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Statistics | For the platinum sensitive study, we used the AGO registration study as a historical control with an ORR of 47% and the trial sample size was designed to detect an improvement in ORR from 40% to 60%. | PMC10020803 | ||
Results | PMC10020803 | |||
Accrual and Treatment | DISEASE | The sensitive study enrolled all 41 patients between December 9, 2009 and February 12, 2012. The resistant study enrolled 46 of the planned 48 patients between December 11, 2009 and December 16, 2012, and 1 patient though enrolled, did not receive any study medication. Sixteen patients (39%) with sensitive disease continued iniparib as maintenance therapy. This number was only 8 (18%) for resistant patients. Demographics are shown in Demographics.
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Efficacy | BEST | Best overall response is shown in Response data.Inevaluable patients: *5 for withdrawal of consent and 1 with SAE.Objective response in platinum sensitive GCI patients.Objective response in platinum resistant GCI patients.PFS in platinum sensitive GCI patients.PFS in platinum resistant GCI patients.In the platinum resistant population the ORR was 26.2% (95% CI, 13.9-42.0). Among the 14 patients for whom | PMC10020803 | |
Toxicity | neutropenia, intestinal obstruction, fatigue, toxicity, anemia, dehydration, vomiting, small, nausea,, Toxicity, deaths, TEAE, hypokalemia | PULMONARY EMBOLISM, NEUTROPENIA, THROMBOCYTOPENIA, ANEMIA, DEHYDRATION, ADVERSE EVENT, URINARY TRACT INFECTION | Safety profiles consistent with those observed in prior clinical studies with GC. There were no deaths on study or within 60 days of the last dose of study drug. In the sensitive study 12 patients (29%) experienced a serious treatment fmergent adverse event (SAEs), and the most common were neutropenia and thrombocytopenia, 5 (12%) SAEs were considered related to study drug (thrombocytopenia (2 pts), neutropenia, urinary tract infection, and pulmonary embolism). In the resistant study 22 patients (49%) experienced a SAE and in 9 patients (26%) the SAEs were considered related to study drug (thrombocytopenia (2 pts), anemia, nausea, vomiting, small intestinal obstruction, fatigue, dehydration, and hypokalemia), and in 4 (9%) this lead to discontinuation of treatment. Toxicity is shown in Toxicity.Toxicity, TEAE (treatment emergent adverse event) occurring in 15%.Dose reductions or delays due to an AE were common and almost all due to hematologic toxicity (89% for platinum sensitive and 91% for platinum resistant). Dose reductions and delays 81% and 32%, respectively, for platinum sensitive; 85% and 27% for platinum resistant patients. The majority of patients in the platinum sensitive group received >6 cycles: 22 (54%) of the patients received 7-12 cycles, two (5%) 10-18 cycles, and one >18 cycles of therapy. Thirty of the platinum sensitive patients (73%) received G-CSF whereas this was only required in 27% of the platinum resistant patients. | PMC10020803 |
Discussion | toxicities, thrombocytopenia, BRCA mutated tumors, neutropenia | NEUTROPENIA, RECURRENT OVARIAN CANCER, THROMBOCYTOPENIA, RECURRENT DISEASE, ONCOLOGY, CYTOTOXICITY | These phase II clinical trials investigated a promising novel agent, thought to be a PARP inhibitor with potential synergy with gemcitabine and carboplatin in 2 cohorts of patients with recurrent ovarian cancer. Subsequent studies have clarified the lack of even additive benefit, and the mechanism of in vitro cytotoxicity observed with iniparib remains obscure.Sanofi purchased iniparib from BiPar Sciences Inc. in 2009, 2 years before we presented these data at the American Society of Clinical Oncology (ASCO) annual meeting, at a cost of up to $500 million if iniparib met its development targets.Gemcitabine and carboplatin remains a standard combination with proven efficacy in platinum sensitive recurrent disease,It is noteworthy that almost one quarter of the platinum resistant group carried a gIn summary, GCI produced a confirmed ORR of 66% in the platinum sensitive patient population and 26% in the platinum resistant population. The GCI combination was generally well tolerated despite high incidence of thrombocytopenia and neutropenia, with no new toxicities, and safety profiles consistent with those observed in prior clinical studies with GC. Higher than expected response rates should be anticipated when there are selective pressures, such as the promise of benefit from a new investigational agent, heralded as a first in class breakthrough, that disproportionately draws in more patients with BRCA mutated tumors. For example, the SOLO3 trial which evaluated the PARP inhibitor, olaparib as a single agent against non-platinum based single agent chemotherapy in patients with | PMC10020803 |
Acknowledgments | Jennifer A., Cancer | ONCOLOGY, GYNECOLOGIC CANCER, CANCER | We remain indebted to the participating patients, their families, and the clinical trial investigators and research coordinators of the Dana-Farber/Harvard Cancer Center Gynecologic Cancers Program. We want to acknowledge the support of Sanofi in ensuring that these data are peer reviewed and published and Jennifer A. Smith, Sr., previously Director Biometrics BiPar Sciences and Sanofi, for help with access to and analysis of the data. Presented in part at the 2011 American Society of Clinical Oncology Annual Meeting. | PMC10020803 |
Funding | This study was supported by an investigator-initiated grant from BiPar Sciences, Inc., and Sanofi Aventis US LLC. | PMC10020803 | ||
Conflict of Interest | PMC10020803 | |||
Author Contributions | Conception/design: R.T.P., M.J.B. Provision of study material or patients: R.T.P., C.N.K., P.A.K., U.A.M., M.J.B. Collection and/or assembly of data: All authors. Data analysis and interpretation: All authors. Manuscript writing: All authors. Final approval of manuscript: All authors. | PMC10020803 | ||
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10020803 | ||
References | PMC10020803 | |||
1. Introduction | Media, depressed, ’ | EVENTS | Background: Media affects the trajectory of many individuals’ mental health—with media news, individuals experience negative bias more than positive bias. However, there is also evidence of an age-related positivity effect, with negativity bias generally fading with age. With the rise of COVID-19 cases, older adults (aged 55 years and older) who consume media frequently are at a high risk for declining mental health. To date, there has been no research on the positivity vs. negativity bias of media news on older adults. Here, we investigated whether positivity or negativity bias plays a larger role in affecting how older adults react to COVID-19 news. Methods: Sixty-nine older adults (aged 55–95) answered questions about their weekly media consumption and how closely they followed news relating to COVID-19. They also completed a general health questionnaire. They were then randomly assigned to read either positive or negative COVID-19 news (Past studies suggested that individuals are affected more by negative rather than by positive events or stimuli [Regardless of the differing theoretical accounts, negativity bias appears to be common and relevant across all human populations and becomes even more prevalent when individuals consume media. For example, negative news tends to disproportionately grab readers’ attention, while good news is treated as no news [However, there is also evidence of an age-related positivity effect, signifying that the negativity bias in youth fades with age. For example, the socio-emotional selectivity theory proposes that the perception of time influences an individual’s decision-making [When exposed to the immense stress of negative COVID-19 news, a person’s mental health may be affected. For example, ref. [To date, no research has been conducted that focuses on older adults (age 55+) and investigates whether a positivity or negativity bias plays a larger role in affecting the way older adults react to COVID-19 news. Thus, in this study, we seek to investigate how and to what degree media reports concerning positive and negative COVID-19 news affect older adults’ mental health and emotional reactions (measured by the General Health Questionnaire, GHQ-12, and a self-reported survey; see the Methods section for more details). Based on past studies, we designed our study to examine whether 1) the more frequently older adults consume media and follow COVID-19 news, the more they feel unhappy and depressed, and 2) reading positive COVID-19 news leads older adults to feel more happy more than reading negative COVID-19 news would lead them to feel unhappy (positivity bias). | PMC10002267 |
