scholarly journals Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024008 ◽  
Author(s):  
Anne Haugstvedt ◽  
Ingvild Hernar ◽  
Ragnhild Bjarkøy Strandberg ◽  
David A Richards ◽  
Roy Miodini Nilsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Clinical Diabetes ◽  
Diabetes Distress ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionAlthough diabetes distress is found to be associated with decreased glycaemic control among adults with type 1 diabetes, the psychological and emotional impact of living with the condition is often not recognised and often under-reported in diabetes care. Therefore, regular assessment of diabetes distress is recommended. Assessment of diabetes distress using patient-reported outcome measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient–clinician communication. In this study protocol, we describe a pilot randomised controlled trial (RCT) aiming to test the feasibility of all components of an empowerment-based intervention using PROMs as dialogue support in clinical diabetes consultations, and to address the uncertainties associated with running a fully powered evaluation study.Methods and analysisWe will undertake a two-arm pilot RCT of an intervention using the Problem Areas In Diabetes (PAID) scale in clinical diabetes consultations in order to conclude whether a fully powered trial is appropriate and/or feasible. The study will also include qualitative indepth interviews with participants and healthcare providers. Our objectives are to (1) evaluate the recruitment procedures and attrition rates; (2) evaluate the performance of the randomisation procedure; (3) evaluate the participants’ mean scores on the outcome measures before and after the intervention; (4) evaluate if the intervention consultations are acceptable and feasible; and (5) explore patients’ and healthcare providers’ experiences with the use of PAID as dialogue support and empowerment-based communication skills in clinical diabetes consultations. The quantitative data analysis includes descriptive statistics (frequencies, percentages, means, SD and CI). For the qualitative data, we will perform thematic analysis.Ethics and disseminationEthical approval has been obtained from the Western Norway Regional Committee for Medical and Health Research Ethics (2017/1506/REC west). We will present the findings from the study phases at national and international conferences and submit manuscripts to peer-reviewed journals and popular science journals.Trial registration numberNCT03471104; Pre-results.

scholarly journals A randomised controlled trial assessing the efficacy of co-phenylcaine nasal spray in flexible transnasal pharyngolaryngoscopy

2017 ◽  
Vol 99 (4) ◽  
pp. 313-318 ◽  
Author(s):  
F Javed ◽  
A Parmar ◽  
A Hussain ◽  
D Hajioff ◽  
D Pinder
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Significant Difference ◽  
Patient Reported ◽  
Randomised Controlled

INTRODUCTION The aim of this study was to assess whether using co-phenylcaine nasal spray before flexible transnasal pharyngolaryngoscopy results in reduced pain and discomfort during the procedure. METHODS This was a randomised controlled trial. Eighty-four patients were randomised to receive either co-phenylcaine nasal spray or placebo nasal spray before performing transnasal flexible pharyngolaryngoscopy. Patient reported outcome measures included pain, discomfort, unpleasantness and willingness to repeat the procedure while clinician reported outcome measures comprised ease of examination and quality of view obtained during the procedure. RESULTS There was no statistically significant difference in scores for pain, discomfort, unpleasantness and willingness to repeat the procedure between the co-phenylcaine and placebo groups. On the other hand, ease of examination scores were significantly better for the co-phenylcaine group than for the placebo group. CONCLUSIONS The majority of patients do not find flexible pharyngolaryngoscopy unpleasant or painful with or without topical nasal anaesthesia. However, the spray does appear to help the examiner in completing a satisfactory assessment.

scholarly journals Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial

BMJ ◽  
2019 ◽  
pp. l185 ◽  
Author(s):  
Antony J R Palmer ◽  
Vandana Ayyar Gupta ◽  
Scott Fernquest ◽  
Ines Rombach ◽  
Susan J Dutton ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Hip Surgery ◽  
Surgery Group ◽  
Patient Reported ◽  
Physiotherapy Programme ◽  
Randomised Controlled

Abstract Objective To compare arthroscopic hip surgery with physiotherapy and activity modification for improving patient reported outcome measures in patients with symptomatic femoroacetabular impingement (FAI). Design Two group parallel, assessor blinded, pragmatic randomised controlled trial. Setting Secondary and tertiary care centres across seven NHS England sites. Participants 222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging) were randomised (1:1) to receive arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification (n=110). Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle <20 degrees). Interventions Participants in the physiotherapy group received a goal based programme tailored to individual patient needs, with emphasis on improving core stability and movement control. A maximum of eight physiotherapy sessions were delivered over five months. Participants in the arthroscopic surgery group received surgery to excise the bone that impinged during hip movements, followed by routine postoperative care. Main outcome measures The primary outcome measure was the hip outcome score activities of daily living subscale (HOS ADL) at eight months post-randomisation, with a minimum clinically important difference between groups of 9 points. Secondary outcome measures included additional patient reported outcome measures and clinical assessment. Results At eight months post-randomisation, data were available for 100 patients in the arthroscopic hip surgery group (89%) and 88 patients in the physiotherapy programme group (80%). Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme. After adjusting for baseline HOS ADL, age, sex, and study site, the mean HOS ADL was 10.0 points higher (6.4 to 13.6) in the arthroscopic hip surgery group compared with the physiotherapy programme group (P<0.001)). No serious adverse events were reported in either group. Conclusions Patients with symptomatic FAI referred to secondary or tertiary care achieve superior outcomes with arthroscopic hip surgery than with physiotherapy and activity modification. Trial registration ClinicalTrials.gov NCT01893034 .

scholarly journals Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042353
Author(s):  
Ingvild Hernar ◽  
Marit Graue ◽  
David A Richards ◽  
Ragnhild B Strandberg ◽  
Roy Miodini Nilsen ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Pilot Trial ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Full Scale ◽  
Diabetes Distress ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Distress Scale

ObjectiveTo pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible.DesignTwo-arm pilot RCT.ParticipantsAdults aged ≥18–39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision.Randomisation and interventionAll participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores (Problem Areas In Diabetes scale) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed.OutcomesRecruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores (Diabetes Distress Scale (DDS), WHO 5-Well-being Index, Perceived Competence for Diabetes Scale and glycaemic control) and DDS correlation with baseline scores, to assist sample size calculations.ResultsWe randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9).ConclusionsThe pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.

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