[From start to finish - Responsible reporting of clinical trials at Karolinska Institutet]. / Ansvarsfull rapportering av kliniska läkemedelsprövningar.

In the autumn of 2020, Karolinska Institutet (KI) began the process of centralizing the registration and results reporting of clinical pharmaceutical trials. Up until that point, KI had not reported results for any trial in EudraCT, which is required by law. In response, two full-time employees were recruited to contact researchers and provide hands-on support in uploading their results to the portal. As the EudraCT portal can be perceived as non-user friendly, clear guidelines were written, and a webpage developed to make information more accessible. The response from researchers has been positive. However, the shift to centralization has required a considerate amount of work for KI staff. In addition, motivating researchers to upload old trial results is challenging, particularly if they are not responsive or are no longer employed at KI. Therefore, it is crucial to have support from management for investment in long-term solutions. Currently, the results reporting for completed trials at KI has increased from 0% to 61%.

Physical activity in women attending a dissonance-based intervention after Roux-en-Y Gastric Bypass: A 2-year follow-up of a randomized controlled trial.

BACKGROUND: The majority of Roux-en-Y gastric bypass (RYGB) patients are not sufficiently physically active post-surgery, yet little support from the Swedish healthcare system is offered. We investigated if a dissonance-based group intervention, aiming to increase health-related quality of life after surgery, had any effect on patients' physical activity two years post-RYGB. METHODS: Women undergoing RYGB surgery were recruited from five Swedish hospitals and randomized to intervention or control group (standard post-surgery care). The dissonance-based intervention was conducted three months post-RYGB and consisted of four group sessions, each with a specific topic, of which one addressed physical activity. ActiGraph GT3X+ accelerometers were used to measure physical activity at pre-RYGB, one- and two-years post-surgery. RESULTS: At pre-RYGB, 259 women were recruited and randomized (intervention n = 156 and control n = 103). Participants had a mean age of 44.7 years (SD 10.3) and pre-RYGB body mass index of 40.8 (SD 4.5) kg/m2. At two-years follow-up, 99 participants (63.5%) in intervention group and 68 (66.0%) in control group had valid accelerometer-measurements. Pre- to post-surgery increases were seen in all physical activity outcomes, but no statistically significant differences between the groups were observed at the two-years follow-up, and intervention effects were poor (d = 0.02-0.35). CONCLUSION: To our knowledge, this is the first dissonance-based intervention targeting women undergoing RYGB surgery. At two-years follow-up, we did not observe any differences in physical activity levels between the intervention group and control group. Trial registration number: ISRCTN16417174.

Accelerometer-measured versus self-reported physical activity levels in women before and up to 48 months after Roux-en-Y Gastric Bypass.

BACKGROUND: Roux-en-Y Gastric Bypass (RYGB) patients overestimate their time spent in moderate-to-vigorous physical activity (MVPA) to a greater extent post-surgery than pre-surgery. However, there is no data on discrepancy between self-reported and accelerometer-measured MVPA beyond nine months post-RYGB. The aim was to investigate how the duration of MVPA (main outcome) differs when comparing a self-administered questionnaire to accelerometer-data from pre-surgery and up to 48 months post-RYGB. METHODS: Twenty-six (38%) RYGB-treated women with complete data from the original cohort (N = 69) were included. Participants were recruited from five Swedish hospitals. Mean pre-surgery BMI was 38.9 (standard deviation (SD) = 3.4) kg/m2 and mean age 39.9 (SD = 6.5) years. MVPA was subjectively measured by a self-administered questionnaire and objectively measured by the ActiGraph GT3X+ accelerometer at 3 months pre-RYGB and 9- and 48 months post-RYGB. Means and SD were calculated at 3 months pre- and 9- and 48 months post-RYGB. We calculated the P-values of the differences with Wilcoxon Signed-Rank test. For correlations between the self-administered questionnaire and the accelerometers, Spearman's rank correlation was used. RESULTS: Participants significantly overestimated (i.e. self-reported more time spent in MVPA compared to accelerometry) their MVPA in a higher degree post- compared to pre-RYGB surgery. Compared to pre-surgery, self-reported MVPA increased with 46.9 and 36.5% from pre- to 9- and 48 months, respectively, whereas changes were a 6.1% increase and 3.5% decrease with accelerometers. Correlations between self-reported and accelerometer-measured MVPA-assessments were poor at all measurement points (r = 0.21-0.42) and only significant at 48 months post-RYGB (P = 0.032). CONCLUSIONS: The discrepancy between self-reported and objectively assessed MVPA within the same individual is greater up to 48 months post-RYGB compared to before surgery. To help bariatric patients understand and hopefully increase their physical activity behaviors post-surgery, objective measures of physical activity should be used.

One-year follow-up of a dissonance-based intervention on quality of life, wellbeing, and physical activity after Roux-en-Y gastric bypass surgery: a randomized controlled trial.

BACKGROUND: Health-related quality of life (HRQoL) peaks around 1 year after Roux-en-Y gastric bypass (RYGB) surgery, and thereafter, in many patients, slowly deteriorates. OBJECTIVES: The aim of the present study was to test early effects (study endpoint 2 years) of a dissonance-based group intervention on HRQoL (primary outcome) and wellbeing among women who underwent RYGB: a 1-year follow-up of the WELL-GBP trial. SETTING: Women were recruited from 5 different hospitals in Sweden pre-RYGB surgery. Participants were randomized to intervention or a control group (regular care). METHODS: The intervention consisted of 4 group sessions, 2 to 3 months post-surgery, comprising the following 4 different topics: (1) physical activity, (2) eating behavior, (3) social relationships, and (4) intimate relationships. Participants answered questionnaires about HRQoL (SF-36, Short-Form Health Survey), social adjustment, body esteem, eating behavior, and wore an accelerometer for 7 days at pre- and 1 year post-RYGB. RESULTS: Two hundred fifty-nine women were recruited and 203 (78%) completed 1-year follow-up measurements. Mean body mass index pre-surgery was 40.8 (standard deviation = 4.5), mean age 44.7 (standard deviation = 10.3) years, and 61 of 120 women in the intervention group received the intervention according to protocol (≥3 group sessions). We observed no difference between the intervention and the control group at 1-year post-RYGB surgery. All scales improved in both groups from pre- to 1 year post-surgery. CONCLUSIONS: We did not observe any 1-year early effects on HRQoL from a dissonance-based group intervention among female RYGB patients. Future studies may investigate long-term effects of the intervention.

