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Conclusion | The study confirmed the psychological determinants of long-term abstinence from smoking and provided a framework to explore why such an intervention is effective. This approach may be applicable to the development or analysis of interventions targeting other health behaviours. | PMC10042092 | ||
Résumé | PMC10042092 | |||
Objectif | autour | Présenter une intervention de sevrage tabagique articulée autour de messages SMS envoyés sur les téléphones mobiles et personnalisés en fonction de la théorie du changement de comportement, puis déterminer pourquoi cette intervention a porté ses fruits. | PMC10042092 | |
Méthodes | avons | Nous avons mené un essai contrôlé randomisé en double aveugle et à deux volets dans cinq villes de Chine entre avril et juillet 2021. Nous avons recruté des fumeurs quotidiens ou hebdomadaires âgés de 18 ans et plus. L'intervention, qui s'étalait sur 90 jours, s'est déroulée par l'intermédiaire d'une application de chat sur téléphone mobile. À différents stades du sevrage, les participants du groupe d'intervention ont reçu des messages SMS personnalisés basés sur une analyse de leur degré de volonté et de leur motivation à arrêter de fumer, mais aussi de leurs capacités autodéclarées à y parvenir. De leur côté, les participants du groupe de contrôle ont reçu des messages SMS non personnalisés. Le taux d'abstinence à six mois vérifié par test biochimique constituait le critère d'évaluation principal. Les critères d'évaluation secondaires étaient l'évolution des scores au niveau des composantes de la théorie de la motivation à la protection. Toutes les analyses reposaient sur l'intention de traiter. | PMC10042092 | |
Résultats | avons | Nous avons réparti aléatoirement 722 participants entre groupes d'intervention et de contrôle. Le taux d'abstinence à six mois vérifié par test biochimique s'élevait à 6,9% (25/360) au sein du groupe d'intervention et à 3,0% (11/362) au sein du groupe de contrôle. Dans le cadre de l'analyse fondée sur la théorie de la motivation à la protection, les fumeurs ayant fait l'objet d'une action personnalisée ont obtenu des scores plus faibles en matière de récompense intrinsèque provoquée par le tabagisme et de coûts d'intervention du sevrage. Ces deux variables se sont également révélées décisives dans l'abstinence prolongée, ce qui explique pourquoi le groupe d'intervention a affiché un taux de sevrage plus conséquent. | PMC10042092 | |
Conclusion | L'étude a confirmé l'impact des déterminants psychologiques de l'abstinence à long terme et fourni des pistes d'exploration des raisons pour lesquelles une telle action est efficace. Cette approche pourrait être utilisée dans le développement ou l'analyse d'interventions ciblant d'autres comportements liés à la santé. | PMC10042092 | ||
Resumen | PMC10042092 | |||
Objetivo | Describir una intervención para | DEL | Describir una intervención para dejar de fumar mediante el uso de mensajes de texto personalizados para teléfonos móviles basada en la teoría del cambio de conducta y evaluar por qué la intervención fue eficaz. | PMC10042092 |
Métodos | autoinformado | DEL | Se realizó un ensayo aleatorizado, con enmascaramiento doble y con dos grupos en cinco ciudades de China entre abril y julio de 2021. Se preseleccionaron fumadores diarios o semanales mayores de 18 años. La intervención de 90 días se realizó mediante una aplicación de chat para teléfonos móviles. En las diferentes etapas de abstinencia, los participantes del grupo de intervención recibieron mensajes de texto personalizados según los análisis de la fuerza de su intención de dejar de fumar, su motivación para dejar de fumar y su éxito autoinformado al dejar de fumar. Los participantes del grupo comparativo recibieron mensajes de texto no personalizados. El criterio de valoración principal fue la tasa de abstinencia verificada mediante pruebas bioquímicas a los 6 meses. Los criterios de valoración secundarios fueron los cambios en las puntuaciones de los componentes de la teoría de la motivación de protección. Todos los análisis se realizaron por intención de tratar. | PMC10042092 |
Resultados | DEL | Se asignaron aleatoriamente 722 participantes a los grupos de intervención o comparativos. La abstinencia continua verificada mediante pruebas bioquímicas a los 6 meses fue del 6,9 % (25/360) en el grupo de intervención y del 3,0 % (11/362) en el grupo comparativo. Los fumadores que recibieron la intervención personalizada tuvieron puntuaciones más bajas en las recompensas intrínsecas de fumar y en los costes de respuesta de dejar de fumar en el análisis de la teoría de la motivación de protección. Estas dos variables también fueron determinantes de la abstinencia prolongada, lo que explica por qué el grupo de intervención tuvo una tasa de abstinencia más elevada. | PMC10042092 | |
Conclusión | DEL | El estudio confirmó los determinantes psicológicos de la abstinencia del tabaco a largo plazo y proporcionó un marco para explorar por qué una intervención de este tipo es eficaz. Este enfoque podría aplicarse al desarrollo o análisis de intervenciones dirigidas a otros hábitos saludables. | PMC10042092 | |
ملخص | PMC10042092 | |||
الغرض | وصف التدخل للإقلاع عن تعاطي التبغ باستخدام رسائل نصية مخصصة للهاتف المحمول بناءً على نظرية تغيير السلوك، وتقييم سبب فعالية التدخل. | PMC10042092 | ||
الطريقة | والذي | قمنا بإجراء تجربة تحكم عشوائية، ثنائية التعمية، ثنائية الذراع، في خمس مدن في الصين في الفترة من أبريل/نيسان إلى يوليو/تموز 2021. قمنا بتوظيف مدخنين يوميًا أو أسبوعيًا بعمر 18 عامًا أو أكبر. تم تنفيذ التدخل لمدة 90 يومًا باستخدام تطبيق للدردشة على الهاتف المحمول. في مراحل مختلفة من الإقلاع، تلقى المشاركون في مجموعة التدخل رسائل نصية مخصصة بناءً على تحليلات شدة عزمهم على الإقلاع، ودوافعهم للإقلاع، ونجاحهم المبلغ عنه ذاتيًا في الإقلاع. تلقى المشاركون في مجموعة التحكم رسائل نصية غير مخصصة. كانت النتيجة الأولية هي معدل الامتناع عن ممارسة الجنس لمدة 6 أشهر، والذي تم التحقق منه كيميائياً. كانت النتائج الثانوية هي تغييرات في الدرجات على مكونات نظرية دافع الحماية. كانت جميع التحليلات مرتكزة على نية العلاج. | PMC10042092 | |
النتائج | والذي | قمنا بتعيين 722 مشاركًا بشكل عشوائي لمجموعات التدخل أو مجموعات التحكم. كان الامتناع المتواصل عن ممارسة الجنس لمدة 6 أشهر، والذي تم التحقق منه كيميائيا، عند معدل | PMC10042092 | |
الاستنتاج | أكدت الدراسة المحددات النفسية للامتناع طويل المدى عن التدخين، وقدمت إطار عمل لاستكشاف سبب فعالية مثل هذا التدخل. قد يكون هذا النهج قابلاً للتطبيق لتطوير أو تحليل التدخلات التي تستهدف السلوكيات الصحية الأخرى. | PMC10042092 | ||
摘要 | PMC10042092 | |||
目的 | 描述基于行为改变理论的个性化手机短信戒烟干预，并评估干预有效的原因。 | PMC10042092 | ||
方法 | 我们于 2021 年 4 月至 7 月在中国五个城市进行了一项双臂双盲随机对照试验。我们招募了年龄为 18 岁或以上且每日或每周吸烟的人。使用手机聊天应用程序进行为期 90 天的干预。在戒烟的不同阶段，干预组的研究对象会收到个性化的短信，这些短信是根据对他们的戒烟意愿强度、戒烟动机和自我报告的戒烟成功情况的分析编制的。对照组的研究对象会收到非个性化的短信。主要结局指标是经生化指标验证的 6 个月持续戒烟率。次要结局指标是保护动机理论各组成部分的分数变化。所有分析均按照意向性治疗原则。 | PMC10042092 | ||
结果 | 我们将 722 名参与者随机分配到干预组或对照组。干预组经生化指标验证的6 个月持续戒烟率为 6.9% (25/360)，对照组为 3.0% (11/362)。在保护动机理论分析中，接受个性化干预的吸烟者在吸烟的内部回报和戒烟的反应代价方面得分较低。这两个变量也是持续戒烟的决定因素，从而解释了干预组戒烟率较高的原因。 | PMC10042092 | ||
结论 | 该研究证实了长期戒烟的心理决定因素，并为探索为什么这种干预有效提供了一个框架。这种方法可能适用于针对其他健康行为的干预措施的开发或分析。 | PMC10042092 | ||
Резюме | PMC10042092 | |||
Цель | меры | Описать меры по прекращению употребления табака с использованием персонализированных текстовых сообщений для мобильного телефона, основанные на теории изменения моделей поведения, и оценить причины эффективности этих мер. | PMC10042092 | |
Методы | В период с апреля по июль 2021 года в пяти городах Китая было проведено двойное слепое рандомизированное контролируемое исследование в двух группах. Для исследования были отобраны курильщики в возрасте 18 лет и старше, курящие ежедневно или еженедельно. На протяжении 90 дней проводились мероприятия с использованием приложения для чата на мобильном телефоне. На разных этапах отказа от курения участники экспериментальной группы получали персонализированные текстовые сообщения, основанные на анализе силы их намерения отказаться от курения, их мотивации отказаться от курения и отмеченных самими участниками успехов в отказе от курения. Участники контрольной группы получали неперсонализированные текстовые сообщения. Первичным исходом был биохимически подтвержденный показатель отказа от курения в течение 6 месяцев. Вторичными исходами были изменения в баллах по компонентам теории мотивации защиты. Все анализы проводили по всем пациентам, рандомизированным для участия в исследовании. | PMC10042092 | ||
