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1.  Measurement of Physician-Patient Communication—A Systematic Review 
PLoS ONE  2014;9(12):e112637.
Background
Effective communication with health care providers has been found as relevant for physical and psychological health outcomes as well as the patients' adherence. However, the validity of the findings depends on the quality of the applied measures. This study aimed to provide an overview of measures of physician-patient communication and to evaluate the methodological quality of psychometric studies and the quality of psychometric properties of the identified measures.
Methods
A systematic review was performed to identify psychometrically tested instruments which measure physician-patient communication. The search strategy included three databases (EMBASE, PsycINFO, PubMed), reference and citation tracking and personal knowledge. Studies that report the psychometric properties of physician-patient communication measures were included. Two independent raters assessed the methodological quality of the selected studies with the COSMIN (COnsensus based Standards for the selection of health status Measurement INtruments) checklist. The quality of psychometric properties was evaluated with the quality criteria of Terwee and colleagues.
Results
Data of 25 studies on 20 measures of physician-patient communication were extracted, mainly from primary care samples in Europe and the USA. Included studies reported a median of 3 out of the nine COSMIN criteria. Scores for internal consistency and content validity were mainly fair or poor. Reliability and structural validity were rated mainly of fair quality. Hypothesis testing scored mostly poor. The quality of psychometric properties of measures evaluated with Terwee et al.'s criteria was rated mainly intermediate or positive.
Discussion
This systematic review identified a number of measures of physician-patient communication. However, further psychometric evaluation of the measures is strongly recommended. The application of quality criteria like the COSMIN checklist could improve the methodological quality of psychometric property studies as well as the comparability of the studies' results.
doi:10.1371/journal.pone.0112637
PMCID: PMC4273948  PMID: 25532118
2.  Assessment of Trust in Physician: A Systematic Review of Measures 
PLoS ONE  2014;9(9):e106844.
Over the last decades, trust in physician has gained in importance. Studies have shown that trust in physician is associated with positive health behaviors in patients. However, the validity of empirical findings fundamentally depends on the quality of the measures in use. Our aim was to provide an overview of trust in physician measures and to evaluate the methodological quality of the psychometric studies and the quality of psychometric properties of identified measures. We conducted an electronic search in three databases (Medline, EMBASE and PsycInfo). The secondary search strategy included reference and citation tracking of included full texts and consultation of experts in the field. Retrieved records were screened independently by two reviewers. Full texts that reported on testing of psychometric properties of trust in physician measures were included in the review. Study characteristics and psychometric properties were extracted. We evaluated the quality of design, methods and reporting of studies with the COnsensus based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. The quality of psychometric properties was assessed with Terwee’s 2007 quality criteria. After screening 3284 records and assessing 169 full texts for eligibility, fourteen studies on seven trust in physician measures were included. Most of the studies were conducted in the USA and used English measures. All but one measure were generic. Sample sizes range from 25 to 1199 participants, recruited in very heterogeneous settings. Quality assessments revealed several flaws in the methodological quality of studies. COSMIN scores were mainly fair or poor. The overall quality of measures’ psychometric properties was intermediate. Several trust in physician measures have been developed over the last years, but further psychometric evaluation of these measures is strongly recommended. The methodological quality of psychometric property studies could be improved by adhering to quality criteria like the COSMIN checklist.
doi:10.1371/journal.pone.0106844
PMCID: PMC4160203  PMID: 25208074
3.  The Assessment of Complementary and Alternative Medicine Use Among Individuals with HIV: A Systematic Review and Recommendations for Future Research 
Abstract
Objectives
The use of complementary and alternative medicine (CAM), a group of health care practices and products that are not considered part of conventional medicine, has increased in recent years, particularly among individuals with human immune deficiency virus (HIV). Assessing the prevalence and predictors of CAM use among HIV-positive populations is important because some CAM therapies may adversely affect the efficacy of conventional HIV medications. Unfortunately, CAM use is not comprehensively or systematically assessed among HIV-positive populations. Therefore, the aim of the present study was to evaluate the quality of the instruments employed in observational studies assessing CAM use among HIV-positive populations by examining the degree to which these studies (1) evaluated the psychometric properties of their CAM instruments and (2) assessed the multidimensional nature of CAM use.
Design
A systematic review of studies was undertaken and specific review criteria were used to guide the inclusion of studies. Specifically, articles were included that were published in English and in a peer-reviewed journal between 1997 and 2007, recruited HIV-positive study participants, and assessed CAM use. Thirty-two (32) studies met these inclusion criteria.
Results
Results suggest that CAM assessment among HIV-positive populations continues to be problematic. For example, approximately 20% of the studies assessed the reliability and 3% assessed the validity of the CAM instrument employed.
Conclusions
CAM assessment—regardless of the specific study population—is a complex and challenging task. However, CAM instruments will not become more refined over time in the absence of rigorous psychometric evaluation. Future research must assess reliability and validity and report these data in a clear and nuanced manner.
doi:10.1089/acm.2010.0669
PMCID: PMC3197081  PMID: 21875350
4.  Translation and adaptation of an international questionnaire to measure usage of complementary and alternative medicine (I-CAM-G) 
Background
The growing body of data on prevalence of complementary and alternative medicine (CAM) usage means there is a need to standardize measurement on an international level. An international team has published a questionnaire (I-CAM-Q), but no validation has yet been provided. The aim of the present study was to provide a German measurement instrument for CAM usage (I-CAM-G) which closely resembles the original English version, and to assess it’s performance in two potential samples for measuring CAM usage.
