Heterogeneity Of Outcome Measures Research Articles

416 The Impact of Pancreas Transplantation on Secondary Diabetic Complications: A Systematic Review

Abstract Aim Pancreas transplantation (PT) provides diabetic cure for patients with complicated Type 1 Diabetes Mellitus (T1DM). We aimed to examine the impact of PT on secondary diabetic complications, including retinopathy, neuropathy, and cardiovascular disease. Method A database search using MedLINE for publications up to April 2023 was conducted employing MeSH terms ‘Pancreas Transplantation’ AND ‘Diabetes Mellitus, Type 1’ AND ‘Diabetic Retinopathy’ OR ‘Heart Disease’ OR ‘Cardiovascular Diseases’ OR ‘Peripheral Vascular Disease’ OR “Amputation’ OR ‘Neuropathy.” Results 223 articles were screened, with 172 excluded as per study design (total included 51). 64.7% (n=33) of studies were retrospective case control studies, 35.3% (n=18) of studies were retrospective cohort studies. A total of 5616 patients with a mean of 99.1 (SD± 262.4) simultaneous kidney transplant (SPK) patients and 48.2 (SD± 262.4) pancreas transplant alone (PTA) patients per article were studied. All articles examining diabetic retinopathy concluded that retinopathy improved or stabilized. 69% (n=11) of papers demonstrated no significant change to visual acuity. An equal number of articles (n=4) demonstrated increased peripheral nerve conduction velocity after SPK and PTA. 40% (n=2) of articles examining vibration perception studies demonstrated an increase post-transplantation. Improvements in cardiac events incidence, metabolic factors, and heart structure were seen in 79% (n=15) of cardiovascular articles. Conclusions Despite significant heterogeneity in outcome measures observed, PT provides benefits in mitigating the complication profile of T1DM. Standardised outcome measurement should be adopted to allow assessment of the impact of beta-cell replacement with the potential for objective evidence reversibility of secondary complications.

The effect of different care delivery models in a hospital setting on patient- and nurse-related outcomes: A systematic review with narrative synthesis.

To synthesize and assess the effectiveness of different care delivery models in a hospital setting, taking into account patient- and nurse-related outcomes. A systematic review with narrative synthesis in which a comparison was made between different care delivery models. The search string consisted of four clusters: 'nursing', 'care delivery models', 'hospital setting' and 'quantitative research designs'. Four electronic databases were searched from the inception of the databases to January 2023: Medline, Embase, CINAHL and Web of Science. In total, 19 studies were included in the systematic review. The most commonly compared care delivery models were functional nursing to primary nursing (n = 6), patient allocation to team nursing (n = 4), team nursing to primary nursing (n = 3) and functional nursing to modular nursing (n = 3). Only one randomized crossover trial was found, other included studies were pretest-posttest designs or quasi-experimental designs. The implementation of a nursing care delivery model was the study intervention. The following aspects of the intervention were not reported or inadequately described by the majority of the authors; tailoring of an intervention, modifications to an intervention and the adherence or fidelity to the intervention. Job satisfaction and quality of nursing care were the most commonly reported nursing outcomes, while patient satisfaction was the most commonly reported patient outcome. Due to a high heterogeneity in outcome measures between the studies, a meta-analysis of the included studies was not possible. All included studies had a high risk of overall bias. This systematic review found mixed evidence, inconsistent reporting of certain elements of the interventions, high heterogeneity in outcome measures and low methodological quality. Although this systematic review could not answer which nursing care delivery model is the most effective or most promising, other important findings from this review may inform future research. There are differences in care delivery model descriptions and a lack of agreement on the strengths and weaknesses of the care delivery models. No clear-cut answer can be given about the effect of different care delivery models in a hospital setting on patient- and nurse-related outcomes. Job satisfaction and quality of nursing care were the most commonly reported nursing outcomes, while patient satisfaction was the most commonly reported patient outcome. This review can support the development of future care delivery redesign strategies. The systematic review was reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). No patient or public contribution.

