The Development of the “Quality of Informed Consent Scale” (QuIC) as Modified for Placebo-Controlled Randomized Double-Blind Trials: Linguistic Validity

2021 ◽  
Vol 52 (4) ◽  
pp. 109-116
Author(s):  
Miho FUJITA ◽  
Yuki YONEKURA ◽  
Kazuhiro NAKAYAMA
Keyword(s):  
Informed Consent ◽  
Double Blind ◽  
Blind Trials

scholarly journals Methods to increase muscle tonus of upper airway to treat snoring: systematic review

2008 ◽  
Vol 66 (3b) ◽  
pp. 773-776 ◽  
Author(s):  
Juliana Spelta Valbuza ◽  
Márcio Moysés de Oliveira ◽  
Cristiane Fiquene Conti ◽  
Lucila Bizari F. Prado ◽  
Luciane Bizari Coin de Carvalho ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Scientific Evidence ◽  
Upper Airway ◽  
Muscle Tonus ◽  
Upper Airways ◽  
Double Blind ◽  
Blind Trials

BACKGROUND: Snoring is the noise caused by vibration during the in-breath; and which structure actually vibrates depends on many factors. OBJECTIVE: The treatment of snoring with methods to increase muscle tonus of upper airway has been controversial, and poorly reported, thus a review of evidence is necessary to evaluate the effectiveness of these methods. METHOD: A review of randomized or quasi-randomized, double blind trials on snoring treatment that have employed any method to increase muscle tonus of upper airway like phonotherapy or physical therapy among others. Outcomes: decrease or completely stop of snoring, sleep quality, quality of life, and adverse events. RESULTS: Three eligible trials were potentially analyzed, but none of them could provide good scientific evidence favoring the intervention. The objective analyses of one study showed improvement of snoring, although the objective sub-analyses and subjective analyses showed controversial results. The adverse events were not reported. CONCLUSION: There is no enough evidence to support the recommendation of methods to increase muscle tonus of upper airways in treatment of snoring. Well designed randomized clinical trials are needed to asses the efficacy of such methods, and a standard and worldwide accepted method for snoring assessment would be useful for future researches.

scholarly journals Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

2021 ◽  
Vol 18 (4) ◽  
pp. 1666 ◽  
Author(s):  
Paulo Fávio Macedo Gouvêa ◽  
Zélia Maria Nogueira Britschka ◽  
Cristina de Oliveira Massoco Salles Gomes ◽  
Nicolle Gilda Teixeira de Queiroz ◽  
Pablo Antonio Vásquez Salvador ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Short Form ◽  
Serum Levels ◽  
Double Blind ◽  
Sf 36 ◽  
Radiographic Grade ◽  
Physical Functions ◽  
Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

scholarly journals Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

scholarly journals Effectiveness of ovarian suspension in preventing postoperative ovarian adhesions in patients with severe pelvic endometriosis—a case-control study

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Zahra Dehbashi ◽  
Shaheen Khazali ◽  
Fateme Davari Tanha ◽  
Farnaz Mottahedian ◽  
Mahsa Ghajarzadeh ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Transvaginal Ultrasound ◽  
Stage Iv ◽  
Clinical Pregnancy ◽  
Reproductive Age ◽  
Deep Infiltrating Endometriosis ◽  
Pelvic Endometriosis ◽  
Double Blind ◽  
Entire Study

Abstract Background Endometriosis can exert obvious negative effects on women’s quality of life. Excisional surgery is among the most effective treatments for severe pelvic endometriosis. The prevalence of severe pelvic adhesions following a laparoscopic examination of severe endometriosis varies between 50 and 100%. Temporary intraoperative ovarian suspension is a method for the reduction of adhesions is in the treatment of severe pelvic endometriosis. Given the importance and the prevalence of endometriosis and its complications, we conducted the present study to determine more effective adhesion-reducing methods with a view to improving the quality of the treatments provided. Methods The present prospective double-blind randomized clinical trial was conducted on 50 women of reproductive age (≥ 19 years) diagnosed with severe pelvic endometriosis on transvaginal ultrasound scans and vaginal examinations at Yas Hospital between 2014 and 2017. Women with severe endometriosis (stage III, stage IV, and deep infiltrating endometriosis) requiring an extensive bilateral dissection of the pelvic walls and the rectovaginal space, with preserved uterus and ovaries, were included in the study. The preoperative severity of ovarian adhesions was assessed in terms of ovarian motility, measured through a combination of gentle pressures applied with the vaginal probe and abdominal pressures applied with the examiner’s free hand. A table of random numbers was used to choose which ovary to suspend. The entire study population received standard general anesthesia. In the laparoscopic examination of the cases with severe endometriosis, both ovaries were routinely suspended to the anterior abdominal wall with PROLENE sutures. At the end of the surgery, one of the ovaries was kept suspended for 7 days, whereas the other ovarian suspension suture was cut. At 3 months postoperatively, all the patients underwent ultrasound scans for the assessment of ovarian motility and adhesions. The severity of pelvic pain was defined according to a visual analog score. After surgery, infertile women were followed for 2-4 years, and were contacted regarding the infertility treatment. Chemical and clinical pregnancy rates was compered between the two groups. Results Three months after laparoscopy, the adhesions were mild in 41 (82%) patients and moderate in 9 (18%) on the suspended side, and mild in 12 (24%) patients and moderate in 38 (76%) on the control side (P < 0.001). The mean dysmenorrhea score was 6.8 ± 1.5 before surgery and 4.5 ± 1.4 after surgery (P < 0.001). The chemical pregnancy rate and clinical pregnancy rate were not different in the suspended and control groups (P = 0. 62, P = 0.64). Conclusions The reduction in adhesions via ovarian suspension surgery promises reductions in the complications of endometriosis.

Placebo response in antidepressant drug trials

1994 ◽  
Vol 9 (3) ◽  
pp. 115-118 ◽  
Author(s):  
M Beneke ◽  
W Rasmus ◽  
J Fritze
Keyword(s):  
Frequency Analysis ◽  
Low Dose ◽  
Antidepressant Drug ◽  
Placebo Response ◽  
Response Patterns ◽  
Relative Efficacy ◽  
Drug Trials ◽  
Double Blind ◽  
Pooled Data ◽  
Blind Trials

SummaryResponse patterns derived from dichotomized (0/1) weekly CGI ratings conducted in antidepressant drug trials (Quitkin et al, 1984) were compared with those found in the pooled data from several randomized double-blind trials comparing the relative efficacy and tolerability low-dose flupenthixol im with that of three trieyclics (amitriptyline sr, imipramine, doxepine). Using the configurational frequency analysis (Krauth and Lienert, 1973), the postulated patterns could be rediscovered in our data apart from “early onset persistent patterns” which were less frequent in Quitkin et al's (1984) drug data. However, apart from this finding no “typical” patterns in terms of drug- or placebo-dependent response patterns could be detected in either the flupenthixol or Quitkin et al's (1984) data. It is concluded that there is little empirical evidence for the assumption of placebo- or drug related change- or response patterns. Moreover, theoretical aspects do not support the usefulness of such concepts.

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