Does the packaging of health information affect the assessment of its reliability? A randomized controlled trial protocol

Background Wikipedia is frequently used as a source of health information. However, the quality of its content varies widely across articles. The DISCERN tool is a brief questionnaire developed in 1996 by the Division of Public Health and Primary Health Care of the Institute of Health Sciences of the University of Oxford. They claim it provides users with a valid and reliable way of assessing the quality of written information. However, the DISCERN instrument’s reliability in measuring the quality of online health information, particularly whether or not its scores are affected by reader biases about specific publication sources, has not yet been explored. Methods This study is a double-blind randomized assessment of a Wikipedia article versus a BMJ literature review using a modified version of the DISCERN tool. Participants will include physicians and medical residents from four university campuses in Ontario and British Columbia and will be randomized into one of four study arms. Inferential statistics tests (paired t-test, multi-level ordinal regression, and one-way ANOVA) will be conducted with the data collected from the study. Outcomes The primary outcome of this study will be to determine whether a statistically significant difference in DISCERN scores exists, which could suggest whether or not how health information is packaged influences how it is assessed for quality. Plain Language Summary The internet, and in particular Wikipedia, is an important way for professionals, students and the public to obtain health information. For this reason, the DISCERN tool was developed in 1996 to help users assess the quality of the health information they find. The ability of DISCERN to measure the quality of online health information has been supported with research, but the role of bias has not necessarily been accounted for. Does how the information is packaged influence how the information itself is evaluated? This study will compare the scores assigned to articles in their original format to the same articles in a modified format in order to determine whether the DISCERN tool is able to overcome bias. A significant difference in ratings between original and inverted articles will suggest that the DISCERN tool lacks the ability to overcome bias related to how health information is packaged.

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A cross-sectional study on quality of diabetes information identified from the Internet (Preprint)

10.2196/preprints.14757 ◽

2019 ◽

Author(s):

Jingchun Fan ◽

Jean Craig ◽

Na Zhao ◽

Fujian Song

Keyword(s):

Health Information ◽

Search Engine ◽

Search Engines ◽

The Internet ◽

Online Health Information ◽

Online Information ◽

Significant Difference ◽

Content Coverage ◽

Google Search

BACKGROUND Increasingly people seek health information from the Internet, in particular, health information on diseases that require intensive self-management, such as diabetes. However, the Internet is largely unregulated and the quality of online health information may not be credible. OBJECTIVE To assess the quality of online information on diabetes identified from the Internet. METHODS We used the single term “diabetes” or equivalent Chinese characters to search Google and Baidu respectively. The first 50 websites retrieved from each of the two search engines were screened for eligibility using pre-determined inclusion and exclusion criteria. Included websites were assessed on four domains: accessibility, content coverage, validity and readability. RESULTS We included 26 websites from Google search engine and 34 from Baidu search engine. There were significant differences in website provider (P<0.0001), but not in targeted population (P=0.832) and publication types (P=0.378), between the two search engines. The website accessibility was not statistically significantly different between the two search engines, although there were significant differences in items regarding website content coverage. There was no statistically significant difference in website validity between the Google and Baidu search engines (mean Discern score 3.3 vs 2.9, p=0.156). The results to appraise readability for English website showed that that Flesch Reading Ease scores ranged from 23.1 to 73.0 and the mean score of Flesch-Kincaid Grade Level ranged range from 5.7 to 19.6. CONCLUSIONS The content coverage of the health information for patients with diabetes in English search engine tended to be more comprehensive than that from Chinese search engine. There was a lack of websites provided by health organisations in China. The quality of online health information for people with diabetes needs to be improved to bridge the knowledge gap between website service and public demand.

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Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/8780325 ◽

2017 ◽

Vol 2017 ◽

pp. 1-9 ◽

Cited By ~ 9

Author(s):

Chunhoo Cheon ◽

Jeong-Eun Yoo ◽

Hwa-Seung Yoo ◽

Chong-Kwan Cho ◽

Sohyeon Kang ◽

...

