This cohort study analyzes review times and approval outcomes of health technology assessments conducted in 6 high-income countries for novel therapeutic agents approved by the US Food and Drug Administration.
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JAMA Internal Medicine
Mission Statement: To advance the equitable, person-centered, and evidence-based practice of internal medicine through publication of scientifically rigorous, innovative, and inclusive research, review, and commentary that informs dialogue and action with clinical, public health, and policy impact.
Errors in Network Meta-Analysis
In the Original Investigation titled “Psychotherapies for Generalized Anxiety Disorder in Adults: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials,” published online October 18, 2023, the authors had erroneously included a secondary analysis of a primary trial already included in the network, thus counting the same cohort of patients twice. Additionally, a standard error had been misinterpreted as a standard deviation during data extraction. All analyses have been rerun, and the article was corrected to fix errors in the Abstract, Key Points, text, References, Table 2, Figures 1-3, and eAppendixes D-N in Supplement 1. The 95% CI for behavior therapy vs waiting list no longer crosses the line of no effect in the primary efficacy analysis, but overall, the corrections do not affect the clinical interpretations or conclusions. The article was corrected online.
Preparing occupational therapy students for practice in rural areas: a scoping review protocol
Introduction
Despite greater needs in rural areas, occupational therapists are maldistributed to urban spaces which limits service access and health outcomes for rural people and communities. Preparation of students for rural practice may improve rural workforce recruitment and retention; however, the range and scope of preparation strategies employed by education providers are unclear. This scoping review aims to understand and describe the range of strategies education services use to prepare occupational therapy students for rural practice across the globe.
Methods and analysis
The study will include all publications about strategies used to prepare occupational therapy students for future rural practice, prior to enrolment, during the programme or on graduation. MEDLINE (Ovid), Emcare (Ovid), APA PsychInfo (Ovid), CINAHL (EBSCOhost), Health Source: Nursing/Academic (EBSCOHost), Educational Resources Information Centre (ERIC), Open Access Theses and Dissertations (OATD), and Scientific Electronic Library Online (SciELO) databases will be systematically searched in English, Spanish, French and Portuguese languages. Citations will be screened by two or more independent researchers against inclusion criteria and data extracted from included publications using a customised extraction tool. Frequency counts will be provided for study type, student location and sociodemographics, and the timing/educational strategy. The extracted data will be analysed using a matrix framework and presented in diagrammatic/tabular form and accompanied by a narrative summary which will describe how the results relate to the reviews’ questions.
Ethics and dissemination
This study will not involve human/animal subjects and does not require ethics approval. Results will be disseminated to relevant groups in peer-reviewed journal(s) and at relevant occupational therapy, higher education and/or rural health conferences. Results will also be translated and shared in blogs/social media to support access for non-research audiences and shared with other regional universities to influence curriculum design.
Breastfeeding assessment and management instruments: a scoping review protocol
Introduction
Different aspects are involved in the breastfeeding process that may vary according to the target population, postpartum phase and evaluation scenario. The identification of such instruments, their constructs and applicability in health services will contribute to the understanding of the most relevant aspects and dissemination of tools that can be implemented in the necessary spaces to promote breast feeding. This article describes a review protocol to map the assessment and management instruments applied to breast feeding in the puerperal period existing in the literature.
Methods and analysis
This is a protocol of a scoping review that follows the methodological recommendations of the Joanna Briggs Institute (JBI). In March 2024, a search will be carried out in the databases Medical Literature Analysis and Retrieval System Online—Medline (PubMed), Latin American and Caribbean Health Science Literature—Lilacs (BVS), Cochrane Library and Embase (CAPES). Peer-reviewed studies that address instruments for evaluating the breastfeeding process during the puerperium will be included, regardless of year of publication or language. The selection of studies and data extraction will be done by peers and disagreements will be resolved by a third researcher. The selection will be made through the Rayann platform (https://www.rayyan.ai/). Data extraction and synthesis will be performed by pairs, using a semistructured instrument, based on the model available in the JBI manual. The studies will be summarised according to the postpartum period in which the instrument was used (immediate, remote or late postpartum) and their constructs, domains and contexts of utilisation will be identified.
