Ethics reporting practices in randomized controlled trials of physical therapy interventions after stroke

Ethics reporting practices in randomized controlled trials of physical therapy interventions... Background: Adequate reporting of ethics-related research methods promotes convergence on best ethics practices. In physical therapy, studies on ethics reporting are limited to few aspects, and none focuses on stroke research. Our objectives were to investigate the reporting of multiple ethics-related features and its variation over time, and the characteristics of the studies associated with ethics reporting in Randomized Controlled Trials (RCTs) of physical therapy interventions after stroke. Methods: A random sample of RCTs published in the years 2004, 2009 and 2014, was extracted from the PubMed database, regardless of the publishing journal. For each trial we investigated year of publication, trial registration, sample size, stroke subtype, phase of the disease, setting, interventions and dosing, outcome measures, outcome of the study, PEDro score and 5-year impact factor of the publishing journal. Reporting of ethics-related issues was analyzed. Differences between groups were examined. Multiple regression was used to evaluate the relationship between ethics-related issues reporting and some studies’ characteristics. Results: Eighty studies were reviewed. Groups differed in the proportion of registered trials (p = .009), 5-year impact factor (p = .011), assessment of cognitive capacity (p = .049), declaration about conflict of interest (p < .001), and number of ethics-related issues reported (p = .009). The proportion of issues reported ranged from 92.5% (consent obtaining) to 0% (eventual follow up care). Post-hoc comparisons showed significantly greater reporting of ethics issues in trials published in the year 2014 compared to 2004 (p = .014, 95%CI = 0.40/4.26). Year of publication and PEDro score were significant predictors of adequate reporting. Conclusions: Authors, editors, and reviewers should be more rigorous and demanding about the reporting of ethic-related methods in randomized controlled trials of physical therapy interventions after stroke. Keywords: Ethics reporting, Physical therapy, Randomized controlled trials, Stroke Background Randomized controlled trial (RCT), systematic review The importance of ethics in clinical research has been and meta-analysis of RCTs are considered reliable re- well-established for many decades [1]. A growing atten- search designs, able to evaluate the effectiveness of an tion is given to determine the best ethical practices for intervention [1]. The design of a clinical trial implies ad- conducting observational and experimental studies [2]. herence to challenging and multifaceted ethical and Methodological quality, approval by a research ethics methodological standards that must integrate each other committee, and obtaining informed consent from partic- [4]; Ashton et al. in their taxonomy indeed identified five ipants are the main ethical issues in research with hu- major categories, with over 5900 possible standards [4]. man beings [3]. Differences among research topics and study designs may add further variability in ethical requirements [5–8]. Research conducted with little methodological * Correspondence: francescoferrarello@tiscali.it rigor does not lead to knowledge or benefit, and ex- Functional Rehabilitation, Azienda USL Toscana Centro, Via Cavour 118/120, poses participants to unnecessary burden or harm [9]. 59100 Prato, Italy Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 2 of 10 Thus methodological and ethical requirements of a recommendations [21]. Based on a sample of RCTs of study have a symbiotic relationship [10] and, in order to physical therapy interventions after stroke, our objectives make readers able to fully evaluate clinical research, both were to investigate the reporting of multiple ethics-related should be appropriately reported [3]. Adequate reporting features and its variation over time, as well as the charac- of research findings may promote the implementation of teristics of the studies associated with ethics reporting. evidence-based clinical practice in many fields, including A random sample of RCTs indexed in PubMed was physical therapy [11]. However, reporting of scientific extracted, regardless of the publication journal. To be methods receives considerably greater attention, as com- included, the studies had to be published in English in pared with reporting of research ethics issues [12]. Many the years 2004, 2009 and 2014, involve a parallel-group guidelines have been published to improve the reporting design, and evaluate an experimental physical therapy of RCTs, and adherence to these guidelines is usually intervention administered to adult (age ≥ 18 years) indi- considered necessary for publication [12]. Recommenda- viduals with stroke. tions on how ethics issues should be reported in re- The rationale for choosing the three years was the fol- search studies are also available [13], although evidence lowing. The year 2014 had just ended when we drafted suggests flaws in publication requirements and reporting the protocol; it was chosen to give a contemporary view. of ethical protections [14]. Thus, descriptions provided To have a time perspective, we chose the years 2004 and by journal articles contain little information about 2009 as comparators, thus covering a period of ten research ethics methods [12]. years. Research reproducibility refers to the possibility to du- Interventions were considered suitable if included in the plicate the results of prior studies, and is based on a clear classification proposedbyDeJongetal. [22], or listed in the and comprehensive description of study design [15]. The book “Guide to Physical Therapist Practice”[23], or reviewed concept of ethical reproducibility was recently introduced. in the Clinician’s Handbooks of the Evidence-Based Review Ethical reproducibility prescribes thorough reporting and of Stroke Rehabilitation-motor rehabilitation [24]. critical evaluation of the ethics methods employed in For the selection of the studies, the term “stroke” biomedical research [16]. Although ethics committee followed by “physical therapy” was entered in the search approval is a crucial aspect of ethics in research and is box, filtered by the type of study (RCT). Additional fil- usually considered as a proxy measure for the fulfillment ters related to the year of publication (2004, 2009 and of all ethical requirements in research [14], it is not suffi- 2014) were then added one at a time to obtain a list of cient to judge the overall ethical quality of an RCT [17]. studies for each of the years of interest. The resulting Including ethics-related methods in research reports may search strategy was the following: ((“stroke”[MeSH address concerns raised by researchers, clinicians, and Terms] OR “stroke”[All Fields]) AND (“physical therapy other stakeholders [2]. Moreover, ethical reproducibility modalities”[MeSH Terms] OR (“physical”[All Fields] AND can promote benefits such as learning, inner reflection, “therapy”[All Fields] AND “modalities”[All Fields]) OR increase of ethical responsibility, critical research assess- “physical therapy modalities”[All Fields] OR (“physical”[All ment, and use of better ethical practices [12]. Fields] AND “therapy”[All Fields]) OR “physical thera- In the physical therapy field, interest on ethical issues py”[All Fields])) AND Randomized Controlled Trial[ptyp] of the profession is remarkable, yet it mainly focuses on AND ((“2004/01/01”[PDAT]: “2004/12/31”[PDAT]) OR clinical practice, whereas only few papers have been (“2009/01/01”[PDAT]: “2009/12/31”[PDAT]) OR (“2014/ published over the years addressing ethics in physical 01/01”[PDAT]: “2014/12/31”[PDAT])). therapy research [18]. Studies on issues related to ethics In each year, a random sample of the studies in the in RCTs reporting were limited to ethics committee ap- PubMed-generated list was extracted. A formal sample proval, informed consent, and confidentiality [14, 19]. size calculation was not performed because of lack of Although stroke represents a major topic in physical preliminary data; indeed, previous studies differed from therapy research [20], none of the studies published on the present one in eligibility criteria, sources and ethical aspects of physical therapy research focused on methods of studies selection, and variables of interest. In stroke. Therefore, because available knowledge does not the absence of references, to quantify the sample size we appear to be exhaustive and satisfactory, we designed were inspired by Pinto et al. research on RCTs registra- the present study with the aim to investigate ethics tion,[25] and we established 20 % of the studies as the reporting characteristics in RCTs of physical therapy target sample. We performed calculations based on the interventions after stroke. total number of articles present in the lists, before the screening process. The random selection was performed Methods in August 2015, by entering the sequence numbers of The reporting of this study conforms to the Strengthening the lists acquired through search in an on-line the Reporting of Observational studies in Epidemiology randomization program [26]; the studies were then Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 3 of 10 assessed for eligibility following the randomized sequence,  incentives or compensation for participants until the desired sample size was reached. Full texts of the  details about incentives or compensation given to articles were retrieved following a flow-chart (Fig. 1). participants Reasons for exclusion were given for each study ex-  funders cluded. Two reviewers (MV; FF) independently evaluated  details about funders the studies selected for final inclusion; disagreement was  potential conflicts of interest resolved by consensus.  