OBJECTIVE: This study investigated whether the inclusion of video games in the upper limb amputee rehabilitation protocol could have a beneficial impact for muscle preparation, coordination, and patient motivation among individuals who have undergone transradial upper limb amputation.
METHODS: Ten participants, including five amputee participants and five able-bodied participants, were enrolled in 10 1-hour sessions within a 4-week rehabilitation program. In order to investigate the effects of the rehabilitation protocol used in this study, virtual reality box and block tests and electromyography (EMG) assessments were performed. Maximum voluntary contraction was measured before, immediately after, and 2 days after interacting with four different EMG-controlled video games. Participant motivation was assessed with the Intrinsic Motivation Inventory (IMI) questionnaire and user evaluation survey.
RESULTS: Survey analysis showed that muscle strength and coordination increased at the end of training for all the participants. The results of Pearson correlation analysis indicated that there was a significant positive association between the training period and the box and block test score (r8=0.95, P
Objective: To examine the effects of a quality improvement intervention comprising information and communications technology and contact with nonphysician personnel on the care and cardiometabolic risk factors of patients with type 2 diabetes in 8 Asia-Pacific countries.
Design, Setting, and Participants: This 12-month multinational open-label randomized clinical trial was conducted from June 28, 2012, to April 28, 2016, at 50 primary care or hospital-based diabetes centers in 8 Asia-Pacific countries (India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam). Six countries were low and middle income, and 2 countries were high income. The study was conducted in 2 phases; phase 1 enrolled 7537 participants, and phase 2 enrolled 13 297 participants. Participants in both phases were randomized on a 1:1 ratio to intervention or control groups. Data were analyzed by intention to treat and per protocol from July 3, 2019, to July 21, 2020.
Interventions: In both phases, the intervention group received 3 care components: a nurse-led Joint Asia Diabetes Evaluation (JADE) technology-guided structured evaluation, automated personalized reports to encourage patient empowerment, and 2 or more telephone or face-to-face contacts by nurses to increase patient engagement. In phase 1, the control group received the JADE technology-guided structured evaluation and automated personalized reports. In phase 2, the control group received the JADE technology-guided structured evaluation only.
Main Outcomes and Measures: The primary outcome was the incidence of a composite of diabetes-associated end points, including cardiovascular disease, chronic kidney disease, visual impairment or eye surgery, lower extremity amputation or foot ulcers requiring hospitalization, all-site cancers, and death. The secondary outcomes were the attainment of 2 or more primary diabetes-associated targets (glycated hemoglobin A1c <7.0%, blood pressure <130/80 mm Hg, and low-density lipoprotein cholesterol <100 mg/dL) and/or 2 or more key performance indices (reduction in glycated hemoglobin A1c≥0.5%, reduction in systolic blood pressure ≥5 mm Hg, reduction in low-density lipoprotein cholesterol ≥19 mg/dL, and reduction in body weight ≥3.0%).
Results: A total of 20 834 patients with type 2 diabetes were randomized in phases 1 and 2. In phase 1, 7537 participants (mean [SD] age, 60.0 [11.3] years; 3914 men [51.9%]; 4855 patients [64.4%] from low- and middle-income countries) were randomized, with 3732 patients allocated to the intervention group and 3805 patients allocated to the control group. In phase 2, 13 297 participants (mean [SD] age, 54.0 [11.1] years; 7754 men [58.3%]; 13 297 patients [100%] from low- and middle-income countries) were randomized, with 6645 patients allocated to the intervention group and 6652 patients allocated to the control group. In phase 1, compared with the control group, the intervention group had a similar risk of experiencing any of the primary outcomes (odds ratio [OR], 0.94; 95% CI, 0.74-1.21) but had an increased likelihood of attaining 2 or more primary targets (OR, 1.34; 95% CI, 1.21-1.49) and 2 or more key performance indices (OR, 1.18; 95% CI, 1.04-1.34). In phase 2, the intervention group also had a similar risk of experiencing any of the primary outcomes (OR, 1.02; 95% CI, 0.83-1.25) and had a greater likelihood of attaining 2 or more primary targets (OR, 1.25; 95% CI, 1.14-1.37) and 2 or more key performance indices (OR, 1.50; 95% CI, 1.33-1.68) compared with the control group. For attainment of 2 or more primary targets, larger effects were observed among patients in low- and middle-income countries (OR, 1.50; 95% CI, 1.29-1.74) compared with high-income countries (OR, 1.20; 95% CI, 1.03-1.39) (P = .04).