Keyword(s):

Placebo Group ◽

Large Scale ◽

Controlled Trial ◽

Unmet Need ◽

Double Blind ◽

Patients With Cancer ◽

Significant Difference ◽

Cancer Anorexia

Background. Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need. Objective. The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. Methods. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests. Results. Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group. Conclusions. Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02468141.

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Testosterone replacement for fatigue in male hypogonadic patients with advanced cancer: A preliminary double-blind placebo-controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e19643 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e19643-e19643

Author(s):

Kalyan Pulivarthi ◽

Rony Dev ◽

Jose Garcia ◽

J. Lynn Palmer ◽

Eduardo Bruera ◽

...

Keyword(s):

Quality Of Life ◽

Advanced Cancer ◽

Controlled Trial ◽

Depression Scale ◽

T Test ◽

Testosterone Replacement ◽

Double Blind ◽

Significant Difference ◽

Edmonton Symptom Assessment Scale

e19643 Background: Hypogonadism affects two thirds of men with advanced cancer. Uncontrolled studies show fatigue, anorexia, depression,and insomnia are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary goal of this study was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)at day 29. Methods: Randomized, double-blinded placebo controlled at two centers. Clinic outpatients with advanced cancer, bioavailable testosterone (BT) <70ng/dL, hemoglobin>9g/dL, and moderate to severe fatigue assessed by a score >3/10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.Contraindications to testosterone therapy or other causes of fatigue such as hypothyroidism, hypercalcemia, or chronic kidney disease excluded subjects. Weight-based intra-muscular testosterone or a sesame seed oil placebo administered every 14 days to achieve a BT level 70-270ng/dL. Initial sample size was for fifty evaluable patients per group. One-sided t test was used to analyze differences in FACIT scores between arms. Results: Accrual was slower than anticipated with a final total of 43 eligible males randomized to testosterone(19) or placebo(24). Neither age nor site was statistically significant (<0.05) between arms. 14 placebo and 12 testosterone treated patients were evaluable for the primary outcome.No statistically significant difference was found for FACIT-F total scores between arms, with a trend for testosterone to improve scores (-5.5±19 for placebo, 3.9±14 for testosterone, p=0.09) using a one-sided t test. Adverse events were similar between groups. There were no significant differences in secondary outcomes of ESAS scores, Hospital Anxiety and Depression Scale, hand-grip or 6 minute walk. Conclusions: Testosterone replacement in hypogonadal male patients with advanced cancer had a trend to improve fatigue and quality of life in this preliminary trial.

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Quality of life in RCT of pasireotide to reduce pancreatic complications following resection.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.393 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 393-393

Author(s):

Anne Eaton ◽

Mithat Gonen ◽

Paul Jack Karanicolas ◽

Michael Ian D'Angelica ◽

Ronald P. DeMatteo ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Unmet Need ◽

Secondary Analysis ◽

Primary Objective ◽

Recent Trial ◽

Double Blind ◽

Significant Difference ◽

Eortc Qlq

393 Background: A recent trial demonstrated that prophylactic pasireotide reduces pancreatic complication (PC) rates (primary objective). In this secondary analysis, we describe quality of life (QoL) in this population before and after resection using a standard instrument (the EORTC QLQ-C30) and the EORTC pancreatic cancer module (PAN26), which was recently developed to address the unmet need for QoL assessment in this subpopulation. Also of interest is assessing the association between PC and QoL and testing the hypothesis that pasireotide improves QoL. Methods: We conducted a randomized, double-blind, placebo-controlled trial of preoperative subcutaneous pasireotide in 300 patients undergoing pancreaticoduodenectomy or distal pancreatectomy. Participants completed the C30 and PAN26 preoperatively and on postoperative days 14 and 60. Scores were compared using paired t-tests. Results: All patients completed at least one questionnaire and 87% of patients completed all three. No major differences in QoL were seen between treatment groups so pooled results were reported. A significant worsening of function at 14 days was detected on all PAN26 and C30 function scales except hepatic and emotional functioning (EF), and all C30 symptom scales (all p<.01). These effects lessened by 60 days, but scores remained significantly worse than baseline with the exception of the sexuality, cognitive functioning, nausea and vomiting, insomnia and constipation scales, which returned to near baseline, and EF, which was significantly better than baseline (p=0.03). PC occurred in 45 patients and was associated with worse body image, dyspnea, financial difficulties and physical, role, emotional and social functioning at 14 and 60 days (all p<.05). Conclusions: During the first 14 days following resection, patients can be expected to have a significant decline in QoL. Many symptoms abate by 60 days, and EF improves. Although pasireotide effectively reduced PC, its effect did not appear to translate to improved QoL based on this sample of 300 patients. While PC was associated with worse QoL, most patients in both pasireotide and placebo groups did not experience PC, which may explain why no significant difference in QoL was observed. Clinical trial information: NCT00994110.

