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.
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”).
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.
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.
Reproducibility of results; Validation studies; Outcome assessment; Psychometrics; Systematic review; Questionnaire
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.
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.
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.
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.
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.
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 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.
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.
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).
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.
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).
Many adolescents with IBD either currently use or would consider using mind-body CAM for symptom management.
complementary and alternative medicine; quality of life; adolescents; inflammatory bowel disease
To critically appraise, compare and summarize the measurement properties of self-report fatigue questionnaires validated in patients with multiple sclerosis (MS), Parkinson’s disease (PD) or stroke.
MEDLINE, EMBASE, PsycINFO, CINAHL and SPORTdiscus were searched. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to assess the methodological quality of studies. A qualitative data synthesis was performed to rate the measurement properties for each questionnaire.
Thirty-eight studies out of 5,336 records met the inclusion criteria, evaluating 31 questionnaires. Moderate evidence was found for adequate internal consistency and structural validity of the Fatigue Scale for Motor and Cognitive functions (FSMC) and for adequate reliability and structural validity of the Unidimensional Fatigue Impact Scale (U-FIS) in MS.
We recommend the FSMC and U-FIS in MS. The Functional Assessment of Chronic Illness Therapy Fatigue subscale (FACIT-F) and Fatigue Severity Scale (FSS) show promise in PD, and the Profile of Mood States Fatigue subscale (POMS-F) for stroke. Future studies should focus on measurement error, responsiveness and interpretability. Studies should also put emphasis on providing input for the theoretical construct of fatigue, allowing the development of questionnaires that reflect generic and disease-specific symptoms of fatigue.
Electronic supplementary material
The online version of this article (doi:10.1007/s11136-011-0009-2) contains supplementary material, which is available to authorized users.
Fatigue; Assessment; Psychometrics; Multiple sclerosis; Parkinson disease; Cerebrovascular disorders
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.
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.
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.
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.
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.
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.
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.
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.
Use of complementary and alternative medicine (CAM) is prevalent among HIV+ individuals despite the success of antiretroviral treatments and limited evidence of CAM's safety and efficacy. To characterize the potential impact of CAM use on HIV care, we conducted a systematic review of 40 studies of CAM use among HIV+ people. The goals of this review are to: (a) describe the demographic, biomedical, psychosocial, and health behavior correlates of CAM use; (b) characterize patient-reported reasons for CAM use; and (c) identify methodological and conceptual limitations of the reviewed studies. Findings confirm that a high proportion of HIV+ individuals report CAM use (M = 60%). Overall, CAM use is more common among HIV+ individuals who are men who have sex with men (MSM), non-minority, better educated, and less impoverished. CAM use is also associated with greater HIV symptom severity and longer disease duration. HIV+ CAM users commonly report that they use CAM to prevent or alleviate HIV-related symptoms, reduce treatment side-effects, and improve quality of life. Findings regarding the association between CAM use, psychosocial adjustment, and adherence to conventional HIV medications are mixed. While the reviewed studies are instrumental in describing the characteristics of HIV+ CAM users, this literature lacks a conceptual framework to identify causal factors involved in the decision to use CAM or explain implications of CAM use for conventional HIV care. To address this concern, we propose the use of health behavior theory and discuss implications of review findings for HIV care providers.
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.
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.
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.
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.
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.
Complementary and alternative medicine; Infertility; Lebanon
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.
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.
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.
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.
Limited information exists on how adolescents decide to use complementary/alternative medicine (CAM). There are also no instruments specific to CAM, for the young adult population, which makes it difficult to explore knowledge in this area. The purpose of this study was to develop and examine the psychometric properties of the CAM Questionnaire for Young Adults which measures young adults’ attitudes about CAM. Participants for this cross-sectional survey were selected from enrolled undergraduate students at an urban university. Factor analysis identified three subscales: 1) positive beliefs about CAM; 2) environmental influence; and 3) psychological comfort. The scale has good internal consistency (Cronbach’s alpha = 0.79) and shows beginning demonstration of validity. Its use in this sample revealed that young adults who are female and have used CAM in the past for preventing or treating illness have the most positive attitude towards CAM and the greatest likelihood for continued use. The implication that prevention may play a role in young adults’ attitudes about CAM is a potential focus for future research.
CAM; adolescent; questionnaire; beliefs
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.
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.
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.
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.
The COSMIN checklist is a tool for evaluating the methodological quality of studies on measurement properties of health-related patient-reported outcomes. The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist (n = 114).
