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A considerable number of pregnant women experience fear of childbirth (FOC), characterized by worries and fear of the unpredictable. Despite this, the psychological processes in FOC have received notably little attention. The aim of this study was to advance the understanding by exploring the applicability of the Intolerance of Uncertainty (IU) model on FOC. Anonymous data was collected in a sample of pregnant women (N = 357) with varying levels of FOC. Analyses supported the associations between FOC and all proposed psychological processes: IU, negative problem orientation, positive beliefs about worry and avoidance of inner experiences. The exploration of potential mediators of the relation between IU and FOC revealed that, of the three processes from the model, only positive beliefs about worry were a mediator, and more specifically, a partial mediator between IU and FOC. These findings add to the theoretical understanding of FOC, by indicating that the role of IU may be similar to other conditions inflicted by worry and anxiety, which may inform treatment development. © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

In both pain research and clinical practice, patient-reported outcome measures are used to assess dimensions of health. Interpreting these instruments requires understanding their measurement error and what magnitude of change has subjective importance for patients. This study estimated the standard error of measurement (SEM), one-year minimal detectable change, and one-year minimal clinically important difference (MCID) for the Short Form-36 Health Survey physical component summary (SF-36 PCS) and mental (SF36 MCS), the Hospital Anxiety and Depression Scale anxiety symptoms (HADS-A) and depression symptoms (HADS-D) subscales, and the Numeric Rating Scale (NRS) for past-week average pain intensity. MCIDs for these instruments have not previously been estimated in a large sample of chronic pain patients participating in interdisciplinary pain rehabilitation. Data were drawn from the Swedish Quality Registry for Pain Rehabilitation (n=8854 patients). MCID was estimated as average change and change difference, based on three different anchors. MCID estimates were 2.62-4.69 for SF-36 PCS, 4.46-6.79 for SF-36 MCS, 0.895-1.48 for NRS, 1.17-2.13 for HADS-A, and 1.48-2.54 for HADS-D. The common assumption of an identical SEM for pre- and post-treatment measurements was not always applicable. When estimating MCID, researchers should select an estimation method and anchor aligned with the study's context and objectives.

PERSPECTIVE: This article presents estimates of minimal clinically important difference and minimal detectable change for several commonly used patient-reported outcome measures among patients with chronic pain. These estimates can help clinicians and researchers to determine when a measured health improvement is subjectively important to the patient and greater than measurement error.

DATA AVAILABILITY: Data Availability Statement: The data utilized in this study are not available due to ethical considerations and the need for appropriate ethical approval.

BACKGROUND: Modelling and analysing repeated measures data, such as women's experiences of pain during labour, is a complex topic. Traditional end-point analyses such as t-tests, ANOVA, or repeated measures [rANOVA] have known disadvantages. Modern and more sophisticated statistical methods such as mixed effect models provide flexibility and are more likely to draw correct conclusions from data. The aim of this study is to study how labour pain is analysed in repeated measures design studies, and to increase awareness of when and why modern statistical methods are suitable with the aim of encouraging their use in preference of traditional methods.

METHODS: Six databases were searched with the English language as a restriction. Study eligibility criteria included: Original studies published between 1999 and 2016, studying pregnant women in labour with the aim to compare at least two methods for labour pain management, with at least two measurements of labour pain separated by time, and where labour pain was analysed. After deduplication, all records (n = 2800) were screened by one of the authors who excluded ineligible publication types, leaving 737 records remaining for full-text screening. A sample of 309 studies was then randomly selected and screened by both authors.

RESULTS: Among the 133 (of 309) studies that fulfilled the study eligibility criteria, 7% used mixed effect models, 20% rANOVA, and 73% used end-point analysis to draw conclusions regarding treatment effects for labour pain between groups. The most commonly used end-point analyses to compare groups regarding labour pain were t-tests (57, 43%) and ANOVA (41, 31%). We present a checklist for clinicians to clarify when mixed effect models should be considered as the preferred choice for analysis, in particular when labour pain is measured.

CONCLUSIONS: Studies that aim to compare methods for labour pain management often use inappropriate statistical methods, and inaccurately report how the statistical analyses were carried out. The statistical methods used in analyses are often based on assumptions that are not fulfilled or described. We recommend that authors, reviewers, and editors pay greater attention to the analysis when designing and publishing studies evaluating methods for pain relief during labour.