Statin use in total joint arthroplasty: a systematic review

Introduction: There has been increased interest in the use of Statins in total hip and knee arthroplasty (THA and TKA) patients to improve outcomes and reduce postoperative complications. This study was performed to systematically review the evidence on Statin use in total joint arthroplasty, specifically its benefits and complications. Methods: Adhering to the PRISMA guidelines, a systematic review of PubMed, Embase, Scopus, Web of Science, and the Cochrane database was performed to find studies reporting on the effects of Statin use on outcomes of THA and TKA. Two authors independently selected relevant papers to include. Results: A total of 18 papers were included in the final analysis. Most were retrospective studies, with heterogeneous patient selection and outcome measures. The evidence on the risks and benefits of Statin use on outcomes of total joint arthroplasty was very limited and heterogeneous. Studies were focusing on perioperative cardiac outcomes, clinical outcomes and complications, renal, pulmonary, and gastrointestinal outcomes. Due to the heterogeneity of reported data, a formal meta-analysis was not possible. Conclusions: There is some evidence in the literature suggesting that perioperative use of Statins, especially in Statin-naïve patients, may reduce cardiac (e.g. atrial fibrillation) and noncardiac (e.g. delirium) complications, while not increasing the risk of muscle or liver toxicity. The authors also found low levels of evidence that Statin use may reduce the long-term risk for revision surgery and osteolysis.

Responsiveness of the condition-specific OVAMA questionnaire to measure symptoms and appearance in patients with vascular malformations.

Evidence-based guidelines for the treatment of vascular malformations are not readily available, possibly due to the diversity in methods used to evaluate treatment efficacy in clinical research, complicating the aggregation and comparison of study results. The OVAMA (Outcome Measures for VAscular Malformations) questionnaire was developed to uniformly measure symptoms and appearance, i.e., condition-specific core outcome domains, in patients with vascular malformations. However, the OVAMA questionnaire needs to be responsive to changes in these constructs in order to assess whether the disease status has altered since treatment. To assess the responsiveness of the OVAMA questionnaire in patients with vascular malformations. In a prospective longitudinal study, patients completed the OVAMA questionnaire at baseline and eight weeks follow-up since treatment or watchful waiting policy. Additionally, patients completed the Global rating of change (GRC) scales at follow-up. Responsiveness was evaluated following the criterion approach of testing predefined hypotheses about expected relationships between the OVAMA questionnaire and GRC scales, measuring the same constructs. The OVAMA questionnaire was considered responsive if ≥ 75% of the hypotheses were confirmed. Between July 2020 and September 2022, 89 patients were recruited in a vascular anomaly centre in the Netherlands, of which 63 patients completed the questionnaires at baseline and follow-up. In total, fifteen constructs of the OVAMA questionnaire were assessed for five hypotheses. Of these 75 hypotheses, 63 (84%) hypotheses were confirmed and thereby providing evidence that the OVAMA questionnaire is responsive to change. Our study found convincing evidence that the OVAMA questionnaire is responsive to changes in symptoms and appearance in patients with vascular malformations. In addition to determining a baseline of symptoms and appearance, the OVAMA questionnaire can now be used to evaluate the effect of treatment from the patient's perspective. The responsive OVAMA questionnaire allows for uniform evaluation and comparison of the effects of treatment on the condition-specific core outcome domains, tackling heterogeneity in outcome measurement and improving the clinical research of vascular malformations.

Non-pharmacological treatments for anticipatory nausea and vomiting during chemotherapy: a systematic review and meta-analysis of the Clinical Practice Guidelines for Antiemesis 2023.

