scholarly journals Stepped approach to improving sexual function after gynaecological cancer: the SAFFRON feasibility RCT

2019 ◽  
Vol 23 (6) ◽  
pp. 1-92
Author(s):  
Sue Gessler ◽  
Michael King ◽  
Alessandra Lemma ◽  
Julie Barber ◽  
Louise Jones ◽  
...  
Keyword(s):  
Sexual Function ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Clinical Skills ◽  
Pilot Trial ◽  
Health Technology ◽  
Gynaecological Cancer ◽  
Stepped Care ◽  
Treatment Level ◽  
Psychosocial Studies

Background Women affected by gynaecological cancer are often unaware of the sexual consequences of both the cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the effect on their sexuality may be profound, both physically and emotionally. However, several potential therapies can be effective in helping recover some sexual engagement and change self-perception around sex. A major initial challenge is informing and involving patients in an appropriate and sensitive manner, and a further issue is delivering therapies in busy gynaelogical oncology clinics. This study was conceived in response to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA) call asking for proposals to improve sexual functioning in women treated for gynaecological cancer while taking into account associated issues of mood. Existing evidence-based therapies for improving sexual function after cancer treatment were adapted and placed within a ‘stepped care’ model for delivering these in the NHS setting. An assessment and treatment stepping algorithm was developed in parallel, both to assign women to a treatment level at assessment and to follow their progress session by session to advise on changing intervention level. The assessment tool was applied to all participants on the principle that the problem was sexual difficulty, not the cancer of origin. Participants Women aged > 18 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions. Design A feasibility two-arm, parallel-group randomised controlled pilot trial. Setting Two NHS gynaecological cancer centres, one in London and one in Bristol. Interventions A three-level stepped care intervention. Objective To assess the feasibility of conducting a full-scale investigation of stepped therapy and indicate the potential benefits to patients and to the NHS generally. Primary outcome measures Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial. Results Development of the intervention and accompanying algorithm was completed. The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded. Limitations As the study did not proceed, the intervention and its accompanying algorithm have not been evaluated in practice, and the capacity of the NHS system to deliver it has not been examined. Conclusions None, as the study was halted. Future work The intervention could be studied within a clinical setting; however, the experience of the study group points to the need for psychosocial studies in medical settings to establish pragmatic and innovative mechanisms to ensure adequate resource when extending staff clinical skills and time to deliver any new intervention for the duration of the trial. Trial registration Current Controlled Trials ISRCTN12010952 and ClinicalTrials.gov NCT02458001. Funding This project was funded by the NIHR HTA programme and will be published in full in Health Technology Assessment; Vol. 23, No. 5. See the NIHR Journals Library website for further project information.

scholarly journals Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial

2016 ◽  
Vol 20 (48) ◽  
pp. 1-68 ◽  
Author(s):  
Chris Metcalfe ◽  
Kerry Avery ◽  
Richard Berrisford ◽  
Paul Barham ◽  
Sian M Noble ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Open Surgery ◽  
Outcome Measure ◽  
Pilot Trial ◽  
Health Technology ◽  
Definitive Trial ◽  
Post Surgery ◽  
Patient Reported

BackgroundLocalised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6–9 months. Minimal-access surgery may accelerate recovery.ObjectivesThe ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches.DesignPilot parallel three-arm randomised controlled trial nested within feasibility work.SettingTwo UK NHS departments of upper gastrointestinal surgery.ParticipantsPatients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy.InterventionsOesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access.Main outcome measureThe primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited.ResultsDuring 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients blind while pain was assessed during the first week post surgery. Postsurgical length of stay and risk of adverse events were within the typical range for this group of patients, with one death occurring within 30 days among 76 patients. There were good completion rates for the assessment of pain at 6 days post surgery (88%) and of the patient-reported outcomes at 6 weeks post randomisation (74%).ConclusionsRapid recruitment to the pilot trial and the successful refinement of methodology indicated the feasibility of a definitive trial comparing different approaches to oesophagectomy. Although we have shown a full trial of open compared with minimally invasive oesophagectomy to be feasible, this is necessarily based on our findings from the two clinical centres that we could include in this small preliminary study.Trial registrationCurrent Controlled Trials ISRCTN59036820.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 48. See the NIHR Journals Library website for further project information.

