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Comparison of viral loads according to RDT result, and duration and intensity of symptoms | Viral loads (by NP PCR) were significantly higher in patients with RDT positive (median 1.9x10Log viral loads by NP PCR and saliva PCR according to A) RDT result and B) intensity band of positive RDT.The sensitivity of RDT according to symptoms duration varied between 80% and 90%. It was lowest the day of symptoms onset (80%, 95%CI 44.4–97.5%) and highest on day 4 (90.0%, 73.5–97.9%) (Log viral loads according to symptoms duration by nasopharyngeal PCR (A) and sensitivity of antigen RDT (B).Viral loads (by NP PCR) were significantly higher (median 1.3x10 | PMC9955963 | ||
Viral loads according to PCR type of sampling | VLs of patients with positive saliva PCR (median 1.3x10 | PMC9955963 | ||
Comparison between log viral loads by nasopharyngeal PCR and saliva PCR. | VIRUS | A) Log viral loads in RDT positive (black dots) and negative (white dots) patients. Dotted lines: Mean log viral loads; Black line: Considered threshold for presence of cultivable virus (nasopharyngeal PCR); B) Bland-Altman analysis showing the difference between nasopharyngeal and saliva log viral loads; SD = Standard deviation.Viral loads (by saliva PCR) were not significantly higher in patients with high volume of saliva (median 1.3x10 | PMC9955963 | |
Log viral loads by saliva PCR saliva volume: Low volume corresponds to a gingivo-buccal swab only; high volume corresponds to a gingivo-buccal swab with <0.5 ml of saliva in addition. | sore throat, anosmia, ageusia | SORE THROAT | The two PCR were equivalent also in patients with ageusia or sore throat and no other symptom outside anosmia (p = 0.7). | PMC9955963 |
Discussion | The results of the present study show that the detection rate of positive COVID-19 cases by RDT was high, especially for those with a VL of ≥10The detection rate of SARS-CoV-2 by PCR performed on a saliva sample was equivalent to that of RT-PCR performed on NP swabs. The sensitivity of PCR of one type of sampling compared to the other were similar and above 95%. The two positive saliva PCR but negative NP PCR patients who were still detected by RDT illustrates that some but rare false negative results of tests based on NP swabs are likely due to sampling procedure. | PMC9955963 | ||
RDT versus PCR | cough, fever | The sensitivity of RDT of more than 95% in patients with VL≥10There was a slight variability in performance between the three different RDTs with STANDARD Q® having a higher sensitivity (93%) than those of PanbioIn our study, the specificity of all three tests was 100%, which is impressive considering the potential for inter-observer variation in RDT test line reading. This observation implies that the assessed RDTs brands are easy to read, and that faint lines can still be easily detected. This excellent specificity, which was also shown in the other studies on high quality RDT, allows to state that there is no need to confirm a positive RDT test result by an additional PCR test.One of the strengths of our study also lies in the fact that the study population represented that of routine COVID-19 diagnostic centres, namely symptomatic outpatients with fever or cough or anosmia/ageusia or symptomatic close contacts. The study was performed at the end-user level in real-life conditions, which is in agreement with WHO recommendations for evaluating the performance of new diagnostic tests [ | PMC9955963 | |
Saliva PCR versus NP PCR | Having a detection rate of saliva PCR equivalent to that of NP PCR is in line with a previous study done on 70 patients COVID-19 positive that showed excellent concordance between the two sampling methods [The median SARS-CoV-2 VL in saliva was approximately two log lower than that in the NP swab. With such a difference, an overall lower sensitivity of saliva PCR when compared to NP PCR would have been expected. This was not the case in the present evaluation because it is essentially the peak and not the extremes of the VL distribution curve that is shifted towards a lower value for saliva.In terms of procedures, patients were able to easily perform the saliva sampling on themselves after getting a precise explanation by the health professional. Some were not able though to drool saliva in the tube, but this did not affect the sensitivity, the VL being not significantly lower in this group.The FDA has granted emergency use authorization to various saliva-based assays for the SARS-CoV-2. Our pragmatic approach, using the same transport medium tube as for NP swabs, can be applied in any testing facility. The similar sensitivity and specificity achieved by sampling the saliva instead of the nasopharynx validates the sampling method and procedure, at least in this outpatient population with relatively high viral load. The results of the present study, together with that of Wyllie | PMC9955963 | ||
Clinical significance | If RDT would be used in settings with a lower SARS-CoV-2 prevalence, such as 10%, a negative test would have a negative predictive value (NPV) of 98.6%. Such an NPV is acceptable if the patients do not belong to high-risk populations (severe cases, hospitalized patients). If the prevalence would be only 1%, the NPV would be 99.9%. Considering a specificity of 100%, other NPV, whenever for RDT or PCR, can be simply calculated using the following formula: (1-P)/1-SP (P = prevalence; S = sensitivity).Regarding the positive predictive value (PPV), even taking the lowest specificity confidence interval (99.3%), it would be 93% at 10% prevalence, which is high enough. At a lower prevalence, the PPV would drop, and the solution would be to restrict testing to patients with a high enough pre-test probability rather than confirming each positive case by PCR. | PMC9955963 | ||
Limitations | The present study was conducted in a well-defined outpatient population with usual testing criteria for COVID-19 and presenting within 7 days after symptom onset for most of them. Our results might not apply in a setting where patients would have lower viral loads and/or attend after one week of symptoms, keeping in mind that these outpatients would be much less likely to transmit [ | PMC9955963 | ||
Conclusion | The good performance of the best available RDTs allows point of care management of patients at primary care level, as well as community testing aimed at stopping transmission chains. RDT results allow immediate isolation of the vast majority of contagious individuals, without confining unnecessarily those who are not. The almost perfect concordance between saliva PCR and NP PCR results, the ease of administration and the safety of the procedure could trigger change in sampling method using saliva as reference standard, at least in outpatients who have higher viral loads than inpatients. RDT complies with the ASSURED (Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users) criteria, which makes them very useful in primary care practices, and, thanks to its very low price, even more so in resource-constrained settings [ | PMC9955963 | ||
Supporting information | PMC9955963 | |||
Patient’s database. | (PDF)Click here for additional data file. | PMC9955963 | ||
Study’s protocol. | (PDF)Click here for additional data file. | PMC9955963 | ||
Strobe checklist. | (PDF)Click here for additional data file. | PMC9955963 | ||
TREND checklist. | René, Meige | MARION, MEIGE, RECRUITMENT | (PDF)Click here for additional data file.(XLSX)Click here for additional data file.We thank Yann Sancosme, Maxime Hostettler, Marion de Vallière and Maria Daniela Garrido for help in patient recruitment; Pierrette Meige, Catherine Mialet, Chantal Ngarambe, Tina Wyllie, Mani Souvannaraj, Annie Herard, Vincent Gliven, Maxime Naoux, Vania Carreira Augusto, Mélanie Crelier, Marie Jampen, Alain Lagacé and Jean-Luc Billaud of the testing centres for their work, the patients for consenting to have all samples collected and the health authorities of the canton de Vaud for their support. We thank René Brouillet, Marie-Anne Page, Zahera Naseri and all the team of the Laboratory of Molecular Diagnostics of the Institute of Microbiology. | PMC9955963 |
