Measurement of the major ignored burden of multiple myeloma, pernicious anaemia and of other haematological conditions on partners and family members: A cross-sectional study.

BACKGROUND: Having a haematological condition can adversely affect the quality of life (QoL) of family members/partners of patients. It is important to measure this often ignored burden in order to implement appropriate supportive interventions. OBJECTIVE: To measure current impact of haematological conditions on the QoL of family members/partners of patients, using the Family Reported Outcome Measure-16 (FROM-16). METHODS: A cross-sectional study, recruited online through patient support groups, involved UK family members/partners of people with haematological conditions completing the FROM-16. RESULTS: 183 family members/partners (mean age = 60.5 years, SD = 13.2; females = 62.8%) of patients (mean age = 64.1, SD = 12.8; females = 46.4%) with 12 haematological conditions completed the FROM-16. The FROM-16 mean total score was 14.0 (SD = 7.2), meaning 'a moderate effect on QoL'. The mean FROM-16 scores of family members of people with multiple myeloma (mean = 15.8, SD = 6.3, n = 99) and other haematological malignancies (mean = 13.9, SD = 7.8, n = 29) were higher than of people with pernicious anaemia (mean = 10.7, SD = 7.5, n = 47) and other non-malignant conditions (mean = 11, SD = 7.4, n = 56, p < .01). Over one third (36.1%, n = 183) of family members experienced a 'very large effect' (FROM-16 score>16) on their quality of life. CONCLUSIONS: Haematological conditions, in particular those of malignant type, impact the QoL of family members/partners of patients. Healthcare professionals can now, using FROM-16, identify those most affected and should consider how to provide appropriate holistic support within routine practice.

Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16).

BACKGROUND: The FROM-16 is a generic family quality of life (QoL) instrument that measures the QoL impact of patients' disease on their family members/partners. The study aimed to assess the responsiveness of FROM-16 to change and determine Minimal Important Change (MIC). METHODS: Responsiveness and MIC for FROM-16 were assessed prospectively with patients and their family members recruited from outpatient departments of the University Hospital Wales and University Hospital Llandough, Cardiff, United Kingdom. Patients completed the EQ-5D-3L and a global severity question (GSQ) online at baseline and at 3-month follow-up. Family members completed FROM-16 at baseline and a Global Rating of Change (GRC) in addition to FROM-16 at follow-up. Responsiveness was assessed using the distribution-based (effect size-ES, standardized response mean -SRM) and anchor-based (area under the receiver operating characteristics curve ROC-AUC) approaches and by testing hypotheses on expected correlation strength between FROM-16 change score and patient assessment tools (GSQ and EQ-5D). Cohen's criteria were used for assessing ES. The AUC ≥ 0.7 was considered a good measure of responsiveness. MIC was calculated using anchor-based (ROC analysis and adjusted predictive modelling) and distribution methods based on standard deviation (SD) and standard error of the measurement (SEM). RESULTS: Eighty-three patients with 15 different health conditions and their relatives completed baseline and follow-up questionnaires and were included in the responsiveness analysis. The mean FROM-16 change over 3 months = 1.43 (SD = 4.98). The mean patient EQ-5D change over 3 months = -0.059 (SD = 0.14). The responsiveness analysis showed that the FROM-16 was responsive to change (ES = 0.2, SRM = 0.3; p < 0.01). The ES and SRM of FROM-16 change score ranged from small (ES = 0.2; SRM = 0.3) for the distribution-based method to large (ES = 0.8, SRM = 0.85) for anchor-based methods. The AUC value was above 0.7, indicating good responsiveness. There was a significant positive correlation between the FROM-16 change scores and the patient's disease severity change scores (p < 0.001). The MIC analysis was based on data from 100 family members of 100 patients. The MIC value of 4 was suggested for FROM-16. CONCLUSIONS: The results of this study confirm the longitudinal validity of FROM-16 which refers to the degree to which an instrument is able to measure change in the construct to be measured. The results yield a MIC value of 4 for FROM-16. These psychometric attributes of the FROM-16 instrument are useful in both clinical research as well as clinical practice.