Результаты | меры, Биохимически | 722 участника были случайным образом распределены в экспериментальную или контрольную группу. Биохимически подтвержденный показатель непрерывного отказа от курения через 6 месяцев составил 6,9% (25 из 360) в экспериментальной группе и 3,0% (11 из 362) в контрольной группе. У курильщиков, получивших персонализированные меры воздействия, наблюдались более низкие показатели по внутреннему вознаграждению за курение и реакции на отказ от курения при анализе теории мотивации защиты. Эти две переменные также определяли продолжительный отказ от курения, что объясняет причину более высокого показателя отказа от курения в экспериментальной группе. | PMC10042092 | |
Вывод | В ходе исследования были подтверждены психологические детерминанты долгосрочного отказа от курения и создана основа для изучения причин эффективности подобных мер воздействия. Этот подход может быть применим к разработке или анализу мер воздействия, направленных на другие модели поведения в отношении здоровья. | PMC10042092 | ||
Introduction | deaths, death, functional disabilities | Tobacco use is still a major public health problem worldwide. The most common type of tobacco use is cigarette smoking, which is one of the leading preventable causes of death, responsible for more than 600 million deaths globally every year. Available data suggest that tobacco users lose 15 years of life and live with functional disabilities. Therefore, helping people stop using tobacco is the most cost–effective public health intervention.Smoking cessation services are a critical part of the intervention. However, providing universal smoking cessation support can be a challenge for health services in most low- and middle-income countries, as it requires sufficient resources.Many studies have shown that mobile phones have the potential to provide smoking cessation support. One previous randomized trial published in Although mobile phone-based tobacco cessation initiatives have generated considerable enthusiasm,To help fill the evidence gap, we conducted a randomized, controlled trial of a personalized mobile phone-based smoking cessation intervention in China. We aimed to assess why such an intervention is effective and to provide an analysis framework to explore the reasons behind the quitting rate. The study extends the previous research in two ways. First, the intervention used personalized text messages in a country with a limited tobacco control policy. Second, we go beyond simply determining the quitting rate to study the psychological determinants of successful quitting and quitting behaviours. | PMC10042092 | |
Methods | PMC10042092 | |||
Study design | We conducted a two-arm, double-blind, randomized controlled trial in five cities in China (Beijing, Baotou, Dezhou, Linzi and Yakeshi). The locations of the study provinces are shown in the author’s online repository.The trial was approved by the ethics committeee of Peking University Health Science Center (IRB00001052–30063). All the participants signed informed consent forms before randomization and knew that they could withdraw from the study at any time. All patients’ information was accessible only by the personnel participating in the study. We did not provide money to the participants, but we provided gifts (a towel, an umbrella or a cup) if the participants completed one follow-up visit. The clinical trial registration number is ChiCTR2100041942. This study has no changes from the original proposal in terms of methods or outcome measures after the trial began. | PMC10042092 | ||
Theoretical framework | The theoretical framework of the intervention was based on the transtheoretical model of behaviour change and the protection motivation theory. Both models have been independently applied to study health behaviour change interventions.The transtheoretical model proposes a systematic relationship between the stages and processes of behaviour change. To apply the model, we therefore used several strategies to strengthen change (in this case, quitting smoking) or to achieve the next stage of change. To prepare smokers for quitting, we formulated messages based on an analysis of smokers’ quitting intention. Messages for smokers with weak quitting intention were based on consciousness raising, dramatic relief and environmental re-evaluation (see | PMC10042092 | ||
Explanation of the components of two models used in the study of a personalized smoking cessation intervention, China | PMC10042092 | |||
anxiety | Consciousness raising: finding and learning new facts, ideas and tips that support the healthy behavioural change.Dramatic relief: experiencing the negative emotions (fear, anxiety, worry) that go along with unhealthy behavioural risks.Environmental re-evaluation: realizing the negative impact of the unhealthy behaviour or the positive impact of the healthy behaviour on one’s social and physical environment.Self-re-evaluation: realizing that the behavioural change is an important part of one’s identity as a person. | PMC10042092 | ||
EVENT, DISEASES | Perceived severity: beliefs about the negative consequences of the health threat.Perceived vulnerability: vulnerability to the negative consequences of the threatened event.Intrinsic and extrinsic rewards: the benefits of the performance of the maladaptive behaviour.Self-efficacy: confidence in one’s ability to perform the preventive behaviour.Response efficacy: beliefs about the effectiveness of the preventive behaviour for the threatened event.Response cost: barriers to performance of the preventive behaviour.For smokers who remained abstinent, messages were only based on protection motivation theory. The protection motivation theory has seven components (sub-constructs) which we applied to study the psychological determinants of participants’ smoking behaviour: perceived severity of smoking-related diseases; perceived vulnerability to smoking-related diseases; intrinsic rewards of smoking; extrinsic rewards of smoking; self-efficacy of quitting; response efficacy of quitting; and response cost of quitting. | PMC10042092 | ||
Intervention | A detailed framework of the intervention based on the two behaviour change models is shown in | PMC10042092 | ||
Theoretical framework for the study of a personalized smoking cessation intervention, China | NA: not applicable.We designed a message bank for WeChat with a three-layer framework. The first layer was divided based on the timing of messages and consisted of the pre-quitting message (days 1–7), quitting day message (day 8), withdrawal symptom management message (days 9–18), early quit phase message (days 19–36) and late quit phase message (days 37–90). The second layer was divided based on the transtheoretical model. Before the quit day, messages were classified as: strong quitting intention or weak quitting intention. After the quit day, messages were classified as: maintained abstinence or relapsed. The third layer was divided based on the protection motivation theory. Because of some overlap among the seven components of the protection motivation theory, we merged them into three groups: increased severity and susceptibility; decreased response cost and intrinsic and extrinsic rewards; or increased self-efficacy and response efficacy. The core motivational messages consisted of 14 sub-groups with a total of 200 text messages. There were also approximately 200 contact messages. The intervention group participants received partial information, and the information they received varied depending on their smoking status and scores on the protection motivation theory components.The WeChat application calculated each participant’s score in the protection motivation theory by delivering questions and recording information. The programme then automatically calculated the lower score of the components of the model that needed to be strengthened. Specifically, the scale comprised 21 items using a 7-point Likert-type scale with responses ranging from 1 (definitely disagree) to 7 (definitely agree). Each construct of protection motivation theory included three items, and we computed the mean of the sub-scale score. We have published the details of this scale and evaluation process elsewhere. | PMC10042092 | ||