2. Methods | PMC10002267 | |||
2.2. Materials | Media | Background Information Survey. The survey consisted of questions that asked the participants about their age, gender, highest level of education, living status, and socioeconomic status (household income) (see Media Exposure. This consisted of two questions about the participants’ media consumption habits. For example, the first question in this section asked the participants how many days per week, on average, they consumed media: (1 = 0–1 days; 2 = 2–3 days; 3 = 4–5 days; or 4 = 6–7 days). The second question concerned how closely the participant followed news, specifically about the COVID-19 pandemic, and was measured using a five-point scale (1 = not at all; 5 = very closely).General Health Questionnaire (GHQ-12; [COVID-19 News. There were a total of four COVID news articles, adapted from news articles (from online news sources including Response to COVID-19 news questionnaire. The questionnaire administered to all participants after reading the articles inquired about how the participant felt in response to each of the two COVID-19 news articles they had just read. There were a total of four questions per news article: (1) whether the article made them feel happy, (2) if they wanted to read more about the subject discussed in the article, (3) if the news article made them feel fearful, and (4) whether they wanted to forget or ignore the news article. Responses to the questions were scored using a five-point scale (1 = Strongly Disagree; 5 = Strongly Agree). As the third and fourth questions were negatively framed, they were reverse scored (e.g., a score of 5 was converted to 1, 4 was converted to 2, and so on) such that a composite score, i.e., a positive response score, was computed based on the sum of responses for easy interpretation. Multivariate ANOVA analyses revealed no significant effect concerning whether the COVID news questions were framed positively (Q1 and Q2) or negatively (Q3 and Q4) ( | PMC10002267 | |
3. Procedure | The 69 participants were given URL links to the | PMC10002267 | ||
Design | This study was conducted as an online survey during the time period of 29 January to 6 February 2022. The participants were invited to take part in the online survey through | PMC10002267 | ||
4. Results | depressed | Preliminary analyses using a multivariate ANOVA revealed no significant effects of age, education, living status, and household income on GHQ and positive response scores (First, in order to understand how much of an impact media consumption had on the participants’ mental health, we ran two-tailed correlational analyses on three key variables: how much older adults consumed media, how closely they followed COVID-19 news, and their GHQ-12 items. The analyses revealed that media consumption and following COVID-19 news have no significant relationships with the overall mental well-being of the older adults (GHQ score). Instead, we found that, specifically, the more often older adults consumed media and the more they closely followed COVID-19 news, the more they felt worse (being unhappy and depressed, Q9 and Q11 respectively), Next, to determine whether positive and negative COVID-19 news have similar or different effects on older adults’ emotional responses and wellbeing, we ran a multivariate ANOVA with the condition as the independent variable, and the positive response scores and GHQ as the dependent variables. We found there was a significant condition effect on the positive response scores, | PMC10002267 | |
5. Discussion | depressed | EVENTS, DISEASE | In summary, our findings indicate that the more often older adults consumed media and the more closely they followed COVID-19 news, the more they felt unhappy and depressed. This is largely in line with past studies, suggesting the detrimental impact of general media consumption on mental health. Importantly, we found that positive news evokes significantly stronger reactions than negative news in older adults. In particular, older adults appeared to have a strong positivity bias for COVID-19 news—positive news had a greater impact on older adults than negative news. A similar study investigated the age difference in preferences for fear-enhancing and fear-reducing news in a disease outbreak [Our results provide insights into the mindset and outlook on life of older adults. This increased knowledge and understanding of older adults’ positive outlook are important and can be used to our advantage in different areas to possibly reframe how society attempts to improve the mental well-being of older adults during stressful periods by allowing others, e.g., family members and caretakers, to help them more effectively. For example, due to the presence of a positivity bias, it might be beneficial to include more positive news in the media on TV networks, such as Another possibility is to create special programs that focus on a subset of the news—positive news—for individuals living in separate communities, either orally, online, or in print. Social service agencies can connect with a news studio to present special programs at night or during the day that are specifically targeted to older adults and focus on positive news only. Special news magazines that present only positive news can also be created, and such publications are currently available in schools for students of all ages. These publications could be given a wider circulation. Other ideas include developing and broadcasting special radio shows and podcasts. All these special programs and efforts do not suggest that negative news cannot be shared; rather, it suggests that the news can be structured in such a way that it brings out the positive aspects and is not perceived as negative.These efforts to reframe the news are critical, as having a positivity bias may be a coping mechanism for older adults in the context of the pandemic. This may be similar to how people’s recollections of the past are often positively biased as a healthy coping mechanism, resulting in people perceiving events in their lives to often be more pleasant than unpleasant [One limitation of our study is that we did not include younger adults as a comparison group. Thus, it is not definitive if the positivity bias is, in fact, due to the age-related positivity effect, or if the positivity bias toward COVID-19 news also applies to younger adults. However, in line with the socio-emotional selectivity theory [Another possible limitation is that our study was conducted online via Google Forms. We did not print the forms on a hard copy and distribute them to those who do not use internet. Thus, we might have excluded older adults who do not have access to the internet, leading to a skewed representation of the older adults in the USA. However, according to the Pew Research Center [In this study we focused on traditional media and did not include social media. Recent statistics published by Statista Research Department [It is imperative to mention that we had uneven representation of males and females in the two conditions. Although we employed a random assignment for the experimental conditions, the positive news condition had 18 males and 17 females, while the negative news condition had 13 males and 21 females. Similarly, 44.4% of participants in the positive news condition group had an income of USD 160 k+, compared with 17.6% of participants in the negative news condition. However, we did not find any significant differences in male/female participants or the income level between the two conditions. This indicates that, even though the raw numbers are not equal, they are not statistically different. We also ran Chi-square tests using Fisher’s exact test, and no significant difference was found: χ2 = 1.21; We also note that our sample was recruited from communities with high Asian populations. This suggests that our results should be interpreted with caution and may not be generalized to populations of other ethnicities. Some studies showed there is no correlation between ethnicity (White, Latinx, and Asian American) and negativity bias [Finally, we only examined self-reports of emotional outcomes from positive and negative COVID-19 news. The Differential Susceptibility to Media Effects Model (DSMM; [ | PMC10002267 |
