.0 and that of the scale-level content validity index/average (Scale-CVI/Ave) was 0.97. The domain scores on the CHD-DPBSPQ were in close relation to the scores on a questionnaire for damp phlegm pattern in coronary heart disease patients (CHD-DPPQ) and a questionnaire for blood stasis pattern in coronary heart disease patient (CHD-BSPQ) ( < 0.01). The root mean square error of approximation (RMSEA) was equal to 0.05 (90% CI: 0.044, 0.059). Convergent validity was demonstrated with a moderate correlation. Conclusion:The CHD-DPBSPQ is a reliable and valid instrument. 10.1155/2019/6856085
    A cross-cultural translation and adaptation of the Arabic Cardiac Self-Efficacy Questionnaire for patients with coronary heart disease. Shajrawi Abedalmajeed,Khalil Heba,Al-Smadi Ahmed Mohammad,Al Dweik Ghadeer,Slater Paul International journal of nursing practice AIM:The aim of this study is to cross-culturally translate and adapt the Cardiac Self-Efficacy Questionnaire into Arabic and subsequently evaluate the psychometric properties of that translation in a population of Arabic patients. METHOD:The original English version of the Cardiac Self-Efficacy Questionnaire was translated into Arabic following a process recommended by the World Health Organization. A convenience sample consisting of 268 Jordanian patients with coronary heart disease was recruited from a university-affiliated hospital in Amman, Jordan. Data were collected from October 2018 to March 2019. The factor structure, face and content validities, and internal consistency of the Arabic Cardiac Self-Efficacy Questionnaire (A-CSEQ) were evaluated. RESULTS:The factor structure analysis supported a three-factor high-order structure of the A-CSEQ. Face validity showed that the language used, style, and format were clear. The content validity demonstrated a very good content validity index. The reliability was good with ranging from 0.89 to 0.93 for all questionnaire subscales. CONCLUSION:The A-CSEQ is a valid and reliable instrument to assess the cardiac self-efficacy of Arabic patients diagnosed with coronary heart disease. Further assessment of the psychometric properties of the A-CSEQ with different cardiac problems is now recommended. 10.1111/ijn.12827
    Keeping hostility in perspective: coronary heart disease and the Hostility Scale on the Minnesota Multiphasic Personality Inventory. Maruta T,Hamburgen M E,Jennings C A,Offord K P,Colligan R C,Frye R L,Malinchoc M Mayo Clinic proceedings Three prospective studies from the early 1980s found that high scores on the Hostility (Ho) Scale of the Minnesota Multiphasic Personality Inventory (MMPI) were associated with an increased incidence of coronary heart disease (CHD) and mortality from CHD and other causes. In the current study, the association between the Ho score and subsequent health status was examined in a 20-year follow-up of 620 general medical patients who completed the MMPI between 1962 and 1965. Univariately, the Ho score from the MMPI was a significant factor for predicting the development of CHD, CHD-related mortality, and total mortality. When two simple risk factors for CHD--age and sex--were also considered, however, the MMPI Ho score was no longer a significant predictive factor. 10.1016/s0025-6196(12)60156-6
    Emotional distress and fatigue in coronary heart disease: the Global Mood Scale (GMS). Denollet J Psychological medicine Evidence indicates that emotional distress has a long-term impact on morbidity and mortality in patients with coronary heart disease (CHD), and that symptoms of depression, fatigue, and reduced energy may identify high-risk patients. This study was designed to: (1) devise a sound and practical measure of emotional distress in CHD patients; (2) examine the relationship between emotional distress and fatigue following CHD; and (3) examine changes in emotional distress as a function of cardiac rehabilitation. A sample of 478 men with CHD (mean age = 57.8 +/- 8.7 y) filled out questionnaires 3-6 weeks following a myocardial infarction (N = 110), bypass surgery (N = 302), or coronary angioplasty (N = 66). Statistical analyses of 56 Dutch mood terms were used to produce the 20-item Global Mood Scale (GMS) which measures negative affect (characterized by fatigue and malaise), as well as positive affect (characterized by energy and sociability), in patients with CHD. The GMS was found to be a reliable scale (alpha > 0.90; r > 0.55 over a 3-month period), and correlations with existing measures of emotional functioning and self-deception indicated its convergent and discriminant validity. Most importantly, fatigue was not related to cardiorespiratory fitness in a subset of 140 patients, but clearly was associated with negative affect. Consistent with the self-efficacy model, scores on the GMS mood scales improved significantly as a function of rehabilitation (P < 0.0001). Although symptoms of emotional distress are easily explained away by situational factors, previous research suggests that failure to recognize the clinical significance of these symptoms in CHD patients may result in the delay of much needed intervention. The current findings suggest that the GMS is a theoretically and psychometrically sound measure of emotional distress in CHD patients, and that this scale is sufficiently sensitive to assess change.
    A psychometric evaluation of the Chinese version of the Hospital Anxiety and Depression Scale in patients with coronary heart disease. Wang Wenru,Chair Sek Ying,Thompson David R,Twinn Sheila F Journal of clinical nursing AIM:To evaluate further the psychometric properties of the Chinese version of the Hospital Anxiety and Depression Scale (HADS) as a screening instrument for anxiety and depression in Chinese patients with coronary heart disease (CHD) in Xian, China. BACKGROUND:There is considerable evidence that anxiety and depression are common in patients with CHD and are associated with increased morbidity and mortality. A valid, reliable and sensitive screening tool that can be used readily on this group of patients would be useful for assessment, intervention and outcome evaluation. DESIGN:A single group, cross-sectional study. METHOD:Measurement performance was tested on 314 Chinese patients with CHD and repeated on 173 of them two weeks later. RESULTS:The Chinese version of HADS (C-HADS) had acceptable internal consistency and test-retest reliability, with a Cronbach's alpha of 0.85 and intraclass correlation coefficient of 0.90, respectively. There was acceptable concurrent validity with significant (p < 0.05) correlations between the anxiety and depression subscales of the C-HADS and CHD patients' perceived health status as measured by the Chinese-Mandarin version of the Short Form-36 health survey (CM:SF-36). Principal components analysis revealed a three-factor solution accounting for 53% of the total variance. The three underlying sub-scale dimensions are depression, psychic anxiety and psychomotor anxiety. The responsiveness of the C-HADS was also satisfactory with significant correlation between the changes in the C-HADS score and the changes in the mental health domain of the CM:SF-36 (p < 0.01). Finally, over one-third of the patients demonstrated psychological distress. CONCLUSION:Empirical data support the C-HADS as a reliable and valid screening instrument for the assessment of anxiety and depression in Chinese-speaking patients with CHD. A tri-dimensional scoring approach should be considered as potentially clinically useful for this group of patients. RELEVANCE TO CLINICAL PRACTICE:The C-HADS can guide and evaluate the delivery of psychological care for Chinese patients with CHD. 10.1111/j.1365-2702.2008.02736.x
    A psychometric evaluation of the Chinese version of the Hospital Anxiety and Depression Scale in patients with coronary heart disease. Wang Wenru,Chair Sek Ying,Thompson David R,Twinn Sheila F Journal of clinical nursing AIM:To evaluate further the psychometric properties of the Chinese version of the Hospital Anxiety and Depression Scale (HADS) as a screening instrument for anxiety and depression in Chinese patients with coronary heart disease in Xian, China. BACKGROUND:There is considerable evidence that anxiety and depression are common in patients with coronary heart disease (CHD) and are associated with increased morbidity and mortality. A valid, reliable and sensitive screening tool that can be used readily on this group of patients would be useful for assessment, intervention and outcome evaluation. DESIGN:A single group, cross-sectional study. METHOD:Measurement performance was tested on 314 Chinese patients with coronary heart disease and repeated on 173 of them two weeks later. RESULTS:The Chinese version of HADS (C-HADS) had acceptable internal consistency and test-retest reliability, with a Cronbach alpha of 0.85 and intraclass correlation coefficient of 0.90, respectively. There was acceptable concurrent validity with significant (p < 0.05) correlations between the anxiety and depression subscales of the C-HADS and CHD patients' perceived health status as measured by the Chinese Mandarin version of the Short Form-36 health survey (CM:SF-36). Principal components analysis revealed a three-factor solution accounting for 53% of the total variance. The three underlying sub-scale dimensions are depression, psychic anxiety and psychomotor anxiety. The responsiveness of the C-HADS was also satisfactory with significant correlation between the changes in the C-HADS score and the changes in the Mental Health domain of the CM:SF-36 (p < 0.01). Finally, over one-third of the patients demonstrated psychological distress. Conclusion. Empirical data support the C-HADS as a reliable and valid screening instrument for the assessment of anxiety and depression in Chinese-speaking patients with CHD. A tri-dimensional scoring approach should be considered as potentially clinically useful for this group of patients. RELEVANCE TO CLINICAL PRACTICE:The C-HADS can guide and evaluate the delivery of psychological care for Chinese patients with CHD. 10.1111/j.1365-2702.2009.02807.x
    A psychometric evaluation of the Chinese version of the Hospital Anxiety and Depression Scale in patients with coronary heart disease. Watson Roger Journal of clinical nursing 10.1111/j.1365-2702.2009.03043.x
    [Establishment and primary screening of primitive entry pool of rating scale for patient-reported outcomes of coronary heart disease angina]. He Qing-yong,Wang Jie,Yao Kui-wu Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine OBJECTIVE:To establish and screen the primitive entry pool of scale for patient-reported outcomes of coronary heart disease angina (CHDA). METHODS:Under the guidance of Chinese medical theory, the original entry pool was preliminarily established in referring the international scale development methods and the characteristics of angina pectoris, which was screened by focus group discussions, semi-open questionnaires investigation, and expert's interviews. RESULTS:Thirty-six entries were screened out from the 41 entries of initially established entry pool, in which 14 entries dealt with physiological domain, 8 with psychological domain, 4 with independent domain, 3 with social relations domain, 6 with social environment domain and 1 for overall assessment. CONCLUSIONS:The preliminary entries screened out have covered all the 5 commonly concerned domains of CHD-AP, could reflect the connotation of the disease more comprehensively. And it has good content validity due to its popular language, which is easily to be understood, comprehended and responded.