scholarly journals Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study

2018 ◽  
Vol 22 (36) ◽  
pp. 1-162 ◽  
Author(s):  
Naiem Moiemen ◽  
Jonathan Mathers ◽  
Laura Jones ◽  
Jonathan Bishop ◽  
Philip Kinghorn ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Standard Care ◽  
Pilot Trial ◽  
Health Technology ◽  
Burn Scar ◽  
Individual Interviews ◽  
Scar Management

Background Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness. Objective To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible. Design Web-based surveys, semistructured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation. Setting UK NHS burns services. Interviews and the pilot trial were run in seven burns services. Participants Thirty NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews. Face-to-face interviews were held with 24 adult patients and 16 parents of paediatric patients who had undergone PGT. The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy. Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with eight staff from six sites at the end of the trial. Interventions The intervention was standard care with pressure garments. The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage three or four times per day with moisturiser, silicone treatment, stretching and other exercises. Main outcome measures Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments. The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery. Results NHS burns services treat 2845 patients per annum (1476 paediatric and 1369 adult) and use pressure garments for 6–18 months, costing £2,171,184. The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment. Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT. A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden. The outcome tools evaluated in the pilot trial did not cover all of these domains. The planned 88 participants were recruited: the eligibility rate was 88% [95% confidence interval (CI) 83% to 92%], the consent rate was 47% (95% CI 40% to 55%). Five (6%) participants withdrew, 14 (16%) were lost to follow-up and 8 (9%) crossed over. Adherence was as in clinical practice. Completion of outcomes was high for adult patients but poorer from parents of paediatric patients, particularly for quality of life. Sections on range of movement and willingness to pay were found to be challenging and poorly completed. Limitations The Brisbane Burn Scar Impact Profile appears more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study. Conclusions A definitive RCT of PGT in burn scar management appears feasible. However, staff attitudes to the use of pressure garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are required. Future work We recommend that any future trial include an in-depth mixed-methods recruitment investigation and a process evaluation to account for this. Trial registration Current Controlled Trials ISRCTN34483199. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 36. See the NIHR Journals Library website for further project information

Versorgungsforschung in der Klinischen Neuropsychologie – eine Standortbestimmung

2008 ◽  
Vol 19 (4) ◽  
pp. 253-269 ◽  
Author(s):  
Sabine Heel ◽  
Sonja Fischer ◽  
Stefan Fischer ◽  
Tobias Grässer ◽  
Ellen Hämmerling ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Empirische Forschung

Zunächst führt dieser Artikel in die wesentlichen Begrifflichkeiten und Zielstellungen der Versorgungsforschung ein. Er befasst sich dann mit der Frage, wie die einzelnen Teildisziplinen der Versorgungsforschung, (1) die Bedarfsforschung, (2) die Inanspruchnahmeforschung, (3) die Organisationsforschung, (4) das Health Technology Assessment, (5) die Versorgungsökonomie, (6) die Qualitätsforschung und zuletzt (7) die Versorgungsepidemiologie konzeptionell zu fassen sind, und wie sie für neuropsychologische Anliegen ausformuliert werden müssen. In diesem Zusammenhang werden die in den einzelnen Bereichen jeweils vorliegenden versorgungsrelevanten Studienergebnisse referiert. Soweit es zulässig ist, werden Bedarfe für die Versorgungsforschung und Versorgungspraxis in der Neurorehabilitation daraus abgeleitet und Anregungen für die weitere empirische Forschung formuliert. Der Artikel bezieht sich – entsprechend seines Anliegens – ausschließlich auf Studien, die sich mit der Situation der deutschen Neurorehabilitation befassen.

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