Anticipatory chemotherapy-induced nausea and vomiting (CINV) is a conditioned response influenced by the severity and duration of previous emetic responses to chemotherapy. We aimed to evaluate the efficacy of non-pharmacologic interventions for anticipatory CINV among patients with cancer. We conducted a systematic search in databases, including PubMed, the Cochrane Library, CINAHL, and Ichushi-Web, from January 1, 1990, to December 31, 2020. Randomized controlled trials, non-randomized designs, observational studies, or case-control studies that utilized non-pharmacological therapies were included. The primary outcomes were anticipatory CINV, with an additional investigation into adverse events and the costs of therapies. The risk-of-bias for each study was assessed using the Cochrane risk-of-bias tool, and meta-analysis was performed using Revman 5.4 software. Of the 107 studies identified, six met the inclusion criteria. Three types of non-pharmacological treatments were identified: systematic desensitization (n = 2), hypnotherapy (n = 2), and yoga therapy (n = 2). Among them, systematic desensitization significantly improved anticipatory CINV as compared to that in the control group (nausea: risk ratio [RR] = 0.60, 95% confidence interval [CI] = 0.49-0.72, p < 0.00001; vomiting: RR = 0.54, 95% CI = 0.32-0.91, p = 0.02). However, heterogeneity in outcome measures precluded meta-analysis for hypnotherapy and yoga. Additionally, most selected studies had a high or unclear risk of bias, and adverse events were not consistently reported. Our findings suggest that systematic desensitization may effectively reduce anticipatory CINV. However, further research is warranted before implementation in clinical settings.

Clinical Assessment of Osteoarthritis Pain: Contemporary Scenario, Challenges, and Future Perspectives.

The multifaceted nature of osteoarthritis (OA) pain presents a challenge in understanding and managing the condition. The diverse pain experiences, progression rates, individual responses to treatments, and complex disease mechanisms contribute to heterogeneity in the clinical studies outcomes. The lack of a standardized methodology for assessing and classifying OA pain challenges healthcare practitioners. This complicates the establishment of universally applicable protocols or standardized guidelines for treatment. This article explores the heterogeneity observed in clinical studies evaluating OA pain treatments, highlighting the necessity for refined methodologies, personalized patient categorization, and consistent outcome measures. It discusses the role of the multidimensional nature of OA pain, underlying pain mechanisms, and other contributing factors to the heterogeneity in outcome measures. Addressing these variations is crucial to establishing a more consistent framework for evidence-based treatments and advancing care of the patient with OA pain.

How can healthcare organisations increase doctors’ research engagement? A scoping review

PurposeClinician engagement in research has positive impacts for healthcare, but is often difficult for healthcare organisations to support in light of limited resources. This scoping review aimed to describe the literature on health service-administered strategies for increasing research engagement by medical practitioners.Design/methodology/approachMedline, EMBASE and Web of Science databases were searched from 2000 to 2021 and two independent reviewers screened each record for inclusion. Inclusion criteria were that studies sampled medically qualified clinicians; reported empirical data; investigated effectiveness of an intervention in improving research engagement and addressed interventions implemented by an individual health service/hospital.FindingsOf the 11,084 unique records, 257 studies were included. Most (78.2%) studies were conducted in the USA, and were targeted at residents (63.0%). Outcomes were measured in a variety of ways, most commonly publication-related outcomes (77.4%), though many studies used more than one outcome measure (70.4%). Pre-post (38.8%) and post-only (28.7%) study designs were the most common, while those using a contemporaneous control group were uncommon (11.5%). The most commonly reported interventions included Resident Research Programs (RRPs), protected time, mentorship and education programs. Many articles did not report key information needed for data extraction (e.g. sample size).Originality/valueThis scoping review demonstrated that, despite a large volume of research, issues like poor reporting, infrequent use of robust study designs and heterogeneous outcome measures limited application. The most compelling available evidence pointed to RRPs, protected time and mentorship as effective interventions. Further high-quality evidence is needed to guide healthcare organisations on increasing medical research engagement.

