Patient satisfaction with clinical trial participation

Verheggen, Frank W.S.M.; Nieman, Fred; Reerink, E.; Kok, Gerjo

doi:10.1093/intqhc/10.4.319

Cited by 55 publications

(41 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The reason for this is that voluntary participation in clinical trials is influenced by patients' prior expectations and general attitudes towards dental care and research. 3 Thus, people who volunteer to participate, for example, in RCT, which are inherently associated with an element of risk, may not be representative of others who may have strong treatment preferences, for right or wrong reasons of their own. It is unfortunate therefore that there are so few trials in the dental literature that have used those alternative designs that take into account participants' preferences.…”

Section: Commentarymentioning

confidence: 99%

Implant retained or conventional dentures, which give more patients satisfaction?

Jokstad

2006

Evid Based Dent

View full text Add to dashboard Cite

Design This was a randomised controlled trial (RCT) set in a dental hospital. Intervention The implant group (IG) had two implants placed in the interforaminal region of the lower jaw followed (after healing) by a denture fixed to the implants by a ball attachment mechanism. In the conventional dentures group (CG), dentures were constructed using conventional replacement denture techniques. Patients in the IG had conventional upper dentures made in the same fashion. Outcome measure The performance of the dentures was evaluated using an oral health impact profile (OHIP) and a denture satisfaction scale before treatment and 3 months post-treatment. Results Analysis was conducted on an intention-to-treat basis. Substantial improvements in oral-health-related quality of life and denture satisfaction were reported by both groups. There were, however, no significant differences post-treatment between the groups. Patients randomised to the IG who declined implants had significantly lower pretreatment OHIP scores and there were significantly greater pre-/ post-treatment change-scores for individuals who had implants compared with the change-scores of people who declined. Conclusions There were no significant post-treatment differences between the groups, but a treatment effect may be masked by the intention-to-treat analysis. The pre-/ post-treatment OHIP change-scores were significantly greater for people receiving implants than for those who refused. CommentaryThis very interesting study is the first RCT in dentistry where the post-randomised single-consent design described by Zelen in 1979 1 has been used. The rationale for introducing a study design where the participants are randomised before acquiring consent was that it might enhance patient recruitment to clinical trials. Interestingly, not many trials in biomedicine have applied this design, and the majority of those that have suggest that the reason is to avoid bias due to a Hawthorne effect a distortion of the results caused by the response the participants to the special attention they receive from researchers rather than to improve recruitment. 2

show abstract

Section: Commentarymentioning

confidence: 99%

Implant retained or conventional dentures, which give more patients satisfaction?

Jokstad

2006

Evid Based Dent

View full text Add to dashboard Cite

show abstract

“…It has also been documented that purely participating in a clinical trial can lead patients to report an improvement in their state of health. 40 It should be noted, however, that comparable results in terms of improvement in quality-of-life issues were found in the RCT, which compared the SNaP Wound Care System with an electrically powered NPWT device-patients also reported less impact on daily activities, mobility, social interactions, and sleep when using SNaP during this study 30 -although it is acknowledged that these data were gained purely from a comparable study exit survey rather than a validated QoL tool.…”

Section: Evaluation Of a Novel Tnp Device In Healing Chronic Woundsmentioning

confidence: 62%

Clinical Evaluation of a Novel Topical Negative Pressure Device in Promoting Healing in Chronic Wounds

Bradbury

Walkley

Ivins

et al. 2015

Advances in Wound Care

View full text Add to dashboard Cite

Aim: This observational study evaluated the use of a novel, ultraportable, mechanically powered topical negative pressure device in promoting healing in chronic wounds, including venous and mixed etiology leg ulcers and neuropathic foot ulcers. Materials and Methods: Evaluable patients (n = 37) received treatment with the SNaP Ò Wound Care System for up to 6 weeks. The primary objective was percentage change in wound size, with secondary objectives of clinical assessment of wound parameters, ease of use, and impact on quality of life. Results: A 42.64% mean percentage decrease in wound area was observed, with an overall decrease for each wound etiology subgroup. Increased granulation tissue, decreased exudate levels, and decreased wound pain were reported. Quality-of-life scores increased overall, and the device was easy to use, comfortable, portable, and inconspicuous.

show abstract

“…Most patients are overall satisfied with their experiences in phase 1 trials. 32,33 The regimented routine that patients undergo as part of a phase 1 trial, which may include routine physical examinations, laboratory draws, biopsies, and radiological examinations, help alleviate some fear about the gravity of their disease, and patients were generally satisfied to receive more information about their disease as well as to supply information themselves. 33 Given the very nature of toxicity reporting in a phase 1 trial -with every symptom scrutinized -patients unexpectedly viewed this as being positive.…”

Section: Patient Benefitsmentioning

confidence: 99%

“…Many of these patients developed trust in the trial physician and were content knowing that their participation might contribute to future patients' health. 11,32 Many also felt empowered by attempting to control their disease.…”

Section: Patient Benefitsmentioning

confidence: 99%

“…35 With regard to patient satisfaction, many patients do not feel better about their disease once their trial participation is completed. 32 With the advent of biomarker-driven trials that require the testing of tumor tissue, the unavailability of tissue for future trials can become an issue. Moreover, many early-phase trials require fresh biopsies that subject individual patients to risks without any direct benefit to them.…”

Section: Patient Risksmentioning

confidence: 99%

See 1 more Smart Citation