Mapping of Family Reported Outcome Measure (FROM-16) scores to EQ-5D: algorithm to calculate utility values.

OBJECTIVE: Although decision scientists and health economists encourage inclusion of family member/informal carer utility in health economic evaluation, there is a lack of suitable utility measures comparable to patient utility measures such those based on the EQ-5D. This study aims to predict EQ-5D-3L utility values from Family Reported Outcome Measure (FROM-16) scores, to allow the use of FROM-16 data in health economic evaluation when EQ-5D data is not available. METHODS: Data from 4228 family members/partners of patients recruited to an online cross-sectional study through 58 UK-based patient support groups, three research support platforms and Welsh social services departments were randomly divided five times into two groups, to derive and test a mapping model. Split-half cross-validation was employed, resulting in a total of ten multinomial logistic regression models. The Monte Carlo simulation procedure was used to generate predicted EQ-5D-3L responses, and utility scores were calculated and compared against observed values. Mean error and mean absolute error were calculated for all ten validation models. The final model algorithm was derived using the entire sample. RESULTS: The model was highly predictive, and its repeated fitting using multinomial logistic regression demonstrated a stable model. The mean differences between predicted and observed health utility estimates ranged from 0.005 to 0.029 across the ten modelling exercises, with an average overall difference of 0.015 (a 2.2% overestimate, not of clinical importance). CONCLUSIONS: The algorithm developed will enable researchers and decision scientists to calculate EQ-5D health utility estimates from FROM-16 scores, thus allowing the inclusion of the family impact of disease in health economic evaluation of medical interventions when EQ-5D data is not available.

Evaluation of the clinical impact and In Vitro antibacterial activities of two bioactive restoratives against S. mutans ATCC 25175 in class II carious restorations.

Background: Streptococcus mutans is a Gram-positive opportunistic bacterial pathogen and that causes dental caries and then restorative treatment remains the best clinical practice approach to repair and prevent dental caries. Aims: This study compared the antimicrobial performance of resin modified glass ionomer cement (RM-GIC) and ACTIVA restoratives by evaluating the S. mutans count, pH levels, and plaque index (PI) scores before and on the 7th day of restoration, and then determined the antimicrobial activities against S. mutans ATCC 25175 in both restoratives in vitro. Materials and Methods: Seventy-eight eligible Saudi female participants, with class II carious lesions, were randomly distributed into RM-GIC and ACTIVA restorative groups. We evaluated the S. mutans count by the serial dilution technique and salivary pH by using a portable pH meter. The PI scores were determined by Silness-Löe method and the antibacterial activity by the agar well diffusion method. Statistical analysis of normality distribution was performed with the Kolmogorov-Smirnov and the difference between groups was an analysis by paired t-test. In addition, the independent sample was compared with the independent samples t-test. Results: Both groups reduced the S. mutans count, pH acidity, and PI scores, and this reduction was statistically significant on the 7th day of restoration (P < 0.05), preference for ACTIVA. The in vitro antibacterial activity against S. mutans ATCC 25175 showed a non-significant difference between both bioactive restorative materials (P < 0.05). Conclusion: The novel application of ACTIVA restorative material is a promising option for patients at risk of caries.

Family reported outcomes, an unmet need in the management of a patient's disease: appraisal of the literature.

BACKGROUND: A person's chronic health condition or disability can have a huge impact on the quality of life (QoL) of the whole family, but this important impact is often ignored. This literature review aims to understand the impact of patients' disease on family members across all medical specialities, and appraise existing generic and disease-specific family quality of life (QoL) measures. METHODS: The databases Medline, EMBASE, CINHAL, ASSIA, PsycINFO and Scopus were searched for original articles in English measuring the impact of health conditions on patients' family members/partner using a valid instrument. RESULTS: Of 114 articles screened, 86 met the inclusion criteria. They explored the impact of a relative's disease on 14,661 family members, mostly 'parents' or 'mothers', using 50 different instruments across 18 specialities including neurology, oncology and dermatology, in 33 countries including the USA, China and Australia. These studies revealed a huge impact of patients' illness on family members. An appraisal of family QoL instruments identified 48 instruments, 42 disease/speciality specific and six generic measures. Five of the six generics are aimed at carers of children, people with disability or restricted to chronic disease. The only generic instrument that measures the impact of any condition on family members across all specialities is the Family Reported Outcome Measure (FROM-16). Although most instruments demonstrated good reliability and validity, only 11 reported responsiveness and only one reported the minimal clinically important difference. CONCLUSIONS: Family members' QoL is greatly impacted by a relative's condition. To support family members, there is a need for a generic tool that offers flexibility and brevity for use in clinical settings across all areas of medicine. FROM-16 could be the tool of choice, provided its robustness is demonstrated with further validation of its psychometric properties.

