[Factors Influencing Patient Decisions Regarding Cancer Clinical Trial Participation: A Systematic Review].

BACKGROUND: Cancer is the top cause of death in Taiwan. Cancer clinical trials are crucial for developing new treatments. Understanding the motivations and barriers related to the factors of influence on patient decisions regarding participation in cancer clinical trials may help clinical researchers improve patients' understanding of clinical trials and improve their ability to make autonomous decisions regarding informed consent. PURPOSE: This study was designed to explore the factors affecting patient decisions regarding cancer clinical trial participation using a systematic review of the literature. METHODS: A systematic review was used. Articles were retrieved from electronic databases including Cochrane Library, Embase, PubMed, CINAHLE, and Scopus. The following keywords and MeSH terms were used to search for articles on cancer, clinical trials, participation, factors or motivations, and decision making. A total of 9353 articles published from 2011 to January 2021 that matched the search criteria were extracted. After screening the topics, deleting repetitions, and doing critical appraisals, 40 articles were selected for analysis. Research quality was assessed using Joanna Briggs Institute Levels of Evidence criteria. RESULTS: Eight motivations and nine barriers were found to significantly influence patient participation in cancer clinical trials. These motivations were: (1) trust in health professionals, (2) hope for therapeutic benefits, (3) the last treatment option, (4) altruism, (5) family support, (6) extra care, (7) patients' or others' past therapy experience, and (8) other demographic factors. The barriers to participation identified were: (1) fear of side effects or treatment efficacy, (2) concerns about trial requirements and randomization, (3) heavy financial burden, (4) inability to maintain quality of life, (5) inability to participate due to disease progression, (6) having treatment preferences, (7) health professionals' negative attitudes toward clinical trials, (8) family opposition, and (9) providing trial information at an inappropriate time. CONCLUSIONS / IMPLICATIONS FOR PRACTICE: Eight motivational factors and nine barriers influencing patient decisions regarding cancer clinical trial participation were extracted from the selected articles. In addition to personal and situational factors, family and health professionals were found to influence patient decisions regarding cancer clinical trial participation. The authors hope that the findings of this study help clinical researchers further improve patient understanding of clinical trials and help patients make autonomous decisions with regard to informed consent.

[Treatment of far lateral lumbar disc herniation with unilateral pedicle screw fixation and intervertebral body fusion after decompression].

OBJECTIVE: To investigate the surgical outcomes of unilateral lumbar pedicle screw fixation and intervertebral body fusion in treating far lateral lumber disc herniation. METHODS: From June 2007 to June 2009, 25 patients with far lateral lumbar disc herniation were treated with unilateral lumbar pedicle screw fixation and intervertebral body fusion. There were 12 males and 13 females,which ranged in age from 37 to 68, with an average of 54.6 years. The course of disease was from 3 to 36 months with an average of 8.8 months. All the patients had pain and/or numbness and/or soreness in front and/or the back of unilateral leg and buttocks; muscle strength, sensation and tendon reflexes had declined of different degrees. Lumbar CT or MRI showed far lateral lumbar disc herniation. Neurological function and lumbar function were respectively evaluated according to JOA 29 score system (including subjective, objective symptom and bladder function) and Oswestry disability index (ODI). RESULTS: All the patients were followed-up from 12 to 36 months with an average of 24 months. Postoperative wound healed well and no perioperative complications and follow-up complications were found. Neurological function of patients obtain recovery of difference degrees. At final follow-up, JOA score and ODI improved compared with that of preoperative data (P < 0.01); the mean improvement rate of JOA score was 94.3%. All patients got good bone fusion and no recurrence cases were found. CONCLUSION: Unilateral lumbar pedicle screw fixation and intervertebral body fusion could increase the initial stability after fusion, restore and maintain the intervertebral height, and elevate the improvement rate in treating far lateral lumber disc herniation. The surgical method is safe, effective and reliable, but need to strictly control indications.