Ethics and dissemination
Ethical approval is not necessary for this scoping review. The results of the review will be shared through publications in peer-reviewed journals, at relevant scientific conferences and seminars and meetings with maternal and child healthcare providers.
Study registration
This study was registered with Open Science Framework registry (osf.io/f4hz8) on 27 April 2023.
Effects of cardiopulmonary resuscitation training on mortality rates after out-of-hospital cardiac arrest: protocol for a systematic review and meta-analysis
Introduction
An out-of-hospital cardiac arrest occurs at a rate of 67–170 cases per 100 000 inhabitants per year in Europe. The early recognition of the occurrence of a cardiac arrest, placing an emergency call, performing cardiopulmonary resuscitation (CPR) and performing defibrillation are the most important response measures. The objective of this systematic review and meta-analysis is to assess the effects of laypersons’ CPR training with respect to CPR initiation rates, cardiovascular mortality rates, survival rate and the use of an automated external defibrillator.
Methods and analysis
The literature search will be performed in the following databases: MEDLINE, Web of Science, the Cochrane Central Register of Controlled Studies, CINAHL, HBI, TESEO and NTX. Intervention studies and quasi-experimental studies in which CPR training interventions were performed will be included. We will exclude studies in which the participants do not meet the inclusion criteria, without a control group and in which the methodology of the intervention applied is unclear. There will be no restrictions on publication date or language of publication. The risk of bias will be assessed using the Risk of Bias in Non-randomized Studies of Interventions tool for randomised controlled trials (RCT), non-RCT and quasi-experimental trials. Data analysis and synthesis will be performed using RevMan V.5.4.1 software. The findings will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance.
Ethics and dissemination
Ethical approval is not required, as only secondary data will be used. The findings will be published in a journal and presented at conferences.
PROSPERO registration number
CRD42022365288.
Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study
Introduction
The prevalence of both obesity and gestational diabetes mellitus (GDM) has increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy and caesarean delivery. Women with GDM who are also overweight or obese have higher rates of pregnancy complications when compared with normal-weight women with GDM, which may occur in part due to suboptimal glycaemic control. The current recommendations for glycaemic targets in pregnant women with diabetes are based on limited evidence and exceed the mean fasting (70.9±7.8 mg/dL) and 1-hour postprandial (108.9±12.9 mg/dL) glucose values in pregnant individuals without diabetes. Our prior work demonstrated that the use of intensive (fasting
Digital computerised cognitive training for preventing cognitive decline among hypertensive patients: a study protocol for a multicentre randomised controlled trial (DELIGHT trial)
Introduction
Mild cognitive impairment (MCI) is an important intervenable stage for the prevention of dementia. Hypertension is associated with impaired cognition, and when combined with MCI, it may lead to a poor prognosis. Digital computerised cognitive training (CCT) has recently become a potential instrument for improving cognition, but evidence for its efficacy remains limited. This study aims to evaluate the efficacy of a digital adaptive CCT intervention in older patients with hypertension and MCI.
Methods and analysis
The multicentre, double-blinded, randomised, actively -controlled clinical trial will recruit 200 older (≥60 years) patients with hypertension and MCI from 11 hospitals across China. Participants will be randomly assigned in a 1:1 ratio to the intervention group (multidomain adaptative CCT) and active control group (non-adaptive cognitive training) for 12-week cognitive training for 30 min/day and 5 days/week. Those who have completed their 12-week training in the intervention group will be rerandomised into the continuation and discontinuation training groups. All participants will be followed up to 24 weeks. Neuropsychological assessments and structural and functional 7.0 T MRI will be obtained at baseline and at 12-week and 24-week follow-up. The primary outcome is the possible improvement of global cognitive function at 12 weeks, as measured by the Basic Cognitive Aptitude Tests. Secondary and exploratory endpoints include the major cognitive domain function improvement, self-efficacy, mental health, quality of life and MRI measurements of the brain.
Ethics and dissemination
The trial has been approved by the institutional review board of Beijing Anzhen Hospital and thereafter by all other participating centres. Trial findings will be disseminated in peer-reviewed journals and conference presentations.
