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1. Usability and Usefulness of a Mobile Health App for Pregnancy-Related Work Advice: Mixed-Methods Approach

Author

van Beukering, Monique, Velu, Adeline, van den Berg, Liesbeth, Kok, Marjolein, Mol, Ben Willem, Frings-Dresen, Monique, de Leeuw, Robert, van der Post, Joris, and Peute, Linda

Subjects
Information technology, T58.5-58.64, Public aspects of medicine, RA1-1270
Abstract

BackgroundPregnant women are often unaware of the potential risks that working conditions can cause to them and their unborn child. A mobile health (mHealth) app, the Pregnancy and Work (P and W) app, developed by a multidisciplinary team and based on an evidence-based guideline for occupational physicians, aims to provide advice on work adjustment during pregnancy. ObjectiveThis study evaluates the usability of the mHealth P and W app and the perceived usefulness of the work advice, the main goal of the app, by potential end users. MethodsA total of 12 working pregnant women participated in think aloud usability sessions and performed 9 tasks. All think aloud sessions were recorded, transcribed, and coanalyzed. The usability problems were rated for their severity in accordance with Nielsen severity scale. The completion rates and time taken for completion of tasks were registered. In addition, participants were questioned on demographics and user characteristics and were asked to evaluate the value of the app by filling in the Intrinsic Motivation Inventory (IMI) score and the System Usability Scale (SUS) questionnaire. ResultsIn total, 82 usability problems with a severity ≥1 were identified, of which 40 had severity ≥3. The main usability problems concerned the interpretation of terminology used in the app’s questionnaires and difficulties in finding and understanding the work advice. Furthermore, 10 out of 12 participants were able to open the work advice page in the app. Only 7 out of these 10 participants understood and intended to follow the work advice. The overall mean IMI score was relatively high (5 out of 7), indicating that the participants did indeed value the use of the app. This IMI score corresponded to the overall mean SUS score (68 out of 100) and the mean grade given to the P and W app (7 out of 10). ConclusionsThis think aloud usability study showed that the information provided in the P and W app was considered valuable by the end users, working pregnant women, and it meets their needs; however, usability issues severely impacted the perceived usefulness of the work advice given in the app.

Published
2019
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5. Effect of single blastocyst-stage versus single cleavage-stage embryo transfer on cumulative live births in women with good prognosis undergoing in vitro fertilization: Multicenter Randomized Controlled Trial

Author

Ma, Xiang, Wang, Jing, Shi, Yuhua, Tan, Jichun, Guan, Yichun, Sun, Yun, Zhang, Bo, Zhao, Junli, Liu, Jianqiao, Cao, Yunxia, Li, Hong, Zhang, Cuilian, Chen, Feng, Yi, Honggang, Wang, Ze, Xin, Xing, Kong, Pingping, Lu, Yao, Huang, Ling, Yuan, Yingying, Liu, Haiying, Li, Caihua, Mol, Ben Willem J., Hu, Zhibin, Zhang, Heping, Chen, Zi-Jiang, and Liu, Jiayin

Published
2024
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8. Journal Editors and Publishers' Legal Obligations with Respect to Medical Research Misconduct

Author

Holbeach, Naomi, Freckelton A.O. Q.C., Ian, and Mol, Ben W.

Abstract

As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers play an essential role in protecting the veracity of the medical literature. Whilst ethical guidance for journal editors and publishers is important, it is not as readily enforceable as legal obligations might be. This article questions the legal obligations that might exist for journal editors and publishing companies with respect to ensuring the veracity of the published literature. Ultimately, there is no enforceable legal obligation in Australia, the United Kingdom, or the United States. In light of this, more robust mechanisms are needed to deliver greater confidence and transparency in the investigative process, the management of concerns or findings of misconduct and the need to cleanse the literature. We show that the law disincentivises journals and publishers from ensuring truth in their publications. There are harmful consequences for medical care and public confidence in the medical profession and health care system when the foundations of medical science are questionable.

Published
2023
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9. A survey of experts to identify methods to detect problematic studies: stage 1 of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews project

Author

Wilkinson, Jack, Heal, Calvin, Antoniou, George A., Flemyng, Ella, Avenell, Alison, Barbour, Virginia, Bordewijk, Esmee M., Brown, Nicholas J.L., Clarke, Mike, Dumville, Jo, Grohmann, Steph, Gurrin, Lyle C., Hayden, Jill A., Hunter, Kylie E., Lam, Emily, Lasserson, Toby, Li, Tianjing, Lensen, Sarah, Liu, Jianping, Lundh, Andreas, Meyerowitz-Katz, Gideon, Mol, Ben W., O'Connell, Neil E., Parker, Lisa, Redman, Barbara, Seidler, Anna Lene, Sheldrick, Kyle, Sydenham, Emma, Dahly, Darren L., van Wely, Madelon, Bero, Lisa, and Kirkham, Jamie J.

