耳穴贴压疗法治疗失眠症的随机对照研究

目的 探讨耳穴贴压疗法及特定穴位治疗失眠症的有效性.方法 选择符合纳入标准的失眠症患者125例,随机分为真穴治疗组63例和伪穴对照组62例.真穴组选取神门、皮质下、心、肾、肝、脾、枕等穴位,伪穴组选上述穴位旁开2～3mm处,疗程1个月.每组治疗前后均采用匹兹堡睡眠质量指数量表(PSQI)评价疗效.结果 (1)两组治疗前后PSQI各因子评分差及总分差均有统计学意义(P＜0.01);(2)两组间治疗后各因子评分及总分的比较显示,两组在睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍和日间功能障碍6项的差异有统计学意义(P＜0.01);两组治疗前后其评分差值的比较也有统计学意义;(3)对两组各因子治疗前后的等级差值进行秩次分析,其差异均有统计学意义(P＜0.01).结论 耳穴贴压疗法近期内能有效改善睡眠质量,缩短入睡时间,延长睡眠时间,提高睡眠效率.     

Zinc supplementation fails to increase the immunogenicity of oral poliovirus vaccine: A randomized controlled trial

BackgroundPolio eradication remains a challenge in Pakistan and the causes for the failure to eradicate poliomyelitis are complex. Undernutrition and micronutrient deficiencies, especially zinc deficiency, are major public health problems in Pakistan and could potentially affect the response to enteric vaccines, including oral poliovirus vaccine (OPV).ObjectiveTo assess the impact of zinc supplementation among infants on immune response to oral poliovirus vaccine (OPV).MethodsA double-blind, randomized placebo-controlled trial was conducted in newborns (aged 0–14 days). Subjects were assigned to either receive 10 mg of zinc or placebo supplementation daily for 18 weeks. Both groups received OPV doses at birth, at 6 weeks, 10 weeks and 14 weeks. Data was collected on prior immunization status, diarrheal episodes, breastfeeding practices and anthropometric measurements at recruitment and at 6 and 18 weeks. Blood samples were similarly collected to determine the antibody response to OPV and for micronutrient analysis. Logistic regression was used to determine the relationship between seroconversion and zinc status.ResultsOverall, 404 subjects were recruited. At recruitment, seropositivity was already high for poliovirus (PV) serotype 1 (zinc: 91.1%; control: 90.5%) and PV2 (90.0%; 92.7%), with lower estimates for PV3 (70.0%; 64.8%). By week 18, the proportion of subjects with measured zinc levels in the normal range (i.e. ≥60 μg/dL) was significantly greater in the intervention group compared to the control group (71.9%; 27.4%; p < 0.001). No significant difference in seroconversion was demonstrated between the groups for PV1, PV2, or PV3.ConclusionsThere was no effect of zinc supplementation on OPV immunogenicity. These conclusions were confirmed when restricting the analysis to those with measured higher zinc levels.     

真实世界研究与随机对照试验、单病例随机对照试验在临床治疗性研究中的关系比较

真实世界研究、随机对照试验及单病例随机对照试验在设计及具体的实施环节上存在明显不同.随机对照试验属于新治疗措施实施前的研究,真实世界研究属于新治疗措施实施后的研究.两者不是对同一个问题的平行论证,而是承启关系.精心设计的随机对照试验是临床上任何干预措施效果评价的基础,其结果需要真实世界研究的进一步验证及拓展补充,综合考虑二者才是最佳的选择.单病例随机对照试验更易在短时间内获得一些特殊病例的信息,是随机对照试验结果的良好补充,也是一定条件下最经济的真实世界研究.临床工作及其研究是十分复杂的过程.不同个体虽患同种疾病,但临床表现互有差异,且临床反应的变化也不尽相同.因此,无法获得同一干预措施下不同个体的相同治疗效果;加之有的治疗措施缺乏真实性和实用价值,从而使得疗效评价成为一个难题.近些年来,普遍采用试验性的研究结果作为证据指导临床实践活动,其中以随机对照试验(RCT)最为受到重视,但由于RCT属于药物面市前研究,对研究对象的选择、治疗措施的应用等均有严格的限定.     

