Progress in the assessment and introduction of new treatments is impeded by the failure to recruit eligible patients into clinical trials. Little is known about the attitudes of U.K. cancer specialists towards trial participation, therefore a postal survey was conducted of 553 British clinical, medical and surgical oncologists. A 45-item questionnaire was returned by 357 clinicians (65% response rate). Although 353 (99%) of respondents stated that they were participating in trials, median 3 (range 0–62), 269 (75%) of clinicians were entering fewer than 50% of eligible patients. Differences were seen between professional groups within oncology; medical oncologists placed more emphasis on research than on clinical activities, felt greater pressure to participate in trials and were more likely to value being known by national and international colleagues than did surgeons or clinical oncologists. Surgeons were more likely to rely on clinical experience rather than enter patients into a trial but were more likely to keep patients on study following relapse. The survey identified constraints imposed by the healthcare system which impede trial participation including lack of time, communication difficulties and conflicts between the role of clinician and scientist. Such factors need consideration when trials are designed. Comparison of British data with those from the U.S. clinicians were broadly similar. The few differences found suggest that the more protocol-driven culture of the U.S. might encourage recruitment and a greater commitment to keep patients on trials.
2020, European Journal of Obstetrics and Gynecology and Reproductive Biology
Despite the widely acknowledged importance of research for improving patient care and outcomes, research in pregnant women is lacking. Many challenges innate to conducting research in pregnant women may discourage maternity care providers from engaging in research. Thus, the current study assessed maternity care providers’ involvement in research, their perception of the relevance of research, as well as facilitators and barriers to participating in research.
A total sample of 145 maternity care providers were recruited from a large tertiary-referral university-based teaching maternity hospital. Maternity care providers included, midwives, nurses, sonographers, consultant obstetricians, and non-consultant hospital doctors. Participants completed a cross-sectional survey between May and October 2018.
The present study found that overall, 49.7% of maternity care providers who participated reported never taking part in conducting research. Medical staff were more likely to report being given the opportunity and to have ever conducted research compared to midwives (p < 0.05). Participants agreed that research is important to maintain the quality of care provided to women (Mean = 4.86/5 in agreeance). However, medical staff were more likely to report understanding research methodology and feeling competent to undertake research compared to midwives (Mean = 3.85 v 3.28, p = 0.002; Mean = 3.56 v 2.60, p < 0.05).
The findings suggest future strategies aimed at increased opportunities and additional research training will likely support maternity care providers’, specifically midwives, involvement in conducting effective research studies in pregnancy. Such actions hold the potential to contribute research evidence lacking in pregnant women necessary to provide appropriate maternity care.
The objective of this study was to describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment.
One of three training workshops was offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to 3 months after training; perceived impact of training on practice was assessed after. Data were analyzed using two-sample t-tests and supplemented with findings from the content analysis of free-text comments.
Sixty-seven surgeons and 32 nurses attended. Self-confidence scores for all 10 questions increased after training [range of mean scores before 5.1–6.9 and after 6.9–8.2 (scale 0–10, all 95% confidence intervals are above 0 and all P-values <0.05)]. Awareness of hidden challenges of recruitment following training was high—surgeons' mean score 8.8 [standard deviation (SD), 1.2] and nurses' 8.4 (SD, 1.3) (scale 0–10); 50% (19/38) of surgeons and 40% (10/25) of nurses reported on a 4-point Likert scale that training had made “a lot” of difference to their RCT discussions. Analysis of free text revealed this was mostly in relation to how to convey equipoise, explain randomization, and manage treatment preferences.
Surgeons and research nurses reported increased self-confidence in discussing RCTs with patients, a raised awareness of hidden challenges and a positive impact on recruitment practice following QuinteT RCT Recruitment Training. Training will be made more available and evaluated in relation to recruitment rates and informed consent.
Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials.
Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.
2015, Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen
Im Januar 2014 startete die Deutsche Prostatakrebsstudie PREFERE (www.prefere.de). PREFERE ist eine randomisiert kontrollierte und präferenzbasierte Studie, die erstmalig alle vier zur Behandlung des organbegrenzten Prostatakarzinoms infrage kommenden Behandlungsmöglichkeiten untersucht. Das sind - entsprechend der ‚Interdisziplinären Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms‘ [1] - die radikale Prostatektomie, die perkutane Strahlentherapie, die Brachytherapie mittels Seed-Implantation und die aktive Überwachung (Active Surveillance). Die Präferenzbasierung der PREFERE-Studie sieht vor, dass potenzielle Studienteilnehmer, die sich nicht auf alle vier Optionen randomisieren lassen möchten, bis zu maximal zwei Optionen ablehnen können. Das stellt große Anforderungen an die Aufklärungsstrategie und die hierzu erforderlichen Informationsmaterialien.
Zur Patientenaufklärung im Rahmen der PREFERE-Studie waren Materialien (Broschüre und Patientenvideo) zu entwickeln, die Patienten ausgewogen und leitlinienbasiert über ihre Erkrankung und die Behandlungsoptionen informieren, über die Notwendigkeit einer Randomisierung und insbesondere über die PREFERE-Studie aufklären und die individuelle Präferenz- und partizipative Entscheidungsfindung zur Studienteilnahme unterstützen.
Die Entwicklung der Materialien erfolgte in einem strukturierten, iterativen Verfahren basierend auf einer vorangegangenen Literaturrecherche. An der Entwicklung und Testung der Patientenbroschüre und des Patientenvideos waren sechs Fokusgruppen mit insgesamt 40 Teilnehmern aus drei verschiedenen Selbsthilfegruppen, Betroffene, die keiner Selbsthilfegruppe angehören, gesunde Männer sowie als Experten die Mitglieder des Steering Commitees der PREFERE Studie und eine Fokusgruppe mit 18 Urologinnen und Urologen beteiligt.
