scholarly journals Research Study Protocol: Using health information systems to address patients concerns in general practice: the COAC Intervention development and feasibility study

2021 ◽  
Author(s):  
Mairead Murphy ◽  
Chris Salisbury ◽  
Tom Palmer ◽  
Geoff Wong ◽  
Jude Hancock ◽  
...  
Keyword(s):  
General Practice ◽  
Feasibility Study ◽  
Complex Intervention ◽  
Online Survey ◽  
Health Knowledge ◽  
Well Being ◽  
Randomised Control Trial ◽  
Programme Theory ◽  
Patient Reported

Abstract BackgroundProblems are missed in up to 50% of primary care consultations. This is costly for the NHS, both in terms of reconsultation rates and in missed opportunities to increase patient empowerment. Research suggests that interventions at each end of the consultation can help to address patient concerns. At consultation initiation, sharing the results from electronic patient-reported outcome measures (ePROMs) with clinicians can help to elicit concerns. At consultation closure, providing the patient with written information to supplement spoken can improve recall and adherence.Aims and ObjectivesAim: To develop and test a complex intervention designed to more comprehensively address patients’ concerns in general practice, thereby reducing re-consultation rates, improving patients’ well-being and health knowledge, reducing health concerns and increasing patients’ confidence in their health provision and health plan. The aims will be achieved through two studies. Firstly a complex intervention will be designed, which uses an ePROM at consultation opening and a report printed or texted at consultation closure. Secondly, this intervention will be tested to establish the feasibility both of the intervention and of a randomised control trial (RCT) of the intervention.Methods1. Intervention Design Study: This will involve:1. Design of an online questionnaire system using practice SMS/email systems and online survey software to allow patient self-completion of a pre-consultation questionnaire and a report showing low-scoring questionnaire items, which is shared with GPs or nurses.2. Testing the pre-consultation system with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient, administrator, receptionist, nurse and GP feedback after each round.3. Design of an electronic template, integrated with the patient record, to provide a printable consultation-closure report to patients on issues raised in the consultation, advice given, treatment, follow-up and safety-netting.4. Testing the consultation-closure report iteratively with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient and GP/nurse feedback after each round.2. Feasibility Study: The intervention will be tested in a cluster-randomised framework as follows:1. Refinement of the intervention and update to programme theory.2. Randomisation of six practices: four randomised to intervention, and two to control.3. Recruitment of 30 patients per practice: 120 intervention and 60 control.4. Data Collection of quantitative data via GP/nurse-report, patient-report and health records. Interview of GPs, nurses, practice manager, administrators and receptionists and up to 30 patients.5. Realist evaluation of the data to identify and understand the mechanisms by which outcomes have occurred within the programme theory.6. Data analysis of recruitment rates, follow-up rates, data completeness, re-consultation rates within one/three months and other outcomes measures to assess feasibility of a future RCT.7. Evaluation of pre-agreed success criteria to decide whether to continue to RCT, stop, or modify the intervention.Timelines for deliveryStudy 1 will be completed from October 2019 – March 2021 and study 2 from April 2021 – April 2022.Anticipated impact and disseminationResults will be disseminated through targeted communications in social media, the University of Bristol website, policy briefings, academic papers, patient participation groups, community associations and seminars and conferences. The study output resources will be made available for immediate use. If progression criteria are met, we will aim to complete a randomised control trial within five years.

scholarly journals 1031 A Mixed Methods Feasibility Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
L Hitchman ◽  
J Totty ◽  
R Lathan ◽  
M Sidapra ◽  
G Smith ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mixed Methods ◽  
Feasibility Study ◽  
Randomised Control Trial ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Patient Reported ◽  
The Mean

