Gac Sanit. 2021;35(3):264–269 Original article Decision-making in HIV clinical trials: a study with patients enrolled in antiretroviral trials Maria Feijoo-Cida,b , Amado Rivero-Santanac,d,∗ , David Moriñae,f , Carina Cesarg , Valeria Finkg , Omar Suedg a Department of Nursing, Faculty of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain b Grup de REcerca Multidisciplinar en SAlut i Societat (GREMSAS) (2017 SGR 917), Spain c Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Santa Cruz de Tenerife, Las Palmas de Gran Canaria, Spain d Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain e Barcelona Graduate School of Mathematics (BGSMath), Bellaterra, Cerdanyola del Vallès, Barcelona, Spain f Departament de Matemàtiques, Universitat Autònoma de Barcelona, Barcelona, Spain g Fundación Huésped, Buenos Aires, Argentina a r t i c l e i n f o a b s t r a c t Article history: Objective: To explore the decisional process of people living with human immunodeficiency virus (HIV) Received 23 July 2019 currently enrolled in antiretroviral clinical trials. Accepted 27 November 2019 Method: Cross-sectional retrospective study. Outcome variables were reasons to participate, perceived Available online 18 March 2020 decisional role (Control Preference Scale), the Decisional Conflict Scale and the Decisional Regret Scale. Descriptive statistics were calculated, and associations among these variables and with sociodemographic Keywords: and clinical characteristics were analyzed with non-parametric techniques. Clinical trial Results: Main reasons to participate were gratitude towards Fundación Huesped (47%), the doctor’s rec- Human immunodeficiency virus Patient participation ommendation (32%), and perceived difficulty to access treatment in a public hospital (28%). Most patients Decisional conflict thought that they made their decision alone (54.8%) or collaboratively with the physician (43%). Decisional conflict was low, with only some conflict in the support subscale (median = 16.67). Education was the only significant correlate of the total decisional conflict score (higher in less educated patients; p = 0.018), whereas education, recent diagnosis, living alone, lower age, being man and doctor’s recommendation to go to Fundación Huésped related to higher conflict in different subscales. Nobody regretted to participate. Conclusions: The decision making regarding participation in HIV trials, from the perspective of partic- ipants, was made respecting their autonomy and with very low decisional conflict. Currently, patients show no signs of regret. However, even in this favorable context, results highlight the necessity of enhanc- ing the decision support in more vulnerable patients (e.g., less educated, recently diagnosed or with less social support), thus warranting equity in the quality of the decision making process. © 2020 SESPAS. Published by Elsevier España, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Toma de decisiones en los ensayos clínicos sobre el VIH: estudio con pacientes incluidos en ensayos de antirretrovirales r e s u m e n Palabras clave: Objetivo: Explorar el proceso de decisión de las personas que viven con el virus de la inmunodeficiencia Ensayo clínico humana (VIH) y participan en ensayos clínicos de antirretrovirales. Virus de la inmunodeficiencia humana Método: Estudio retrospectivo transversal. Las variables de resultado fueron los motivos para participar, Participación del paciente el rol de participación percibido (Escala de preferencia de control), la Escala de conflicto decisional y la Conflicto decisional Escala de arrepentimiento decisional. Se realizó una estadística descriptiva y se establecieron asociaciones entre estas variables con variables sociodemográficas y clínicas usando técnicas no paramétricas. Resultados: Las razones para participar fueron la gratitud hacia la Fundación Huésped (47%), la recomen- dación del médico (32%) y la dificultad percibida para acceder al tratamiento en un hospital público (28%). Los pacientes opinan que tomaron su decisión solos (54,8%) o en colaboración con el médico (43%). El conflicto en la decisión fue bajo, aunque hubo cierto conflicto en la subescala de apoyo (mediana = 16,67). La educación se relacionó con el conflicto en la decisión (mayor en pacientes con menor nivel educativo; p = 0.018), mientras que la educación, el diagnóstico reciente, vivir solo, la menor edad y la recomen- dación del médico de ir a la Fundación Huésped se relacionaron con un mayor conflicto en diferentes subescalas. Nadie se arrepintió de su participación. ∗ Corresponding author. E-mail address: amado.riverosantana@sescs.es (A. Rivero-Santana). https://doi.org/10.1016/j.gaceta.2019.11.008 0213-9111/© 2020 SESPAS. Published by Elsevier España, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc- nd/4.0/). M. Feijoo-Cid et al. / Gac Sanit. 