Mittels Fragebogen und ausführlicher Diskussion wurden die Verständlichkeit und Eignung von Patientenbroschüre und Video zur Präferenz- und Entscheidungsfindung zur Teilnahme an der PREFERE-Studie getestet. Die Ergebnisse dieser Laien-Bewertungen flossen in die abschließende Überarbeitung ein.
Für die Ärztinnen und Ärzte wurde eine Gesprächshilfe erarbeitet, die wesentliche Aspekte der PREFERE-Patientenaufklärung enthält. Das Vorgehen bei der Aufklärung sowie die Patientenaufklärungsmaterialien sind Gegenstand einer Kurzschulung für niedergelassene Urologen und Strahlentherapeuten, die deutschlandweit durchgeführt wird.
Der Beitrag beschreibt das methodische Vorgehen bei der Erstellung der beschriebenen Materialien. Inwieweit die Patientenaufklärung durch die behandelnden Ärzte und die Patientenaufklärungsmaterialien die Entscheidung zur Teilnahme an der PREFERE-Studie tatsächlich beeinflusst hat, ist Gegenstand einer Befragung im Rahmen der Lebensqualitätserhebungen nach erfolgter Behandlung bzw. Randomisation (im Fall von Active Surveillance) während der Laufzeit von PREFERE.
The German prostate cancer study PREFERE (www.prefere.de) started in January 2014. It is the first randomised controlled and preference-based trial to investigate all four options available for the treatment of organ-confined prostate cancer. According to the “Interdisciplinary evidence-based S3 guideline for the early detection, diagnosis and treatment of the different stages of prostate cancer” [1], these options include: radical prostatectomy, external radiotherapy, brachytherapy and active surveillance. In the context of PREFERE preference-based means that potential study participants who do not agree to being randomised into all four treatment arms can maximally refuse two treatment arms. This poses a big challenge to the patient education strategy employed and the information material it requires.
In order to inform patients in the context of the PREFERE trial patient education materials (patient leaflet and video) had to be designed that provide patients with balanced and guideline-based information about the disease and the treatment options available, about the need for randomisation and, in particular, about the PREFERE trial and support their individual preference finding and shared decision making for participating in the trial.
An iterative structured approach was used to develop the information materials on the basis of a previous literature search. Six focus groups with a total of 40 participants from three different self-help groups, affected men that do not belong to a self-help group, healthy men as well as experts, the members of the steering committee of the PREFERE trial and a focus group consisting of 18 male and female urologists were involved in the development and testing of both the patient information leaflet and the patient video.
Both the patient information leaflet and the video supporting preference finding and decision making for participating in the PREFERE trial were tested for understandability and suitability by using a questionnaire and conducting a comprehensive discussion. The results of these lay evaluations have been included in the final revision.
Also, a communication resource for physicians has been created comprising all the essential aspects of the PREFERE patient education materials. A short course conducted all over Germany will focus on the process of patient teaching as well as patient education materials.
Whether and to what extent the decision for participating in the PREFERE trial has actually been influenced 1) by what the treating physicians communicated to the patient and 2) by the patient education materials used is one of the subjects of a quality of life survey that will be conducted following treatment or – in the case of the active surveillance option – after randomisation during the PREFERE trial.
A Question Prompt List (QPL) is a proven, simple intervention to aid patients to be active participants in consultations with their physicians by asking questions. We aimed to further develop and test the efficacy of a targeted QPL for clinical trials (QPL-CT).
Breast, Lung and Genitourinary cancer patients who were facing a discussion about a therapeutic clinical trial completed short pre- and post-consultation questionnaires and used the QPL-CT in their discussions with their oncologists.
30 participants were recruited from 6 oncologists. All QPL-CT questions were selected by at least one-third of participants. Participants mostly wanted and asked questions about personal trial benefit. Oncologists provided information about personal benefit to varying degrees, thus patients did not ask some questions. Patients were still left with some unasked and unanswered questions.
The QPL-CT has potential as a simple, inexpensive intervention to aid such communication. Further investigation is needed to demonstrate the efficacy of the QPL-CT in improving cancer patient outcomes.
These preliminary finding suggest that important areas of clinical trials are overlooked in clinical consultations. The QPL-CT may be an effective method to encourage oncologists to endorse patient question asking about clinical trials and prompt patient questions.
It has been reported that the oncologists' subspecialty was one of the factors independently predicting enrolment [12]. Medical oncologists placed more emphasis on research than on clinical activities [11], and participation in clinical trials by medical oncologists was significantly higher than for radiation oncologists [15]. Secondly, the physicians and nurses participating in this study were quite young (Table 1).
This study aimed to assess the attitudes of oncology physicians and nurses toward phase I, II, and III cancer clinical trials.
A questionnaire was administered to 358 oncology physicians and nurses.
The effective response rate was 79.3%. Of the respondents, 67.6%, 95.1%, and 98.6% reported that cancer patients would benefit from phase I, II, and III trials, respectively. Respondents would also recommend that their patients participate in phase I (64.4%), II (88.4%), and III trials (95.1%). When asked to assume the role of cancer patients, the respondents themselves were willing to participate in phase I (48.2%), II (72.9%), and III trials (89.8%). Respondents who admitted having little or no understanding of cancer clinical trials were not willing to recommend participation in phase I clinical trials to their patients (OR 0.187, 95% CI 0.110–0.319, p < 0.001). No factor was significantly associated with respondents' willingness to recommend that their patients participate in phase II or III clinical trials.
Most physicians and nurses hold positive attitudes toward clinical trials, especially phases II and III. The number of medical staff who approved of clinical trials was positively associated with the stage of the phase trial.