details about conflicts of interest Relevant data were extracted using a standard data  steps taken to assess if eligible individuals were able recording spreadsheet, including characteristics of the to provide informed consent (e.g. use of validated studies and research ethics-related issues. screening tools for cognitive ability) Data related to year of publication, clinical trial regis-  measures taken to ensure the best interests of tration, sample size, stroke subtype, phase of the disease, participants with reduced competence setting, interventions administered, dosing of the inter-  steps taken to ensure that the sample size was ventions, outcome measures, and outcome of the study sufficient to achieve adequate statistical power were extracted from each article included. Information  appropriateness of comparators about 5-year impact factor of the publishing journal was  justification for the eventual use of placebo acquired [27].  potential harm for participants In the absence of a standardized comprehensive list,  plans for collecting, assessing, reporting, and issues related to ethics in RCTs reporting were chosen managing adverse events and other unintended considering what has been contemplated in previous effects of trial interventions or trial conduct publications [2, 14, 17, 28]. The following aspects were  appropriate follow up care investigated in each article:  steps taken to prevent unauthorized access to personal and clinical data (confidentiality) ethics review committee or institutional review  accordance with the Helsinki Declaration. board study approval details about the ethics committees We assumed the definition of appropriateness of com- obtainment of informed consent parator proposed by Caprino and Russo [29]; in the pres- details about the consent process ence of multiple interventions groups, we considered the Fig. 1 Full text retrieving flow chart Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 4 of 10 most active comparator intervention. For each study in- based on the year of publication were examined using cluded, the number of ethics-related issues reported was the Kruskal-Wallis or the one-way ANOVA tests for calculated by summing up any reported or mentioned interval variables. Pearson χ test was used for nominal issue. The maximum achievable was 22 issues. The and ordinal variables, except when cell counts were extended list of questions is detailed in the Appendix. < 5, in which case Fisher exact test was used. Linear Data were extracted from an investigator (MV) and subse- trends (across years) were considered as appropriate. In quently double-checked (FF). Any disagreement was re- case of significant results, post-hoc tests were performed solved by consensus. The PEDro score of methodological to explore differences between any two pairs of years. quality was verified for each study [30]. This tool is reli- Multiple linear regression was performed to assess the able [31] and useful for assessing the quality of studies in ability of year of publication, trial registration, PEDro stroke rehabilitation [30]. Criteria for quality assessment score, and 5-year impact factor to predict the number of are represented by randomness and concealment of ethics-related issues reported in each article selected. allocation, baseline comparability between groups, blind- Preliminary analysis was performed to ensure there was ing of participants, therapists, and assessors, adequacy no violation of the assumption of normality, linearity, of follow-up assessments, intention-to-treat analysis, and multicollinearity. between-group comparisons, reporting of point esti- Analyses were performed using IBM SPSS Statistics mates and variability. The PEDro score ranges from 0 for Windows (version 20.0; IBM Corp, Armonk, NY). (poor quality) to 10 (excellent quality); a score of 6 is The significance level was set at a p value of <.05. conventionally considered as a threshold to identify high-quality studies [32]. Results The search on PubMed generated lists of 57, 119, and Statistical analysis 177 articles (total 353) for the years 2004, 2009, and Descriptive statistics was initially performed. Five-year 2014, respectively. The target sample size was set at 11 impact factor equal to zero were attributed to the three studies for 2004, 24 studies for 2009, and 35 studies for journals not found in the Journal Citation Reports data- 2014. After randomization, a total of 162 papers were base [27]. In one case where only the impact factor was retrieved; the selection process led to the inclusion in available, the same value was assigned as 5-year impact the study of 80 articles (Fig. 2). factor. Expectation-maximization imputation was used to address missing values (2.5 and 5% respectively) of Study characteristics the number of sessions per week and the minutes per Studies’ characteristics are presented in Table 1. Eighteen session needed to calculate the dosing of the interven- percent of the selected trials had been registered. The tion in hours. Shapiro-Wilk’s test was used to test the proportion of registered trials increased substantially normality of distribution. Differences between groups across the three years; post-hoc comparison showed that Fig. 2 Studies selection flow chart. /*Including protocols, observational studies, preliminary reporting (e.g. recruitment or sample characteristics), non-randomized trials, and within-subject or cross-over design studies. PT = Physical Therapy. RCT = Randomized Controlled Trial Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 5 of 10 Table 1 Characteristics of the studies Year 2004 2009 2014 p All studies (n = 13) (n = 28) (n = 39) (n = 80) a b 5-year Impact factor 2.967 (2.447/4.625) 4.206 (2.455/4.626) 2.179 (1.647/3.503) .011 2.784 (2.130/4.626) c d Trial registered 0 (0.0) 2 (7.1) 12 (30.8) .009 14 (17.5) a b Sample size 28 (20.0/47.0) 39 (31.5/65.0) 34 (23.0/52.5) .212 38 (23.5/56.5) Intervention groups 2 groups 11 (84.6) 21 (75.0) 34 (87.2) .418 66 (82.5) ≥ 3 groups 2 (15.4) 7 (25.0) 5 (12.8) 14 (17.5) Etiology Ischemic 1 (7.7) 8 (28.6) 5 (12.8) 14 (17.5) Hemorrhagic 0 (0.0) 0 (0.0) 1 (2.6) .305 1 (1.2) Mixed 7 (53.8) 16 (57.1) 21 (53.8) 44 (55.0) None declared 5 (38.5) 4 (14.3) 12 (30.8) 21 (26.2) Phase of the disease-onset < 6 months 4 (30,8) 15 (53.6) 14 (35.9) 33 (41.2) ≥ 6 months 8 (61.5) 12 (42.9) 23 (59.0) .516 43 (53.8) None declared 1 (7.7) 1 (3.6) 2 (5.1) 4 (5.0) c d Placebo-sham comparator 2 (15.4) 5 (17.9) 9 (23.1) .807 16 (20.0) ae b Intervention dosing-hours 18.0 (6.0/22.5) 15.5 (11.0/27.0) 24.0 (10.0/34.7) .139 18.0 (9.0/30.0) At least one outcome Favorable 9 (69.2) 20 (71.4) 25 (64.1) .855 54 (67.5) Nonsignificant 11 (84.6) 25 (89.3) 36 (92.3) .614 72 (90.0) Unfavorable 1 (7.7) 1 (3.6) 3 (7.7) .705 5 (6.2) a b PEDro score 6 (5.0/6.0) 6 (5.0/7.0) 6 (5.0/7.5) .073 6 (5.0/7.0) median (1th quartile/3rd quartile) Kruskal-Wallis test absolute frequencies (percentages) Fisher exact test after Expectation-maximization imputation the probability to be not registered was greater for trials balance (13 studies), walking (9 studies), arm-hand activ- published in the years 2004 and 2009 compared to those ities (26 studies), and activities of daily living (24 studies) published in the year 2014 (Table 2). of the International Classification of Functioning domains. Median 5-year impact factor was 2.784 (1th quartile 2.130, 3rd quartile 4.626). Five-year impact factor was Ethics reporting greater in 2009 than in the other two years, with no Ethics committee or institutional review board study clear linear-by-linear change; post-hoc comparison approval was reported in 65 (81.2%) studies, and 74 indicated that it was significantly greater in RCTs (92.5%) articles mentioned that consent was obtained. published in the year 2009 compared to 2014 Details about the ethics committee and the consent (Table 2). PEDro score ranged from 3 to 8 (median process were available in half of the cases (51.2 and 6); there were no significant differences between years 52.5%, respectively) (Table 3). One paper failed to report of publication (Table 1). both ethics committee approval and obtainment of Neuromuscolar interventions were most frequently informed consent (Fig. 3). applied (53 studies), followed by musculoskeletal inter- The Mini-Mental State Examination or similar test ventions (20 studies). Standard care was frequently used aimed to assess cognitive capacity