The methodological quality of systematic reviews regarding the Core Outcome Set (COS) development

BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) working group proposed core outcome sets (COS) to address the heterogeneity in outcome measures in clinical studies. According to the recommendations of COMET, performing systematic reviews (SRs) usually was the first step for COS development. However, the SRs that serve as a basis for COS are not specifically appraised by organizations such as COMET regarding their quality. Here, we investigated the status of SRs related to development of COS and evaluated their methodological quality.MethodsWe conducted a search on PubMed to identify SRs related to COS development published from inception to May 2022. We qualitatively summarized the disease included in SR topics, and the studies included in the SRs. We evaluated the methodological quality of the SRs using AMSTAR 2.0 and compared the overall quality of SRs with and without protocols using the Mann-Whitney U test.ResultsWe included 175 SRs from 23 different countries or regions, and they mainly focused on five diseases: musculoskeletal system or connective tissue disease (n = 19, 10.86%), injury, poisoning, or certain other consequences of external causes (n = 18, 10.29%), digestive system disease (n = 16, 9.14%), nervous system disease (n = 15, 8.57%), and genitourinary system disease (n = 15, 8.57%). Although 88.00% of SRs included randomized controlled trials (RCTs), only a few SRs (23.38%) employed appropriate tools to assess the risk of bias in RCTs. The assessment results on the basis of AMSTAR 2.0 indicated that most SRs (93.71%) were rated as ‘’critically low’’ to ‘’low’’ in terms of overall confidence. The overall confidence of SRs with protocols was significantly higher than that without protocols (P <.001). Compared to the SRs with protocols on Core Outcome Measures in Effectiveness Trials (COMET), SRs with protocols on PROSPERO were of better overall confidence (P = .017).ConclusionThe overall quality of published SRs regarding COS development was poor. Our findings emphasize the need for researchers to carefully select the disease topic and strictly adhere to the requirements of optimal methodology when conducting a SR for the establishment of a COS.

Effectiveness of shared medical appointments delivered in primary care for improving health outcomes in patients with long-term conditions: a systematic review of randomised controlled trials

ObjectivesTo examine the effectiveness of shared medical appointments (SMAs) compared with one-to-one appointments in primary care for improving health outcomes and reducing demand on healthcare services by people with one...

The information required by people with inflammatory arthritis to take methotrexate: a mixed-methods systematic review.

This mixed-methods systematic review aimed to identify and synthesize knowledge of the characteristics, content, and preferred format of information to support people with inflammatory arthritis (IA) to take methotrexate. A literature search using MEDLINE, The Cochrane Library, Embase, CINAHL, PsychInfo, GreyEU, Web of Science and Open Dissertation was conducted to identify all studies published from 2000 to December 2022. Included studies detailed factors related to methotrexate (MTX) related information needs of people with inflammatory arthritis ≥ 18 years in English. Joanna Briggs Institute Guidelines (JBI) for convergent integrated mixed-methods systematic reviews were followed using validated tools for data extraction and quality. Data was analysed using reflexive thematic analysis. Thirteen studies (seven quantitative, two mixed-methods and four qualitative) were included involving 3425 adults, mainly female n = 2434 (71%), age 20-84 years. An overarching theme of a requirement for person-centred care was developed with three interlinking themes: 1: Accepting the need for treatment with MTX, 2: Concerns about taking MTX, 3: A need for tailored information and support. Limitations of the evidence were use of heterogeneous outcome measures and instruments to measure information needs. People with IA have individual, multi-faceted information, and support needs about MTX that are often unresolved when a one-size-fits-all approach is used. The findings can inform rheumatology training to support a person-centred approach to identifying and addressing specific needs, concerns and the development of consistent easy-to-understand accessible MTX information.

A global core outcome measurement set for snakebite clinical trials

Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation. A globally representative group of key stakeholders came together to reach consensus on a globally relevant set of core outcome measurements. Outcome domains and outcome measurement instruments were identified through searching the literature and a systematic review of snakebite clinical trials. Outcome domains were shortlisted by use of a questionnaire and consensus was reached among stakeholders and the patient group through facilitated discussions and voting. Five universal core outcome measures should be included in all future snakebite clinical trials: mortality, WHO disability assessment scale, patient-specific functional scale, acute allergic reaction by Brown criteria, and serum sickness by formal criteria. Additional syndrome-specific core outcome measures should be used depending on the biting species. This core outcome measurement set provides global standardisation, supports the priorities of patients and clinicians, enables meta-analysis, and is appropriate for use in low-income and middle-income settings.