Implementation | PMC10042092 | |||
Participants | RECRUITMENT, LOCAL DISEASE | The sample size calculation for the study was based on the formula for a two-arm randomized controlled trial. Based on earlier research, we estimated that biochemically verified continuous smoking abstinence at 6 months would be approximately 4% in the control group and 10% in the intervention groups.We advertised the trial to smokers through leaflets, digital advertisements on WeChat and via teachers and community leaders. Potential participants contacted the local disease control and prevention centre to register. Daily or weekly smokers aged 18 years or older were eligible for inclusion if they owned a mobile phone and used the WeChat application. All eligible smokers were told they needed to come to a specific place on a fixed date to finalize the recruitment process. The eligibility of participants was double-checked by the research team or local centre staff, and participants signed an informed consent form at the first face-to-face contact. | PMC10042092 | |
Procedure | Cancer | RECRUITMENT, CANCER | After recruitment, participants were required to complete the baseline questionnaire and register through WeChat. We first classified our participants into two groups: low nicotine dependence; or moderate and high nicotine dependence. Then we used a simple randomization method to assign participants to the intervention group or control group within each nicotine dependence group.All participants in the two groups were instructed to attend face-to-face follow-ups with research staff at 1 month, 3 months and 6 months after randomization. At each follow-up visit for all participants, we recorded smoking status, score on the protection motivation theory components and quitting intention.Participants who were allocated to the intervention group received the intervention programme with personalized text messages, as described above. The information that participants received from the WeChat message bank varied depending on the evaluation of their motivation to quit and their self-reported smoking status. On day 0, all the intervention participants received the same message about registration in the programme and completed the first evaluation via the chat application (Participants in the control group received a set of messages developed by the United States National Cancer Institute, which have been adapted to be culturally appropriate for a Chinese audience.Both groups received 1–2 messages a day for 3 months after randomization. | PMC10042092 |
Outcomes | The primary outcome was the biochemically verified, 6-month sustained abstinence rate, defined as participants’ self-reports of not smoking any cigarettes after the designated quitting date. Self-reported quitting was validated biochemically by an expired carbon monoxide level of less than 6 ppm at each follow-up visit. | PMC10042092 | ||
Data analysis | REGRESSION | We conducted the data analysis in three steps. First, we used descriptive statistics to report smoking abstinence rates and used Second, we analysed the change in the scores on the protection motivation theory components, by group, to evaluate the effect of our intervention in strengthening awareness about quitting. We used generalized estimated equations to analyse the data with repeated follow-up times.Third, we analysed the association between participants’ scores on the protection motivation theory components and their continuous abstinence behaviour to explore why the intervention group reported a higher quitting rate. We changed the dependent variable to a dummy variable indicating whether the respondent remained abstinent during the follow-up period (if yes = 1; otherwise = 0). The explanatory variables were the protection motivation theory component scores. We used the second generalized estimated equations to assess which components were associated with sustained abstinence to further explore the reason for the higher sustained abstinence rate in the intervention group. We chose an exchangeable correlation structure for the matrix structure, and binary logistic regression for the model setting. We conducted all statistical analyses using SPSS, version 19.0 (Armonk, IBM, United States of America). A | PMC10042092 | |
Results | We randomly assigned 722 participants to the intervention or control group (Flowchart of the study of a personalized text message smoking cessation intervention, China | PMC10042092 | ||
Participants’ scores on protection motivation theory components, by group and time after starting quitting, in the personalized smoking cessation intervention, China | SD: standard deviation. | PMC10042092 | ||
Association between participants’ scores on protection motivation theory components and sustained abstinence from smoking in the personalized smoking cessation intervention, China | thumb pain | REGRESSION | CI: confidence interval; OR: odds ratio; Ref.: Reference group.Notes: We changed the dependent variable to a dummy variable indicating whether the respondent remained abstinent during the follow-up period (if yes = 1; otherwise = 0). The explanatory variables were the protection motivation theory component scores. We used the second generalized estimated equations to assess which protection motivation theory components were associated with sustained abstinence to further explore the reason for the higher sustained abstinence rate in the intervention group. We chose an exchangeable correlation structure for the matrix structure and binary logistic regression for the model setting.We have not received any reports of harm or adverse effects related to this intervention, for example, thumb pain while texting or any road traffic accidents. | PMC10042092 |
Discussion | BLIND | This study joins the recent debate on mobile phone-based cessation interventions and provides some new information. The intervention group receiving personalized text messages about smoking cessation based on behaviour change theory had a 6-month quitting rate that was twice that of the intervention group getting non-personalized messages. We found that messages designed to counteract the intrinsic rewards of smoking was one of the important variables associated with sustained abstinence. Examples of intrinsic rewards include: “Smoking makes me feel comfortable”, “Smoking helps me concentrate” or “Smoking enhances brainwork”. In contrast, extrinsic rewards may be less important in influencing this behaviour. Examples include “Smoking looks cool and fashionable”, “Smoking is good for social networking” or “The life of a smoker is happier than that of a non-smoker”. This association has been confirmed by other studies in China.The comparison between groups shows that the personalized intervention decreased the intrinsic rewards of smoking and the response cost of quitting; this finding is worth noting, as both are determinants of long-term abstinence. This finding also provides some indications of why the intervention group had better results than the control group and provides further guidance for scaling up our intervention.This study has several limitations. First, although we made efforts to ensure that both the researchers and participants remained blind to the allocation, the blinding may have been broken during multiple face-to-face contacts. Second, expired air carbon monoxide testing is the common method of detecting recent smoking and is recommended as a standard for the assessment of smoking cessation in trials. However, these biochemical tests are not perfect; expired air carbon monoxide can only be detected for approximately 24 hours after tobacco use. Third, the scale we used to evaluate protection motivation theory components was the same at each follow-up visit, and some participants may have remembered some of the questions and provided inaccurate answers. Fourth, there were only six female smokers in the