To be or not to be active - a matter of attitudes and social support? Women's perceptions of physical activity five years after Roux-en-Y Gastric Bypass surgery.

PURPOSE: Despite positive health advantages of post-surgery physical activity (PA) for bariatric surgery patients, the majority is not sufficiently physically active. The aim was to explore women's perceptions and experiences concerning PA five years after Roux-en-Y Gastric Bypass (RYGB) surgery. METHODS: Eleven women were interviewed five years post-surgery. Grounded Theory approach was applied. RESULTS: The core-category "Attitudes and surrounding environment influence activity levels" includes three attitudes towards PA: "Positive attitudes", "Shifting attitudes" and "Negative attitudes". Participants with a positive attitude were regularly physically active, felt supported and proud of their achievements. Contrary, participants with a negative attitude didn't prioritize PA, didn't feel supported and saw no need or benefit of PA. Some participants revealed an on-off behaviour, hovering between the attitudes of vigorous PA and sedentary lifestyle, without sustainable balance. The majority mostly viewed PA as a mean to lose weight. CONCLUSION: The level of perceived post-surgery PA was related to the participants' attitudes towards PA and whether or not they had a supportive environment. These findings might explain why bariatric surgery patients often fail to be sufficiently active post-surgery, and highlight the need for prolonged support and motivational interventions to promote sustainable PA post-bariatric surgery.

Meeting physical activity recommendations is associated with health-related quality of life in women before and after Roux-en-Y gastric bypass surgery.

PURPOSE: Meeting physical activity (PA) recommendations is positively associated with health-related quality of life (HRQoL), but it is still unclear whether PA (specifically objectively measured) is associated with HRQoL in bariatric surgery candidates, both before and after surgery. Thus, the aim of this study was to examine the cross-sectional association between meeting objectively measured PA recommendations and HRQoL before and after Roux-en-Y gastric bypass (RYGB) surgery. METHODS: Sixty-six women undergoing RYGB with pre-surgery and 62 women with post-surgery valid PA and HRQoL data were included from the control group of a RCT study aiming at improving HRQoL and PA post-RYGB surgery. Measures before and 12 months after RYGB included the Short Form Health Survey (SF-36) and objectively measured PA, sedentary time (ST), and step counts with GT3X+ accelerometers. Multiple linear regression models were used to analyze the associations between PA and HRQoL. RESULTS: Participants who engaged in more than 150 min of moderate to vigorous PA (MVPA)/week (PA recommendations) had considerably higher SF-36 scores (HRQoL) than those who did not, both pre and 12-month post-surgery, with greatest difference in the subscale bodily pain, 15.5 (p = 0.021) higher score (higher scores means less pain) pre-surgery and a 19.7 (p = 0.004) higher score post-surgery. Higher LPA and step counts and lower ST also showed positive associations in some of the subscales of SF-36. CONCLUSIONS: Meeting the PA recommendations and overall engaging in more PA was associated with higher HRQoL, pre-, and post-RYGB surgery, highlighting the importance of PA both pre- and post-surgery.

A dissonance-based intervention for women post roux-en-Y gastric bypass surgery aiming at improving quality of life and physical activity 24 months after surgery: study protocol for a randomized controlled trial.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) surgery is the most common bariatric procedure in Sweden and results in substantial weight loss. Approximately one year post-surgery weight regain for these patient are common, followed by a decrease in health related quality of life (HRQoL) and physical activity (PA). Our aim is to investigate the effects of a dissonance-based intervention on HRQoL, PA and other health-related behaviors in female RYGB patients 24 months after surgery. We are not aware of any previous RCT that has investigated the effects of a similar intervention targeting health behaviors after RYGB. METHODS: The ongoing RCT, the "WELL-GBP"-trial (wellbeing after gastric bypass), is a dissonance-based intervention for female RYGB patients conducted at five hospitals in Sweden. The participants are randomized to either control group receiving usual follow-up care, or to receive an intervention consisting of four group sessions three months post-surgery during which a modified version of the Stice dissonance-based intervention model is used. The sessions are held at the hospitals, and topics discussed are PA, eating behavior, social and intimate relationships. All participants are asked to complete questionnaires measuring HRQoL and other health-related behaviors and wear an accelerometer for seven days before surgery and at six months, one year and two years after surgery. The intention to treat and per protocol analysis will focus on differences between the intervention and control group from pre-surgery assessments to follow-up assessments at 24 months after RYGB. Patients' baseline characteristics are presented in this protocol paper. DISCUSSION: A total of 259 RYGB female patients has been enrolled in the "WELL-GBP"-trial, of which 156 women have been randomized to receive the intervention and 103 women to control group. The trial is conducted within a Swedish health care setting where female RYGB patients from diverse geographical areas are represented. Our results may, therefore, be representative for female RYGB patients in the country as a whole. If the intervention is effective, implementation within the Swedish health care system is possible within the near future. TRIAL REGISTRATION: The trial was registered on February 23th 2015 with registration number ISRCTN16417174 .