Conclusions and Relevance: In this 12-month clinical trial, the use of information and communications technology and nurses to empower and engage patients did not change the number of clinical events but did reduce cardiometabolic risk factors among patients with type 2 diabetes, especially those in low- and middle-income countries in the Asia-Pacific region.
Trial Registration: ClinicalTrials.gov Identifier: NCT01631084.
METHODS: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis.
RESULTS: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning, and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation, and dissemination. Challenges identified include lack of clarity within common language, roles, and research boundaries, while logistical needs include extra time, training, and funding. Researchers report struggling to report involvement and avoid tokenism.
CONCLUSIONS: Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
OBJECTIVE: The objective of this study was to examine perceived involvement and role preferences of patients with hypertension in treatment decision-making.
METHODS: A cross-sectional survey was conducted among 210 patients with hypertension in a teaching hospital in Malaysia.
RESULTS: The majority of respondents agreed that their doctor recognized that a decision needs to be made (89.5%) and informed them that different options are available (77.1%). However, respondents' perceived level of involvement in other aspects of treatment decision-making process was low, including in the selection of treatment and in reaching an agreement with their doctor on how to proceed with treatment. In terms of preferred decision-making roles, 51.4% of respondents preferred a collaborative role with their physicians, 44.8% preferred a passive role while only 1.9% preferred an active role. Age and educational level were found to be significantly related to patient preferences for involvement in SDM. Younger patients (<60 years) and those with higher educational level preferred SDM over passive decision-making (ρ < 0.01). Encouragement from health care providers was perceived as a major motivating factor for SDM among patients with hypertension, with 91% of respondents agreeing that this would motivate their participation in SDM.
CONCLUSION: Preferences for involvement in decision-making among patients with hypertension are varied, and influenced by age and educational level. Physicians have a key role in encouraging patients to participate in SDM.
Subjects and methods: A cross-sectional study was conducted among patients with chronic diseases and pharmacists from three public hospitals in Malaysia. The Revised United States Leeds Attitudes toward Concordance (RUS-LATCon) was used to measure attitudes toward concordance in both patients and pharmacists. Patients also rated their perceived level of involvement in decision making and completed the Decision Self-Efficacy scale. One-way analysis of variance (ANOVA) and independent t-test were used to determine significant differences between different subgroups on attitudes toward concordance, and multiple linear regression was performed to find the predictors of patients' self-efficacy in decision making.
Results: A total of 389 patients and 93 pharmacists participated in the study. Pharmacists and patients scored M=3.92 (SD=0.37) and M=3.84 (SD=0.46) on the RUS-LATCon scale, respectively. Seven items were found to be significantly different between pharmacists and patients on the subscale level. Patients who felt fully involved in decision making (M=3.94, SD=0.462) scored significantly higher on attitudes toward concordance than those who felt partially involved (M=3.82, SD=0.478) and not involved at all (M=3.68, SD=0.471; p<0.001). Patients had an average score of 76.7% (SD=14.73%) on the Decision Self-Efficacy scale. In multiple linear regression analysis, ethnicity, number of medications taken by patients, patients' perceived level of involvement, and attitudes toward concordance are significant predictors of patients' self-efficacy in decision making (p<0.05).
Conclusion: Patients who felt involved in their consultations had more positive attitudes toward concordance and higher confidence in making an informed decision. Further study is recommended on interventions involving pharmacists in supporting patients' involvement in medication-related decision making.