A three-arm single blind randomised control trial of naïve medical students performing a shoulder joint clinical examination.

BACKGROUND: Technological advances have previously been hailed as a new dawn in Higher Education, with the advent of 'massive open online courses' (MOOCs) and online learning. Virtual platforms have potential advantages such as accessibility and availability but simply transferring educational material to the online environment may not ensure high quality learning. Clinical examination is a fundamental principle of medical assessment, and this study aimed to assess the role of technology in teaching these skills. AIMS/OBJECTIVES: To determine whether three teaching modalities were of equal efficacy in teaching examination of the shoulder joint to naïve medical students. METHODS: Sixty-seven pre-clinical medical students naïve to large joint examination were recruited. Participants completed a learning style questionnaire and were then block randomised to three study: textbook study, face-to-face seminar, or video tutorial via online platform. The same examination technique was taught in all groups, with the intervention being the method of delivery All second year students were eligible for inclusion. The single exclusion criteria was previous exposure to clinical examination teaching. Students were assessed using a standardised scoring system at baseline (pre-intervention), and days 5 and 19 post-intervention (maximum score 30). Assessors were blinded to group allocation. The primary outcome was assessment score at day 5 post intervention. RESULTS: There was no difference between the three groups at baseline assessment (mean scores 2.4 for textbook, 2.8 for face-to-face, and 3.1 for video; p = 0.267). Mean post-intervention scores were 16.5 textbook, 25.5 face-to-face, and 22.4 video (p < 0.001, η2 = .449). There was no change between day 5 and day 19 post-intervention assessment scores in any group (p = 0.373), Preferred learning style did not affect scores (p = 0.543). CONCLUSION: Face-to-face teaching was the most effective method for teaching clinical examination of the shoulder. Technology can potentially increase accessibility and remove geographic barriers, but is not as effective if teaching techniques are simply mirrored in an online format. Online platforms allow in depth data analysis of how learners interact with educational material and this may have value in improving the design of online educational materials, and is a potential area for further research.

Clinical experience and psychometric properties of the Cardiff Acne Disability Index (CADI).

The Cardiff Acne Disability Index (CADI) is a questionnaire designed to measure the quality of life of teenagers and young adults with acne. It has been used clinically and within therapeutic research globally. This review aims to appraise all published data regarding the clinical and research experience of the CADI, its psychometric properties and validation, from its publication in 1992 until September 2020, in a single reference source. A literature search was conducted using MEDLINE via Ovid, PubMed, EBSCOhost, Web of Science and Scopus. All full articles in the English language were included. A total of 96 clinical studies were identified and analysed. The CADI has been used in 44 different countries, including four multinational studies, and has validated translations in 25 languages. Overall, 29 therapeutic interventions have used the CADI, demonstrating its responsiveness to change. The reliability of the CADI has been assessed in 14 studies through test-retest and internal consistency studies. In total, 57 studies have demonstrated aspects of its validity through correlation to other measures, and five studies have investigated the dimensionality of the CADI. There is evidence of high internal consistency, test-retest reliability, responsiveness to change and significant correlation with other objective measures. The minimal clinically important difference and validated score meaning bands have not yet been reported. This information is needed to improve the interpretability of CADI scores for clinical use and in research. The authors of the CADI have also rephrased Question 2 of the measure to ensure inclusivity.