2021;35(3):264–269 265 Conclusiones: Desde la perspectiva de los participantes, en el proceso de toma de decisiones se respetó su autonomía, hubo poco conflicto decisional y no aparecen signos de arrepentimiento. A pesar de este contexto favorable, los resultados destacan la necesidad de mejorar el apoyo a las decisiones en las per- sonas más vulnerables (con menos educación, de diagnóstico reciente o con menos apoyo social) para garantizar la equidad en la calidad del proceso de decisión. © 2020 SESPAS. Publicado por Elsevier España, S.L.U. Este es un artı́culo Open Access bajo la licencia CC BY-NC-ND (http://creativecommons.org/licenses/by-nc-nd/4.0/). Introduction Sample Clinical trials are essential to assessing new therapies and Fundación Huésped is one of the main clinical research sites advancing evidence-based treatments. Currently, the vast major- for HIV in Argentina, having participated in several national and ity of research about factors that influence participation in clinical international multisite clinical trials of antiretroviral treatment. trials, as well as interventions to improve it, has been carried out in This treatment is not included in the usual services provided by the field of cancer,1,2 in which only a small percentage of patients the institution (since it is covered by the national health system), consent to participate.3 Results have shown that barriers to par- and only patients participating in clinical trials have access to ticipate exist at different levels, related to the patient, the trial, or it in Fundación Huésped. Inclusion criteria were adult diagnosed contextual factors. Among personal factors, cultural and linguistic with HIV, participating in a HIV trial at Fundación Huésped, and diversity, lower income, or less trust in the physician or the health having signed the informed consent for trial participation within system are associated to a lower participation.4 Regarding the trial, the previous year. During the recruitment period, approximately uncertainties related to randomization and the benefit/risk balance 150 patients were participating in several clinical trials. Doctors at of the intervention investigated are basic aspects in the decision Fundación Huésped explained the study and invited to consecutive to participate.5 Finally, contextual factors such as distance to the eligible patients, and those who agreed signed consent and were research centre, the number of required visits or medical tests also individually interviewed by a researcher. The study was approved play an important role in potential participants’ decision.3 by the Research Ethics Committee of the Fundación Huésped (Study The few existing studies with patients diagnosed with human Fh-23). immunodeficiency virus (HIV) considering participation in clin- ical trials have focused on issues associated with the informed Measures consent process,6 ethnic minorities recruitment,7,8 or on barriers and motivators to participate in vaccination of people at high risk • Sociodemographic: age, sex, education, income (whether it cov- of infection.9,10 A recent systematic review of qualitative studies ers basic needs or not), job status, living alone (yes/no), country in sub-Saharan Africa (including studies of vaccination or treat- of origin. ment) concluded that participation in HIV research is associated • Clinical: time since diagnosis (more/less than 1 year), disease with considerable fear and uncertainty.11 Both feelings are influ- transmission (dichotomized into “Man who has sex with man enced by social relationships, socioeconomic and domestic factors, vs. other”), and viral load (detectable/undetectable). the research clinic context and the relationships with research • Decision-making: staff. Although these studies have produced a valuable knowledge about the psychological experience of HIV patients considering trial participation, specific variables related to the decision-making pro- - Control variables: months after signing informed consent, pre- cess (e.g., preference and perception of involvement, decisional vious participation in clinical trials (yes/no), whether they conflict and regret) remain mostly unexplored. In standard care actively asked for participation in the trial (yes/no), time to settings, research on HIV patients’ participation is also very scarce; make the decision (the same day/later). the few existing studies show that a majority of patients want - Reasons to participate: conjointly with doctors