OBJECTIVES: To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM.
SEARCH METHODS: We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects.
DATA COLLECTION AND ANALYSIS: Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates.
MAIN RESULTS: We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both individual- and group-based.A meta-analysis of all psychological interventions combined versus usual care showed no firm effect on DRD (standardised mean difference (SMD) -0.07; 95% CI -0.16 to 0.03; P = 0.17; 3315 participants; 12 trials; low-quality evidence), HRQoL (SMD 0.01; 95% CI -0.09 to 0.11; P = 0.87; 1932 participants; 5 trials; low-quality evidence), all-cause mortality (11 per 1000 versus 11 per 1000; risk ratio (RR) 1.01; 95% CI 0.17 to 6.03; P = 0.99; 1376 participants; 3 trials; low-quality evidence) or adverse events (17 per 1000 versus 41 per 1000; RR 2.40; 95% CI 0.78 to 7.39; P = 0.13; 438 participants; 3 trials; low-quality evidence). We saw small beneficial effects on self-efficacy and HbA1c at medium-term follow-up (6 to 12 months): on self-efficacy the SMD was 0.15 (95% CI 0.00 to 0.30; P = 0.05; 2675 participants; 6 trials; low-quality evidence) in favour of psychological interventions; on HbA1c there was a mean difference (MD) of -0.14% (95% CI -0.27 to 0.00; P = 0.05; 3165 participants; 11 trials; low-quality evidence) in favour of psychological interventions. Our included trials did not report diabetes-related complications or socioeconomic effects.Many trials were small and were at high risk of bias for incomplete outcome data as well as possible performance and detection biases in the subjective questionnaire-based outcomes assessment, and some appeared to be at risk of selective reporting. There are four trials awaiting further classification. These are parallel RCTs with cognition-focused and emotion-cognition focused interventions. There are another 18 ongoing trials, likely focusing on emotion-cognition or cognition, assessing interventions such as diabetes self-management support, telephone-based cognitive behavioural therapy, stress management and a web application for problem solving in diabetes management. Most of these trials have a community setting and are based in the USA.
AUTHORS' CONCLUSIONS: Low-quality evidence showed that none of the psychological interventions would improve DRD more than usual care. Low-quality evidence is available for improved self-efficacy and HbA1c after psychological interventions. This means that we are uncertain about the effects of psychological interventions on these outcomes. However, psychological interventions probably have no substantial adverse events compared to usual care. More high-quality research with emotion-focused programmes, in non-US and non-European settings and in low- and middle-income countries, is needed.
DESIGN: Cross-sectional study.
SETTING: This study is part of a larger national study on the perception of the Malaysian public healthcare professionals on FMSs.
PARTICIPANTS: PHCPs from three categories of health facilities, namely hospitals, health clinics and health offices.
MAIN OUTCOME MEASURES: Qualitative analysis of written comments of respondents' expectation of FMSs.
RESULTS: The participants' response rate was 58% (780/1345) with an almost equal proportion from each public healthcare facility. We identified 21 subthemes for the 623 expectation comments. The six emerging themes are (1) need for more FMSs, (2) clinical roles and functions of FMSs, (3) administrative roles of FMSs, (4) contribution to community and public health, (5) attributes improvement and (6) research and audits. FMSs were expected to give attention to clinical duty. Delivering this responsibility with competence included having the latest medical knowledge in their own and others' medical disciplines, practising evidence-based medicine in prehospital and posthospital care, better supervision of staff and doctors under their care, fostering effective teamwork, communicating more often with hospital specialists and making appropriate referral. Expectations ranged from definite and strong for more FMSs at the health clinics to low expectation for FMSs' involvement in research; to mal-expectation on FMSs' involvement in community and public health programmes.
CONCLUSIONS: There were some remarkable differences in expectations on FMSs from the three different PHCPs. These ranged from being clinically competent and administratively available for patients and staff at the health clinics, to mal-expectations on FMSs to engage in public health affairs. Relevant parties, including FMSs themselves, could take appropriate self-improvement initiatives to enhance public practice of family medicine and patient care.
TRIAL REGISTRATION NUMBER NMRR ID: 08-12-1167.
METHODS: This was an exploratory sequential mixed methods study, where the qualitative case study was conducted in Hainan and Dalian, while the survey was conducted in Xi'an, Nanjing, Shenyang, and Xiamen. The validation of EASNH-Q also included exploratory and confirmatory factor analyses. Multinomial logistic regression analysis was used to estimate the determinants of expectations and acceptability of SNHs.