Improving oral healthcare using academic detailing - design of the ADVOCATE Field Studies.

Background: Academic detailing (AD) is a defined form of educational outreach that can be deployed to intrinsically motivate practitioners towards improving quality of care. This paper describes the design of the ADVOCATE Field Studies. This proof of concept study aims to evaluate the feasibility, acceptability and usefulness of AD, reinforced with feedback information to promote prevention-oriented, patient-centred and evidence-based oral healthcare delivery by general dental practitioners (GDPs). Methods: Six groups of GDPs will be recruited; two groups of six to eight GDPs in each of three countries - the Netherlands, Germany and Denmark. GDPs will meet for four Academic Detailing Group (ADG) meetings for open discussions using comparative feedback data to stimulate debate about their dental practice performance and care delivery. Group meetings will be moderated using the AD methodology. Qualitative data will be collected through focus group interviews, an online discussion forum, field notes and debriefs of ADG meetings and analysed by conventional content analysis using MaxQDA software. Discussion: The results of the study will provide novel information on the feasibility, perceived acceptability and usefulness of AD and feedback data for GDPs to improve oral healthcare delivery.

Comparison of the paper-based and electronic versions of the Dermatology Life Quality Index: evidence of equivalence.

BACKGROUND: The use of patient-reported outcome measures in electronic format has been increasing. However, these formats are usually not validated or compared with the original paper-based formats, so there is no evidence that they are completed in the same way. OBJECTIVES: To compare the conventional paper version with a web-based application (iPad® ) version of the Dermatology Life Quality Index (DLQI) to assess equivalence of scores. METHODS: The study employed a randomized crossover design using a within-subjects comparison of the two formats of the questionnaire. International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were followed. Participants aged over 18 years with any confirmed skin condition were recruited from a teaching hospital dermatology outpatient clinic. Expected intraclass correlation coefficient (ICC) was 0·9 (α = 0·05). RESULTS: A total of 104 patients were recruited, median age 53·5 years (interquartile range 37·3-67·8; 43% male). The ICC showed high concordance between the total DLQI scores from paper and iPad versions (ICC 0·98; 95% confidence interval 0·97-0·99). Patients took a median of 78 s to complete the electronic version and 73 s for paper (P = 0·008): 76% preferred the electronic version and perceived completion to take a shorter time. CONCLUSIONS: There is high concordance and thus equivalence between the iPad and paper versions of the DLQI, with an ICC of 0·98, and a clear patient preference for the iPad version.

A systematic review of the use of quality-of-life instruments in randomized controlled trials for psoriasis.

Planners of interventional studies in psoriasis face the dilemma of selecting suitable quality-of-life (QoL) measures. Systematic reviews have the potential of identifying psychometrically sound measures in a given therapeutic area, while guiding the development of practice guidelines. The aim of this systematic review was to generate evidence of the use of QoL instruments in randomized controlled trials (RCTs) for interventions in psoriasis. The methodology followed the PRISMA guidelines. Six databases were searched with 388 search terms. Abstracts of articles were reviewed independently by two assessors, and a third adjudicator resolved any opinion differences. Risk of bias was assessed using the Jadad scale. Of 3646 screened publications, 99 articles (100 trials) met the eligibility criteria for inclusion, describing research on 33 215 patients. Thirty-three trials tested topical therapy, 18 systemic, 39 biologics, nine phototherapy and 10 other interventions. The Dermatology Life Quality Index (DLQI) was the most commonly used QoL instrument (83 studies, 83%), followed by the 36-Item Short Form Survey (SF-36) (31, 31%), EuroQoL-5D (EQ-5D) (15, 15%), Psoriasis Disability Index (14, 14%) and Skindex (five, 5%). There was widespread inconsistency in the way that QoL data were reported. Of the 100 trials identified, 37 reported minimal clinically important difference (MCID): 32 for DLQI, 10 for SF-36 and six for EQ-5D. QoL measurement is increasingly being reported in RCTs of psoriasis. Formal guidelines are needed for assessment and publishing of QoL data. Researchers should consider whether MCID information is available, and development of MCID data should be encouraged.

