Investigating Digital Patient-Reported Outcome Measures in Patient-Centered Diabetes Specialist Outpatient Care (DigiDiaS): Protocol for a Multimethod Prospective Observational Study.

BACKGROUND: Living with type 1 diabetes is challenging, and to support self-management, repeated consultations in specialist outpatient care are often required. The emergence of new digital solutions has revolutionized how health care services can be patient centered, providing unprecedented opportunities for flexible, high-quality care. However, there is a lack of studies exploring how the use of digital patient-reported outcome measures (PROMs) for flexible specialist care affects diabetes self-management. To provide new knowledge on the relevance of using PROMs in standard care, we have designed a multimethod prospective study. OBJECTIVE: The overall aim of this protocol is to describe our prospective multimethod observational study designed to investigate digital PROMs in a routine specialist outpatient setting for flexible patient-centered diabetes care (DigiDiaS). METHODS: This protocol outlines the design of a multimethod prospective observational cohort study that includes data from electronic health records, self-reported questionnaires, clinical consultation field observations, and individual in-depth interviews with patients and diabetes health care personnel. All patients with type 1 diabetes at a designated outpatient clinic were invited to participate and use the digital PROM implemented in clinical care. Both users and nonusers of the digital PROM were eligible for the prospective study, allowing for a comparison of the two groups. Data were collected at baseline and after 12 months, including self-management as the primary outcome assessed using the Patient Activation Measure, along with the secondary outcomes of digital health literacy, quality of life, health economy, and clinical variables such as glycated hemoglobin. RESULTS: The digital solution was implemented for routine clinical care in the department in November 2021, and data collection for the prospective study started in October 2022. As of September 6, 2023, 84.6% (186/220) of patients among those in the digital PROM and 15.5% (34/220) of patients among the nonusers have consented to participate. We expect the study to have enough participants by the autumn of 2023. With 1 year of follow-up, the results are expected by spring 2025. CONCLUSIONS: In conclusion, a multimethod prospective observational cohort study can offer valuable insights into the relevance, effectiveness, and acceptability of digital tools using PROMs in diabetes specialist care. Such knowledge is crucial for achieving broad and successful implementation and use of these tools in a large diabetes outpatient clinic. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52766.

Sickness absence among mothers caring for a child with disability: Examining the impact of mechanical and psychosocial occupational exposures.

Background: Sickness absence is more prevalent among mothers caring for children with disability compared to those caring for non-disabled children. Working in a poor working environment may worsen the impact of care burden on health outcomes among mothers of children with disabilities. Objective: The study investigated how sickness absences are associated with mechanical and psychosocial occupational exposures among mothers caring for children with and without disabilities. Methods: The study included children born between 2005 and 2013 and their respective mothers (N = 147, 507). Using register data from Statistics Norway, a Zero-Inflated Negative Binominal Regression was fitted to estimate the relationship between mechanical and psychosocial occupational exposures and sickness absence among employed mothers. Results: Mothers caring for children with disability had higher levels of sickness absences, even after adjusting for psychosocial and mechanical occupational exposures, and other possible confounding factors. When the occupational exposures analysed separately, both mechanical and psychosocial indices had a significant positive main effect on the number of sick days. The main effect of psychosocial exposure was no more significant in a simultaneous analysis, but mechanical exposure maintained its significant positive effect. However, we found no statistically significant differences in the number of sick absence days between mothers of children with and without disability based on their levels of psychosocial or mechanical job exposures. Conclusions: The findings emphasize the need of providing support to mothers caring for children with disability that help them manage occupational health risks.

Impact of child disability on parental employment and labour income: a quasi-experimental study of parents of children with disabilities in Norway.

BACKGROUND: Caring for children with disabilities has both immediate and long-term economic costs that affect the well-being of children, parents, and society. The purpose of this study was to investigate the impact of child disability on parental employment and labour income by examining differences by parental gender, disability severity, and child age. METHODS: The study included children with disabilities born between 2004 to 2011 and their mothers (n = 139,189) and fathers (n = 134,457). Longitudinal data on employment, working hours and labour income was obtained from Statistics Norway, specifically the National Education Database, the Central Population Register and the Event History Database. A quasi-experimental difference-in-differences model was used to examine differences in employment, working hours and labour income. RESULTS: The results showed that caring for children with disabilities has a negative effect on mothers' labour market participation, working hours and labour income. The more severe a child's condition is, the more likely the mother was to work and earn less, or to stop working entirely. Additionally, the differences in labour market participation and income between mothers of children with and without disabilities increased as their children reached school age. Labour market participation, working hours, and labour income for fathers of children with less severe disabilities is comparable to those of fathers of children without disabilities. Caring for children with more severe disabilities reduces fathers' labour income but has no effect on their working hours or labour market participation. CONCLUSION: Policymakers and child welfare stakeholders should evaluate policy options and provide the necessary welfare support particularly to mothers caring for children with a more severe disability.

Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study).