    Development of an evaluation scale for self-management behavior related to physical activity of patients with coronary heart disease. Tokunaga-Nakawatase Yuri,Taru Chiemi,Miyawaki Ikuko European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology BACKGROUND:To provide patients with effective self-management education that takes their lifestyle into account, medical personnel need to provide education and evaluation of self-management behaviors which patients can apply to their daily life. AIM:This study aimed to assess the reliability and validity of the evaluation scale for self-management behavior related to physical activity of patients with coronary heart disease (ES-SMBPA-CHD). METHODS AND RESULTS:Outpatients with coronary heart disease (n = 76) completed a self-administered questionnaire supported by a previous study of ours. The ES-SMBPA-CHD was divided into two domains, the first dealing with self-management behavior to enhance physical activity in daily life and the second with behavior to maintain the level of physical activity. Factor analysis showed that the first part comprised four factors and the second five. The ES-SMBPA-CHD was associated with the International Physical Activity Questionnaire (IPAQ) subscales and activity energy expenditure (measured by Lifecorder EX). Cronbach's α coefficient was between 0.71 and 0.90. The intraclass test-retest correlation coefficient of the subscale was between 0.75 and 0.93. CONCLUSIONS:The ES-SMBPA-CHD is reasonably reliable and valid and is expected to prove useful for the assessment of patients' self-management behavior and for individualized instruction. 10.1016/j.ejcnurse.2011.01.001
    Psychometric properties of the cardiac depression scale in patients with coronary heart disease. Kiropoulos Litza A,Meredith Ian,Tonkin Andrew,Clarke David,Antonis Paul,Plunkett Julie BMC psychiatry BACKGROUND:This study examined the psychometric properties of the Cardiac Depression Scale (CDS) in a sample of coronary heart disease (CHD) patients. METHODS:A total of 152 patients were diagnosed with coronary heart disease and were administered the CDS along with the Beck Depression Inventory- 2 (BDI-2) and the State Trait Anxiety Inventory (STAI) 3.5-months after cardiac hospitalization. RESULTS:The CDS's factorial composition in the current sample was similar to that observed in the original scale. Varimax-rotated principal-components analyses extracted six factors, corresponding to mood, anhedonia, cognition, fear, sleep and suicide. Reliability analyses yielded internal consistency α - coefficients for the six subscales ranging from 0.62 to 0.82. The CDS showed strong concurrent validity with the BDI-II (r = 0.64). More patients were classified as severely depressed using the CDS. Both the CDS and the BDI-2 displayed significantly strong correlations with the STAI (r = 0.61 and r = 0.64), respectively. CONCLUSIONS:These findings encourage the use of the CDS for measuring the range of depressive symptoms in those with CHD 3.5 months after cardiac hospitalization. 10.1186/1471-244X-12-216
    Perceptions of coronary heart disease: the development and psychometric testing of a measurement scale. Chan C W Psychology, health & medicine Individuals' perceptions of coronary heart disease (CHD) have implications for the ways in which they respond to the disease, process risks, make decisions, and take action to reduce CHD risks. This study aimed to develop and evaluate the psychometric properties of the perceptions of coronary heart disease scale (PCS) among a Hong Kong Chinese population. A cross-sectional study was conducted using a convenient sample (n = 232) of participants recruited from a variety of catchments including public domains, a cardiac unit, and a cardiac rehabilitation and prevention center. Exploratory factor analysis identified a nine-item, two-factor model that accounted for 52.5% of the total explained variance. The two factors were the perceived risk (five items) and perceived seriousness (four items) of CHD. The PCS demonstrated good content validity; acceptable total, and subscale internal consistency (.73, .61 - .81); and significant contrast-group differences with higher levels of CHD perceptions among males (p = .002), younger participants (p < .001), and those with higher educational levels (p < .001), suggesting excellent construct validity. The newly developed PCS demonstrates acceptable psychometric properties as a short measurement scale, which supports its use in future research. Future validation of this scale is warranted. 10.1080/13548506.2013.802354
    Development and validation of the coronary heart disease scale under the system of quality of life instruments for chronic diseases QLICD-CHD: combinations of classical test theory and Generalizability Theory. Wan Chonghua,Li Hezhan,Fan Xuejin,Yang Ruixue,Pan Jiahua,Chen Wenru,Zhao Rong Health and quality of life outcomes BACKGROUND:Quality of life (QOL) for patients with coronary heart disease (CHD) is now concerned worldwide with the specific instruments being seldom and no one developed by the modular approach. OBJECTIVES:This paper is aimed to develop the CHD scale of the system of Quality of Life Instruments for Chronic Diseases (QLICD-CHD) by the modular approach and validate it by both classical test theory and Generalizability Theory. METHODS:The QLICD-CHD was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, pre-testing and quantitative statistical procedures. 146 inpatients with CHD were used to provide the data measuring QOL three times before and after treatments. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness employing correlation analysis, factor analyses, multi-trait scaling analysis, t-tests and also G studies and D studies of Genralizability Theory analysis. RESULTS:Multi-trait scaling analysis, correlation and factor analyses confirmed good construct validity and criterion-related validity when using SF-36 as a criterion. The internal consistency α and test-retest reliability coefficients (Pearson r and Intra-class correlations ICC) for the overall instrument and all domains were higher than 0.70 and 0.80 respectively; The overall and all domains except for social domain had statistically significant changes after treatments with moderate effect size SRM (standardized response mea) ranging from 0.32 to 0.67. G-coefficients and index of dependability (Ф coefficients) confirmed the reliability of the scale further with more exact variance components. CONCLUSIONS:The QLICD-CHD has good validity, reliability, and moderate responsiveness and some highlights, and can be used as the quality of life instrument for patients with CHD. However, in order to obtain better reliability, the numbers of items for social domain should be increased or the items' quality, not quantity, should be improved. 10.1186/1477-7525-12-82
    The Perceptions of Coronary heart disease Scale: psychometric validation using confirmatory factor analysis. Chan Choi Wan Journal of clinical nursing 10.1111/jocn.12223
    Psychometric properties of the coronary heart disease scale of the quality-of-life instruments for chronic diseases (QLICD-CHD): an application to Cantonese patients. Fan An,Zhong Shou Qiang,Zuo Xiao Yu,Liang Yan,Mai Wei Yi,Chen Can,Su Wei Yang,Zhang Fan,Zhao Xiao Lei,Lin Mei Hua,Wan Chong Hua,Ding Yuan Lin,Rao Shao Qi Asia-Pacific journal of public health The purpose of this study was to validate the applicability of our proposed disease-specific questionnaire to Cantonese coronary heart disease (CHD) patients. During the investigation from August 2010 to March 2012, 1000 Cantonese inpatients were recruited. The reliability of the scale was judged by the internal consistency, and the content and construct validity were assessed by using Pearson correlation and confirmatory factor analysis, respectively. Results showed that the Cronbach's α coefficient for the whole scale and most domains/facets were larger than .70 (.59 to .93). Most items had moderate to strong Pearson correlations with their respective facets (r > 0.50). Confirmatory factor analysis showed that the indices for goodness of fit were nearly acceptable. Overall, the QLICD-CHD scale has adequate psychometric properties when applied to Cantonese CHD patients. 10.1177/1010539514555706
    Chinese translation and psychometric testing of the cardiac self-efficacy scale in patients with coronary heart disease in mainland China. Zhang Xuelin,Zhan Yan,Liu Jun,Chai Shouxia,Xu Lanlan,Lei Meirong,Koh Karen Wei Ling,Jiang Ying,Wang Wenru Health and quality of life outcomes BACKGROUND:A person's self-efficacy plays a critical role during the chronic management process of a health condition. Assessment of self-efficacy for patients with heart diseases is essential for healthcare professionals to provide tailored interventions to help patient to manage the disease. OBJECTIVE:To translate and test the psychometric properties of the Chinese version of Cardiac Self-efficacy Scale (C-CSES) as a disease-specific instrument for patients with coronary heart disease (CHD) in mainland China. METHODS:The original English version of the CSES was translated into Chinese using a forward-backward translation approach. A convenience sample consisting of 224 Chinese patients with CHD were recruited from a university-affiliated hospital in Shiyan, China. The C-CSES and the General Self-efficacy Scale (GSES) were used in this study. The factor structure, convergent and discriminative validities, and internal consistency of the C-CSES were evaluated. RESULTS:The confirmatory factor analysis (CFA) supported a three-factor high-order structure of the C-CSES with model fit indexes (RMSEA = 0.084, CFI = 0.954, NNFI = 0.927, IFI = 0.954 and χ /df = 2.572). The C-CSES has good internal consistency with a Cronbach's alpha of 0.926. The convergent validity of the C-CSES was established with significantly moderate correlations between the C-CSES and the Chinese version of the GSES (p < 0.001). The C-CSES has also shown good discriminative validity with significant differences of cardiac self-efficacy being found between patients with and without comorbidities of hypertension, diabetes, or heart failure. CONCLUSION:The empirical data supported that the C-CSES is a valid and reliable disease-specific instrument for assessing the self-efficacy of Chinese patients with CHD. 10.1186/s12955-018-0872-4
