A Nested Qualitative Evaluation of User Experiences in a Randomized Trial of a Digital Intervention To Support Total-Skin-Self-Examination By Melanoma Survivors

Abstract BackgroundMelanoma is a common cancer with a high survival rate, as well as a high chance of recurrence. Combined, this leads to a high burden of follow-up. Total-Skin-Self-Examination (TSSE) improves clinical outcomes of melanoma via early detection of new primaries and recurrences, and technology is an increasingly popular means of facilitating TSSE. Thus, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) digital healthcare intervention was developed. Embedded within a randomised control trial (RCT), this nested study used qualitative interviews to explore in depth participants’ experiences of TSSE, their orientation toward technology and both participant and professionals’ practical and technical experiences of the ASICA intervention.MethodsSemi-structured telephone interviews were undertaken during the RCT with participants and the coordinating Dermatology Nurse Practitioner (DNP). Participants were purposively sampled to achieve a representative sample. Interviews were transcribed verbatim and analysed using a Framework Analysis approach applied within NVivo12.ResultsTwenty-two interviews were completed with participants and one with the coordinating DNP. ASICA appeared to change participants’ perceptions of skin checking: users were more likely to report routinely performing TSSE thoroughly. There was some variation in beliefs about skin-checking and using technology for healthcare generally. Overall, ASICA was experienced positively by participants and the DNP. Several clear practical suggestions were made for how ASICA can be improved.ConclusionThe ASICA app appears to have positively influenced the attitudes and TSSE practices of melanoma survivors. Technical improvements are required, but the app offers promise for technologically enhanced melanoma follow-up in future.Trial RegistrationClinical Trials.gov, NCT03328247. Registered on 1 November 2017 - https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1

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The State of Education and Training for Antimicrobial Stewardship Programs in Indian Hospitals―A Qualitative and Quantitative Assessment

Antibiotics ◽

10.3390/antibiotics8010011 ◽

2019 ◽

Vol 8 (1) ◽

pp. 11 ◽

Cited By ~ 1

Author(s):

Sanjeev Singh ◽

Esmita Charani ◽

Chand Wattal ◽

Anita Arora ◽

Abi Jenkins ◽

...

Keyword(s):

Antimicrobial Stewardship ◽

Online Survey ◽

Healthcare Professionals ◽

Qualitative Interviews ◽

Education And Training ◽

Healthcare Organizations ◽

Telephone Interviews ◽

And Training

Background: To understand the role of infrastructure, manpower, and education and training (E&T) in relation to Antimicrobial Stewardship (AMS) in Indian healthcare organizations. Methods: Mixed method approach using quantitative survey and qualitative interviews was applied. Through key informants, healthcare professionals from 69 hospitals (public & private) were invited to participate in online survey and follow up qualitative interviews. Thematic analysis was applied to identify the key emerging themes from the interviews. The survey data were analyzed using descriptive statistics. Results: 60 healthcare professionals from 51 hospitals responded to the survey. Eight doctors participated in semi-structured telephone interviews. 69% (27/39) of the respondents received E&T on AMS during undergraduate or postgraduate training. 88% (15/17) had not received any E&T at induction or during employment. In the qualitative interviews three key areas of concern were identified: (1) need for government level endorsement of AMS activities; (2) lack of AMS programs in hospitals; and, (3) lack of postgraduate E&T in AMS for staff. Conclusion: No structured provision of E&T for AMS currently exists in India. Stakeholder engagement is essential to the sustainable design and implementation of bespoke E&T for hospital AMS in India.

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Exploring education preferences of Australian women regarding long-term health after hypertensive disorders of pregnancy: a qualitative perspective

BMC Women s Health ◽

10.1186/s12905-021-01524-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Heike Roth ◽

Amanda Henry ◽

Lynne Roberts ◽

Lisa Hanley ◽

Caroline S. E. Homer

Keyword(s):