References | PMC9955963 | |||
Supplementary Information | SECONDARY, INSULIN RESISTANCE | In animal studies, β-nicotinamide mononucleotide (NMN) supplementation increases nicotinamide adenine dinucleotide (NAD) concentrations and improves healthspan and lifespan with great safety. However, it is unclear if these effects can be transferred to humans. This randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial included 80 middle-aged healthy adults being randomized for a 60-day clinical trial with once daily oral dosing of placebo, 300 mg, 600 mg, or 900 mg NMN. The primary objective was to evaluate blood NAD concentration with dose-dependent regimens. The secondary objectives were to assess the safety and tolerability of NMN supplementation, next to the evaluation of clinical efficacy by measuring physical performance (six-minute walking test), blood biological age (Aging.Ai 3.0 calculator), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and subjective general health assessment [36-Item Short Form Survey Instrument (SF-36)]. Statistical analysis was performed using the Per Protocol analysis with significant level set at The online version contains supplementary material available at 10.1007/s11357-022-00705-1. | PMC9735188 | |
Keywords | PMC9735188 | |||
Introduction | β-Nicotinamide mononucleotide (NMN) is a natural product which exists in small quantity in most plants, such as edamame, broccoli, and cucumber [Many preclinical studies on NMN supplementation have been reported [ | PMC9735188 | ||
Materials and methods | PMC9735188 | |||
Study design, ethical approval, and participants | ICH, high-density lipoprotein, hemoglobin/erythrocytes, coronavirus disease 2019 | BLOOD, SECONDARY, CORONAVIRUS DISEASE 2019, RECRUITMENT | This multicenter, randomized, parallel, double-blinded, placebo-controlled, dose-dependent clinical trial on NMN supplementation at daily oral doses of 300 mg, 600 mg, and 900 mg for 60 days aimed to test the effect of NMN supplementation on blood NAD concentration (primary outcome), safety, tolerability, and clinical efficacy (secondary outcomes) of NMN supplementation.This clinical trial was conducted in accordance with the ethical principles laid down by Declaration of Helsinki (Taipei 2016), the principles of ICH Guidelines for Good Clinical Practice (GCP) (1997), and New Drugs and Clinical Trial Rules, 2019. The “Royal Ethics Committee, Pune, India” reviewed and approved the clinical trial protocol and informed consent form submitted by the two principal investigators (PI) of this trial. The conduct of trial-related activities commenced after the approval from the ethics committee. The “Royal Ethics Committee, Pune, India” is an independent ethics committee formed as per the “New Drugs and the Clinical Trials Rule 2019”. The ethics committee is duly registered with Drugs Controller General of India (DCGI) via number - ECIV45/Indt/MII/2013/RR-19. This trial was registered with ClinicalTrials.gov, NCT04823260 and Clinical Trial Registry - India, CTRI/2021/03/032421. The trial was monitored by ProRelix Services LLP, a clinical research organization (CRO), Pune, India.The trial was conducted at two clinic centers: Lotus Healthcare and Aesthetics Clinic, and Sunad Ayurved (both in Pune, India), with an experienced principal investigator (PI) at each site. Recruitment was facilitated by targeted advertisement to healthy volunteers from the PIs’ own databases and referrals of other physicians at the two centers. Each volunteer was firstly given trial information and signed an informed consent form (ICF) before screening. The screening process entailed demographic data (name, sex, date of birth, age, race, height, weight) and medical history. Physical examinations including general and systemic examinations and vital signs (blood pressure, pulse rate, respiration rate, systolic and diastolic pressure, and body temperature), electrocardiogram (ECG), and X-ray of chest were performed on each volunteer. All volunteers were symptomatically assessed for coronavirus disease 2019 (COVID-19). Blood and urinary samples were taken at the two clinical centers, stored, and transported to Suburban Diagnostics (Pune, India) by following standard operation procedure (SOP) according to good clinical practice (GCP). Suburban Diagnostics (Pune, India) conducted the clinical lab tests which included hematology [hemoglobin, hematocrit, white blood count (WBC) (total and differential), red blood cell count (RBC), platelet count, prothrombin time (PT), activated partial thromboplastin time (aPTT), mean corpuscular hemoglobin concentration (MCHC), and mean corpuscular volume (MCV)], clinical chemistry [blood glucose (random), serum triglyceride, low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol, serum creatinine, urea, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, sodium, blood urea nitrogen (BUN), glomerular filtration rate (GFR), uric acid, chloride, calcium, potassium, albumin, total proteins], and urinalysis (pH, specific gravity, protein, glucose, ketone bodies, leukocytes, nitrite, hemoglobin/erythrocytes, urobilinogen, and bilirubin). For female volunteers, urine pregnancy test was assessed.Inclusion criteria for participants were 40-65 years and healthy volunteers of both males and females, body mass index (BMI) between 18.5 and 35 kg/m | PMC9735188 |
Investigational product | The investigational product was food-grade NMN bulky powder with the brand name “AbinoNutra™NMN,” which was developed and manufactured by Aba Chemicals Co., Ltd. (Shanghai, China) in collaboration with Abinopharm, Inc. (Connecticut, USA) on manufacturing process development, quality control, and regulatory compliance. The two companies co-sponsored this human clinical trial. The NMN bulky powder was packed into capsules containing 150 mg NMN/capsule by Polifarma (Nanjing, China). Placebo was also produced by Polifarma as capsules of the same make, size, shape, and opaque white color filled with 150 mg/capsule rice flour. Both NMN and placebo capsules were shipped to the site of ProRelix Services, the CRO (Pune, India). The CRO did the blinding by packing the NMN or placebo capsules into opaque bottles that all labeled the same as “NMN or placebo”. Each bottle was then placed into a coded kit. A statistician at the CRO company did the randomization to evenly divide the 80 participants into 4 groups for placebo, 300 mg, 600 mg, and 900 mg NMN with 20 participants per group. The randomization code was generated and digitally locked in CRO’s database by the statistician. The statistician was the only person who was able to access and decode the randomization list.Trial staff at the two clinical centers allocated these coded kits to participants and instructed participants to take two capsules [300 mg NMN (Trial flow for evaluating efficacy and safety of β-nicotinamide mononucleotide (AbinoNutra™NMN). Each recruited participant was instructed to take the assigned amount of either placebo or NMN orally once a day before breakfast with water of ambient temperature for 60 days. PO = orally, QD = once daily dosing. *Due to 1 participant each from placebo and 900 mg groups did not fast, Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) was based on 19 participants for these two groups | PMC9735188 | ||