    Prospective Validation of the Chinese Version of the Self-Efficacy for Exercise Scale Among Middle-Aged Patients With Coronary Heart Disease. Wong Eliza M L,Leung Doris Y P,Sit Janet W H,Chan Aileen W K,Chair Sek Ying Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses PURPOSE:The aim of this study was to further evaluate the psychometric properties of the Chinese version of the Self-Efficacy for Exercise Scale (SEE-C) among middle-aged outpatients with coronary heart disease (CHD). DESIGN:Psychometric evaluation design. METHODS:A convenience sample of 355 CHD patients was recruited and followed up at 3 and 6 months. Cronbach's alpha, construct validity (exploratory factor analysis), and concurrent and predictive validity were examined. FINDINGS:The SEE-C had a single-factor structure that was stable over time and had high internal consistency. Baseline SEE-C scores were significantly and positively associated with quality of life and total exercise time per week and significantly and negatively associated with anxiety and depression. They also significantly predicted total exercise per week at the 3- and 6-month follow-ups. CONCLUSIONS:The SEE-C is a robust, reliable, and valid measure of exercise self-efficacy for middle-aged Chinese CHD outpatients. CLINICAL RELEVANCE:The SEE-C can assess patients' exercise self-efficacy, so that appropriate interventions to improve exercise self-efficacy can be provided. 10.1097/rnj.0000000000000156
    Assessment of Intermingled Phlegm and Blood Stasis Syndrome in Coronary Heart Disease: Development of a Diagnostic Scale. Zhou Xuan,Li Xian-Tao,Liu Xiao-Qi,Wang Bing,Fang Ge Evidence-based complementary and alternative medicine : eCAM Background:Intermingled Phlegm and Blood Stasis Syndrome (IPBSS) is a common feature in patients with coronary heart disease (CHD). In clinical practice, the diagnostic agreement of clinical doctor of Chinese Medicine (CM) is poor. We previously developed a IPBSS diagnostic scale for use by general practitioner. Objectives:To assess a IPBSS diagnostic scale that we previously developed for use by non-experts. Methods:This is a multicenter, prospective study involving eight study sites across China. Eligible patients were adults (≥18 years) with CHD as demonstrated by a history of myocardial infarction, stenosis, or past coronary revascularization. IPBSS was assessed using a scale that consisted of 14 items in two domains (e.g., phlegm and blood stasis). The score range for each item was 0 to 3 points. Maximum total score was 72 points. Diagnostic accuracy was verified using consensus opinion by two independent experts as reference. Results:A total of 1,142 CHD patients were included. IPBSS was established in 729 subjects using the IPBSS diagnostic scale. In ROC curve analyses, at the optimal cut-off of 25.5, the sensitivity and specificity of the IPBSS scale were 67.6% and 72.4%, respectively. The area under the ROC curve was 0.741 (95%CI: 0.711-0.772). Conclusions:The newly developed IPBSS scoring system showed moderate performance in diagnosing IPBSS in CHD patients. Data from further large-scale diagnostic test accuracy studies are warranted. This trial is registered with ChiCTR-OOC-15006599. 10.1155/2018/4683431
    Diagnostic Accuracy of Chinese Medicine Diagnosis Scale of Phlegm and Blood Stasis Syndrome in Coronary Heart Disease: A Study Protocol. Liu Xiao-Qi,Peng Dan-Hong,Wang Yan-Ping,Xie Rong,Chen Xin-Lin,Yu Chun-Quan,Li Xian-Tao Chinese journal of integrative medicine BACKGROUND:Phlegm and blood stasis syndrome (PBSS) is one of the main syndromes in coronary heart disease (CHD). Syndromes of Chinese medicine (CM) are lack of quantitative and easy-implementation diagnosis standards. To quantify and standardize the diagnosis of PBSS, scales are usually applied. OBJECTIVE:To evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD. METHODS:Six hundred patients with stable angina pectoris of CHD, 300 in case group and 300 in control group, will be recruited from 5 hospitals across China. Diagnosis from 2 experts will be considered as the "gold standard". The study design consists of 2 phases: pilot test is used to evaluate the reliability and validity, and diagnostic test is used to assess the diagnostic accuracy of the scale, including sensitivity, specificity, likelihood ratio and area under the receiver operator characteristic (ROC) curve. DISCUSSION:This study will evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD. The consensus of 2 experts may not be ideal as a "gold standard", and itself still requires further study. (No. ChiCTR-OOC-15006599). 10.1007/s11655-018-2793-9
    Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). Löwe Bernd,Kroenke Kurt,Herzog Wolfgang,Gräfe Kerstin Journal of affective disorders BACKGROUND:The nine-item depression module from the Patient Health Questionnaire (PHQ-9) is well validated and widely used as a brief diagnostic and severity measure, but its validity as an outcome measure for depression has not yet been established. Therefore, we investigated the sensitivity to change of the PHQ-9 in three groups of patients whose depression status either improved, remained unchanged, or deteriorated over time. METHODS:From three cohorts of medical outpatients, with an equal distribution of major depressive disorder, other depressive disorders, or no depressive disorder, 167 patients (82.7%) were followed up after a mean of 12.3 +/- 3.0 months. The PHQ-9 and the Structured Clinical Interview for DSM-IV (SCID) were completed at both baseline and follow-up. Depression diagnoses from the SCID were used as the criterion standard to divide patients into subgroups with (a) improved depression status, (b) unchanged depression status, and (c) deteriorated depression status. RESULTS:Effect sizes (ES) of PHQ-9 change scores were ES = -1.33 for the improved depression status subgroup (n = 52), ES = -0.21 for the unchanged status subgroup (n = 91), and ES = 0.47 for the deteriorated status subgroup (n = 24). PHQ-9 change scores differed significantly between the three depression outcome groups. LIMITATIONS:The PHQ-9 and the SCID were completed in person at baseline, whereas they were completed in a telephone interview at follow-up. CONCLUSIONS:This study demonstrates the ability of the PHQ-9 to detect depression outcome and changes over time. Data from treatment trials will help further establish the sensitivity to change of the PHQ-9 in comparison to other depression severity measures. 10.1016/S0165-0327(03)00198-8
    Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force. Matza Louis S,Patrick Donald L,Riley Anne W,Alexander John J,Rajmil Luis,Pleil Andreas M,Bullinger Monika Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research BACKGROUND:Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. OBJECTIVE:The purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling. The recommendations are based on the consensus of an interdisciplinary group of researchers who were assembled for a task force associated with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). In those areas in which supporting evidence is limited or in which general principles may not apply to every situation, this task force report identifies factors to consider when making decisions about the design and use of pediatric PRO instruments, while highlighting issues that require further research. GOOD RESEARCH PRACTICES:Five good research practices are discussed: 1) Consider developmental differences and determine age-based criteria for PRO administration: Four age groups are discussed on the basis of previous research (<5 years old, 5-7 years, 8-11 years, and 12-18 years). These age groups are recommended as a starting point when making decisions, but they will not fit all PRO instruments or the developmental stage of every child. Specific age ranges should be determined individually for each population and PRO instrument. 2) Establish content validity of pediatric PRO instruments: This section discusses the advantages of using children as content experts, as well as strategies for concept elicitation and cognitive interviews with children. 3) Determine whether an informant-reported outcome instrument is necessary: The distinction between two types of informant-reported measures (proxy vs. observational) is discussed, and recommendations are provided. 4) Ensure that the instrument is designed and formatted appropriately for the target age group. Factors to consider include health-related vocabulary, reading level, response scales, recall period, length of instrument, pictorial representations, formatting details, administration approaches, and electronic data collection (ePRO). 5) Consider cross-cultural issues. CONCLUSIONS:Additional research is needed to provide methodological guidance for future studies, especially for studies involving young children and parents' observational reports. As PRO data are increasingly used to support pediatric labeling claims, there will be more information regarding the standards by which these instruments will be judged. The use of PRO instruments in clinical trials and regulatory submissions will help ensure that children's experience of disease and treatment are accurately represented and considered in regulatory decisions. 10.1016/j.jval.2013.04.004
    Validation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force. Zbrozek Arthur,Hebert Joy,Gogates Gregory,Thorell Rod,Dell Christopher,Molsen Elizabeth,Craig Gretchen,Grice Kenneth,Kern Scottie,Hines Sheldon Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods. 10.1016/j.jval.2013.04.002