The Impact of Musical Rehabilitation on Complex Sound Perception in Cochlear Implant Users: A Systematic Review.

Musical rehabilitation has been used in clinical and nonclinical contexts to improve postimplantation auditory processing in implanted individuals. This systematic review aimed to evaluate the efficacy of music rehabilitation in controlled experimental and quasi-experimental studies on cochlear implant (CI) user speech and music perception. PubMed/MEDLINE, EMBASE, Web of Science, PsycARTICLES, and PsycINFO databases through July 2022. Controlled experimental trials and prospective studies were included if they compared pretest and posttest data and excluded hearing aid-only users. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were then used to extract data from 11 included studies with a total of 206 pediatric and adult participants. Interventions included group music therapy, melodic contour identification training, auditory-motor instruction, or structured digital music training. Studies used heterogeneous outcome measures evaluating speech and music perception. Risk of bias was assessed using the National Heart, Lung, and Blood Institute Quality Assessment Tool. A total of 735 studies were screened, and 11 met the inclusion criteria. Six trials reported both speech and music outcomes, whereas five reported only music perception outcomes after the intervention relative to control. For music perception outcomes, significant findings included improvements in melodic contour identification (five studies, p < 0.05), timbre recognition (three studies, p < 0.05), and song appraisal (three studies, p < 0.05) in their respective trials. For speech prosody outcomes, only vocal emotion identification demonstrated significant improvements (two studies, p < 0.05). Music rehabilitation improves performance on multiple measures of music perception, as well as tone-based characteristics of speech (i.e., emotional prosody). This suggests that rehabilitation may facilitate improvements in the discrimination of spectrally complex signals.

Determination of Relationships between Symmetry-Based, Performance-Based, and Functional Outcome Measures in Patients Undergoing Total Hip Arthroplasty.

Due to the high heterogeneity in outcome measures after total hip arthroplasty (THA), the prospective observational study investigated the relationships between symmetry-based (SBMs), performance-based (PBMs), and functional outcome measures in THA patients to determine necessary or redundant categories of tests. The study material consisted of 24 patients with end-stage hip osteoarthritis scheduled for THA. The patients were examined one day before surgery and consecutively on the 4th day, 9th day, and 10th week postoperatively using the SBMs (weight-bearing chair-rising test, measurements of the maximal isometric torque of the quadriceps muscle); the PBMs (10-m walk, timed up-and-go, and stair-climbing tests); and the functional outcome measure (Harris Hip Score). The results obtained in a given category of tests at different time points were compared, and the correlations between the tests were determined. The reliability of the outcome measures was determined. The results of tests in the studied categories statistically significantly (p < 0.05) improved at the 10th week postoperatively compared to preoperative results. No strong correlations were revealed between the three studied types of outcome measures in THA patients. Therefore, none of them can be considered redundant. It also means that the relevance of symmetry for a core measurement set to describe the domain function in THA patients must be further clarified.

Real-world effectiveness of mRNA COVID-19 vaccines in the elderly during the Delta and Omicron variants: Systematic review.

