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Background | Media | Most people now know that physical activity is vital for health. Over the past few decades, if one has seen a physician, read the news, or obtained brochures from their health insurance or flyers from a local gym, they are likely aware of this fact. Indeed, we are constantly reminded of the need to engage in adequate physical activity. Media and public health messages frequently assert that “Regular physical activity is one of the most important things people can do to improve their health” [However, to many of us, it is less clear how exactly to engage in an “adequate” amount of physical activity and whether we are doing enough. Guidelines on the amounts and types of physical activity needed to promote one’s health have shifted over time [A large body of research has explored how to promote higher levels of physical activity, for example, by leveraging wearable activity trackers and smartphone apps [ | PMC9909519 |
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Mindsets and Their Effects on Health and Well-being | ’ motivation, behavior | Mindsets are our core assumptions regarding a domain or category (eg, intelligence, healthy eating, stress, and physical activity) [Decades of psychological research show that mindsets are critical yet often overlooked factors influencing individuals’ motivation, behavior, and performance (eg, mindsets about intelligence) [In the context of physical activity, initial research suggests that people have mindsets about their physical activity level’s adequacy and its corresponding health consequences (In experimental research, a study examined a sample of hotel room attendants who objectively met physical activity guidelines through their work but still perceived themselves as inactive as they were unaware that their work counted as exercise. An intervention informing room attendants that their work constituted adequate exercise resulted in reduced weight, body fat, and blood pressure 1 month later compared with a control group [Although these studies provide suggestive evidence that AAMs may affect health and well-being, other studies have yielded less promising results. In particular, one intervention failed to induce positive changes in mindsets about physical activity [To better understand when and why AAMs can influence health and well-being, it is important to explain Conceptual model of how activity adequacy mindset (AAM) may influence health and well-being through affective, behavioral, and physiological processes and how these are measured in this study.Second, a person’s AAM may affect their Third, a person’s AAM may induce | PMC9909519 |
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Can Wearable Technology Shape AAMs? | Individuals’ AAMs do not simply reflect their objective physical activity levels; indeed, a study found a moderate correlation of 0.32 between actual and perceived activity levels [The basic idea behind wearable activity trackers is simple: help users engage in adequate physical activity by providing feedback about their progress toward specific activity goals (eg, 10,000 steps a day, standing for at least 1 minute per hour during 12 hours of the day, or exercising for a target number of minutes). Much research attention has been devoted to eHealth and mobile health interventions to promote physical activity [ | PMC9909519 |
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How Can We Harness Mindsets to Promote Health and Well-being at Scale? | AAMs have the potential to improve health and well-being, but to date, interventions to leverage AAMs at scale are lacking. First, to establish causal effects, research has used deceptive methods to manipulate mindsets [An alternative approach is to share scientific insights about the power of mindsets with individuals directly and teach them strategies to harness mindsets in their own lives. This | PMC9909519 |
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This Research | depression, anxiety | This research explored 4 questions arising from the theory and evidence reviewed previously. First, we examined whether receiving step count feedback from a wearable tracker (in this case, Apple Watch [Apple Inc]) affects one’s AAM. Second, we experimentally manipulated step count feedback with the intent of inducing different levels of AAM and thereby investigate whether AAMs causally influence health and well-being (eg, weight and blood pressure, anxiety and depression, and ability to engage in everyday tasks) independently of how active individuals actually are. Third, we explored AAMs’ effects on several affective and behavioral determinants of health (eg, positive and negative affective experiences, physical activity, and diet). Fourth, we tested the effectiveness of a meta-mindset intervention designed to empower individuals to deliberately adopt AAMs that can benefit their health and well-being. | PMC9909519 |
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Methods | PMC9909519 |
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Overview | This study was preregistered on ClinicalTrials.gov [ | PMC9909519 |
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Participants and Procedures | WEST | Participants were a diverse sample of 162 West Coast community-dwelling adults recruited via flyers and web-based platforms (ie, Craigslist and Nextdoor) between September 2017 and September 2019. The posting advertised an opportunity to participate in a paid research study to develop more effective fitness trackers. To be eligible to participate, they had to meet the following criteria assessed via a web-based prescreening survey: walking as the primary source of physical activity in the previous 6 months (to ensure relevance of the step count manipulation), health status allowing for engagement in physical activity according to the Physical Activity Readiness Questionnaire [Each participant attended a personal onboarding and offboarding session in a laboratory of the Computer Science department at Stanford University at the start and end of their 5-week study participation (Study timeline.Throughout the following 5 weeks, participants’ step counts were tracked using the Apple Watch. In addition, participants completed weekly web-based surveys assessing affective and behavioral processes and daily web-based check-ins to ensure step count awareness. A researcher monitored participants’ survey response rates and watch activity to ensure study adherence. When step counts had not been uploaded to the cloud database for an extended time, researchers communicated with participants via SMS text message or email to remind them to wear the watch or assist with any technical issues. At the end of the 5 weeks, participants returned for the offboarding session, completing the same measures as in the onboarding session. They were then fully debriefed, thanked, and paid US $175 for satisfactory participation. Suspicions regarding the experimental manipulations and study purpose were probed with up to 10 progressively specific questions during poststudy interviews. The degree of suspicion was then rated by the researcher (1=not at all, 2=slightly, 3=somewhat, 4=very, and 5=extremely).A total of 45 participants were excluded from the analysis because of incomplete study participation (n=30, 67%), substantial suspicion about experimental manipulations (ie, correctly guessing inflation or deflation of step count, with suspicion rating >3; n=4, 9%), noncompliance (ie, using other activity-tracking apps or comparing step counts with friends; n=9, 20%, including 7, 16%, who also expressed substantial suspicion), or pregnancy discovered during the study period (n=2, 4%), yielding the final sample size of 162.Further details on the methods are included in | PMC9909519 |
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Ethics Approval | This study was approved by the Stanford University institutional review board (protocol 36098). | PMC9909519 |
