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.

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 Effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044888
Author(s):  
Rita McMorrow ◽  
Barbara Hunter ◽  
Christel Hendrieckx ◽  
Dominika Kwasnicka ◽  
Leanne Cussen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Outcome Measures ◽  
Study Design ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Diabetes Distress ◽  
Controlled Trials ◽  
Patient Reported

IntroductionType 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes.Methods and analysisMEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case–control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate.Ethics and disseminationEthics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42020200246.

scholarly journals The Olympia anatomic polished cemented stem is associated with a high survivorship, excellent hip-specific functional outcome, and high satisfaction levels: follow-up of 239 consecutive patients beyond 15 years

2021 ◽  
Author(s):  
Gareth S. Turnbull ◽  
Claire Marshall ◽  
Jamie A. Nicholson ◽  
Deborah J. MacDonald ◽  
Nicholas D. Clement ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Femoral Stem ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
High Satisfaction ◽  
Age At Surgery ◽  
Patient Reported ◽  
Cemented Stem ◽  
Oxford Hip Score

Abstract Introduction The Olympia femoral stem is a stainless steel, anatomically shaped, polished and three-dimensionally tapered implant designed for use in cemented total hip arthroplasty (THA). The primary aim of this study was to determine the long-term survivorship, radiographic outcome, and patient-reported outcome measures (PROMs) of the Olympia stem. Patients and methods Between May 2003 and December 2005, 239 patients (264 THAs) underwent a THA with an Olympia stem in our institution. Patient-reported outcome measures were assessed using the Oxford Hip Score (OHS), EuroQol-5 dimensions (EQ-5D) score, and patient satisfaction at mean 10 years following THA. Patient records and radiographs were then reviewed at a mean of 16.5 years (SD 0.7, 15.3–17.8) following THA to identify occurrence of complications or revision surgery for any cause following surgery. Radiographs were assessed for lucent lines and lysis according to Gruen’s zones Results Mean patient age at surgery was 68.0 years (SD 10.9, 31–93 years). There were 156 women (65%, 176 THAs). Osteoarthritis was the indication for THA in 204 patients (85%). All cause stem survivorship at 10 years was 99.2% (95% confidence interval [CI], 97.9%–100%) and at 15 years was 97.5% (94.6%–100%). The 15-year stem survival for aseptic loosening was 100%. Analysis of all-cause THA failure demonstrated a survivorship of 98.5% (96.3%–100%) at 10 years and 95.9% (92.4%–99.4%) at 15 years. There were 9 THAs with non-progressive lucent lines in a single Gruen zone and 3 had lines in two zones, and no patient demonstrated signs for lysis. At a mean of 10-year (SD 0.8, 8.7–11.3) follow-up, mean OHS was 39 (SD 10.3, range 7–48) and 94% of patients reported being very satisfied or satisfied with their THA. Conclusions The Olympia stem demonstrated excellent 10-year PROMs and very high rates of stem survivorship at final follow-up beyond 15 years.

scholarly journals Patient-Reported Outcome Measures and Clinical Outcomes in Children with Foregut Anomalies

Children ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 587
Author(s):  
Isabel I. Sreeram ◽  
Chantal A. ten Kate ◽  
Joost van Rosmalen ◽  
Johannes M. Schnater ◽  
Saskia J. Gischler ◽  
...  
Keyword(s):  
Linear Regression ◽  
Clinical Outcomes ◽  
Outcome Measures ◽  
Clinical Decision Making ◽  
Linear Regression Analysis ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Added Value ◽  
Patient Reported

Increasing numbers of children and adults with chronic disease status highlight the need for a value-based healthcare system. Patient-reported outcome measures (PROMs) are essential to value-based healthcare, yet it remains unclear how they relate to clinical outcomes such as health and daily functioning. We aimed to assess the added value of self-reported PROMs for health status (HS) and quality of life (QoL) in the long-term follow-up of children with foregut anomalies. We evaluated data of PROMs for HS and/or QoL among eight-year-olds born with congenital diaphragmatic hernia (CDH), esophageal atresia (EA), or congenital lung malformations (CLM), collected within the infrastructure of a multidisciplinary, longitudinal follow-up program. Clinical outcomes were categorized into different outcome domains, and their relationships with self-reported HS and QoL were assessed through multivariable linear regression analyses. A total of 220 children completed HS and/or QoL self-reports. In children with CDH and EA, lower cognition was significantly associated with lower self-reported HS. Due to the low number of cases, multivariable linear regression analysis was not possible in children with CLM. HS, QoL, and clinical outcomes represent different aspects of a child’s wellbeing and should be measured simultaneously to facilitate a more holistic approach to clinical decision making.

scholarly journals Surgical Treatments of Talar Osteochondral Lesion: A Long-term Follow-up of Return to Sport and Patient-Reported Outcome Measures