Procedures and outcome measurements | CRF | ADVERSE EVENTS, CRF | Participants were required to visit one of the two clinic centers four times. The first visit was for screening of eligibility; second visit (day 0) for baseline assessment and randomization; third visit (day 30) for mid-point efficacy, safety, and dosing compliance assessment; and fourth visit (day 60) for end-of-trial efficacy, safety, and dosing compliance assessment.At the 2nd visit (day 0, baseline), participants were allocated with the coded kits containing bottles of the investigational product for the entire trial and were advised to take the capsules orally with water of ambient temperature once daily before breakfast. They were instructed to maintain the record of dosing details in the participant diaries. To confirm participant’s dosing compliance with the protocol, the trial staff at the two centers checked the number of capsules dispensed and returned at 3rd visit (day 30) and 4th visit (day 60) to record the number of capsules consumed in Case Report Form (CRF), and reviewed participant dairies. Treatment compliance was considered adequate if participants had used on average at least 75% and no more than 125% of scheduled doses.Participants could be removed from the trial at any time for any of the following reasons: participant’s withdrawal of informed consent and withdrawal by his/her own free will to not continue in the trial, participant’s non-compliance with dosing schedule (75-125% non-compliance), the development of adverse events requiring the withdrawal of the trial, and pregnancy confirmed anytime during the trial. Reasons why subjects were discontinued from the clinical trial were documented in the CRF. | PMC9735188 |
Blood NAD concentration | Colorimetric NAD test kit from MyBioSource, Inc. (catalog# MBS841786; California, USA) was used for the measurement of NAD concentration in participants’ blood samples. The test measures the total blood concentration of NAD | PMC9735188 | ||
Safety and tolerability | ADVERSE EVENTS, ADVERSE EVENT | Safety evaluation of NMN supplementation was to assess if NMN would cause significant changes to clinical lab parameters from blood and urinary samples and to adverse events (AE) when compared to placebo and baseline. Clinical lab tests of blood and urinary samples were conducted at baseline and day 60. The lab clinical tests at 1st visit for screening served as baseline. Physical examination of general and systematic exam and vital signs was conducted, documented, and analyzed for safety concern at each visit. Adverse events (AE) were also monitored, recorded, and analyzed for NMN supplementation-related safety issues throughout the course of trial. Tolerability study was conducted through the comparison analysis of treatment vs. placebo on the number of dropout due to AEs. | PMC9735188 | |
Six-minute walking test | THORACIC | The 6-minute walking test was conducted by adapting the protocol issued by the American Thoracic Society [ | PMC9735188 | |
Blood biological age | The Aging.Ai 3.0 calculator (Insilico Medicine, Inc., Hong Kong and New York) [ | PMC9735188 | ||
Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) test | The HOMA-IR was assessed by taking blood samples from participants when fasting at days 0 and 60. Fasting insulin and glucose levels was then measured by Suburban Diagnostics (Pune, India). HOMA-IR index was calculated by an online HOMA2 IR calculator at | PMC9735188 | ||
36-Item Short Form Survey (SF-36 Questionnaire) | Assess participants’ overall health status or quality of life [ | PMC9735188 | ||
Statistical analysis | The statistical analysis was performed using the R software (version 4.1.2). Statistical significance was set at | PMC9735188 | ||
Results | PMC9735188 | |||
Blood NAD concentration | The NAD concentrations are given in Table Efficacy of the placebo and three NMN treated groups, comparisons of treatment over baseline within the same group
Efficacy of the placebo and three NMN-treated groups, comparisons of the three treated groups vs. placebo, 600 mg vs. 300 mg, and 900 mg vs. 600 mg on the changes of efficacy (Δmean ± SEM) from baseline to day 30 and/or day 60. Compared to the 300 mg NMN group, the 600 mg NMN group had statistically significantly higher NAD concentrations at both 30-day and 60-day ( | PMC9735188 | ||
Six-minute walking test | The walking distance of the six-minute walking test is given in Table Participants in the 600 mg NMN-treated group had a statistically longer walking distance compared to the 300 mg NMN-treated group at days 30 and 60 (both | PMC9735188 | ||
Blood biological age | Results of the blood biological age are given in Table | PMC9735188 | ||
HOMA-IR index | HOMA-IR results are summarized in Table | PMC9735188 | ||
SF-36 Questionnaire scores | SF-36 scores are summarized in Table | PMC9735188 | ||
Discussion | prediabetic, skeletal muscle | ADVERSE EVENTS, SECONDARY, OBESE, INSULIN SENSITIVITY | This randomized, double-blinded, placebo-controlled trial investigated the efficacy and safety of NMN supplementation with 300 mg, 600 mg, and 900 mg daily oral doses in healthy adults of 40-65 years old. The primary objective was to evaluate blood NAD concentration. The secondary objectives were to assess the safety and tolerability of NMN supplementation, next to the evaluation of clinical efficacy by measuring six-minute walking test, blood biological age (Aging.Ai 3.0 calculator), HOMA-IR, and SF-36 scores.In mice, oral NMN can be quickly absorbed through the intestine, efficiently transported into blood circulation, and immediately converted into NAD at various tissues, such as blood, liver, and skeletal muscle [This trial showed that NMN supplementation is safe and well tolerated at up to 900 mg oral daily doses. There were no NMN treatment-related adverse events and dropouts. Lab parameters and physical examination did not show significant abnormal changes during the 60-day NMN treatments of all three doses. Our safety and tolerability observations are consistent with results of other published human clinical trials [It was reported that NMN supplementation in aged mice increased NAD concentrations and improved physical activity [Biological age has been gaining attention including epigenetic clock and blood biological age [One previous human clinical trial reported that NMN supplementation can increase the skeletal muscle insulin sensitivity of prediabetic and obese female adults [Previous human clinical trials reported that NMN supplementation had no effect on sleep quality [This trial was completed without dropout and by strictly following our trial protocol and GCP guidelines. We achieved positive results on many of our trial end points on efficacy and safety of NMN supplementation. However, an even higher number of participants and longer trial duration might have given even more insightful results of trial end points. Furthermore, additional biological age clocks and longer trial duration are needed to confirm our results. It will also be very interesting to conduct a larger study to assess the impact of gender on many of our trial end points since males and females could respond differently to NMN supplementation. Finally, our trial measured the total “NADIn conclusion, blood NAD concentration was significantly and dose-dependently increased during the NMN treatment. Oral administration of NMN up to 900 mg/day for 60 days was safe and well tolerated. NMN supplementation had a positive impact on the physical endurance and general health conditions of healthy adults as demonstrated in the significant improvement of six-minute walking test, blood biological age, and SF-36 scores. The 900 mg/day oral dose did not give significantly better efficacy than 600 mg/day dose. | PMC9735188 |
Acknowledgements | RS | We would like to thank the teams of Suburban Diagnostics, Pune, India for testing all the clinic laboratory samples. We sincerely appreciate Professor Abel Zhou at University of Canberra for his insightful observations of our clinical data. Finally, we are thankful that Dr. Susan Cho from AceOne RS, Inc. in the USA helped prepare Table | PMC9735188 | |
Author contribution | ABM | LY contributed to the trial design and wrote this report. ABM contributed to the data analysis and co-wrote this report. AV contributed to the trial operation overview and clinical study report (CSR). SP contributed to the clinical trial operations, data review, and analysis. ST contributed to the trial design, quality assurance of clinical trial process, and data interpretation. NA oversighted the whole clinic trial process. GA and VK were the principal investigators, conducted the clinical trial, and reviewed the manuscript. RST developed the proprietary manufacturing process for β-nicotinamide nucleotide (NMN) that made it possible to provide NMN as the investigational product of this trial. ZGL was responsible for the development of analytical methods for the quality control of NMN and the production of NMN under cGMP that made it possible to provide NMN as the investigational product for this trial. | PMC9735188 | |