    Technical report: an ePRO patient reported outcome program for the evaluation of patients with irritable bowel syndrome. Gerson C D,Gerson M-J Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society BACKGROUND:Patient reported outcome (PRO) is an important healthcare concept that describes patient's participation in their care by self-evaluation, usually in the form of questionnaires. This report describes an unique computerized technique, electronic PRO (ePRO), for following the progress of patients with irritable bowel syndrome (IBS). METHODS:Patients first completed a series of questionnaires, including questions about their illness history, symptom severity, and, in this application, psychological and relationship issues. The symptom severity and psychological questionnaires were then completed at intervals by the patients on their own computers. The ePRO was constructed to allow scores to be automatically summed and placed on a time-line graph for review at the time of the next office visit. KEY RESULTS:Of the 32 patients who completed the initial set of questionnaires, 20 maintained participation in the program for a 6-month period. Of those 20 patients, median number of submissions was 7.0; median interval between questionnaire submissions was 3.0 weeks, whereas median interval between office visits was 5.9 weeks. On average, questionnaire completion took less than 5 min and was positively experienced by the patients. CONCLUSIONS & INFERENCES:The ePRO program proved to be technically feasible, clinically useful, and positively experienced by the patients. It provides a focus on a collaborative conversation between physician and patient. It has significant potential as a technique for evaluating outcome in response to various therapies. 10.1111/nmo.12255
    Patient-Reported Outcome Coordinator Did Not Improve Quality of Life Assessment Response Rates: A Report from the Children's Oncology Group. Johnston Donna,Gerbing Robert,Alonzo Todd,Aplenc Richard,Nagarajan Rajaram,Schulte Fiona,Cullen Patricia,Sung Lillian PloS one PURPOSE:Health related quality of life (HRQL) assessments during therapy for pediatric cancer provide valuable information to better understand the patient experience. Our objective was to determine the impact of a patient-reported outcome (PRO) coordinator on HRQL questionnaire completion rates during a pediatric acute myeloid leukemia (AML) trial. METHODS:AAML1031 is a multicenter Children's Oncology Group therapeutic trial for de novo AML with a secondary aim to assess HRQL of children and adolescents treated with chemotherapy and hematopoietic stem cell transplantation (HSCT). Parents/guardians are the primary respondents and four questionnaires are administered at eight time points. The questionnaires are the PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and the Pediatric Inventory for Parents. To improve response rates, a central PRO coordinator was instituted and reminded sites about upcoming and delinquent questionnaires. The proportion of HRQL questionnaires completed were compared prior to, and following institution of the PRO coordinator. This analysis evaluated the first five assessment time points. RESULTS:There were231 families who consented to participate in the HRQL aim. Overall response rates for all questionnaires were 73-83%. At time point 1, within 14 days of chemotherapy initiation, post-PRO coordinator completion rates were significantly higher for three of four questionnaires. However, the effect was not sustained and at time point 4, one month following last chemotherapy or HSCT, completion rates were significantly lower post-PRO coordinator for all four questionnaires. CONCLUSION:Addition of a central PRO coordinator did not result in sustained improvement in HRQL questionnaire completion rates. Efforts to improve response rates must consider other strategies. 10.1371/journal.pone.0125290
    Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis. Rolfson Ola,Bohm Eric,Franklin Patricia,Lyman Stephen,Denissen Geke,Dawson Jill,Dunn Jennifer,Eresian Chenok Kate,Dunbar Michael,Overgaard Søren,Garellick Göran,Lübbeke Anne, Acta orthopaedica - The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question ("During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?"; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome ("How satisfied are you with your [right/left] [hip/knee] replacement?"; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data. 10.1080/17453674.2016.1181816
    Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report. Benjamin Katy,Vernon Margaret K,Patrick Donald L,Perfetto Eleanor,Nestler-Parr Sandra,Burke Laurie Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research BACKGROUND:Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. OBJECTIVE:To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. GOOD PRACTICES FOR OUTCOMES RESEARCH:This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing instruments developed for a similar condition or that contain symptoms of importance to the RD patient population, or using a generic instrument validated for the context of use. CONCLUSIONS:This report provides state-of-the-art solutions to patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments challenges in clinical trials of patients with RDs. These recommended solutions are both pragmatic and creative and posed with clear recognition of the global regulatory context used in RD clinical development programs. 10.1016/j.jval.2017.05.015
    A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group. Black Rachel J,Robson Joanna C,Goodman Susan M,Hoon Elizabeth,Lai Lana Y H,Simon Lee S,Harrison Eileen,Neill Lorna,Richards Pam,Nelsen Linda M,Nebesky J Michael,Mackie Sarah L,Hill Catherine L The Journal of rheumatology OBJECTIVE:The need for a standardized instrument to measure the effect of glucocorticoid (GC) therapy has been well documented in the literature. The aim of the first GC Special Interest Group was to define a research agenda around the development of a patient-reported outcome measure (PROM) in this area. METHODS:The results of a background literature search and the preliminary results of a pilot survey and 2 qualitative studies were presented to facilitate the development of a research agenda. RESULTS:It was agreed that there was a need for a data-driven PROM that identified both positive and negative effects of GC therapy to be used across all inflammatory indications for systemic GC use in adults. A research agenda was developed, consisting of further qualitative work to assess the effect of GC across different groups including various indications for GC use, different age groups, different dosages, and duration of treatment. CONCLUSION:There was agreement on the need for a PROM in this area and a research agenda was set. 10.3899/jrheum.161083
    Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Veit-Rubin Nikolaus,Dubuisson Jean-Bernard,Gayet-Ageron Angèle,Lange Sören,Eperon Isabelle,Dubuisson Jean International urogynecology journal INTRODUCTION AND HYPOTHESIS:Sacropexy is considered the gold standard for the treatment of pelvic organ prolapse (POP) although dissection of the promontory may be challenging, particularly in obese women. Laparoscopic lateral suspension with mesh (LLS) could be an alternative. METHODS:LLS provides lateral attachment by fibrosis of a vesicovaginal mesh. Clinical evaluation was performed at 1 year using the simplified POP quantification system (POP-Q). Primary outcomes were objective and subjective cure at 1 year. After a mean of 7.2 years the rates of reoperation and complications were assessed as secondary outcomes. Patient satisfaction was evaluated by telephone interview using a ten-point-scale and the PGI-I scale. Factors predicting satisfaction were determined by logistic regression analysis. RESULTS:A total of 417 patients were treated between 2003 and 2011. At 1 year 78.4% of patients were asymptomatic and anatomic success rates were 91.6% for the anterior compartment, 93.6% for the apical compartment and 85.3% for the posterior compartment. The complication rate of Clavien-Dindo grade III or higher was 2.2%. The mesh exposure rate was 4.3% and the reoperation rate was 7.3%. Of the 417 patients, 214 participated in the telephone interview. Over 85% rated their situation as improved and satisfaction was associated with the absence of concomitant hysterectomy. CONCLUSIONS:LLS is a safe technique with promising results in terms of a composite outcome, low complication rates and high long-term patient satisfaction. However, a randomized controlled trial is needed to establish the technique as an alternative to sacropexy in the treatment of POP in obese and high morbidity patients. 10.1007/s00192-017-3327-2
    Cataract surgery patient-reported outcome measures: a head-to-head comparison of the psychometric performance and patient acceptability of the Cat-PROM5 and Catquest-9SF self-report questionnaires. Sparrow J M,Grzeda M T,Frost N A,Johnston R L,Liu C S C,Edwards L,Loose A,Elliott D,Donovan J L Eye (London, England) Background Cataract surgery is the most frequently undertaken NHS surgical procedure. Visual acuity (VA) provides a poor indication of visual difficulty in a complex visual world. In the absence of a suitable outcome metric, recent efforts have been directed towards the development of a cataract patient-reported outcome measure (PROM) of sufficient brevity, precision, and responsiveness to be implementable in routine high volume clinical services.Aim To compare and contrast the two most promising candidate PROMs for routine cataract surgery.Method The psychometric performance and patient acceptability of the recently UK developed five-item Cat-PROM5 questionnaire was compared with the English translation of the Swedish nine-item Catquest-9SF using Rasch-based performance metrics and qualitative semistructured interviews.Results Rasch-based performance was assessed in 822 typical NHS cataract surgery patients across four centres in England. Both questionnaires demonstrated good to excellent performance for all metrics assessed, including Person Reliability Indices of 0.90 (Cat-PROM5) and 0.88 (Catquest-9SF), responsiveness to surgery (Cohen's standardized effect size) of 1.45 SD (Cat-PROM5) and 1.47 SD (Catquest-9SF) and they were highly correlated with each other (R=0.85). Qualitative assessments confirmed that both questionnaires were acceptable to patients, including in the presence of ocular comorbidities. Preferences were expressed for the shorter Cat-PROM5, which allowed patients to map their own issues to the questions as opposed to the more restrictive specific scenarios of Catquest-9SF.Conclusion The recently UK developed Cat-PROM5 cataract surgery questionnaire is shorter, with performance and patient acceptability at least as good or better than the previous 'best of class' Catquest-9SF instrument. 10.1038/eye.2017.297