As of 31 December 2022, there were over 6.6 million coronavirus disease 2019 (COVID-19) deaths and over 651 million cases across 200 countries worldwide. Despite the increase in vaccinations and booster shots, COVID-19 cases and deaths continue to remain high. While the effectiveness of these vaccines has already been established by different manufacturers, the fact remains that these vaccines were created quickly for global emergency use, tested under controlled clinical conditions from voluntary subjects and age groups whose general characteristics may differ from the actual general population. To conduct a systematic review to determine the real-world effectiveness of mRNA COVID-19 vaccines in the elderly during the predominance of Delta and Omicron variants in preventing COVID-19 related infection, hospital, intensive care unit (ICU) admission and intubation, and death. A combination of Medical Subject Headings and non-Medical Subject Headings was carried out to identify all relevant research articles that meets the inclusion and exclusion criteria from PubMed, Cochrane, CINAHL, Scopus, ProQuest, Embase, Web of Science, and Google Scholar databases, as well as qualified research studies from pre-print servers using medRxiv and Research Square, published from January 1, 2021 - December 31, 2022. As per the inclusion and exclusion criteria, the effectiveness of Pfizer-BioNTech and Moderna vaccines were evaluated from an estimated total study population of 26,535,692 using infection, hospital, ICU admission and intubation, and death as outcome measures from studies published between 2021 and 2022, conducted in New York, Finland, Canada, Costa Rica, Qatar, Greece, and Brazil. The risk of bias was evaluated using risk of bias in nonrandomized studies of interventions (ROBINS-I) tool for cohort, case-control, and cross-sectional studies. While clinical trial data on Pfizer-BioNTech and Moderna vaccines demonstrated 94% vaccine effectiveness in the elderly, the results in this study showed that vaccine effectiveness in real-world settings is marginally lower against infection (40%-89%), hospitalization (92%), ICU admission and intubation (98%-85%), and death (77%-87%) with an indication of diminished effectiveness of vaccine over time. Furthermore, 2 doses of mRNA vaccines are inadequate and only provides interim protection. Because of the natural diminishing effectiveness of the vaccine, the need for booster dose to restore its efficacy is vital. From a research perspective, the use of highly heterogeneous outcome measures inhibits the comparison, contrast, and integration of the results which makes data pooling across different studies problematic. While pharmaceutical intervention like vaccination is important to fight an epidemic, utilizing common outcome measurements or carrying out studies with minimal heterogeneity in outcome measurements, is equally crucial to better understand and respond to an international health crisis.

A Systematic Review and Meta-Analysis of the Association Between Psychopathology and Social Functioning in Schizophrenia.

Impaired social functioning is a major, but under-elucidated area of schizophrenia. It's typically understood as consequential to, eg, negative symptoms, but meta-analyses on the subject have not examined psychopathology in a broader perspective and there's severe heterogeneity in outcome measures. To enhance functional recovery from schizophrenia, a more comprehensive understanding of the nature of social functioning in schizophrenia is needed. In this systematic review and meta-analysis, we searched PubMed, PsycInfo, and Ovid Embase for studies providing an association between psychopathology and social functioning. Meta-analyses of the regression and correlation coefficients were performed to explore associations between social functioning and psychopathology, as well as associations between their subdomains. Thirty-six studies with a total of 4742 patients were included. Overall social functioning was associated with overall psychopathology (95% CI [-0.63; -0.37]), positive symptoms (95% CI [-0.39; -0.25]), negative symptoms (95% CI [-0.61; -0.42]), disorganized symptoms (95% CI [-0.54; -0.14]), depressive symptoms (95% CI [-0.33; -0.11]), and general psychopathology (95% CI [-0.60; -0.43]). There was significant heterogeneity in the results, with I2 ranging from 52% to 92%. This is the first systematic review and meta-analysis to comprehensively examine associations between psychopathology and social functioning. The finding that all psychopathological subdomains seem to correlate with social functioning challenges the view that impaired social functioning in schizophrenia is mainly a result of negative symptoms. In line with classical psychopathological literature on schizophrenia, it may be more appropriate to consider impaired social functioning as a manifestation of the disorder itself.