Funding | The clinical trial is fully funded by Aba Chemicals Co. (Shanghai, China) and Abinopharm, Inc. (Connecticut, USA). | PMC9735188 | ||
Data availability | All data will be available on reasonable request to the corresponding author. A proposal will be needed for assessment of request. | PMC9735188 | ||
Declarations | PMC9735188 | |||
Conflict of interest | LY is an employee of Abinopharm, Inc., RT and ZL are employees of Aba Chemicals, Co., and AM, AV, SP, ST, NA, GA, and VK declare no conflict of interest. | PMC9735188 | ||
References
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Subject terms | COVID-19 (CORONAVIRUS DISEASE 2019), DISEASES | The purpose of this study was to determine the discount rates for money and health outcomes in the Thai context, including the discount rates for communicable and non-communicable diseases. Moreover, this study aimed to explore the socio-demographic characteristics that influence discounting. The computer-based experimental design was used to obtain time preferences for money and health in a total of 1202 Chiang Mai province population, aged 25–50, individually interviewed by trained interviewers. Money-related questions were carried out in all subjects. For health-related questions, all subjects were randomly assigned in a 1:1 ratio for response to questions about Coronavirus Disease 2019 (COVID-19) (N = 602) and air pollution (N = 600). A choice-based elicitation procedure was performed in the experiment to obtain the indifference values from subjects’ time preferences. The cumulative weighting functions were generated using the indifference values to indicate the degree of discounting. The discount factors were computed from the cumulative weighting functions. The discount rates were estimated using a continuous approximation based on the relationship between the discount factors and the parameters governing the discounting model. The Tobit model was applied to investigate the relationships between discounting and socio-demographic characteristics. Discounting for money was greater than discounting for health. Money and health had annual discount rates of 6.2% and 1.3%, respectively. Furthermore, in the COVID -19 situation, the annual discount rate for health was higher than that in the air pollution situation (2.4% vs. 0.7%). Generation X subjects (aged 42 years and above), children under the age of 15 in the household, and underlying diseases were positively related to discounting, while household income was negatively related to discounting. Health should be discounted at a lower rate than money. Moreover, different discount rates should be considered for different types of diseases. | PMC9969024 | |
Introduction | DISEASES | Discounting is a method of adjusting the future costs and benefits of healthcare interventions such as devices, medicines, vaccines, procedures, and healthcare systems to their present value. The impact of discounting, according to the context of economic evaluation, is dependent on the timing of costs and benefits, implying that society values future costs and benefits less than current costs and benefits. As a result, discounting costs and health outcomes should be taken into accountSeveral controversies in terms of theoretical rationale exist regarding whether costs and health benefits should be discounted at the same rateDelay discounting is another issue that plays an important role in different outcomes. Based on the review study conducted by Odum et al.Most of the recommendations for discounting costs and health outcomes are taken into action by government agencies or regulatory bodies. For example, the National Institute of Clinical Excellence (NICE), an organization in the United Kingdom (UK) that provides national guidance and advice to improve public health policy and social care, recommends discounting the costs and benefits of healthcare interventions at the same rate (3.5% per year)Previous studies on discounting in economic evaluation revealed that the choice experiment was commonly conducted to estimate the discount rate of monetary and/or health outcomes. The discount rate for monetary and health outcomes was found in the range of 2–28.5% and 3–29.4%, respectivelyIn Thailand, the annual discount rates for cost and outcome at the same rate of 3% are still recommended for the economic evaluation of healthcare interventions in accordance with the Thai HTA guidelinesTherefore, the purpose of this study was to determine the discount rates for costs and health outcomes in the Thai context, including discount rates for health derived from communicable and non-communicable diseases. Moreover, this study aimed to explore the socio-demographic characteristics that influence discounting. | PMC9969024 | |
Methods | A computer-based experimental design was used, along with a choice-based elicitation procedure, to obtain time preferences for money and health. The experiment based on money-related questions was carried out in all subjects. For health-related questions, the subjects were divided into two subgroups, one to answer questions about COVID-19 and the other about air pollution caused by fine particulate matter. The data were collected from a large representative sample of the Chiang Mai Province population aged 25–50 years. | PMC9969024 | ||
Experimental design | DISEASE, CORONAVIRUS DISEASE 2019 | An experimental design method from a previous study by Attema et al.For each iteration, a choice-based elicitation procedure was performed to obtain the subjects’ time preferences. After subjects had chosen their preferred option, the next iteration was altered to make the chosen option less attractive and the non-chosen option more attractive. The indifference values were determined after the experiment was completed. Detailed information on eliciting indifference values is provided in the data analysis section.In terms of health, the subjects were required to imagine that they had suffered from either COVID-19 or an air pollution situation. The interviewer informed the subjects that new health technology such as a vaccine or screening program was available and effective for disease treatment, resulting in the subjects’ full health state. The subjects were then asked to choose the most preferable period based on changes in their health condition (Fig. Example of questions about health and money. COVID-19, Coronavirus disease 2019. | PMC9969024 | |
Population | cognitive impairment, a disability, acute illness | The sample size was calculated using a formula by Vaughan et al.The following subjects were eligible for this study: (1) Chiang Mai Province residents aged 25–50 years (as of September 30th, 2020) with Thai nationality according to the civil registration; (2) the participants must have lived in their own residence for at least 1 year before the data collection date; (3) be able to read and write Thai; and (4) be able to provide informed consent. The subjects who presented with a disability, acute illness, or cognitive impairment, or who had been unemployed for more than 1 year before taking the questionnaire were excluded.A stratified multistage random sampling technique was performed to recruit the subjects in Chiang Mai Province, Thailand. To begin, all districts in Chiang Mai Province were classified into 5 groups based on their geographic locations and the Chiang Mai Province’s patient referral system. Next, a quota sampling technique was used to select the districts based on the population ratios among groups. All districts in groups 1 and 2 were selected. For groups 3–5, two districts per group were randomly selected. As a result, 16 out of 25 districts in Chiang Mai Province were selected. For each selected district, 2–4 subdistricts were purposely selected. The accidental sampling method was used to select subjects from the general Thai population who met the eligibility criteria. Required and actual samples for each selected district are presented in Table | PMC9969024 | |