    Patient-reported outcome domains for the esophageal CONDUIT report card: a prospective trial to establish domains. Lee Minji K,Yost Kathleen J,Pierson Karlyn E,Blackmon Shanda H Health and quality of life outcomes BACKGROUND:Health-related quality of life (QoL) deteriorates immediately after esophagectomy. Patients may benefit from periodic assessments to detect increased morbidity on the basis of subjective self-reports. Using input from patients and health care providers, we developed a brief prototype for the esophageal conduit questionnaire (Mayo Clinic Esophageal Conduit Outcomes Noting Dysphagia/Dumping, and Unknown outcomes with Intermittent symptoms over Time after esophageal reconstruction [CONDUIT] Report Card) and previously used it in comparative research. The present study aimed to expand its content and establish health-related QoL and symptom domains of a patient-reported postesophagectomy conduit evaluation tool. METHODS:We expanded tool content by selecting items measuring patient-reported symptoms from existing questionnaires or written de novo. A multidisciplinary group of clinician content-matter experts approved the draft tool, together with a designated patient advocate. The expanded tool was administered to patients postesophagectomy from March 1 to November 30, 2016. We established domains of conduit performance for score reporting through data analysis with exploratory factor analyses. We assessed psychometric properties such as dimensionality, internal consistency, and inter-item correlations in each domain and compared content coverage with other existing measures intended for this patient population. For data that were missing less than 50% of patient responses, the missing values were imputed. RESULTS:Five multi-item domains were established from data of 76 patients surveyed after esophagectomy; single items were used to assess stricture and conduit emptying. For every multi-item domain, dominance of 1 factor was present. Internal consistency reliability estimates for the domains were 0.87, 0.78, 0.75, 0.80, and 0.83 and average inter-item correlations were 0.40, 0.50, 0.40, 0.33, and 0.73 for dysphagia, reflux, dumping-gastrointestinal symptoms, dumping-hypoglycemia, and pain, respectively. Some items observed to have lower inter-item correlation were reworded or flagged for removal at future validation. For reflux and dumping-related hypoglycemia, additional items were written after these analyses. CONCLUSIONS:The CONDUIT Report Card is a novel questionnaire for assessing QoL and symptoms of patients after esophageal reconstruction. It covers major symptoms of these patients and has good content validity and psychometric properties. The tool can be used to help direct patient care, guide intervention, and compare efficacy of different treatment options. TRIAL REGISTRATION:ClinicalTrials.gov identifier No. 02530983 on 8/18/2015. 10.1186/s12955-018-1023-7
    Implementation and early adaptation of patient-reported outcome measures into an electronic health record: A technical report. Gold Heather Taffet,Karia Raj J,Link Alissa,Lebwohl Rachel,Zuckerman Joseph D,Errico Thomas J,Slover James D,Buckland Aaron J,Mann Devin M,Cantor Michael N Health informatics journal We integrated and optimized patient-reported outcome measures into the electronic health record to provide quantitative, objective data regarding patients' health status, which is important for patient care, payer contracts, and research. With a multidisciplinary team from information technology, clinical informatics, population health, and physician champions, we used formal human-computer interaction techniques and user-centered design to integrate several technology platforms and computerized adaptive testing for the National Institutes of Health Patient-Reported Outcomes Measurement Information System. The patient-reported outcome measure system leverages software frequently used by health systems and provides data for research and clinical care via a mobile-responsive web application using Symfony, with REDCap for configuring assessments and de-identified data storage. The system incorporates Oracle databases and Epic flowsheets. Patients complete patient-reported outcome measures, with data viewable in MyChart and Epic Synopsis Reports. Researchers can access data portals. The highly usable, successful patient-reported outcome measures platform is acceptable to patients and clinicians and achieved 73 percent overall completion rates. 10.1177/1460458218813710
    [Application and prospect of scale measurement and appraisal in the assessment in TCM therapeutic efficacy evaluation]. Liu Feng-Bin Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine The assessing contents of the health related quality of life (HRQOL) and the patient reported outcomes (PRO) are identical with the inquiry of traditional Chinese medicine (TCM), which are uniformly soft indicators which could be evaluated with the scales for instruments. The assessing method for the soft indicator in the HRQOL and PRO was gradually accepted by TCM practitioners and applied in evaluating the curative effect of TCM. The applying scale in the assessment of curative effect of TCM and the developing scale with the TCM features just started in the TCM field. There was much inadequacy in the scale study, such as no penetrating understanding of the theory and connotation of the scale in the HRQOL and PRO, on scale system for TCM, no direction in selecting scale, not standardizing in the design of the study with scale in the practice. So, it is necessary that the international guideline of developing scale applied for worldwide should be carried out in the study for developing scale. Meanwhile, it must also be under the guidance of TCM theory in the whole course. It will promote the normalization development of applying scale in the assessment of curative effect in the TCM practice.
    [Development of patient-reported outcome scale for myasthenia gravis: a psychometric test]. Chen Xin-lin,Liu Feng-bin,Guo Li,Liu Xiao-bin Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine OBJECTIVE:To investigate the scientificity of patient-reported outcome (PRO) scale for myasthenia gravis (MG), which was used to evaluate the clinical effects of traditional Chinese and Western medicine treatment on MG patients. Psychometric performance of the MG-PRO scale was also expected to be evaluated in this study. METHODS:A total of 100 MG patients and 100 healthy people were face-to-face interviewed by well-trained investigators, and the data of MG-PRO scale were collected. The classical theory test (CTT) and item response theory (IRT) methods were used to analyze the psychometric performance such as validity, reliability, person separation index (PSI) and differential item functioning (DIF) in the MG-PRO scale. RESULTS:The results of CTT analysis showed that the split-half reliabilities of the MG-PRO scale and each dimension were greater than 0.7. In the analysis of internal consistency of each dimension, the Cronbach's alpha was greater than 0.8. Each facet had greater correlation with its dimension than the other dimensions. Four principal components were extracted by exploratory factor analysis, which represented all dimensions of the scale, and the cumulative variance was 55.54%. The scores of each of the 8 facets between MG patients and healthy people were different (P<0.01). The results of IRT showed that the PSI of each model was greater than 0.8, and all items did not have uniform DIF and non-uniform DIF. CONCLUSION:The MG-PRO scale reflects the definition and connotation of quality of life and contains special issues of MG patients as well, and shows good reliability (split-half reliability, Cronbach's alpha), validity (content validity, construct validity, discriminate validity) from the results of CTT, and good psychometric performance from the results of IRT.
    [Development of a patient-reported outcome scale for stable chronic obstructive pulmonary disease and its clinical applicability]. Zhu Yan-bo,Li You-lin,Wang Wei,Jiang Fang-chao Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine OBJECTIVE:To develop a patient-reported outcome (PRO) scale for patients with stable chronic obstructive pulmonary disease (sCOPD) and to study its clinical applicability in traditional Chinese medicine (TCM). METHODS:According to standardized procedures, the test version of PRO scale for sCOPD (sCOPD-PRO scale) was developed based on the theory of "unity of body and spirit" and was used to test 324 patients selected from six clinical centers. Five methods were used to analyze the items; the reliability, validity and responsiveness of the remaining items of the scale were evaluated. RESULTS:(1) sCOPD-PRO consisted of 23 items after item analysis, and according to the content of each item, these items could be grouped into four domains, namely, lung and kidney deficiency symptom, spleen deficiency symptom, functional activities and emotional impact. (2) Cronbach's alpha coefficient for sCOPD-PRO scale was more than 0.75 in four domains and total scores. (3) sCOPD-PRO scale and St. George's Respiratory Questionnaire (SGRQ) were moderately correlated or highly correlated in corresponding domains: the correlation coefficient between the total score of sCOPD-PRO scale and the total score of SGRQ was 0.72 (P<0.01), the correlation coefficient between functional activities domain of sCOPD-PRO scale and activity domain of SGRQ was 0.77 (P<0.01), and the correlation coefficient between emotional impact domain of sCOPD-PRO scale and impact domain of SGRQ was 0.51 (P<0.01). Factor analysis revealed that four factors could explain 65.06% of the total variance. (4) The four domains and total scores of sCOPD-PRO scale were significantly different before and after intervention in TCM group and Western medicine group (P<0.01); moreover, the effect size and standardized response mean of two groups were more than 0.4. CONCLUSION:The development process and method of sCOPD-PRO scale, which is based on the theories of "unity of body and spirit", are standard, and the reliability, validity and responsiveness of the scale are sound and can be relied upon for sCOPD clinical efficacy evaluation of TCM.