Methods
The English I-CAM-Q questionnaire was translated into German, and adapted slightly. The resulting I-CAM-G questionnaire was then pre-tested on 16 healthy volunteers, and 12 cognitive interviews were carried out. The questionnaire was employed in a sample of breast cancer patients (N = 92, paper and pencil), and a sample from the general population (N = 210, internet survey). Descriptive analyses of items and missing data, as well as results from the cognitive interviews, are presented in this paper.
Results
The translated questionnaire had to be adapted to be consistent with the German health care system. All items were comprehensible, whereby some items were unambiguous (e.g. CAM use yes/no, helpfulness), while others gave rise to ambiguous answers (e.g. reasons for CAM use), or high rates of missing data (e.g. number of times the CAM modality had been used during the last 3 months). 78% of the breast cancer patients and up to 85% of a sample of the general population had used some form of CAM.
Conclusions
Following methodologically sound and comprehensive translation, adaptation and assessment processes using recognized translation procedures, cognitive interviews, and studying the performance of the questionnaire in two samples, we arrived at a German questionnaire for measuring CAM use which is comparable with the international (English) version. The questionnaire appropriately measures CAM use, with some items being more appropriate than others. We recommend the development of a short version.
doi:10.1186/1472-6882-12-259
PMCID: PMC3562528  PMID: 23256756
5.  Development and validation of the CAM Health Belief Questionnaire (CHBQ) and CAM use and attitudes amongst medical students 
Background
The need for Complementary and Alternative Medicine (CAM) and holistic approaches in allopathic medical school curricula has been well articulated. Despite increased CAM instruction, feasible and validated instruments for measuring learner outcomes in this content area do not widely exist. In addition, baseline attitudes or beliefs of medical students towards CAM, and the factors that may have formed them, including use of CAM itself, remain unreported.
Methods
A 10-item measure (CHBQ – CAM Health Belief Questionnaire) was constructed and administered to three successive classes of medical students simultaneously with the previously validated 29-item Integrative Medicine Attitude Questionnaire (IMAQ). Both measures were imbedded in a baseline needs assessment questionnaire. Demographic and other data were collected on students' use of CAM modalities and their awareness and use of primary CAM information resources. Analysis of CHBQ items was performed and its reliability and criterion-related validity were established.
Results
Response rate was 96.5% (272 of 282 students studied). The shorter CHBQ compared favorably with the longer IMAQ in internal consistency reliability. Cronbach's coefficient alpha was 0.75 and 0.83 for the CHBQ and IMAQ respectively. Students showed positive attitudes/beliefs towards CAM and high levels of self-reported CAM use. The majority (73.5%) of students reported using at least one CAM modality, and 54% reported using at least two modalities. Eighty-one percent use the internet as a primary source of information for CAM.
Conclusions
The CHBQ is a practical, valid and reliable instrument for measuring medical student attitudes/beliefs and has potential utility for measuring the impact of CAM instruction. Medical students showed a high self-reported rate of CAM use and positive attitudes towards CAM. Short, didactic exposure to CAM instruction in the first year of medical school did not additionally impact these already positive attitudes. Unlike the IMAQ, which was intended for use with physicians, the CHBQ is generic in design and content and applicable to a variety of learner types. Evaluation measures must be appropriate for specific CAM instructional outcomes.
doi:10.1186/1472-6920-4-2
PMCID: PMC373452  PMID: 14718061
6.  Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist 
Quality of Life Research  2011;21(4):651-657.
Background
The COSMIN checklist is a standardized tool for assessing the methodological quality of studies on measurement properties. It contains 9 boxes, each dealing with one measurement property, with 5–18 items per box about design aspects and statistical methods. Our aim was to develop a scoring system for the COSMIN checklist to calculate quality scores per measurement property when using the checklist in systematic reviews of measurement properties.
Methods
The scoring system was developed based on discussions among experts and testing of the scoring system on 46 articles from a systematic review. Four response options were defined for each COSMIN item (excellent, good, fair, and poor). A quality score per measurement property is obtained by taking the lowest rating of any item in a box (“worst score counts”).
Results
Specific criteria for excellent, good, fair, and poor quality for each COSMIN item are described. In defining the criteria, the “worst score counts” algorithm was taken into consideration. This means that only fatal flaws were defined as poor quality. The scores of the 46 articles show how the scoring system can be used to provide an overview of the methodological quality of studies included in a systematic review of measurement properties.
Conclusions
Based on experience in testing this scoring system on 46 articles, the COSMIN checklist with the proposed scoring system seems to be a useful tool for assessing the methodological quality of studies included in systematic reviews of measurement properties.
doi:10.1007/s11136-011-9960-1
PMCID: PMC3323819  PMID: 21732199
Reproducibility of results; Validation studies; Outcome assessment; Psychometrics; Systematic review; Questionnaire
7.  Internal health locus of control in users of complementary and alternative medicine: a cross-sectional survey 
Background
Complementary and alternative medicine (CAM) is widely used in Germany, with some treatments eligible for health insurance reimbursements. CAM encourages patients to play an active role in their healing process. The belief that a person’s own behavior influences health is assessed as the internal health locus of control (IHLOC). Studies on the association between IHLOC and CAM use yield inconsistent results. Using various indicators of CAM use, we evaluated whether there were differences in IHLOC between different groups of CAM users.
Methods
A cross-sectional online survey was conducted. IHLOC was compared between participants with high and low appraisal of CAM, between participants who used different types of medications (none, CAM, conventional, both), and who consulted with different health care professionals (none, CAM, conventional, both). Independent samples t-tests and ANOVAs were conducted for the total group and for subgroups of chronically ill and healthy participants. Post-hoc, we conducted a multivariate linear regression evaluating which indicators of CAM use or other characteristics showed the strongest association with IHLOC.