were administered in as side intervention, or comparator (32 studies). The the inclusion stage in 41 (51.2%) publications, namely outcome measures used to investigate the efficacy of the in 3 (23.1%), 18 (64.3%), and 20 (51.3%) studies in year interventions mainly belonged to muscle and movement 2004, 2009, and 2014, respectively; this difference functions (21 studies), gait pattern functions (17 studies), across the three years was borderline significant but Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 6 of 10 Table 2 Post-hoc test results published in the years 2004 and 2009 compared to those published in the year 2014 (Table 2). Variable 95% CI p Statements about sample size estimation were identi- Trial registration b fied in 30 (37.5%) articles, 27 of which performed a 2004 vs 2009 1.077 .972 to 1.193 1.000 power calculation. We considered appropriate the com- 2004 vs 2014 1.444 1.172 to 1.781 .024 parator interventions in 68 (85.0%) cases; participants 2009 vs 2014 1.341 1.062 to 1.693 .031 received the same amount of attention in 60 (75.0%) 5-year impact factor trials, whereas in the remaining ones the attention was 2004 vs 2009 −.264 −1.659 to .629 .480 minor, or the control inactive. Justification for the use of placebo was always reported. Out of the 16 RCTs reporting 2004 vs 2014 .745 −.528 to 1.399 .219 the use of placebo/sham controls, the experimental inter- 2009 vs 2014 1.100 .328 to 1.842 .002 vention was represented by electrical stimulation in 10, by Assessment of reduced competence acupuncture in 2, by a combination of acupuncture and 2004 vs 2009 2.154 1.207 to 3.844 .020 electrical stimulation in 2, by action observation train- 2004 vs 2014 1.579 1.018 to 2.448 .110 ing in 1, and by respiratory muscles training in 1. 2009 vs 2014 .733 .405 to 1.325 .289 Potential harm for participants was mentioned in 17 (21.2%) studies, and mainly included increased pain and/ Potential conflicts of interest b or fatigue, risk of falls, and unstable cardiovascular 2004 vs 2009 1.077 .737 to 1.573 1.000 status. Plans for collecting, assessing, reporting, and 2004 vs 2014 3.333 1.748 to 6.358 .001 managing adverse events and other unintended effects 2009 vs 2014 1.341 1.062 to 1.693 .031 of trial interventions were reported respectively in 13, Number of ethics-related issues reported 11, 3, and 8 of these articles. The reporting of presence/ 2004 vs 2009 −0.96 −2.98 to 1.06 .494 absence of harm or adverse events was observed in 31 (38.8%) cases (Table 3). None of the studies mentioned 2004 vs 2014 −2.33 −4.26 to −0.40 .014 eventual follow up care. 2009 vs 2014 −1.37 −2.86 to 0.12 .078 Although we found a clear reference to steps taken to CI Confidence Interval protect anonymity in only one article, confidentiality was Relative risk for the absence of the characteristic Fisher exact test always preserved. Eighteen publications (30%) showed Mann-Whitney test and Hodges-Lehmann estimator, data are pictures depicting models or participants: with only two median differences d 2 Pearson χ test exceptions, faces were shown only in part (twice masking Tukey’s test, data are mean differences the eyes region) or were shielded. As previously noted, one study reported a specific consent for publication of the participant’sphotos. had no linear-by-linear association (Table 3). In a The number of ethics-related issues reported was sig- post-hoc test a significantly greater probability that nificantly different across the three years considered such assessment would not be performed was observed (one-way ANOVA F(5.07) = 6.345, p = .009) (Table 3); for studies published in the year 2004 compared to Tukey post-hoc comparisons showed that this number 2009 (Table 2), Only 3 papers published in 2009 was significantly higher in RCTs published in the year specified how consent was acquired for vulnerable 2014 compared to 2004, whereas there was no signifi- participants. Separate consents for videotaping or for cant difference between the years 2004 and 2009, and publication of participant’s photos were reported, each the years 2009 and 2014 RCTs (Table 2). in one study. Incentives or compensation for participants (money or Multivariable predictors of ethics reporting gifts, or free transportation to the research center) were Multiple regression showed that the number of stated in 3 articles published in 2014. Funders of the ethics-related issues reported could be predicted as studies and details related were reported in 56 (70.0%) 1.167 + .893* year of publication (coded as 1 = 2004, 2 = cases. The proportion of RCTs that declared the pres- 2009, and 3 = 2014) + .799* PEDro score (F = 11.103, [4,75] ence/absence of conflict of interest increased signifi- p < .001, adjusted R of .338). Five-year impact factor cantly across the three years, from 23.1% (3/13) in 2004, and clinical trial registration (coded as 0 = absent and to 28.6% (8/28) in 2009, to 76.9% (30/39) in 2014 1 = present) were not significant predictors (Table 4). (Table 3). Authors declared conflict of interest only in 2 (2.5%) studies. Post-hoc comparisons showed that the Discussion probability that potential conflict of interest and re- In our study, we observed a broad variability in the lated details were not reported was greater for trials reporting proportions of ethics-related components of Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 7 of 10 Table 3 Ethics-related issues reporting Year 2004 (n = 13) 2009 (n = 28) 2014 (n = 39) p All studies (n = 80) Ethic committee study approval 9 (69.2) 23 (82.1) 33 (84.6) .470 65 (81.2) Details about ethic committee 6 (46.2) 13 (46.4) 22 (56.4) .667 41 (51.2) Consent 11 (84.6) 26 (92.9) 37 (94.9) .443 74 (92.5) Details about the consent process 4 (30.8) 16 (57.1) 22 (56.4) .245 42 (52.5) Assessment of reduced cognitive competence 3 (23.1) 18 (64.3) 20 (51.3) .049 41 (51.2) Incentives or compensation, and details 0 (0.0) 0 (0.0) 3 (7.7) .278 3 (3.8) Funders and details 10 (76.9) 20 (71.4) 26 (66.7) .848 56 (70.0) Potential conflicts of interest 3 (23.1) 8 (28.6) 30 (76.9) <.001 41 (51.2) Statement about sample size estimates 5 (38.5) 8 (28.6) 17 (43.6) .455 30 (37.5) Performing of power calculations 5 (38.5) 7 (25.0) 15 (38.5) .478 27 (33.8) Appropriateness of comparators 10 (76.9) 24 (85.7) 34 (87.2) .638 68 (85.0) Matching of comparators 11 (84.6) 19 (67.9) 30 (76.9) .509 60 (75.0) Potential harm for participants 1 (7.7) 6 (21.4) 10 (25.6) .470 17 (21.2) Reporting presence/absence of adverse events 4 (30.8) 7 (25.0) 20 (51.3) .081 31 (38.8) Accordance with the Helsinki declaration. 0 (0.0) 3 (10.7) 6 (15.4) .403 9 (11.2) a d Number of ethics-related issues reported 7.5 (1.6) 8.5 (2.3) 9.9 (2.9) .009 9.0 (2.6) Data are presented as absolute frequencies (percentages) except mean (standard deviation) b c 2 d Fisher exact test, Pearson χ test, one-way ANOVA research methods. Ethics committee approval and events were definitively underreported, and details about obtaining an informed consent, the main ethical issues, incentives or compensation for participants and steps were the most reported. Approximately half of the stud- taken to protect confidentiality were almost ignored. ies reported details such as name and location of the The year of publication and PEDro score were associated committee, or how consent was acquired, but only 3 with the completeness of the reporting of ethics-related papers specified how consent was obtained for vulner- issues. able participants. Information about funding was fre- quently reported (70% of studies), whereas that about Limitations conflict of interest was mentioned in about half of the Articles analyzed in the present study were limited in studies, with a significantly increasing trend over the terms of year of publication (2004, 2009, and 2014). In years. Statement about sample size estimates, potential the absence of references, we established a 20 % of the harm for participants, and presence/absence of adverse gained studies as the target sample. However, we made Fig. 3 Ethic Committee approval and Informed Consent reporting. / Data are presented as percentages. EC = ethics review committee study approval. IC = obtainment of informed consent Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 8 of 10 Table 4 Multiple regression analysis results B ± Std. Error 95% CI for B β t p (Costant) 1.167 ± 1.410 −1.641 to 3.975 .828 .410 Year of publication .893 ± .368 .159 to 1.627 .251 2.424 .018 5-year Impact Factor .261 ± .164 −.066 to .589 .162 1.591 .116 Clinical trial registration .708 ± .721 −.727 to 2.144 .102 .983 .329 PEDro score .799 ± .212 .376 to 1.222 .391 3.761 <.001 B regression coefficients, followed by the respective standard error, CI confidence interval; β standardized regression coefficient our calculation based on the total number of articles International Committee of Medical Journal Editors rec- present in the PubMed-generated lists, and before the ommendations [13]. The statement underlines that details screening process. Thus, the representativeness of our about the approval from an ethics committee, the obtain- random sample may be hypothesized higher than we ing of informed consent, and the research