Health Management ◽

Hypertensive Disorders Of Pregnancy ◽

Framework Analysis ◽

Public Health Importance ◽

Heart Attacks ◽

Telephone Interviews ◽

Hypertensive Disorders ◽

History Of

Abstract Background Hypertensive disorders of pregnancy (HDP) affect 5–10% of pregnant women. Long-term health issues for these women include 2–3 times the risk of heart attacks, stroke and diabetes, starting within 10 years after pregnancy, making long-term health after HDP of major public health importance. Recent studies suggest this knowledge is not being transferred sufficiently to women and how best to transmit this information is not known. This study explored women’s preferred content, format and access to education regarding long-term health after HDP. Methods This was a qualitative study and framework analysis was undertaken. Women with a history of HDP who had participated in a survey on long-term health after HDP were invited to participate in this study. During telephone interviews women were asked about preferences and priorities concerning knowledge acquisition around long-term health after HDP. Results Thirteen women were interviewed. They indicated that they wanted more detailed information about long-term and modifiable risk factors. Their preference was to receive risk counselling from their healthcare provider (HCP) early after giving birth along with evidence-based, print or web-based information to take home. All women suggested more structured postnatal follow-up, with automated reminders for key appointments. Automated reminders should detail rationale for follow-up, recommended tests and discussion topics to be addressed at the appointment. Conclusion Our findings show that most participants wanted information soon after birth with all women wanting information within 12 months post birth, complemented with detailed take-home evidence. Participants indicated preference for structured follow-up via their HCP with automated alerts about the appointment and recommended tests. This evidence can be used to guide the development of education programs for women on health after HDP which may enhance knowledge, preventive health management and more generally improve women’s health trajectories.

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Parent and Clinician Views of Managing Children with Symptoms of a Lower Respiratory Tract Infection and Their Influence upon Decisions to Take Part in a Placebo-Controlled Randomised Control Trial

Antibiotics ◽

10.3390/antibiotics10040356 ◽

2021 ◽

Vol 10 (4) ◽

pp. 356

Author(s):

Catherine J. Woods ◽

Zoe Morrice ◽

Nick A. Francis ◽

Paul Little ◽

Theo Verheij ◽

...

Keyword(s):

Respiratory Tract ◽

Lower Respiratory Tract ◽

Controlled Trial ◽

Randomised Control Trial ◽

Antibiotic Prescribing ◽

Parent Attitudes ◽

Telephone Interviews ◽

Tract Infections ◽

Interview Studies ◽

Safety Netting

Children presenting with uncomplicated lower respiratory tract infections (LRTIs) commonly receive antibiotics despite public campaigns on antibiotic resistance. Qualitative interview studies were nested in a placebo-controlled trial of amoxicillin for LRTI in children. Thirty semi-structured telephone interviews were conducted with sixteen parents and fourteen clinicians to explore views of management and decisions to participate in the trial. All interviews were audio-recorded, transcribed and analysed using thematic analysis. Parents found it difficult to interpret symptoms and signs, and commonly used the type of cough (based on sound) to judge severity, highlighting the importance of better information to support parents. Provision of a clinical examination and reassurance regarding illness severity were key motivations for consulting. Many parents now acknowledge that antibiotics should only be used when ‘necessary’, and clinicians reported noticing a shift in parent attitudes with less demand for antibiotics and greater satisfaction with clinical assessment, reassurance and advice. Decisions to take part in the trial were influenced by the perceived risks associated with allocation to a placebo, and concerns about unnecessary use of antibiotics. Clear communication about self-management and safety-netting were identified as important when implementing ‘no antibiotic’ prescribing strategies to reassure parents and to support prescribing decisions.

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Evaluation of a multidisciplinary lipid clinic to improve the care of individuals with severe lipid conditions: a RE-AIM framework analysis

Implementation Science Communications ◽

10.1186/s43058-021-00135-8 ◽

2021 ◽

Vol 2 (1) ◽

Author(s):

Laney K. Jones ◽

Megan McMinn ◽

David Kann ◽

Michael Lesko ◽

Amy C. Sturm ◽

...

Keyword(s):