Abstract Aim The purpose of this mixed methods feasibility study was to assess the feasibility of delivering ESWT to patients with DFUs. It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT may offer any patient reported benefits. Method A single centre mixed methods feasibility study. Patients with a DFU who met the eligibility criteria underwent ESWT 3 times in over 7 days. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFU healed at 12 weeks and quality of life. Semi-structured interviews explored participants experience of undergoing ESWT. Results 22.6% (24/106) of patients screened were recruited. The mean attendance to clinic was 90.9% and 65.1% to follow up. The mean score for acceptability and tolerability was 9.86 (SD 0.48, 95% CI 9.62-10.01) and 9.15 (SD 2.57, 95% CI 7.87-10.42) respectively. There were no serious adverse events or side effects. 45.5% of DFU healed during follow up and quality of life scores improved until 8 weeks. Key themes identified from the qualitative interviews were desire for the fast healing, improved quality of life, new treatments must be flexible and accessible on transport. Conclusions This study has shown it is possible to recruit and retain patents into this research. This study supports development of a large randomised control trial to determine the clinical and cost effectiveness of ESWT for DFU healing.

Significance of patient-reported outcomes for occupational resumption and quality of life after cardiac rehabilitation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Performance ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Funding Source ◽  
Patient Reported ◽  
Returning To Work

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance

scholarly journals Feasibility study of peer-led and school-based social network Intervention (STASH) to promote adolescent sexual health

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kirstin R. Mitchell ◽  
Carrie Purcell ◽  
Sharon A. Simpson ◽  
Chiara Broccatelli ◽  
Julia V. Bailey ◽  
...  
Keyword(s):  
Sexual Health ◽  
Sex Education ◽  
Feasibility Study ◽  
Intervention Group ◽  
Weight Of Evidence ◽  
Control Group ◽  
Programme Theory ◽  
Scale Evaluation ◽  
Social Network Intervention

Abstract Background Effective sex education is the key to good sexual health. Peer-led approaches can augment teacher-delivered sex education, but many fail to capitalise on mechanisms of social influence. We assessed the feasibility of a novel intervention (STASH) in which students (aged 14–16) nominated as influential by their peers were recruited and trained as Peer Supporters (PS). Over a 5–10-week period, they spread positive sexual health messages to friends in their year group, both in-person and via social media, and were supported to do so via weekly trainer-facilitated meetings. The aims of the study were to assess the feasibility of STASH (acceptability, fidelity and reach), to test and refine the programme theory and to establish whether the study met pre-set progression criteria for continuation to larger-scale evaluation. Methods The overall design was a non-randomised feasibility study of the STASH intervention in 6 schools in Scotland. Baseline (n=680) and follow-up questionnaires (approx. 6 months later; n=603) were administered to the intervention year group. The control group (students in year above) completed the follow-up questionnaire only (n=696), 1 year before the intervention group. The PS (n=88) completed a brief web survey about their experience of the role; researchers interviewed participants in key roles (PS (n=20); PS friends (n=22); teachers (n=8); trainers (n=3)) and observed 20 intervention activities. Activity evaluation forms and project monitoring data also contributed information. We performed descriptive quantitative analysis and thematic qualitative analysis. Results The PS role was acceptable; on average across schools >50% of students nominated as influential by their friends, signed up and were trained (n=104). This equated to 13% of the year group. Trained PS rarely dropped out (97% completion rate) and 85% said they liked the role. Fidelity was good (all bar one trainer-led activity carried out; PS were active). The intervention had good reach; PS were reasonably well connected and perceived as ‘a good mix’ and 58% of students reported exposure to STASH. Hypothesised pre-conditions, contextual influences and mechanisms of change for the intervention were largely confirmed. All bar one of the progression criteria was met. Conclusion The weight of evidence supports continuation to full-scale evaluation. Trial registration Current controlled trials ISRCTN97369178

scholarly journals Long-Term Patient Satisfaction and Quality of Life After Breast-Conserving Therapy: A Prospective Study Using the BREAST-Q

2021 ◽  
Author(s):  
Ilona Stolpner ◽  
Jörg Heil ◽  
Fabian Riedel ◽  
Markus Wallwiener ◽  
Benedikt Schäfgen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Patient Satisfaction ◽  
Repeated Measures ◽  
Aesthetic Surgery ◽  
Well Being ◽  
Breast Conserving Therapy ◽  
Patient Reported

Abstract Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.