Procedure | A total of 1202 subjects were asked to complete the money-related questionnaire. For health-related questions, all subjects were randomly assigned in a 1:1 ratio. A total of 602 subjects were assigned to the first group and were asked to complete a questionnaire about the COVID-19 situation. For the second group, 600 people completed a questionnaire about scenarios of air pollution with fine particulate matter. | PMC9969024 | ||
Study instrument | The questionnaires were developed based on the literature review and were revised in response to recommendations from the expert meeting. There were two versions of the questionnaire. The first version was associated with COVID-19 scenarios, whereas the second version was involved with air pollution caused by fine particulate matter, or PM2.5. Each version included the following 3 major parts: (1) socio-demographic data; (2) health status; and (3) time preferences for money and health. The questionnaires were tested for content validity based on the expert meeting’s recommendations. Following the development of all questionnaires, a face validity test was conducted.The experiment was run on a web-based computer and was developed based on a questionnaire involving time preferences for money and health (part 3 in each of the questionnaires). The web-based experiment was also tested for validity and reliability. | PMC9969024 | ||
Outcomes | SECONDARY | The primary outcome of this study was the discount rates for money and health determined from the subjects' indifference values and the secondary outcome was the socio-demographic characteristics that influence discounting. | PMC9969024 | |
Data collection | The officers in local organizations such as the District Office, District Public Health Office, Sub-district Municipality, and Health Promoting Hospital were contacted to coordinate and recruit the volunteers or subjects in the selected districts. The general Thai population that met the eligibility criteria of this study was included in the study. The questionnaire survey sessions were conducted in local government meeting rooms near the study subjects’ homes. Depending on the number of subjects, there were 12–15 respondents per session and 4–6 sessions per day. After respondents registered, they were assigned a well-trained interviewer to help them with the interview. All interviewers were trained to standardize the data collection process, including the study protocol, informed consent, and experimental design, and they also underwent a practice with a pilot sample.Face-to-face, computer-assisted, one-on-one interviews were performed to collect data. The questionnaires consist of 3 parts: (1) demographic data, (2) health data, and (3) time preference experiment. The lead instructor explained each step of this survey, but the standardized details were presented to the respondents via the instructional video clips. Subjects privately completed the demographic data and answered the health questions with the help of the interviewer. In the web-based experiment, subjects decided and indicated their preferred option in Fig. | PMC9969024 | ||
Data analyses | The statistical analyses were divided into 4 steps. First, a choice-based elicitation procedure was performed to measure the individual’s indifference values of time preference for money and health outcomes. Second, the indifference values from each subject were summarized using descriptive statistics. Third, the cumulative weighting functions were generated using the indifference values from each time point and the discount rates were measured using a continuous approximation. Finally, the socio-demographic variables influencing the discount rate were explored. The detailed information was provided as follows. | PMC9969024 | ||
Step 1: measurement of individual indifference values | A choice-based elicitation procedure was performed to obtain the subjects’ time preferences for money and health. The health and money profiles covered the next 20-year time interval. The time interval was divided into 7 time points: tThe elicitation procedure began at time point tNext, the elicitation of the remaining 4 time points was examined. The order of elicitation at time points tBecause the remaining intervals were narrowed to allow eliciting new values, some subjects did not complete all questions. The subjects who always selected all first-period options or all later-period options were categorized as extremely impatient or extremely patient, respectively. Those subjects who preferred the first-period option (tThe subjects with extreme preferences were excluded from the measurements of cumulative weighting functions and discount rates. However, all subjects were included in the analysis of the relationships between discounting and socio-demographic characteristics using the Tobit model. | PMC9969024 | ||
Step 2: summary of the indifference values | The descriptive statistics were used to summarize the indifference values from the choice-based elicitation and were displayed as mean, standard deviation (SD), median, and interquartile range (IQR). | PMC9969024 | ||
Step 3: measurement of cumulative weights | The cumulative weighting functions were generated using the mean and median of the indifference values from each time point. The degree of discounting was indicated by the area under the cumulative weighting function. The greater the size of this area, the more the subjects discount the future. | PMC9969024 | ||
Step 4: measurement of discount factors and discount rates | The discount factors were computed from the cumulative weighting functions in the discounting modelCumulative weighting functions and discount factor equations.Remark: δ, κ, ∝ , r, and p represent parameters governing discounting model.To determine which discount model best described subjects' preferences, this study used these 5 discounting models to fit the cumulative weighting functions. The subject’s indifference values for 5 time points were used to compute the individual parameters for 5 discounting models. The squared error for each model is calculated using the following equation.Then, the individual best-fitting model was selected based on the minimum squared error. Finally, the best-fitting discounting model was the one with the highest proportion of subjects for whom each of the discount models fit best.Discount rates, or the rates at which future consequences are devalued, were estimated using a continuous approximation based on the relationship between the discount factors and the parameter governing the discounting model. Each discounting model yielded the discount rate results. The discount rate results were chosen using the best-fit discounting model. | PMC9969024 | ||
The effect of socio-demographic variables on discounting | Because the areas under the normalized weighting functions were censored between 0 and 1, the Tobit model was applied to investigate the relationships between discounting and socio-demographic characteristics | PMC9969024 | ||
Data analysis tools | Descriptive statistics and the Tobit model were performed using the STATA software version 14.0 (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP). The continuous approximation for discount rate was analyzed using R software (R Core Team. 2013. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria). | PMC9969024 | ||
Ethical approval and consent to participate | The ethics approval was obtained from the Institutional Review Board of the Faculty of Pharmacy, Chiang Mai University (Certificate of Approval No.006/2564/E). All procedures were carried out in accordance with the applicable guidelines and regulations. The study protocol was explained to all subjects. All subjects signed informed consent forms after agreeing to participate in the study. | PMC9969024 | ||