funding should expected. We performed our search on PubMed, which be reported while publishing an article. The presence of has been recognized as a comprehensive database index- conflict of interest is also highly emphasized, and we ing RCTs of physical therapy interventions [33]. To be notice in our sample a significant increase over time in indexed in PubMed, journals should demonstrate one the related reporting. The document does not clearly for- certain quality of the editorial work, including features mulate recommendations about the ethical issues that we such as statements indicating adherence to ethical guide- found not properly reported. Nevertheless, ethics aspects lines and evidence that authors have disclosed financial like sample size dimension and risk of harm for partici- conflicts of interest. This condition suggests that in our pants are relevant [10, 18, 35, 36]. Compensation to sample the reporting of ethics issues may be of better participants may impact the statistical inferences, and quality than in the general population. Moreover, since transparency on the topic is desirable when reporting we reviewed only English-language publications, we do clinical trials [37]. not know if similar ethics reporting characteristics could Despite the progress observed, and in accordance with be observed in non-English language publications. These other authors, [35] our findings suggest that the reporting factors limit the generalizability of the findings. of many ethics-aspects needs to be improved in RCTs of A wide range of ethical issues was considered in our physical therapy interventions after stroke. Reporting study. When we drafted the protocol, we tried to be com- guidelines should be updated [35]; however, adding brief prehensive. However, establishing which ethics-related and clear sentences to the text (e.g., “The occurrence of issues should be contained in a fully comprehensive list adverse events has been monitored”, “No compensation would require consensus from a broad multidisciplinary was offered to participants”, “Data were managed and expert team, which was beyond our intentions and cap- accessed only by authorized personnel”) could be a abilities. Extracting data on the reporting of the ethical as- starting point. pects contained in our list was challenging in the absence of clear statements; for example, we found it difficult to Conclusion extrapolate data on issues such as those related to the Though improved over time, ethics reporting practices in potential harm for participants. Thus, we acknowledge RCTs of physical therapy interventions after stroke should that objectivity might have not been maintained in these be ameliorated. With its limitations, our study shows circumstances. deficiencies of various degrees. Authors, editors, and re- viewers should be more rigorous and demanding about Interpretation the reporting of ethic-related methods regarding the Associations between methodological quality and ethics reproducibility of research. Almost all the ethics-related reporting practices have already been observed, [3]as issues in our list have been recognized as part of the mini- well as improvement of ethical approval and consent mum set of items to be addressed drawing a protocol for a reporting in RCTs [34]. Compared to a previous study RCT [28]. If protocols are drawn up in accordance with on physical therapy publications, we observed a greater the expected standard, and subsequent trials are reported rate of trials reporting both ethics committee approval faithfully, this should result in an increase in quantity and and consent obtainment (+ 11%), as well as a smaller quality of the ethics reporting practices in RCTs. Thus, rate of those who did not report either (− 16%) [14]. the understanding of ethical methods and the convergence The reporting of research ethics-related issues and on best practices will be promoted, [12, 28]and a virtuous methods observed in our sample met, to some extent, the circle originated. Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 9 of 10 Appendix Table 5 Questions a a 1.0 Was ethics review committee or institutional review board 6.0 Were information about sample size estimates reported? study approval reported? 1.1 Was the name of the committee reported? 6.1 Were power calculations performed? 1.2 Was the location of the committee reported? 7.0 Were comparator interventions appropriate? a a 1.4 Were details about the ethics committee reported? 7.1 Was the dosage of the intervention provided to groups comparable? 2.0 Was it reported if informed consent was obtained? 8.0 Was the eventual use of placebo justified? 2.1 Was the consent for participation written? 9.0 Was potential harm for participants mentioned? 2.2 Was the consent for participation oral? 9.1 Were plans for collecting adverse events and other unintended effects mentioned? 2.3 How was consent (and possibly assent) acquired for members 9.2 Were plans for assessing adverse events and other unintended effects of vulnerable populations? mentioned? a a 2.4 Were details about the consent process reported? 9.3 Were plans for reporting adverse events and other unintended effects mentioned? a a 3.0 Were incentives or compensation for participants reported? 9.4 Were plans for managing adverse events and other unintended effects mentioned? 3.1 What did they receive, money, a gift, free medical care or 9.5 Were presence/absence of harm or adverse events reported? treatment, free transportation or other services? 3.2 Were details about incentives or compensation given to 10.0 Was mentioned if appropriate follow up care was assured? participants reported? a a 4.0 Were funders reported? 11.0 Were steps taken to assess if participants had reduced competence (eg. use of validated screening tools for cognitive ability) reported? 4.1 How many organizations were involved? 11.1 Which measures were taken to protect participants with reduced competence best interests? 4.2 What were the funding sources? Governmental agencies, 12.0 Were steps taken to prevent unauthorized access to personal and clinical private foundations, or some other type? data (confidentiality) mentioned? 4.3 Were details about funders reported? a a 5.0 Were there statements about potential conflicts of interest? 12.1 Was confidentiality preserved? 5.1 Was any conflict declared? 13.0 Was reported if the study was conducted in accordance with the Helsinki Declaration? 5.2 Were details about conflicts of interest reported? item counted in the number of ethics-related issues reported Author details Abbreviation Functional Rehabilitation, Azienda USL Toscana Centro, Via Cavour 118/120, RCT: Randomized controlled trial 59100 Prato, Italy. Outpatient Rehabilitation, CRT Clinica di Riabilitazione Toscana Terranuova Bracciolini Spa, Via Gaetano Donizetti 2, 52028 Availability of data and materials Terranuova Bracciolini, AR, Italy. Department of Experimental and Clinical The datasets analysed during the current study are available from the Medicine, Research Unit of Medicine of Aging, University of Florence, and corresponding author on reasonable request. Azienda Ospedaliero–Universitaria Careggi, Viale Pieraccini 18, 50139 Florence, Italy. Authors’ contributions FF and MDB provided concept/idea/research design. FF, MV and MDB Received: 14 February 2018 Accepted: 15 May 2018 provided writing. MV and FF provided data collection. FF and MDB provided data analysis. FF and MV provided project management. MDB provided consultation (including review of manuscript before submission). All authors References read and approved the final manuscript. 1. Vergnes JN, Marchal-Sixou C, Nabet C, et al. Ethics in systematic reviews. J Med Ethics. 2010;36(12):771–4. Ethics approval and consent to participate 2. Jacobsen KH. Reporting of ethics-related methods in epidemiological Not applicable. research. J Med Ethics. 2009;35(4):262–7. 3. Ruiz-Canela M, de Irala-Estevez J, Martínez-González MA, et al. Methodological quality and reporting of ethical requirements in clinical Competing interests trials. J Med Ethics. 2001;27(3):172–6. The authors declare that they have no competing interests. 4. Ashton CM, Wray NP, Jarman AF, Kolman JM, Wenner DM, Brody BA. A taxonomy of multinational ethical and methodological standards for clinical Publisher’sNote trials of therapeutic interventions. J Med Ethics. 2011;37(6):368–73. Springer Nature remains neutral with regard to jurisdictional claims in 5. Roberts LW. Ethical dimensions of psychiatric research: a constructive, published maps and institutional affiliations. criterion-based approach to protocol preparation. The research Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 10 of 10 protocol ethics assessment tool (RePEAT). Biol Psychiatry. 1999;46(8): 33. Michaleff ZA, Costa LO, Moseley AM, et al. 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Clinician’s Handbook, Motor rehabilitation [internet]. Evidence-Based Review of Stroke Rehabilitation. Available from: http://www.ebrsr.com/clinician-handbook. [Accessed 2017 Jan 22] 25. Pinto RZ, Elkins MR, Moseley AM, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther. 2013;93(3):299–309. 26. Urbaniak GC, Plous S (2015). Research Randomizer (Version 4.0) [Computer software]. Retrieved on January 22, 2017, from: http://www.randomizer.org/ 27. 2014 Journal Citation Reports ® Science Edition (Clarivate Analytics, 2017). Available from: https://jcr.incites.thomsonreuters.com/JCRJournalHomeAction.action. [accessed 2017 Jan 5] 28. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. 29. Caprino L, Russo P. Developing a paradigm of drug innovation: an evaluation algorithm. Drug Discov Today. 2006;11(21–22):999–1006. 30. Armijo Olivo S, Macedo LG, Gadotti IC, et al. Scales to assess the quality of randomized controlled trials: a systematic review. Phys Ther. 2008;88(2):156–75. 31. Maher CG, Sherrington C, Herbert RD, et al. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther. 2003;83(8):713–21. 32. Foley NC, Teasell RW, Bhogal SK, Speechley MR. Stroke rehabilitation evidence-based review: methodology. Top Stroke Rehabil. 2003;10(1):1–7. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Physiotherapy Springer Journals