Published
2024
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10. Impact of COVID-19 mitigation measures on perinatal outcomes in the Netherlands

Author

Ambrosino, Elena, Van den Auweele, Kim, Been, Jasper, Beijers, Roseriet, Bertens, Loes, Bloemenkamp, Kitty, Boderie, Nienke, Burdorf, Lex, Burgos Ochoa, Lizbeth, de Jonge, Ank, de Weerth, Caroline, Franx, Arie, Harper, Sam, Kazemier, Brenda M., Klein, Peter Paul, Kretz, Daniëlle, Labrecque, Jeremy, Mol, Ben Willem, Muris, Jean, Nieuwenhuijze, Marianne, Obermann, Sylvia, Oudijk, Martijn, Peters, Lilian, Ramerman, Lotte, Ravelli, Anita, Schonewille- Rosman, Ageeth, Schoenmakers, Sam, Struijs, Jeroen, Torij, Hanneke, Van Beukering, Monique, van den Akker, Thomas, van den Heuvel, Marion, van Dillen, Jeroen, van Lenthe, Frank, Van Ourti, Tom, Verhoeff, Arnoud, Vermeulen, Marijn, Visser, Nettie, Willers, Saskia, Burgos-Ochoa, Lizbeth, Bertens, Loes CM., Boderie, Nienke W., Gravesteijn, Benjamin Y., Obermann-Borst, Sylvia, Rosman, Ageeth, de Groot, Christianne J., and Been, Jasper V.

Published
2024
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33. Reporting of Cochrane Systematic Review Protocols with Network Meta-Analyses--A Scoping Review

Author

Wang, Rui, Dwan, Kerry, Showell, Marian G., van Wely, Madelon, Mol, Ben W., Askie, Lisa, and Seidler, Anna Lene

Abstract

Publishing systematic review protocols is a fundamental part of systematic reviews to ensure transparency and reproducibility. In this scoping review, we aimed to evaluate reporting of Cochrane systematic review protocols with network meta-analyses (NMA). We searched all Cochrane NMA protocols published in 2018 and 2019, and assessed the characteristics and reporting of methodologies relevant to NMA. We reported frequencies for each reporting item. Forty-five protocols were assessed, including two for overviews and 43 for intervention reviews. Thirty-three (73%) were labelled as NMA protocols in the title. Forty-two (95%) justified the need of an NMA and 40 (89%) used appropriate search strategies to identify potential eligible studies. About half (24, 53%) considered the transitivity assumption when reporting inclusion criteria and 35 (78%) specified potential effect modifiers. Forty-three (96%) reported statistical software for NMA, 25 (56%) reported NMA model choice, 32 (71%) reported framework choice and 32 (71%) reported assumption about heterogeneity variances. Protocols varied in whether they reported methods for relative ranking (35, 78%), statistical inconsistency (40, 89%), reporting bias (44, 98%) and sources of heterogeneity (39, 87%). In conclusion, Cochrane NMA protocols reported multiple NMA-specific items well, but could be further improved, especially regarding transitivity assumptions. Our recommendations for NMA protocol reporting based on this scoping review could assist authors, reviewers, and editors to improve NMA protocols.

Published
2022
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35. Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome

Author

Arlt, Wiebke, Azziz, Ricardo, Balen, Adam, Bedson, Lisa, Berry, Lorna, Boivin, Jacky, Boyle, Jacqueline, Brennan, Leah, Brown, Wendy, Burgert, Tania, Busby, Maureen, Ee, Carolyn, Garad, Rhonda M., Gibson-Helm, Melanie, Harrison, Cheryce, Hart, Roger, Hopkins, Kim, Hirschberg, Angelica Lindén, Ho, Tuong, Hoeger, Kathleen, Jordan, Cailin, Legro, Richard S., Li, Rong, Lujan, Marla, Ma, Ronald, Mansfield, Darren, Marsh, Kate, Mocanu, Edgar, Mol, Ben, Mormon, Rachel, Norman, Robert, Oberfield, Sharon, Patel, Malika, Pattuwage, Loyal, Peña, Alexia, Redman, Leanne, Rombauts, Luk, Romualdi, Daniela, Shah, Duru, Spritzer, Poli Mara, Stener-Victorin, Elisabet, Tehrani, Fahimeh Ramezani, Thangaratinam, Shakila, Thondan, Mala, Vanky, Eszter, Wijeyaratne, Chandrika, Witchel, Selma, Yang, Dongzi, Yildiz, Bulent, Alesi, Simon, Alur-Gupta, Snigdha, Avery, Jodie, Khomami, Mahnaz Bahri, Benham, Jamie, Bidstrup, Hugh, Chua, Su Jen, Cooney, Laura, Coster, Thisara, Fitz, Victoria, Flanagan, Madeline, Forslund, Maria, Jiskoot, Geranne, Kazemi, Maryam, Kempegowda, Punith, Louwers, Yvonne, Melin, Johanna, Melson, Eka, Mengistu, Yitayeh Belsti, Naderpoor, Negar, Neven, Adriana, Pastoor, Hester, Rocha, Thais, Sabag, Angelo, Subramanian, Anuradhaa, Tan, Katrina, Teede, Helena J., Tay, Chau Thien, Laven, Joop, Dokras, Anuja, Moran, Lisa J., Piltonen, Terhi T., Costello, Michael F., M. Redman, Leanne, A. Boyle, Jacqueline, Norman, Robert.J., Mousa, Aya, and Joham, Anju E.