RESULTS: The newly developed EASNH-Q uses a Likert Scale ranging from 1 (strongly disagree) to 5 (strongly agree), and underwent validation and refinement from 49 items to the final 24 items. The content validity indices for relevance, comprehensibility, and comprehensiveness were all above 0.95. The expectations and acceptability of SNHs exhibited a strong correlation (r = 0.85, p
METHODS: In this study, we conducted a comprehensive literature review to collect information on healthcare decision-making in Malaysia. We also consulted medical education researchers, key opinion leaders, governmental organisations, and patient support groups to assess the extent to which patient involvement was incorporated into the medical curriculum, healthcare policies, and legislation.
RESULTS: There are very few studies on patient involvement in decision-making in Malaysia. Existing studies showed that doctors were aware of informed consent, but few practised SDM. There was limited teaching of SDM in undergraduate and postgraduate curricula and a lack of accurate and accessible health information for patients. In addition, peer support groups and 'expert patient' programmes were also lacking. Professional medical bodies endorsed patient involvement in decision-making, but there was no definitive implementation plan.
CONCLUSION: In summary, there appears to be little training or research on SDM in Malaysia. More research needs to be done in this area, including baseline information on the preferred and actual decision-making roles. The authors have provided a set of recommendations on how SDM can be effectively implemented in Malaysia.
DESIGN: Cross-sectional study.
SETTING: This study is part of a larger national study on the perception of Malaysian public healthcare professionals on FMSs (PERMFAMS).
PARTICIPANTS: PHCPs from three categories of health facility: hospitals, health clinics and health offices.
MAIN OUTCOME MEASURES: Qualitative analyses of written comments of respondents' general impression of FMSs.
RESULTS: The participants' response rate was 58.0% (780/1345), with almost equal proportions from each public healthcare facility. A total of 23 categories for each of the 648 impression comments were identified. The six emerging themes were: (1) importance of FMSs; (2) roles of FMSs; (3) clinical performance of FMSs; (4) attributes of FMSs; (5) FMS practice challenges; (6) misconception of FMS roles. Overall, FMS practice was perceived to be safe and able to provide effective treatments in a challenging medical discipline that was in line with the current standards of medical care and ethical and professional values. The areas of concern were in clinical performance expressed by PHCPs from some hospitals and the lack of personal attributes and professionalism among FMSs mentioned by PHCPs from health clinics and offices.
CONCLUSIONS: FMSs were perceived to be capable of providing effective treatment and were considered to be important primary care physicians. There were a few negative impressions in some areas of FMS practice, which demanded attention by the FMSs themselves and the relevant authorities in order to improve efficiency and safeguard the fraternity's reputation.
METHODS AND ANALYSIS: This cross-sectional study will recruit 459 postpartum mothers during their 4-week postnatal follow-up in five selected public health clinics in Perak from September 2019 to May 2020. Participants will be mothers aged 18 years and above at 4 weeks postdelivery who are able to understand the English and Malay languages. Non-Malaysians and mothers with known diagnosis of psychotic disorders will be excluded from the study. Sociodemographic information and possible risk factors of the participants will be captured via a set of validated questionnaires, postpartum depression (PPD) will be measured using the Edinburgh Postpartum Depression Scale questionnaire and general depressive symptoms, anxiety and stress will be measured using the 21-item Depression, Anxiety and Stress Scale. Data analysis will be conducted using SPSS V.25.0 (IBM). Besides descriptive statistics, multivariable regression analyses will be done to identify possible risk factors and their independent associations with depression (PPD and general depressive symptoms, combined and separately), anxiety and stress.
ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Medical Research Ethics Committee, Ministry of Health Malaysia on 7 August 2019. Results of this study will be reported and shared with the local health stakeholders and disseminated through conference proceedings and journal publications.
REGISTRATION NUMBER: This study is registered in the Malaysian National Medical Research Register with the ID: NMRR-19-868-47647.
METHODS AND ANALYSIS: The study will be modelled according to the Capability, Opportunity, Motivation and Behaviour and Behaviour Change Wheel techniques, and use the DoTTI framework to identify needs, solutions and testing of a preliminary mobile app, respectively. In phase 1 (design and development), a focus group discussion (FGDs) of 5-8 individuals will be conducted with an estimated 60 women with GDM and 40 HCPs (doctors, dietitians and nurses). Synthesised data from the FGDs will then be combined with content from an expert committee to inform the development of the mobile app. In phase 2 (testing of early iterations), a preview of the mobile app will undergo alpha testing among the team members and the app developers, and beta testing among 30 women with GDM or with a history of GDM, and 15 HCPs using semi-structured interviews. The outcome will enable us to optimise an intervention using the mobile app as a diabetes prevention intervention which will then be evaluated in a randomised controlled trial.
ETHICS AND DISSEMINATION: The project has been approved by the Malaysia Research Ethics Committee. Informed consent will be obtained from all participants. Outcomes will be presented at both local and international conferences and submitted for publications in peer-reviewed journals.
OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.
METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).
RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.
CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.