6. Conclusions | In conclusion, our findings suggest that older adults have a positivity bias with respect to information and have the ability to remain hopeful during periods of stress. While there are certain limitations to the results, our findings provide novel and valuable insight into the way older adults view information, especially information related to public health crises. This increased understanding will be useful for developing solutions and ideas with respect to maintaining or improving the mental health of older adults, which can ultimately be realized moving forward. | PMC10002267 | ||
Author Contributions | Conceptualization: Z.Z.N., G.L. and W.Q.Y.; Methodology: Z.Z.N., G.L. and W.Q.Y.; Data curation: Z.Z.N. and G.L.; Investigation: Z.Z.N. and G.L.; Project Administration: Z.Z.N. and G.L.; Resources: Z.Z.N. and G.L.; Formal analysis and Visualization: Z.Z.N., G.L. and W.Q.Y.; Supervision: S.F. and W.Q.Y.; Writing (original draft): Z.Z.N. and G.L.; Writing (review and editing): Z.Z.N., G.L., S.F. and W.Q.Y.; All authors have read and agreed to the published version of the manuscript. | PMC10002267 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, IRB approved protocol number IRB 21-395, and an exemption from the Institutional Review Board of the Singapore University of Technology and Design (SUTD) for the students collecting the data as they were not SUTD students. | PMC10002267 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10002267 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10002267 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10002267 | ||
Introduction | obesity, weight loss | OBESITY | Across the world there are over a billion individuals living with obesity (13% prevalence of a BMI >30kg/m2) [The UK’s National Institute for Health and Care Excellence recommends that bariatric surgery should be supplemented by psychological support, though it does not specify a particular therapy modality [Analysis of the psychological profile of patients living with obesity found poor self-regulation and negative mood as the strongest predictors of variance in weight loss [Support for this comes from a recent systematic review [In previous studies of ACT for weight management [Despite guidelines recommending psychological interventions in post-operative care, routine clinical practice has not caught up [ | PMC10128967 |
Methods | The full protocol for this trial has been published in the International Journal of Clinical Trials [ | PMC10128967 | ||
Design | This was a feasibility study for a single-centre, parallel-group, single-blind, two-arm trial, with randomisation to either a 10 weeks ACT group therapy or Usual Care Support Group control (SGC). Favourable ethical opinion was obtained from London-Westminster REC (18/LO/1256). The trial was registered at Researchregistry.com, UIN: 3959 (date registered: 10 April 2018); ISRCTN registry ID: ISRCTN52074801. | PMC10128967 | ||
Participants | ideation, RA, PIS | RECRUITMENT, RECRUITMENT | All participants were adults (≥18years) post bariatric-surgery (>15 to < 18 months) at a London-based weight management centre. Patients who expressed suicidal ideation (score >0 on Q9 of thePHQ-9 [Initially, potentially eligible patients were given a Participant Information Sheet (PIS) and PHQ-9 at their regular post-surgical follow up appointments, but due to reduced operating capacity in the previous year, recruitment was hampered by low numbers in follow up clinics. Therefore, all eligible patients were contacted and posted or emailed the PIS. Interested patients were approached by the RA and an appointment made to obtain consent and baseline data. Written consent was obtained for all participants. Recruitment ceased when the target was reached. | PMC10128967 |
Randomisation | This was performed by an independent researcher running R program scripts [ | PMC10128967 | ||
Sample size | We aimed to recruit 58 participants. However, due to high attrition, including before the first session, we ran extra groups (i.e. 4 iterations rather than 2) and recruited 80 participants. Loss to follow up and group attrition are presented in a consort diagram ( | PMC10128967 | ||
CONSORT flow diagram. | ACT, acceptance and commitment therapy; SCG, support group control.As this was a feasibility study, we did not carry out a formal sample size calculation when planning the study. However, we provide an estimate of the precision of the primary endpoints ( | PMC10128967 | ||
Data to inform sample size of a future trial. | *The denominator here is the number of patients still in the study at 12 months**The numbers attending the therapy sessions were averaged over all cohorts, both randomisation groups and all 10 sessions, although it has already been noted that the number attending each session decreased as the study progressed. | PMC10128967 | ||
Intervention | This comprised ACT group therapy delivered weekly (10 x 90-minute sessions) by a psychologist trained in bariatric psychological support and ACT. The intervention was adapted from an existing manual which addressed all six core processes of ACT: acceptance, defusion, contacting the present moment, self as context, committed action, values awareness [ | PMC10128967 | ||
Control (usual care) | This comprised the support group control (SCG) (10 x 90-minute meetings), delivered weekly by a psychology graduate with no formal therapy training. The groups were unstructured to allow patients to talk freely. The groups were held at the same time and venue, but on a different day of the week to the ACT groups. | PMC10128967 | ||
Outcomes | obesity, Obesity | OBESITY, RECRUITMENT, OBESITY, RECRUITMENT | Primary outcomes related to the feasibility of the trial. Measures of the success of recruitment, data collection and acceptability of trial procedures included (1) willingness of participants to be randomised, i.e. the number of participants who drop out of the study after they had been randomised, (2) number of eligible patients attending clinic i.e. the percentage of patients who met eligibility criteria at screening, (3) follow-up rates, i.e. the percentage of participants retained until 12 month follow-up and providing complete datasets, (4) adherence to the intervention or control i.e. number of sessions attended, (5) reasons for attrition, (6) time needed to collect data.Secondary outcomes explored related to obesity, health and wellbeing. The following validated measures were used: King’s Obesity Staging Criteria [Economic costs were calculated from the perspective of the NHS. Annual staff training budgets typically fund ACT training, which costs £450 (ranging from £350 to £550) for a healthcare professional with an existing psychology qualification. The ACT group was led by a Band 7 psychologist as part of their regular duties. A Band 4 psychology graduate with no formal therapy training led the support group. The CSRI was used to track healthcare resource use during the trial period [Outcome measures were completed at baseline, 3, 6 and 12 months follow up, except for weight and the King’s Obesity Staging Criteria [Participants from both arms were invited to be interviewed after the 12 month follow up in order to understand acceptability of the trial and group processes. Recruitment stopped once equal numbers from each arm had been recruited and the team agreed that data saturation had been achieved. The ACT group participants also completed further ACT process measures at each session as part of the intervention: openness to experience (OE), behavioural awareness (BA), and valued action (VA). | PMC10128967 |
