Impact Of Study Participation Research Articles

How a study on lived experiences impacted German occupation children – A mixed-method long-term approach

ObjectiveResearch on the impact study participation has on participants has shown that, even though they may find it stressful during participation, overall, they appear to benefit personally and emerge with a positive cost-benefit-balance. In 2013, the first psychological study on German occupation children (GOC), a potentially vulnerable and hidden study population, was conducted, after which respondents shared a high volume of positive feedback. In the context of a follow-up survey, the impact of study participation on participants was investigated to determine the causes of this distinctly positive outcome.MethodsMixed-methods approach using the standardized Reactions to Research Participation Questionnaire (RRPQ) as well as open-ended questions on expectations toward participation, and changes due to participation in dealing with GOC background and in personal life. Analyses included N = 65 participants (mean age 68.92, 40% men) and were carried out with descriptive measures for RRPQ and inductive content analysis for open-ended questions.ResultsParticipants specified six motives for participation besides answering the standardized form; 46.2% (n = 30) saw their expectations met. Although participation was related to negative emotions during participation, participants' overall experience was positive; 89.2% (n = 58) stated an inclination to participate again. 52.3% (n = 34) reported participation had helped develop new ways of dealing with their GOC experiences; five contributing factors were observed. Changes in private life were reported by 24.6% (n = 16); three aspects were identified. The vast majority (81.5%; n = 53) stated, following participation, they were able to disclose their GOC background to others. Participants placed emphasis on four aspects of this experience.ConclusionAlthough study participation was described as emotionally challenging during participation, participants felt that the overall impact it had on them was positive. The study was the first of its kind and thus presented an opportunity for a previously hidden population to step out of the dark, simultaneously gaining insight that helped them better understand themselves as GOC, and thereby increase their capacity for self-acceptance. Participants also benefitted from learning about the study's findings and connecting with other GOC through activities that ensued. In conclusion, results suggest that vulnerable and/or hidden populations benefit from specific attention to their lived experiences even at higher age.

Do patients enrolled in observational studies have better outcomes than non-participants? A retrospective analysis

Patients are commonly enrolled into clinical trials. It has been reported that these patients may have better outcomes than those not enrolled into the study. The reasoning from these improvements could be attributable to closer follow-up, better patient adherence, more health aware patients have, or reaction to observation such as the Hawthorne effect. Three hundred forty-six patients were approached for a prospective skin toxicity study in adjuvant breast cancer radiotherapy (RT) but declined participation between January 2018 and July 2019 (non-trial group). They were retrospectively reviewed and patient, treatment and RT-related characteristics, as well as the occurrence of skin reactions, and the usage of topical treatments were collected. This was compared with a comparison cohort of 349 patients who were enrolled into a previously conducted prospective study (trial group). More patients in the trial group had conventional RT (CFRT) versus hypofractionated RT (HFRT). Data was further stratified and there was no significant difference in moist desquamation, topical antibiotic usage, dressing application, home care use, topical corticoid steroid use, and oral analgesic use. There was a significantly lower pain score in the group compared with the non-trial group in both HFRT and CFRT (OR = 0.091 and OR = 0.348, p < 0.0001). Our results demonstrated no differences other than pain between the trial group and non-trial group. Therefore, in this cohort, patients enrolled into an observational trial while undergoing adjuvant breast RT demonstrated similar experiences of skin reactions. There are challenges to assessing differences between these groups, as confounding is likely. Therefore, it is recommended for future studies to additionally assess the impact of study participation on outcomes such as quality of life, quality of care received, and/or anxiety levels.

Conducting reproductive research during a new childhood cancer diagnosis: ethical considerations and impact on participants.

Research among adults shows benefits and low perceived burden of engaging in behavioral research. However, questions remain regarding the ethics of conducting behavioral research in pediatric populations during sensitive situations, including during a new life-threatening diagnosis or at end-of-life. We examined reactions to participating in a behavioral reproductive research study among male adolescents newly diagnosed with cancer and their parents, as a step towards optimizing fertility preservation utilization in a population where future infertility is common. Pediatric literature regarding the ethics of behavioral research was reviewed. In our pilot, forty-four participants (19 mothers, 11 fathers, 14 male adolescents newly diagnosed with cancer) from 20 families completed demographic questionnaires and a fertility preservation decision tool developed by the study team. Qualitative interviews exploring the impact of study participation were subsequently conducted. Verbatim transcripts were coded for thematic content using the constant comparison method. Literature review showed positive reactions to research participation among youth/caregivers. In our pilot study, 89% (n = 17) of mothers, 64% (n = 7) of fathers, and 71% (n = 10) of adolescents reported at least one benefit of participating. Eleven percent (n = 2) of mothers, 36% (n = 4) of fathers, and 29% (n = 4) of adolescents said they were not affected; none of the participants reported a negative effect. Consistent with prior literature, our study suggests behavioral reproductive research prior to cancer treatment can offer direct benefits to participants and society, without increasing burden. These findings will inform future interventions to improve long-term psychosocial and reproductive outcomes for youth with cancer.