cohort. Therefore, the situation among female smokers may not be fully represented when interpreting these results. Fifth, we only investigated the effects of the intervention for 6 months. We therefore do not know if anyone changed their smoking habits after 6 months. Sixth, the profile of our intervention consisted of one or two messages a day. We have no idea of what the effect would have been if a more extensive intervention were used, so we could not have a measure of what we might consider an optimal level of intervention. Seventh, some participants may live in the same community or have close contact. There was a risk of sharing messages with other participants. This could have biased our results.Despite these limitations, our study has theoretical and policy implications. First, mobile phone-based cessation studies often suffer from insufficient reporting of the principles, and our study provides a full description of the intervention with a clear framework that can allow other researchers to take advantage of our experience. Second, we identified the psychological determinants of long-term abstinence that can allow future smoking cessation interventions to focus more on those points. However, researchers should not ignore other components of the protection motivation theory. For example, why did other variables, such as extrinsic rewards and response efficacy, show a relatively weak association with long-term abstinence? How do those variables contribute to changing smoking behaviour to achieve sustained abstinence? These questions have strong theoretical implications and need to be studied further.Our findings suggest that the intervention we used in this study is acceptable and effective for adult smokers, without the need for additional resources, and no major challenges were encountered. It might be suitable for use in other settings with limited smoking cessation resources. The message and skills used in this intervention are not closely related to any cultural background; therefore, it might technically be easy to implement in other settings or countries with different cultural backgrounds or to target other health behaviours. The personalized evaluation tools disseminated via WeChat are also easily achieved by other online chatting tools or applications at a low cost.This personalized text message intervention increased the rate of biochemically verified smoking cessation at 6 months. China has the world’s largest number of smokers but has inadequate resources to provide cessation services via medical institutions. If this intervention is scaled up nationwide and again demonstrated to be effective, it may benefit smokers, particularly in rural areas. | PMC10042092 | |
Funding: | This work was supported by the National Natural Science Foundation of China, grant number 82173637. | PMC10042092 | ||
Competing interests: | None declared. | PMC10042092 | ||
References | PMC10042092 | |||
Subject terms | CAP | COMMUNITY ACQUIRED PNEUMONIA, ADVERSE EVENT | Patients hospitalised with community acquired pneumonia (CAP) have low peripheral blood vitamin C concentrations and limited antioxidant capacity. The feasibility of a trial of vitamin C supplementation to improve patient outcomes was assessed. Participants with moderate and severe CAP (CURB-65 ≥ 2) on intravenous antimicrobial treatment were randomised to either intravenous vitamin C (2.5 g 8 hourly) or placebo before switching to oral intervention (1 g tds) for 7 days when they were prescribed oral antimicrobial therapy. Of 344 patients screened 75 (22%) were randomised and analysed. The median age was 76 years, and 43 (57%) were male. In each group, one serious adverse event that was potentially intervention related occurred, and one subject discontinued treatment. Vitamin C concentrations were 226 µmol/L in the vitamin C group and 19 µmol/L in the placebo group ( | PMC10363531 |
Introduction | CAP, death | COMMUNITY ACQUIRED PNEUMONIA | Administering supplemental vitamin C to treatment regimens for community acquired pneumonia (CAP) is an attractive option, but evidence of benefit is lackingThe published studies of the effect of vitamin C treatment on the outcome of CAP have been reviewed by the Cochrane collaboration, which identified one randomised controlled trial (N = 57)This study included patients with moderate and severe CAP. While the most secure endpoint to establish efficacy is death, the FDA has recommended an early clinical response of symptoms as an endpoint in clinical trials of CAPThis study was conducted to inform the design of a double-blind randomised controlled clinical trial embedded within routine ward based care in an acute tertiary care admitting hospital | PMC10363531 |
Results | PMC10363531 | |||
Treatment delivery | ADVERSE EFFECTS | The median (IQR) number of intravenous doses of vitamin C administered was 3 (3, 6) and for placebo was 6 (3, 7). All 75 subjects received their intravenous course in hospital and 22 completed their oral course in hospital. Two subjects discontinued the oral formulation in hospital because of adverse effects (see below). An intravenous dose of vitamin C was missed in one subject (3%) and 6 (15%) subjects missed a placebo intravenous dose. Two subjects (6%) missed an oral dose of vitamin C and 6 (16%) missed an oral dose of the placebo while in hospital. Fifty-one subjects were discharged to complete the course of treatment at home. Of those discharged with oral therapy, 29 (81%) were prescribed vitamin C and 22 (56%) placebo. At follow-up, 25 of 29 (86%) taking vitamin C and 20 of 22 (91%) taking placebo reported completing their course of treatment at home. | PMC10363531 | |
Acceptability and safety and of treatment | nausea or vomiting, bronchitis, deaths, COPD, diabetes | ADVERSE EVENTS, COPD, BRONCHITIS, URINARY TRACT INFECTION, DIABETES | Of those who fulfilled the entry criteria only three patients (3%) who were eligible on screening (n = 96) declined to be enrolled after completing the consenting process. Of those who were consented and included all subjects completed the intravenous part of the study (100%). Two subjects stopped oral treatment in hospital for adverse events (see below). At follow-up, 25 of 29 (86%) self-reported taking vitamin C and 20 of 22 (91%) taking placebo to complete their course of treatment at home.Thirty-one adverse events in the 30 days from randomisation were reported. There were 8 serious adverse events, including 2 deaths, and two readmissions for CAP (Table The other 20 adverse events reported were: prescription of further antibiotic therapy from their general practitioner (vitamin C 7, placebo 5); worsening of existing health conditions (vitamin C 2, diabetes control and exacerbation of COPD); deconditioning after admission to hospital (vitamin C 1, placebo 1); new episode of bronchitis (placebo 1) and urinary tract infection (vitamin C 1); nausea or vomiting after enrolment but prior to administration of the intervention (vitamin C 1, placebo 1). | PMC10363531 |
Plasma vitamin C concentrations | Baseline samples were available in 67 patients (89%). The median (IQR) baseline vitamin C concentrations were 15 (7, 25) µmol/L in the vitamin C group (31/36, 86%), and 16 (6, 27) µmol/L (36/39, 92%), in the placebo group. There was no difference between these groups ( | PMC10363531 | ||