75 articles evaluating measurement properties were randomly selected from the bibliographic database compiled by the Patient-Reported Outcome Measurement Group, Oxford, UK. Raters were asked to assess the methodological quality of three articles, using the COSMIN checklist. In a one-way design, percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item.
88 raters participated. Of the 75 selected articles, 26 articles were rated by four to six participants, and 49 by two or three participants. Overall, percentage agreement was appropriate (68% was above 80% agreement), and the kappa coefficients for the COSMIN items were low (61% was below 0.40, 6% was above 0.75). Reasons for low inter-rater agreement were need for subjective judgement, and accustom to different standards, terminology and definitions.
Results indicated that raters often choose the same response option, but that it is difficult on item level to distinguish between articles. When using the COSMIN checklist in a systematic review, we recommend getting some training and experience, completing it by two independent raters, and reaching consensus on one final rating. Instructions for using the checklist are improved.
The safety and effectiveness of CAM interventions are of great relevance to pediatric health care providers. The objective of this study is to identify sources of reported randomized controlled trials (RCTs) in the field of pediatric complementary and alternative medicine (CAM).
Reports of RCTs were identified by searching Medline and 12 additional bibliographic databases and by reviewing the reference lists of previously identified pediatric CAM systematic reviews.
We identified 908 reports of RCTs that included children under 18 and investigated a CAM therapy. Since 1965, there has been a steady growth in the number of these trials that are being published. The four journals that published the most reported RCTs are The American Journal of Clinical Nutrition, Pediatrics, Journal of Pediatrics, and Lancet. Medline, CAB Health, and Embase were the best database sources for identifying these studies; they indexed 93.2%, 58.4% and 42.2 % respectively of the journals publishing reports of pediatric CAM RCTs.
Those working or interested in the field of pediatric CAM should routinely search Medline, CAB Health and Embase for literature in the field. The four core journals identified above should be included in their collection.
alternative medicine; bibliometrics; information services; medical informatics applications; pediatrics, evidence-based medicine
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.
The study design was a cross-sectional survey.
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.
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.
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.
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]).
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.
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.
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.
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.
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.
To assess pediatricians' attitudes toward & practice of Complementary/Alternative Medicine (CAM) including their knowledge, experience, & referral patterns for CAM therapies.
An anonymous, self-report, 27-item questionnaire was mailed nationally to fellows of the American Academy of Pediatrics in July 2004.
648 of 3500 pediatricians' surveyed responded (18%).
The median age ranged from 46–59 yrs; 52% female, 81% Caucasian, 71% generalists, & 85% trained in the US. Over 96% of pediatricians' responding believed their patients were using CAM. Discussions of CAM use were initiated by the family (70%) & only 37% of pediatricians asked about CAM use as part of routine medical history. Majority (84%) said more CME courses should be offered on CAM and 71% said they would consider referring patients to CAM practitioners. Medical conditions referred for CAM included; chronic problems (headaches, pain management, asthma, backaches) (86%), diseases with no known cure (55.5%) or failure of conventional therapies (56%), behavioral problems (49%), & psychiatric disorders (47%). American born, US medical school graduates, general pediatricians, & pediatricians who ask/talk about CAM were most likely to believe their patients used CAM (P < 0.01).
Pediatricians' have a positive attitude towards CAM. Majority believe that their patients are using CAM, that asking about CAM should be part of routine medical history, would consider referring to a CAM practitioner and want more education on CAM.
The use of complementary and alternative medicine (CAM) has not been widely studied among children in Italy. ISTAT-2005 survey showed a prevalence of 10% concerning children treated with CAM. The lack of data about the use of CAM in pediatrics in the South of Italy aimed us to conduct an epidemiological inquiry in Calabria.
The study has been conducted from 2009 and 2011 at the Pediatric Units of: University “Magna Graecia”- Catanzaro (CZ), Pugliese-Ciaccio Hospital-Catanzaro (CZ), Annunziata Hospital-Cosenza (CS), Jazzolino Hospital- ViboValentia (VV), Riuniti Hospitals- Reggio Calabria (RC) and San Giovanni di Dio Hospital- Crotone (KR). All information was collected through a questionnaire proposed to children’s parents admitted to these hospitals as out-patients or in-patients.
1387 parents were approached to complete the questionnaire. 21(1,5%) refused to answer. A total of 1366 questionnaire was analyzed: 378 at CZ , 450 at CS, 131 at KR, 201 at VV and 206 at RC, with a response rate of 98,5%. In total, the percentage of children using CAM varied from 18% in Crotone to 38% in Cosenza. The parents who used CAM for their children were older and with a higher education. Phytotherapy was preferred to homeopathy. The gastrointestinal pathologies and upper respiratory tract are those ones for which frequently parents recur to CAM. Of note we have not to disregard their use “ to strengthen” the immune system. In most of cases CAM have been prescribed by pediatrician.