Efficacy and safety of very-low-calorie diet in Taiwanese: A multicenter randomized, controlled trial

ObjectiveVery-low-calorie diets (VLCDs) are an effective method for weight reduction in Caucasians. This study investigated the efficacy and safety of two different VLCDs (450 or 800 kcal/d) in obese Taiwanese.Methods132 participants with BMI ≥30 kg/m² were randomized to two VLCD groups for body weight reduction for 12 weeks. Each group had 66 participants. Anthropometric and metabolic parameters were measured.ResultsThe intention-to-treat analysis revealed that the percentage change in body weight over the 12-week treatment period was –9.14% in the VLCD-450 group and –8.98% in the VLCD-800 group. A total of 27 (40.9%) participants in the VLCD-450 group and 29 (43.9%) participants in the VLCD-800 group achieved 10% or more weight loss at the end of treatment. The body weight, waist circumference, hip circumference, fat mass, blood pressure, triglycerides, and blood glucose were statistically improved from baseline but not between the two groups. The improvement rate of nonalcoholic fatty liver disease (NAFLD) was 41.5% in the VLCD-450 group and 50.0% in the VLCD-800 group. The incidence of adverse events did not differ significantly between the groups and no serious adverse events were reported in either group.ConclusionBoth the VLCD-450 and 800 kcal/d can effectively and safely reduce body weight and improve NAFLD in 12 weeks in obese Taiwanese participants. However, there is no additional benefit in prescribing the more restrictive diet intervention in Taiwanese.     

Lottery incentives did not improve response rate to a mailed survey: a randomized controlled trial

OBJECTIVES: Our study aimed to examine the effect of an instant lottery ticket incentive on the response rate to a mailed questionnaire in a population of trauma patients. STUDY DESIGN AND SETTING: A randomized controlled trial at a major trauma center with 728 patients randomized into 2 groups prior to mailing of a questionnaire. One group of patients (Group A) had a sentence inserted into the cover letter stating that they would receive a $4 instant lottery ticket upon receipt of a completed questionnaire; Group B did not have an incentive. The response rate for both groups was measured after the initial mailing and at the end of the study. The results were analyzed using the X2 test to compare 2 proportions and a P value of .05 was considered significant. RESULTS: The early response rate in Group A was lower than in Group B, and the response rates for both groups were similar at final follow-up. The differences at both time periods were not statistically significant. CONCLUSION: The use of an instant lottery ticket incentive did not improve the response rate to a mailed questionnaire.     

Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination

BACKGROUND: Mifepristone was compared with laminaria for cervical ripening in second-trimester induction of labor (IOL). STUDY DESIGN: We performed a randomized, controlled, open-label study of women undergoing second-trimester IOL for fetal demise, aneuploidy or anomalies at a single tertiary care center from January 2004 to May 2006. Main outcome measures were induction-to-delivery time and pain with cervical ripening. RESULTS: Of 50 eligible women, 37 were enrolled in the study, of whom 33 completed the study: 16 were randomized to laminaria and 17 to mifepristone. Induction-to-delivery time was significantly shorter in the mifepristone arm (mean=10 h vs. 16 h, p=.01; median=7.5 h vs. 13.4 h, p=.01). Pain with cervical ripening was also significantly less in the mifepristone group than in the laminaria group (median=1 vs. 6 on an 11-point visual analogue scale, p<.001). Maternal age, parity, gestational age, fetal demise prior to induction, need for postpartum curettage, blood loss, pain during induction, delivery and at the time of discharge were not significantly different between the two groups. CONCLUSION: Mifepristone shortens the induction-to-delivery time and decreases pain with cervical ripening when compared with laminaria for second-trimester induction.     

A randomized trial of electronic reminders showed a reduction in the time to respond to postal questionnaires

Objective

To assess the effect of electronic reminders (ERs) on response rate and time to response for the return of postal questionnaires.

Study Design and Setting

This open randomized controlled trial (RCT) was conducted at the University of York. Participants who were taking part in an established RCT and who provided an electronic mail address and/or mobile telephone number were eligible to take part in the study. The intervention group received ERs on the day they were expected to receive postal questionnaires.

Results

One hundred forty-eight participants (19 male and 129 female) aged 47 ± 11 (range, 19-65) years were studied. About 89.2% of participants returned postal questionnaires. There was no difference in questionnaire response rates in control (64 of 74 [86.5%]) vs. intervention (68 of 74 [91.9%]), groups (relative risk = 1.063, 95% confidence interval: 0.949-1.189). Median questionnaire time to response was 4 days less in the intervention group (10.0 ± 0.2; range, 10-14 days) compared with the control group (14.0 ± 1.4; range, 10-23 days) (χ²_1df = 5.27, P = 0.022).