Results
A total of 1,054 undergraduate students completed the survey. Participants with high CAM appraisal showed higher IHLOC than those with low CAM appraisal, regardless of whether they were chronically ill (p < .001). Participants without chronic conditions showed higher IHLOC when only using CAM medications than when using either conventional medications alone or both conventional and CAM medications (p < .05). All participants showed higher IHLOC when visiting only CAM practitioners than when visiting either only conventional or both conventional and CAM practitioners (p < .05). CAM appraisal was associated the strongest with IHLOC in the linear regression model.
Conclusions
Generally, participants using CAM more or exclusively, and participants with higher appraisal of CAM showed higher IHLOC than those with less CAM use or lower CAM appraisal. Because of the cross-sectional design, it is not possible to determine whether differences in IHLOC are reasons for or consequences of CAM use. Research using a longitudinal design is needed. The sample, though more representative than most student samples, might not represent the general population. Studies evaluating clinical populations might add to the findings.
doi:10.1186/1472-6882-14-320
PMCID: PMC4158078  PMID: 25174734
Internal-external control; Complementary therapies; Cross-sectional studies
8.  Psychometric Properties of Questionnaires on Functional Health Status in Oropharyngeal Dysphagia: A Systematic Literature Review 
BioMed Research International  2014;2014:458678.
Introduction. Questionnaires on Functional Health Status (FHS) are part of the assessment of oropharyngeal dysphagia. Objective. To conduct a systematic review of the literature on the psychometric properties of English-language FHS questionnaires in adults with oropharyngeal dysphagia. Methods. A systematic search was performed using the electronic databases Pubmed and Embase. The psychometric properties of the questionnaires were determined based on the COSMIN taxonomy of measurement properties and definitions for health-related patient-reported outcomes and the COSMIN checklist using preset psychometric criteria. Results. Three questionnaires were included: the Eating Assessment Tool (EAT-10), the Swallowing Outcome after Laryngectomy (SOAL), and the Self-report Symptom Inventory. The Sydney Swallow Questionnaire (SSQ) proved to be identical to the Modified Self-report Symptom Inventory. All FHS questionnaires obtained poor overall methodological quality scores for most measurement properties. Conclusions. The retrieved FHS questionnaires need psychometric reevaluation; if the overall methodological quality shows satisfactory improvement on most measurement properties, the use of the questionnaires in daily clinic and research can be justified. However, in case of insufficient validity and/or reliability scores, new FHS questionnaires need to be developed using and reporting on preestablished psychometric criteria as recommended in literature.
doi:10.1155/2014/458678
PMCID: PMC4022074  PMID: 24877095
9.  Complementary and alternative medicine use by visitors to rural Japanese family medicine clinics: results from the international complementary and alternative medicine survey 
Background
There is growing interest in the use of complementary and alternative medicine (CAM) throughout the world, however previous research done in Japan has focused primarily on CAM use in major cities. The purpose of this study was to develop and distribute a Japanese version of the International Complementary and Alternative Medicine Questionnaire (I-CAM-Q) to assess the use of CAM among people who visit rural Japanese family medicine clinics.
Methods
Using a Japanese version of the International Complementary and Alternative Medicine Questionnaire (I-CAM-Q), a cross-sectional survey was conducted in three rural family medicine clinics. All patients and those accompanying patients who met inclusion criteria were eligible to participate. Data were entered into SPSS Statistics and analyzed for use by age, gender, and location.
Results
Of the 519 respondents who participated in the project, 415 participants reported CAM use in the past 12 months (80.0%). When prayer is excluded, the prevalence of CAM use drops to 77.3% in the past year, or 403 respondents. The most common forms of CAM used by respondents were pain relief pads (n = 170, 32.8%), herbal medicines/supplements (n = 167, 32.2%), and massage by self or family (n = 166, 32.0%). Female respondents, individuals with higher levels of education, and those with poorer overall health status were more likely to use CAM than respondents without these characteristics. Only 22.8% of CAM therapies used were reported to physicians by survey participants.
Conclusions
These data indicate that CAM use in rural Japan is common. The results are consistent with previous studies that show that Japanese individuals are more interested in forms of CAM such as pain relief pads and massage, than in mind-body forms of CAM like relaxation and meditation. Due to the high utilization of certain CAM practices, and given that most CAM users do not disclose their CAM use to their doctors, we conclude that physicians in rural Japan would benefit by asking about CAM use during patient interviews, and by familiarizing themselves with the potential benefits and risks of commonly used CAM modalities.
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6882-14-360) contains supplementary material, which is available to authorized users.
doi:10.1186/1472-6882-14-360
PMCID: PMC4192731  PMID: 25256591
Complementary and Alternative Medicine (CAM), Integrative medicine; Primary care, Family medicine; Japan, International Complementary and Alternative Medicine Questionnaire (I-CAM-Q)
10.  Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine 
BMC Pediatrics  2002;2:3.
Objective
To examine the quality of reports of complementary and alternative medicine (CAM) systematic reviews in the pediatric population. We also examined whether there were differences in the quality of reports of a subset of CAM reviews compared to reviews using conventional interventions.
Methods
We assessed the quality of reports of 47 CAM systematic reviews and 19 reviews evaluating a conventional intervention. The quality of each report was assessed using a validated 10-point scale.