Association between lysosomal cysteine protease cathepsin's activation and left ventricular function and remodeling in hypertensive heart failure rats / 中华心血管病杂志

<p><b>OBJECTIVE</b>To observe myocardial cathepsin (Cat) S expression and activity in hypertensive heart failure rats.</p><p><b>METHODS</b>The expression and activity of Cat S were determined in the left ventricular (LV) myocardium (LVM) of Dahl salt-sensitive rats fed either a high-salt (HS, 8%) or low-salt (LS, 0, 3%, controls) diet starting at age 7 weeks for 12 weeks (hypertrophy model, H-LVH) or 19 weeks (heart failure model, H-HF). Age-matched rats served as controls and human normal, hypertensive and heart failure myocardial specimen were also examined for changes on the expression and activity of Cat S.</p><p><b>RESULTS</b>Reverse transcription and real-time polymerase chain reaction analysis revealed significantly upregulated Cat S mRNA in rats with H-HF than in rats with H-LVH or in control rats and Cat S mRNA expression is negatively correlated with LVEF (r = -0.88, P < 0.05). In situ and immunohistochemistry examinations showed that Cat S was localized predominantly in cardiac myocytes (CMCs) and coronary vascular smooth muscle cells (SMC). Elastic lamina fragmentations and Cat S-dependent elastolytic activity were significantly increased in H-HF-rats. The expression of interleukin-1 beta was also increased in the LVM of H-HF rats, and this cytokine was found to increase the Cat S protein expression in culture neonatal CMCs. Similar results were revealed in human myocardial specimens.</p><p><b>CONCLUSION</b>Elastolytic Cat S might play an important role in the pathogenesis of myocardial remodeling and heart failure and Cat S might serve as a novel therapeutic target in preventing or reversing hypertension induced LV remodeling and heart failure.</p>

[Contraceptive efficacy of bioadhesive benzalkonium chloride gel in comparison with nonoxynol-9 gel].

OBJECTIVE: To compare the contraceptive efficacy of a new spermicide, bioadhesive benzalkonium chloride (BZK) gel, with the traditional nonoxynol (NP-9) gel. METHODS: A total of 240 child-bearing age women volunteers were randomly divided into two groups: 120 using the BZK gel for contraception, and the other 120 using the NP-9 gel. Using life table method and log-rank test, we compared the pregnancy rates and discontinuation rates after follow-up for 6 months in two groups. RESULTS: No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100.0% and 99.2% in the BZK group and the NP-9 group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 1.72 and 0.91 per 100 women (P > 0.05), respectively. If we excluded the 2 pregnant women (1 in each group), who did not correctly or consistently use the spermicides for every intercourse, the cumulative pregnancy rates at 6 months in perfect use would be 0.87 and 0 per 100 women (P > 0.05). And the gross cumulative discontinuation rates due to allergy or other adverse reactions at 6 months in typical use were 0 and 2.68 per 100 women (P > 0.05), respectively. CONCLUSION: The contraceptive efficacy of bioadhesive BZK gel is the same as that of the NP-9 gel, and it is more acceptable in clinical use.

[Contraceptive efficacy of bioadhesive nonoxynol-9 Gel: comparison with nonoxynol-9 suppository].

OBJECTIVE: To compare the contraceptive efficacy of a new spermicide, bioadhesive nonoxynol (N-9) gel, with a traditional N-9 suppository. METHODS: A total of 240 child-bearing aged woman volunteers were randomly divided into two groups: 120 cases using the gel for contraception, and another 120 using the suppository. Using lifetable method and log rank test, we compared the pregnancy rates and other discontinuation rates after follow-up for 6 months in two groups. RESULTS: No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100.0% and 97.5% in the gel group and the suppository group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 6.39 and 2.95 per 100 women (P > 0.05), respectively. If we eliminated the 5 pregnancy women (3 in the gel group, and 2 in the suppository one), who did not consistently use the spermisides for every intercourse, the cumulative pregnancy rates at 6 month in perfect use would be 3.71 and 2.03 (P > 0.05). And the discontinuation rates due to allergy or other side effects at 6 months in typical use were 3.45 and 4.57 (P > 0.05), respectively. All of the results observed between two groups in this study were not statistically significant. CONCLUSION: The contraceptive efficacy of bioadhesive N-9 gel is as same as that of the N-9 suppository, and its clinical use is quite safe.