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Efficacy of Hawthorn fruit extract on blood pressure and quality of sleep in patients with hypertension along with sleep disorders: A randomized double-blind controlled trial

Journal of Contemporary Medical Sciences ◽

10.22317/jcms.v7i4.1017 ◽

2021 ◽

Vol 7 (4) ◽

Keyword(s):

Blood Pressure ◽

Sleep Disorder ◽

Controlled Trial ◽

Intervention Group ◽

Study Groups ◽

Quality Of Sleep ◽

Fruit Extract ◽

Double Blind ◽

Significant Difference

Objective: This study aimed to investigate the effect of Crataegus monogyna (C.monogyna) on controlling the blood pressure in patients with hypertension along with sleep disorder. Methods: This was a parallel double-blind, placebo-controlled trial study from May, 2018 to December, 2019. Total of 60 patients with hypertension and sleep disorder were randomly assigned to C.monogyna and placebo groups. The groups received C.monogyna and placebo capsules twice-daily for 8 weeks. The primary outcomes were the changes of systolic and diastolic blood pressure and Pittsburgh questionnaire’s scores from baseline measurements. The secondary outcomes were changes in serum biochemical markers from baseline. Results: Before treatment, there was no significant difference between study groups in terms of demographic data and outcomes (P>0.05) except body mass index (P=0.02). After treatments, the intervention group had a significant improvement in systolic and diastolic blood pressure compared to placebo ((118.14±6.76 vs 129.76±8.28, 95% CI: 7.54 – 15.69, P<0.001 and 77.14±5.32 vs 83.57±6.73, 95% CI: 3.17 – 9.68, P<0.001, respectively) analysis revealed no significant difference observed between study groups in terms of baseline characteristics and pre-and posttreatment laboratory tests. Also, none of the groups had superiority in terms of the Pittsburgh questionnaire’s scores (P=0.44); however, the intragroup analysis revealed significant improvements in the intervention group (P= 0.001). Conclusion: C.monogyna fruit extract as a supplementary medication has beneficial effects on controlling blood pressure and quality of sleep in patients with hypertension along with sleep disorders.

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Comparing the Effect of Dienogest and OCPS on Pain and Quality of Life in Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Trial

Archives of Iranian Medicine ◽

10.34172/aim.2021.96 ◽

2021 ◽

Vol 24 (9) ◽

pp. 670-677

Author(s):

Gelareh Niakan ◽

Samaneh Rokhgireh ◽

Majid Ebrahimpour ◽

Abolfazl Mehdizadeh Kashi

Keyword(s):

Quality Of Life ◽

Pelvic Pain ◽

Controlled Trial ◽

Primary Objective ◽

Secondary Outcome ◽

Double Blind ◽

Oral Contraceptive Pills ◽

Significant Difference ◽

The Difference

Background: Endometriosis is an estrogen-dependent disease that adversely affects women’s quality of life (QOL). We aimed to compare the effect of dienogest and oral contraceptive pills (OCPs) on pain and QOL in women with endometriosis. Methods: This randomized double-blind trial was conducted at Rasoul-e-Akram hospital, affiliated to Iran University of Medical Sciences, Tehran, Iran, from March 2018 to March 2020, on women with severe endometriosis confirmed by laparoscopic surgery. Ninety patients were randomly given either dienogest (Vissane 2 mg tablet; n = 30), or OCPs (LD; n = 30), or placebo (n = 30) daily for 12 weeks. The primary objective of this study was to evaluate the patient’s pain including dyspareunia, dysuria, dyschezia, and pelvic pain. The secondary outcome was considered as a change in patients’ QOL score. Results: The mean age of population was 32.99 ± 7.1 years. There was no significant difference in the three groups regarding baseline characteristics. Pelvic pain was significantly reduced, while the effect of medication on dysuria and dyschezia was not significant. The overall QOL score between the control and dienogest (P = 0.02) and OCPs groups (P = 0.001) was significantly different; however, the difference was not significant between the two intervention groups Conclusion: The finding of the present study revealed that there is no difference in the efficacy of dienogest and OCPs in management of pain and the QOL. But there was a significant difference between the placebo and intervention groups.