Results | PMC9969024 | |||
Demographic characteristics | respiratory diseases | RESPIRATORY DISEASE, DISEASES | A total of 1202 subjects participated in the experiment, ranging from 25 to 50 years old, with a mean age of 37.3 ± 7.9 years. Of those, 66.6% were female, 40.9% were generation X (aged 42 years and above), and 42.4% were married. The average number of years of education was 12.9 (standard deviation; SD 0.1). The average monthly household income was 30,497 THB (SD 41,611). In the money and health scenarios, the extreme subjects were 47.9% and 62.5%, respectively. Except for underlying diseases that are risk factors for COVID-19 and/or respiratory diseases, all characteristics were similar between COVID-19 and air pollution situations. The detailed descriptions of the subjects’ characteristics are reported in Table Socio-demographic characteristics.5) Children below 15 years of agein the household(6) Elderly in the household(aged ≥ 60 years)(7) Mean years of education(standard deviation)(11) Mean household income per month(standard deviation)Remark: * Statistical analysis using independent t-test. | PMC9969024 |
Cumulative weighting functions | CORONAVIRUS DISEASE 2019 | A table with descriptive statistics was presented in the Supplement (Table Cumulative weighting functions. COVID-19, Coronavirus disease 2019; PM2.5, Air pollution with fine particulate matter.The mean areas for the COVID-19 situation and the air pollution situation in the health scenario (Fig. Figure Relation between the area measures for money and health. | PMC9969024 | |
Discounting models | CORONAVIRUS DISEASE 2019 | The analyses used 5 parametric forms to fit the cumulative weighting functions to determine which discount function best described subjects’ preferences. The medians of the individual estimates of the parameters in each of the models are shown in Table Estimated discount functions.Remarks: (1) Estimated discount functions based on non-extreme subjects.(2) [ ] depicts 1st and 3rd quantile of discount factor.According to the estimated parameters in the constant discounting model (Table Figure Cumulative distribution functions of the discount rates. Representations: COVID-19 = Coronavirus disease 2019, PM2.5 = Air pollution with fine particulate matter. | PMC9969024 | |
Effect of socio-demographic characteristics on discounting | respiratory diseases | RESPIRATORY DISEASE, CORONAVIRUS, REGRESSION, DISEASE, DISEASES | Table The effect of socio-demographic characteristics on discounting.COVID-19, Coronavirus Disease 2019.Remarks: (1) ( ) depicts the standard error.(2) Tobit model, with the left-censored value at 0 and the right-censored value at 1.(3) *,**,*** denote statistically significant at the 0.01, 0.05, and 0.1 levels, respectively.Overall (Model I), several socio-demographic characteristics including generation X subjects (aged 42 years and above), children under the age of 15 in the household, and underlying diseases that are risk factors for COVID-19 and/or respiratory diseases, are positively related to discounting, while household income is negatively related. However, other variables such as marital status, education, occupation, and smoking had no effect on the discounting rate. The pooled regression reveals that discounting for money differed from discounting for health (p 0.024), confirming that discounting was domain-specific in our study.Household income and money-related scenario first presented to subjects were negatively related to discounting in Model II (money scenario). Being generation X subjects was positively related to discounting in Models III (health scenario), IV (COVID-19 situation), and V (air pollution situation). Moreover, in Model III (health scenario) and Model IV, the COVID-19 situation, children under the age of 15 in the household, and underlying diseases that are risk factors for COVID-19 and/or respiratory diseases were positively related to discounting, while household income was negatively related to discounting in Models III and V. | PMC9969024 |
Discussion | COVID-19 infection | RESPIRATORY DISEASE, COMMUNICABLE DISEASES, COVID-19 INFECTION, REGRESSION, DISEASES | To the best of our knowledge, this study is the experimental attempt to use a direct method to obtain time preferences for money and health in a large representative sample in Thailand. As the subjects discounted money more than health, discounting in this study was domain-specific. The correlation between discounting for money and health was moderate (Kendall’s correlation coefficient 0.202). These findings are in line with previous studiesOur findings regarding the discount rates are consistent with those of a previous study conducted by Attema et al.Furthermore, from the present study, the discount rate for health in the COVID -19 situation was higher than that in the air pollution situation (2.4% vs. 0.7%). This could be because the health consequences are different between communicable diseases and noncommunicable diseases; thus, leading to differences in risk perception and discounting degree. COVID-19 is the current pandemic that would have a significant impact on the population and economy at both the individual and the societal levels. As a result, there is an urgent need to protect against COVID-19 infection rather than the long-term effects caused by air pollution including respiratory diseases.Furthermore, the pooled regression reveals that discounting for money differed from discounting for health (p 0.024), confirming that the discounting was domain-specific. A statistically significant discount was found to be positively correlated with the sample data in the money situation. This means that discounting for money is higher than discounting for health. According to Attema et al.Several limitations in this study should be taken into consideration. First, the study gathered data on time preferences for money and health in a large representative sample of the Chiang Mai Province population. This may limit the study’s generalizability to other provinces or Thailand's representatives. However, the findings of this study might be useful for future studies into determining appropriate discount rates for money and health in the context of health economic evaluation in Thailand. Second, COVID-19 and air pollution situations were used in this study to reflect the current health issues in Chiang Mai Province, particularly, the air pollution with fine particulate matter that occurs every year from January to April has been a common concern. As a result, these situations may have limited generalizability once applied to other contexts. Third, most subjects examined had extreme preferences. This might be due to the data were gathered between April and July 2021, which was the period of the COVID-19 pandemic in Thailand. There were limited vaccinations available to Thais at the time. COVID-19 had an impact on the economy at both the individual and the societal levels. Furthermore, air pollution from PM2.5 was a significant health concern in northern Thailand, particularly in Chiang Mai province. Therefore, there was an urgent need of the given benefits from both money and health scenarios. However, we established the study protocol and trained all interviewers to standardize the data collection process and avoid errors. Each step of the experimental design was explained by the interviewer. The respondents were shown the standardized information via instructional video clips. Before the experiment began, the subjects had the opportunity to request additional information or clarification. | PMC9969024 |
Conclusion | DISEASES | This study’s findings revealed that discounting for money was greater than discounting for health. Money and health had annual discount rates of 6.2% and 1.3%, respectively. Furthermore, in the COVID -19 situation, the annual discount rate for health was higher than that in the air pollution situation (2.4% vs. 0.7%). Health should be discounted at a lower rate than money. In addition, different discount rates should be considered for different types of diseases. | PMC9969024 | |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-30559-2. | PMC9969024 | ||