Discussion | CAP, deaths, death | RECRUITMENT, HYPOVITAMINOSIS, RECRUITMENT, PATHOPHYSIOLOGY, SECONDARY | The study was designed and powered as a feasibility study of supplemental vitamin C in moderate to severe CAP and provided some important insights on recruitment, acceptability, and clinical outcomes that will help design future studies.Recruitment of patients was feasible as the percentage enrolled (27%) was similar to that expected (25%) but the recruitments rates were lower than expected (62 vs > 100 per year). This was attributable to several factors. The study was done during the COVID pandemic when there were strict lockdown periods in New Zealand. That resulted in major reductions in transmission of both COVID-19 and other respiratory pathogensThere was a high rate of acceptability, administration and delivery of the intravenous agents but there was a delay between admission and administration of the first dose of vitamin C (median 22 h) shortening the course of parenteral therapy. Ideally, adjunctive vitamin C should be administered concurrently with the antimicrobial therapy by randomising and treating patients in the emergency department. This would reduce the nadir of vitamin C concentration, replenish stores more quickly, and maximise any potential benefit of the vitamin C. The time course of action of vitamin C is not known but given the multiple metabolic benefits, this may be quite short. Seven intravenous doses were missed overall. Most of these occurred when subjects were transferred between the acute admission ward and the general medical wards or ICU. This problem was promptly eliminated once it was recognised. After discharge, patients self-administered the oral medication and 88% reported completing their course of treatment. The dose of vitamin C administered produced a rapid rise in the peripheral blood concentrations and these were about 12-fold higher in the treatment group compared with controls after one day and over three-fold higher than saturating levels (> 70 µmol/L), whereas the median concentration remained in the hypovitaminosis range in the placebo groupWe did not identify a difference in our primary or secondary outcome measure between the groups. However, our study was not powered to show such differences and a benefit cannot be ruled out. The consistent signal towards a benefit from vitamin C across the measures including mortality, clinical stability, and length of hospital stay indicates that a definitive trial is warranted. The mortality in the control group of 5% (95% CI 1.4–17%) was lower than expected although still consistent with results from large multicentre data sets. Reports of case fatality ratios for CURB-65 score 2 of 9.2%, and CURB-65 > 2 of 22.3% give an estimated case fatality ratio in moderate/severe CAP of 16%Despite the low mortality there were fewer deaths in the vitamin C treatment group than the control group. This is a similar finding to that of Hunt et alThe endpoint for future trials needs careful consideration. All-cause mortality at 30 days death is a secure endpoint but would require a large multicentre studyThe strength of this study has been the rigorous design and pragmatic execution within routine practice. Our study includes patients with less severe CAP who may benefit from vitamin C administration early in the clinical course when the pathophysiology is more reversable. Limitations include number of severe cases included, exclusion of those unable to consent, and the time to administer the first dose of intravenous vitamin C. The follow up data was limited by using self-reporting of adherence to study medication.We conclude that dosing of vitamin C at 2.5 g IV Q8H followed by 1 g PO thrice daily was safe and well tolerated. The rise in vitamin C was saturating, and sufficient to achieve any expected benefits. Recruitment for a definitive trial would be feasible in a multi-centre study but would require approximately 930 participants to determine any effect on mortality, or 200 participants for a composite end-point. | PMC10363531 |
Materials and methods | PMC10363531 | |||
Study design and participants | pneumonia, acute illness, cough, feverishness, shortness of breath | INFILTRATE, SECONDARY, PNEUMONIA, RECRUITMENT | The study was conducted in Christchurch Hospital, New Zealand, a secondary and tertiary care referral hospital serving more than 550,000 people. Participants were adults (aged ≥ 18 years) admitted to the general medical or respiratory services from November 2019 to April 2021 with CAP. This was defined as an acute illness acquired outside a health care setting with clinical features that included increased cough, sputum production, shortness of breath and feverishness, and a new inflammatory infiltrate on chest radiograph.Potential participants were identified upon admission and notified to the investigators for possible enrolment. The exclusion criteria were: (1) admission to hospital > 48 h prior to screening, (2) unable to give informed consent, (3) CURB65 pneumonia severity score of < 2Patients who were randomised, but subsequently found to have an alternative diagnosis, or were switched to oral therapy before receiving an intravenous dose of study agent were excluded from the study.All clinical decisions were made by the clinical care team. Local guidelines that recommend dual therapy with a beta lactam antimicrobial agent (amoxicillin, amoxicillin/clavulanate or cefuroxime) and a macrolide (azithromycin) for all patients with CURB-65 score of ≥ 2 with some clinical discretionThe initial patient review, recruitment and consenting was done by one of the clinical team (S.T.C, M.M) after notification together with a research assistant. The clinical data was entered first into a paper form with pre-specified fields, and then into a RedCap database by the research assistant. Overall this required a morning for the clinician each day and a whole day for the research assistant for maintaining the database.The study was approved by the New Zealand Northern B Health and Disability Ethics Committee (18/NTB/218) and all participants gave written informed consent. The trial was conducted according to the principles of the Declaration of Helsinki and was registered with the Universal trial number U1111-1222-3105 (20/02/2019) and Australia New Zealand Clinical Trials Registry, | PMC10363531 |
Intervention | The interventions (2.5 g vitamin C or placebo) was added to 100 ml of normal saline and administered over 20–30 min 8 hourly until the attending clinical team changed from intravenous antimicrobials to oral therapy. The initial supplier of the intravenous therapy was ASCOR L-500, McGuff Pharmaceuticals Inc, Santa Ana, CA, USA, but this became unavailable during lockdown and was changed to Sodium Ascorbate Solution (Biological Therapies, Braeside, VIC, Australia). The intravenous placebo was normal saline. Both the vitamin C and placebo tablets were sourced from Tishcon Corp, NY, USA and were identical in appearance. | PMC10363531 | ||
Randomisation and masking | The randomisation was done by the biostatistician (J.W.) by computer generated code (1:1 allocation) which was stored in the Christchurch Hospital Pharmacy. The process and dispensing of the intravenous and oral preparations were performed by Christchurch Hospital Pharmacy under the direction of the study biostatistician (J.W.) to ensure those recruiting, enrolling and assessing outcomes were blinded to treatment allocation. The interventions were transported and stored in identical opaque packaging and accessed and administered only by the nursing staff assigned to care for the patient in the ward. None of the research staff was responsible for administering the interventions. | PMC10363531 | ||
Study procedures | pneumonia | EVENTS, PNEUMONIA, ADVERSE EFFECTS | The participants baseline characteristics were obtained at enrolment included smoking, current medications and supplement use. The highest CURB-65 score (pneumonia severity) in the 12 h prior to enrolment was recordedAdverse events were monitored by regular review of participants during hospitalisation. Reasons for missed doses of the study medication were taken from the electronic medication records (Medchart), electronic nursing notes, and interviewing subjects.Thirty days after admission the investigators administered a brief questionnaire by telephone to record compliance with oral medication, adverse effects, persistence of symptoms from their presenting illness, and return to normal activityStudy data were collected and managed using REDCap electronic data capture tools hosted at University of OtagoSamples for plasma vitamin C concentrations (lithium heparin tubes) were retrieved from the refrigerated (− 20 °C) storage facility in the diagnostic laboratory within 6 h for baseline measures | PMC10363531 |