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0037
Author(s):  
Andrew Schwartz ◽  
Shuo Niu ◽  
Faris Mirza ◽  
Ashley Thomas ◽  
Sameh Labib
Keyword(s):  
Outcome Measures ◽  
Osteochondral Lesion ◽  
Return To Sport ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Surgical Interventions ◽  
Patient Reported ◽  
Long Term Follow Up ◽  
And Function

Category: Ankle, Arthroscopy, Sports, Trauma Introduction/Purpose: Talar osteochondral lesion (TOCL) is a common problem in the young athletic population, mostly related to trauma. TOCL surgical treatment algorithm remains controversial, though results are improving as we gain experience. The results of TOCL surgical treatment on function and return to sport are promising, but quantified return to sport metrics remain largely unknown. Methods: A total of 156 consecutive patients following TOCL chondroplasty (10/1/2000-5/31/2018) by a single practice were retrospectively reviewed and included in this study. There were 54.5% female with a mean age 38.2 years, and mean follow-up 40.2 months following the index surgery. Patients were divided into four groups according to the type of chondroplasty performed: Antegrade arthroscopic drilling and/or microfracture (antegrade, 83 patients), retrograde arthroscopic drilling (retrograde, 35 patients), osteochondral autograft transfer (OATS, 26 patients), and allograft cartilage implantation (allograft, 12 patients). VAS scores for pain and function at the final clinic visit were collected. Patient-reported outcome measures including the short form-12 (SF-12), The Foot and Ankle Disability Index Sports Module (FADI-sports), Tegner score, Marx scale, Naal’s Sports inventory are also actively being collected. Results: Nearly 75% of patients are satisfied with surgical intervention of TOCLs. Allograft transplant was the least satisfying (71.4%), while OATS was the most satisfying (90%). Each surgical intervention yielded significantly decreased pain and increased function postoperatively (all p<0.001). Currently, 57 patients (36%) provided patient-reported outcome measures, with an average follow up of 79.8 months (Table 1). All surgical interventions trended toward decreased Tegner score, though only antegrade drilling showed a significant decrease (p<0.001). Based on Naal’s sports inventory, 85.7% of surgically treated patients reported participating in sport activities, on average 3 times/week and 50.6 minutes/session. Conclusion: Traditionally, TOCLs presented a difficult problem that is marred by unsatisfactory surgical outcomes in typically active patients. As our surgical understanding has evolved, we’ve continued to improve on outcomes. Our patients demonstrated a 74.5% satisfaction rate, a statistically significant improvement in pain and function, and a high rate of return to sport with little difference between surgical interventions at a long-term follow-up.

scholarly journals Feasibility of Collecting Multiple Patient-Reported Outcome Measures Alongside the Dutch Arthroplasty Register

2019 ◽  
Vol 7 (4) ◽  
pp. 484-492
Author(s):  
Claire Tilbury ◽  
Claudia S Leichtenberg ◽  
Bart L Kaptein ◽  
Lennard A Koster ◽  
Suzan H M Verdegaal ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Short Form ◽  
Response Rates ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Participation Rates ◽  
Arthroplasty Register ◽  
Patient Reported ◽  
Lost To Follow Up

Background: Compliance rates with patient-reported outcome measures (PROMs) collected alongside arthroplasty registries vary in the literature. We described the feasibility of a routinely collected set PROMs alongside the Dutch Arthroplasty Register. Methods: The longitudinal Leiden Orthopaedics Outcomes of OsteoArthritis Study is a multicenter (7 hospitals), observational study including patients undergoing total hip or total knee arthroplasty (THA or TKA). A set of PROMs: Short Form-12, EuroQol 5 Dimensions, Hip/Knee injury and Osteoarthritis Outcome Score, Oxford Hip/Knee Score was collected preoperatively and at 6, 12, 24 months, and every 2 years thereafter. Participation rates and response rates were recorded. Results: Between June 2012 and December 2014, 1796 THA and 1636 TKA patients were invited, of whom 1043 THA (58%; mean age 68 years [standard deviation, SD: 10]) and 970 TKA patients (59%; mean age 71 years [SD 9.5]) participated in the study. At 6 months, 35 THA/38 TKA patients were lost to follow-up. Response rates were 90% for THA (898/1000) and 89% for TKA (827/932) participants. At 1 and 2 years, 8 and 18 THA and 17 and 11 TKA patients were lost to follow-up, respectively. The response rates among those eligible were 87% (866/992) and 84% (812/972) for THA and 84% (771/917) and 83% (756/906) for TKA patients, respectively. The 2-year questionnaire was completed by 78.5% of the included THA patients and by 77.9% of the included TKA patients. Conclusions: About 60% of patients undergoing THA or TKA complete PROMs preoperatively, with more than 80% returning follow-up PROMs. To increase the participation rates, more efforts concerning the initial recruitment of patients are needed.

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