Data analysis | REGRESSION, SECONDARY, RECRUITMENT | Descriptive statistical analyses were conducted for the feasibility and potential primary and secondary outcomes at baseline and each follow-up time point. Although this feasibility study was not powered to detect differences between groups in questionnaire-based outcomes, multi-level linear regression models were fitted to the data from each questionnaire to explore the direction and magnitude of effects. This method of analysis uses data from all time-points, and provides unbiased estimates, providing data can be assumed to be missing-at-random.A cost-consequence analysis (CCA) was performed from a National Health Service (NHS) perspective. This analysis is commonly used in the literature to investigate the intervention’s impact on costs and health outcomes in a feasibility study [Interview data were analysed using a directed content analysis technique [Data relating to participation in the trial and SCG and in the ACT intervention were coded separately. Codes were agreed between the coding team (MB, HG, SB, EB) using one transcript before MB and EB coded all transcripts independently. Similarities and differences in views between the groups were highlighted and examples of disconfirming data were sought for each acceptability construct. The coding frequencies were presented as counts along with supporting quotes for each TFA component. Coding was discussed and agreed at multidisciplinary team meetings including the service user advisors.This was a change from protocol where inductive thematic analysis was planned. However, given findings of successful recruitment but high attrition, it was felt that using a focused, structured approach to understand the acceptability, of both the trial processes and experience of the ACT group, would enable identification of specific areas to be addressed in future work. The TFA has been applied in this way to various interventions, including a men’s mental health promotion program [ | PMC10128967 | |
Participant characteristics. | F/T, full time; P/T, part time; BMI, Body Mass index. | PMC10128967 | ||
Data collection | This information is displayed in Questionnaires took an average of 56 mins to complete at baseline when they were completed face to face and an average of 29 mins to complete at 12 months by phone (as at 3 and 6 months). | PMC10128967 | ||
Acceptability of the intervention | There were high levels of drop out from both groups ( | PMC10128967 | ||
Acceptability of the intervention: number of participants who attended each session. | ACT, acceptance and commitment therapy; SCG, support group control. | PMC10128967 | ||
Process evaluation | Only six ACT participants competed the in-session measures of OE, BA, VA more than five times. Weekly changes were analysed over time. Results indicated that scores fluctuated throughout the intervention but there was no clear indication of improvement in any measure across the time points. No linear or non-linear patterns in the results could be identified. | PMC10128967 | ||
Exploration of primary and secondary outcome measures for a full RCT | REGRESSION | Data from all questionnaires at each time point are included in the S1 Questionnaire data and include the levels of missing data. Changes from baseline and differences between groups: Findings from the multi-level linear regression models for the outcome measures are provided in Health service use and costs: The ACT group had fewer hospital admissions (0 percent vs 13 percent), A&E visits (7.6 percent vs 20 percent), social worker visits (0 percent vs 7 percent), district nurse or health visitor visits (0 percent vs 6 percent), and visits to ‘therapy in the community’ (0 percent vs 6 percent) (0 percent vs 7 percent). They were more likely to visit an outpatient hospital (46 percent vs 26 percent), a GP (69 percent vs 40 percent) or a practise nurse (46 percent vs 27 percent), any telephone consultation (31 percent vs 20 percent), any day centre visit (38 percent vs 7 percent), a chiropractor (7 percent vs 0 percent), or any counselling, psychiatry, or community mental health visit (8 percent vs 7 percent). Except for any day centre visit (p = 0.04), no differences between groups were statistically significant (please see The cost of providing ACT services includes one hour of clinical psychologist time (£70) divided among ten patients. The training costs approximately £2.25 per patient (£450 per year for 200 patients). As a result, the total cost of providing ACT services is £72.25 per patient. SGC service delivery costs include one hour of assistant psychologist time (£34) divided among ten patients. This equates to £3.4 per patient or £34 for ten sessions. Last year, the ACT group spent £560 on medical expenses, while the usual care group spent £441. The intervention cost £633 for the ACT group and £475 for the usual/standard care group.QALYs (Quality-adjusted Life Years): The unadjusted mean QALYs from baseline to 12 month follow-up were: ACT group = 0.61 (SD = 0.26); SGC = 0.59 SD = 0.37. The study only included 32 patients with baseline and 12-month EQ-5D measurements (19 in the usual care group and 13 in the ACT group). We then used a regression analysis to estimate the differences in QALY between two groups, adjusting for patients’ age, gender, baseline health-related quality of life, and body mass index. The ACT group was associated with a 0.07 point reduction in QALY (P>0.05) in the adjusted analysis. The regression results were summarised in | PMC10128967 | |
Costs and outcomes for the ACT and usual care groups. | PMC10128967 | |||
Acceptability: Qualitative findings | Eighteen participants were interviewed: nine from each arm (female n = 11). Three interviews were face to face and the subsequent 15 were by telephone; interview duration ranged from 35 to 65 minutes. Three of those interviewed did not attend any session (ACT n = 2, SGC n = 1), this was due to health reasons and being unable to attend due to other commitments. The 15 remaining participants interviewed attended from 1 to 9 sessions (ACT median = 5, SGC median = 8), though the ACT participants were able to ‘catch up’ on course content with the psychologist prior to the subsequent session. | PMC10128967 | ||
Coding results | All acceptability constructs were coded, except ‘self efficacy’ was not coded for the trial or SGC attendance, and though ‘opportunity costs’ was coded in relation to attending sessions it was not coded specifically in relation to participating in either group. Most codes related to ‘perceived effectiveness’ (50 in 7 interviews SGC, 46 in 6 interviews ACT). Findings are presented as themes within each acceptability construct, supported by illustrative quotes (quotes are linked to a participant via participant number (1–80), gender (m/F) and the number of sessions attended out of 10). | PMC10128967 | ||