Conclusion

ERs are useful tools for reducing participant time to response for postal questionnaires. We found little evidence for an effect of ERs on response rate for postal questionnaires.     

Regular aerobic exercise increases dispositional mindfulness in men: A randomized controlled trial

Dispositional mindfulness is a construct described as the propensity to be aware of one's actions in everyday life. Although high dispositional mindfulness has been demonstrated to be beneficial for improved mental and physical health, little is known about ways to improve dispositional mindfulness for individuals not practicing meditation or mindful exercises. The study aimed at investigating (1) whether dispositional mindfulness can also be trained by regular aerobic exercise and (2) whether changes in dispositional mindfulness are associated with changes in mental and physical health. 149 healthy men were randomly allocated to one of two 12-week interventions (aerobic exercise or relaxation training) or a waitlist control condition. Dispositional mindfulness and mental and physical health were assessed before and after the intervention by self-report questionnaires. Over the course of the intervention, increases in dispositional mindfulness occurred in the aerobic exercise group but not in the relaxation or waitlist control conditions (p = .018). Increases in dispositional mindfulness were moderately correlated with improvements in mental health. For the first time, this study shows that dispositional mindfulness can be increased through regular aerobic exercise. Future research is needed to identify how the mindfulness-enhancing potential of aerobic exercise can be used most effectively.     

Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial

BackgroundAlthough pregnant women are the highest priority group for seasonal influenza vaccination, maternal influenza vaccination rates remain suboptimal. The purpose of this study was to evaluate the effect of a brief education intervention on maternal influenza vaccine uptake.MethodsDuring the 2013–14 and 2014–15 influenza seasons, we recruited 321 pregnant women from the antenatal clinics of 4 out of 8 public hospitals in Hong Kong with obstetric services. Hospitals were geographically dispersed and provided services to pregnant women with variable socioeconomic backgrounds. Participants were randomized to receive either standard antenatal care or brief one-to-one education. Participants received telephone follow-up at 2 weeks postpartum. The primary study outcome was self-reported receipt of influenza vaccination during pregnancy. The secondary outcomes were the proportion of participants who initiated discussion about influenza vaccination with a health care professional and the proportion of participants who attempted to get vaccinated.ResultsCompared with participants who received standard care, the vaccination rate was higher among participants who received brief education (21.1% vs. 10%; p = 0.006). More participants in the education group initiated discussion about influenza vaccination with their HCP (19.9% vs. 13.1%; p = 0.10), but the difference was not statistically significant. Of participants who did not receive the influenza vaccine (n = 271), 45 attempted to get vaccinated. A significantly higher proportion of participants who attempted to get vaccinated were in the intervention group (82.2% vs. 17.8%; p < 0.001). If participants who had attempted vaccination had received the vaccine, vaccination rates would have been substantially higher (44.1% vs. 15%; p < 0.001). Twenty-six participants were advised against influenza vaccination by a healthcare professional, including general practitioners, obstetricians, and nurses.ConclusionAlthough brief education was effective in improving vaccination uptake among pregnant women, overall vaccination rates remain suboptimal. Multicomponent approaches, including positive vaccination recommendations by healthcare professionals, are needed to promote maternal influenza vaccination.Clinical Trial Registration: www.clinicaltrials.gov (NCT01772901).     

Computer-assisted cognitive rehabilitation in persons with multiple sclerosis: Results of a multi-site randomized controlled trial with six month follow-up

Background

The effects of multiple sclerosis (MS) on cognition have gained increasing recognition as one of the major disabling symptoms of the disease. Despite the prevalence of these symptoms and their impact on quality of life, limited attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS.

再论观察与实验：大数据现实世界研究不能取代随机对照试验

传统上,流行病学多以干预划分观察和实验,干预研究等于实验研究,还认为干预研究的科学性高于观察性研究。在一般科学实验里,干预指人为施加的改变自然状况的措施。干预并不一定是有益的,也并不一定是研究者当下施加的,研究者、受试者或第三者目前或过去施加的措施都可以形成"有效的"干预。例如,由研究者、受试者和第三者通过某种方法致使视神经损伤,都可以形成有效改变视神经正常功能的干预,研究者可以由此观察到视神经和视力的关系。以此推论,由受试者自己过去施加的不良干预（如吸烟）也属于干预,那么研究吸烟和肺癌的观察性队列研究就等同于实验研究了。由此看来,干预本身并不足以有效地区分观察和实验。如果认为实验的科学性高于观察,那么在干预的基础上,只能从科学性上（即设计特征）区分观察和实验。在评估医学干预效果的临床试验中,随机分组是在传统认为的观察研究基础上引入的最重要的偏倚控制措施,应该是区分观察和实验的核心属性。如果一定要把人群研究分成观察和实验,随机对照试验才是真正的实验研究,非随机分组形成的干预研究属于试验,但不是实验。基于大数据的现实世界研究,如果没有随机分组,不能构成实验,也不能成为对干预效果的最终检验。大数据现实世界研究不能取代随机对照试验,这是本文希望传达的最重要的信息。     