Results
Authors were particularly good at reporting: eligibility criteria for including primary studies, combining the primary studies for quantitative analysis appropriately, and basing their conclusions on the data included in the review. Reviewers were weak in reporting: how they avoided bias in the selection of primary studies, and how they evaluated the validity of the primary studies. Overall the reports achieved 43% (median = 3) of their maximum possible total score. The overall quality of reporting was similar for CAM reviews and conventional therapy ones.
Conclusions
Evidence based health care continues to make important contributions to the well being of children. To ensure the pediatric community can maximize the potential use of these interventions, it is important to ensure that systematic reviews are conducted and reported at the highest possible quality. Such reviews will be of benefit to a broad spectrum of interested stakeholders.
doi:10.1186/1471-2431-2-3
PMCID: PMC99047  PMID: 11914146
11.  Complementary and Alternative Medicine Use and Quality of Life in Pediatric Diabetes 
Abstract
Objectives
The objectives of this study were to explore the association between complementary and alternative medicine (CAM) use as reported by youth, and parents' and children's reported quality of life in youth with diabetes.
Design
The study design was a cross-sectional survey.
Setting
Youth in Washington State participated in the SEARCH for Diabetes in Youth study, a national, multisite epidemiological study designed to assess the prevalence and incidence of diabetes in U.S. youth. Surveys assessing CAM utilization were mailed in January and April 2006.
Participants
One thousand four hundred and thirty-nine (1439) youth were mailed a CAM survey. The final sample consisted of 467 youth with both CAM survey results and quality-of-life data.
Outcome measures
Difference in mean scores on Pediatric Quality of Life Inventory (PedsQL) between CAM users and nonusers overall, and specific CAM therapies were the outcome measures.
Results
Of the 1439 participants approached, 587 (40.8%) returned the CAM survey. In adjusted analyses, children reported any CAM use as associated with more barriers to treatment (difference in mean scores −3.48, 95% confidence interval [CI] −6.65, −0.31). Children following a CAM diet reported higher quality of life (PedsQL Core Total difference 4.01, 95% CI [0.10–7.91]; Core Psychosocial difference was 6.45, 95% CI [1.95 to 10.95]), but those using stress-reduction activities reported poorer quality of life (Diabetes Total difference −4.19, 95% CI [−8.35 to −0.04]). Parent-reported quality of life was lower for children who used “other supplements” (Core Total difference −6.26, 95% CI [−11.29 to −1.24]; Core Psychosocial difference was −5.92, 95% CI [−11.65 to −0.19]).
Conclusions
CAM diets were associated with increased quality of life in youth with diabetes, whereas supplement use and stress-reduction activities were associated with decreased quality of life. The temporal sequence between CAM use and quality of life requires further study.
doi:10.1089/acm.2008.0566
PMCID: PMC3110095  PMID: 20180689
12.  Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures 
Background
Central to the development of a sound evidence base for Complementary and Alternative Medicine (CAM) interventions is the need for valid, reliable and relevant outcome measures to assess whether the interventions work. We assessed the specific needs for a database that would cover a wide range of outcomes measures for CAM research and considered a framework for such a database.
Methods
The study was a survey of CAM researchers, practitioners and students. An online questionnaire was emailed to the members of the Canadian Interdisciplinary Network for CAM Research (IN-CAM) and the CAM Education and Research Network of Alberta (CAMera). The majority of survey questions were open-ended and asked about outcome measures currently used, outcome measures' assessment criteria, sources of information, perceived barriers to finding outcome measures and outcome domains of importance. Descriptive quantitative analysis and qualitative content analysis were used.
Results
One hundred and sixty-four completed surveys were received. Of these, 62 respondents reported using outcome measures in their CAM research and identified 92 different specific outcomes. The most important barriers were the fact that, for many health concepts, outcome measures do not yet exist, as well as issues related to accessibility of instruments. Important outcome domains identified included physical, psychological, social, spiritual, quality of life and holistic measures. Participants also mentioned the importance of individualized measures that assess unique patient-centered outcomes for each research participant, and measures to assess the context of healing and the process of healing.
Conclusion
We have developed a preliminary framework that includes all components of health-related outcomes. The framework provides a foundation for a larger, comprehensive collection of CAM outcomes. It fits very well in a whole systems perspective, which requires an expanded set of outcome measures, such as individualized and holistic measures, with attention to issues of process and context.
doi:10.1186/1472-6882-6-38
PMCID: PMC1661594  PMID: 17118197
13.  Quality of Life, Perceptions of Health and IIIness, and Complementary Therapy Use Among People with Type 2 Diabetes and Cardiovascular Disease 
Abstract
Objectives
To explore perceptions of health and illness, and the use of complementary and alternative medicine (CAM), among people with type 2 diabetes and/or cardiovascular disease (CVD), and relate these to quality of life.
Design
A self-administered survey was delivered by mail and internet. The questionnaire was designed from data generated from qualitative research and other sources, to collect information on health-status, CAM use, and health and illness perceptions. Quality of life was compared among participants using Assessment of Quality of Life (AQoL-4D).
Subjects
Adults with type 2 diabetes and/or CVD residing in Victoria, Australia, whether or not they used CAM therapies as well as conventional medical treatment.
Outcome measures
Comparisons were made of AQoL-4D utility scores, demographic, health and wellbeing status, care-seeking and health management behaviors, and behavioral and illness perception variables. A range of descriptive statistical and predictive modeling techniques were used to assess significant associations (p<0.01) between CAM-user and non-user populations.
Results
From a sample of 2766 people, 45.1% had used CAM in the past 12 months and the remainder had never used CAM; ages ranged from 20-96 years. CAM-users tended to report lower (worse) quality of life measures than non-users, and a greater number of chronic conditions in addition to diabetes and CVD. Despite this, CAM-users reported their illness perception and behavioral change more positively than non-users. There was little difference between CAM and non-users in use of prescription medications despite CAM-users greater disease burden.