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Design and Manipulations | PMC9909519 |
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Overview | This study used a parallel trial design (allocation ratio 1:1:1:1). Participants were assigned to one of four conditions––(1) accurate step count (41/162, 25.3%), (2) deflated step count (40/162, 24.7%), (3) inflated step count (40/162, 24.7%), or (4) meta-mindset intervention plus accurate step count (41/162, 25.3%)––via criteria-based randomization, a novel procedure that helps minimize imbalances in premanipulation covariate distributions across experimental groups to increase precision and statistical power [ | PMC9909519 |
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Step Count Feedback Manipulations | After the no-feedback baseline period (week 1), participants in the accurate step count condition started to view their step count as recorded by the Apple Watch (Illustration of an Apple Watch (Apple Inc) with the AccuSteps app displaying the manipulated step count. | PMC9909519 |
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Meta-Mindset Intervention | The meta-mindset intervention was included in the first weekly survey and consisted of 3 videos and reflection activities. The 3- to 5-minute–long videos informed participants about health-related mindsets in general, AAMs in particular, and how mindsets can create self-fulfilling effects. The reflection activity prompted participants to | PMC9909519 |
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Measures | PMC9909519 |
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Overview | All measures (ie, health outcomes, AAM, and affective and behavioral measures) were measured in the laboratory at onboarding and offboarding. In addition, a subset of measures (ie, AAM and affective and behavioral measures) was taken in weekly surveys. Survey scales providing reference periods referred to either the last 30 days (in onboarding or offboarding surveys) or the last 7 days (in weekly surveys). Step count was continuously tracked via the Apple Watch. | PMC9909519 |
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AAM (Manipulation Check) | A 5-item version of the Activity Adequacy Mindset Scale [ | PMC9909519 |
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Affective Processes | The Affect Valuation Index [ | PMC9909519 |
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Analytical Approach | The mean within-participant changes in AAM, health and well-being outcomes, and affective and behavioral processes from the baseline period to the treatment period were calculated. First, for each participant separately, all baseline measurements of a particular variable were averaged, all treatment measurements were averaged, and the resulting averages were subtracted (treatment average – baseline average) to obtain the within-participant change score. Second, within-participant change scores were averaged per condition, and 95% CIs were calculated.In addition, a multilevel longitudinal analysis was conducted to examine changes in average levels of each variable from the baseline period to the treatment period. For each variable, 2 models were fitted. Model 1 examined changes within the accurate step count condition from the baseline period to the treatment period and compared changes in the accurate step count condition (reference group) with changes in the deflated and inflated step count conditions. Model 2 compared changes from the baseline period to the treatment period in the accurate step count condition (reference group) with the meta-mindset intervention condition. This 2-model approach was chosen to account for the slight differences in what counted as baseline period for the different interventions. The step count manipulations started on day 8, the day after the first weekly survey, so that this survey was part of the baseline period. However, the meta-mindset intervention started on day 7 as part of the first weekly survey so that this survey was already part of the treatment period. AAM and affective and behavioral processes were theorized as mechanisms explaining changes in health. Thus, only their weekly (not onboarding or offboarding) measurements were used in model 1. However, because of the timing of the meta-mindset intervention, model 2 included onboarding (the only baseline measurements of AAM, affect, diet, smoking, and alcohol consumption), weekly, and offboarding measurements for these variables.To account for the within-subject design, we included by-participant random intercepts and random slopes for the period. For models predicting changes in health and well-being outcomes, which were measured only twice, no random slopes were included because of a lack of | PMC9909519 |
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Results | PMC9909519 |
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Effects of (Accurate) Step Count Feedback | First, we examined whether AAM, health, affect, and behavior changed from the baseline (no step count) period to the treatment period in the accurate step count condition. | PMC9909519 |
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Changes in AAM | Receiving step count feedback was associated with significant improvements in AAM from the baseline period to the treatment period (baseline mean 3.18, SD 1.05; treatment mean 3.47, SD 1.12; | PMC9909519 |
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Health Outcomes | Receiving step count feedback was associated with significant improvements in | PMC9909519 |
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Affective and Behavioral Processes | No changes were detected in | PMC9909519 |
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Effects of Manipulated Step Count Feedback | Next, we examined whether deflated and inflated step count feedback led to changes in outcomes over time that differed from the changes resulting from accurate step count feedback. | PMC9909519 |
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Health Outcomes | The deflated step count led to slight declines in | PMC9909519 |
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Affective and Behavioral Processes | Changes in | PMC9909519 |
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Effects of the Meta-Mindset Intervention | Finally, we examined whether the meta-mindset intervention improved AAM, affect, behavior, and health outcomes by comparing changes in these outcomes from the baseline period to the treatment period in the meta-mindset condition with changes in the accurate step count condition. | PMC9909519 |
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Changes in AAM | As predicted, AAM improved in the meta-mindset condition, and this improvement was significantly greater than that in the accurate step count condition (baseline mean 3.48, SD 1.19; treatment mean 4.06, 1.13; | PMC9909519 |
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Health Outcomes | Participants in the meta-mindset condition experienced slight improvements in | PMC9909519 |
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Affective and Behavioral Processes | In line with predictions, the meta-mindset intervention improved | PMC9909519 |
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Discussion | PMC9909519 |