at Fundación to be involved in the decision about treatment,12–14 and that Huésped who recruit participants for clinical trials, we devel- this preference is associated to a better adherence to antiretrovi- oped a list of reasons/facilitators to participate in the trial ral treatment.12 Patients presented more decisional conflict (i.e., (yes/no format): 1) patient did not know where to go; 2) not uncertainty about treatment uptake) when they did not perceive having employment-based (private) health insurance (due to this desired level of participation.13 being unemployed); 3) perceived difficult to access treatment This study aims to explore the decisional process of people in a public hospital (due to bureaucracy, waiting lists); 4) their with HIV currently enrolled in clinical trials about pharmacological doctor recommended to go to Fundación Huésped; 5) feeling treatment. Specifically, we want to describe: 1) patients’ motives well treated or in debt with Fundación Huésped; 6) preferring for participating in the clinical trial; 2) their perceived decisional a modern treatment; 7) doing good to other patients; 8) pres- role; 3) the level of decisional conflict; 4) their current regret about sure to participate by the family; and 9) pressure to participate trial participation; and 5) associations among these variables as by their doctor. well as with sociodemographic and clinical factors. - Perceived decisional role was assessed with one item from the Control Preference Scale,15 but with three response options instead of five (mainly or only them/shared decision/the prac- Method titioner). - Decisional conflict was assessed retrospectively with the Span- This cross-sectional retrospective study was conducted from ish version of the Decisional Conflict Scale (DCS).16 It has 16 November 2016 to February 2017 in the Fundación Huésped, a not- items and five subscales: informed (about the alternatives, ben- for-profit organization located in Buenos Aires (Argentina), that efits and risks of the clinical trial), values (feeling clear about offers health and education services to people at risk or diagnosed personal values associated with the potential consequences of with transmissible diseases, especially HIV. the clinical trial), support (having advice and no pressure in 266 M. Feijoo-Cid et al. / Gac Sanit. 2021;35(3):264–269 decision-making), uncertainty (being clear about the choice) Table 1 Sociodemographic and clinical characteristics of participants (N = 93). and effectiveness (feeling that the decision was informed and congruent with own values). Patients were encouraged to Characteristics n (%) respond how they felt when making the decision to participate Age, mean (SD) 34.4 (11.5) in the trial. Scores were transformed to a 0-100 scale (higher Under 25 years 19 (20.4) scores indicates more conflict). 25-45 years 56 (60.2) - Regret about trial participation was assessed with the Decision Older than 45 years 18 (19.4) Regret Scale (DRS, 5 items from completely agree to com- Sex pletely disagree).17 The original English scale was translated Women 10 (10.8) Women trans 11 (11.8) into Spanish by the authors and then back-translated by an Men 72 (77.4) independent bilingual researcher. There were only a few dis- crepancies between the two versions, which were resolved by Educational level University Degree or some trade school 47 (50.5) consensus. Primary and or Secondary studies 46 (49.5) Country of origin • Subjective experience about trial participation: patients were Argentinian 68 (73.1) asked if they had felt like a guinea pig (yes/no), and whether Immigrant 25 (26.9) they had told their doctors about that (yes/no). They also were Live alone required to briefly explain, in an open answer, why they contin- Yes 54 (58.1) ued in the trial. No 39 (41.9) Employment status Work 74 (79.6) Statistical analyses Do not work 19 (20.4) Descriptive statistics were calculated (means, medians, stan- Monthly personal income Does not cover basic needs 49 (52.7) dard deviations, interquartile ranges, percentages). Associations Covers basic needs 44 (47.3) between categorical variables were assessed by means of ␹2 test. Diagnosis Due to the asymmetric distribution of the DCS total score and Less than 1 year 66 (71.0) subscales, we used non-parametric tests for analyses. In order to More than 1 year 27 (29.0) check the validity of the retrospective measure of decisional conflict Transmission (total score), its associations with the four control variables were Homosexual (men) 57 (61.3) analyzed; we expect a null association with time since informed Heterosexual (men and women) 20 (21.5) consent was signed (Spearman’s