The effectiveness of vibratory stimulation in reducing pain in children receiving vaccine injection: A randomized controlled trial

BackgroundAlthough vaccine injections are important, children experience pain and discomfort upon their administration. BUZZY®, a vibratory stimulation tool with an ice pack, was reported to be an effective tool for reducing the pain caused to children during injection administration; its mechanisms were explained by gate control theory. However, the evidence is inadequate because of insufficient methodology in previous reports. Therefore, we aimed to assess whether the application of vibration would significantly reduce children’s pain during vaccine injections.MethodsA single-blind randomized controlled trial recruiting children aged ≤6 years who were receiving vaccine injections was conducted between August and December 2019. If the children’s parents consented to their participation, BUZZY® was attached to the child’s arm prior to vaccination. BUZZY® was switched on before injection in the intervention group but not in the control group. The vaccination procedure was recorded, and researchers and parents assessed each child’s pain using validated pain scales. Researchers conducted their assessment using video data to ensure blinding. Parents were administered a questionnaire after the children’s vaccination. Data were analyzed using the t-test or chi-square test.ResultsWe analyzed 118 children (intervention group = 62, control = 56). No between-group difference was observed according to the researchers’ assessment (mean score = 6.98 and 7.63, respectively; p = 0.25); however, a significant difference was found based on the parents’ assessment (mean score = 7.39 versus 8.46; p = 0.02). Most responses received to open-ended questions were positive comments for this study.ConclusionsWe revealed that the effect of vibration is not significant in reducing vaccine injection pain among children. Further studies are needed to examine the other components of BUZZY®, which include its cooling effect, and the effect of BUZZY® itself in terms of whether children will undergo vaccination without resistance and have reduced trauma related to vaccination.     

Sensitivity to change of health status measures in a randomized controlled trial: comparison of the COOP charts and the SF-36

This study compared the sensitivity to change of comparable dimensions of a multi-item multi-dimensional health status measure (the SF-36) with the equivalent single item domains on the Dartmouth COOP charts. One hundred and twenty nine patients were randomized to either day case laparoscopic surgery (n=60) or open inguinal hernia repair (n=69). Respondents completed the SF-36 and COOP charts at baseline (prior to surgery) and at follow up at 10 days and 6 weeks. Equivalent dimensions of physical functioning, mental health/emotional condition, social activities, pain and overall condition/general health on the two questionnaires were compared. Despite slightly different pictures of change provided by the physical functioning and overall condition/general health dimensions the general picture of change provided by the two instruments was similar. At 10 days, patients who underwent open surgery reported far greater levels of dysfunction than those who underwent laparoscopic surgery on both questionnaires. At 6 weeks the pain dimension of both questionnaires indicated a large improvement from baseline, whilst no other domain on either questionnaire for either group indicated such improvement. The general picture of change provided by the two measures was similar. The results suggest that both the SF-36 and the COOP charts may prove suitable for the assessment of health perception outcomes in surgical clinical trials. Differences on certain domains were caused in large measure by the nature of the questions posed. The study once again highlights the importance of checking item content to determine the suitability of any particular measure for a given study.     

Electronic reminders did not improve postal questionnaire response rates or response times: a randomized controlled trial

Objective

We aim to evaluate the effectiveness of electronic reminders (ERs) to improve the response rates and time to response of postal questionnaires in a health research setting.

Study Design and Setting

This pragmatic randomized controlled trial (RCT) was nested within a multicenter RCT of yoga for lower back pain. Participants who provided an electronic mail address and/or mobile phone number were randomized to receive an ER or no reminder (controls) on the day they were due to receive a follow-up questionnaire.

Results

One hundred twenty-five participants (32 males and 93 females) mean age 46 (standard deviation: 11, range: 20-65) were randomized to ER (n = 62) or controls (n = 63). Overall 85.6% of participants returned postal questionnaires (87.1% ER group and 84.1% from controls). No significant differences were found between the two groups for response rate (difference between groups = 3.0%, 95% confidence interval [CI] = −10, 16; P = 0.64) or time to response after adjusting for age, gender, and treatment allocation (χ² _[3df] = 7.10; P = 0.07).