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Principal Findings | This 5-week longitudinal field experiment examined the effects of wearable fitness tracker feedback on AAM. In addition, it explored the effects of AAMs on health and well-being and several affective and behavioral determinants of health. Finally, this research developed and tested a transparent, scalable meta-mindset intervention that empowers individuals to adopt beneficial activity mindsets deliberately.The results showed that simply receiving accurate step count feedback led to improvements in participants’ AAMs, helping them realize that they were engaging in more health-promoting physical activity than they had previously believed. (However, note that participants in our sample were relatively active, with an average of 7066 steps per day at baseline compared with the US average of 4774 steps [Experimentally deflating participants’ step counts by 40% led them to adopt more inadequate activity mindsets. Compared with participants receiving accurate feedback, those receiving deflated feedback adopted an unhealthier diet and felt negative affect more frequently. They also experienced declines in mental health and self-esteem and increases in resting HR and blood pressure. Finally, participants who received the meta-mindset intervention (in addition to accurate step count feedback) adopted more adequate activity mindsets and had improvements in affective experiences and functional health compared with participants receiving accurate feedback only.Interestingly, the step count displayed by the wearable tracker appeared not to influence engagement in physical activity (in line with other research showing inconsistent or null effects of wearables and smartphone apps) [ | PMC9909519 |
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Limitations | This research was preregistered as an exploratory study seeking to discover uncharted territory and generate novel hypotheses [ | PMC9909519 |
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Implications | This research has important theoretical and practical implications. First, we showed that individuals’ AAMs can shape their health and well-being independently of their actual physical activity. Although previous research provided suggestive evidence that AAMs may influence health [Second, this study adds to an emerging body of research suggesting that technology design typically overlooks effects on and of health-related mindsets [Third, we provide evidence for a novel meta-mindset intervention that empowers participants to deliberately adopt more positive mindsets and use them to improve health and well-being. Our findings increase the applied utility of mindset research as meta-mindset interventions are nondeceptive and ethical outside the research context. Moreover, meta-mindset interventions have the potential to be mindfully embedded in a wide range of health promotion programs––including technology applications, public health campaigns, and workplace health programs––thereby providing a cost-effective and scalable way to enhance population health. The videos and reflection activities designed for this study (included in | PMC9909519 |
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Areas for Future Research | Further research is needed to investigate the mechanisms underlying AAMs. This will advance our theoretical understanding of mindsets and facilitate the design of interventions that target the most critical pathways in a given context. We theorize that AAMs induce a range of affective, behavioral, and physiological processes, which in turn shape health and well-being (as shown by an extensive evidence base; see the In addition, the relationship between AAM and actual physical activity merits further study. We did not find robust evidence that more adequate activity mindsets lead to higher physical activity levels. Perhaps mindset does not in fact shape physical activity. Alternatively, there may be counteracting forces. For example, an adequate activity mindset may Moreover, future research could shed light on how individuals interpret step count. For example, a possible reason why the inflated step count condition failed to induce more adequate activity mindsets (compared with accurate step count) is that people may be less sensitive to changes in step count beyond a certain threshold. Participants reached approximately 7000 steps per day on average, which translates into a deflated step count of 4200 and an inflated step count of 9800. Participants may have perceived 7000 and 9800 steps as qualitatively similar (ie, in the high thousands but below the common 10,000-step target), whereas 4200 may have seemed qualitatively different (ie, <5000 steps and, thus, relatively low). This is consistent with previous findings that mindsets are a subjective interpretation of reality, which can be influenced by factors such as social comparison, guidelines, and targets [Finally, future research could examine the role of mindsets in predicting wearable tracker adoption, abandonment, and user engagement, which are major obstacles to trackers’ effectiveness as well as their systematic evaluation [ | PMC9909519 |
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Conclusions | Physical activity is a critical determinant of health and well-being. This research suggests that it is not only our actual physical activity behavior that matters but also our mindsets about the adequacy and health consequences of our physical activity. Moreover, it shows that wearable fitness trackers can shape these mindsets. These insights may be used to support the design of wearable trackers and other health technologies that more effectively boost users’ health and well-being. In addition, health psychology research and public health policy may design more successful public health interventions by more deliberately––and more effectively––harnessing the power of mindsets.This research was supported in part by a grant from the National Center for Complementary and Integrative Health (grant 1DP2AT009511-01), the Stanford Catalyst for Collaborative Solutions Research Grant, and the Stanford Center for Digital Health 2017 Apple Watch Seed Research Grant. The authors thank A Martin, J Pfeffer, and the Stanford Mind and Body Lab (including D Barbiani) and Design and Process of Experimental Research Lab for their contributions to this research or comments on this paper. OHZ is now affiliated with the European Central Bank. The views expressed in this paper are the author's own and do not necessarily reflect those of the Eurosystem or the ECB. EM is now affiliated with the School of Engineering, Dartmouth College.Conflicts of Interest: None declared.Supplemental methods, materials, and results.CONSORT-eHEALTH checklist (V 1.6.1). | PMC9909519 |
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Abbreviations | activity adequacy mindsetbehavior change techniquediastolic blood pressureheart ratemean arterial pressurePatient-Reported Outcomes Measurement Information Systemsystolic blood pressure | PMC9909519 |
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1. Introduction | disability, deaths, hypertensive | HIGH BLOOD PRESSURE | Current Institution: Department of Nutrition, Harvard T.H. Chann School of Public Health, Boston, MA 02115, USA.There is sound evidence showing the efficacy of non-pharmacological interventions in lowering blood pressure (BP); however, adherence is usually poor. Interventions to induce behavioral changes aim to improve the ability to read labels, choose foods, and eat low-sodium meals, reinforcing adherence to sodium restriction. In this randomized parallel-controlled trial, we assessed the effectiveness of an educational intervention using the Dietary Sodium Restriction Questionnaire (DSRQ) scores. A follow-up period of 6 months was conducted. Participants were randomized into (1) an educational intervention provided by a registered dietitian on individual visits and dietary planning; (2) a control group with the usual care and dietary recommendations. Patients underwent 24-h ambulatory BP monitoring, 12-h fasting blood tests, spot urine collection, and assessment using DSRQ. We randomized 120 participants (67.5% women and 68.3% Caucasians), and 25 participants were lost to follow-up. The 24-h sodium urinary excretion changed in the control (Δ −1610 mg/day; 95% confidence interval [CI] −1800 to −1410) and intervention groups (Δ −1670 mg/day; 95% CI −1800 to −1450) over time. There was no significant difference in the 24-h estimated sodium between groups. In hypertensive patients, DSRQ-based educational intervention is effective for improving the ability to detect and overcome obstacles to a low-sodium restriction diet but is as effective as dietary recommendations for lowering sodium.High blood pressure (BP) is the primary preventable cause of mortality and disability worldwide, resulting in over 10.4 million deaths and 218 million disability-adjusted life-years [Despite recommendations to cook with low sodium and prefer fresh foods, the average Brazilian population consumes 4700 milligrams of sodium per day [The TPB emphasizes that a person’s behavioral intention is the most crucial factor, with attitude, subjective norm, and perceived behavioral control being the determinants of behavioral intention. The validation of the Dietary Sodium Restriction Questionnaire (DSRQ) as a valuable tool [ | PMC10180840 |