Endpoints | death | ADVERSE EVENTS, RECRUITMENT, HYPERTENSION, COMMUNITY-ACQUIRED PNEUMONIA | The feasibility endpoints were:Recruitment. Defined as the percentage of patients admitted to hospital with CURB-65 ≥ 2 CAP who were enrolled in the study.Treatment delivery. Measured by the number of prescribed doses of intravenous and oral therapy in hospital and self-reported adherence of oral therapy after discharge.Acceptability. This was defined as (a) the percentage of patients who fulfilled the entry criteria and consented into the study, (b) the percentage of patients who completed the intravenous treatment, (c) completed oral therapy, and (d) suffered no significant adverse events.Adequacy of vitamin regimen. Determined by measurement of vitamin C concentrations at 24 h in comparison with placebo.Endpoints proposed for the main study were: all-cause mortality was defined as death within 30 days of the index admission; length of hospital stay; time to clinical stabilityThe time to clinical stability was defined as the time (hours) until all vital signs were stable for ≥ 24 h, or 24 h after discharge from hospital if clinical stability has not been reached at the time of discharge. Stable vital signs were temperature of 37.8 °C or lower, heart rate of 100 beats per min or lower, spontaneous respiratory rate of 24 breaths per min or lower, systolic blood pressure of 90 mm Hg or higher (≥ 100 mm Hg for patients diagnosed with hypertension) without vasopressor support, mental status back to level before occurrence of community-acquired pneumonia, ability for oral intake, and adequate oxygenation on room air (PaO | PMC10363531 |
Sample size | pneumonia | PNEUMONIA | There are an estimated 800 CAP admissions to Christchurch Hospital each year. Large prospective cohorts (n = 718 and 3233) report 50–55% of participants have moderate or severe CAP (CURB-65 of ≥ 2 or pneumonia severity index (PSI) > 3) | PMC10363531 |
Statistical analysis | death, pneumonia | RECRUITMENT, PNEUMONIA, EVENT | Recruitment was assessed by determining the number of patients approached during the study period, and the proportion who meet initial eligibility criteria, were randomised, were treated, and were ultimately deemed eligible for inclusion in the analysis. Randomised patients were not considered eligible for inclusion in the analysis if, upon review, it was discovered that pneumonia was not the primary diagnosis or the patient had changed to oral antimicrobial therapy before intravenous therapy could be given. Acceptability of the intervention and study processes were assessed by calculating the proportions of patients completing the prescribed course of treatment and follow-up questionnaires respectively.Participant characteristics were summarised descriptively and tabulated by treatment group. Clinical outcomes of interest and treatment compliance were summarized as counts (percentages) for categorical variables, and median (interquartile ranges) for continuous time to event data. Between-group differences in outcomes by treatment group were explored using fisher’s exact tests for binary outcomes, or log-rank tests for time to event data censoring for death. All data was analysed using R (version 3.2.1 Vienna, Austria) statistical software. Two-sided statistical tests were used to generate p values and point estimates reported with 95% confidence intervals | PMC10363531 |
Institutional review board statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Health and Disability Ethics Committee (18/NTB/218, approved 13 March 2019). | PMC10363531 | ||
Informed consent | Informed consent was obtained from all subjects involved in the study. Informed consent has been obtained from the patient(s) to publish data from the study. | PMC10363531 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-37934-z. | PMC10363531 | ||
Acknowledgements | Dr David Jardine and the staff of the General Medical Services at Christchurch Hospital, staff at the Pharmacy of Christchurch Hospital and Canterbury Health Laboratories. Biological Therapies, Braeside, VIC, Australia for providing Sodium Ascorbate Solution after COVID-19 lockdown. | PMC10363531 | ||
Author contributions | Conceptualization, S.T.C., M.M., M.E., A.C. and M.S.; methodology, S.T.C., M.M., M.E., D.M., H.I., J.W. and A.C.; acquisition of subjects S.T.C., A.S.T., S.M., S.S., D.M., H.I. and M.S.; validation, M.S., J.W., S.S., A.S.T. and S.T.C.; formal analysis, S.T.C. and J.W.; data curation, M.S., S.S., A.S.T., and J.W.; writing—original draft preparation, S.T.C.; writing—review and editing, M.M., A.S.T., J.W., A.C., H.I. and M.S.; project administration, M.S., A.S.T., and S.S.; funding acquisition, S.T.C., M.M., M.E., H.I., D.M. and S.M. All authors have read and agreed to the published version of the manuscript. | PMC10363531 | ||
Funding | This research was funded Health Research Council, Grant Number 18/623. | PMC10363531 | ||
Data availability | The data presented in this study are available on request from the corresponding author. The data are not publicly available and stored on a secure system at the University of Otago, Christchurch. | PMC10363531 | ||
Competing interests | ’ disease, MM | MM has received funding from the Health Research Council of New Zealand for Legionnaires’ disease research. The other authors declare no competing interests. | PMC10363531 | |
References | PMC10363531 | |||
1. Introduction | (1) Background: While goat milk formula (GMF) is an alternative to cow milk formula (CMF), infants’ preferences for one over the other have not been formally assessed. Specifically, our aim in this study was to determine whether infants experience fewer feeding behavior problems with whole milk-based GMF than with conventional whey-based CMF. (2) Methods: This was a multicenter, double-blind, randomized controlled trial with two-arm parallel assignment conducted in six pediatricians’ offices in or near Paris, France, between June 2018 and 31 December 2021. Overall, 64 healthy infants (≤4 months old), predominantly formula-fed, were randomly assigned to either the whole milk-based GMF (During the first weeks of life, changes in infant formula for bottle-fed infants are frequent [Although breastfeeding is the most appropriate way to feed infants in the first months of life, most infants are no longer breastfed after 6 months [Goat milk is an alternative source of protein for infant formula. Hence, goat milk formula (GMF), either based on whole goat milk or whey based, offers an alternative to whey-based cow milk formula (CMF) [Taste development in early life is complex and still poorly described [Several randomized and non-randomized trials have compared growth—i.e., changes in weight, length, and head circumference—in children fed a CMF or a GMF. A recent double-blind, randomized controlled trial (RCT) by He et al., comparing a whey-based GMF, a conventional CMF, and breastfeeding in the first 4 months of life, found similar levels of growth between the CMF and GMF groups [Accordingly, in the present study, we compared the feeding behavior and quality of life of infants fed either whole milk-based GMF or whey-based CMF and measured degrees of GI discomfort for these study groups. | PMC10537215 | ||
2. Materials and Methods | PMC10537215 | |||
2.1. Design and Participants | private-practice | CHRONIC DISEASES, PROTEIN ALLERGY | This trial was a double-blind RCT with two-arm parallel assignment conducted at six pediatrician’s offices in the greater Paris area of France. An independent ethics committee approved the study protocol (CPP Sud Méditerranée 3, France; ref.: 2018.01.01), which complied with the Declaration of Helsinki. Both legal representatives of each patient provided their written informed consent before inclusion. The study was registered prospectively at ClinicalTrials.gov (NCT03488758).Eligible patients were healthy infants ≤4 months old who were predominantly formula fed and followed by a private-practice pediatrician. Patients were ineligible if born at a gestational age of <37 weeks, had a confirmed or suspected cow’s milk protein allergy, were predominantly breastfed (≥50% of feeding volume), or suffered from chronic diseases.At trial initiation, participants were randomly assigned to the GMF or CMF groups at a 1:1 ratio, applying a double-blind procedure. After checking inclusion/exclusion criteria, the investigators explained the study to the legal representatives at the screening visit. The clinical and demographic characteristics, and relevant medical and maternal history, of participating individuals were recorded at the inclusion visit (baseline), which took place 1 to 5 days before milk delivery. Outcome ascertainment and collection of safety assessment data were performed at trial centers during the inclusion visit and the final visit (day 28 ± 3 after milk delivery). Participants’ parents were contacted via phone on day 14 ± 3 to verify compliance and safety assessments. Compliance at days 14 and 28 was defined as having maintained exclusive bottle feeding (with or without additional breastfeeding) with the study formula delivered. | PMC10537215 |