Author contributions | P.B., U.P., and J.Y. initiated the study design and methodology. All authors participated in material preparation, subject enrollment, and data acquisition. J.Y. and P.B. performed the data analyses. J.Y. and U.P. drafted the manuscript. All authors contributed to the interpretation and validation of the results, revised the manuscript, and approved the final version for submission. | PMC9969024 | ||
Funding | This study was supported by the National Research Council of Thailand (NRCT) under the Integrated Strategic Research Program on Social Sciences: Khonthai 4.0 (Grant No. 2563/5-04) and the Royal Golden Jubilee Ph.D. (RGJ-Ph.D.) Program (Grant No. PHD/0112/2561). The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. | PMC9969024 | ||
Data availability | All data generated or analyzed during this study are included in this published article and its supplementary information file. Additional raw data files can be available from the corresponding author upon reasonable request. | PMC9969024 | ||
Competing interests | The authors declare no competing interests. | PMC9969024 | ||
References | PMC9969024 | |||
Introduction | fractures, pelvic fractures, trauma | The incidence of low-energy pelvic ring fractures has sharply increased over the past decade and is projected to continue doing soDespite the increasing incidence of fragility fractures of the pelvis, adequate and evidence based treatment strategies are still missing. For high-energy trauma resulting in unstable and dislocated pelvic fractures, surgical stabilization is known to reduce mortality | PMC10522702 | |
Materials and methods | trauma, fracture, fractures, fractureS | METASTATIC TUMORS, PATHOLOGIC FRACTURES, OSTEOPOROSIS | This randomized prospective nonblinded study (PRESS—Prospective Randomized Evaluation of Sacral fractureS), was conducted from October 2017 to April 2020 with a parallel design at the University Medical Center Hamburg-Eppendorf. The mid-term outcomes of two different treatment options in elderly patients with sacral fractures were evaluated. Patients older than 60 years with a type B2.1 or FFP II posterior pelvic ring fracture and a fracture age of less than 3 weeks were eligible for inclusion. Patients under 60 years of age also met the inclusion criteria if they had a previously confirmed history of osteoporosis.Exclusion criteria were metastatic tumors in the pelvis, pathologic fractures, or a high-energy trauma mechanism. The diagnosis was confirmed using CT imaging. Appropriate informed consent was obtained from the patient’s or their legal guardians. The participants were randomized using a previously prepared randomization list with a random sequence of zeros and ones representing the two treatment arms of the study by a staff member at our hospital who was not involved in the study. Treatment group I received surgical treatment during the first three days after admission (ST group), while treatment group II received a comprehensive conservative treatment regime (CCT group). Data collection was planned at admission (t | PMC10522702 |
Treatment | dislocation, pain | SECONDARY | In the ST group, percutaneous minimally invasive navigated S1 sacroiliac screw osteosynthesis (Showing an X-ray postoperatively after percutaneous S1 Screw fixation and application of anterior supraacetabular external fixator.In the CCT group radiological follow-up imaging was performed after 3–5 days to exclude significant secondary dislocation. If mobilization was impossible or if severe pain (VAS > 5) still occurred during mobilization after 3 days, CCT participants changed study arms and were scheduled for surgery. These specific patients were assigned to the ST group in the statistical evaluation. | PMC10522702 |
Outcome measures | Data were collected at admission by Barthel questionnaires | PMC10522702 | ||
Statistical analysis | SPSS statistical program 25.0 (SPSS, Chicago, IL) and GraphPad Prism 9 (GraphPad Software, La Jolla, CA) were used for statistical analyses. Continuous variables are expressed as mean ± standard deviations (SD), while categorial variables are expressed as numbers and percentages. Normality distribution of the data was analyzed using the Shapiro–Wilk test.For normally distributed data, a Bonferroni-adjusted Student’s t-test assessed possible differences between the ST and CCT groups at each of the measurements and the Mann–Whitney-U-Test for non-normal distributed data. Longitudinal analyses were performed as per protocol (PP) and intention-to-treat (ITT) analyses using the conservative last observation carried forward (LOCF) method in case of missing data for non-deceased patients. Survival rate was estimated by the Kaplan–Meier method with univariate Log-Rank test used to compare the ST group with the CCT group. In accordance with accepted standards, statistical significance was set to a 2-tailed p-value of 0.05. | PMC10522702 | ||
Sample size calculation | The sample size was calculated for the primary outcome, mortality at 24 months follow-up, with the scope of non-inferiority of the non-surgical. This calculation was performed considering the expected effect size, power, and design effect (log rank test). Based on a crossover rate of 11% reported by Höch et al. | PMC10522702 | ||
Ethical approval | This study conforms to the Declaration of Helsinki, was approved by the local research ethics committee called “Ärztekammer Hamburg” (reference number: PV5550) and was retrospectively registered with the German Clinical Trials Registry (DRKS00013703) on 10/12/2018. | PMC10522702 | ||
Consent to participate | mentally impaired, dementia | For this vulnerable group, written informed consent was obtained from all participants or their legal representatives. If no legal guardian was available but the patient was mentally impaired (dementia), a legal guardian was appointed by the Hamburg authority in an expedited procedure after a personal assessment by a local judge within a few days. | PMC10522702 | |
Award | Trauma | This trial received the award as best evidence-based Study provided by the German Society for Orthopedic and Trauma Surgery (DGOU) in 2021. | PMC10522702 | |
Complications and survival rate | infection | INFECTION, COMPLICATION | The median follow-up time was 12.9 months. Ten patients (25.6%) were lost to follow-up at 12 months. Three patients in the ST group and in the one patient in the CCT group died. Patients treated surgically showed a 17.6% complication rate (n = 3). One patient was diagnosed with a pin infection and loosening of the external fixator needing removal of the fixator. In another patient, asymptomatic loosening of the SI screw was noted, without the need for revision. A third patient had an infection of the surgical site due to inadequate wound care at the nursing home. There was no screw or pin misplacement noted in the cohort. The overall patient survival probability rates were 92.3% at 6 weeks and 89.5% at 6 and 12 months. The CCT group survival rates were 100% at 6 weeks and 95.0% at 6 and 12 months. Patients who were treated surgically showed a survival rate of 82.4% at 6 weeks as well as at 6 and 12 months. Nevertheless, no significant difference between the ST and CCT group survival rates was observed (Log Rank Chi1-year Kaplan–Meier-curve patient survival compared between patients with surgical and non-surgical treatment. | PMC10522702 |
Intention-to-treat and per protocol outcome analyses | When comparing the preoperative to the follow-up measurements in all patients in the ITT multivariate analysis, there was a significant decrease in VAS-pain (Short- and mid-term improvements of primary outcome measures. | PMC10522702 | ||