Ethics reporting practices in randomized controlled trials of physical therapy interventions after stroke

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Medicine & Public Health; Physiotherapy; Rehabilitation; Chiropractic Medicine
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Abstract

Background: Adequate reporting of ethics-related research methods promotes convergence on best ethics practices. In physical therapy, studies on ethics reporting are limited to few aspects, and none focuses on stroke research. Our objectives were to investigate the reporting of multiple ethics-related features and its variation over time, and the characteristics of the studies associated with ethics reporting in Randomized Controlled Trials (RCTs) of physical therapy interventions after stroke. Methods: A random sample of RCTs published in the years 2004, 2009 and 2014, was extracted from the PubMed database, regardless of the publishing journal. For each trial we investigated year of publication, trial registration, sample size, stroke subtype, phase of the disease, setting, interventions and dosing, outcome measures, outcome of the study, PEDro score and 5-year impact factor of the publishing journal. Reporting of ethics-related issues was analyzed. Differences between groups were examined. Multiple regression was used to evaluate the relationship between ethics-related issues reporting and some studies’ characteristics. Results: Eighty studies were reviewed. Groups differed in the proportion of registered trials (p = .009), 5-year impact factor (p = .011), assessment of cognitive capacity (p = .049), declaration about conflict of interest (p < .001), and number of ethics-related issues reported (p = .009). The proportion of issues reported ranged from 92.5% (consent obtaining) to 0% (eventual follow up care). Post-hoc comparisons showed significantly greater reporting of ethics issues in trials published in the year 2014 compared to 2004 (p = .014, 95%CI = 0.40/4.26). Year of publication and PEDro score were significant predictors of adequate reporting. Conclusions: Authors, editors, and reviewers should be more rigorous and demanding about the reporting of ethic-related methods in randomized controlled trials of physical therapy interventions after stroke. Keywords: Ethics reporting, Physical therapy, Randomized controlled trials, Stroke Background Randomized controlled trial (RCT), systematic review The importance of ethics in clinical research has been and meta-analysis of RCTs are considered reliable re- well-established for many decades [1]. A growing atten- search designs, able to evaluate the effectiveness of an tion is given to determine the best ethical practices for intervention [1]. The design of a clinical trial implies ad- conducting observational and experimental studies [2]. herence to challenging and multifaceted ethical and Methodological quality, approval by a research ethics methodological standards that must integrate each other committee, and obtaining informed consent from partic- [4]; Ashton et al. in their taxonomy indeed identified five ipants are the main ethical issues in research with hu- major categories, with over 5900 possible standards [4]. man beings [3]. Differences among research topics and study designs may add further variability in ethical requirements [5–8]. Research conducted with little methodological * Correspondence: francescoferrarello@tiscali.it rigor does not lead to knowledge or benefit, and ex- Functional Rehabilitation, Azienda USL Toscana Centro, Via Cavour 118/120, poses participants to unnecessary burden or harm [9]. 59100 Prato, Italy Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 2 of 10 Thus methodological and ethical requirements of a recommendations [21]. Based on a sample of RCTs of study have a symbiotic relationship [10] and, in order to physical therapy interventions after stroke, our objectives make readers able to fully evaluate clinical research, both were to investigate the reporting of multiple ethics-related should be appropriately reported [3]. Adequate reporting features and its variation over time, as well as the charac- of research findings may promote the implementation of teristics of the studies associated with ethics reporting. evidence-based clinical practice in many fields, including A random sample of RCTs indexed in PubMed was physical therapy [11]. However, reporting of scientific extracted, regardless of the publication journal. To be methods receives considerably greater attention, as com- included, the studies had to be published in English in pared with reporting of research ethics issues [12]. Many the years 2004, 2009 and 2014, involve a parallel-group guidelines have been published to improve the reporting design, and evaluate an experimental physical therapy of RCTs, and adherence to these guidelines is usually intervention administered to adult (age ≥ 18 years) indi- considered necessary for publication [12]. Recommenda- viduals with stroke. tions on how ethics issues should be reported in re- The rationale for choosing the three years was the fol- search studies are also available [13], although evidence lowing. The year 2014 had just ended when we drafted suggests flaws in publication requirements and reporting the protocol; it was chosen to give a contemporary view. of ethical protections [14]. Thus, descriptions provided To have a time perspective, we chose the years 2004 and by journal articles contain little information about 2009 as comparators, thus covering a period of ten research ethics methods [12]. years. Research reproducibility refers to the possibility to du- Interventions were considered suitable if included in the plicate the results of prior studies, and is based on a clear classification proposedbyDeJongetal. [22], or listed in the and comprehensive description of study design [15]. The book “Guide to Physical Therapist Practice”[23], or reviewed concept of ethical reproducibility was recently introduced. in the Clinician’s Handbooks of the Evidence-Based Review Ethical reproducibility prescribes thorough reporting and of Stroke Rehabilitation-motor rehabilitation [24]. critical evaluation of the ethics methods employed in For the selection of the studies, the term “stroke” biomedical research [16]. Although ethics committee followed by “physical therapy” was entered in the search approval is a crucial aspect of ethics in research and is box, filtered by the type of study (RCT). Additional fil- usually considered as a proxy measure for the fulfillment ters related to the year of publication (2004, 2009 and of all ethical requirements in research [14], it is not suffi- 2014) were then added one at a time to obtain a list of cient to judge the overall ethical quality of an RCT [17]. studies for each of the years of interest. The resulting Including ethics-related methods in research reports may search strategy was the following: ((“stroke”[MeSH address concerns raised by researchers, clinicians, and Terms] OR “stroke”[All Fields]) AND (“physical therapy other stakeholders [2]. Moreover, ethical reproducibility modalities”[MeSH Terms] OR (“physical”[All Fields] AND can promote benefits such as learning, inner reflection, “therapy”[All Fields] AND “modalities”[All Fields]) OR increase of ethical responsibility, critical research assess- “physical therapy modalities”[All Fields] OR (“physical”[All ment, and use of better ethical practices [12]. Fields] AND “therapy”[All Fields]) OR “physical thera- In the physical therapy field, interest on ethical issues py”[All Fields])) AND Randomized Controlled Trial[ptyp] of the profession is remarkable, yet it mainly focuses on AND ((“2004/01/01”[PDAT]: “2004/12/31”[PDAT]) OR clinical practice, whereas only few papers have been (“2009/01/01”[PDAT]: “2009/12/31”[PDAT]) OR (“2014/ published over the years addressing ethics in physical 01/01”[PDAT]: “2014/12/31”[PDAT])). therapy research [18]. Studies on issues related to ethics In each year, a random sample of the studies in the in RCTs reporting were limited to ethics committee ap- PubMed-generated list was extracted. A formal sample