Trial registration number
NCT05704270.
Thiamine as adjunctive therapy for diabetic ketoacidosis (DKAT) trial protocol and statistical analysis plan: a prospective, single-centre, double-blind, randomised, placebo-controlled clinical trial in the USA
Introduction
Diabetic ketoacidosis (DKA) is a potentially life-threatening diabetic complication. Despite the high prevalence of DKA and the substantial associated healthcare burden, limited research on strategies to improve outcomes currently exists.
Thiamine (vitamin B1) is a cofactor of pyruvate dehydrogenase, which plays a key role in aerobic glucose metabolism. Thiamine deficiency is common in patients with DKA, resulting in a shift to anaerobic metabolism and hyperlactatemia, which can prolong and complicate recovery. Therefore, we hypothesise that thiamine administration will improve aerobic metabolism and lead to faster resolution of acidemia in patients with DKA.
Methods and analysis
In this single centre, double-blind, randomised, placebo-controlled, parallel group interventional trial, 100 patients admitted to the hospital with DKA will be randomised to receive either intravenous thiamine (200 mg in 50 mL 0.9% saline) or placebo (0.9% saline identical in appearance and volume) two times per day for 2 days. The primary outcome will be the change in bicarbonate level over 24 hours as compared between the two treatment groups. Additional secondary outcomes include the change over time in anion gap, lactate levels, oxygen consumption by circulating mononuclear cells, intensive care unit and hospital length-of-stay and hospital resource usage when comparing the two study arms.
Ethics and dissemination
This trial was approved by the Committee on Clinical Investigations, the institutional review board of Beth Israel Deaconess Medical Center (protocol number 2018P000475). Findings will be disseminated through peer-reviewed publications and professional conference presentations.
Trial registration number
NCT03717896; clinicaltrials.gov.
Women in Health and their Economic, Equity and Livelihood statuses during Emergency Preparedness and Response (WHEELER) protocol: a mixed methods study in Kenya
Introduction
Kenya reported its first COVID-19 case on 13 March 2020. Pandemic-driven health system changes followed and unforeseen societal, economic and health effects reported. This protocol aims to describe the methods used to identify the gender equality and health equity gaps and possible disproportional health and socioeconomic impacts experienced by paid and unpaid (community health volunteer) female healthcare providers in Kilifi and Mombasa Counties, Kenya during the COVID-19 pandemic.
Methods and analysis
Participatory mixed methods framed by gender analysis and human-centred design will be used. Research implementation will follow four of the five phases of the human-centred design approach. Community research advisory groups and local advisory boards will be established to ensure integration and the sustainability of participatory research design.
Ethics and dissemination
Ethical approval was obtained from the Institutional Scientific and Ethics Review Committee at the Aga Khan University and the University of Manitoba.
This study will generate evidence on root cultural, structural, socioeconomic and political factors that perpetuate gender inequities and female disadvantage in the paid and unpaid health sectors. It will also identify evidence-based policy options for future safeguarding of the unpaid and paid female health workforce during emergency preparedness, response and recovery periods.
Knowledge, practice and attitudes regarding substance use disorder treatment and harm reduction strategies among pharmacists: a scoping review protocol
Introduction
Pharmacists provide a spectrum of services and comprehensive medication management for patients with substance use disorders (SUDs) with many providing timely and increased access to care for patients. Prior studies have evaluated other healthcare professionals’ attitudes, knowledge and practice in regard to SUD treatment and harm reduction services. However, no reviews to date summarise the available literature on the attitudes, knowledge and practice in regard to SUD treatment and harm reduction services from the pharmacist perspective. This scoping review aims to systematically map the extent, range and nature of available evidence and identify and describe gaps in knowledge, practice and attitudes towards SUD treatment among pharmacists with the goal of providing information for meaningful integration of pharmacists into SUD care.