Primary Care ◽

Program Effectiveness ◽

Primary Care Providers ◽

Care Providers ◽

Lipid Levels ◽

Framework Analysis ◽

Lipid Clinic ◽

Adherence Counseling ◽

Clinically Significant

Abstract Background Individuals with complex dyslipidemia, or those with medication intolerance, are often difficult to manage in primary care. They require the additional attention, expertise, and adherence counseling that occurs in multidisciplinary lipid clinics (MDLCs). We conducted a program evaluation of the first year of a newly implemented MDLC utilizing the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to provide empirical data not only on program effectiveness, but also on components important to local sustainability and future generalizability. Methods The purpose of the MDLC is to increase the uptake of guideline-based care for lipid conditions. Established in 2019, the MDLC provides care via a centralized clinic location within the healthcare system. Primary care providers and cardiologists were invited to refer individuals with lipid conditions. Using a pre/post-study design, we evaluated the implementation outcomes from the MDLC using the RE-AIM framework. Results In 2019, 420 referrals were made to the MDLC (reach). Referrals were made by 19% (148) of the 796 active cardiology and primary care providers, with an average of 35 patient referrals per month in 2019 (SD 12) (adoption). The MDLC saw 83 patients in 2019 (reach). Additionally, 50% (41/82) had at least one follow-up MDLC visit, and 12% (10/82) had two or more follow-up visits in 2019 (implementation). In patients seen by the MDLC, we found an improved diagnosis of specific lipid conditions (FH (familial hypercholesterolemia), hypertriglyceridemia, and dyslipidemia), increased prescribing of evidence-based therapies, high rates of medication prior authorization approvals, and significant reductions in lipid levels by lipid condition subgroup (effectiveness). Over time, the operations team decided to transition from in-person follow-up to telehealth appointments to increase capacity and sustain the clinic (maintenance). Conclusions Despite limited reach and adoption of the MDLC, we found a large intervention effect that included improved diagnosis, increased prescribing of guideline-recommended treatments, and clinically significant reduction of lipid levels. Attention to factors including solutions to decrease the large burden of unseen referrals, discussion of the appropriate number and duration of visits, and sustainability of the clinic model could aid in enhancing the success of the MDLC and improving outcomes for more patients throughout the system.

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Evaluation of adherence monitoring system using evriMED with a differentiated response compared to standard of care among drug-sensitive TB patients in three provinces in South Africa: a protocol for a cluster randomised control trial

Trials ◽

10.1186/s13063-021-05337-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Noriah Maraba ◽

Catherine Orrell ◽

Candice M. Chetty-Makkan ◽

Kavindhran Velen ◽

Rachel Mukora ◽

...

Keyword(s):

South Africa ◽

Treatment Success ◽

Standard Of Care ◽

Treatment Completion ◽

Phone Call ◽

Randomised Control Trial ◽

Improve Medication Adherence ◽

Tb Treatment ◽

Differentiated Care

Abstract Background South Africa has achieved drug-susceptible TB (DS-TB) treatment success of only 77% among people with new and previously treated TB. Alternative approaches are required to improve medication adherence and treatment completion to limit transmission, TB relapse and the development of resistance. This study aims to implement and evaluate the use of adherence medication monitors (Wisepill evriMED 1000) with a differentiated response to patient care, among DS-TB patients in three provinces of South Africa. Methods In total, 18 public health clinics across three provinces were selected. Clinics were randomised to intervention or standard of care clinics. In each clinic, approximately 145 DS-TB patients are being enrolled to reach a total of 2610. All patients have their daily adherence monitored using medication monitors. In the intervention arm, patients are receiving medication monitor reminders and differentiated care in response to adherence data. This weekly review of daily real-time monitoring will be undertaken from a central database. The differentiated care model includes automated SMS reminders with a missed dose, research staff-initiated phone call to the patient with a second or third missed dose, a home visit if four or more doses are missed, and motivational counselling if four or more doses are missed repeatedly. Fidelity of the intervention will be measured through process evaluation. Patients in control clinics will receive medication monitors for adherence tracking, standard of care TB education, and normal clinic follow-up procedures. The primary outcome is the proportion of patients by arm with >80% adherence, as measured by the medication monitor. The feasibility and acceptability of the intervention will be assessed by in-depth interviews with patients, stakeholders, and study staff. A cost effectiveness analysis of the intervention and standard of care clinics will be conducted. Significance This trial will provide evidence for the use of an intervention, including medication monitors and differentiated care package, to improve adherence to TB treatment. Improved adherence should also improve TB treatment completion rates, thus reducing loss to follow-up rates, and TB relapse among people with TB. The intervention is intended to ultimately improve overall TB control and reduce TB transmission in South Africa. Trial registration Pan African Trial Registry PACTR201902681157721. Registered on 11 February 2019.

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Cognitive decline in patients with prostate cancer: study protocol of a prospective cohort, NEON-PC

BMJ Open ◽

10.1136/bmjopen-2020-043844 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043844

Author(s):

Natalia Araujo ◽

Samantha Morais ◽

Ana Rute Costa ◽

Raquel Braga ◽

Ana Filipa Carneiro ◽

...