Discussion | death, pelvic fractures, pain, Tile B1, fractures, trauma | RECRUITMENT, APC, MEDICAL COMPLICATION | The aim of this study was to compare clinical outcomes as well as the one-year mortality of comprehensive conservative versus surgical treatment of low-energy posterior pelvic ring fractures that are typically found in older populations. We found no significant difference between the surgically and conservatively treated groups in need of care (Barthel Index), level of pain (VAS), quality of life (EQ5D), gait performance (Tinetti) and in terms of mortality.Our data showed that non- to minimally displaced fractures of the posterior pelvic ring have a major impact on the patient’s well-being, which is reflected in all measured scores. However, pain improvement occurred quickly, usually within the first 6 weeks. It was achieved slightly faster in the surgical group and remained generally low after one year. The restoration of mechanical stability of the posterior pelvic ring using surgical stabilization is a well-established treatment for unstable pelvic fractures caused by high-velocity traumaRommens et al.Successful surgical fixation via a transiliosacral bar, sacroiliac screw, or a triangular osteosynthesis of the posterior pelvic ring has already been described and validated in this particular cohort by the literature in recent yearsThe utilization of external fixation for stabilizing the anterior pelvic ring has become an established practice in the management of high-velocity trauma, particularly in cases involving open book fractures (Tile B1 or APC I) in young adults, as part of damage control surgeryOur primary objective was to pursue a minimally invasive approach, but it is essential to acknowledge that alternative techniques for stabilizing the anterior pelvic ring exist. These include open reduction and internal fixation using contoured plates or minimally invasive retrograde transpubic screw fixation that show adequate pain reliefThe Barthel index was lower in the surgical patients in the first 6 weeks, which may be explained by the external fixator interfering with upright sitting and the daily pin care. However, the patient quality of life with an external fixation device was not found to be worse when compared to the conservative group.The primary endpoint of our study was patient mortality during the 12-month follow-up period. An overall mortality of 4 out of 39 patients (10%) was measured, with three patients dying in the ST group, and one in the CCT group. It is known that immobilization, even for only 24 to 48 h, is one of the main risk factors for death in frail patients due to medical complications after a proximal femur fractureThere are retrospective studies from the early 2000s without adequate diagnostics that investigated unilateral pubic ramus fractures in patients immobilized and hospitalized due to painThere are several limitations to our study. First, the number of patients included is not as high as was deemed necessary in our a priori analysis (n = 130), mainly due to the study participants not willing or able to be randomized and the COVID-19 pandemic, which forced us to discontinue recruitment and follow-up. This must be considered when interpreting the results of this randomized controlled trial, as its design is underpowered. However, this study represents the first attempt to prospectively investigate FFP II fractures. As usual when studying frail patient groups recruitment is difficult. Therefore, the information provided in this paper may likely add scientific information to the field of pelvic surgery, although it is underpowered. Secondly, we had a 25% loss of follow-up, which is not unusual in geriatric cohorts. Nevertheless, the achieved follow-up rate is still representative, especially in this older population. Thirdly, we conducted a non-blinded follow-up and evaluation because the nature of the surgery did not allow for blinded follow-up. Understandably, sham surgeries would have been unethical in a cohort of elderly with a number of pre-existing conditions. There are also some noteworthy strengths of our study. Most prominently, this is the first study to examine this emerging injury in a prospective manner without the surgical selection bias often seen in previous publications. | PMC10522702 |
Conclusion | fracture, fractures | The result of this randomized controlled pilot trial indicates that surgical treatment of FFP II fractures in geriatric patients may not be superior to conservative treatment. Non-displaced posterior pelvic ring fractures (FFP II) in an older population may be treated with comprehensive conservative therapy (analgesia and physical therapy with full weight bearing). It is crucial to note that if early mobilization is not possible, a switch to operative treatment should occur promptly, rather than attempting conservative management for an extended period. Vigilant follow-up is essential to prevent prolonged immobilization and detect any fracture progression.The methodology used in this pilot trial may be valuable for designing larger, multi-center trials to confirm these findings and improve clinical decision-making for FFP II fractures in the elderly. | PMC10522702 | |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-43249-w. | PMC10522702 | ||
Author contributions | D.M.T.: study conception and design, data collection, drafting manuscript, G.A.: data collection, drafting manuscript, A.S.: statistical analysis, T.R.: data interpretation, review manuscript, K.H.F.: review manuscript, L.K.: Data collection, statistical analysis, C.A.: data collection, drafting manuscript, T.B.: study conception, data collection, interpreting data, D.D.: data collection, draft manuscript, review manuscript, and M.J.H.: study conception and design, interpreting data and drafting manuscript. The authors affirm that human research participants provided informed consent for publication of the images in Fig. | PMC10522702 | ||
Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC10522702 | ||
Data availability | The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request. | PMC10522702 | ||
Competing interests | The authors declare no competing interests. | PMC10522702 | ||
References | PMC10522702 | |||
Background | The Delphi technique has steeply grown in popularity in health research as a structured approach to group communication process. Rating and ranking are two different procedures commonly used to quantify participants’ opinions in Delphi surveys. We explored the influence of using a rating or ranking approach on item prioritization (main outcome), questionnaire completion time, and evaluation of task difficulty in a Delphi survey aimed at identifying priorities for the organization of primary cardiovascular care. | PMC10436639 | ||
Methods | A randomized controlled parallel group trial was embedded in a three-round online Delphi survey. After an “open” first round, primary care patients, trained patient partners, and primary care clinicians from seven primary care practices were allocated 1:1 to a rating or ranking assessment group for the remainder of the study by stratified permuted block randomization, with strata based on participants’ gender and status. Agreement on item prioritization between the experimental groups was measured by calculating Krippendorff’s alpha reliability coefficient on the aggregate rank order of items in each group after the final round. Self-reported ease or difficulty with the assessment task was measured with the Single Ease Question. | PMC10436639 | ||
Results | Thirty-six panelists (13 clinic patients, 7 patient partners, 16 clinicians; 60% females) were randomized to the rating ( | PMC10436639 | ||
Conclusions | A rating or ranking procedure led to modestly similar item prioritization in a Delphi survey, but ranking was more difficult. This study should be replicated with a larger number of participants and with variations in the ranking and rating procedures. | PMC10436639 | ||
Trial registration | Not applicable. | PMC10436639 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07442-6. | PMC10436639 | ||
Keywords | PMC10436639 |
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