Methods and analysis
We will use the framework proposed by Arksey and O’Malley (2005) updated with recommendations by Levac et al (2010) and the Joanna Briggs Institute (2020). The protocol is registered via Open Science Framework (https://osf.io/92dek). We will search for peer-reviewed literature containing empirical evidence investigating SUD treatment or harm reduction with outcomes pertaining to the knowledge, practice or attitudes of pharmacists. Findings will be guided and assessed by research objectives and summarised using descriptive statistics and thematically for quantitative and qualitative findings, respectively. This review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.
Ethics and dissemination
Our findings will provide crucial information and support for future interventions and programmes which aim to meaningfully integrate pharmacists into SUD care. We will disseminate findings at conferences and publish in a peer-reviewed journal. In addition, we will integrate feedback on search strategy, data extraction and our dissemination approach from multidisciplinary collaborators including those within our team’s institution and outside experts with clinical or administrative knowledge in SUD care.
Anti-racist interventions to reduce ethnic disparities in healthcare in the UK: an umbrella review and findings from healthcare, education and criminal justice
Objectives
To assess the evidence for anti-racist interventions which aim to reduce ethnic disparities in healthcare, with a focus on implementation in the UK healthcare system.
Design
Umbrella review.
Data sources
Embase, Medline, Social Policy and Practice, Social Care Online and Web of Science were searched for publications from the year 2000 up to November 2023.
Eligibility criteria
Only systematic and scoping reviews of anti-racist interventions reported in English were included. Reviews were excluded if no interventions were reported, no comparator interventions were reported or the study was primarily descriptive.
Data extraction and synthesis
A narrative synthesis approach was used to integrate and categorise the evidence on anti-racist interventions for healthcare. Quality appraisal (including risk of bias) was assessed using the AMSTAR-2 tool.
Results
A total of 29 reviews are included in the final review. 26 are from the healthcare sector and three are from education and criminal justice. The most promising interventions targeting individuals include group-based health education and providing culturally tailored interventions. On a community level, participation in all aspects of care pathway development that empowers ethnic minority communities may provide an effective approach to reducing ethnic health disparities. Interventions to improve quality of care for conditions with disproportionately worse outcomes in ethnic minority communities show promise. At a policy level, structural interventions including minimum wage policies and integrating non-medical interventions such as housing support in clinical care has some evidence for improving outcomes in ethnic minority communities.
Conclusions
Many of the included studies were low or critically low quality due to methodological or reporting limitations. For programme delivery, different types of pathway integration, and providing a more person-centred approach with fewer steps for patients to navigate can contribute to reducing disparities. For organisations, there is an overemphasis on individual behaviour change and recommendations should include a shift in focus and resources to policies and practices that seek to dismantle institutional and systemic racism through a multilevel approach.
Effects of vitamin D levels during pregnancy on prematurity: a systematic review protocol
Introduction
Prematurity is an urgent public health problem worldwide. Recent studies associate maternal hypovitaminosis D during pregnancy with an increased risk of prematurity. However, the evidence on this association remains inconclusive, and there is lack of consensus in the literature. The exact mechanism by which low vitamin D levels may increase the risk of preterm birth is not yet fully understood. Nevertheless, it is known that vitamin D may play a role in maintaining a healthy pregnancy by regulating inflammation and immunomodulation by acting on the maternal and fetal immune systems. Inflammation and immune dysregulation are both associated with preterm birth, and low vitamin D levels may exacerbate these processes. The results of this review may have important implications for clinical practice and public health policy, particularly regarding vitamin D supplementation during pregnancy.
Methods and analysis
A systematic review of the literature will be conducted. The search will be performed in electronic databases: CINAHL; MEDLINE; Cochrane Central Register of Controlled Trials; Cochrane Library; Academic Search Complete; Information Science and Technology Abstracts; MedicLatina; SCOPUS; PubMed; and Google Scholar, with the chronological range of January 2018 to November 2022. The search strategy will include the following Medical Subject Headings or similar terms: ‘Vitamin D’; ‘25-hydroxyvitamin D’; ‘Hypovitaminosis D’; ‘Pregnancy’; ‘Pregnant women’; ‘Expectant mother’; ‘Prematurity’; ‘Premature birth’; ‘Premature delivery’; ‘Preterm birth’; and ‘Preterm labour’. This review will include quantitative primary studies, both experimental (clinical trials) and observational (cohort, cross-sectional, and case–control). The quality of each selected study and the results obtained will be assessed by two reviewers separately, using the Cochrane risk of bias tool for evaluating randomised clinical trials or the Newcastle Ottawa Scale for non-randomised studies, following the respective checklist. In case of disagreement, a third reviewer will be consulted.