Conclusion
Higher CAM use and low quality of life appear to reflect comorbidity and poor general health. Greater evidence is needed of how CAM use might support chronic illness prevention and complement chronic disease management, with important policy implications concerning the integration of CAM therapies with mainstream health services.
doi:10.1089/acm.2012.0617
PMCID: PMC3842878  PMID: 23790230
14.  Is complementary and alternative medicine (CAM) cost-effective? a systematic review 
Background
Out-of-pocket expenditures of over $34 billion per year in the US are an apparent testament to a widely held belief that complementary and alternative medicine (CAM) therapies have benefits that outweigh their costs. However, regardless of public opinion, there is often little more than anecdotal evidence on the health and economic implications of CAM therapies. The objectives of this study are to present an overview of economic evaluation and to expand upon a previous review to examine the current scope and quality of CAM economic evaluations.
Methods
The data sources used were Medline, AMED, Alt-HealthWatch, and the Complementary and Alternative Medicine Citation Index; January 1999 to October 2004. Papers that reported original data on specific CAM therapies from any form of standard economic analysis were included. Full economic evaluations were subjected to two types of quality review. The first was a 35-item checklist for reporting quality, and the second was a set of four criteria for study quality (randomization, prospective collection of economic data, comparison to usual care, and no blinding).
Results
A total of 56 economic evaluations (39 full evaluations) of CAM were found covering a range of therapies applied to a variety of conditions. The reporting quality of the full evaluations was poor for certain items, but was comparable to the quality found by systematic reviews of economic evaluations in conventional medicine. Regarding study quality, 14 (36%) studies were found to meet all four criteria. These exemplary studies indicate CAM therapies that may be considered cost-effective compared to usual care for various conditions: acupuncture for migraine, manual therapy for neck pain, spa therapy for Parkinson's, self-administered stress management for cancer patients undergoing chemotherapy, pre- and post-operative oral nutritional supplementation for lower gastrointestinal tract surgery, biofeedback for patients with "functional" disorders (eg, irritable bowel syndrome), and guided imagery, relaxation therapy, and potassium-rich diet for cardiac patients.
Conclusion
Whereas the number and quality of economic evaluations of CAM have increased in recent years and more CAM therapies have been shown to be of good value, the majority of CAM therapies still remain to be evaluated.
doi:10.1186/1472-6882-5-11
PMCID: PMC1182346  PMID: 15932647
15.  Complementary and Alternative Medicine Use Was Associated with Higher Perceived Physical and Mental Functioning in Early Systemic Sclerosis 
Explore (New York, N.Y.)  2008;4(4):259-263.
Objective
This study assessed the use of complementary and alternative medicine (CAM) therapies in patients with early systemic sclerosis (scleroderma, SSc).
Methods
At the annual visit, SSc patients enrolled in the Genetics versus Environment in Scleroderma Outcomes Study (GENISOS) were queried about their use of CAM therapies and intended symptom target, including herbal or nutriceutical therapy, acupuncture, transcutaneous electrical neural stimulation (TENS) and mind-body therapy (relaxation, meditative, imagery). The CAM user SSc patients were compared to matched non-CAM users over two years for database results of demographic, clinical and health-related quality of life SF-36 questionnaires by analysis of covariance.
Results
25% of the university GENISOS group were CAM users: age: 54 years; female: 89%; diffuse cutaneous involvement: 47%; total skin score: 13.5; Medsger severity index: 5.8. Over 70% used ≥1 CAM therapies for over 1 year, independent of health insurance. Symptoms targeted included arthritis/arthralgia, pain, GI dysmotility and fatigue. CAM users had significantly higher mean mental component summary (MCS) scores on SF-36 at Baseline and Year 2, (49 and 49.9), compared to non-CAM users (42 and 40.2, respectively, p<0.01). At Year 2, the CAM user group had significantly higher scores of SF-36 domains physical component score, role-physical, bodily pain and vitality, whereas scores declined in the non-CAM user group.
Conclusion
In SSc, 70% of those in the CAM user group reported a long-term commitment to CAM therapies. Higher perceived mental functioning in CAM users might reflect more self-motivation to manage symptoms and subsequently, promote practices that result in higher perceived physical functioning.
doi:10.1016/j.explore.2008.04.004
PMCID: PMC2875784  PMID: 18602619
CAM; SF-36; Integrative Medicine; Pain; Arthritis; GI Hypomotility; Scleroderma; GENISOS
16.  Measurement properties of translated versions of neck-specific questionnaires: a systematic review 
Background
Several disease-specific questionnaires to measure pain and disability in patients with neck pain have been translated. However, a simple translation of the original version doesn't guarantee similar measurement properties. The objective of this study is to critically appraise the quality of the translation process, cross-cultural validation and the measurement properties of translated versions of neck-specific questionnaires.
Methods
Bibliographic databases were searched for articles concerning the translation or evaluation of the measurement properties of a translated version of a neck-specific questionnaire. The methodological quality of the selected studies and the results of the measurement properties were critically appraised and rated using the COSMIN checklist and criteria for measurement properties.
Results
The search strategy resulted in a total of 3641 unique hits, of which 27 articles, evaluating 6 different questionnaires in 15 different languages, were included in this study. Generally the methodological quality of the translation process is poor and none of the included studies performed a cross-cultural adaptation. A substantial amount of information regarding the measurement properties of translated versions of the different neck-specific questionnaires is lacking. Moreover, the evidence for the quality of measurement properties of the translated versions is mostly limited or assessed in studies of poor methodological quality.