Published
2023
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38. A lifestyle intervention randomized controlled trial in obese women with infertility improved body composition among those who experienced childhood adversity

Author

van Dammen, Lotte, Bush, Nicole R, de Rooij, Susanne, Mol, Ben Willem, Mutsaerts, Meike, van Oers, Anne, Groen, Henk, Hoek, Annemieke, and Roseboom, Tessa

Subjects
Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, Nutrition, Behavioral and Social Science, Pediatric, Prevention, Obesity, Clinical Research, Prevention of disease and conditions, and promotion of well-being, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Metabolic and endocrine, Cardiovascular, Adolescent, Adult, Adverse Childhood Experiences, Body Composition, Body Mass Index, Female, Follow-Up Studies, Humans, Infertility, Female, Life Style, Netherlands, Treatment Outcome, Young Adult, childhood adversity, effectiveness, lifestyle intervention, obesity, Public Health and Health Services, Business and Management, Psychology, Psychiatry, Biomedical and clinical sciences
Abstract

Previous research indicates that tailoring lifestyle interventions to participant characteristics optimizes intervention effectiveness. Our objective was to assess whether the effects of a preconception lifestyle intervention in obese infertile women depended on women's exposure to adversity in childhood. A follow-up of a preconception lifestyle intervention randomized controlled trial (the LIFEstyle study) was conducted in the Netherlands among 577 infertile women (age 18-39 years) with a body mass index (BMI) ≥29 kg/m2 at time of randomization; N = 110 (19%) consented to the follow-up assessment, 6 years later. A 6-month preconception lifestyle intervention aimed weight loss through improving diet and increasing physical activity. The control group received care as usual. Outcome measures included weight, BMI, waist and hip circumference, body fat percentage, blood pressure and metabolic syndrome. The potential moderator, childhood adversity, was assessed with the Life Events Checklist-5 questionnaire. Among the 110 women in our follow-up study, n = 65 (59%) reported no childhood adverse events, n = 28 (25.5%) reported 1 type of childhood adverse events and n = 17 (15.5%) reported ≥2 types of childhood adverse events. Regression models showed significant interactions between childhood adversity and effects of lifestyle intervention at the 6-year follow-up. Among women who experienced childhood adversity, the intervention significantly reduced weight (-10.0 [95% CI -18.5 to -1.5] kg, p = 0.02), BMI (-3.2 [-6.1 to -0.2] kg/m2 , p = 0.04) and body fat percentage (-4.5 [95% CI -7.2 to -1.9] p < 0.01). Among women without childhood adversity, the intervention did not affect these outcomes (2.7 [-3.9 to 9.4] kg, p = 0.42), (0.9 [-1.4 to 3.3] kg/m2 , p = 0.42) and (1.7 [95% CI -0.3 to 3.7] p = 0.10), respectively. Having a history of childhood adversity modified the effect of a preconception lifestyle intervention on women's body composition. If replicated, it may be important to consider childhood adversity as a determinant of lifestyle intervention effectiveness.

Published
2021

41. Childhood adversity and women’s cardiometabolic health in adulthood: associations with health behaviors, psychological distress, mood symptoms, and personality

Author

van Dammen, Lotte, Bush, Nicole R, de Rooij, Susanne R, Mol, Ben Willem J, Groen, Henk, Hoek, Annemieke, and Roseboom, Tessa J