proval, informed consent, and confidentiality [14, 19]. size calculation was not performed because of lack of Although stroke represents a major topic in physical preliminary data; indeed, previous studies differed from therapy research [20], none of the studies published on the present one in eligibility criteria, sources and ethical aspects of physical therapy research focused on methods of studies selection, and variables of interest. In stroke. Therefore, because available knowledge does not the absence of references, to quantify the sample size we appear to be exhaustive and satisfactory, we designed were inspired by Pinto et al. research on RCTs registra- the present study with the aim to investigate ethics tion,[25] and we established 20 % of the studies as the reporting characteristics in RCTs of physical therapy target sample. We performed calculations based on the interventions after stroke. total number of articles present in the lists, before the screening process. The random selection was performed Methods in August 2015, by entering the sequence numbers of The reporting of this study conforms to the Strengthening the lists acquired through search in an on-line the Reporting of Observational studies in Epidemiology randomization program [26]; the studies were then Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 3 of 10 assessed for eligibility following the randomized sequence,  incentives or compensation for participants until the desired sample size was reached. Full texts of the  details about incentives or compensation given to articles were retrieved following a flow-chart (Fig. 1). participants Reasons for exclusion were given for each study ex-  funders cluded. Two reviewers (MV; FF) independently evaluated  details about funders the studies selected for final inclusion; disagreement was  potential conflicts of interest resolved by consensus.  details about conflicts of interest Relevant data were extracted using a standard data  steps taken to assess if eligible individuals were able recording spreadsheet, including characteristics of the to provide informed consent (e.g. use of validated studies and research ethics-related issues. screening tools for cognitive ability) Data related to year of publication, clinical trial regis-  measures taken to ensure the best interests of tration, sample size, stroke subtype, phase of the disease, participants with reduced competence setting, interventions administered, dosing of the inter-  steps taken to ensure that the sample size was ventions, outcome measures, and outcome of the study sufficient to achieve adequate statistical power were extracted from each article included. Information  appropriateness of comparators about 5-year impact factor of the publishing journal was  justification for the eventual use of placebo acquired [27].  potential harm for participants In the absence of a standardized comprehensive list,  plans for collecting, assessing, reporting, and issues related to ethics in RCTs reporting were chosen managing adverse events and other unintended considering what has been contemplated in previous effects of trial interventions or trial conduct publications [2, 14, 17, 28]. The following aspects were  appropriate follow up care investigated in each article:  steps taken to prevent unauthorized access to personal and clinical data (confidentiality) ethics review committee or institutional review  accordance with the Helsinki Declaration. board study approval details about the ethics committees We assumed the definition of appropriateness of com- obtainment of informed consent parator proposed by Caprino and Russo [29]; in the pres- details about the consent process ence of multiple interventions groups, we considered the Fig. 1 Full text retrieving flow chart Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 4 of 10 most active comparator intervention. For each study in- based on the year of publication were examined using cluded, the number of ethics-related issues reported was the Kruskal-Wallis or the one-way ANOVA tests for calculated by summing up any reported or mentioned interval variables. Pearson χ test was used for nominal issue. The maximum achievable was 22 issues. The and ordinal variables, except when cell counts were extended list of questions is detailed in the Appendix. < 5, in which case Fisher exact test was used. Linear Data were extracted from an investigator (MV) and subse- trends (across years) were considered as appropriate. In quently double-checked (FF). Any disagreement was re- case of significant results, post-hoc tests were performed solved by consensus. The PEDro score of methodological to explore differences between any two pairs of years. quality was verified for each study [30]. This tool is reli- Multiple linear regression was performed to assess the able [31] and useful for assessing the quality of studies in ability of year of publication, trial registration, PEDro stroke rehabilitation [30]. Criteria for quality assessment score, and 5-year impact factor to predict the number of are represented by randomness and concealment of ethics-related issues reported in each article selected. allocation, baseline comparability between groups, blind- Preliminary analysis was performed to ensure there was ing of participants, therapists, and assessors, adequacy no violation of the assumption of normality, linearity, of follow-up assessments, intention-to-treat analysis, and multicollinearity. between-group comparisons, reporting of point esti- Analyses were performed using IBM SPSS Statistics mates and variability. The PEDro score ranges from 0 for Windows (version 20.0; IBM Corp, Armonk, NY). (poor quality) to 10 (excellent quality); a score of 6 is The significance level was set at a p value of <.05. conventionally considered as a threshold to identify high-quality studies [32]. Results The search on PubMed generated lists of 57, 119, and Statistical analysis 177 articles (total 353) for the years 2004, 2009, and Descriptive statistics was initially performed. Five-year 2014, respectively. The target sample size was set at 11 impact factor equal to zero were attributed to the three studies for 2004, 24 studies for 2009, and 35 studies for journals not found in the Journal Citation Reports data- 2014. After randomization, a total of 162 papers were base [27]. In one case where only the impact factor was retrieved; the selection process led to the inclusion in available, the same value was assigned as 5-year impact the study of 80 articles (Fig. 2). factor. Expectation-maximization imputation was used to address missing values (2.5 and 5% respectively) of Study characteristics the number of sessions per week and the minutes per Studies’ characteristics are presented in Table 1. Eighteen session needed to calculate the dosing of the interven- percent of the selected trials had been registered. The tion in hours. Shapiro-Wilk’s test was used to test the proportion of registered trials increased substantially normality of distribution. Differences between groups across the three years; post-hoc comparison showed that Fig. 2 Studies selection flow chart. /*Including protocols, observational studies, preliminary reporting (e.g. recruitment or sample characteristics), non-randomized trials, and within-subject or cross-over design studies. PT = Physical Therapy. RCT = Randomized Controlled Trial Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 5 of 10 Table 1 Characteristics of the studies Year 2004 2009 2014 p All studies (n = 13) (n = 28) (n = 39) (n = 80) a b 5-year Impact factor 2.967 (2.447/4.625) 4.206 (2.455/4.626) 2.179 (1.647/3.503) .011 2.784 (2.130/4.626) c d Trial registered 0 (0.0) 2 (7.1) 12 (30.8) .009 14 (17.5) a b Sample size 28 (20.0/47.0) 39 (31.5/65.0) 34 (23.0/52.5) .212 38 (23.5/56.5) Intervention groups 2 groups 11 (84.6) 21 (75.0) 34 (87.2) .418 66 (82.5) ≥ 3 groups 2 (15.4) 7 (25.0) 5 (12.8) 14 (17.5) Etiology Ischemic 1 (7.7) 8 (28.6) 5 (12.8) 14 (17.5) Hemorrhagic 0 (0.0) 0 (0.0) 1 (2.6) .305 1 (1.2) Mixed 7 (53.8) 16 (57.1) 21 (53.8) 44 (55.0) None declared 5 (38.5) 4 (14.3) 12 (30.8) 21 (26.2) Phase of the disease-onset < 6 months 4 (30,8) 15 (53.6) 14 (35.9) 33 (41.2) ≥ 6 months 8 (61.5) 12 (42.9) 23 (59.0) .516 43 (53.8) None declared 1 (7.7) 1 (3.6) 2 (5.1) 4 (5.0) c d Placebo-sham comparator 2 (15.4) 5 (17.9) 9 (23.1) .807 16 (20.0) ae b Intervention dosing-hours 18.0 (6.0/22.5) 15.5 (11.0/27.0) 24.0 (10.0/34.7) .139 18.0 (9.0/30.0) At least one outcome Favorable 9 (69.2) 20 (71.4) 25 (64.1) .855 54 (67.5) Nonsignificant 11 (84.6) 25 (89.3) 36 (92.3) .614 72 (90.0) Unfavorable 1 (7.7) 1 (3.6) 3 (7.7) .705 5 (6.2) a b PEDro score 6 (5.0/6.0) 6 (5.0/7.0) 6 (5.0/7.5) .073 6 (5.0/7.0) median (1th quartile/3rd quartile) Kruskal-Wallis test absolute frequencies (percentages) Fisher exact test after Expectation-maximization imputation the probability to be not registered was greater for trials balance (13 studies), walking (9 studies), arm-hand activ- published in the years 2004 and 2009 compared to those ities (26 studies), and activities of daily living (24 studies) published in the year 2014 (Table 2). of the International