Conclusions
Until results from high quality studies are available, we advise to use the Catalan, Dutch, English, Iranian, Korean, Spanish and Turkish version of the NDI, the Chinese version of the NPQ, and the Finnish, German and Italian version of the NPDS. The Greek NDI needs cross-cultural validation and there is no methodologically sound information for the Swedish NDI. For all other languages we advise to translate the original version of the NDI.
doi:10.1186/1471-2288-11-87
PMCID: PMC3118950  PMID: 21645355
17.  Prevalence and determinants of complementary and alternative medicine use among infertile patients in Lebanon: a cross sectional study 
Background
Complementary and alternative medicine (CAM) is widely used for the treatment of infertility. While the Middle East and North Africa region has been shown to house one of the fastest growing markets of CAM products in the world, research describing the use of CAM therapies among Middle-Eastern infertile patients is minimal. The aim of this study is to examine the prevalence, characteristics and determinants of CAM use among infertile patients in Lebanon.
Methods
A cross sectional survey design was used to carry out face-to-face interviews with 213 consecutive patients attending the Assisted Reproductive Unit at a major academic medical center in Beirut. The questionnaire comprised three sections: socio-demographic and lifestyle characteristics, infertility-related aspects and information on CAM use. The main outcome measure was the use of CAM modalities for infertility treatment. Determinants of CAM use were assessed through the logistic regression method.
Results
Overall, 41% of interviewed patients reported using a CAM modality at least once for their infertility. There was a differential by gender in the most commonly used CAM therapies; where males mostly used functional foods (e.g. honey & nuts) (82.9%) while females mostly relied on spiritual healing/prayer (56.5%). Factors associated with CAM use were higher household income (OR: 0.305, 95% CI: 0.132–0.703) and sex, with females using less CAM than males (OR: 0.12, 95% CI: 0.051–0.278). The older patients were diagnosed with infertility, the lower the odds of CAM use (p for trend <0.05). Almost half of the participants (48%) were advised on CAM use by their friends, and only 13% reported CAM use to their physician.
Conclusions
The considerably high use of CAM modalities among Lebanese infertile patients, added to a poor CAM use disclosure to physicians, underscore the need to integrate CAM into the education and training of health professionals, as well as enhance infertile patients' awareness on safe use of CAM products.
doi:10.1186/1472-6882-12-129
PMCID: PMC3512516  PMID: 22901284
Complementary and alternative medicine; Infertility; Lebanon
18.  The Relationship between Complementary and Alternative Medicine Use and Breast Cancer Early Detection: A Critical Review 
Objective. Complementary and alternative medicine (CAM) use is prevalent. Concurrently, breast cancer is the most common cancer in women worldwide, with early detection techniques widely available. This paper examined the overlap between participation in allopathic breast cancer early detection activities and CAM use. Methods. A systematic review examined the association between breast screening behaviors and CAM use. Searches were conducted on the PubMed, Embase, CINAHL, and NCCAM databases and gray literature between 1990 and 2011. STROBE criteria were used to assess study quality. Results. Nine studies met the search criteria. Four focused on CAM use in women at high breast cancer risk and five on average risk women. CAM use in women ranged from 22% to 82% and was high regardless of breast cancer risk. Correlations between CAM use and breast cancer early detection were not strong or consistent but significant relationships that did emerge were positive. Conclusions. Populations surveyed, and measures used to assess CAM, breast cancer screening, and correlates, varied widely. Many women who obtained allopathic screening also sought out CAM. This provides a foundation for future interventions and research to build on women's motivation to enhance health and develop ways to increase the connections between CAM and allopathic care.
doi:10.1155/2012/506978
PMCID: PMC3536331  PMID: 23320029
19.  Mindfulness: A systematic review of instruments to measure an emergent patientreported outcome (PRO) 
Purpose
Mindfulness has emerged as an important health concept based on evidence that mindfulness interventions reduce symptoms and improve health-related quality of life. The objectives of this study were to systematically assess and compare the properties of instruments to measure self-reported mindfulness.
Methods
Ovid Medline®, CINAHL®, and PsycINFO® were searched through May 2012, and articles were selected if their primary purpose was development or evaluation of the measurement properties (validity, reliability, responsiveness) of a self-report mindfulness scale. Two reviewers independently evaluated the methodological quality of the selected studies using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. Discrepancies were discussed with a third reviewer, and scored by consensus. Finally, a level of evidence approach was used to synthesize results and study quality.
Results
Our search strategy identified a total of 2,588 articles. Forty-six articles, reporting 79 unique studies, met inclusion criteria. Ten instruments quantifying mindfulness as a unidimensional scale (n=5) or as a set of 2 to 5 subscales (n=5) were reviewed. The Mindful Attention Awareness Scale (MAAS) was evaluated by the most studies (n=27), and had positive overall quality ratings for most of the psychometric properties reviewed. The Five Facet Mindfulness Questionnaire (FFMQ) received the highest possible rating (“consistent findings in multiple studies of good methodological quality”) for two properties, internal consistency and construct validation by hypothesis testing. However, none of the instruments had sufficient evidence of content validity. Comprehensiveness of construct coverage had not been assessed; qualitative methods to confirm understanding and relevance were absent. In addition, estimates of test-retest reliability, responsiveness, or measurement error to guide users in protocol development or interpretation of scores were lacking.