INTRODUCTION: Research suggests that current care for shoulder pain is not in line with the best available evidence. This project aims to assess the effectiveness, cost-effectiveness and the implementation of an evidence-based guideline for shoulder pain in general practice in Norway. METHODS AND ANALYSIS: A stepped-wedge, cluster-randomised trial with a hybrid design assessing clinical effectiveness, cost-effectiveness and the effect of the implementation strategy of a guideline-based intervention in general practice. We will recruit at least 36 general practitioners (GPs) and randomise the time of cross-over from treatment as usual to the implemented intervention. The intervention includes an educational outreach visit to the GPs, a computerised decision tool for GPs and a self-management application for patients. We will measure outcomes at patient and GP levels using self-report questionnaires, focus group interviews and register based data. The primary outcome measure is the patient-reported Shoulder Pain and Disability Index measured at 12 weeks. Secondary outcomes include the EuroQol Quality of Life Measure (EQ5D-5L), direct and indirect costs, patient's global perceived effect of treatment outcome, Pain Self-Efficacy and Brief Illness Perception Questionnaire. We will evaluate the implementation process with focus on adherence to guideline treatment. We will do a cost-minimisation analysis based on direct and selected indirect costs and a cost-utility analysis based on EQ5D-5L. We will use mixed effect models to analyse primary and secondary outcomes. ETHICS AND DISSEMINATION: Ethics approval was granted by the Regional Committee for Medical and Health Research Ethics-South East Norway (ref. no: 2019/104). Trial results will be submitted for publication in a peer-reviewed medical journal in accordance with Consolidated Standards of Reporting Trials. TRIAL REGISTRATION NUMBER: NCT04806191.

Health-related quality of life in patients with colorectal cancer in the palliative phase: a systematic review and meta-analysis.

BACKGROUND: The occurrence of colorectal cancer has doubled over the last 50 years and many people are living with the disease in the palliative phase. Therefore, it is important that healthcare personnel have knowledge about the patient's health-related quality of life (HRQoL). The aim of this review is to investigate how HRQoL is reported by means of different measures for patients in the palliative phase of colorectal cancer and examine which sociodemographic and clinical factors are associated with the mean scores reported for HRQoL. METHOD: A systematic review and meta-analysis using forest plots in STATA were conducted. The databases MEDLINE, CINAHL, Embase, Amed, and SveMed+ were used for the systematic searches with combinations of terms for colorectal cancer, the palliative phase and HRQoL. The Cochrane handbook and the PRISMA checklist from 2009 were utilised. RESULTS: In total, 710 articles were identified. Eleven quantitative studies met the inclusion criteria and six were included in the meta-analysis. Five of the 11 studies had a longitudinal design, while the other six had a cross-sectional design. The meta-analyzes shows that the average HRQoL in palliative phase was 62.9 (56.8-69.0) 15D was 0.76 (0.73-0.79), EQ-5D was 0.67 (0.62-0.73), and VAS was 64.1 (53.7-74.4). Multiple sociodemographic and clinical variables were associated with HRQoL and a higher prevalence of common cancer symptoms were reported than gastrointestinal symptoms. CONCLUSION: This systematic review revealed that patients with colorectal cancer report low HRQoL. Furthermore, it shows that what affects HRQoL is complicated, including multiple clinical and sociodemographic variables. This underlines the need for further research. To ensure the best possible care, it is important that all healthcare professionals have easy access to knowledge about HRQoL in patients with colorectal cancer, and what impacts it in the last phase of life.

Empowerment in healthcare: A thematic synthesis and critical discussion of concept analyses of empowerment.

OBJECTIVE: The objective of this study is to shed light on common characteristics revealed in concept analyses of empowerment to contribute to further understanding. A further objective is to discuss how the perspective of healthcare service users appeared in the concept analyses. METHODS: The review was performed by systematically searching Medline, CINAHL, EMBASE, PsycINFO and ERIC. The search yielded 255 abstracts, which were reduced by relevance and critical appraisal to the 12 concept analyses included. The analysis process involved thematic synthesis as described by Thomas and Harden. RESULTS: The synthesis led to 13 descriptive themes structured according to antecedents, attributes and consequences of empowerment. The synthesis revealed how sparsely the question of equality and power in the relation between health professionals and healthcare service users is addressed. DISCUSSION: To a great extent empowerment is viewed as a helping process of making patients act differently, rather than redistribution of power. For groups that are particularly vulnerable to oppression, questions of power are of severe importance. PRACTICE IMPLICATIONS: As user participation is a growing discourse in health policy, health professionals need education to develop and address dimensions of power and reciprocity in empowering relations between users and themselves.

Beliefs, attitudes and perceptions to sun-tanning behaviour in the Norwegian population: a cross-sectional study using the health belief model.