2. Materials and Methods | Hypertension | HYPERTENSION | This parallel randomized controlled trial included participants from the general population and the Hypertension outpatient clinic at Hospital de Clínicas de Porto Alegre (HCPA). Prior to enrollment, participants provided informed consent, and the study protocol (protocol number 150496) was approved by the hospital’s institutional review board. Additionally, the study protocol has been registered at ClinicalTrials.gov (NCT02848690) and published [ | PMC10180840 |
2.1. Participants and Randomization | gastrointestinal tract disease, hypertension, cognitive impairment | DIABETES MELLITUS, HYPERTENSION | Participants were recruited from the outpatient clinic or through media advertisements. Potentially eligible participants were screened and those who met the criteria were invited to a clinical visit. Eligible participants were men and women aged 40 to 80 years who had a diagnosis of hypertension and were undergoing BP-lowering drug treatment at the clinic and had not been visiting a nutritionist in the previous six months. Participants were invited to participate and, after signing a consent form, were randomly allocated to either the educational intervention or the control group. Exclusion criteria included gastrointestinal tract disease, inflammatory disease, chemotherapy treatment, physician diagnosis of diabetes mellitus, those with cognitive impairment detected during the interview, and those unable to participate without third-party involvement, pregnant or lactating women. The follow-up was carried out for up to six months with monthly monitoring. | PMC10180840 |
2.2. Randomization, Allocation Concealment, and Blinding | A randomization list was generated using software (randomization.com) at a 1-to-1 ratio, with participants allocated in blocks of six, and the randomization sequence was created by an independent researcher outside the clinic. The sequence was stored in opaque sealed envelopes which were kept outside the clinical center for blinding purposes.Participants and the research team were not blinded to the intervention and control groups. However, the assessment of outcomes was conducted by an independent blinded researcher.Between November 2015 and October 2017, we screened 460 participants. Out of these, 160 did not meet the eligibility criteria, and 180 declined to participate. A total of 120 participants were randomized to the intervention and control groups. By April 2018, 15 and 10 participants were lost to follow-up in the intervention and control groups, respectively. | PMC10180840 |
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2.3. Educational Intervention Group | hypertension | HYPERTENSION | A registered dietitian oversaw the educational intervention and provided participants in the intervention group with detailed guidance and recommendations on adhering to a low-sodium diet. During their initial consultation, the participants received a dietary plan that emphasized the consumption of fruits, vegetables, low-fat dairy, and low-fat and minimally processed food. Additionally, their daily energy intake was reduced by 500 to 1000 kcal based on their baseline weight. To ensure continued adherence to the low-sodium diet, the participants attended monthly 60-min face-to-face sessions with the registered dietitians who provided encouragement and motivation.The DSRQ [The activities were developed according to the instrumental subscales: (i) attitude and subjective norm, participants received explanations to understand the low-sodium dietary importance to control hypertension and the influence of family and others in choices and food preparation; (ii) perceived behavioral control, they identified barriers to low sodium adherence, such as lack of knowledge, interference with socialization, and lack of food selections; they learned to increase information about food choices, cooking or preparing food without sodium, low-sodium diet shopping, evaluating recipes and making suggestions for changes to low-sodium food, and to read labels; (iii) dependent behavior, they received learning sessions on the amount of sodium in food, including sodium quantity demonstrations, low-sodium food selection, changes in food choices in restaurants, and being aware of the need to change both taste and food preferences.The educational intervention was individualized and based on dietary information provided by the patient. They answered the 24-h dietary recall for monitoring low-sodium diet adherence. The 24-h dietary recall was analyzed by computer software, the DietSys [ | PMC10180840 |
2.4. Control Group | hypertension | HYPERTENSION | Participants allocated to the control group had monthly appointments with registered dietitians, in line with standard care practices. During the first visit, participants received an explanatory leaflet on hypertension and provided general recommendations. These recommendations included reducing sodium intake, avoiding high-sodium foods and alcoholic beverages, and losing weight if a body mass index was greater than 25 kg/mAnthropometric and office BP measurements were performed monthly. The 24-h ambulatory BP monitoring was performed at baseline and at the end of the study.Instruments used for data collection: The DSRQ has been validated for patients with hypertension [The subscale scores for attitude and subjective norm vary from 9 to 40, where higher scores indicate a more positive attitude toward a low-sodium diet and greater motivation to follow it due to the approval of significant others. On the other hand, the scores for perceived behavioral control range from 3 to 15, where a higher score indicates a lower perceived ability to stick to a low-sodium diet. Finally, the scores for dependent behavior subscale range from 4 to 20, where a higher score signifies greater challenges in adhering to the low-sodium diet. Trial management:The research team comprised trained graduate students from the Nursing and Medicine Schools, as well as two registered dietitians who were postgraduate students. Their responsibilities included recruiting participants, inviting them to participate, administering informed consent, screening for eligibility, and collecting data. Additionally, the registered dietitians applied the DSRQ.The collection of data took place at the Clinical Research Center located at HCPA. To measure BP, ABPM was conducted at the beginning and end of the six-month intervention period using Spacelabs 90207 devices (Redmond, WA, USA). BP was recorded every 15 min from 6 am to 10 pm and every 20 min during nighttime. The validity of ABPM required at least 16 daytime and 8 nighttime readings [ | PMC10180840 |
2.5. Outcomes | The outcomes were calculated based on the difference between follow-up and baseline estimated 24-h sodium consumption, and systolic and diastolic BP (intervention delta minus control delta) assessed by ABPM. The 24-h sodium excretion was estimated from a spot of urine using a simple formula with high sensitivity to detect patients with sodium intake greater than 3600 mg/day [Men: Estimated 24-h urinary sodium excretion (g/day) = 0.96 + (weight in kg × 0.03) + (sodium in the urine specimen in g/L × 0.63). | PMC10180840 |