    The Clinical Relevance of Serum NDKA, NMDA, PARK7, and UFDP Levels with Phlegm-Heat Syndrome and Treatment Efficacy Evaluation of Traditional Chinese Medicine in Acute Ischemic Stroke. Han Xiuxiu,Gao Yonghong,Ma Bin,Gao Ying,Sun Yikun,Jiang Ru,Wang Yayun Evidence-based complementary and alternative medicine : eCAM According to the methods of Patient-Reported Outcome (PRO) based on the patient reports internationally and referring to U.S. Food and Drug Administration (FDA) guide, some scholars developed this PRO of stroke which is consistent with China's national conditions, and using it the feel of stroke patients was introduced into the clinical efficacy evaluation system of stoke. "Ischemic Stroke TCM Syndrome Factor Diagnostic Scale (ISTSFDS)" and "Ischemic Stroke TCM Syndrome Factor Evaluation Scale (ISTSFES)" were by "Major State Basic Research Development Program of China (973 Program) (number 2003CB517102)." ISTSFDS can help to classify and diagnose the CM syndrome reasonably and objectively with application of syndrome factors. Six syndrome factors, internal-wind syndrome, internal-fire syndrome, phlegm-dampness syndrome, blood-stasis syndrome, qi-deficiency syndrome, and yin-deficiency syndrome, were included in ISTSFDS and ISTSFES. TCM syndrome factor was considered to be present if the score was greater than or equal to 10 according to ISTSFDS. In our study, patients with phlegm-heat syndrome were recruited, who met the diagnosis of both "phlegm-dampness" and "internal-fire" according to ISTSFDS. ISTSFES was used to assess the syndrome severity; in our study it was used to assess the severity of phlegm-heat syndrome (phlegm-heat syndrome scores = phlegm-dampness syndrome scores + internal-fire syndrome scores). 10.1155/2015/270498
    [Scientific Evaluation of TCM Clinical Outcomes Rating Scale for Heart Failure Based on Patients Report]. Zhao Zhi-qiang,Mao Jing-yuan,Wang Xian-liang,Hou Ya-zhu,Bi Ying-fei Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine OBJECTIVE:To evaluate the reliability, validity, and responsiveness of traditional Chinese medicine (TCM) clinical outcomes rating scale for heart failure (HF) based on patients' report. METHODS:TCM clinical outcomes rating scale for HF (TCM-HF-PRO) were evaluated based on 340 HF patients' report from multiple centers. The completion of the investigation was recorded. Cronbach's α coefficient and split-half reliability were used for reliability analysis, and factor analysis was used to assess the construct validity of the rating scale. Pearson correlation analysis was then used for criterion validity analysis. Discriminant analysis was used to assess the responsiveness of the scale. All 340 HF patients having complete TCM-HF-PRO data were assigned to the treatment group and the control group by central randomization. The total TCM-HF-PRO scores of the two groups were compared using paired t-test to reflect the longitude responsiveness of the scale before treatment and at week 2 after treatment. RESULTS:(1) The recycling rate of the scale was 100.0%. One of them was not filled completely, which was rejected thereby. So the completion rate was 99.7%. The completion time for TCM-HF-PRO scale ranged 15 to 25 min. (2) The Cronbach's α coefficient of rating scale was 0.903, split-half reliability was 0.844 and 0.849. (3) Confirmatory factor analysis showed that 7 factors and items formed according to maximum load factor basically coincided with the construct of the rating scale, 7 factors accumulated contribution rate was 43.8%. TCM clinical outcomes rating scale for HF based on patients' report was relatively better correlated with the Minnesota living with HF questionnaire (r = 0.726, P < 0.01). (4) Discriminant analysis showed that the rating scale correctly classified more than 78.8% of case studies having confirmed initial differential diagnosis by experts. The total scale of the rating scale decreased more in the two group after treatment, with significant difference as compared with before treatment (P < 0.01. CONCLUSION:TCM clinical outcomes rating scale for HF based on patients' report had good reliability, validity and responsiveness, hence it could be used to assess clinical efficacy for HF patients.
    Development and Evaluation of a Patient-Reported Outcome (PRO) Scale for Breast Cancer. Zhang Jun,Yao Yu-Feng,Zha Xiao-Ming,Pan Li-Qun,Bian Wei-He,Tang Jin Hai Asian Pacific journal of cancer prevention : APJCP BACKGROUND:This study was guided by principles of the theoretical system of evidence-based medicine. In particular, when searching for evidence of breast cancer, a measuring scale is an instrument for evaluating curative effects in accordance with the laws and characteristics of medicine and exploring the establishment of a system for medically assessing curative effects. At present, there exist few tools for evaluating curative effects. Patient- reported outcomes (PROs) refer to outcomes directly reported by patients (without input or explanations from doctors or other intermediaries) with respect to all aspects of their health. Data obtained from PROs provide evidence of treatment effects. MATERIALS AND METHODS:In accordance with the tenets of theoretical medicine and ancient medical theory regarding breast cancer, principles for developing a PRO scale were established, and a theoretical model was developed and a literature review was performed, items from this pool were combined and split, and an initial scale was constructed. After a pilot survey and additional modifications, a pre-questionnaire scale was formed and used in a field investigation. After the application of statistical methods, the item pool was used to create a formal scale. The reliability, validity and feasibility of this formal scale were then assessed. RESULTS:In a clinical investigation, 479 responses were recovered, with an acceptance rate of 95%. a combination of various methods was employed, and the items that were selected by all methods or more than half of the methods were employed in the questionnaire. In these cases, the screening methods were combined with certain features of the item, A total of four domains and 38 items were reserved. The reliability analysis indicated that the PRO scale was relatively reliable. CONCLUSIONS:Scientific assessment proved that the proposed scale exhibited good reliability and validity. This scale was readily accepted and could be used to assess the curative effects of medical therapy. However, given the limited scope of this investigation, the capacity for adapting this scale to incorporate other theories could not be determined. 10.7314/apjcp.2015.16.18.8573
    Validation and Application of the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM). Li Zhandong,Shi Qiuling,Liu Meng,Jia Liqun,He Bin,Yang Yufei,Liu Jie,Lin Hongsheng,Lin Huei-Kai,Li Pingping,Wang Xin Shelley Journal of the National Cancer Institute. Monographs Background:The MD Anderson Symptom Inventory (MDASI) is a brief, yet thorough, patient-reported outcomes measure for assessing the severity of common cancer-related symptoms and their interference with daily functioning. We report the development of an MDASI version tailored for use with Traditional Chinese Medicine in China (the MDASI-TCM). Methods:Chinese-speaking patients with mixed cancer types (n = 317) participated in the study. The development and validation process included four steps: 1) identify candidate TCM-specific items, with input from patients, oncologists, and TCM specialists; 2) eliminate candidate TCM items lacking relevance, based on patient report; 3) psychometrically examine the MDASI-TCM's validity and reliability in cancer patients receiving TCM-based care; and 4) cognitively debrief patients to assess the MDASI-TCM's relevance, understandability, and acceptability. Results:Seven TCM-specific symptom items (sweating, feeling cold, constipation, bitter taste, coughing, palpitations, and heat in palms/soles) were clinically and psychometrically meaningful to add to the core MDASI. Approximately 61% of patients had moderate to severe symptoms (rated ≥5 on the MDASI-TCM's 0-10 scale). Cronbach α coefficients were .90 for symptom-severity items and .93 for interference items, indicating internal consistency reliability. Known-group validity was substantiated by the MDASI-TCM's detection of differences in symptom severity according to performance status (P < .001) and interference levels by cancer stage (P < .05). Cognitive debriefing indicated that patients found the MDASI-TCM to be an understandable, easy-to-use tool. Conclusions:The Chinese MDASI-TCM is a valid, reliable, and concise measure of symptom severity and interference that can be used to assess Chinese cancer patients and survivors receiving TCM-based care. 10.1093/jncimonographs/lgx010
    Review and analysis of literature on indicators of women's drinking problems. Schmidt C,Klee L,Ames G British journal of addiction Our goal is to identify more relevant indicators of women's drinking problems. We first reviewed the literature on women's drinking problems to uncover the major issues and research problems that previous studies have raised. We then systematically analyzed 464 indicators of women's alcohol problems cited in the literature from 1970-86. We calculated the frequency of their appearance by source (literature review, clinical studies, research articles, or surveys) and organized them into a comprehensive indicator taxonomy that included physiological, social, psychological and behavioral categories. The resulting taxonomy can serve as a baseline for grounding indicators of women's alcohol problems collected from other sources, such as ethnographic studies of particular populations or surveys of the general population.
    [Mathematical analysis of the relationship between yang deficiency syndrome in traditional Chinese medicine and its objective indicators in clinical literature]. Jin Rui,Lin Qian,Liu Sen-Mao,Zhao Qian,Zhang Qian,Zhang Bing Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine OBJECTIVE:The primary aim of this research is to systematically sort out and analyze available documents for yang deficiency syndrome in traditional Chinese medicine, providing innovative ideas and methods for statistical study of yang deficiency syndrome. METHODS:Based on the China National Knowledge Internet (CNKI) and Chongqing VIP databases, using "yang deficiency", "deficiency cold", and "patient" as keywords, we searched literature of clinical researches and used "ratio-comparison" and "integration-comparison" to analyze objective data after data preprocessing. Relative importance value of physiological and biochemical parameters were reflected by P value calculated by ratio-comparison or Q value by integration-comparison. RESULTS:With calculation of relative importance values of clinical indicators among various systems, we got the ranking of relative importance of different indexes. Triiodothyronine and urine 17-hydroxycorticosteroid of endocrine system, immunoglobulin A of immune system, and the ratio of cyclic adenosine monophosphate to cyclic guanosine monophosphate, which had great |P| (or |Q|) values and negative P (or Q) values, had a clearly lower level in yang deficiency patients than in the control; hemorheological indicators such as plasma viscosity, whole blood reduced viscosity and erythrocyte electrophoresis time had small |P| (or |Q|) values. These indicators, however, showed less importance for reflecting yang deficiency. CONCLUSION:Ratio-comparison method and integration-comparison method employed in this study have merits of efficiency and robustness. After detailed compiling and mining of all available data, we have made reasonable advice on the most relevant index of yang deficiency for further study of the essence of this syndrome.
