METHODS: We reviewed measures of decision quality and decision process in 86 randomized controlled trials (RCTs) from the 2011 Cochrane Collaboration systematic review of PtDAs. Data on development of the measures, reliability, validity, responsiveness, precision, interpretability, feasibility, and acceptability were independently abstracted by 2 reviewers.
RESULTS: Information from 178 instances of use of measures was abstracted. Very few studies reported data on the performance of measures, with reliability (21%) and validity (16%) being the most common. Studies using new measures were less likely to include information about their psychometric performance. The review was limited to reporting of measures in studies included in the Cochrane review and did not consult prior publications.
CONCLUSIONS: Very little is reported about the development or performance of measures used to evaluate the effectiveness of PtDAs in published trials. Minimum reporting standards are proposed to enable authors to prepare study reports, editors and reviewers to evaluate submitted papers, and readers to appraise published studies.
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.
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.
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.
MATERIALS AND METHODS: The questionnaires were distributed in the Umra Private Hospital in Selangor. The questionnaire had four parts and covered social-demographic questions, respondent knowledge about CRC and colorectal tests, attitude towards CRC and respondentaction regarding CRC. More than half of Malay participants (total n=187) were female (57.2%) and 36.9% of them were working as professionals.
RESULTS: The majority of the participants (93.6%) never had a CRC screening test. The study found that only 10.2% of the study participants did not consider that their chances of getting CRC were high. A high percentage of the participants (43.3%) believed that they would have good chance of survival if the cancer would be found early. About one third of the respondents did not want to do screening because of fear of cancer, and concerns of embarrassment during the procedure adversely affected attitude to CRC screening as well. Age, gender, income, family history of CRC, vegetable intake and physical activity were found to be significant determinants of knowledge on CRC.
CONCLUSIONS: The major barriers identified towards CRC screening identified in our study were fear of pain and embarrassment. The findings have implications for understanding of similarities and differences in attitude to CRC amongst elderly patients in other cultural/ geographic regions.
METHODS: We conducted a qualitative study involving 12 patients diagnosed with metastatic breast cancer, 16 healthcare professionals and 5 policymakers from surgical and oncology departments at public healthcare centres in Malaysia. Semi-structured in-depth interviews and focus group discussions were conducted. The interviews were recorded, transcribed verbatim and analysed using the thematic approach. Nvivo software was used to manage and analyse the data.
RESULTS: Five main themes emerged from the study: healthcare provider-patient communication, workforce availability, cultural and belief systems, goals of care and paternalism versus autonomy. Other strategies proposed to overcome barriers to implementing shared decision-making were training of healthcare professionals and empowering nurses to manage patients' psychosocial issues.
CONCLUSION: This study found that practising shared decision-making in the public health sector remains challenging when managing patients with metastatic breast cancer. The utilization of decision-making tools, patient empowerment and healthcare provider training may help address the system and healthcare provider-patient barriers identified in this study.
PATIENT OR PUBLIC CONTRIBUTION: Patients were involved in the study design, recruitment and analysis.
OBJECTIVE: This study aimed to assess the determinants of surgery choice in Asian patients with early breast cancer in a middle-income country.
MATERIALS AND METHODS: 184 patients with early breast cancer treated between Jan 2008 and Dec 2010 were recruited to complete a questionnaire. Chi-square test was used to analyze the association between surgery choice and demographic and tumour factors, surgeon recommendation, family member and partner opinions, fear of recurrence, avoidance of second surgery, fear of disfigurement, interference with sex life, fear of radiation and loss of femininity.
RESULTS: 85 (46%) had BCS while 99 (54%) had mastectomy. Age >60, Chinese ethnicity, lower education level, and larger tumour size were significantly associated with mastectomy. Surgeon recommendation was important in surgery choice. Although both groups did not place much importance on interference with sex life, 14.1% of the BCS group felt it was very important compared to 5.1% in the mastectomy group and this was statistically significant. There was no statistical difference between the two groups in terms of the other factors. When analyzed by ethnicity, significantly more Malay and Indian women considered partner and family member opinions very important and were more concerned about loss of femininity compared to Chinese women. There were no statistical differences between the three ethnic groups in terms of the other factors.
CONCLUSIONS: When counseling on surgical options, the surgeon has to take into account the ethnicity, social background and education level, age and reliance on partner and family members. Decision-making is usually a collective effort rather than just between the patient and surgeon, and involving the whole family into the process early is important.
AIM: To assess the diabetes empowerment scores and its correlated factors among type 2 diabetes patients in a primary care clinic in Malaysia.
METHODS: This is a cross sectional study involving 322 patients with type 2 diabetes mellitus (DM) followed up in a primary care clinic. Systematic sampling method was used for patient recruitment. The Diabetes Empowerment Scale (DES) questionnaire was used to measure patient empowerment. It consists of three domains: (1) Managing the psychosocial aspect of diabetes (9 items); (2) Assessing dissatisfaction and readiness to change (9 items); and (3) Setting and achieving diabetes goal (10 items). A score was considered high if it ranged from 100 to 140. Data analysis was performed using SPSS version 25 and multiple linear regressions was used to identify the predictors of total diabetes empowerment scores.
RESULTS: The median age of the study population was 55 years old. 56% were male and the mean duration of diabetes was 4 years. The total median score of the DES was 110 [interquartile range (IQR) = 10]. The median scores of the three subscales were 40 with (IQR = 4) for "Managing the psychosocial aspect of diabetes"; 36 with (IQR = 3) for "Assessing dissatisfaction and readiness to change"; and 34 with (IQR = 5) for "Setting and achieving diabetes goal". According to multiple linear regressions, factors that had significant correlation with higher empowerment scores among type 2 diabetes patients included an above secondary education level (P < 0.001), diabetes education exposure (P = 0.003), lack of ischemic heart disease (P = 0.017), and lower glycated hemoglobin (HbA1c) levels (P < 0.001).
CONCLUSION: Diabetes empowerment scores were high among type 2 diabetes patients in this study population. Predictors for high empowerment scores included above secondary education level, diabetes education exposure, lack of ischemic heart disease status and lower HbA1c.
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.