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ObjectiveRandomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients’ preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.DesignSystematic review and meta-analyses.Data sourcesMEDLINE, Embase, PsycINFO and the Cochrane Library.Eligibility criteria for selecting studiesRPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.Data extraction and synthesisTwo independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.ResultsIn total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%–100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%–99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI −0.178 to 0.364, p=0.502).ConclusionsPatients’ preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.PROSPERO registration numberCRD42019094438.

Cervical cancer has high incidence and mortality rates, especially in less-developed countries. Prevention methods are well established, but there are still barriers preventing some Brazilian women from undergoing a Pap sample. The objective of the study was to evaluate the acceptance, preferences and completion of four screening methods. This has an experimental design (community trial). A total of 164 participants who had never had a Pap sample or had not had one for more than three years were included. The city’s urban area was stratified by census tracts and divided according to income and education levels. Women belonging to the lower-income strata were considered in the study. Random blocks were numbered into five intervention groups (Group 1- Pap sample at the hospital; Group 2- Pap sample in the mobile unit; Group 3- urine self-collection; Group 4- vaginal self-collection; Group 5- woman’s choice). Only 164 women met all of the eligibility criteria (15.3%). Most of them accepted the assigned method (92%), but only 84% of the women completed the collection step. The acceptance rates were as follows: Group 1 (100%), Group 2 (64.5%), Group 3 (100%) and Group 4 (91.4%). In Group 5, the women’s preferences were distributed as follows: examination performed at the hospital, 13 women (33.3%); examination performed at the mobile unit, 11 women (28.2%); urine self-collection, 11 women (28.2%); and vaginal self-collection, 4 women (10.3%). This study suggests that methods that allow cervical sampling collected near the women’s domicile might improve the acceptance and completion of preventive tests. This finding is relevant for the development of new cervical cancer screening strategies.

Abstract Background Feasibility of exercise in patients with metastatic cancer is still a challenge. This study aimed to determine the feasibility and preliminary efficacy of an exercise intervention based on a patient-preferred delivery mode in patients affected by metastatic cancer. Materials and Methods Forty-four patients with a confirmed diagnosis of metastatic cancer were recruited in a 3-month exercise program. Whereas the exercise program consisted of aerobic and resistance activities performed twice a week, the participants may choose the mode of delivery: home based, personal training, or group based. The primary endpoint was the feasibility, defined by recruitment rate, attendance, adherence, dropout rate, tolerability (comparing the session RPE with the target RPE), and safety (using the Common Terminology Criteria for Adverse Events, version 5.0). Secondary endpoints included cardiorespiratory fitness (six minutes walking test), muscle strength (handgrip strength test and isometric leg press test), flexibility (the back scratch and chair sit and reach tests), anthropometric parameters (body mass index and waist-hip ratio), quality of life (EORTC QLQ C-30 questionnaire), and amount of physical exercise (Godin’s Shepard Leisure Time Exercise Questionnaire). Descriptive statistics, Student t test, and Wilcoxon signed rank test were used to analyze data. Results The study recruitment rate was 81%. Out of 44 recruited patients, 28 chose the personal training program, 16 chose the home-based program, and none chose the group-based program. Nine dropouts occurred (20%), 6 in the personal training program, and 3 in the home-based intervention. The median attendance rate was 92%, adherence was 88%, tolerability was 100%, and 9 nonsevere adverse events were registered during the exercise sessions. An increase in cardiorespiratory fitness (P < .001) and flexibility (P = .011 for chair sit and reach; P = .040 for back scratch) was observed at the end of the intervention, while no changes in anthropometric values and muscle strength were detected. Different quality-of-life domains were improved following the intervention, including physical (P = .002), emotional (P < .001), and role functioning (P = .018), fatigue (P = .030), and appetite loss (P = .005). Conclusion A 3-month exercise program based on a patient-preferred delivery mode is feasible in patients with metastatic cancer and may improve physical function and quality of life. Trial Registration NCT04226508 This study aimed to determine the feasibility and preliminary efficacy of an exercise intervention based on a patient-preferred delivery mode in patients affected by metastatic cancer.