Opportunity costs | Participants reported having to change their weekly schedule so that they could attend sessions and the issue of travel costs was raised as a potential barrier to attendance. No opportunity costs were coded specific to attending either the ACT group or SGC. | PMC10128967 | ||
Discussion | obesity, type-2 diabetes | OBESITY, SECONDARY, SAID, RECRUITMENT | This trial tested the feasibility of delivering an RCT of ACT It appeared that although data collection was hampered by lack of retention, other trial processes (i.e. recruitment, consent, data collection in those retained in the trial) would be feasible for a future trial but that the intervention, as delivered, may not be. We therefore decided to explore acceptability of the trial processes and intervention in detail using an established framework–The TFA [Our interview data also suggested that the acceptability construct of ‘ethicality’ was important. This refers to the fit of trial and intervention with an individual’s values. The intervention fitted with what the participants said they wanted (i.e. information and psychological support), and satisfaction with this was expressed as evidenced by the positive comments coded under the ‘Affective Attitude’ acceptability construct. However, joining the trial was commonly motivated by a desire to ‘help others’ or ‘give back’. This, and another expressed desire, namely to meet other patients and share their experiences, was thwarted by the high levels of attrition in both groups This may explain why poor attendance at the first session led to reduced motivation to return, with subsequent drop out having a negative impact on future attendance.Further, our finding that participants consented to join the study out of a motivation to help others, may suggest that they were not ‘ready’ for therapy themselves, an idea supported by our PPI advisors. The impact on weight loss of ‘readiness’ or motivation for bariatric surgery has been tested retrospectively [With regard to perceived effectiveness and intervention coherence, few participants received a sufficient course of ACT for it to be meaningful. It is, therefore, unsurprising that no trends indicating a difference between the groups were identified. However, participants who attended the ACT groups reported some benefits and behaviour changes linked to ACT processes, especially regarding contacting the present moment, becoming more aware of behaviours and improved self efficacy. ACT group participants varied in their understanding of ACT processes, this appeared linked to attendance, but participants’ description of the intervention was generally simplistic, with few able to give concrete examples of the processes covered in sessions and homework.Nevertheless, this work has demonstrated that it is possible to deliver group ACT as part of routine care post bariatric care with minimal additional cost to services. Future trials could impact on large numbers of individuals and, if successful, reduce NHS costs significantly. For instance, in 2017/18 (latest available data NHS digital) there were 6,627 hospital admissions with a primary diagnosis of obesity and a main or secondary procedure of bariatric surgery; an increase of 2% on 2016/17 (6,492). However, approximately 20% of bariatric surgery patients regain lost weight with cost implications of £10,000 per re-operation as well as return of co-morbidities such as type-2 diabetes. If ACT is found, in future trials, to be effective at preventing weight regain, significant saving could be made. This study also highlights that the decision regarding the best primary and secondary outcome measures for a full RCT of ACT would require the careful consideration of many aspects of the proposed trial, including consensus in the most relevant patient-centred outcome to demonstrate efficacy. The data collected during this feasibility study for a range of outcomes would be sufficient to inform the necessary sample size calculations for a future trial through estimates of standard deviation of the chosen outcome, but the final decision on the choice of primary endpoint should be taken by the research team following extensive consultation with patient representatives.A strength of this feasibility trial is that, to reduce selection bias, we invited all eligible patients to participate. We noted early on that there was low attendance, so we ran additional iterations of the groups which confirmed that retention to the group rather than recruitment to the trial was an issue. We then explored acceptability of the trial and group processes with both high and low attenders using an established framework. This allowed us to pinpoint areas to address in a future trial to increase acceptability and retention. Nevertheless, due to the lack of attendance, few people received a meaningful level of the ACT intervention, so we are unable to recommend a definitive primary outcome for a future trial or suggest the processes by which ACT may work.In conclusion, this study has demonstrated that an RCT of group ACT is feasible to deliver in bariatric patients post-surgery, but that the intervention is not feasible or acceptable as delivered. Low attendance at groups, due mainly to travel and scheduling difficulties, reduced acceptability as participants were unable to gain the peer support or to provide the help to others that had motivated them to join the trial. This suggests that acceptability, and hence retention, could be improved in a future full trial of effectiveness by using online intervention delivery whilst taking care to maximise participant satisfaction by providing opportunity for interaction with peers. The data from this trial also suggest the need for future research to explore the factors which influence when and which bariatric patients are most likely to benefit from psychological therapy and why in order to inform recruitment of suitable candidates to trials. | PMC10128967 |
Supporting information | PMC10128967 | |||
CONSORT checklist. | (PDF)Click here for additional data file. | PMC10128967 | ||
Individual weight changes. | (PDF)Click here for additional data file. | PMC10128967 | ||
Results from mixed models–unadjusted. | (PDF)Click here for additional data file. | PMC10128967 | ||
FAB_fulldata_26SEP2022. | (CSV)Click here for additional data file. | PMC10128967 | ||
Questionnaire data. | (PDF)Click here for additional data file. | PMC10128967 | ||
Questionnaire results. | (PDF)Click here for additional data file. | PMC10128967 | ||
Results from multi-level linear regression models. | (PDF)Click here for additional data file. | PMC10128967 | ||
Service use and costs. | (PDF)Click here for additional data file. | PMC10128967 | ||
Feasibility of acceptance and commitment therapy for post-bariatric surgery patients: the FAB study protocol. | (PDF)Click here for additional data file.The authors would like to thank the study’s PPI representatives, Georgina Hayman and Roy Ebbs, for bringing a service user perspective to every aspect of the study, including during regular Project Advisory Group meetings. We thank Ms Hayman for chairing this group. | PMC10128967 | ||
Background | There is a long latent period for the sciatic nerve block before a satisfactory block is attained. Changes in the temperature of local anesthetics may influence the characters of the peripheral nerve block. This study was designed to evaluate the effect of warming ropivacaine on the ultrasound-guided subgluteal sciatic nerve block. | PMC10641952 | ||
Methods | Fifty-four patients for distal lower limbs surgery were randomly allocated into warming group (group W, | PMC10641952 | ||
Results | The onset time of sensory blockade was shorter in group W than in group R (16 (16,18) min vs 22 (20,23) min, | PMC10641952 | ||
Conclusions | Warming ropivacaine 0.5% to 30℃ accelerates the onset time of sensory and motor blockade in the ultrasound-guided subgluteal sciatic nerve block and it has no influence on the duration of sensory and motor blockade. | PMC10641952 | ||