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Efficacy of ah shi Point Acupuncture on Acne Vulgaris

Acupuncture in Medicine ◽

10.1136/aim.2010.003004 ◽

2010 ◽

Vol 28 (3) ◽

pp. 126-129 ◽

Cited By ~ 13

Author(s):

Byeong-Kook Son ◽

Younghee Yun ◽

In-Hwa Choi

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Acne Vulgaris ◽

Inflammatory Lesion ◽

Subjective Symptom ◽

Acupuncture Points ◽

Double Blind ◽

Significant Difference ◽

Quality Of Life Scale

Background Ah shi point acupuncture involves inserting needles at painful or pathological sites. Objective To evaluate the efficacy of ah shi point and general acupuncture point treatment of acne vulgaris. Methods 36 subjects were recruited and randomised in a double-blind (patient-blind and observer-blind) controlled trial to receive acupuncture either at general acupuncture points only, or at both general acupuncture points and ah shi points 12 times over 6 weeks. The subjects were evaluated using the following outcome measurements: an inflammatory lesion count, a quality-of-life scale (Skindex-29) and a subjective symptom score. Results After 12 treatment sessions, there was a significant reduction in the inflammatory acne lesion counts, the Skindex-29 scores and the subjective symptom scores from baseline in both groups, but no significant difference between groups. Conclusions Acupuncture treatment of moderate acne vulgaris was associated with reduction of inflammatory lesions and improvement of the quality of life.

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: The KOSMOS Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/8856149 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Kiyoshi Takamatsu ◽

Mariko Ogawa ◽

Satoshi Obayashi ◽

Takashi Takeda ◽

Masakazu Terauchi ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Premenopausal Women ◽

Japanese Women ◽

Double Blind ◽

Double Blind Placebo ◽

Traditional Japanese Medicine ◽

Significant Difference ◽

High Level

Objective. The KOSMOS study, a multicenter, randomized, double-blind, placebo-controlled trial, investigated the effects and safety of kamishoyosan (TJ-24), a traditional Japanese medicine, in the treatment of climacteric disorder. Methods. Japanese women with climacteric disorder were administered a placebo during a 4-week run-in period, after which they were classified as placebo responders (R group) if their score on the modified Questionnaire for the Assessment of Climacteric Symptoms in Japanese Women (m-QACS) with excitability and irritability as the primary outcome improved by ≥ 3 points and as placebo nonresponders (NR group) otherwise. Members of the NR group were randomly allocated to receive either TJ-24 or placebo. After 12 weeks, their m-QACS scores, anxiety and depression, sleep, and overall quality of life (QOL) were compared. Results. The TJ-24 and placebo arms in the NR group included 20 patients each. The change in the m-QACS scores of members of the NR group for excitability and irritability at 12 weeks versus baseline was –3.1 ± 1.7 in the TJ-24 arm, a significant decrease, but compared with –2.7 ± 2.2 in the placebo arm, no significant difference was between two arms. However, the proportion of participants whose score improved by ≥3 points was significantly higher in the TJ-24 arm. In the subgroup analysis of premenopausal women, the changes in the score for excitability and irritability were significantly larger in the TJ-24 arm. The incidence of adverse drug reactions or adverse events did not differ between the two arms, and no serious events were reported. Conclusion. Although no significant difference was identified for the primary outcome, a significantly higher proportion of patients who received TJ-24 displayed improvement. Its high level of safety and effects on excitability and irritability in premenopausal women suggest that TJ-24 may be a useful treatment.

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