    Assessment of the reporting quality of randomized controlled trials on treatment of coronary heart disease with traditional chinese medicine from the chinese journal of integrated traditional and Western medicine: a systematic review. Fan Fang-fang,Xu Qin,Sun Qi,Zhao Sheng-jun,Wang Ping,Guo Xue-rui PloS one BACKGROUND:Due to language limitations, little is known about the reporting quality of randomized clinical trials (RCTs) on the treatment of coronary heart disease (CHD) with traditional Chinese medicine (TCM) in Chinese Journal of Integrated Traditional and Western Medicine (CJITWM). OBJECTIVE:In this study, we utilized the CONSORT 2010 statement to understand the reporting quality of RCTs on CHD with TCM from the CJITWM. METHODS:The China National Knowledge Infrastructure (CNKI) electronic database was searched for CJITWM RCTs on the treatment of CHD with TCM, published between January 1, 2006 and December 31, 2011. We excluded articles reported as "animal studies," "topic review," "diagnostic test," "editorials," or "others." The CONSORT checklist was applied to evaluate the reporting quality of all eligible articles by two independent authors after extensive discussion. Each item was graded as either "yes" or "no" depending on whether the authors had reported it or not. RESULTS:We identified 21 articles meeting our inclusion criteria. The percentage of 11 of the 37 items was 4.8 ∼ 95.2%, 14 of the 37 items were reported in all included articles, while 12 items were not mentioned at all. The average reporting percentage for the "title and abstract" section was 52.4%, for the "introduction" section 100.0%, for the "methods" section 45.4%, for the "results" section 57.1%, for the "discussion" section 79.4%, and for the "other information" section 17.5%. CONCLUSION:In general, the reviewed RCTs were not consistent with the CONSORT 2010 statement. Authors should adhere to the CONSORT statement in reporting RCTs; editorial departments may consider the CONSORT statement as a guideline and should instruct authors to write manuscripts, and reviewers to judge them according to CONSORT statutes. 10.1371/journal.pone.0086360
    Reporting of randomized controlled trials in andrology journals: a quality assessment. Jo Jung Ki,Chung Jae Hoon,Kim Kyu Shik,Song Soo Hyun,Lee Seung Wook The journal of sexual medicine INTRODUCTION:Quality assessment of randomized controlled trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. AIM:The aim of this study was to analyze the quality of studies reporting RCTs in andrology journals (The Journal of Sexual Medicine [JSM], the Asian Journal of Andrology [AJA], the Journal of Andrology [JOA], the International Journal of Andrology [IJA]). METHODS:A quality assessment was conducted on all studies identified as RCTs published in andrology journals (JSM, AJA, JOA, IJA) until 2011. The review period was divided into three terms: early, mid, and late each journal. MAIN OUTCOME MEASURES:The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool (CCRBT) were employed. The RCTs were also categorized by country of origin, the inclusion of institutional review board (IRB) approval, funding, and blindness. RESULTS:There were1,954 original articles published in the JSM, 893 articles in the AJA, 2,527 articles in the JOA, and 2,086 articles in the IJA for the review period. There were 172 studies reporting on RCTs in the JSM, 33 RCTs in the AJA, 63 RCTs in the JOA, and 29 RCTs in the IJA. No significant increase in Jadad or van Tulder scale scores were found over time, nor were there any significant changes in the number of high-quality articles as assessed by CCRBT. However, significant differences in quality analysis were found according to blinding, funding, and IRB approval. CONCLUSION:The number of original articles and RCTs in andrology increased over time. However, the ratio of RCTs to original articles as well as RCT quality was statistically insignificant. It would be required for the researchers to focus efforts in performing high-quality studies to ensure appropriate randomization, reviews by IRB, financial support, and inclusion of allocation concealment during study performance. 10.1111/jsm.12784
    Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement. Peters Jeroen P M,Hooft Lotty,Grolman Wilko,Stegeman Inge PloS one BACKGROUND:Randomised Controlled Trials (RCTs) are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed. OBJECTIVES:(1) To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2) to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3) to formulate recommendations for authors and editors of otorhinolaryngologic ('ENT') journals. METHODS:Based on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types. RESULTS:Otorhinolaryngologic RCTs (n = 15) published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%-94.7%) of CONSORT items adequately, whereas RCTs (n = 18) published in ENT journals reported a mean of 71.8% (66.7%-76.8%) adequately (p < 0.001). For abstracts, means of 70.0% (63.7%-76.3%) and 32.3% (26.6-38.0%) were found respectively (p < 0.001). Large differences for specific items exist between the two journal types. CONCLUSION:The quality of reporting of RCTs in otorhinolaryngologic journals is suboptimal. RCTs published in general medical journals have a higher quality of reporting than RCTs published in ENT journals. We recommend authors to report their trial according to the CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts. 10.1371/journal.pone.0122328
    Reporting Quality Assessment of Randomized Controlled Trials Published in Nephrology Urology Monthly Journal. Mehrazmay Alireza,Karambakhsh Alireza,Salesi Mahmood Nephro-urology monthly CONTEXT:Randomized controlled trials (RCTs) are important tools for evidence-based health care decisions. It is, therefore, important that they be conducted and reported with the highest possible standards. The aim of this study was to evaluate the reporting quality of the RCTs published in nephrology urology monthly journal and to examine whether there was a change over time in the reporting quality. EVIDENCE ACQUISITION:The quality of each report was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement checklist and a 5-point quality assessment instrument, i.e. the Jadad scale. RESULTS:Eighteen (14 Iranian and 4 non-Iranian) RCTs were published from 2012 to 2014 on topics including renal stone (16.6%), hemodialysis and transplantation (38.8%), and prostate conditions (11.1%). Interventions comprised surgery, drugs, and teaching method in 7 (38 %), 10 (55%), and 1 (5%) of them, respectively. According to the CONSORT checklist, the weakest reported items were registration number, identification as a randomized trial in the title, and settings and locations where the data were collected. The mean Jadad score of the reports was 2.72 ± 1.36 (54% of their maximum possible total score). According to the Jadad and CONSORT scales, there was an increase in the quality of reporting from 2012 to 2014. CONCLUSIONS:This assessment shows low reporting quality scores in reports. Training courses for researchers, using standard reporting tools (e.g. CONSORT 2010 Statement checklist), and consultation with methodologists can improve the quality of published RCTs. 10.5812/numonthly.28752
    Quality of reporting and assessment of patient-reported health-related quality of life in patients with brain metastases: a systematic review. DiRisio Aislyn C,Harary Maya,van Westrhenen Anouk,Nassr Eman,Ermakova Anastasia,Smith Timothy R,Dirven Linda,Taphoorn Martin J B,Mekary Rania A,Broekman Marike L D Neuro-oncology practice Brain metastases (BMs) have become increasingly prevalent and present unique considerations for patients, including neurocognitive sequelae and advanced disease burden. Therefore, assessing health-related quality of life (HRQoL) via patient-reported outcome measures (PROMs) is an important element of managing these patients. A systematic review of the literature was conducted with the aims of (1) assessing how PROMS used in BM patients were validated, (2) assessing PROM content, and (3) evaluating quality of PROM-results reporting. PROM validation and quality of reporting were assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) grading criteria and International Society of Quality of Life (ISOQOL)-recommended PROM-reporting standards, respectively. Forty-seven studies reporting on 5178 patients with a range of primacy cancer types were included. Eight different PROMs were applied, ranging from general to brain-specific questionnaires. Weaknesses in the validation of these PROMs were assessed by the COSMIN criteria. Many of these PROMs were not developed for BM patients and contained little information on cognitive symptoms. The overall quality of PROM reporting was insufficient based on the ISOQOL scale. Given the unique clinical considerations in BM patients, our results indicate the need for a standardized, validated questionnaire to assess HRQoL in this population. Additionally, there is room for quality improvement with regard to reporting of PROM-related results. 10.1093/nop/npy024
    Assessment of the quality of reporting of randomized clinical trials in paediatric dentistry: A comparative systematic review. Alnamankany Abeer,Ashley Paul Journal of Taibah University Medical Sciences Objectives:This systematic review aimed to determine the improvement in quality of the reporting of randomized clinical trials (RCTs) in paediatric dentistry. The quality of reporting during the period 2014-2015 was compared with the quality of reporting during 1985-2006. Methods:This systematic review compared the scientific quality of RCTs in paediatric dentistry published in five paediatric dentistry journals during the defined periods. The Consolidated Standards for Reporting Trials (CONSORT) checklist of 2010 was used to evaluate the quality of reporting. The inter-reviewers' agreement was assessed by calculating the kappa score, and disagreements between reviewers were resolved by consequent discussion. The values and percentages were used to test for significant differences between the two reviews (1985-2006 and 2014-2015). Results:A total of 40 articles were included. Although the quality of reporting showed considerable heterogeneity, the overall quality of reporting by RCTs was satisfactory and had improved over the years. Conclusions:Using CONSORT checklist, this study showed general improvement in the quality of reporting of RCTs published in pediatric dentistry journals in all article's sections. 10.1016/j.jtumed.2019.12.006