Trial registration | The trial was registered on October 3, 2022 in the Chinese Clinical Trial Registry ( | PMC10641952 | ||
Keywords | PMC10641952 | |||
Background | nerve block, sciatic nerve block | The sciatic nerve block is frequently applied alone or in combination with other peripheral nerve blocks for orthopedic procedures involving the foot and lower limb [In the literature, few studies focused on the effect of warming local anesthetics on peripheral nerve block [ | PMC10641952 | |
Methods | obesity, loss of pinprick sensation, muscle weakness, mellitus diabetes, swelling, neurological disorder, paralysis, pain, sensory disability, coagulopathy | OBESITY, MUSCLE WEAKNESS, NEUROLOGICAL DISORDER, BLIND, COAGULOPATHY, COMPLICATIONS | The protocol utilized in this study was granted approval by the ethics committee at Cixi People’s Hospital on July 24, 2022, and subsequently reviewed and registered at the Chinese Clinical Trials Registry (ChiCTR-TRC-0000054) on October 3, 2022. This study was conducted from October 2022 to February 2023 at Cixi People’s Hospital.Fifty-four adult patients (18 to 70 yr), classified as American Society of Anesthesiologists (ASA) Physical Status Class I to II, who underwent distal lower extremity surgery, were estimated for eligibility to enter this study. Patients with obesity (BMI ≥ 35), mellitus diabetes, or a history of coagulopathy or neurological disorder were excluded from the study. Following the acquisition of signed informed consent forms, all patients were randomly allocated into warming group (group W, The solutions of ropivacaine 0.5% were prepared with a 1:1 mixture of ropivacaine 1% (Qilu Pharmaceutical, Jinan, China) and normal saline (China Otsuka Pharmaceutical Co.,Ltd., Tianjin, China). For group R, the extension tubes and 20-ml syringes with ropivacaine 0.5% were stored in the operating room set at 23°C before initiating the block. For group W, the extension tubes and 20-ml syringes with ropivacaine 0.5% were stored in an incubator (DHG9011A, Jinghong Laboratory Instrument Co.,Ltd., shanghai, China) set at 30°C for at least 2 h before initiating the block. The solutions were all prepared by a nurse who was not involved in the performance of the intraoperative management, or data collection and analysis.All patients were routinely prohibited from drinking for 6 h and fasted for 8 h. They were monitored by standard noninvasive monitors (MX500, Philips, Boeblingen, Germany) with blood pressure (BP), heart rate (HR), electrocardiograph (ECG) and blood oxygen saturation (SpOPatients were positioned laterally with the affected limb elevated and flexed at the hip and knee. A ultrasound device (MP80, Mindray, Shenzheng, China) with a low-frequency (5–2 MHz), curved-array ultrasound transducer (C5-1S) was used. The ultrasound transducer was performed on the skin in the subgluteal region, oriented parallel to a line between the ischial tubercle and greater trochanteric for sciatic nerve imaging. On this level, the sciatic nerve could be visualized on sonography as an oval or flattened hyperechoic nodule in a transverse plane. Subsequently, the longitudinal section image of the sciatic nerve could be obtained by rotating the transducer 90 degrees from its original position. The position of the sciatic nerve was confirmed by a combination of longitudinal and transverse scanning. The width, thickness and depth of the sciatic nerve were measured on ultrasonography.A 80-mm, 22-gauge needle (TWLB, Kindly Medical Devices Co., Ltd., Zhejiang, China) was carefully advanced in parallel with the ultrasound beam towards the sciatic nerve until the needle tip was positioned adjacent to the nerve tissues on ultrasound imaging. Subsequently, 2–3 ml of saline solution was injected to confirm the correct placement of needle tip by observing a spread around the sciatic nerve. After confirmation of negative aspiration, 30 ml of ropivacaine 0.5% (23℃ or 30℃) was incrementally injected to spread along the dorsal aspect of the nerve tissue without changing the initial position of the needle tip, within less than 20 s. In order to avoid intraneural injection, all injections were administered using 20-mL syringes in incremental doses. Meanwhile, the ultrasound video recorded the injection process around the sciatic nerve for subsequent assessment of the occurrence of intraneural injection. All nerve blocks were performed by a single anesthesiologist proficient in ultrasound regional anesthetic techniques, who remained blinded to group assignment.The sensory and motor blockade was evaluated every 2 min for 30 min after injection. The pinprick (22G) was used on three regions of the lower limb for the assessment of sensory blockade, including the dorsal aspect of the foot (common peroneal nerve, CPN), the plantar aspect of the foot (tibial nerve, TN) and the lateral cutaneous side of the lower leg (sural nerve, SN). Sensation to pinprick was classified as follows: 0 = normal sensation (no block); 1 = blunted sensation (analgesia); 2 = absence of sensation (anesthesia). It was considered complete when patients received complete loss of pinprick sensation (score = 2). The onset time of sensory blockade was defined as the time from the end of injection to complete blockade in three dermatomes. The degree of dorsal and plantar flexion in the foot and toes was assessed as an evaluation index for motor blockade. It was classified as follows: 0 = normal movement; 1 = decreased movement; 2 = absence of movement (complete motor block). It was considered complete if the patient showed paralysis with dorsal and plantar flexion of the foot and toes (score = 2). The onset time of motor blockade was defined as the time from the end of injection to completion of motor block. Block failure was defined that the completion of sensory and motor block was not achieved whithin 30 min after injection and these patients were excluded from analysis. The time for resolution of motor blockade and the first request for pain medication were documented on the first day after surgery. Additionally, the neural complications for patients such as sensory disability and/or muscle weakness in the lower limbs were assessed on the second day after surgery. All data was collected by an investigator blinded to randomization. A comprehensive review of all videos was conducted by another investigator who was blind to all the information and data of patients, including the group assignment.Intraneural injection was defined that any segment of the nerve showed significant swelling in a transverse plane on ultrasonography during administration of local anesthetics [After achieving successful sensory and motor blockade, LMA general anesthesia was induced using propofol at a dosage of 2–3 mg/kg, followed by maintenance with sevoflurane (2.0%-2.5%) while ensuring spontaneous breathing of the patient. During the surgery, sufentanil citrate was administered intermittently with dosage adjustments based on the patient’s noninvasive blood pressure, respiratory rate, and heart rate. | PMC10641952 |
Sample size calculation | In advance, we conducted a preliminary experimental study with 10 patients in each group. The results indicated that the mean onset time of sensory block was 19.8 ± 2.27 min in warming group and 17.8 ± 1.89 min in room temperature group. Drawing on these statistics, a minimum of 24 patients were included in each group to detect a difference of onset time for 2 min between both groups with a 2-tailed α error = 0.05, and power 90%. Taking into account potential block failures and patient dropouts, 60 patients were enrolled. | PMC10641952 | ||