2.2. Study Products | The whole milk-based GMF (20:80 whey:casein ratio and about 48% milk fat; Capricare with added DHA and arachidonic acid) or whey-adjusted CMF (60:40 whey:casein ratio and about 22% milk fat) were produced by Dairy Goat Co-operative (N.Z.) Ltd., Hamilton, New Zealand. The composition (see | PMC10537215 | ||
2.3. Outcome Measures | ADVERSE EVENTS | The primary outcome measure was the change in food enjoyment, assessed as the difference in BEBQ Enjoyment of Food subscale scores between the inclusion visit (baseline) and final visit (day 28 ± 3). Secondary outcome measures were the other BEBQ subscale scores; Montreal Children’s Hospital Feeding Scale (MCH-FS) scores; quality of life, as reflected by modified QUALIN scores; GI symptoms; and anthropometric variables.The BEBQ, developed in 2011 by Llewelyn et al. [Designed by pediatricians and healthcare professionals, the MCH-FS is a 14-item parent reporting instrument for identifying feeding difficulties in children [At baseline and the final visit, health-related quality of life was assessed using a modified version of the 34-item QUALIN questionnaire (French version), intended for children 3 months to 3 years old and completed by parents or caregivers [Data on adverse events during the study period were recorded during each participant visit. Safety was evaluated in all participants who underwent randomization and received ≥1 serving of formula. | PMC10537215 | |
2.4. Statistical Analysis | non-compliance | SENSITIVITY | The number of infants needed for detecting a statistical difference was calculated based on differences in the BEBQ Enjoyment of Food subscale reported by Llewellyn et al. [Summary statistics described the demographic and clinical characteristics of participants. Categorical data were described using frequencies and percentages. Quantitative data were described by the mean and standard deviation (SD).The ITT population was included in the primary outcome analysis. Participants from parents who refused to participate just after randomization and refused the milk delivery were excluded from the study. Changes in BEBQ and modified QUALIN scores for the two groups were compared using Student’s Sensitivity analyses were performed for the PP population, composed of all participants who underwent randomization but for whom no severe non-compliance to the intervention was observed. Analysis of outcomes for the PP population applied the same methods as for the ITT population.All statistical tests were two-sided. The threshold for statistical significance was set to | PMC10537215 |
3. Results | fracture, constipation, feeding difficulties, viral gastroenteritis, regurgitation or fussing, trauma | ADVERSE EVENTS, URINARY INFECTION, VIRAL GASTROENTERITIS, BRONCHIOLITIS | Between June 2018 and December 2021, 70 patients were screened for eligibility. Due to the COVID-19 pandemic, inclusions were suspended between March and June 2020, as non-urgent medical appointments were impossible then. Then, due to the expiry date of the study milk cans, inclusions were stopped in December 2021. A total of 5 of the 70 screened patients declined to participate, and family consent was withdrawn for one other just after randomization. The ITT population consisted of 64 participants: 33 in the GMF group and 31 in the CMF group. Of these, 3 in the CMF group and 1 in the GMF group stopped treatment due to regurgitation or fussing (Demographic and clinical characteristics were similar between groups (Differences in five BEBQ subscale scores between baseline and day 28 ± 3 for the CMF and GMF groups were compared (QUALIN scores (According to MCH-FS scores, 2 (6%) GMF children had mild feeding difficulties and 1 (3%) CMF child had a moderate feeding difficulty at the end of follow-up (Finally, at the end of the study, parents were asked to use a four-level visual analog scale to evaluate how much their children liked the formula they were fed, and ratings did not differ between formula types (Overall, 10 non-serious adverse events were reported during the study period. In the CMF group, one patient had a fracture after a trauma, and another experienced bronchiolitis. In the GMF group, 3 patients suffered from constipation, 3 had viral gastroenteritis and 1 patient a urinary infection. None of these adverse events were linked to the study products by the investigators. | PMC10537215 |
4. Discussion | ’ feeding behavior, constipation | GI DISORDERS, RECRUITMENT, ADVERSE EFFECT | This double-blind RCT is, to our knowledge, the only one to compare feeding behaviors and preferences of infants fed either with GMF or conventional CMF. We observed similar levels of food enjoyment, i.e., subjective degree of pleasure experienced during feeding, for both types of formula. However, infants fed GMF, unlike those fed CMF, showed improved food responsiveness, general appetite, and quality of life.These findings are somewhat similar to those for animals and human adults. Klockars et al. [Infant formulas, e.g., CMF or GMF, must adhere to strict regulations governing their protein, carbohydrate, lipid, mineral, and vitamin content [Beyond their general composition, dairy-based infant formulas vary by source of milk ingredients (bovine or caprine and whole milk or skim milk or whey protein concentrate) and types of lipids added (vegetable oils alone or mixed with milk fat) [Our study did not detect any difference in tolerance or GI discomfort between the two formulas tested. However, the presence or absence of GI disorders was not a criterion for inclusion, i.e., there was no record at baseline. At the end of the 28 days feeding period, 27.6% of children in the ITT population (for whom data were available) exhibited constipation, with greater prevalence in the GMF group. Nevertheless, most published studies have reported that bowel movement frequency in infants given GMF is similar to or higher than with a CMF diet [Our study had limitations. For instance, we lacked the information to precisely calculate the number of subjects required for our study. Thus, we initially planned to include 100 infants. However, we fell short of this number, primarily due to the COVID-19 pandemic, which slowed recruitment and caused difficulty in obtaining parental consent for their child’s participation. On the other hand, those successfully included children were seldom lost to follow-up. Finally, while the infants’ feeding behavior was assessed using a validated scale adapted to their age group, their quality of life was measured with a modified version of the QUALIN instrument, omitting items not suitable for infants <3 months old. Unlike the original version, this modified version has not been validated. In addition, the CMF used in this study was made with whole milk instead of the more traditionally used skim milk and therefore contained some milk fat, which may have different sensory characteristics to a conventional CMF with vegetable oils only as the source of lipids.Our study also had strengths despite the intricacy of this kind of trial particularly, as parents could be perturbed by not knowing what formula their child was receiving. This situation could limit inclusions. However, we were able to include an acceptable number of patients and the compliance was good. Also, the BEBQ proved to be a useful tool for healthcare professionals to easily determine infant feeding behavior when switching to a new formula. Finally, our study provides valuable estimates for planning further trials assessing food enjoyment in infants.Although there were no differences in the enjoyment of the different formulas, infants fed with whole milk-based GMF experienced better food responsiveness and quality of life than those fed with whey-based CMF. Also, besides constipation that was more common in GMF-fed infants by parental report, no adverse effect was observed with higher frequency in the GMF group. However, studies with a larger number of subjects and with a longer follow-up duration are needed to confirm these results: trials assessing food enjoyment in infants are feasible, and further similar trials could help to draw firm conclusions about the better enjoyment of whole milk-based GMF over conventional CMF. | PMC10537215 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10537215 | ||