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2.6. Statistical Analysis | To determine the appropriate sample size, the average sodium intake of 3900 ± 1602 mg/day (168.5 mmol) [The characteristics of the sample were presented as mean with standard deviation or absolute numbers and percentages. Group comparisons were conducted using Pearson’s chi-square test for categorical variables and Student’s The analysis was conducted following the intention-to-treat principle and utilized PASW Statistics 18 | PMC10180840 |
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4. Discussion | hypertensive | The aim of this randomized controlled trial was to compare the effectiveness of an educational intervention that used DSRQ with usual care provided by registered dietitians. After six months, the estimated sodium urinary excretion was similarly reduced in both groups. However, no statistically significant reduction was observed in 24-h ABPM measurements after six months.For the initial time, the validated edition of the DSRQ was employed in a randomized clinical trial, specifically for hypertensive patients located in southern Brazil. At the follow-up, the DSRQ score for the attitude and subjective norm scale showed that participants in the intervention group identified more benefits of following a low-sodium diet compared to the control group. They also reported fewer barriers related to reducing sodium intake, which improved their perceived behavioral control subscale. Furthermore, the participants were incentivized to modify their conduct and acquire abilities for creating meals with reduced sodium content. In addition, the individuals expressed that they had adjusted to the flavor of low-sodium foods. However, on the subscale that measures dependent behavior, the choice of a bistro or restaurant did not affect the participants’ commitment to maintaining a low-sodium diet. On the other hand, subjects stated that they became accustomed to the taste of low-sodium foods and changed their meal preparation habits, reducing sodium and abstaining from sodium-based condiments. Participants also expressed a preference for homemade meals and buying unprocessed foods such as meats, cereals, fruits and vegetables, avoiding ultra-processed foods.After a 6-week intervention, the results of a study [Our results agree with a study performed on hypertensive adults and the elderly, who had an intake above the recommended, primarily based on sodium added during cooking and at the table [It is worth mentioning that a few participants in our study had also taken part in a prior study and had received extensive guidance on diet, sodium restriction, and lifestyle changes from different healthcare teams for a considerable length of time. As a result, the residual impact of their previous experiences may have played a role in the reduction in sodium intake observed in both groups.Shamsi et al. reported that a lifestyle intervention in the form of a continuous care model decreased the mean dietary sodium intake and systolic and diastolic BP in hypertensive patients compared with usual care [Our findings corroborate previous interventions based on the Theory of Planned Behavior in Brazilian hypertensive patients to promote low-sodium intake [This study presented some limitations that deserve consideration. The collection of urine spots can be utilized to estimate sodium intake; however, its accuracy remains a topic of controversy [Nevertheless, predictive equations for estimating an individual’s mean 24-h sodium excretion may have some value in monitoring sodium intake progress, despite the limitations [ | PMC10180840 |
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5. Conclusions | HYPERTENSION | In conclusion, implementing an educational intervention for sodium restriction based on the DSRQ by a multidisciplinary team, including a dietitian, improves attitude and subjective norms in patients with hypertension. This intervention also reinforces their knowledge, skills, and perception of the benefits of low-sodium diets. However, it is not enough to overcome the effect of regular advice. | PMC10180840 |
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Author Contributions | Conceptualization, L.B.M. and M.P.R.; methodology, L.B.M. and M.P.R.; software, S.L.R. and M.P.R.; validation, L.B.M. and M.P.R.; formal analysis, L.B.M. and M.P.R.; investigation, M.P.R., C.B.F., K.A.M.D.S., and P.N.M.; resources, L.B.M.; writing—original draft preparation, L.B.M. and M.P.R.; writing—review and editing, L.B.M., S.L.R., and S.C.F.; visualization, L.B.M.; supervision, L.B.M.; project administration, L.B.M. and M.P.R.; funding acquisition, L.B.M. All authors have read and agreed to the published version of the manuscript. | PMC10180840 |
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Institutional Review Board Statement | This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Hospital de Clínicas de Porto Alegre Ethics Committee (protocol CAAE 47912215.8.0000.5327, date of approval 08-24-2015. | PMC10180840 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10180840 |
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Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10180840 |
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Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10180840 |
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References | Study flowchart.Changes in 24-h urinary sodium excretion over time, with adjustments made for baseline SBP and DBP, as well as the use of diuretics, adrenergic blockers, beta-blockers, ACE inhibitors, vasodilators, calcium channel blockers, AT1 receptor antagonists of angiotensin II. The reduction in urinary sodium excretion over time was statistically significant for within-group comparisons (Baseline participants’ characteristics [n (%) or mean ± SD].ACE, angiotensin-converting enzyme; AT1R, Angiotensin II Receptor Type-1. Laboratory reference values: Total cholesterol <190 mg/dL; LDL-C <130 mg/dL; HDL-C >40 mg/dL; Triglycerides <150 mg/dL; Fasting glucose <100 mg/dL; Creatinine 0.50–1.20 women and 0.60–1.30 mg/dL men; Potassium 3.5–5.1 mEq/L.Patient barriers to low-sodium dietary adherence, attitude, and benefit scores [mean ± SD].* Higher score indicates a more positive attitude toward a low-sodium diet. ** Higher score indicates greater difficulty in adhering to the low-sodium diet.Delta differences for 24-h sodium estimated, blood pressure, and weight, index between groups.* The number of participants analyzed is different between variables due to missing data. ** Intervention delta minus control delta. *** General linear model (GLM) adjusted for respective baseline values. SBP, systolic blood pressure; DBP, diastolic blood pressure. | PMC10180840 |
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Key Points | PMC9856772 |
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Question | diabetic foot ulcers | DIABETIC FOOT ULCERS | Is adding a novel macrophage-regulating drug, ON101 cream, to general wound care (GWC) cost-effective compared with GWC alone for treating diabetic foot ulcers (DFUs) from a health care sector perspective? | PMC9856772 |
Findings | EVENTS, COMPLICATIONS | In this economic evaluation, the ON101 with GWC strategy vs GWC alone strategy gained more wound healing events, averted more DFU-related complications, and cost $14 922/quality-adjusted life-year gained. | PMC9856772 |