Keyword(s):

Prostate Cancer ◽

Cognitive Decline ◽

Cognitive Performance ◽

Androgen Deprivation Therapy ◽

Survival Rates ◽

Cardiovascular Complications ◽

Androgen Deprivation ◽

High Survival ◽

The Impact

IntroductionProstate cancer is the most prevalent oncological disease among men in industrialised countries. Despite the high survival rates, treatments are often associated with adverse effects, including metabolic and cardiovascular complications, sexual dysfunction and, to a lesser extent, cognitive decline. This study was primarily designed to evaluate the trajectories of cognitive performance in patients with prostate cancer, and to quantify the impact of the disease and its treatments on the occurrence of cognitive decline.MethodsParticipants will be recruited from two main hospitals providing care to approximately half of the patients with prostate cancer in Northern Portugal (Portuguese Institute of Oncology of Porto and São João Hospital Centre), and will comprise a cohort of recently diagnosed patients with prostate cancer proposed for different treatment plans, including: (1) radical prostatectomy; (2) brachytherapy and/or radiotherapy; (3) radiotherapy in combination with androgen deprivation therapy and (4) androgen deprivation therapy (with or without chemotherapy). Recruitment began in February 2018 and is expected to continue until the first semester of 2021. Follow-up evaluations will be conducted at 1, 3, 5, 7 and 10 years. Sociodemographic, behavioural and clinical characteristics, anxiety and depression, health literacy, health status, quality of life, and sleep quality will be assessed. Blood pressure and anthropometrics will be measured, and a fasting blood sample will be collected. Participants’ cognitive performance will be evaluated before treatments and throughout follow-up (Montreal Cognitive Assessment and Cube Test as well as Brain on Track for remote monitoring). All participants suspected of cognitive impairment will undergo neuropsychological tests and clinical observation by a neurologist.Ethics and disseminationThe study was approved by the Ethics Committee of the hospitals involved. All participants will provide written informed consent, and study procedures will be developed to ensure data protection and confidentiality. Results will be disseminated through publication in peer-reviewed journals and presentation in scientific meetings.

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The Contribution of Pharmacists and Pharmacy Technicians to Person-Centred Care within a Medicine’s Optimisation in Care Homes Service: A Qualitative Evaluation

Pharmacy ◽

10.3390/pharmacy9010034 ◽

2021 ◽

Vol 9 (1) ◽

pp. 34

Author(s):

Sally Fowler Davis ◽

Rachel Cholerton ◽

Louise Freeman-Parry ◽

Jo Tsoneva

Keyword(s):

Care Home ◽

Pharmacy Practice ◽

Qualitative Evaluation ◽

Care Homes ◽

Framework Analysis ◽

Medicines Management ◽

Team Members ◽

Care Home Staff ◽

Management Interventions ◽

Pharmacy Technicians

Pharmacists and pharmacy technicians seek to improve person-centred care. Improvements to systems for care homes seeks to reduce medicines waste and inefficiency, particularly through supporting care home staff, to enhance safer administration of medicines. A complex evaluation used qualitative design and utilised narrative enquiry, and team members and key stakeholders were interviewed. Framework analysis was used, aligning findings to a person-centred care framework for older people. The Medicines Optimisation in Care Homes (MOCH) team brokered improvement practices across care homes to enhance person-centred care. The framework analysis confirms that the team used ‘authentic attention’ in relation to the residents’ experiences and flexibility in relation to negotiating medication. The importance of transparency of processes and systems in medicines management is highlighted, alongside requirements for person-centred care to make explicit the reason for taking a medication, and the continuous discussion with a range of stakeholders about the continuing need for particular medications. The outcome of the evaluation includes insights into a new area of pharmacy practice in community, based on the skills, knowledge, and experience of pharmacists and pharmacy technicians working in the care home sector. Further study is needed into the efficacy and outcomes of medicines management interventions.

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Remeex® System Effectiveness in Male Patients with Stress Urinary Incontinence

Journal of Clinical Medicine ◽

10.3390/jcm10102121 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2121

Author(s):

Gerardo-Alfonso Márquez-Sánchez ◽

Bárbara-Yolanda Padilla-Fernández ◽

Miguel Perán-Teruel ◽

Pedro Navalón-Verdejo ◽

Sebastián Valverde-Martínez ◽

...

Keyword(s):