75 Parental perspective about the health and development of their extremely preterm child

2021 ◽  
Vol 26 (Supplement_1) ◽  
pp. e55-e57
Author(s):  
Audrey-Anne Milette ◽  
Lindsay Richter ◽  
Claude-Julie Bourque ◽  
Annie Janvier ◽  
Kate Robson ◽  
...  
Keyword(s):  
Online Survey ◽  
Birth Outcome ◽  
Well Being ◽  
Subject Area ◽  
Common Source ◽  
Perinatal Medicine ◽  
Extremely Preterm ◽  
Health And Development ◽  
Parental Responses

Abstract Primary Subject area Neonatal-Perinatal Medicine Background Preterm birth outcome studies and clinical follow-up have traditionally focused on neurodevelopment. We previously showed in a selected sample of parents that they also valued other types of outcomes. Objectives This study aimed to validate these findings in a more diverse cohort by examining parental perspectives about the positive and negative aspects of their very preterm child’s health and development in relation to level of neurodevelopment impairment (NDI). Design/Methods Parents of children born < 29 weeks gestational age in 2016-2018 and seen at two Canadian neonatal follow-up clinics were invited to complete an online survey about their level of agreement with statements about their child’s health, development, and well-being. Parental responses in relation to their child’s level of NDI were examined using Kruskal-Wallis and chi-square for trends tests. Results 199 parental responses were obtained for 165 children (65% of eligible children). Of these children, 52%, 27% and 21% had, respectively, no, mild to moderate, and severe NDI. Development was the most common source of concerns (49%), followed by the child’s future (35%), and physical health (35%). Parents of children with severe NDI were more likely to express concerns than those with mild to moderate or no NDI. Parents rated their child’s health relatively high with a median score of 8/10 (range 3-10). Children with no NDI were given higher scores than those with NDI (p = 0.004). Regardless of level of NDI, almost all parents agreed with their child being happy (p = 1.000) and having a positive personality (p = 0.207). Figure 1 shows that parental concerns increased with level of NDI. Conclusion Parents of preterm children have a balanced perspective on their child’s outcome. Integrating their views when developing core sets of important outcomes for neonatal follow-up is critical.

Research in Genetic Counseling

2019 ◽  
pp. 171-186
Author(s):  
Barbara B. Biesecker ◽  
Kathryn F. Peters ◽  
Robert Resta
Keyword(s):  
Genetic Counseling ◽  
Self Regulation ◽  
Well Being ◽  
Genetic Counselors ◽  
National Society ◽  
Patient Reported ◽  
Key Variables ◽  
Regulation Model

The field of genetic counseling has historically valued the role of research. More recently, graduate programs have raised the standards for student thesis projects so that a greater percent are of publishable quality. The profession has acknowledged key research gaps, such as a lack of consensus on the primary client outcomes of counseling. Further, the National Society of Genetic Counselors has endorsed the importance of evidence that may be used to guide practice. Herein we present the role of genetic counselors as researchers and discuss approaches to designing research studies to answer key service delivery questions and patient-reported outcomes. To frame research in genetic counseling, health behavior and social psychology theories offer models for identifying key variables likely to predict client decisions and their outcomes. To date, studies in genetic counseling have been framed by the self-regulation model and the theory of planned behavior. A systematic review of randomized controlled trials in genetic counseling identified psychological well-being and gain in knowledge as the most prevalent patient outcomes. Evidence can be used to predict decisions to undergo genetic testing or follow up on results.