Environmental carcinogen exposure and lifestyle factors affecting cancer risk in Qatar: findings from a qualitative review.

To meet the country's health goals for 2011-2016, a qualitative review of exposure to risk factors for cancer in Qatar was conducted in 2013. The review included exposure to environmental agents carcinogenic to humans (International Agency for Research on Cancer classification), as well as lifestyle factors known to affect cancer risk. Information from all available sources was assembled and reviewed. The levels of particulate matter reported in Qatar were in the upper range of ambient air pollutants reported internationally, and may influence the country's future lung cancer burden. The limited data on occupational exposure suggests that the greatest risks for workers in the construction industry are likely to be from environmental dust and related air pollutants. The greatest cancer risks for Qatari nationals may be lifestyle factors, particularly obesity, physical inactivity and tobacco use. Extended monitoring of the composition of and human exposure to air pollutants is recommended.

Prevalence and characterization of extended-spectrum beta-lactamases producing Enterobacteriaceae in healthy children and associated risk factors.

BACKGROUND: Community acquired infections due to extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) had been increased. The fecal flora of children in the community represents a huge potential reservoir for ESBLs which are located on highly transmissible plasmids. This study examined the prevalence of ESBL-PE fecal carriage, antimicrobial susceptibility pattern, possible risk factors, and characterized the genes encoding these ESBL enzymes in Lebanese children community. METHODS: A total of 125 rectal swabs were taken from healthy children aged from 1 to 5 years. Detection of ESBLs was carried out using combination-disc method test and multiplex PCR. A questionnaire concerning child's lifestyle and risk factors for ESBL carriage was illustrated. RESULTS: Thirty-one of 125 participants (24.8 %) carried ESBL-PE. Regular consumption of meat, and chicken were significantly associated with high carriage rate of ESBL-PE, while dairy products (milk, yogurt, cheese) association was non-significant. Intimate hygiene habits were found also affecting the carriage rate. Multiple bla genes were the most common, 48.4 % (15/31) of ESBL-PE carried both bla CTX-M and bla TEM, and 22.6 % (7/31) carried bla CTX-M, bla SHV, and bla TEM, 29 % (9) carried bla CTX-M only. Concerning CTX-M-types, CTX-M-9 was the most predominant (24/31) and mostly in combination with CTX-M-15 type. CONCLUSION: High rate of colonization in healthy children with ESBL-PE was observed, regular consumption of dietary products from animal source (meat or chicken) were associated with this colonization in the community in non-hospitalized children. To our best knowledge it is the first study about regular consumption of dairy product as a risk factor for ESBL-PE community carriage, the first data about the carriage rate of ESBL-PE in community children in Lebanon and Middle East, and for the wide dissemination of CTX-M-9 type in this population.

Environmental carcinogen exposure and lifestyle factors affecting cancer risk in Qatar:findings from a qualitative review

To meet the country's health goals for 2011-2016,a qualitative review of exposure to risk factors for cancer in Qatar was conducted in 2013.The review included exposure to environmental agents carcinogenic to humans [International Agency for Research on Cancer classification], as well as lifestyle factors known to affect cancer risk.Information from all available sources was assembled and reviewed.The levels of particulate matter reported in Qatar were in the upper range of ambient air pollutants reported internationally,and may influence the country's future lung cancer burden.The limited data on occupational exposure suggests that the greatest risks for workers in the construction industry are likely to be from environmental dust and related air pollutants.The greatest cancer risks for Qatari nationals may be lifestyle factors,particularly obesity,physical inactivity and tobacco use.Extended monitoring of the composition of and human exposure to air pollutants is recommended