Statistical analysis | SD | Data analysis was conducted using SPSS software version 27 (IBM Corporation, Armonk, NY). Normal distribution was evaluated using the Shapiro–Wilk test. Continuous variables for normality were expressed as mean ± SD and were analyzed with the Student t-test. Nonnormally distributed data was expressed as medians (interquartile range) and were analyzed with the Mann–Whitney U test. Categorical variables were presented as numbers (percentage). Data on ASA classification and gender were assessed using Chi-square. Fisher’s exact test was applied to text the differences in the side effects, patient satisfaction and types of operations between the two groups. A | PMC10641952 | |
Discussion | peripheral nerve block, sciatic nerve tract, connective and adipose | CYTOTOXICITY | In the present study, we demonstrated that warming ropivacaine 0.5% to 30℃ shortened the onset time of sensory and motor blockade in the ultrasound-guided subgluteal sciatic nerve block. The duration of sensory and motor blockade showed no significant difference between the studied groups. No evident clinical neural symptoms were detected and the proportion of the patient satisfaction with the anesthetic effect was equal in both groups.The sciatic nerve is the largest peripheral nerve in the body whoes anatomical structure determines the prolonged latency of sciatic nerve block. The sciatic nerve tract is surrounded by a variety of non-neural tissues, primarily composed of abundant connective and adipose tissues, which serve as a physical barrier to slow down the diffusion of local anesthetics [The basic mechanism that warming local anesthetics accelerate the onset of sensory and motor blockade still remains uncertain. The hypothetical explanation is that with temperature increasing, a lower pKa value of local anesthetic solutions leads to an increased proportion of non-ionized molecules which have greater lipophilicity to enhance the diffusion capacity of local anesthetics across tissues and nerve membranes [Similarly, in theory, the alkalinization of local anesthetics can also accelerate the onset time of nerve block by increasing the proportion of non-ionized molecules. However, the use of the alkalinization technique is limited in clinical practice for its uncertain efficacy, because the precipitation generated by alkalization of local anesthetic solutions may reduce drug bioavailability [Makharita et al. [Apart from peripheral nerve block, several studies have investigated the effect of warming local anesthetics on neuraxial block. Liu et al. [In an animal study, Nikolaos et al. [We recognize several limitations in our study. First, we just warmed the ropivacaine to 30℃, which was different from previous studies where the target temperature was set at 37℃. Since the storage temperature of ropivacaine should be strictly controlled below 30℃ as specified, the off-label use was not permitted by the ethics committee for safety reasons. Currently, the effect of warming temperature beyond 30℃ on the ingredients, properties and potential cytotoxicity [ | PMC10641952 |
Conclusions | peripheral nerve block | ADVERSE EFFECTS | In conclusion, our study shows that warming the ropivacaine 0.5% to 30℃ can accelerate the onset time of the ultrasound-guided subgluteal sciatic nerve block whithout obvious adverse effects. Therefore, warming the local anesthetics is a simlpe, safe and effective method to reduce the latency of peripheral nerve block, which is of benefit to shorten patient waiting time in the preoperative room and improve the clinical efficiency in busy surgical settings. | PMC10641952 |
Acknowledgements | Not applicable. | PMC10641952 | ||
Authors’ contributions | J.L.H.wrote the main manuscript text. N.N.Z. and J.P.X. conducted statistical analyses. Y.J.M. conducted the block procedure. J.J.J. collected data. J.L.H.and F.J.Z. designed study and conducted the analysis and interpretation of results. F.J.Z. and W.D.W. reviewed the manuscript. All authors reviewed the manuscript. | PMC10641952 | ||
Funding | This research was funded by the Zhejiang Provincial Natural Science Foundation of China 2023 (No.LY23H090015). | PMC10641952 | ||
Availability of data and materials | The data associated with the paper are not publicly available but are available from the corresponding author (YG) on reasonable request. | PMC10641952 | ||
Declarations | PMC10641952 | |||
Ethics approval and consent to participate | The study has been conducted in accordance with the principles set forth in the Helsinki Declaration, and all patients provided written informed consent for participation in the research study. Ethical approval for this study (2022-LP-KY020) was provided by the Institutional Review Board of Cixi People’s Hospital, Hushan Street, Cixi City, Zhejiang Province (contact:Weina Xu) on 10/07/2022. | PMC10641952 | ||
Consent for publication | Not applicable. | PMC10641952 | ||
Competing interests | The authors declare no competing interests. | PMC10641952 | ||
References | PMC10641952 | |||
Patients and methods | SECONDARY | This randomized, controlled, prospective study evaluates the functional results and costs of the 2 casting positions in patients 65 and older with DRF. Primary end point in this study was Patient-Reported Wrist Evaluation (PRWE) at 24 months, and secondary end points were cost-effectiveness of treatment, health-related quality of life measurement (15D), short version of Disabilities of arm, shoulder and hand score (QuickDASH), and VAS at 24 months. The trial was registered in ClinicalTrials.gov (NCT02894983, | PMC10079055 | |
Results | We enrolled 105 patients, of which 81 (77%) continued until 24-month follow-up. 8 patients (18%) were operated in the VFUDC group and 4 (11%) in the FC group. Patients in the VFUDC group also received more frequent physical therapy. The difference in PRWE score between the VFUDC and FC groups at 24 months was -4.31. The difference in the cost of treatment per patient was €590. Both findings favored FC. | PMC10079055 | ||
Interpretation | Colles’ type DRF | We found a slight, but consistent difference in the functional results between groups. These results suggest that VFUDC is not superior to FC when treating Colles’ type DRF. Cost analysis revealed overall costs in the VFUDC group are nearly double those in the FC group, mostly due to more physical therapy, additional visits to hospital, and additional examinations. Therefore, we recommend FC in older patients with Colles’ type DRF. | PMC10079055 | |
Data Availability | Data cannot be shared publicly due to the legislation in Finland and EU area (Finnish Data Protection Act). Data are available from the Institutional Data Access for researchers who meet the criteria for access to confidential data. Contact information: Tampere University Hospital. Research Services. Elämänaukio 1. 33200 Tampere, Finland. Email: | PMC10079055 | ||
Introduction | fracture, disability | Distal radius fracture (DRF) is the most common fracture among adults. Individuals 65 years and older are at the highest risk of sustaining DRF, Court-Brown & Caesar [The volar-flexion and ulnar deviation cast (VFUDC) is still widely used as the primary immobilization method for DRF. It has been suggested, that in the VFUDC method fracture reduction is maintained using the principle of ligamentotaxis, Agee [The treatment of DRF causes not only disability to individual patients but also significant costs for health care systems globally. The cost of treatment varies greatly between countries, ranging from €533 in Spain to €4 028 in Sweden, Borgström et al. [ | PMC10079055 | |
Patients and methods | PMC10079055 | |||
Study design | fracture | This pragmatic, randomized controlled, multicenter trial compared two commonly used below elbow cast positions (VFUDC and FC) in patients 65 years and older who had sustained a dorsally angulated distal radius fracture. The patients for this study were enrolled at three large emergency hospitals in Finland: Tampere University Hospital (Tampere), Central Finland Central Hospital (Jyväskylä), and Satakunta Central Hospital (Pori). The study protocol has been published elsewhere, Raittio et al. [ | PMC10079055 | |