Conclusions
Current mindfulness scales have important conceptual differences, and none can be strongly recommended based solely on superior psychometric properties. Important limitations in the field are the absence of qualitative evaluations and accepted external referents to support construct validity. Investigators need to proceed cautiously before optimizing any mindfulness intervention based on the existing scales.
doi:10.1007/s11136-013-0395-8
PMCID: PMC3745812  PMID: 23539467
Mindfulness; Instruments; Psychometrics; Measurement properties; COSMIN checklist; Systematic review
20.  Individualised medicine from the perspectives of patients using complementary therapies: a meta-ethnography approach 
Background
Personalised (or individualised) medicine in the days of genetic research refers to molecular biologic specifications in individuals and not to a response to individual patient needs in the sense of person-centred medicine. Studies suggest that patients often wish for authentically person-centred care and personal physician-patient interactions, and that they therefore choose Complementary and Alternative medicine (CAM) as a possibility to complement standard care and ensure a patient-centred approach. Therefore, to build on the findings documented in these qualitative studies, we investigated the various concepts of individualised medicine inherent in patients’ reasons for using CAM.
Methods
We used the technique of meta-ethnography, following a three-stage approach: (1) A comprehensive systematic literature search of 67 electronic databases and appraisal of eligible qualitative studies related to patients’ reasons for seeking CAM was carried out. Eligibility for inclusion was determined using defined criteria. (2) A meta-ethnographic study was conducted according to Noblit and Hare's method for translating key themes in patients’ reasons for using CAM. (3) A line-of-argument approach was used to synthesize and interpret key concepts associated with patients’ reasoning regarding individualized medicine.
Results
(1) Of a total of 9,578 citations screened, 38 studies were appraised with a quality assessment checklist and a total of 30 publications were included in the study. (2) Reasons for CAM use evolved following a reciprocal translation. (3) The line-of-argument interpretations of patients’ concepts of individualised medicine that emerged based on the findings of our multidisciplinary research team were “personal growth”, “holism”, “alliance”, “integrative care”, “self-activation” and “wellbeing”.
Conclusions
The results of this meta-ethnographic study demonstrate that patients’ notions of individualised medicine differ from the current idea of personalised genetic medicine. Our study shows that the “personal” patients’ needs are not identified with a specific high-risk group or with a unique genetic profile in the sense of genome-based “personalised” or “individualised” medicine. Thus, the concept of individualised medicine should include the humanistic approach of individualisation as expressed in concepts such as “personal growth”, “holistic” or “integrative care”, doctor-patient “alliance”, “self-activation” and “wellbeing” needs. This should also be considered in research projects and the allocation of healthcare resources.
doi:10.1186/1472-6882-13-124
PMCID: PMC3679787  PMID: 23731970
CAM; Qualitative studies; Meta-ethnography; Person-centred medicine; Individualised medicine; Personalised medicine
21.  Complementary and Alternative Medicine: Comparison of Current Knowledge, Attitudes and Interest among German Medical Students and Doctors 
Although it has been agreed that complementary and alternative medicine (CAM) should be included in the German medical curriculum, there is no consensus on which methods and how it should be taught. This study aimed to assess needs for CAM education by evaluating current knowledge, attitudes and interests of medical students, general physicians and gynecologists. Two instruments based on established and validated questionnaires were developed. One was given to seventh semester medical students and the other to office-based doctors. Data were analyzed by bivariate correlation and cross-tabulation. Altogether 550 questionnaires were distributed—280 to doctors and 270 to medical students. Completed questionnaires were returned by 80.4% of students and 78.2% of doctors. Although 73.8% (160/219) of doctors and 40% (87/217) of students had already informed themselves about CAM, neither group felt that they knew much about CAM. Doctors believed that CAM was most useful in general medicine, supportive oncology, pediatrics, dermatology and gynecology, while students believed that dermatology, general medicine, psychiatry and rheumatology offered opportunities; both recommended that CAM should be taught in these areas. Both groups believed that CAM should be included in medical education; however, they believed that CAM needed more investigation and should be taught “critically". German doctors and students would like to be better informed about CAM. An approach which teaches fundamental competences to students, chooses specific content based on evidence, demographics and medical conditions and provides students with the skills they need for future learning should be adopted.
doi:10.1093/ecam/nen079
PMCID: PMC3153080  PMID: 19098296
22.  Characteristics and job satisfaction of general practitioners using complementary and alternative medicine in Germany - is there a pattern? 
Background
The use of Complementary and Alternative medicine (CAM) has increased over the past years. In Germany, many general practitioners (GPs) use CAM in their daily practice. However, little is known about possible differences of GPs using CAM compared to GPs not using CAM. The aim of the study was to explore differences in personal and practice characteristics, work load and job satisfaction of GPs depending on their use of and attitude towards CAM. Furthermore, predictors for CAM use should be explored.
Methods
A questionnaire was developed based on qualitatively derived data. In addition, a validated instrument assessing job satisfaction was included in the questionnaire, which was sent to 3000 randomly selected GPs in Germany.
Results
1027 returned the questionnaire of which 737 indicated to use CAM in daily practice. We found that GPs using CAM are more female, younger and have a trend towards a healthier life style. Their practices have higher proportions of privately insured patients and are slightly better technically equipped with ultrasound. GPs with a positive attitude had significant better values within the job satisfaction scale and lower working hours per week compared to GPs with neutral/negative attitude. Significant predictors for CAM use were a positive attitude towards CAM, holding a special qualification in CAM, own CAM use and the availability of an ultrasound in practice.