Urinary Incontinence ◽

Stress Urinary Incontinence ◽

Surgical Techniques ◽

High Survival ◽

Complication Rates ◽

Exact Test ◽

Number Of Patients ◽

Male Stress Urinary Incontinence ◽

Group B

Background: When conservative management fails, patients with stress urinary incontinence (SUI) are considered for surgical treatment. Simpler, more economical and less invasive surgical techniques, such as the Remeex® system, have been developed. Objectives: To analyze the objective effectiveness of the Remeex® system in the treatment of male stress urinary incontinence. To study survival and complication rates of the Remeex® system in male SUI patients. Materials and methods: Prospective observational study between July 2015 and May 2020. Group A (n = 7; GA) patients with mild SUI. Group B (n = 22; GB) patients with moderate SUI. Group C (n = 18; GC) patients with severe SUI. Effectiveness was assessed by the number of patients achieving complete and partial dryness. Complete dryness was defined as patients using 0–1 safety pads per day; partial dryness as a >50% reduction in the number of pads used. Results were analyzed using descriptive statistics, Student’s t-test. Chi2, Fisher’s exact test, ANOVA, and multivariate analysis. Significance was set at p < 0.05. Results: Mean age 69.76 years, mean follow-up 33.52 months. Objective effectiveness was observed in 89.36% of patients with incontinence. The effectiveness was 85.71% in GA, 90.91% in GB and 88.89% in GC. There were no significant differences among groups (p = 1.0000). 34.04% of patients with an implant required at least one readjustment, while 66.00% did not require any. There were no significant differences among groups (p = 0.113) Chi2 = 4.352. 95.74% of implants remained in place by the end of follow-up. We observed complications in 17.02% of patients. Conclusions: Remeex® system is an effective and safe method for male stress urinary incontinence treatment, regardless of the severity of the incontinence, with high survival and low complication and removal rates. System readjustments are required in one-third of the cases.

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Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)

BMJ Open ◽

10.1136/bmjopen-2020-040117 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040117

Author(s):

Carole Clair ◽

Aurélie Augsburger ◽

Priska Birrer ◽

Isabella Locatelli ◽

Joelle Schwarz ◽

...

Keyword(s):

Type 2 Diabetes ◽

Smoking Cessation ◽

Smoking Cessation Intervention ◽

Randomised Control Trial ◽

Primary Study ◽

Smoking Abstinence ◽

Open Label ◽

Cessation Intervention

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysisThe study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and disseminationEthical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbersClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.

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Trials and Tribulations: mHealth Clinical Trials in the COVID-19 Pandemic

Yearbook of Medical Informatics ◽

10.1055/s-0041-1726487 ◽

2021 ◽

Author(s):

Praveen Indraratna ◽

Uzzal Biswas ◽

Jennifer Yu ◽

Guenter Schreier ◽

Sze-Yuan Ooi ◽

...

Keyword(s):

Decompensated Heart Failure ◽

Hospital Staff ◽

Outpatient Setting ◽

World Health ◽

Randomised Control Trial ◽

Contact Method ◽

Model Of Care ◽

Coronary Syndrome ◽

Health Organization

Introduction: Mobile phone-based interventions in cardiovascular disease are growing in popularity. A randomised control trial (RCT) for a novel smartphone app-based model of care, named TeleClinical Care - Cardiac (TCC-Cardiac), commenced in February 2019, targeted at patients being discharged after care for an acute coronary syndrome or episode of decompensated heart failure. The app was paired to a digital sphygmomanometer, weighing scale and a wearable fitness band, all loaned to the patient, and allowed clinicians to respond to abnormal readings. The onset of the COVID-19 pandemic necessitated several modifications to the trial in order to protect participants from potential exposure to infection. The use of TCC-Cardiac during the pandemic inspired the development of a similar model of care (TCC-COVID), targeted at patients being managed at home with a diagnosis of COVID-19. Methods: Recruitment for the TCC-Cardiac trial was terminated shortly after the World Health Organization announced COVID-19 as a global pandemic. Telephone follow-up was commenced, in order to protect patients from unnecessary exposure to hospital staff and patients. Equipment was returned or collected by a ‘no-contact’ method. The TCC-COVID app and model of care had similar functionality to the original TCC-Cardiac app. Participants were enrolled exclusively by remote methods. Oxygen saturation and pulse rate were measured by a pulse oximeter, and symptomatology measured by questionnaire. Measurement results were manually entered into the app and transmitted to an online server for medical staff to review. Results: A total of 164 patients were involved in the TCC-Cardiac trial, with 102 patients involved after the onset of the pandemic. There were no hospitalisations due to COVID-19 in this cohort. The study was successfully completed, with only three participants lost to follow-up. During the pandemic, 5 of 49 (10%) of patients in the intervention arm were readmitted compared to 12 of 53 (23%) in the control arm. Also, in this period, 28 of 29 (97%) of all clinically significant alerts received by the monitoring team were managed successfully in the outpatient setting, avoiding hospitalisation. Patients found the user experience largely positive, with the average rating for the app being 4.56 out of 5. 26 patients have currently been enrolled for TCC-COVID. Recruitment is ongoing. All patients have been safely and effectively monitored, with no major adverse clinical events or technical malfunctions. Patient satisfaction has been high. Conclusion: The TCC-Cardiac RCT was successfully completed despite the challenges posed by COVID-19. Use of the app had an added benefit during the pandemic as participants could be monitored safely from home. The model of care inspired the development of an app with similar functionality designed for use with patients diagnosed with COVID-19.

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