scholarly journals The MELFO Study: A Multicenter, Prospective, Randomized Clinical Trial on the Effects of a Reduced Stage-Adjusted Follow-Up Schedule on Cutaneous Melanoma IB–IIC Patients—Results After 3 Years

2019 ◽  
Vol 27 (5) ◽  
pp. 1407-1417 ◽  
Author(s):  
Eric A. Deckers ◽  
Josette E. H. M. Hoekstra-Weebers ◽  
Samantha Damude ◽  
Anne Brecht Francken ◽  
Sylvia ter Meulen ◽  
...  
Keyword(s):  
Cutaneous Melanoma ◽  
Well Being ◽  
Significant Group ◽  
Event Scale ◽  
Free Survival ◽  
Stage Ib ◽  
Ajcc Stage ◽  
Patient Reported ◽  
Melanoma Patients

Abstract Background This study compares well-being, recurrences, and deaths of early-stage cutaneous melanoma patients in follow-up, as recommended in the Dutch guideline, with that of patients in a stage-adjusted reduced follow-up schedule, 3 years after diagnosis, as well as costs. Methods Overall, 180 eligible pathological American Joint Committee on Cancer (AJCC) stage IB–IIC, sentinel node staged, melanoma patients (response rate = 87%, 48% male, median age 57 years), randomized into a conventional (CSG, n = 93) or experimental (ESG, n = 87) follow-up schedule group, completed patient-reported outcome measures (PROMs) at diagnosis (T1): State-Trait Anxiety Inventory–State version (STAI-S), Cancer Worry Scale (CWS), Impact of Event Scale (IES), and RAND-36 (Mental and Physical Component scales [PCS/MCS]). Three years later (T3), 110 patients (CSG, n = 56; ESG, n = 54) completed PROMs, while 42 declined (23%). Results Repeated measures analyses of variance (ANOVAs) showed a significant group effect on the IES (p = 0.001) in favor of the ESG, and on the RAND-36 PCS (p = 0.02) favoring the CSG. Mean IES and CWS scores decreased significantly over time, while those on the RAND-36 MCS and PCS increased. Effect sizes were small. Twenty-five patients developed a recurrence or second primary melanoma, of whom 13 patients died within 3 years. Cox proportional hazards models showed no differences between groups in recurrence-free survival (hazard ratio [HR] 0.71 [0.32–1.58]; p = 0.400) and disease-free survival (HR 1.24 [0.42–3.71]; p = 0.690). Costs per patient after 3 years (computed for 77.3% of patients) were 39% lower in the ESG. Conclusion These results seemingly support the notion that a stage-adjusted reduced follow-up schedule forms an appropriate, safe, and cost-effective alternative for pathological AJCC stage IB–IIC melanoma patients to the follow-up regimen as advised in the current melanoma guideline.

scholarly journals Feasibility study to evaluate cycloidal vibration therapy for the symptomatic treatment of intermittent claudication

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Leanne Atkin ◽  
John Stephenson ◽  
Karen Ousey
Keyword(s):  
Intermittent Claudication ◽  
Feasibility Study ◽  
Treatment Phase ◽  
Randomised Control Trial ◽  
Essential Information ◽  
Vibration Therapy ◽  
Supervised Exercise ◽  
Walking Time ◽  
Leg Pressure