Conclusions
The identified differences suggest that those GPs using and believing in CAM have a different medical orientation and approach which in turn may influence their job satisfaction. With this finding CAM use turns out to be a relevant factor regarding job satisfaction and, with this, may be a possible lever to counteract the growing dissatisfaction of GPs in Germany. This finding could also be important for designing strategies to promote the recruitment of young doctors to general practice.
doi:10.1186/1472-6882-11-131
PMCID: PMC3258195  PMID: 22182710
23.  Development of an International Questionnaire to Measure Use of Complementary and Alternative Medicine (I-CAM-Q) 
Abstract
Objectives
Existing studies on the use of complementary and alternative medicine (CAM) have produced diverse results regarding the types and prevalence of CAM use due, in part, to variations in the measurement of CAM modalities. A questionnaire that can be adapted for use in a variety of populations will improve CAM utilization measurement. The purposes of this article are to (1) articulate the need for such a common questionnaire; (2) describe the process of questionnaire development; (3) present a model questionnaire with core questions; and (4) suggest standard techniques for adapting the questionnaire to different languages and populations.
Methods
An international workshop sponsored by the National Research Center in Complementary and Alternative Medicine (NAFKAM) of the University of Tromsø, Norway, brought CAM researchers and practitioners together to design an international CAM questionnaire (I-CAM-Q). Existing questionnaires were critiqued, and working groups drafted content for a new questionnaire. A smaller working group completed, tested, and revised this self-administered questionnaire.
Results
The questionnaire that was developed contains four sections concerned with visits to health care providers, complementary treatments received from physicians, use of herbal medicine and dietary supplements, and self-help practices. A priori–specified practitioners, therapies, supplements, and practices are included, as well as places for researcher-specified and respondent-specified additions. Core questions are designed to elicit frequency of use, purpose (treatment of acute or chronic conditions, and health maintenance), and satisfaction. A penultimate version underwent pretesting with “think-aloud” techniques to identify problems related to meaning and format. The final questionnaire is presented, with suggestions for testing and translating.
Conclusions
Once validated in English and non-English speaking populations, the I-CAM-Q will provide an opportunity for researchers to gather comparable data in studies conducted in different populations. Such data will increase knowledge about the epidemiology of CAM use and provide the foundation for evidence-based comparisons at an international level.
doi:10.1089/acm.2008.0521
PMCID: PMC3189003  PMID: 19388855
24.  How parents choose to use CAM: a systematic review of theoretical models 
Background
Complementary and Alternative Medicine (CAM) is widely used throughout the UK and the Western world. CAM is commonly used for children and the decision-making process to use CAM is affected by numerous factors. Most research on CAM use lacks a theoretical framework and is largely based on bivariate statistics. The aim of this review was to identify a conceptual model which could be used to explain the decision-making process in parental choice of CAM.
Methods
A systematic search of the literature was carried out. A two-stage selection process with predetermined inclusion/exclusion criteria identified studies using a theoretical framework depicting the interaction of psychological factors involved in the CAM decision process. Papers were critically appraised and findings summarised.
Results
Twenty two studies using a theoretical model to predict CAM use were included in the final review; only one examined child use. Seven different models were identified. The most commonly used and successful model was Andersen's Sociobehavioural Model (SBM). Two papers proposed modifications to the SBM for CAM use. Six qualitative studies developed their own model.
Conclusion
The SBM modified for CAM use, which incorporates both psychological and pragmatic determinants, was identified as the best conceptual model of CAM use. This model provides a valuable framework for future research, and could be used to explain child CAM use. An understanding of the decision making process is crucial in promoting shared decision making between healthcare practitioners and parents and could inform service delivery, guidance and policy.
doi:10.1186/1472-6882-9-9
PMCID: PMC2680396  PMID: 19386106
25.  Mind-Body Complementary Alternative Medicine Use and Quality of Life in Adolescents with Inflammatory Bowel Disease 
Inflammatory bowel diseases  2010;16(3):501-506.
Objective
Mind-body complementary and alternative medicine (CAM) modalities (e.g., relaxation or meditation) for symptom management have not been well studied in adolescents with inflammatory bowel disease (IBD). The purposes of this study were to: 1) determine the prevalence of 5 types of mind-body CAM use, and consideration of use for symptom management; 2) assess characteristics associated with regular mind-body CAM use; and 3) examine whether regular and/or considered mind-body CAM use are associated with health-related quality of life (HRQOL).
Methodology
Sixty-seven adolescents with IBD ages 12-19 recruited from a children’s hospital completed a questionnaire on CAM use and the Pediatric Quality of Life Inventory. Logistic regression models were estimated for regular and considered CAM use.
Results
Participants mean (SD) age was 15.5 (2.1) years; 37 (55%) were female; 53 (79%) were white; and 20 (30%) had moderate disease severity. Adolescents used prayer (62%), relaxation (40%), and imagery (21%) once/day to once/week for symptom management. In multivariable analyses, females were more likely to use relaxation (OR=4.38, 95% CI= 1.25-15.29, c statistic=.73). Younger adolescents were more likely to regularly use (OR=.63, 95% CI=.42-.95, c statistic=.72) or consider using (OR=.77, 95% CI=.59-1.00, c statistic=.64) meditation. Adolescents with more severe disease (OR=4.17, 95% CI=1.07-16.29, c statistic=.83) were more willing to consider using relaxation in the future. Adolescents with worse HRQOL were more willing to consider using prayer and meditation for future symptom management (P<.05).
Conclusions
Many adolescents with IBD either currently use or would consider using mind-body CAM for symptom management.
doi:10.1002/ibd.21045
PMCID: PMC2821958  PMID: 19705417
complementary and alternative medicine; quality of life; adolescents; inflammatory bowel disease

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