Subjects
Biomedical and Clinical Sciences, Midwifery, Public Health, Health Sciences, Reproductive Medicine, Behavioral and Social Science, Brain Disorders, Obesity, Mental Health, Prevention, Pediatric, Clinical Trials and Supportive Activities, Basic Behavioral and Social Science, Clinical Research, Depression, Aetiology, 2.3 Psychological, social and economic factors, Mental health, Good Health and Well Being, Adult, Adult Survivors of Child Abuse, Affect, Cardiovascular Diseases, Child, Feeding Behavior, Female, Health Behavior, Humans, Life Change Events, Metabolic Diseases, Netherlands, Personality, Sleep, Stress Disorders, Post-Traumatic, Stress, Psychological, Childhood adversity, Cardiometabolic health, Health behaviors, Mental wellbeing, Nursing, Paediatrics and Reproductive Medicine, Public Health and Health Services, Obstetrics & Reproductive Medicine, Reproductive medicine, Public health
Abstract

BackgroundWe tested whether childhood adversity is associated with poor cardiometabolic health in adulthood among a sample of overweight or obese Dutch women of reproductive age. Health behaviors, psychological distress, mood symptoms, or personality traits were included as potential mediators.MethodsData came from a follow-up visit (N = 115), carried out in 2016/2017, of a randomized controlled lifestyle intervention trial in 577 obese infertile women. The associations between total adversity exposure score and cardiometabolic health were tested with regression models. Sleep, smoking and eating behavior, symptoms of depression, anxiety and stress, and personality traits were potential mediators.ResultsChildhood adversity scores were not associated with cardiometabolic outcomes but were associated with poorer sleep quality score (M = 7.2 (SD = 3.5) for those with ≥2 types of events versus 4.8 (2.9) for those with no events; p = 0.022), higher external eating score (26.4 (8.7) versus 21.8 (10.3); p = 0.038), higher perceived stress score (17.1 (6.8) versus 12.3 (4.5); p = 0.016), post-traumatic stress score (1.9 (1.5) versus 0.6 (1.1); p

Published
2019

43. Novel Genetic Risk and Metabolic Signatures of Insulin Signaling and Androgenesis in the Anovulation of Polycystic Ovary Syndrome

Author

Wu, Xiaoke, Wang, Chi Chiu, Cao, Yijuan, Li, Jian, Li, Zhiqiang, Ma, Hongli, Gao, Jingshu, Chang, Hui, Zhang, Duojia, Cong, Jing, Wang, Yu, Wu, Qi, Han, Xiaoxiao, Chung, Pui Wah Jacqueline, Li, Yiran, Zheng, Xu, Chen, Lingxi, Zeng, Lin, Borchert, Astrid, Kuhn, Hartmut, Chen, Zi-Jiang, Ng, Ernest Hung Yu, Stener-Victorin, Elisabet, Zhang, Heping, Legro, Richard S., Mol, Ben Willem J., and Shi, Yongyong

Published
2023
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49. Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial

Author

Ahmed, Amna, Alexander, Hazel, Anderson, Sonal, Arya, Rita, Awadzi, Gabriel, Baumgarten, Miriam, Behrens, Renee, Bingham, Kelly, Bottomley, Cecilia, Bourne, Tom, Cheong, Ying, Chu, Justin, Collins, Frances, Cresswell, Janet, Devarajan, Sangeetha, Durgadevi, Punukollu, Esen, Umo, Faraj, Radwan, Fernandez, Priscilla, Fletcher, Joanne, Galea, Benjamin, Granne, Ingrid, Gupta, Pratima, Hogg, Susannah, Huda, Shahzya, Iyengar, Sucheta, Izuwah-Njoku, Ngozi, Izzat, Feras, Katimada-Annaiah, Thangamma, Khatri, Pinky, King, Kathleen, Kirk, Emma, Kumar, Chitra, Kumar, Geeta, Linsell, Louise, Madhra, Mayank, Madhvani, Krupa, McKay, Rebecca, Memon, Fouzia, Menon, Usha, Mohan, Shruti, Nelson, Scott, Nik, Helena, Nosib, Hema, Oghoetuoma, Jerry, Oliver, Abigail, Pande, Binita, Pathak, Mamta, Peace-Gadsby, Alexandra, Putran, Janaki, Raajkumar, Sundararajah, Raheja, Vinita, Raja, Malar, Raje, Gautam, Rao, Sandhya, Robshaw, Penny, Rodger, Faye, Ross, Jackie, Saleh, Sherif, Sankharan, Sridevi, Sharma, Mona, Sinha, Sanjay, Stewart, Kate, Sutherland, Lauren, Thompson, Rebecca, Tirumuru, Sakunthala, Watson, Nicola, Watson, Sandra, Winters, Ursula, Wykes, Catherine, Horne, Andrew W, Tong, Stephen, Moakes, Catherine A, Middleton, Lee J, Duncan, W Colin, Mol, Ben W, Whitaker, Lucy H R, Jurkovic, Davor, Coomarasamy, Arri, Nunes, Natalie, Holland, Tom, Clarke, Fiona, Doust, Ann M, and Daniels, Jane P

Published
2023
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