Background Effective techniques for eliciting patients’ preferences regarding their own care, when treatment options offer marginal gains and different risks, is an important clinical need. We sought to evaluate the association between patients’ considerations of the time burdens of care (“time toxicity”) with decisions about hypothetical treatment options. Methods We conducted a secondary analysis of a multicenter, mixed-methods study that evaluated patients’ attitudes and preferences toward palliative-intent cancer treatments that delayed imaging progression-free survival (PFS) but did not improve overall survival (OS). We classified participants based on if they spontaneously volunteered one or more consideration of time burdens during qualitative interviews after treatment trade-off exercises. We compared the percentage of participants who opted for treatments with no PFS gain, some PFS gain, or who declined treatment regardless of PFS gain (in the absence of OS benefit). We conducted narrative analysis of themes related to time burdens. Results The study cohort included 100 participants with advanced cancer (55% women, 63% age > 60 years, 38% with gastrointestinal cancer, and 80% currently receiving cancer-directed treatment. Forty-six percent (46/100) spontaneously described time burdens as a factor they considered in making treatment decisions. Participants who mentioned time (vs not) had higher thresholds for PFS gains required for choosing additional treatments (P value .004). Participants who mentioned time were more likely to decline treatments with no OS benefit irrespective of the magnitude of PFS benefit (65%, vs 31%). On qualitative analysis, we found that time burdens are influenced by several treatment-related factors and have broad-ranging impact, and illustrate how patients’ experiences with time burdens and their preferences regarding time influence their decisions. Conclusions Almost half of participating patients spontaneously raised the issue of time burdens of cancer care when making hypothetical treatment decisions. These patients had notable differences in treatment preferences compared to those who did not mention considerations of time. Decision science researchers and clinicians should consider time burdens as an important attribute in research and in clinic. Effective techniques for eliciting patients’ preferences regarding their own care, when treatment options offer marginal gains, is an important clinical need. This article evaluates the association between patients’ considerations of the time burdens of care (“time toxicity”) with decisions about hypothetical treatment options.

BackgroundOne-quarter of U.S. patients do not have a primary care provider or do not have complete access to one. Work and personal responsibilities also compete with finding convenient, accessible care. Telehealth services facilitate patients’ access to care, but whether patients are satisfied with telehealth is unclear.ObjectiveWe assessed patients’ satisfaction with and preference for telehealth visits in a telehealth program at CVS MinuteClinics.DesignCross-sectional patient satisfaction survey.ParticipantsPatients were aged ≥18 years, presented at a MinuteClinic offering telehealth in January–September 2014, had symptoms suitable for telehealth consultation, and agreed to a telehealth visit when the on-site practitioner was busy.Main MeasuresPatients reported their age, gender, and whether they had health insurance and/or a primary care provider. Patients rated their satisfaction with seeing diagnostic images, hearing and seeing the remote practitioner, the assisting on-site nurse’s capability, quality of care, convenience, and overall understanding. Patients ranked telehealth visits compared to traditional ones: better (defined as preferring telehealth), just as good (defined as liking telehealth), or worse. Predictors of preferring or liking telehealth were assessed via multivariate logistic regression.Key resultsIn total, 1734 (54 %) of 3303 patients completed the survey: 70 % were women, and 41 % had no usual place of care. Between 94 and 99 % reported being “very satisfied” with all telehealth attributes. One-third preferred a telehealth visit to a traditional in-person visit. An additional 57 % liked telehealth. Lack of medical insurance increased the odds of preferring telehealth (OR = 0.83, 95 % CI, 0.72–0.97). Predictors of liking telehealth were female gender (OR = 1.68, 1.04–2.72) and being very satisfied with their overall understanding of telehealth (OR = 2.76, 1.84–4.15), quality of care received (OR = 2.34, 1.42–3.87), and telehealth’s convenience (OR = 2.87, 1.09–7.94)ConclusionsPatients reported high satisfaction with their telehealth experience. Convenience and perceived quality of care were important to patients, suggesting that telehealth may facilitate access to care.

In absence of a COVID-19 vaccine, testing, contact tracing and social restrictions are among the most powerful strategies adopted around the world to slow down the spread of the pandemic. Citizens of most countries are suffering major physical, psychological and economic distress. At this stage, a safe and effective COVID-19 vaccine is the most sustainable option to manage the current pandemic. However, vaccine hesitancy by even a small subset of the population can undermine the success of this strategy. The objective of this research is to investigate the vaccine characteristics that matter the most to Australian citizens and to explore the potential uptake of a COVID-19 vaccine in Australia. Through a stated preference experiment, preferences towards a COVID-19 vaccine of 2136 residents of the Australian states and territories were collected and analysed via a latent class model. Results show that preferences for mild adverse cases, mode of administration, location of administration, price and effectiveness are heterogeneous. Conversely, preferences for immediacy and severe reactions are homogeneous, with respondents preferring a shorter period until vaccine is available and lower instances of severe side effects. The expected uptake of the vaccine is estimated under three different scenarios, with the value of 86% obtained for an average scenario. By calculating individual preferences, the willingness to pay is estimated for immediacy, effectiveness, mild and severe side effects.

•Treatment preferences are “sticky”: only a minority of patients change their minds about treatment based on N-of-1 trials.•Different schemes for defining treatment success lead to different conclusions about whether patients’ treatment choices are concordant with their own data.•Patients and clinicians need more help interpreting personalized results. To examine pain treatment preferences before and after participation in an N-of-1 trial. In this observational study nested within a randomized trial, we examined chronic pain patients’ preferences before and after treatment in relation to N-of-1 trial results; assessed the influence of different schemes for defining comparative “superiority” on potential conclusions; and generated classification trees illustrating the relationship between pre-treatment preferences, N-of-1 trial results, and post-treatment preferences. Treatment preferences differed pre- and post-trial for 40% of participants. The proportion of patients whose N-of-1 trials demonstrated “superiority” of one treatment regimen over the other varied depending on how superiority was defined and ranged from 24% (using criteria that required statistically significant differences between regimens) to 62% (when relying only on differences in point estimates). Regardless of criteria for declaring treatment superiority, nearly three-fourths of patients with equivocal N-of-1 trial results nevertheless expressed definite preferences post-trial. A large segment of patients undergoing N-of-1 trials for chronic pain altered their treatment preferences. However, the direction of preference change did not necessarily correspond to the N-of-1 results. More research is needed to understand how patients use N-of-1 trial results, why preferences are “sticky” even in the face of personalized data, and how patients and clinicians might be educated to use N-of-1 trial results more informatively.