Enrollment and randomization | fracture, Colles’ type DRF | All patients aged 65 years or older with a Colles’ type DRF and a sufficient reduction result were eligible for randomization (criteria presented in The patients were randomized to either the VFUDC or FC group using a random number matrix in block allocation fashion with a 1 to 1 ratio. The blocks were stratified by age (65 to 74 and 75 and older) and whether the fracture was intra- or extra-articular. The randomization allocations were sealed in consecutively numbered envelopes that were situated in the emergency rooms of the participating hospitals. | PMC10079055 | |
Procedure | fracture, plaster | Following enrollment, closed reduction of the fracture was performed under local anesthesia and the wrist was placed in a volar-flexion and ulnar deviation cast or a functional position cast according to the randomization. No fluoroscopy was used but x-rays were taken following reduction. All casts were non-circumferential, below-elbow plaster casts. Each hospital had an example cast to show the desired position (images of casts provided in | PMC10079055 | |
Follow-up | fracture, loss of reduction | Initially, the aim was that the casting period would last for 5 weeks. The cast was only changed if there were problems with the cast or patient has symptoms related to the cast or if the patient was operated. Follow-up appointments were arranged at 1, 2, and 5 weeks after sustaining the fracture. For some patients, this arrangement was compromised due to loss of reduction and subsequent operative treatment before the end of the intended casting period. Operative treatment was performed after discussion with the patient and consultation with upper extremity surgeons. Guided physiotherapy was introduced when required.Each participating hospital organized an additional follow-up visit at 3 months after the fracture. For research purposes, the questionnaires completed at 12 and 24 months were collected by Tampere University Hospital personnel. The complete assessment table of the protocol is provided in the study protocol, Raittio et al. [ | PMC10079055 | |
Outcome measures | disability, pain | COMPLICATIONS | The primary outcome was the Patient-Reported Wrist Evaluation (PRWE) score between the study groups at 24 months. Secondary outcomes were differences in means in the short version of Disabilities of arm, shoulder and hand, Quick-DASH score (qDASH, gives a scale from 0 to 100), visual analogue scale of pain (VAS, scale from 0 to 100 mm), health-related quality of life (15D, scale from 0 to 1), number of complications, number of surgical interventions, number of cast changes, and differences in the costs of the treatment. The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living, MacDermid et al. [In power calculations, we determined the required sample size per group to be 40 patients. This calculation was done by using the primary outcome variable (PRWE) with 95% confidence interval, power of 0.95, and SD of 14. Thus, to have enough statistical power, 40 patients in both groups had to complete 2-year follow-up. | PMC10079055 |
Cost analysis | We evaluated the costs between the two treatment groups by recording the number of cost-inducing contacts patients had with healthcare professionals. We recorded the number of visits to the hospital due to symptoms in the fractured wrist, surgery when needed, the number of physical therapy guidance visits, and possible additional examinations, such as plain radiographs, electroneuromyography (ENMG) examinations, and possible other imaging. Normal control visits of the study protocol were not included in the analysis since there was no variation between groups due to the protocol. Cost per contact was evaluated using pricing calculated by Tampere University Hospital Diagnosis-Related Group (DRG) for each year.Quality-adjusted life years (QALYs) were calculated using the 15D at 24 months. | PMC10079055 | ||
Statistical analysis | fracture | REGRESSION, REGRESSION | The analysis included all patients who completed the questionnaires at 24-month follow-up. Differences between the two casting groups in PRWE score, qDASH score, VAS, 15D, and the effect of fracture in the dominant hand on PRWE were analyzed using t-test. Linear regression was used to estimate adjusted group difference in each outcome variable. The covariates used were age, gender, articular/non-articular fracture, and hand dominance. Regression diagnostics revealed there was an issue with residuals based on the QQ-plot. Therefore, we excluded one major outlier. This improved the explained variance from 4.5% to 9%. There were still concerns about the modeling assumptions. We augmented our adjusted analyses with a cumulative probability model which only assumed monotonicity of dependent variable, meaning it is insensitive to outliers. The predicted values from this model were reported and compared to the unadjusted and adjusted analyses. All analyses were performed with Rstudio 4 (Version 2021.09.1, Boston, US). | PMC10079055 |
Results | PMC10079055 | |||
Participants | MAY | From July 2016 to May 2017, a total of 105 patients from three Finnish hospitals were recruited into the trial and randomized to 2 groups. In total, 55 patients were assigned to the VFUDC group and 50 to the FC group The patients were then observed for 24 months until May 2019. The baseline characteristics of the recruited patients are presented in | PMC10079055 | |
The baseline characteristics of patients in the Volar Flexion Ulnar Deviation Cast (VFUDC) and Functional Cast (FC) groups. | RECRUITMENT | At 12-months, 19 patients had been lost to follow-up and a total of 24 patients did not return the questionnaires at 24-months following recruitment. Thus, 81 patients were included in the analysis ( | PMC10079055 | |
Randomization of patients and inclusion in the final analysis. | PMC10079055 | |||
Outcomes at 24 months | PMC10079055 | |||
PROMs and health-related quality of life | fracture | The outcome measures, PRWE, VAS, Quick-DASH, and 15D were recorded at 3, 12, and 24 months after fracture. These results are presented in | PMC10079055 | |
Analysis of the outcome measures for DRF at 3, 12, and 24 months in the VFUDC and FC treatment groups. | fracture, hand dominancy | REGRESSION | VFUDC = Volar Flexion Ulnar Deviation Cast, FC = Functional Cast, PRWE = Patient-Reported Wrist Evaluation, Quick-DASH = short version of Disabilities of Arm, Shoulder and Hand, 15D = self-administrated questionnaire for measuring health-related quality of life, VAS = Visual Analogue Scale of painThere was a slight difference between the groups concerning whether the patient had the fracture in the dominant hand (51% in VFUDC vs 36% in FC group). This did not, however, seem to influence the functional results between the groups. The difference between fracture in the dominant and non-dominant hand in PRWE scores at 24 months was 1.6 (95% CI -10 to 7).In a linear regression model, the adjusted difference between groups in PRWE at 24 months was -5.3 points (95% CI -13 to 2.2) in favor of FC when adjusted for age, sex, articular/non-articular fracture, and hand dominancy. This did not exceed the MCID. The adjusted difference between groups in 15D at 24 months was -0.006 points (95% CI -0.06 to 0.05). The results from the cumulative probability model are presented in | PMC10079055 |
Predicted outcomes from the cumulative probability model for PRWE at 24 months for each combination of baseline variables. | FC = Functional Cast group, VFUDC = Volar-Flexion Ulnar Deviation Cast group.The number of cast changes was recorded per patient’s report. The number of cast changes was higher in the VFUDC group (25 cast changes) than in the FC group (15). The number of casts per patient was 1.57 in the VFUDC group and 1.41 in the FC group. | PMC10079055 |
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