correlation and Kruskal-Wallis’ Women trans 11 (11.8) test, categorizing time in 0-3, 4-6, 7-9, and 10-12 months), and Other 5 (5.4) lower conflict in patients with previous experience in clinical tri- Viral load (n = 86) als, in those who actively asked for participating, and in those who Undetectable 68 (79.1) consented the same day they were invited (Mann-Whitney’s U- Detectable 18 (20.9) test). SD: standard deviation. For the remaining independent variables (sociodemographic, clinical, decisional), Mann-Whitney’s U-test was used to identify Table 2 Variables related to the decisional process regarding participation in HIV clinical those related to the DCS (total score and subscales) and DRS. The trials (N = 93). perceived decisional role showed only two subjects who responded “mainly or only the practitioner”, and therefore only the two other Variables n (%) categories were compared. Analyses were conducted with SPSS Months after signing informed consent, mean (±SD) 6.33 (3.7) 21.0. Time spent in decision making The same day the doctor explained the clinical trial 75 (80.6) At least three days later 18 (19.4) Results First clinical trial 82 (88.2) Ninety-nine consecutive patients enrolled in clinical trials were Patient actively asked for participation 12 (12.9) invited to participate, and 93 agreed. Mean age was 34.4 and 77.4% Reasons to participatea were men. Approximately half of the sample had only primary or Did not know where to go 9 (9.7) secondary studies, 58.1% lived alone and almost one-third were Not having employment-based (private) health insurance 12 (12.9) Perceived easier access to treatment than in the public system 26 (27.9) immigrants. Most worked (79.6%) but a 52.7% had a salary insuf- Doctor recommended to go to Fundación Huésped 30 (32.3) ficient to cover basic needs. Seventy-one per cent had the HIV Felt well treated or in debt with Fundación Huésped 44 (47.3) diagnosis within the previous year, and 88.2% were enrolled in their Preferred a modern treatment 12 (12.9) first clinical trial (Tables 1 and 2). Wanted to do good to others 21 (22.6) Felt under pressure to participate by the family 6 (6.5) Felt under pressure to participate by the doctor 3 (3.2) Reasons/facilitators to participate Perceived decisional role Mainly or only the practitioner 2 (2.2) The most frequent reasons to participate in the trial were hav- Patient and practitioner together 40 (43.0) ing feeling well treated or in debt with Fundación Huésped (47.3%), Mainly or only the patient 51 (54.8) the doctor’s recommendation of going there (32.3%), perceived dif- Felt as a guinea pig (n = 89) 18 (20.2) ficulties to access treatment in the public system (27.9%), and the Discussed it with the doctor 4 (4.5) desire of doing good to other patients (22.6%) (Table 2). Only a 12.9% SD: standard deviation. stated that they preferred a modern treatment, and very few felt a The sum of percentages is greater than 100% because participants could choose pressured by their doctor (3.2%) or family (6.5%). more than one reason. M. Feijoo-Cid et al. / Gac Sanit. 2021;35(3):264–269 267 Table 3 obtained p-values of 0.069 and 0.066, respectively (in the latter, Participants’ decisional conflict (retrospectively assessed) and regret with the deci- however, the association was in the contrary direction). For sion (range: 0-100). informed and values, a recent diagnosis (<1 year) was significantly Cronbach’s alpha Mean ± SD Median (IQR) associated to more conflict. Living alone related to less perceived DCS total score 0.66 10.33 (9.10) 9.38 (3.13-15.63) support. For uncertainty, significant correlates were being man DCS informed 0.74 9.32 (17.11) 0 (0-16.67) and lower age. Finally, the perceived effectiveness of the decision DCS values clarity 0.73 7.08 (15.15) 0 (0-0) was lower in younger patients and in those recommended to go DCS support 0.64 26.88 (28.47) 16.67 (0-66.67) to Fundación Huésped by their doctor (none of the remaining DCS uncertainty 0.63 9.14 (14.95) 0 (0-16.67) DCS effectiveness 0.35 2.02 (4.98) 0 (0-0) motives-related variables or the perceived decisional role sig- DRS - 0 (-) 0 (-) nificantly related to decisional conflict). We did not perform the DCS: Decisional Conflict Scale; DRS: Decisional Regret Scale; IQR: interquartile planned multiple regression analyses for the subscales, because range; SD: standard deviation. their non-normality did not resolve after several arithmetic trans- formations. Nonetheless, there were only two predictors in each Table 4 model, and they were unrelated in all cases. Univariate significant correlates of decisional conflict. Independent variables Estimatea (p) Decisional regret DCS total Lower