Helping patients make decisions about their preferences for cardiopulmonary resuscitation (i.e., code status) is an important way to respect patient autonomy in the hospital. There is a gap in understanding which framework of discussion patients prefer for this decision-making. To determine which of two frameworks to code status discussions-information-centered or patient values-centered-make patients feel more heard and understood about their preferences regarding cardiopulmonary resuscitation (CPR). Prospective, randomized study comparing two different frameworks to CPR discussion. We enrolled adult patients with one or more serious illnesses who were recently discharged from an urban, tertiary care, academic medical center in Boston, MA. Subjects were randomized to receive either the information-centered framework, in which their likelihood of recovery following CPR was shared, or the patient values-centered framework, in which their personal values were elicited and used to make a recommendation. Subject-reported heard and understood rating with regard to their preferences for CPR. Of the 46 subjects enrolled, 25 (54.3%) were male, 42 (91.3%) were White, and 3 (6.5%) were Black. Mean age was 66.4 ± 11.8 years. Subjects reported feeling more \"heard and understood\" about their preferences for CPR with the patient values-centered framework compared with after the information-centered framework (p = 0.033). When asked, 89% of subjects \"definitely\" or \"probably\" wanted to hear their doctor's personalized recommendation about CPR (p < 0.001). Patients, in line with palliative care experts, largely support a patient values-centered framework to CPR, including a recommendation made by the clinician based on the patient's expressed values.

Abstract Background Despite the benefits of self-help resources in several chronic diseases, a knowledge gap exists regarding patients’ and clinicians’ experiences and attitudes toward multimodal self-help resources in inflammatory bowel diseases (IBD). Methods Confidence Optimization through Resources for Education, Engagement, and Empowerment (CORE) was a prospective, convergent parallel mixed-methods study conducted across 5 gastroenterology practices participating in the Crohn’s & Colitis Foundation’s IBD Qorus Learning Health System from 2022 to 2023. Five IBD-specific multimodal self-help resources (workbook, 2 smartphone apps, help center, and peer mentoring) were offered to patients. E-surveys (weeks 0, 6, and 12) and three 60-minute focus groups elicited the perspectives and experiences of patients and providers regarding self-help resources. Univariate, bivariate, and multivariate statistical analyses explored patients’ preferences, acceptability, and utilization of self-help resources. Results Of 536 patients with IBD, only 3.7% previously used self-help resources, yet 80.0% (427/536) selected at least one multimodal self-help resource when offered. Patients with low health confidence in managing IBD (adjusted odds ratio [aOR] 2.5, 95% CI, 1.1-5.6, P = .03) and females (aOR 2.5, 95% CI, 1.2-5.2, P = .02) were more likely to choose self-help resources. After 12 weeks, 75.0% (81/108) used at least 1 self-help resource. Asynchronous resources (books and smartphone apps) were used more often than synchronous resources (help center and peer mentorship). Patients preferred resources suggested by their clinicians, although clinicians expressed a lack of time in the clinic and a lack of knowledge about self-help resources as barriers. Conclusions Few patients with IBD use self-help resources, even though the majority regard multimodal self-help resources as acceptable and feasible to get information, find community and support, and manage living with IBD. Lay Summary Few patients with inflammatory bowel disease (IBD) use self-help resources, even though a majority find them feasible and acceptable for getting information, finding community and support, and managing the physical and psychosocial impacts of IBD. Patients prefer accessible self-help resources suggested by their clinicians. Graphical Abstract Graphical Abstract

Shared decision making is an approach to care that seeks to fully inform patients about the risks and benefits of available treatments and engage them as participants in decisions about the treatments. Although recent federal and state policies pursue the expanded use of shared decision making as a way to improve care quality and patient experience, payers and providers want evidence that this emerging model of care is cost-effective. We examined data obtained from a yearlong randomized investigation. The study compared the effects on patients of receiving a usual level of support in making a medical treatment decision with the effects of receiving enhanced support, which included more contact with trained health coaches through telephone, mail, e-mail, and the Internet. We found that patients who received enhanced support had 5.3 percent lower overall medical costs than patients who received the usual level of support. The enhanced-support group had 12.5 percent fewer hospital admissions than the usual-support group, and 9.9 percent fewer preference-sensitive surgeries, including 20.9 percent fewer preference-sensitive heart surgeries. These findings indicate that support for shared decision making can generate savings. They also suggest that a \"remote\" model of support-combining telephonic coaching with decision aids, for example-may constitute a relatively low-cost and effective intervention that could reach broader populations without the need for the direct involvement of regular medical care team members. [PUBLICATION ABSTRACT]