Classification of Functioning domains. Median 5-year impact factor was 2.784 (1th quartile 2.130, 3rd quartile 4.626). Five-year impact factor was Ethics reporting greater in 2009 than in the other two years, with no Ethics committee or institutional review board study clear linear-by-linear change; post-hoc comparison approval was reported in 65 (81.2%) studies, and 74 indicated that it was significantly greater in RCTs (92.5%) articles mentioned that consent was obtained. published in the year 2009 compared to 2014 Details about the ethics committee and the consent (Table 2). PEDro score ranged from 3 to 8 (median process were available in half of the cases (51.2 and 6); there were no significant differences between years 52.5%, respectively) (Table 3). One paper failed to report of publication (Table 1). both ethics committee approval and obtainment of Neuromuscolar interventions were most frequently informed consent (Fig. 3). applied (53 studies), followed by musculoskeletal inter- The Mini-Mental State Examination or similar test ventions (20 studies). Standard care was frequently used aimed to assess cognitive capacity were administered in as side intervention, or comparator (32 studies). The the inclusion stage in 41 (51.2%) publications, namely outcome measures used to investigate the efficacy of the in 3 (23.1%), 18 (64.3%), and 20 (51.3%) studies in year interventions mainly belonged to muscle and movement 2004, 2009, and 2014, respectively; this difference functions (21 studies), gait pattern functions (17 studies), across the three years was borderline significant but Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 6 of 10 Table 2 Post-hoc test results published in the years 2004 and 2009 compared to those published in the year 2014 (Table 2). Variable 95% CI p Statements about sample size estimation were identi- Trial registration b fied in 30 (37.5%) articles, 27 of which performed a 2004 vs 2009 1.077 .972 to 1.193 1.000 power calculation. We considered appropriate the com- 2004 vs 2014 1.444 1.172 to 1.781 .024 parator interventions in 68 (85.0%) cases; participants 2009 vs 2014 1.341 1.062 to 1.693 .031 received the same amount of attention in 60 (75.0%) 5-year impact factor trials, whereas in the remaining ones the attention was 2004 vs 2009 −.264 −1.659 to .629 .480 minor, or the control inactive. Justification for the use of placebo was always reported. Out of the 16 RCTs reporting 2004 vs 2014 .745 −.528 to 1.399 .219 the use of placebo/sham controls, the experimental inter- 2009 vs 2014 1.100 .328 to 1.842 .002 vention was represented by electrical stimulation in 10, by Assessment of reduced competence acupuncture in 2, by a combination of acupuncture and 2004 vs 2009 2.154 1.207 to 3.844 .020 electrical stimulation in 2, by action observation train- 2004 vs 2014 1.579 1.018 to 2.448 .110 ing in 1, and by respiratory muscles training in 1. 2009 vs 2014 .733 .405 to 1.325 .289 Potential harm for participants was mentioned in 17 (21.2%) studies, and mainly included increased pain and/ Potential conflicts of interest b or fatigue, risk of falls, and unstable cardiovascular 2004 vs 2009 1.077 .737 to 1.573 1.000 status. Plans for collecting, assessing, reporting, and 2004 vs 2014 3.333 1.748 to 6.358 .001 managing adverse events and other unintended effects 2009 vs 2014 1.341 1.062 to 1.693 .031 of trial interventions were reported respectively in 13, Number of ethics-related issues reported 11, 3, and 8 of these articles. The reporting of presence/ 2004 vs 2009 −0.96 −2.98 to 1.06 .494 absence of harm or adverse events was observed in 31 (38.8%) cases (Table 3). None of the studies mentioned 2004 vs 2014 −2.33 −4.26 to −0.40 .014 eventual follow up care. 2009 vs 2014 −1.37 −2.86 to 0.12 .078 Although we found a clear reference to steps taken to CI Confidence Interval protect anonymity in only one article, confidentiality was Relative risk for the absence of the characteristic Fisher exact test always preserved. Eighteen publications (30%) showed Mann-Whitney test and Hodges-Lehmann estimator, data are pictures depicting models or participants: with only two median differences d 2 Pearson χ test exceptions, faces were shown only in part (twice masking Tukey’s test, data are mean differences the eyes region) or were shielded. As previously noted, one study reported a specific consent for publication of the participant’sphotos. had no linear-by-linear association (Table 3). In a The number of ethics-related issues reported was sig- post-hoc test a significantly greater probability that nificantly different across the three years considered such assessment would not be performed was observed (one-way ANOVA F(5.07) = 6.345, p = .009) (Table 3); for studies published in the year 2004 compared to Tukey post-hoc comparisons showed that this number 2009 (Table 2), Only 3 papers published in 2009 was significantly higher in RCTs published in the year specified how consent was acquired for vulnerable 2014 compared to 2004, whereas there was no signifi- participants. Separate consents for videotaping or for cant difference between the years 2004 and 2009, and publication of participant’s photos were reported, each the years 2009 and 2014 RCTs (Table 2). in one study. Incentives or compensation for participants (money or Multivariable predictors of ethics reporting gifts, or free transportation to the research center) were Multiple regression showed that the number of stated in 3 articles published in 2014. Funders of the ethics-related issues reported could be predicted as studies and details related were reported in 56 (70.0%) 1.167 + .893* year of publication (coded as 1 = 2004, 2 = cases. The proportion of RCTs that declared the pres- 2009, and 3 = 2014) + .799* PEDro score (F = 11.103, [4,75] ence/absence of conflict of interest increased signifi- p < .001, adjusted R of .338). Five-year impact factor cantly across the three years, from 23.1% (3/13) in 2004, and clinical trial registration (coded as 0 = absent and to 28.6% (8/28) in 2009, to 76.9% (30/39) in 2014 1 = present) were not significant predictors (Table 4). (Table 3). Authors declared conflict of interest only in 2 (2.5%) studies. Post-hoc comparisons showed that the Discussion probability that potential conflict of interest and re- In our study, we observed a broad variability in the lated details were not reported was greater for trials reporting proportions of ethics-related components of Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 7 of 10 Table 3 Ethics-related issues reporting Year 2004 (n = 13) 2009 (n = 28) 2014 (n = 39) p All studies (n = 80) Ethic committee study approval 9 (69.2) 23 (82.1) 33 (84.6) .470 65 (81.2) Details about ethic committee 6 (46.2) 13 (46.4) 22 (56.4) .667 41 (51.2) Consent 11 (84.6) 26 (92.9) 37 (94.9) .443 74 (92.5) Details about the consent process 4 (30.8) 16 (57.1) 22 (56.4) .245 42 (52.5) Assessment of reduced cognitive competence 3 (23.1) 18 (64.3) 20 (51.3) .049 41 (51.2) Incentives or compensation, and details 0 (0.0) 0 (0.0) 3 (7.7) .278 3 (3.8) Funders and details 10 (76.9) 20 (71.4) 26 (66.7) .848 56 (70.0) Potential conflicts of interest 3 (23.1) 8 (28.6) 30 (76.9) <.001 41 (51.2) Statement about sample size estimates 5 (38.5) 8 (28.6) 17 (43.6) .455 30 (37.5) Performing of power calculations 5 (38.5) 7 (25.0) 15 (38.5) .478 27 (33.8) Appropriateness of comparators 10 (76.9) 24 (85.7) 34 (87.2) .638 68 (85.0) Matching of comparators 11 (84.6) 19 (67.9) 30 (76.9) .509 60 (75.0) Potential harm for participants 1 (7.7) 6 (21.4) 10 (25.6) .470 17 (21.2) Reporting presence/absence of adverse events 4 (30.8) 7 (25.0) 20 (51.3) .081 31 (38.8) Accordance with the Helsinki declaration. 0 (0.0) 3 (10.7) 6 (15.4) .403 9 (11.2) a d Number of ethics-related issues reported 7.5 (1.6) 8.5 (2.3) 9.9 (2.9) .009 9.0 (2.6) Data are presented as absolute frequencies (percentages) except mean (standard deviation) b c 2 d Fisher exact test, Pearson χ test, one-way ANOVA research methods. Ethics committee approval and events were definitively underreported, and details about obtaining an informed consent, the main ethical issues, incentives or compensation for participants and steps were the most reported. Approximately half of the stud- taken to protect confidentiality were almost ignored. ies reported details such as name and location of the The year of publication and PEDro score were associated committee, or how consent was acquired, but only 3 with the completeness of the reporting of ethics-related papers specified how consent was obtained for vulner- issues. able participants. Information about funding was fre- quently reported (70% of studies), whereas that about Limitations conflict of interest was mentioned in about half of the Articles analyzed in the present study were limited in studies, with a significantly increasing trend over the terms of year of publication (2004, 2009, and 2014). In years. Statement about sample size estimates, potential the absence of references, we established a 20 % of the harm for participants, and presence/absence of adverse gained studies as the target sample. However, we made Fig. 3 Ethic Committee approval and