education 775.5 (0.018) Informed Recent diagnosis 660 (0.017) All participants scored zero on the DRS. Values Lower education 732.5 (<0.001) Recent diagnosis 715.5 (0.046) Subjective experience Support Lower education 772.5 (0.012) Living alone 717 (0.006) Uncertainty Age r = − 0.27 (0.007) There was four missing responses to this question (n = 89). Eigh- Being man 545 (0.028) teen patients (20.2%) reported having felt like a guinea pig, and only Effectiveness Age r = − 0.27 (0.008) four of them told about that with the doctor. Open answers revealed Doctor recommended 766.5 (0.026) that in most cases that subjective feeling had not emotional neg- to go to Fundación Huésped ative consequences, and that participants understood that clinical trials are necessary to obtained health benefits for them or for other DCS: Decisional Conflict Scale. a Mann-Whitney’s U, except where indicated (Spearman’s r). people with HIV. Discussion Gratitude towards Fundación Huésped significantly related to the perceived difficulty to access to treatment in a public hospital This study explored retrospectively the decisional process of (␹2 = 12.7; p < 0.001) and not having employment-based insurance patients with HIV, enrolled in clinical trials evaluating antiretrovi- (12.9%) (␹2 = 7.17; p = 0.007). ral treatments, as well as their current regret. Among the assessed reasons/facilitators for trial participation, those associated with Decisional role the personal experience with Fundación Huésped (i.e, gratitude towards the institution due to the services it offers to patients, Most patients thought that they made their decision alone doctor’s recommendation, and easy access to treatment through (54.8%) or shared the decision with the doctor (43.3%) (Table 2). clinical trials) have been more frequent than a desire for modern None of the sociodemographic, clinical and motives-related vari- treatments, altruistic motives or external pressures. The sample ables significantly differed between these two groups. recruited had a considerable level of economic deprivation (52% stated having a monthly income which does not cover their basic Decisional conflict needs), and although treatment for HIV is covered by the national health system, more than a quarter of participants perceived an Cronbach’s alpha for the DCS total score was 0.66 (Table 3). The easier access in Fundación Huésped (due to excessive bureaucracy subscales ranged 0.63-0.74, except effectiveness, which showed a and waiting lists in the public system). value of 0.35. The Kolmogorov-Smirnov’s test for normality yielded These patients’ characteristics could make them more vulner- a p-value of 0.095 for the total score and p < 0.001 for the subscales, able to pressures to participate from doctors or their family, but with scores asymmetrically distributed towards low levels of con- results showed that very few participants perceived this pressure, flict. The median total score was 9.38 (interquartile range [IQR]: and most thought that they had decided autonomously or in col- 3.13–15.63), and four subscales obtained medians of zero. The sub- laboration with the doctor. Professionals in Fundación Huésped scale with higher median was support (16.67; IQR: 0–66.67). have not specific formation in shared decision making, beyond their The DCS was not significantly related to the time elapsed since personal attitudes and abilities in the interaction with patients. In the informed consent for trial participation was signed (Spearman’s standard care settings, where shared decision-making is advocated r = 0.08; p = 0.461), nor after categorizing time into four periods as the gold standard in diagnostic or treatments decisions,18,19 (Kruskal-Wallis’ test; p = 0.621). Compared to their counterparts, a perception of being included in treatment decisions has been conflict was lower in patients who asked for participation (n = 12; shown to be associated to less decisional conflict, in HIV13 and other U = 299; p = 0.031). Results of having previous experience in clinical conditions20,21 (we could not test this association since only two trials (n = 11; U = 297; p = 0.066), and having signed informed con- patients perceived not to be involved in the decision). In the sce- sent the same day of the invitation (n = 75; U = 532, p = 0.161) were nario of clinical trials, however, there is usually more uncertainty in the expected direction of lower conflict, but they did not reach about treatment’s benefits and risks, and the concept of informed significance. (vs. shared) decision-making could be seen more appropriate, due Table 4 shows the significant univariate correlates of the DCS. to ethical and legal concerns. However, many patients prefer and/or Lower education related to more conflict in the total score and the perceive a collaborative decision process with professionals,22 as it subscales values and support, whereas informed and uncertainty has occurred in our sample. 