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Meaning | diabetic foot ulcers | DIABETIC FOOT ULCERS | In this study, ON101-enhanced GWC was cost-effective vs GWC alone at a willingness-to-pay threshold of $32 787/quality-adjusted life-year from the Taiwan health care sector perspective and may be considered in future standard wound care.This economic evaluation assesses the cost-effectiveness of an ON101 cream added on to general wound care vs general wound care alone for diabetic foot ulcers (DFUs) from the Taiwan health care sector perspective. | PMC9856772 |
Importance | amputation, DFUs, Diabetic foot ulcers | DIABETIC FOOT ULCERS | Diabetic foot ulcers (DFUs) and subsequent amputation incur enormous health and economic burdens to patients, health care systems, and societies. As a novel macrophage-regulating drug, ON101 is a breakthrough treatment for DFUs, which demonstrated significant complete wound healing effects in a phase 3 randomized clinical trial, but its economic value remains unknown. | PMC9856772 |
Objective | comorbidity, ulcer | ULCER | To assess the cost-effectiveness of an ON101 cream added on to general wound care (GWC; ie, conventional treatments for DFUs, which comprised initial and regular foot examinations, ulcer management, comorbidity control, patient education, and multidisciplinary care) vs GWC alone for DFUs from the Taiwan health care sector perspective. | PMC9856772 |
Design, Setting, and Participants | diabetes | DIABETES | This economic evaluation used a hypothetical cohort of patients with diabetes, with characteristics mirroring those of the participants in the ON101 trial. A Markov state-transition simulation model was constructed to estimate costs and health outcomes associated with the ON101 with GWC and GWC alone strategies over a 5-year time horizon, discounting costs and effectiveness at 3% annually. Costs were in 2021 US dollars. Data were sourced from the ON101 trial and supplemented from published literature. Deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of input parameters and study generalizability. The analysis was designed and conducted from September 1, 2020, to January 31, 2022. | PMC9856772 |
Exposures | ON101 with GWC vs GWC alone. | PMC9856772 |
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Main Outcomes and Measures | COMPLICATIONS | DFU-related complications, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. | PMC9856772 |
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Results | Patients in the hypothetical cohort had a mean age of 57 years and an uninfected DFU of 1 to 25 cm | PMC9856772 |
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Conclusions and Relevance | DISEASE PROGRESSION | In this economic evaluation study using a simulated patient cohort, the ON101 with GWC strategy represented good value compared with GWC alone for patients with DFUs from the Taiwan health care sector perspective and may be prioritized for those with high risks for disease progression of DFUs. | PMC9856772 |
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Introduction | DFUs, amputation, Diabetic foot ulcers, gangrene, ulcer, diabetes | RECURRENCE, HEALED ULCER, DIABETIC FOOT ULCERS, GANGRENE, ULCER, COMPLICATIONS, DIABETES | Diabetic foot ulcers (DFUs) are among the most serious complications among patients with diabetes. The estimated lifetime incidence of a DFU is 19% to 34%, and roughly 40% to 65% of patients with diabetes undergo recurrence within 1 to 5 years after ulcer healing.To ameliorate health and economic burdens of DFUs, the primary treatment goals include accelerating wound healing, remaining longer in the healing state (ie, a healed ulcer), and preventing gangrene and amputation.ON101 is a first-in-class novel drug to treat DFUs through regulating M1/M2 macrophages.Although the promising efficacy and safety of ON101 were observed in a short-run trial, it remains unknown whether the use of ON101 could provide longer-term economic benefits of treating DFUs. We conducted a computer simulation model to assess the cost-effectiveness of ON101 added on to general wound care (GWC) vs GWC alone for DFUs from the Taiwan health care sector perspective. | PMC9856772 |
Methods | This economic evaluation was approved by the institutional review board of National Cheng Kung University Hospital before its commencement. Informed consent was waived because this study did not include any human participants. Economic analyses complied with the International Society for Pharmacoeconomics and Outcomes Research ( | PMC9856772 |
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Study Model and Simulation | diabetes | EVENTS, DISEASE PROGRESSION, DIABETES | To estimate the cost-effectiveness of ON101 with GWC, a Markov state-transition model, which simulated the chronic and recurrent events in the disease progression of a DFU, was applied to consider a hypothetical cohort of patients with diabetes with a mean age of 57 years who had uninfected DFUs sized 1 to 25 cmThe Markov model in this study was adapted from existing validated decision-analytic models | PMC9856772 |
Six Health States in the Markov State-Transition Model | uninfected diabetic foot ulcer | DIABETIC FOOT ULCER | iDFU indicates infected diabetic foot ulcer; uDFU, uninfected diabetic foot ulcer. | PMC9856772 |
Transition Probabilities, Health Utilities, Costs, and Odds Ratio for Model Inputs in 1-Month Cycle Length | uninfected diabetic foot ulcer | EVENT, DIABETIC FOOT ULCER | Abbreviations: DFU, diabetic foot ulcer; GWC, general wound care; iDFU, infected diabetic foot ulcer; uDFU, uninfected diabetic foot ulcer.Event costs were for the transition from 1 health state to another.Data were estimated from the efficacy analysis report provided by the pharmaceutical company. | PMC9856772 |
Model Inputs: Transition Probabilities, Health Utilities, and Costs | infection, gangrene | INFECTION, EVENT, GANGRENE, TRANSITION | Transition probabilities reflecting risks of progression between health states were derived from published literature (Quality-adjusted life-years (QALYs) were the primary effectiveness outcome and estimated by multiplying health utilities with the number of years spent in each health state. Health utilities were obtained from the study by Kuo et alMonthly health care costs were estimated. Costs were classified as a one-time event or hospitalization costs, which occurred when any health states changed to health states of infection, gangrene, or amputation, and state costs, which represented medical costs incurred in every modeling cycle ( | PMC9856772 |
Statistical Analysis | PMC9856772 |
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Cost-effectiveness Analysis | postamputation | EVENTS, COMPLICATIONS | In the base-case analysis, total health care costs, life expectancy, and QALYs per patient in both groups were simulated over 5 years from the Taiwan health care sector perspective. The cumulative probabilities of patients with healing, uninfected DFU, infected DFU, and postamputation as well as the mean time of staying in the healing health state were computed for each study group. The numbers of healing events and DFU-related complications were estimated through 10 000 times of microsimulation.The incremental cost-effectiveness ratio (ICER) of ON101 with GWC vs GWC alone was the incremental total health care costs divided by the incremental total QALYs. Future costs and health outcomes were discounted at 3% yearly.All study analyses were performed using TreeAge Pro 2020 (TreeAge Software, LLC). The impact inventory for the components considered in economic analyses is provided in eTable 1 in | PMC9856772 |
Sensitivity Analyses | A series of sensitivity analyses were performed to assess the impact of parameter uncertainties on the base-case ICER and examine the generalizability of study results. Deterministic sensitivity analyses (DSAs) were conducted in which all input values were varied within a predefined range (ie, ±50% of the base-case value for probabilities, ORs, and costs; ±10% of the base-case value for health utilities) ( | PMC9856772 |
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Subgroup Analyses | Subgroup analyses were conducted according to baseline HbA | PMC9856772 |