Our study remarks that the use of CAM is increased dramatically among the calabrian children in the last years as well as in other countries. Pediatricians need to improve their knowledge about CAM in order to better manage the parental attitude.
Available measures of patient-reported outcomes for complementary and alternative medicine (CAM) inadequately capture the range of patient-reported treatment effects. The Self-Assessment of Change questionnaire was developed to measure multi-dimensional shifts in well-being for CAM users. With content derived from patient narratives, items were subsequently focused through interviews on a new cohort of participants. Here we present the development of the final version in which the content and format is refined through cognitive interviews.
We conducted cognitive interviews across five iterations of questionnaire refinement with a culturally diverse sample of 28 CAM users. In each iteration, participant critiques were used to revise the questionnaire, which was then re-tested in subsequent rounds of cognitive interviews. Following all five iterations, transcripts of cognitive interviews were systematically coded and analyzed to examine participants' understanding of the format and content of the final questionnaire. Based on this data, we established summary descriptions and selected exemplar quotations for each word pair on the final questionnaire.
The final version of the Self-Assessment of Change questionnaire (SAC) includes 16 word pairs, nine of which remained unchanged from the original draft. Participants consistently said that these stable word pairs represented opposite ends of the same domain of experience and the meanings of these terms were stable across the participant pool. Five pairs underwent revision and two word pairs were added. Four word pairs were eliminated for redundancy or because participants did not agree on the meaning of the terms. Cognitive interviews indicate that participants understood the format of the questionnaire and considered each word pair to represent opposite poles of a shared domain of experience.
We have placed lay language and direct experience at the center of questionnaire revision and refinement. In so doing, we provide an innovative model for the development of truly patient-centered outcome measures. Although this instrument was designed and tested in a CAM-specific population, it may be useful in assessing multi-dimensional shifts in well-being across a broader patient population.
Complementary and alternative medicine (CAM); patient-reported outcomes (PROs); cognitive interviewing; patient-centered care; non-specific outcomes; questionnaire development; retrospective pre-test; well-being
To evaluate the quality of reports of complementary and alternative medicine (CAM) randomized controlled trials (RCTs) in the pediatric population. We also examined whether there was a change in the quality of reporting over time.
We used a systematic sample of 251 reports of RCTs that used a CAM intervention. The quality of each report was assessed using the number of CONSORT checklist items included, the frequency of unclear allocation concealment, and a 5-point quality assessment instrument.
Nearly half (40%) of the CONSORT checklist items were included in the reports, with an increase in the number of items included. The majority (81.3%) of RCTs reported unclear allocation concealment with no significant change over time. The quality of reports achieved approximately 40% of their maximum possible total score as assessed with the Jadad scale with no change over time. Information regarding adverse events was reported in less than one quarter of the RCTs (22%) and information regarding costs was mentioned in only a minority of reports (4%).
RCTs are an important tool for evidence based health care decisions. If these studies are to be relevant in the evaluation of CAM interventions it is important that they are conducted and reported with the highest possible standards. There is a need to redouble efforts to ensure that children and their families are participating in RCTs that are conducted and reported with minimal bias. Such studies will increase their usefulness to a board spectrum of interested stakeholders.
Throughout the world, patients with chronic diseases/illnesses use complementary and alternative medicines (CAM). The use of CAM is also substantial among patients with diseases/illnesses of unknown aetiology. Chronic fatigue syndrome (CFS), also termed myalgic encephalomyelitis (ME), is no exception. Hence, a systematic review of randomised controlled trials of CAM treatments in patients with CFS/ME was undertaken to summarise the existing evidence from RCTs of CAM treatments in this patient population.
Seventeen data sources were searched up to 13th August 2011. All randomised controlled trials (RCTs) of any type of CAM therapy used for treating CFS were included, with the exception of acupuncture and complex herbal medicines; studies were included regardless of blinding. Controlled clinical trials, uncontrolled observational studies, and case studies were excluded.
A total of 26 RCTs, which included 3,273 participants, met our inclusion criteria. The CAM therapy from the RCTs included the following: mind-body medicine, distant healing, massage, tuina and tai chi, homeopathy, ginseng, and dietary supplementation. Studies of qigong, massage and tuina were demonstrated to have positive effects, whereas distant healing failed to do so. Compared with placebo, homeopathy also had insufficient evidence of symptom improvement in CFS. Seventeen studies tested supplements for CFS. Most of the supplements failed to show beneficial effects for CFS, with the exception of NADH and magnesium.