268 M. Feijoo-Cid et al. / Gac Sanit. 2021;35(3):264–269 In the trade-off between motives/psychological needs favoring Second, carrying out the study in the Fundación Huésped increases participation in the trial, and its perceived potential harms or incon- the risk of social desirability bias, possibly contributing to the low veniences, the former clearly prevailed as reflected in the low level level of conflict and regret reported. Third, as discussed above, the of decisional conflict reported. We cannot know the quality of par- assessment of decisional variables, except regret, was retrospec- ticipants’ objective knowledge about the trials’ benefits and risks tive, which could be subjected to memory or reconstruction bias. when making the decision; previous research has shown that less Fourth, the floor effect observed in the DCS could obscure its asso- objectively informed participants were more likely to participate.23 ciations with the remaining variables. Finally, we assessed multiple Patients in our sample stated being well informed about the poten- associations between many variables without adjusting the signifi- tial benefits and harms of the clinical trial (subscale informed), clear cance level, with the subsequent increase in the risk of type I error; about the importance they attribute to those consequences (values) however, the few significant associations found mostly have a clear and sure about the decision (uncertainty, effectiveness). The retro- theoretical sense. spective nature of the measure could influence these results, since the current satisfaction with participation in the trial (reflected in Conclusions the complete absence of decisional regret) might introduce a pos- itive retrospective bias. The validity tests performed were in the Despite its limitations, this study contributes to the limited evi- predicted direction (even in a context of a floor effect), but the risk dence on HIV patients’ decision-making regarding participation in is not disposable. The effectiveness subscale is possibly the most clinical trials. In this sample of HIV patients, the decision-making likely to be sensible to retrospective bias, since it can be seen as a in a clinical trial was perceived retrospectively as respectful with reverse measure of regret, and in fact it obtained by far the lowest their autonomy and with a very low level of decisional conflict. mean score. Participation was mainly driven by a feeling of reciprocity towards The subscale support was the only one which showed some a non-profit organization which offers support and education ser- level of conflict. A majority of participants (58%) lived alone, and vices for patients. Even in this favorable scenario, results highlight this variable significantly related to worse scores on this subscale. the necessity of enhancing the decision support in more vulner- On the other hand, previous research has shown that disclosure able patients (e.g., less educated, recently diagnosed, or in those of HIV status is an important stressor because it may expose peo- with less social support), thus warranting equity in the quality of ple to stigma, discrimination, abandonment, violence and moral the decision making process. More research is needed to deter- challenges.24 Most of our participants had been diagnosed within mine predictors of participation in HIV trials and the quality of the the previous year and enrolled in the trial a mean of 6.6 months decision process. ago. Therefore, it is likely that a number of them still had not shared with many people their fears and uncertainty associated with living with HIV and starting treatment, increasing their feeling of being unsupported. A lower education level was the only significant predictor of the What is known about the topic? decisional conflict total score. This association is possibly medi- ated by a better understanding of doctor’s explanations about the There are few studies with patients diagnosed with human trial in more educated patients, since knowledge of the disease and immunodeficiency virus (HIV) focused on participation in clin- the therapeutic procedures has been shown to be related to less ical trials. The decision-making process of people living with HIV invited to participate in antiretroviral clinical trial remains decisional conflict in other medical conditions.25 Other psycholog- mostly unexplored. Participation