Abstract Introduction Intermittent claudication (IC) is the most common symptom of peripheral arterial disease. Previous research has suggested that cycloidal vibration therapy (CVT) may induce angiogenesis and improvements in circulation. The objective of this feasibility study was to explore trial design and acceptability of the protocol to provide data to estimate the parameters required to design a definitive randomised control trial. This feasibility study specifically aimed to assess recruitment rate; attendance rates at baseline and follow-up; and safety, tolerability, and compliance with therapy device and additionally, to consider the potential efficacy of CVT as a novel treatment for intermittent claudication. Methods Patients with intermittent claudication (IC) were recruited and CVT was applied at home for 30 min twice a day for a period of 12 weeks. Primary outcomes were pain-free walking time (PFWT) and maximum walking time (MWT) after 12 weeks of treatment. Secondary outcomes included the ankle-brachial index and ankle systolic blood pressure. Participants were assessed during active therapy phase at baseline, week 4, week 8, and week 12. Results Thirty-four participants with IC were recruited: 30 (88%) male and 4 (12%) female. The rate of recruitment was 2.4 participants per month from a standard-size district general hospital. No participants left the study during the activity therapy stage, and no participant failed to attend their follow-up appointment. The general compliance with CVT was high. No participants dropped out during the treatment phase. The mean age of all participants was 68 years (IQR 60–75 years). Substantive improvements were seen in a comparison of differences in times to PFWT and MWT, in ABPI, and in systolic leg pressure in the treated leg. There was no evidence of a substantive difference from baseline in systolic leg pressure in the untreated leg. There were no immediate or delated treatment safety concerns of documented adverse effects with the treatment, all patients completed the required 12-week course indicated a high degree of patient acceptability. Conclusion The statistically significant and substantive improvements from baseline after 12 weeks observed in PFWT and MWT in participants experiencing IC are comparable to improvements seen from other treatment options such as supervised exercise as reported by Stewart et al. (N Engl J Med 347:1941–1951, 2002). The substantive improvement in systolic leg pressure in the treated leg and the concurrent absence of a substantive change in systolic leg pressure in the untreated leg over the same period suggests a causative effect. This study has provided novel information relating to the number of potential eligible participants for a further research trial and potential association between CVT and improved symptoms. Additionally, it has established that CVT treatment is highly acceptable, as indicated by no participant drop-out in the treatment phase, and may potentially offer an alternative treatment option for patients experiencing IC. Furthermore, this study has assessed the variability of the primary outcome measure which provides vital information needed to calculate sample sizes for any future studies. In conclusion, this study has established the feasibility of using CVT to improve patients’ symptoms of IC and provides essential information which will contribute to the design of future research investigating whether the improvements seen are directly related to CVT.

Child Health General Practice Hubs: a service evaluation

2015 ◽  
Vol 101 (4) ◽  
pp. 333-337 ◽  
Author(s):  
Sarah Montgomery-Taylor ◽  
Mando Watson ◽  
Robert Klaber
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Child Health ◽  
Service Evaluation ◽  
High Patient Satisfaction ◽  
Patient Reported ◽  
The Impact ◽  
Lower Capacity ◽  
Inside Out

ObjectiveTo evaluate the impact of an integrated child health system.DesignMixed methods service evaluation.Setting and patientsChildren, young people and their families registered in Child Health General Practitioner (GP) Hubs where groups of GP practices come together to form ‘hubs’.InterventionsHospital paediatricians and GPs participating in joint clinics and multidisciplinary team (MDT) meetings in GP practices, a component of an ‘Inside-Out’ change known as ‘Connecting Care For Children (CC4C)’.Main outcome measuresCases seen in clinic or discussed at MDT meetings and their follow-up needs. Hospital Episode data: outpatient and inpatient activity and A&E attendance. Patient-reported experience measures and professionals’ feedback.ResultsIn one hub, 39% of new patient hospital appointments were avoided altogether and a further 42% of appointments were shifted from hospital to GP practice. In addition, there was a 19% decrease in sub-specialty referrals, a 17% reduction in admissions and a 22% decrease in A&E attenders. Smaller hubs running at lower capacity in early stages of implementation had less impact on hospital activity. Patients preferred appointments at the GP practice, gained increased confidence in taking their child to the GP and all respondents said they would recommend the service to family and friends. Professionals valued the improvement in knowledge and learning and, most significantly, the development of trust and collaboration.ConclusionsChild Health GP Hubs increase the connections between secondary and primary care, reduce secondary care usage and receive high patient satisfaction ratings while providing learning for professionals.

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