METHODS: This study used mixed methods to develop a PtDA for use in a UK general practice setting. A 10-member expert panel was convened to guide development and patients and clinicians were also interviewed individually using semi-structured interview guides to identify their decisional needs. Current literature was reviewed systematically to determine the best available evidence. The Ottawa Decision Support Framework was used to guide the presentation of the information and value clarification exercise. An iterative draft-review-revise process by the research team and review panel was conducted until the PtDA reached content and format 'saturation'. The PtDA was then pilot-tested by users in actual consultations to assess its acceptability and feasibility. The IPDAS and UKMRC frameworks were used throughout to inform the development process.
RESULTS: The PANDAs PtDA was developed systematically and iteratively. Patients and clinicians highlighted the needs for information, decisional, emotional and social support, which were incorporated into the PtDA. The literature review identified gaps in high quality evidence and variations in patient outcome reporting. The PtDA comprised five components: background of the treatment options; pros and cons of each treatment option; value clarification exercise; support needs; and readiness to decide.
CONCLUSIONS: This study has demonstrated the feasibility of combining the IPDAS and the UKMRC frameworks for the development and evaluation of a PtDA. Future studies should test this model for developing PtDAs across different decisions and healthcare contexts.
MAIN BODY: As an exemplar, we reflect on how, in the Asthma UK Centre for Applied Research (AUKCAR), we set out to create a supportive, organised environment with the overarching value of 'keeping patients at the heart of everything we do'. The key has been in planning and creating a suitably funded organisational infrastructure with dedicated PPI researchers along with the development of and expectation to abide by an agreed set of norms and values. Specifically, expecting AUKCAR PhD students and early career researchers to engage with PPI has established a working mode that we hope will last. Regular interactions and proactive Patient Leads increase PPI network cohesion.
CONCLUSION: With adaptation, the AUKCAR PPI model can be translated to international contexts.
METHOD: The study applied a quantitative approach based on the cross-sectional survey design and multistage cluster random sampling. A total of 400 women aged 35-69 years, were surveyed at 4 obstetric and gynecologic clinics affiliated to Tehran University of Medical Sciences in Tehran: the participation levels of 86 women who have had a mammogram were analyzed based on their self-efficacy, belief, social influence, and barriers concerning mammography utilization.
RESULTS: Consistent with the study framework, in bivariate analysis, the higher level of women's participation in breast cancer prevention programs was significantly related to more positive belief about mammography (p< .05), greater social influence on mammography (p< .01) and fewer barriers to mammography (p< .01). Self efficacy (p= .114) was not significantly related to the higher level of participation.
CONCLUSION: Results suggest that women's participation levels in breast cancer prevention programs might be associated with the specific psychosocial factors on breast cancer preventive behavior such as mammography screening.
METHODS: The decision aid prototype was developed following a literature review and six focus groups. Alpha testing assessed its comprehensibility, acceptability, usability and desirability through user-centered cognitive interviews. Beta-testing evaluated preliminary evidence on its efficacy using the SDM Scale and PDMS. Feasibility was assessed by timing the consultation.
RESULTS: The alpha testing demonstrated that the decision aid was patient-oriented, comprehensible, comprehensive, concise and objective with an appealing design. Beta-testing indicated that PtDA significantly increased patients satisfaction with SDM from patients' [83.32 (13.92) vs 85.76 (13.80); p patients for decision making from the patients' [PDMS patients: 84.10 (12.69)] and physicians' [PDMS physicians: 83.78 (16.62)] perspectives as well. There was no change in the consultation time between the control and the intervention groups.
CONCLUSIONS: We developed an antidepressant PtDA for Malaysian patients with MDD that increases patients' involvement in shared decision making and enhances their preparedness for decision making.
PRACTICE IMPLICATIONS: Using the PtDA can support collaborative decision-making in routine clinical practice without extending the consultation time.