Author Contributions | RECRUITMENT | Conceptualization, C.J., C.P. and M.B. (Marc Bellaïche); participant recruitment, C.B., E.S., G.G., A.P., I.L. and A.E.; data collection coordination, M.B. (Maxime Brussieux); data analysis, C.J. and A.G.S.; data interpretation, C.J., A.G.S., S.G. and M.B. (Marc Bellaïche); writing—original draft preparation, C.J.; writing—review and editing, S.G. All authors have read and agreed to the published version of the manuscript. | PMC10537215 | |
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by an independent Ethics Committee of CPP Sud Méditerranée 3 (ref: 2018.01.01). | PMC10537215 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10537215 | ||
Data Availability Statement | Data sets are available upon reasonable request. | PMC10537215 | ||
Conflicts of Interest | RECRUITMENT | C.J., A.G.S., C.B., E.S., G.G., A.P., I.L., A.E., M.B. (Maxime Brussieux), and M.B. (Marc Bellaïche) declare no commercial or financial ties related to this research. C.P. was and S.G. is employed by Dairy Goat Co-operative, which funded the study. C.P. was involved in writing the protocol. S.G. was involved in the data interpretation and in writing the manuscript. Neither C.P. nor S.G. were involved in recruitment, data collection, or statistical analysis. | PMC10537215 | |
References | Skin and gastrointestinal symptoms | Study CONSORT Flowchart. CMF: cow milk formula; GMF: goat milk formula; ITT: intention-to-treat; PP: per protocol.Children’s enjoyment of CMF and GMF, according to four-level visual analog scale ratings, for ITT population at end of study. CMF: cow milk formula; GMF: goat milk formula.Patient demographic and clinical characteristics. CMF: cow milk formula; GMF: goat milk formula; SD: standard deviation; Changes in BEBQ subscale scores relative to baseline, according to PP and ITT analyses. CMF: cow milk formula; GMF: goat milk formula; ITT: intention-to-treat; PP: per protocol; SD: standard deviation; D0: Baseline (inclusion visit); D28: D28 ± 3 after milk delivery (end of the study); Δ: change; *: Student’s Change in quality of life from baseline, as measured by modified QUALIN score, for PP and ITT populations. CMF: cow milk formula; GMF: goat milk formula; ITT: intention-to-treat; PP: per protocol; D0: Baseline (inclusion visit); D28: D28 ± 3 after milk delivery (end of study); * Student’s Skin and gastrointestinal symptoms in intention-to-treat population at week 4. Each value expressed as number (%) of participants concerned or probability. CMF: cow milk formula; GMF: goat milk formula. | PMC10537215 | |
Background | The 2022 ASA guidelines recommend the video laryngoscope, video stylet, and flexible videoscope as airway management tools. This study aims to compare the efficacy of three airway devices in intubating patients with difficult airways. | PMC10512610 | ||
Methods | A total of 177 patients were selected and randomized into the following three groups: the video laryngoscope group (Group VL, | PMC10512610 | ||
Results | All patients were successfully intubated with three devices. The first-pass intubation success rate was significantly higher in Groups VS and FV than in Group VL (96.61% vs. 93.22% vs. 83.05%, | PMC10512610 | ||
Conclusions | In patients with difficult airways requiring intubation, use of the video stylet has the advantage of a relatively shorter intubation time, and the flexible videoscope and video stylet yield a higher first-pass intubation success rate and clearer glottic exposure than the use of the video laryngoscope. | PMC10512610 | ||
Trial registration | Chinese Clinical Trial Registry. No: ChiCTR2200061560, June 29, 2022. | PMC10512610 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07641-1. | PMC10512610 | ||
Keywords | PMC10512610 | |||
Background | airway injuries | Currently, visualization techniques are becoming increasingly popular for its reduction in reducing the risk of severe intubation reactions and failed intubations. Nevertheless, both anticipated and unanticipated difficult airways still result in failed intubation, which not only puts the anesthesiologist in an embarrassing dilemma, but also threatens the life and safety of the patients, we cannot use only one device to deal with all difficult airways encountered.The video laryngoscope, a conventional glottic visualization device, has been considered the gold standard device for transoral tracheal intubation by anesthesiologists worldwide, and its availability has led to unprecedented improvements in the field of view during intubation, success rates of tracheal intubation, shortened intubation times, and even reduced intubation-related airway injuries compared with conventional direct laryngoscopy [ | PMC10512610 | |
Method | PMC10512610 | |||
Patients and study design | EGRI, mandibular subluxation, thyromental, Pre-anesthesia, head and neck mobility, weight, mouth opening | The present study was approved by the Ethics Committee of the Lu'an Hospital of Anhui Medical University (NO.2021LL005) and written informed consent forms were signed by all the participants or their relatives before enrollment. We recruited patients from the current hospital between July and September 2022. The trial was prospectively registered at the China Clinical Trial Registration Center (The inclusion criteria were as follows: (1) need for transoral tracheal intubation for general anesthesia during elective surgery in our hospital; (2) ASA class I and II; (3) 18–64 years of age; and (4) EI-Ganzouri risk index (EGRI) (weight, mouth opening, thyromental distance, possibility of mandibular subluxation, Mallampati class, head and neck mobility, history of difficult intubation) greater than or equal to 4 [Pre-anesthesia visits were performed by anesthesiologists not involved in this study, and age, sex, ASA classification, and body mass index were assessed and recorded in all cases. Most importantly, assessment of difficult airways using the EGRI was performed, including weight, head and neck mobility, mouth opening, possibility of mandibular subluxation, thyromental distance, Mallampati classification, and history of difficult intubation. | PMC10512610 | |
Anesthesia protocol | PMC10512610 | |||
Anesthesia preparation | All patients fasted from food and water before surgery. In all patients, dexmedetomidine was given preoperatively intravenously over 10 min before the induction of anesthesia. The patient’s body temperature, heart rate, pulse, oxygen saturation, blood pressure, electrocardiogram, and end-tidal carbon dioxide (PETCO | PMC10512610 | ||
Induction of anesthesia | Anesthesia was inducted by sequential injections of 0.05 mg/kg midazolam, 0.5 μg/kg sufentanil, 0.3 mg/kg etomidate, and 0.8 mg/kg rocuronium in all three groups. We monitored neuromuscular function using a train of four (TOF) stimulation pattern. Intubation took place when a fully relaxed status was reached (TOF 0/4). All intubations were performed by two anesthesiologists, both of whom were attending physicians with more than 5 years but less than 10 years of clinical experience, each intubation device was used more than 200 times after training more than 100 times on manikins. | PMC10512610 | ||
Group VL | The video laryngoscope (TDC- K3, UE Medical Equipment Co. Ltd., Zhejiang, China, Fig. Comparison of three devices used for transoral endotracheal intubation. | PMC10512610 |
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