[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.

Effectiveness of an optimized benzalkonium chloride gel as vaginal contraceptive: a randomized controlled trial among Chinese women.

BACKGROUND: This study was conducted to evaluate the efficacy, safety and acceptability of a newly developed benzalkonium chloride (BZK) contraceptive gel which was compared to nonoxynol-9 (N-9) gel. STUDY DESIGN: A Phase II, multicenter, randomized, controlled study at three Chinese centers was conducted to compare 120 women who used BZK gel with 120 women who used N-9 gel for 6 months. Contraceptive efficacy was assessed by pregnancy rate, and safety was evaluated by adverse events report, gynecologic examination, Papanicolaou smears, leukorrhea test, and blood and urine tests. The acceptability was assessed through follow-up visit forms and a questionnaire at the 6-month visit. RESULTS: Net cumulative rates in the BZK group at 6 months were as follows: follow-up 100%, terminations 5.1%, pregnancy 1.7%, medical reasons 0% and fear of failure 3.4%. At 6 months, the rates in the N-9 group were as follows: follow-up 99.2%, terminations 9.4%, pregnancy 0.9%, medical reasons 2.5%, fear of failure 3.4% and other personal reasons 2.6%. No significant difference in pregnancy rate and termination rate between the two groups was found (p>.05). Seven cases in the BZK group (5.8%) complained about leukorrhagia and vaginal irritation symptoms (itching and burning) at 6 months, while 16 cases in the N-9 group (13.3%) had similar complaints (p<.05). This significant difference continued to exist until the 6-month visit. The general satisfaction rate for BZK gel use (72.8%) is significantly higher than that for N-9 gel (42.5%). CONCLUSION: The optimized BZK gel is comparable to N-9 gel in terms of contraceptive efficacy and safety, and may be more acceptable to Chinese users.

[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.

[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.