Afin d'atteindre les objectifs de sante fixes par le pays pour 2011-2016,une analyse qualitative de L'exposition aux facteurs de risque de cancer au Qatar a ete conduite en 2013.L'analyse incluait L'exposition aux agents environnementauxcancerogenes pour Thomrne [classification du Centre international de recherchesur le cancer]ainsi que les facteurs lies au mode de vie connus pour augmenter le risque de cancer.Des informations ont ete rassemblees a partir de toutes les sources disponibles et ont fait Tobjet d'un examen.Les niveaux de particules rapportes au Qatar se situaient dans la fourchette haute des polluants atmospheriques ambiants au niveau mondial,ce qui pourrait influencer la charge future du cancer du poumon dans le pays.Le nombre IImite de donnees sur 1'exposition professionnelle suggere que les risques ies plus importants pour les professionnels de I'industrie du batiment seraient lies a la poussiere environnementale et aux polluants atmospheriques qu'elle contient.Les risques de cancer les plus eleves pour les Qatariens proviendraient de facteurs associes aux modes de vie,en particulier I'obesite,la sedentarite et le tabagisme.Un suivi accru de la composition des polluants atmospheriques et de 1'exposition de I'homme a ces derniers est recommande

C-reactive protein a better indicator of inflammation after third molar extraction.

PURPOSE: The purpose of this study was to evaluate the relation between pre-operative pain and pre-operative levels of C-reactive and post-operative pain and swelling in impacted third molar surgery. MATERIALS AND METHODS: In this prospective study subjects were patients indicated for mandibular third molar extraction. Patients were assessed for certain inclusion and exclusion criteria's. A standard surgical extraction procedure was followed to reduce the bias. Hematological investigation of C-reactive protein levels were recorded pre-operatively and post-operatively. Pain, swelling and trismus in patients were assessed pre-operatively and post-operatively in an interval of 24 hours, 48 hours and 7 days. Pain and swelling were measured using verbal analogue scale and thread length measurement respectively. The mouth opening was recorded, too. RESULTS: Post-operative C-reactive protein levels were seen consistency raised in those cases which showed high pre-operative levels. Peak levels of C-reactive protein were seen at 48 hours post operatively. It was observed that pre-operative pain swelling and mouth opening were seen to be variable in all the cases having high C-reactive protein levels. CONCLUSION: C-reactive protein was found to be a better indicator of inflammation than pre-operative pain, swelling and mouth opening for post-operative discomfort.

The impact of new national guidelines on screening for gestational diabetes mellitus.

Gestational diabetes mellitus (GDM) has important maternal and fetal implications. In 2010, the Health Service Executive published guidelines on GDM. We examined the impact of the new guidelines in a large maternity unit. In January 2011, the hospital replaced the 100 g Oral Glucose Tolerance Test (OGTT) with the new 75 g OGTT. We compared the first 6 months of 2011 with the first 6 months of 2010. The new guidelines were associated with a 22% increase in women screened from 1375 in 2010 to 1679 in 2011 (p < 0.001). Of the women screened, the number diagnosed with GDM increased from 10.1% (n=139) to 13.2% (n=221) (p<0.001).The combination of increased screening and a more sensitive OGTT resulted in the number of women diagnosed with GDM increasing 59% from 139 to 221 (p = 0.02).This large increase has important resource implications but, if clinical outcomes are improved, there should be a decrease in long-term costs.

Sex hormone status in male rats after exposure to 50 Hz, 5 mTesla magnetic field.

The question of whether extremely low frequency magnetic fields can affect biological system has attracted attention. The theoretical possibility of such an interaction is often questioned and the site of interaction is unknown. The influence of extremely low frequency magnetic field of 50 Hz, 5 mTesla on sex hormone status was studied. 60 male albino rats were divided into 6 groups and were continuously exposed to 50 Hz, 5 mTesla magnetic field generated by magnetic field chamber for periods of 1, 2 and 4 weeks. For each experimental point, sham treated group was used as a control. Assay of serum testosterone LH, FSH, and prolactin were performed. Serum testosterone showed no significant changes. FSH showed significant increase than sham exposed group after 1 week magnetic field exposure. LH showed significant increase than sham exposed group only after 4 weeks magnetic field exposure, while serum prolactin hormone level showed a significant increase in all magnetic field exposed groups than sham exposed animals. Exposure to 50 Hz, 5 mTesla magnetic field for periods of 1, 2 and 4 weeks has no effect on testosterone level, some changes on FSH and LH serum levels and increase in serum prolactin level.