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Results | PMC9856772 |
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Base-Case Analysis | diabetes | DIABETES | The hypothetical cohort of patients with diabetes had a mean age of 57 years and an uninfected DFU of 1 to 25 cmThe ON101 with GWC vs GWC alone yielded a marginal gain of life expectancy and a gain of 0.038 QALYs at an additional cost of $571, resulting in an ICER of $14 922/QALY gained ( | PMC9856772 |
Base-Case Analysis Results Over a 5-Year Model Simulation | Abbreviations: GWC, general wound care; ICER, incremental cost-effectiveness ratio; NA, not applicable; QALY, quality-adjusted life-year.The probability was against the willingness-to-pay threshold of $98 361/QALY gained. | PMC9856772 |
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Sensitivity Analyses | The DSAs ( | PMC9856772 |
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Tornado Diagram for Deterministic Sensitivity Analysis Results | DIABETIC FOOT ULCER | The figure shows the incremental cost-effectiveness ratio (ICER) of ON101 with general wound care (GWC) vs GWC alone for different model input parameters. The influential parameters whose variations yielded a base-case ICER change greater than 40% are illustrated in the figure. DFU indicates diabetic foot ulcer; QALY, quality-adjusted life-year. | PMC9856772 |
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Cost-effectiveness Acceptability Curve | The figure shows the probabilistic sensitivity analysis using Monte Carlo simulation with 10 000 iterations, in which the input parameters varied simultaneously in the plausible statistical distributions that reflected the uncertainty of the cost-effectiveness for ON101 with general wound care (GWC) vs GWC alone at different willingness to pay thresholds. ON101 with GWC had a 28.7%, 59.7%, and 81.8% probability of being cost-effective against the willingness to pay thresholds of $0, $32 787, and $98 361 per quality-adjusted life-year (QALY) gained, respectively. ICER indicates incremental cost-effectiveness ratio. | PMC9856772 |
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Subgroup Analyses | ON101 with GWC vs GWC alone remained cost-effective across different patient subgroups in a range of 65% to 94% of model iterations against the WTP threshold of $98 361/QALY gained. ON101 with GWC was cost-saving among patients with an HbA | PMC9856772 |
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Discussion | DFUs, deteriorative QoL.Given | Given the results of the ON101 trial,Healing of DFUs may take months to years, and without complete healing, patients with DFUs are susceptible to a series of costly health consequences associated with deteriorative QoL.Given the apparent efficacy on wound healing, it is not surprising to find that the healing efficacy of ON101 with GWC vs GWC alone was the most dominant factor for the economic results in sensitivity analyses. However, this result should be interpreted with caution because we used a wide range for healing efficacy (ie, ±50% of the base-case OR value) to bias against the outcomes associated with ON101, and also, the healing effect size was based on a 28-week clinical trial. The drug cost of ON101 was found to be the second most influential factor for the economic results. ON101 with GWC was still cost-effective even at a 1.9-fold increase in cost (eFigure 3 in Consistent with the findings in the base-case analyses, the ON101 with GWC strategy was cost-effective or even cost-saving across patient subgroups, with 65% to 94% certainty for such cost-effectiveness under the WTP threshold of $98 361 according to the results of PSAs (eTable 5 in Previous cost-effective studies favor most preventive or treatment strategies for DFUs. A recent systematic review revealed that the intervention with optimal wound care in compliance with clinical guidelines or adjunctive therapies added on to GWC would be cost-effective or cost-saving, except for the use of an epidermal growth factor due to its high acquisition cost. | PMC9856772 |
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Strengths and Limitations | gangrene | DISEASE, GANGRENE | To our knowledge, this is the first model-based simulation economic analysis of the ON101 with GWC vs GWC alone strategies for DFUs. To ensure the applicability of our economic results to the study setting and the health care sector perspective in the Taiwanese context and to reduce heterogeneity arising from multiple data sources for model input parameters, several methodologic efforts were made, including (1) transformation of the health care costs using the cost ratios to reflect local health care systems and practice patterns; (2) utilization of the Taiwanese population-based health utility data to enhance the applicability of study results to the local setting; (3) adaptation of existing validated disease simulation models to include the gangrene state, which was not well considered in previous cost-effectiveness studies,Some limitations to our study should be acknowledged. First, our analysis may underestimate the cost-effectiveness of ON101 with GWC alone because of 2 conservative modeling assumptions. The relative healing efficacy for ON101 vs GWC alone was adopted directly from the ON101 trial, in which ON101 was compared with a commonly used absorbent dressing for standard care, which has a better wound healing efficacy than GWC. | PMC9856772 |
Conclusions | Given the high cost-effectiveness of the ON101 with GWC strategy vs GWC alone for treating DFUs from the Taiwan health care sector perspective, the ON101-enhanced GWC may be considered in future standard wound care. Health care payers can consider the implementation of ON101 therapy to patients with an uninfected DFU with a Wagner grade of 1 or 2 and even prioritize it to those with poor glycemic control (HbA | PMC9856772 |
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Supplementary Information | pain | COMPLICATIONS | To demonstrate the Tianjin Institute of Urology (TJIU) technique to place and remove the ureteral stent with extraction string after percutaneous nephrolithotomy (PCNL). Additionally, we aim to compare the pain experienced during stent removal, quality of life during stent retention, and stent-related complications between patients with and without extraction string. 65 patients were included in the final analysis in the string group constructed by the TJIU technique and 66 patients in the conventional double-J ureteral stent (non-string) group. All patients underwent the surgery in a prone position under general anesthesia. They completed the Ureteral Stent Symptom Questionnaire (USSQ) on postoperative days (POD) 7, as well as before their ureteral stent was removed. The visual analogue scale (VAS) pain score (0–10) was completed immediately after the removal of the ureteral stent. Moreover, a specialized person was responsible for recording stent-related complications. All patients completed the USSQ on POD 7, and we did not find a difference in scores in each field. However, there was a significant difference in the “sex” domain before removing the ureteral stent (4.34 vs 3.23; The online version contains supplementary material available at 10.1007/s00240-023-01451-5. | PMC10141830 |
Keywords | PMC10141830 |
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Introduction | nephrolithiasis, urolithiasis | NEPHROLITHIASIS, UROLITHIASIS | The incidence of urolithiasis is increasing every year, especially in developed countries. Moreover, as one of the high stone prevalence areas, the incidence of nephrolithiasis in China is about 5.8% [ | PMC10141830 |
Materials and methods | PMC10141830 |
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Study population | renal stones | A total of 133 patients with renal stones who underwent PCNL in our hospital were admitted from September 2021 to September 2022 (Fig. Diagram of study enrollment and final analysis cohort | PMC10141830 |