BACKGROUND: Norway has one of the highest incidences of melanoma in the world. It has been suggested that the majority of all skin cancers could be prevented by changes related to sun-tanning behaviour. This study explores the sun-tanning behaviour of the Norwegian population using a modified Health Belief Model (HBM). Increased knowledge about beliefs, attitudes and sun-tanning behaviour can provide information which may be useful for future sun protection interventions. METHODS: In 2017, 1004 members of the Norwegian population completed cross-sectional online surveys. People who seek the sun for tanning purposes was the eligibility criterion for this study, reducing the study population to 569. With the aid of the constructs from the HBM, predictive factors explaining sun-tanning behaviour were determined using multivariate linear regression adjusted for demographics (gender, age, education and income). Furthermore, the predictor variables, empowerment and benefits of tanning, were added to the model. RESULTS: Five of the constructs in the modified HBM showed significant correlation with sun-tanning behaviour using bivariate analysis. The strongest correlation was perceived barriers of sun protection (0.42), with the next strongest being the benefits of tanning (0.30). The modified model explained 31% of the variation in sun-tanning behaviour using multivariate analysis. Significant predictors from the HBM to sun-tanning behaviour were perceived barriers to sun protection (Beta = 0.36, p < 0.001) and the severity of melanoma (Beta = - 0.20, p < 0.001). In addition, empowerment (Beta = 0.05, p = 0.05) and the benefits of tanning (Beta = 0.28, p < 0.001) proved to be variables with significant effect on sun-tanning behaviour. The demographic factors age, education and income were also associated with sun-tanning behaviour (p < 0.05). CONCLUSION: Based on the results of this study, several factors in the modified HBM had a significant impact on Norwegians' sun-tanning behaviour. The results indicate that future sun protection interventions should focus on reducing barriers in relation to sun protection behaviour, as well as emphasizing the severity of adverse tanning behaviour and melanoma. Efforts to alter the perceptions of the beneficial factors of tanning behaviour can also be appropriate in health promotion campaigns and interventions. Finally, implementing empowerment strategies could have a positive effect on promoting healthy sun-tanning behaviour.

Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

INTRODUCTION: The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM. METHODS AND ANALYSIS: This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ≥9 mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33 weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and χ2 test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child. ETHICS AND DISSEMINATION: The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: NCT02588729, Post-results.

Validation of the Norwegian version of MAPPIN'SDM, an observation-based instrument to measure shared decision-making in clinical encounters.

OBJECTIVE: To validate the Norwegian version of MAPPIN'SDM observer scales with regard to reliability, accuracy and the extent to which the scales include the essentials of the shared decision-making concept. METHODS: Three MAPPIN'SDM scales, focusing on the skills of doctor, patient and dyad, were applied to audiovisual records of 35 decision sequences. Inter-rater reliabilities were determined based on kappa coefficients. Sensitivities and specificities were calculated with regard to an expert reference standard. Convergent validities were calculated with the OPTION5 scale. MAPPIN'SDM was qualitatively compared to OPTION5 using Makoul & Clayman's Integrative Model structure. RESULTS: Inter-rater reliabilities were high on average over 11 items in each of three observer scales (MAPPINdoctor=0.77, MAPPINpatient=0.82, MAPPINdyad=0.77). Patient involvement was detected accurately (MAPPINdyad: mean sensitivity/specificity 93/91%). Comparison with OPTION5 showed weak to moderate correlation (Spearman's ρ/p-value: MAPPINdoctor:=0.44/0.009, MAPPINpatient: 0.38/0.024, MAPPINdyad 0.40/0.016) and little content overlap. CONCLUSION: MAPPIN'SDMnorge is capable of assessing SDM highly reliably and accurately. Divergence from OPTION5 reflects explicit disagreement regarding the concept's assumptions. PRACTICE IMPLICATIONS: MAPPIN'SDMnorge is ready for use in Norway. In-depth debate on the SDM concept's essentials is urgently needed.

Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden.

BACKGROUND: Painful shoulders pose a substantial socioeconomic burden. A prospective cost-of-illness study was performed to assess the costs associated with healthcare use and loss of productivity in patients with shoulder pain in primary health care in Sweden. METHODS: The study was performed in western Sweden, in a region with 24 000 inhabitants. Data were collected during six months from electronic patient records at three primary healthcare centres in two municipalities. All patients between 20 and 64 years of age who presented with shoulder pain to a general practitioner or a physiotherapist were included. Diagnostic codes were used for selection, and the cases were manually controlled. The cost for sick leave was calculated according to the human capital approach. Sensitivity analysis was used to explore uncertainty in various factors used in the model. RESULTS: 204 (103 women) patients, mean age 48 (SD 11) years, were registered. Half of the cases were closed within six weeks, whereas 32 patients (16%) remained in the system for more than six months. A fifth of the patients were responsible for 91% of the total costs, and for 44% of the healthcare costs. The mean healthcare cost per patient was €326 (SD 389) during six months. Physiotherapy treatments accounted for 60%. The costs for sick leave contributed to 84% of the total costs. The mean annual total cost was €4139 per patient. Estimated costs for secondary care increased the total costs by one third. CONCLUSIONS: The model applied in this study provides valuable information that can be used in cost evaluations. Costs for secondary care and particularly for sick leave have a major influence on total costs and interventions that can reduce long periods of sick leave are warranted.