Informed Consent reporting. / Data are presented as percentages. EC = ethics review committee study approval. IC = obtainment of informed consent Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 8 of 10 Table 4 Multiple regression analysis results B ± Std. Error 95% CI for B β t p (Costant) 1.167 ± 1.410 −1.641 to 3.975 .828 .410 Year of publication .893 ± .368 .159 to 1.627 .251 2.424 .018 5-year Impact Factor .261 ± .164 −.066 to .589 .162 1.591 .116 Clinical trial registration .708 ± .721 −.727 to 2.144 .102 .983 .329 PEDro score .799 ± .212 .376 to 1.222 .391 3.761 <.001 B regression coefficients, followed by the respective standard error, CI confidence interval; β standardized regression coefficient our calculation based on the total number of articles International Committee of Medical Journal Editors rec- present in the PubMed-generated lists, and before the ommendations [13]. The statement underlines that details screening process. Thus, the representativeness of our about the approval from an ethics committee, the obtain- random sample may be hypothesized higher than we ing of informed consent, and the research funding should expected. We performed our search on PubMed, which be reported while publishing an article. The presence of has been recognized as a comprehensive database index- conflict of interest is also highly emphasized, and we ing RCTs of physical therapy interventions [33]. To be notice in our sample a significant increase over time in indexed in PubMed, journals should demonstrate one the related reporting. The document does not clearly for- certain quality of the editorial work, including features mulate recommendations about the ethical issues that we such as statements indicating adherence to ethical guide- found not properly reported. Nevertheless, ethics aspects lines and evidence that authors have disclosed financial like sample size dimension and risk of harm for partici- conflicts of interest. This condition suggests that in our pants are relevant [10, 18, 35, 36]. Compensation to sample the reporting of ethics issues may be of better participants may impact the statistical inferences, and quality than in the general population. Moreover, since transparency on the topic is desirable when reporting we reviewed only English-language publications, we do clinical trials [37]. not know if similar ethics reporting characteristics could Despite the progress observed, and in accordance with be observed in non-English language publications. These other authors, [35] our findings suggest that the reporting factors limit the generalizability of the findings. of many ethics-aspects needs to be improved in RCTs of A wide range of ethical issues was considered in our physical therapy interventions after stroke. Reporting study. When we drafted the protocol, we tried to be com- guidelines should be updated [35]; however, adding brief prehensive. However, establishing which ethics-related and clear sentences to the text (e.g., “The occurrence of issues should be contained in a fully comprehensive list adverse events has been monitored”, “No compensation would require consensus from a broad multidisciplinary was offered to participants”, “Data were managed and expert team, which was beyond our intentions and cap- accessed only by authorized personnel”) could be a abilities. Extracting data on the reporting of the ethical as- starting point. pects contained in our list was challenging in the absence of clear statements; for example, we found it difficult to Conclusion extrapolate data on issues such as those related to the Though improved over time, ethics reporting practices in potential harm for participants. Thus, we acknowledge RCTs of physical therapy interventions after stroke should that objectivity might have not been maintained in these be ameliorated. With its limitations, our study shows circumstances. deficiencies of various degrees. Authors, editors, and re- viewers should be more rigorous and demanding about Interpretation the reporting of ethic-related methods regarding the Associations between methodological quality and ethics reproducibility of research. Almost all the ethics-related reporting practices have already been observed, [3]as issues in our list have been recognized as part of the mini- well as improvement of ethical approval and consent mum set of items to be addressed drawing a protocol for a reporting in RCTs [34]. Compared to a previous study RCT [28]. If protocols are drawn up in accordance with on physical therapy publications, we observed a greater the expected standard, and subsequent trials are reported rate of trials reporting both ethics committee approval faithfully, this should result in an increase in quantity and and consent obtainment (+ 11%), as well as a smaller quality of the ethics reporting practices in RCTs. Thus, rate of those who did not report either (− 16%) [14]. the understanding of ethical methods and the convergence The reporting of research ethics-related issues and on best practices will be promoted, [12, 28]and a virtuous methods observed in our sample met, to some extent, the circle originated. Ferrarello et al. Archives of Physiotherapy (2018) 8:8 Page 9 of 10 Appendix Table 5 Questions a a 1.0 Was ethics review committee or institutional review board 6.0 Were information about sample size estimates reported? study approval reported? 1.1 Was the name of the committee reported? 6.1 Were power calculations performed? 1.2 Was the location of the committee reported? 7.0 Were comparator interventions appropriate? a a 1.4 Were details about the ethics committee reported? 7.1 Was the dosage of the intervention provided to groups comparable? 2.0 Was it reported if informed consent was obtained? 8.0 Was the eventual use of placebo justified? 2.1 Was the consent for participation written? 9.0 Was potential harm for participants mentioned? 2.2 Was the consent for participation oral? 9.1 Were plans for collecting adverse events and other unintended effects mentioned? 2.3 How was consent (and possibly assent) acquired for members 9.2 Were plans for assessing adverse events and other unintended effects of vulnerable populations? mentioned? a a 2.4 Were details about the consent process reported? 9.3 Were plans for reporting adverse events and other unintended effects mentioned? a a 3.0 Were incentives or compensation for participants reported? 9.4 Were plans for managing adverse events and other unintended effects mentioned? 3.1 What did they receive, money, a gift, free medical care or 9.5 Were presence/absence of harm or adverse events reported? treatment, free transportation or other services? 3.2 Were details about incentives or compensation given to 10.0 Was mentioned if appropriate follow up care was assured? participants reported? a a 4.0 Were funders reported? 11.0 Were steps taken to assess if participants had reduced competence (eg. use of validated screening tools for cognitive ability) reported? 4.1 How many organizations were involved? 11.1 Which measures were taken to protect participants with reduced competence best interests? 4.2 What were the funding sources? Governmental agencies, 12.0 Were steps taken to prevent unauthorized access to personal and clinical private foundations, or some other type? data (confidentiality) mentioned? 4.3 Were details about funders reported? a a 5.0 Were there statements about potential conflicts of interest? 12.1 Was confidentiality preserved? 5.1 Was any conflict declared? 13.0 Was reported if the study was conducted in accordance with the Helsinki Declaration? 5.2 Were details about conflicts of interest reported? item counted in the number of ethics-related issues reported Author details Abbreviation Functional Rehabilitation, Azienda USL Toscana Centro, Via Cavour 118/120, RCT: Randomized controlled trial 59100 Prato, Italy. Outpatient Rehabilitation, CRT Clinica di Riabilitazione Toscana Terranuova Bracciolini Spa, Via Gaetano Donizetti 2, 52028 Availability of data and materials Terranuova Bracciolini, AR, Italy. Department of Experimental and Clinical The datasets analysed during the current study are available from the Medicine, Research Unit of Medicine of Aging, University of Florence, and corresponding author on reasonable request. Azienda Ospedaliero–Universitaria Careggi, Viale Pieraccini 18, 50139 Florence, Italy. Authors’ contributions FF and MDB provided concept/idea/research design. FF, MV and MDB Received: 14 February 2018 Accepted: 15 May 2018 provided writing. MV and FF provided data collection. FF and MDB provided data analysis. FF and MV provided project management. MDB provided consultation (including review of manuscript before submission). All authors References read and approved the final manuscript. 1. Vergnes JN, Marchal-Sixou C, Nabet C, et al. Ethics in systematic reviews. J Med Ethics. 2010;36(12):771–4. Ethics approval and consent to participate 2. Jacobsen KH. Reporting of ethics-related methods in epidemiological Not applicable. research. 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Archives of PhysiotherapySpringer Journals

Published: Jun 5, 2018

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