Conclusion

In the present RCT, we found little evidence for the effectiveness of ERs to increase response rates or time to respond for the return of questionnaires in this study population group.     

Exploring treatment preferences facilitated recruitment to randomized controlled trials

Objective

To explore how patients' treatment preferences were expressed and justified during recruitment to a randomized controlled trial (RCT) and how they influenced participation and treatment decisions.

Study Design and Setting

Qualitative analysis of audio recordings of recruitment appointments with 93 participants aged 51-70 years in a UK multicenter RCT of localized prostate cancer treatments.

Results

Treatment preferences at recruitment were more complex and dynamic than previously assumed. Most participants expressed views about treatments early in appointments, ranging on a continuum from hesitant to well-formed opinions. As recruiters elicited men’s views and provided detailed evidence-based treatment and study information, some opted for their preference, but many became uncertain and open to RCT recruitment, often accepting a different treatment from their original “preference.” Discussion of treatment preferences did not act as the expected barrier to recruitment but actively enabled many to express their concerns and reach an informed decision that often included RCT participation.

Conclusion

Exploring treatment preferences and providing evidence-based information can improve levels of informed decision making and facilitate RCT participation. Treatment preferences should be reconceptualized from a barrier to recruitment to an integral part of the information exchange necessary for informed decision making about treatments and RCT participation.     

A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia

Objective

Faith Moves Mountains assessed the effectiveness of a faith-placed lay health advisor (LHA) intervention to increase Papanicolaou (Pap) test use among middle-aged and older women in a region disproportionately affected by cervical cancer and low screening rates (regionally, only 68% screened in prior 3 years).

Method

This community-based RCT was conducted in four Appalachian Kentucky counties (December 2005-June 2008). Women aged 40-64 and overdue for screening were recruited from churches and individually randomized to treatment (n = 176) or wait-list control (n = 169). The intervention provided LHA home visits and newsletters addressing barriers to screening. Self-reported Pap test receipt was the primary outcome.

Results

Intention-to-treat analyses revealed that treatment group participants (17.6% screened) had over twice the odds of wait-list controls (11.2% screened) of reporting Pap test receipt post-intervention, OR = 2.56, 95% CI: 1.03-6.38, p = 0.04. Independent of group, recently screened participants (last Pap > 1 but < 5 years ago) had significantly higher odds of obtaining screening during the study than rarely or never screened participants (last Pap ≥ 5 years ago), OR = 2.50, 95% CI: 1.48-4.25, p = 0.001.

Conclusions

The intervention was associated with increased cervical cancer screening. The faith-placed LHA addressing barriers comprises a novel approach to reducing cervical cancer disparities among Appalachian women.     

Internet peer support for individuals with psychiatric disabilities: A randomized controlled trial

Despite the prevalence of Internet support groups for individuals with mental illnesses little is known about the potential benefits, or harm, of participating in such groups. Therefore, this randomized controlled trial sought to determine the impact of unmoderated, unstructured Internet peer support, similar to what is naturally occurring on the Internet, on the well-being of individuals with psychiatric disabilities. Three hundred individuals resident in the USA diagnosed with a Schizophrenia Spectrum or an Affective Disorder were randomized into one of three conditions: experimental Internet peer support via a listserv, experimental Internet peer support via a bulletin board, or a control condition. Three measurement time points, baseline, 4- and 12 months post-baseline, assessed well-being by examining measures of recovery, quality of life, empowerment, social support, and distress. Time × group interactions in the repeated measures ANOVA showed no differences between conditions on the main outcomes. Post-hoc repeated measures ANOVAs found that those individuals who participated more in Internet peer support reported higher levels of distress than those with less or no participation (p = 0.03). Those who reported more positive experiences with the Internet peer support group also reported higher levels of psychological distress than those reporting less positive experiences (p = 0.01). Study results therefore do not support the hypothesis that participation in an unmoderated, unstructured Internet listserv or bulletin board peer support group for individuals with psychiatric disabilities enhances well-being. Counterintuitive findings demonstrating those who report more positive experiences also experienced higher levels of distress are discussed but we also point to the need for additional research. Future research should explore the various structures, formats, and interventions of Internet support, as well as the content and quality of interactions. Knowledge generated from such research can help to inform policies and guidelines for safely navigating online resources and supports to gain maximum benefit.