    Implementing large-scale health system strengthening interventions: experience from the better health outcomes through mentoring and assessments (BHOMA) project in Zambia. Mutale Wilbroad,Cleary Susan,Olivier Jill,Chilengi Roma,Gilson Lucy BMC health services research BACKGROUND:Under the Doris Duke Charitable Foundation's African Health Initiative, five Population Health Implementation and Training partnerships were established as long-term health system strengthening projects in five Sub-Saharan Countries. In Zambia, the Centre for Infectious Disease Research in Zambia began to implement the Better Health Outcomes through Mentorship and Assessments (BHOMA) in 2009. This was a combined community and health systems project involving 42 public facilities and their catchment populations. The impact of this intervention is reported elsewhere, but less attention has been paid to evaluation approaches that generate an understanding of the forces shaping the intervention. This paper is focused on understanding the implementation practices of the BHOMA intervention in Zambia. METHODS:Qualitative approaches were employed to understand and explain health systems intervention implementation practices between 2014 and 2016. We purposively sampled six clinics out of the 42 that participated in the BHOMA project within three districts of Lusaka province in Zambia. At the facility-level we targeted health centre in-charges, health workers, and community health workers. In-depth interviews (n = 22), focus group discussions (n = 3) and observations were also collected and synthesised. RESULTS:The major health system challenges addressed by the BHOMA project included poor infrastructure, lack of human resources, poor service delivery, long distances to health centres and inadequate health information systems. In order to implement this in the districts it was necessary to engage with the Ministry of Health and district managers, however, these partners were not actively engaged in intervention design There was great variation in perceptions about the BHOMA interventions. The implementation team considered BHOMA as a 'proof of concept pilot project', running parallel to the public health system, while district health officials from the Ministry of health understood it as a 'long term partner' and were therefore resistant to the short-term nature of the intervention. CONCLUSIONS:The Normalization Process Theory provided a useful framework to understand and explain implementation processes for the BHOMA intervention in Zambia. We clearly demonstrated the applicability of all the four main components of the NPT: coherence (or sense-making); cognitive participation (or engagement); collective action and reflexive monitoring. We demonstrated how complex and dynamic the intervention played out among different actors and how implementation was affected by difference in appreciation and interpretation of the goal of the intervention. Our findings support the growing demand for process evaluations to use theory based approaches to examine how context interact with local interventions to affect outcomes intended or not. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01942278 . Registered: September 13, 2013 (Retrospectively registered). 10.1186/s12913-018-3619-3
    Further validation of the Health Scale of Traditional Chinese Medicine (HSTCM). Wu Darong,Lai Shilong,Zhou Luojing,Guo Xinfeng,Liang Weixiong,Wen Zehuai,Ou Aihua,Zhang Guangqing,Chen Keji Chinese medicine BACKGROUND:Few health measurement scales are based on Chinese medicine theory. The Health Scale of Traditional Chinese Medicine (HSTCM) was developed to fill this gap. The aim of this study is to validate the HSTCM. METHODS:A convenience sample of 630 participants was recruited in 11 settings. All participants were asked to complete the HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF). RESULTS:Properties of the HSTCM were tested. Intra-class correlation coefficient representing the inter-interviewer reliability was 0.99 (95%CI) for the overall instrument. Spearman-Brown correlation coefficient and Cronbach's coefficient alpha were 0.81 and 0.94 respectively, indicating satisfactory internal reliability and inter-interviewer reliability. Spearman's rho correlation coefficient between the HSTCM and WHOQOL-BREFF was -0.67. A receiver operating characteristic (ROC) curve analysis was performed to test the discriminate validation. Areas under the ROC curve analysis for the HSTCM and its domains ranged 0.71-0.87 and all the lower levels of 95%CI were greater than 0.50. CONCLUSION:The HSTCM was validated as a generic health scale and may complement existing health measurement scales in Chinese medicine health care. 10.1186/1749-8546-4-8
    [A study of scale response for Health Scale of Traditional Chinese Medicine]. Wu Da-Rong,Lai Shi-Long,Liang Wei-Xiong,Guo Xin-Feng,Ou Ai-Hua,Wen Ze-Huai Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine OBJECTIVE:To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM). METHODS:A cross-sectional investigation was carried out among 28 hospital staff members by using 151 scale descriptors. This investigation involved all the descriptors from the initial version of HSTCM. Each response scale had five ordinal descriptors, including two anchors at extreme levels and three intermediates. The participants were invited to determine the two anchors of extreme levels, and then to place each descriptor on a 10-centimeter (0 to 10 cm) line according to where they considered the descriptor lay in relation to the two anchors. RESULTS:The selection of scale descriptors was based on comprehensive considerations regarding the median, average score and standard deviation of each descriptor. The main rule of selection was to choose the descriptor of extreme level anchor with a median value closer to 0 or 10, and the same for the selection of descriptors of the intermediates, which should possess a median value closer to 2.5 or 5 or 7.5. If two descriptors had similar median values, we compare the average score and/or the standard deviation of these descriptors and prefer to keep the one containing either an average score closer to anchor point or a less value of standard deviation. Furthermore, the codes of Chinese language were also considered. Four kinds of response scales including capacity, frequency, evaluation, and intensity with a total of 85 scale descriptors were selected. For HSTCM, a total of 8.24% (7/85) descriptors for 14.9% (7/47) items were revised based on the study results. CONCLUSION:The scale descriptors selected are suitable for HSTCM and the results can be referenced in developing similar health profile assessment. 10.3736/jcim20090803
    Development, reliability and validity of Traditional Chinese Medicine Health Self-Evaluation Scale (TCM-50). Zhang Hui-Min,Bai Ming-Hua,Wang Qi Chinese journal of integrative medicine OBJECTIVE:To develop a health-evaluating scale from a Chinese medicine (CM) perspective and reflecting CM conception of health. METHODS:The Traditional Chinese Medicine Health Self-Evaluation Scale (TCM-50) was developed by verification of dimensions, formation of item pool, verification of scoring methodology, and pilot test of scale and item analysis. RESULTS:TCM-50 composed of 50 items that could be classified into 4 dimensions including physiology and health, psychology and health, nature and health, and society and health. An examination of reliability and validity of TCM-50 yielded Cronbach's α coefficient of 0.927, and half coefficient of was 0.876. The intraclass correlation coefficient of total score was 0.912. After using SF-36 questionnaire to evaluate the criterion validity, the Pearson of the score of the two scales from the same participant was 0.740. CONCLUSIONS:TCM-50 has good reliability and validity, and can yield similar levels of efficacy as SF-36 in terms of evaluating people's overall health level. As a scale based on CM theory, TCM-50 is suitable for self-measuring the general health of Chinese patients. 10.1007/s11655-014-1853-z
    Development of a Traditional Chinese Medicine Syndrome-Specific Scale for Ulcerative Colitis: The Large Intestine Dampness-Heat Syndrome Questionnaire. Chen Xin-Lin,Wen Yi,Wu Zu-Chun,Zhang Bei-Ping,Hou Zheng-Kun,Xiao Jun-Lin,Lin Man-Qing,Hu Yue,Wu Zhe-Li,Deng Jie-Min,Liu Feng-Bin,Liu Tian-Wen Evidence-based complementary and alternative medicine : eCAM The aim of this study was to develop and validate the large intestine dampness-heat syndrome questionnaire (LIDHSQ) for patients with ulcerative colitis (UC). The domains and items of the LIDHSQ were developed according to standard procedures, namely, construct definition, item generation, language testing, content validity, pilot study, and validation study. At first, a total of 20 items in 3 domains were generated based on literature review and expert consultation. After the item selection, the LIDHSQ contains 11 items in three domains: disease-related domain (diarrhoea, abdominal pain, bloody purulent stool, and mucus stool), heat domain (fever, dry mouth, red tongue, yellow fur, and anal burning), and dampness domain (greasy fur and defecation disorder). The Cronbach's alphas of all domains were greater than 0.6. All of the intraclass correlation coefficients were greater than 0.8. The LIDHSQ and domain scores of the patients with LIDHS were higher than those of the patients with other syndromes ( < 0.001). The area under the receiver operating characteristic curve of the LIDHSQ was 0.900, with a 95% confidence interval of 0.872-0.928. When the cut-off value of the LIDHSQ was ≥ 7, the sensitivity and specificity were 0.867 and 0.854, respectively. The LIDHSQ is valid and reliable for measuring LIDHS in UC patients with good diagnostic efficacy. We recommend the use of the LIDHSQ in Chinese UC patients. 10.1155/2018/4039019