The results of our systematic review provide limited evidence for the effectiveness of CAM therapy in relieving symptoms of CFS. However, we are not able to draw firm conclusions concerning CAM therapy for CFS due to the limited number of RCTs for each therapy, the small sample size of each study and the high risk of bias in these trials. Further rigorous RCTs that focus on promising CAM therapies are warranted.
To determine prevalence and predictors of complementary and alternative medicine (CAM) use disclosure to health care providers and whether CAM use disclosure is associated with highly active antiretroviral therapy (HAART) adherence among HIV-infected women, we analyzed longitudinal data collected between October 1994 and March 2002 from HIV-infected CAM-using women enrolled in the Women's Interagency HIV Study. Repeated measures Poisson regression models were constructed to evaluate associations of selected predictors with CAM use disclosure and association between CAM use disclosure and HAART adherence. A total of 1377 HIV-infected women reported CAM use during study follow-up and contributed a total of 4689 CAM-using person visits. The overall prevalence of CAM use disclosure to health care providers was 36% across study visits. Women over 45 years old, with a college education, or with health insurance coverage were more likely to disclose their CAM use to health care providers, whereas women identified as non-Hispanic Black or other ethnicities were less likely to communicate their CAM usage. More health care provider visits, more CAM domains used, and higher health care satisfaction scores had significant relationships with increased levels of CAM use disclosure. Restricting analysis to use of herbal or nonherbal medications only, similar results were obtained. Compared to other CAM domains, mind–body practice had the lowest prevalence of CAM use disclosure. Additionally, CAM use disclosure was significantly associated with higher HAART adherence. From this study, we showed that a high percentage of HIV-infected women did not discuss their CAM use with health care providers. Interventions targeted towards both physicians and patients may enhance communication of CAM use, avoid potential adverse events and drug interactions, and enhance HAART adherence.
To determine prevalence and predictors of complementary and alternative medicine (CAM) use disclosure to health care providers and whether CAM use disclosure is associated with highly active antiretroviral therapy (HAART) adherence among HIV-infected women, we analyzed longitudinal data collected between October 1994 and March 2002 from HIV-infected CAM-using women enrolled in the Women’s Interagency HIV Study. Repeated measures Poisson regression models were constructed to evaluate associations of selected predictors with CAM use disclosure and association between CAM use disclosure and HAART adherence. A total of 1377 HIV-infected women reported CAM use during study follow-up and contributed a total of 4689 CAM-using person visits. The overall prevalence of CAM use disclosure to health care providers was 36% across study visits. Women over 45 years old, with a college education, or with health insurance coverage were more likely to disclose their CAM use to health care providers, whereas women identified as non-Hispanic Black or other ethnicities were less likely to communicate their CAM usage. More health care provider visits, more CAM domains used, and higher health care satisfaction scores had significant relationships with increased levels of CAM use disclosure. Restricting analysis to use of herbal or nonherbal medications only, similar results were obtained. Compared to other CAM domains, mind–body practice had the lowest prevalence of CAM use disclosure. Additionally, CAM use disclosure was significantly associated with higher HAART adherence. From this study, we showed that a high percentage of HIV-infected women did not discuss their CAM use with health care providers. Interventions targeted towards both physicians and patients may enhance communication of CAM use, avoid potential adverse events and drug interactions, and enhance HAART adherence.
In recent years, the use of complementary and alternative medicine (CAM) in pediatric populations has increased considerably, especially for chronic conditions such as cancer, rheumatoid arthritis and cystic fibrosis in which pain may be a significant problem. Despite the growing popularity of CAM approaches for pediatric pain, questions regarding the efficacy of these interventions remain. This review critically evaluates the existing empirical evidence for the efficacy of CAM interventions for pain symptoms in children. CAM modalities that possess a published literature, including controlled trials and/or multiple baseline studies, that focused on either chronic or acute, procedural pain were included in this review. The efficacy of the CAM interventions was evaluated according to the framework developed by the American Psychological Association (APA) Division 12 Task Force on Promotion and Dissemination of Psychological Procedures. According to these criteria, only one CAM approach reviewed herein (self-hypnosis/guided imagery/relaxation for recurrent pediatric headache) qualified as an empirically supported therapy (EST), although many may be considered possibly efficacious or promising treatments for pediatric pain. Several methodological limitations of the existing literature on CAM interventions for pain problems in children are highlighted and future avenues for research are outlined.
complementary medicine; alternative medicine; pediatric pain; pain; children