in HIV research is associated ical variables like decisional self-efficacy could also mediate this with considerable fear and uncertainty. result.26,27 Therefore, a correct understanding of clinical trials’ pro- cedures and outcomes in less educated patients must be enhanced, What does the study add to literature? as occurs with other vulnerable populations such as rural28 or eth- nic minorities.29 Educational and decision support interventions Many participants thought they shared the decision to par- (e.g., decision aids) could help to fill these gaps in knowledge, pro- ticipate with their physicians even though in clinical trials is moting an actual informed decision and also improving attitudes encouraged the informed decision-making. Decisional conflict towards clinical trials.30 was low and nobody regretted participation. Education signifi- cantly related to less conflict in the total score of the decisional Patients did not show decisional regret at all. Previous research conflict scale and the subscales values and support. Living about trial participation has focused mainly on the phase of invi- alone significantly related to less perceived support in the deci- tation and acceptance, but few studies have analyzed participants’ sion. People newly HIV diagnosed, with low education or living regret.31–33 In standard care settings in other medical conditions, alone, should be paid special attention in the informed consent both the decisional conflict when making treatment decisions, and process. the subsequent occurrence of adverse effects, have been shown to be associated (among other factors) with later regret.34,35 Both vari- ables could be responsible of the complete absence of decisional regret in our sample. Editor in charge Limitations Azucena Santillán. This study was a first approximation to the decisional process about participation in HIV trials, and it has several limitations. The Transparency declaration sample was relatively small and represents only part of the “pic- ture”, since it included mostly recently diagnosed patients who The corresponding author on behalf of the other authors guar- consented to participate in trials for initial HIV treatment, and antee the accuracy, transparency and honesty of the data and among these, those who have not discontinued their participation information contained in the study, that no relevant information due to adverse effects or other reasons. Furthermore, results are not has been omitted and that all discrepancies between authors have generalizable to other socioeconomic contexts or health systems. been adequately resolved and described. M. Feijoo-Cid et al. / Gac Sanit. 2021;35(3):264–269 269 Authorship contributions 12. Beach MC, Duggan PS, Moore RD. Is patients’ preferred involvement in health decisions related to outcomes for patients with HIV? J Gen Intern Med. 2007;22:1119–24. All authors made substantial contributions to conception and 13. Kremer H, Ironson G, Schneiderman N, et al. ”It’s My Body”: does patient design of this study. Feijoo-Cid & Sued, worked in the design and involvement in decision making reduce decisional conflict? Med Decis Mak. conceptin of the work. Feijoo-Cid & Rivero-Santana performed 2007;27:522–32. 14. Kumar R, Korthuis PT, Saha S, et al. Decision-making role preferences among data analysis. All authors contributed to the interpretation of data. patients with HIV: associations with patient and provider characteristics and Feijoo-Cid, Rivero-Santana & Sued were involved in drafting the communication behaviors. J Gen Intern Med. 2010;25:517–23. manuscript and the rest of the authors revised it critically for impor- 15. Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997;29:21–43. tant intellectual content. All authors gave final approval of the 16. Urrutia M, Campos S, O’Connor A. Validación de una versión en español de la version to be published. Escala de Conflicto Decisional. Rev Med Chil. 2008;136:1439–47. 17. Brehaut JC, O’Connor AM, Wood TJ, et al. Validation of a Decision Regret Scale. Med Decis Mak. 2003;23:281–92. Acknowledgements 18. Leng G, Clark CI, Brian K, et al. National commitment to shared decision making. BMJ. 2017;359:j4746. We thank all participants who generously answered the ques- 19. Hargraves I, Montori VM. Decision aids, empowerment, and shared decision making. BMJ. 2014;349:g5811. tionnaire. We also thank Horacio Beylis, Emanuel Fojo, Virginia 20. Becerra Pérez MM, Menear M, Brehaut JC, et al. Extent and predictors of decision Salazar and Fernanda Nadir Cardozo for their contributions to the regret about health care decisions. 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