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Surgical procedures | PMC10141830 |
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Fabrication of ureteral stent and catheter with extraction string | The main primary materials included 6 F double-J stent with extraction string (Soft Percuflex™ Stent with HydroPlus™ Coating; Boston Scientific, MA, USA), 5 F ureteral catheter from Cook Medical (Bloomington, IN, USA), 5 ml syringe, scalpel.The extraction string at the end of the double-J stent was snipped from the knot in the string group. Part of the string was fixed at the distal end of the double-J stent (35 cm for the male patient and 25 cm for the female patient) (Fig. Main steps of TJIU technique: | PMC10141830 |
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Percutaneous nephrolithotomy | hydronephrosis | HYDRONEPHROSIS, STERILE | Firstly, the patient was placed in the lithotomy position after general anaesthesia. The ureteral catheter was then inserted in the renal pelvis under the surveillance of the 8/9.8 F ureteroscope along a safety guidewire, attached to a sterile urethral catheter and linked to saline to create artificial hydronephrosis (Fig. Secondly, the patient was placed in a prone position. Under the guidance of a 3.5-MHz ultrasound probe (MEDISON Ultrasound System), a mini (18F) or standard (24F) percutaneous tract was established. Then, under the supervision of an 8/9.8 F ureteroscope or 20.8F nephoscope, stones were fragmented and cleared using a combination of ultrasonic and pneumatic lithotripter (LithoClast Master; EMS Electro Medical Systems) or holmium:YAG laser (SRM-H2B, raykeen, Shanghai, China). In the string group, it was essential to protect the string from accidental breaking if it appeared in the surgeon's visual field.Thirdly, once the stone was fragmented and cleared, we took out the string (Figs. Ureteral Stent Symptom Questionnaire (USSQ) domain scores: Finally, the patient was placed in a supine position. In the string group, the string was gradually withdrawn outward from the external urethral orifice, and the knot was snipped once it was visible, approximately 6–8 cm from the external urethral orifice (Fig. | PMC10141830 |
Removal of the ureteral stent | URETHRA | The ureteral stent was removed from all patients within 2–4 weeks postoperatively. For the string group, we removed the ureteral stent by pulling the extraction string out directly. The ureteral stent in non-string group was removed using rigid cystoscopic procedures in lithotomy position, with oxybuprocaine hydrochloride gel being applied to the urethra. | PMC10141830 |
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Postoperative follow-up | febrile UTI, pain | COMPLICATIONS | In both groups, the Ureteral Stent Symptom Questionnaire (USSQ) was completed on postoperative days (POD) 7 and the day when stent was removed. It is made up of several domains such as “urinary symptoms”, “pain”, “general health”, “work performance”, “sex”, and “additional problems”. The visual analogue scale (VAS) pain score (0–10) was completed immediately after the removal of the ureteral stent. In addition, a designated individual was responsible for recording stent-related complications such as febrile UTI (> 38℃), emergency room (ER) visits, accidental stent dislodgement, and delayed removal. Urological ultrasound or CT was used to assess the presence of residual stones (> 4 mm) one month after surgery. | PMC10141830 |
Statistical analysis | pain | The primary endpoint of our study was the VAS pain scores at stent removal. The sample size was calculated using the PASS software based on the results of previous ureteral stent study with a power of 90% and a type-1 error (α) of 0.05. The number of participants was increased to account for patient loss to follow-up and withdrawals [ | PMC10141830 |
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Discussion | Urolithiasis, infection, staghorn calculi | UROLITHIASIS, INFECTION, URETER, URETERAL STONE, COMPLICATIONS | Urolithiasis is a common urological condition. With the development of technology, PCNL has become the preferred treatment for kidney and upper ureteral stones larger than 2 cm, particularly staghorn calculi [Regardless of traditional PCNL (placing both nephrostomy and ureteral stent) or tubeless PCNL (ureteral stent only), the ureteral stent needs to be removed by rigid or flexible cystoscope in the outpatient setting after surgery. To reduce the morbidity caused by cystoscopic extubation, Agrawal et al. and Shpall et al. tied a string to the proximal end of the double-J stent, and the string was fixed to the skin surface through the nephrostomy tract [Preserving the extraction string equipped on the ureteral stent could solve those problems. Some urologists are concerned that ureteral stent with extraction string may affect patients' quality of life, increase the incidence of infection, lead to premature migration or dislodgement of the stent. Nevertheless, ureteric stent placement with extraction string has been well-studied in URSL. In a prospective randomized controlled study, Barnes et al. demonstrated that ureteral stent with extraction string offered many advantages and did not increase stent-related urologic symptoms, complications, or postoperative morbidity [Similar studies have rarely been performed in PCNL. To assess the safety and efficacy of placing the ureteral stent with extraction string after PCNL in the prone position, we designed this study using the TJIU technique and obtained similar outcomes. The USSQ scores for each domain on POD 7 between the two groups of patients showed no significant difference in the results of our study. Before the ureteral stent removal, the scores were higher in the non-string group than the string group in most domains, although the difference between them was not statistically significant. Except that the score of the “sex” domain was significantly higher in the string group (4.34 vs 3.23; There are some limitations in our study. Firstly, the sample size was relatively small and it was a single-center prospective study. Secondly, we did not statistically analyze the cost differences between the two groups of patients in detail. Finally, the TJIU technique was only applied to PCNL in the prone position in the present trial. Because we could insert the ureteral stent with extraction string retrogradely into the ureter in several selected patients who underwent PCNL combined with retrograde flexible ureteroscopy in the supine lithotomy position. | PMC10141830 |
Conclusion | urethral injury, febrile UTI, pain | COMPLICATIONS | Placing a ureteral stent with extraction string following TJIU technique after PCNL in prone position could reduce the pain associated with ureteral stent removal, and avoid complications such as urethral injury caused by cystoscopic ureteral stent removal, while not increasing complications related to accidental removal and febrile UTI. Therefore, a ureteral stent with extraction string is feasible for PCNL patients, whereas it should be chosen cautiously for sexually active patients. | PMC10141830 |
Acknowledgements | Not applicable. | PMC10141830 |
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Author contributions | Study concept and design: SYQ, YC;
Acquisition of data: YJQ, HNX and HLK;
Analysis and interpretation of data: YJQ, HLK and HNX;
Drafting of the manuscript: YJQ, HLK;
Critical revision of the manuscript for important intellectual content: YC, SYQ;
Statistical analysis: YJQ, HNX;
Obtaining funding: SYQ;
Administrative, technical, or material support: SYQ, YC and ZZH;
Supervision: SYQ; | PMC10141830 |
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Funding | This work was supported by The National Natural Science Foundation of China (82070725). | PMC10141830 |
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