The effect of participation in neoadjuvant clinical trials on outcomes in patients with early breast cancer

Clinical trials can offer novel and more advanced and/or novel treatments to cancer patients in advance of them being approved and available for all patients. While several studies have examined the effect of clinical trial participation on prognosis, there has been no clear conclusion from these studies. Therefore, we chose to test the influence of trial participation on pathological complete response (pCR) and mastectomy rates after neoadjuvant chemotherapy. In this retrospective study, all patients treated with neoadjuvant chemotherapy from 2001 to 2014 were selected. A total of 1038 patients with complete treatment, patient, and tumor characteristics were included. A total of 260 of those were treated in clinical trials. We examined whether study participation status in addition to commonly known predictors for pCR improves prediction of pCR. Similar analyses were conducted for the mastectomy rate outcome measure. Finally, survival analyses were also conducted as part of an exploratory analysis. Study participation was an independent predictor of pCR in addition to commonly known predictors. Adjusted odds ratio (OR) for trial participants versus non-participants was 1.53 (95% CI 1.03-2.28). Additionally, study participation improved the prediction of mastectomy risk. The adjusted OR for trial participants versus non-participants was 0.62 (95% CI 0.42-0.90). Subgroup-specific differences concerning the impact of study participation could not be shown for either pCR or mastectomy rate. Survival comparisons could not be conducted due to large differences in follow-up data in patients participating in clinical trials versus those who did not participate; however, pCR was a predictor of prognosis in both groups. Patients taking part in neoadjuvant chemotherapy clinical trials have a higher pCR rate and a lower mastectomy risk than patients not participating in clinical trials for their cancer care. This finding is a supporting factor for trial participation in neoadjuvant chemotherapy trials.

932Behaviors and attitudes towards Facial Protective Equipment (FPE) use among Healthcare Personnel (HCP) in the ResPECT study: Impact of study participation and a compliance education effort

932Behaviors and attitudes towards Facial Protective Equipment (FPE) use among Healthcare Personnel (HCP) in the ResPECT study: Impact of study participation and a compliance education effort

Acute effects of trauma-focused research procedures on participant safety and distress

The ethical conduct of research on posttraumatic stress disorder (PTSD) requires assessing the risks to study participants. Some previous findings suggest that patients with PTSD report higher distress compared to non-PTSD participants after trauma-focused research. However, the impact of study participation on participant risk, such as suicidal/homicidal ideation and increased desire to use drugs or alcohol, has not been adequately investigated. Furthermore, systematic evaluation of distress using pre- and post-study assessments, and the effects of study procedures involving exposure to aversive stimuli, are lacking. Individuals with a history of PTSD (n=68) and trauma-exposed non-PTSD controls (n=68) responded to five questions about risk and distress before and after participating in research procedures including a PTSD diagnostic interview and a behavioral task with aversive stimuli consisting of mild electrical shock. The desire to use alcohol or drugs increased modestly with study participation among the subgroup (n=48) of participants with current PTSD. Participation in these research procedures was not associated with increased distress or participant risk, nor did study participation interact with lifetime PTSD diagnosis. These results suggest some increase in distress with active PTSD but a participant risk profile that supports a favorable risk–benefit ratio for conducting research in individuals with PTSD.

Practice Benefit from Participating in a Practice-based Research Network Study of Postpartum Depression: A National Research Network (NRN) Report

At the midpoint of a large clinical trial taking place in a practice-based research network (PBRN), we asked leaders of the enrolled practices about the impact of participating in a PBRN study. Using semistructured interviews, the lead study nurse and physician from each site were queried about the impact of study participation on issues related to the study topic of postpartum depression (PPD) as well as any other impacts on the practice not directly related to PPD. From the results, initial themes were identified by 3 of the investigators (BPY, SB, MK) and confirmed by all the authors. Interviewee responses were grouped by theme. Forty-eight study leaders from 28 solo, moderately sized group and residency practices were interviewed during a period of 60 days. Practices were located in 20 different states, and 54% were in rural communities. Six major themes emerged. Study participation led to: ((1)) the recognition of the need for systematic approaches; ((2)) more effective teamwork and communication within the practice; ((3)) adaptation and extension of the PPD study tools and a systematic approach to the care of other chronic conditions; ((4)) increased professional self-worth and community recognition; ((5)) opportunity and support for staff members to "stretch" into new roles; and ((6)) increased research literacy within the practice. Participating in a PBRN research study can provide advantages to practices that extend beyond the study's specific purpose and content. These results provide further support for the value of PBRN research funding.

Impact of study participation on survival of early-stage breast cancer patients: Results from the BRENDA study, a multicenter clinical cohort on quality of breast cancer care

521 Background: Over the past two decades significant progress in treatment of early breast cancer has been accomplished through well designed, clinical trials (CTs). It has been hypothesized that trial participation could also be beneficial for the individual breast cancer patient. The BRENDA study group has been analysing quality of care provided by one university based and 16 regional breast cancer centers in south germany. In this study we investigated the impact of study participation on survival in an unselected clinical cohort of early stage breast cancer patients. Methods: The study population includes 5,966 patients who received primary therapy for early breast cancer between 1992 and 2005. Influence on survival by study participation was calculated by Cox proportional hazard analyses. Model adjustments include prognostic factors, type of treatment, age, risk group and time period. Guideline compliant treatment was assessed based on the St Gallen expert consensus recommendations and the German national S3 Guidelines. Results: A total of 738 patients (12%) received adjuvant (n = 552) or neoadjuvant (n = 186) systemic therapy within one out of 42 registered prospective multicenter phase II or III clinical trials. For patients not receiving neoadjuvant systemic therapy trial participation was associated with improved overall and disease free survival (hazard ratio [HR] = 0.75, 95% confidence interval [CI] 0.57–0.99, HR = 0.78, CI 0.63 - 0.97, respectively). The calculated effect was of similar magnitude after additional adjustment for co-existing morbidity of patients. Descriptional analysis revealed that guideline violations for locoregional or systemic treatment were more frequently found in patients receiving adjuvant treatment outside CTs. No significant effect on survival was calculated for 183 patients receiving neoadjuvant systemic therapy within CT protocols. Conclusions: In our study population participation in prospective clinical trials for adjuvant systemic therapy was associated with improved survival irrespective of treatment actually given. Intrinsic mechanisms within the framework of clinical trials can improve quality of breast cancer patient care. No significant financial relationships to disclose.