(032) Development of a Core Outcome Set for Provoked Vestibulodynia

Abstract Introduction The literature on vulvodynia treatment is heterogeneous in terms of intervention type, study quality, and outcome measures. A systematic review (SR) of vulvodynia treatments was recently published focusing on randomized controlled trials (RCTs) and non-RCTs for provoked vestibulodynia (PVD, a vulvodynia subtype). The authors of the SR concluded that most studies had very low certainty of evidence, which limited the ability to draw conclusions about intervention efficacy. In addition, the authors noted a large degree of heterogeneity in outcome measures, which limited the ability to conduct a meta-analysis, and they recommended that future studies incorporate a core outcome set (COS, an agreed-upon standardized set of outcomes that should be assessed and reported, as a minimum, in all clinical trials in specific areas of health or healthcare) so that results from future clinical trials of PVD can be combined and evaluated. Objective To establish a COS for PVD. Methods The Project Management Team of the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) consists of vulvodynia researchers/clinicians, a patient partner, and health technology methodologists. Since March 2022, the team has conducted a literature review and extracted all outcomes from the PVD treatment literature (as of 1990 for published studies, and no date limit for the clinical trials database). Sixty-six outcomes (e.g., pain during intercourse, sexual function) have been identified. To conduct a two round Delphi survey with multiple stakeholders, registration for participation in the study (ongoing) has been open to a variety of stakeholders: people with current or past lived experience of PVD, relatives of those with lived experience of PVD, healthcare practitioners, researchers, and others (e.g., leaders of patient or funding organizations). Participants who register will provide background information to ensure representativeness of stakeholder identification and sociodemographic status (e.g., country of residence, gender), after which they will be asked to participate in the first survey. The first survey asks participants to rate each of the outcomes on a 9-point scale (from outcome is not important to outcome is critical to include and should always be measured in treatment studies) and to list any outcomes that should be included but were missed. In the second survey, the outcomes with the highest ranks from the first survey and all new outcomes will be presented to the participants, and they will be asked to rate them. Then, a virtual consensus meeting will be held with some members from all stakeholder groups to discuss the highest ranked outcomes and to decide which ones to include in the core outcome set. Results We will report on interim progress of the COS for PVD. Conclusions The results of this study will contribute critical information to standardize outcome reporting across PVD treatment studies so that stakeholders can directly compare the effectiveness of different interventions, identify clinically relevant outcomes, and reduce the risk of reporting bias. In addition, they will allow for the generation of consistent data for meta-analyses. Disclosure No

Randomized Controlled Trial of Isha Kriya versus Observation to Improve Quality of Life in Hematopoietic Cell Transplantation Recipients

Hematopoietic cell transplantation (HCT) impacts its recipients' quality of life (QoL). Few mindfulness-based interventions (MBI) in HCT recipients have shown feasibility, but heterogeneous practices and outcome measures have questioned the real benefit. We hypothesize that a self-guided meditation as a mobile app will improve QoL in the acute HCT setting. This single-center, open-label, randomized controlled trial was conducted in 2021-2022. The study was cleared by Institutional Ethics Committee and registered at the Clinical Trial Registry of India. Recipients were included after obtaining written informed consent. Recipients without access to smartphones or regular practitioners of yoga, meditation, or other mind-body practice were excluded. Autologous + allogeneic HCT recipients of age ≥ 18 years were included in the study. Recipients were randomized to the control arm or Isha kriya arm in a 1:1 ratio stratified by type of transplant. Patients in the Isha kriya arm were recommended to perform the kriya twice daily from pre-HCT to day+30 post-HCT. Isha Kriya is 12-minute guided meditation based on the principles of yoga, focussing on breath, awareness, and thought. The primary endpoint was the QoL summary scores assessed by the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) and the Patient-Reported Outcomes Measurement Information System–Global Health (PROMIS-GH) questionnaires. The secondary endpoints were the difference in QoL domain scores. The validated questionnaires were self-administered before the intervention, day +30, and day +100 after HCT. The analysis of endpoints was done on an intention-to-treat basis. Domain and summary scores were calculated for each instrument as recommended by the developers. A p-value <0.05 was used for statistical significance, and cohen's d effect size determined clinical significance. A total of 72 HCT recipients were randomized to the Isha kriya and the control arm. Patients in both arms were matched for age, gender, diagnosis, and type of HCT. Both arms had no difference in the pre-HCT QoL domain, summary, and global scores. Post-HCT at day+30, there was no difference in the mean FACT-BMT total scores (112.9 ± 16.8 vs.101.2 ± 13.9, p = 0.2) and the mean global health scores (Global mental health 45.1 ± 8.6 vs. 42.5 ± 7.2, p = 0.5, global physical health 44.1 ± 6.3 vs. 44.1 ± 8.3, p = 0.4) in the two groups. There was similarly no difference in the physical, social, emotional, and functional domain scores. However, the mean BMT-subscale scores, which addresses BMT-specific quality-of-life concerns, were statistically and clinically significantly higher in the Isha kriya arm than the control arm (27.9 ± 5.1 vs. 24.4 ± 9.2, p = 0.03, Cohen's d 0.5, medium effect size). This effect was transient as the day+100 scores showed no difference (28.3 ± 5.9 vs. 26.2 ± 9.4, p = 0.3). Isha kriya did not improve the FACT-BMT total and global health scores in the acute HCT setting. However, practicing Isha kriya for a month did show a transient improvement in the FACT-BMT subscale scores on day +30 but not on day +100 post-HCT.