Ethics and dissemination
This study does not involve human subjects and therefore does not require ethics approval. The results will be disseminated through publication in a peer-reviewed scientific journal and through conference presentations. All changes made to the protocol will be registered in PROSPERO, with information on the nature and justification for the changes made.
PROSPERO registration number
CRD42022303901.
Lessons from Japan's Case for Early Helicobacter pylori Screening
Health economic evaluations of preventative care for perinatal anxiety and associated disorders: a rapid review
Objectives
Perinatal mental health problems affect one in five women and cost the UK £8.1 billion for every year of births, with 72% of this cost due to the long-term impact on the child. We conducted a rapid review of health economic evaluations of preventative care for perinatal anxiety and associated disorders.
Design
This study adopted a rapid review approach, using principles of the standard systematic review process to generate quality evidence. This methodology features a systematic database search, Preferred Reporting Items for Systematic Reviews and Meta-Analyses diagram, screening of evidence, data extraction, critical appraisal and narrative synthesis.
Data sources
PubMed, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Applied Social Sciences Index and Abstracts, PsycINFO and MEDLINE.
Eligibility criteria for selecting studies
Studies that evaluated the costs and cost-effectiveness of preventative care for perinatal anxiety and associated disorders carried out within the National Health Service and similar healthcare systems.
Data extraction and synthesis
A minimum of two independent reviewers used standardised methods to search, screen, critically appraise and synthesise included studies.
Results
The results indicate a lack of economic evaluation specifically for perinatal anxiety, with most studies focusing on postnatal depression (PND). Interventions to prevent postnatal mental health problems are cost-effective. Modelling studies have also been conducted, which suggest that treating PND with counselling would be cost-effective.
Conclusion
The costs of not intervening in maternal mental health outweigh the costs of preventative interventions. Preventative measures such as screening and counselling for maternal mental health are shown to be cost-effective interventions to improve outcomes for women and children.
PROSPERO registration number
CRD42022347859.
Investigating the efficacy and safety of olanzapine prophylaxis for opioid-induced nausea and vomiting (JORTC-PAL20): a study protocol for an open-label, single-arm exploratory study
Introduction
In opioid therapy for cancer pain, opioid-induced nausea and vomiting (OINV) occur in 20%–40% of patients during initial opioid treatment or increasing opioid doses. OINV result in failure to achieve pain relief due to poor opioid adherence. Therefore, antiemetics are used to prevent OINV, but their efficacy and safety in this context have not yet been fully elucidated. Olanzapine is a promising antiemetic for the prophylaxis of chemotherapy-induced nausea and vomiting.
Methods and analysis
This single-arm, single-centre exploratory study will evaluate the prophylactic antiemetic efficacy and safety of 5 mg olanzapine in patients with cancer pain who are withholding initial regular opioid therapy. Thirty-five patients will be enrolled. The primary endpoint is the proportion of patients achieving complete control (CC) of OINV during 5 days of opioid treatment. CC was defined as the absence of emetic episodes, no need for rescue medication to treat nausea, and minimal or no nausea (3 or less on an 11-point categorical scale). Secondary endpoints include the complete response, defined as no emetic episodes and no use of rescue medication during the overall assessment period, the time from opioid initiation to first emetic episode, the time from opioid initiation to first rescue antiemetic administration, and adverse events graded by Patient-Reported Outcome (PRO) Common Terminology Criteria for Adverse Events (CTCAE) version 1.0 and CTCAE version 5.0.
Ethics and dissemination
This study protocol was approved by National Cancer Center Hospital Certified Review Board. The results will be used as preliminary data to conduct a validation study.
Trial registration number
Japan Registry of Clinical Trials (jRCT) jRCTs031220008.