Assessing the Impact of Workforce Nutrition Programmes on Nutrition, Health and Business Outcomes: A Review of the Global Evidence and Future Research Agenda

One in three people globally suffers from at least one form of malnutrition, leading to poor health outcomes and low productivity in the workplace. The workplace offers an important, relatively unexploited opportunity to address malnutrition in all its forms. This narrative literature review aims to understand the impact of workforce nutrition programmes on nutrition, health, and business outcomes, based on high-strength-of-evidence studies. We used PubMed as our primary research database, complemented by Google Scholar, to identify systematic reviews, meta-analyses, and randomised controlled trials published between January 2010 and October 2021. In total, 26 records were included. We found that comprehensive workforce nutrition programmes, including a variety of intervention areas, and/or programmes targeting high-risk categories of workers (overweight/obese or (pre-)diabetic) were more likely to be effective on nutrition, health, and business outcomes. Within comprehensive and targeted programmes, individualised counselling and worksite environmental modifications were often mentioned as the most effective components. However, a high degree of heterogeneity in outcome measures and programme designs made it difficult to draw strong conclusions on the impact of workforce nutrition interventions. Limited evidence was found on business outcomes, longer-term effects of interventions, and programme implementation in LMICs. Therefore, further research is needed to address these evidence gaps.

A systematic review comparing allogeneic hematopoietic stem cell transplant to gene therapy in sickle cell disease

ABSTRACTIntroductionAllogeneic hematopoietic stem cell transplant (HSCT) and gene therapy (GT) are two potentially curative approaches for sickle cell disease (SCD), but they have never been compared in clinical trials.ObjectiveTo compare the safety and efficacy of HSCT and GT to assist clinicians and patients in making informed treatment decisions.MethodsPhase I-III clinical trials and case reports/series were included. Regimens included HSCT from all stem cell sources, lentiviral gene therapy, and gene editing, with any conditioning regimen. We searched Medline and EMBASE databases as of 1st June 2020 for studies reporting HSCT and GT outcomes in SCD. The Newcastle-Ottawa scale was used to assess the risk of bias. Descriptive statistics and post-hoc imputation for standard deviations of mean change in FEV1 and FVC were performed.ResultsIn total, 56 studies (HSCT, n = 53; GT, n = 3) representing 1,198 patients met inclusion criteria (HSCT, n = 1,158; GT, n = 40). Length of follow-up was 3,881.5 and 58.7 patient-years for HSCT and GT, respectively. Overall quality of evidence was low, with no randomized controlled trials identified. Two-year overall survival for HSCT was 91%; mortality was 2.5% for GT. Acute chest syndrome and vaso-occlusive episodes were reduced post-HSCT and GT. Meta-analysis was not possible due to lack of comparator and heterogeneity in outcome measures reporting. Very few studies reported post-transplant end-organ function. Six secondary malignancies (5 post-HSCT, 1 post-GT) were reported.DiscussionReporting of SCD-related complications and patient-important outcomes is lacking for both strategies. We advocate for standardized reporting to better compare outcomes within and between treatment groups.

Which outcomes should always be measured in intervention studies for improving work participation for people with a health problem? An international multistakeholder Delphi study to develop a core outcome set for Work participation (COS for Work)

ObjectiveSynthesising evidence of the effects of interventions to improve work participation among people with health problems is currently difficult due to heterogeneity in outcome measurements. A core outcome set for...