Background: Functional bowel and bladder disorders are prevalent among children. The impact of assisted infant toilet training on the prevalence of childhood bowel and bladder disorders has not previously been investigated. As self-reported bowel and bladder symptoms can be unreliable, robust tools are essential to evaluate interventions. The ROME Foundation offers diagnostic criteria for functional gastrointestinal disorders, while the International Children's Continence Society (ICCS) provides definitions for functional bladder disorders. Our research group has launched the BABITT study, a two-armed intervention study to investigate whether assisted infant toilet training reduces the prevalence of functional bowel and bladder disorders.

Aim: To construct a questionnaire, assessing bowel and bladder function in children introduced to infant toilet training and to evaluate content validity as well as feasibility.

Methods: In three consecutive steps, a web-based questionnaire was developed. In Step 1, the questionnaire was outlined based on literature review and consensus panel discussions. In Step 2, the questionnaire was validated regarding relevance and simplicity by the content validity index (CVI) method. In Step 3, a pilot phase allowed for assessment of feasibility in the clinical study setting.

Results: In Step 1, the Rome criteria and ICCS frameworks were selected for primary outcomes. After the final assessment round in Step 2, the i-CVI ranged from 0.88-1.00 in most items, in all domains, for both relevance and simplicity. Generally lower scores on simplicity emphasized revisions of this aspect of the items. In the pilot phase Step 3, respondent burden was analysed and feasibility assessed. The response rate at the 2-months questionnaire was 95% and acceptability of the intervention was satisfactory.

Conclusion: A web- based questionnaire for assessment of parent-reported bladder and bowel function in children who are introduced to infant toilet training was developed. The questionnaire emerged as valid and feasible in its context.

BACKGROUND: Interdisciplinary treatment (IDT) is an internationally recommended intervention for chronic pain, despite inconclusive evidence of its effects on sickness absence.

METHODS: With data from 25,613 patients in Swedish specialist healthcare, we compared sickness absence, in the form of both sick leave and disability pensions, over a 5-year period between patients either allocated to an IDT programme or to other/no interventions (controls). To obtain population-average estimates, a Markov multistate model with theory-based inverse probability weights was used to compute both the proportion of patients on sickness absence and the total sickness absence duration.

RESULTS: IDT patients were more likely than controls to receive sickness absence benefits at any given time (baseline: 49% vs. 46%; 5-year follow-up: 36% vs. 35%), and thereby also had a higher total duration, with a mean (95% CI) of 67 (87, 48) more days than controls over the 5-year period. Intriguingly, sick leave was higher in IDT patients (563 [552, 573] vs. 478 [466, 490] days), whereas disability pension was higher in controls (152 [144, 160] vs. 169 [161, 178] days).

CONCLUSION: Although sickness absence decreased over the study period in both IDT patients and controls, we found no support for IDT decreasing sickness absence more than other/no interventions in chronic pain patients.

SIGNIFICANCE: In this large study of chronic pain patients in specialist healthcare, sickness absence is compared over a 5-year period between patients in an interdisciplinary treatment programme and other/no interventions. Sickness absence decreased over the study period in bothgroups; however, there was no support forthat it decreased more with interdisciplinary treatment than alternative interventions.

Chronic pain-related sickness absence is an enormous socioeconomic burden globally. Optimized interventions are reliant on a lucid understanding of the distribution of social insurance benefits and their predictors. This register-based observational study analyzed data for a seven-year period from a population-based sample of 44,241 chronic pain patients eligible for interdisciplinary treatment (IDT) at specialist clinics. Sequence analysis was used to describe the sickness absence over the complete period and to separate the patients into subgroups based on their social insurance benefits over the final two years. The predictive performance of features from various domains was then explored with machine learning-based modeling in a nested cross-validation procedure. Our results showed that patients on sickness absence increased from 17% five years before to 48% at the time of the IDT assessment, and then decreased to 38% at the end of follow-up. Patients were divided into three classes characterized by low sickness absence, sick leave, and disability pension, with eight predictors of class membership being identified. Sickness absence history was the strongest predictor of future sickness absence, while other predictors included a 2008 policy, age, confidence in recovery, and geographical location. Information on these features could guide personalized intervention in the specialized healthcare. PERSPECTIVE: This study describes sickness absence in patients who visited a Swedish pain specialist interdisciplinary treatment clinic during the period 2005-2016. Predictors of future sickness absence are also identified that should be considered when adapting IDT programs to the patient's needs.

Recent research has highlighted a need for the psychometric evaluation of instruments targeting core domains of the pain experience in chronic pain populations. In this study, the measurement properties of SF-36, EQ-5D, and HADS were analyzed within the item response-theory framework based on data from 35,908 patients. To assess the structural validity of these instruments, the empirical representations of several conceptually substantiated latent structures were compared in a cross-validation procedure. The most structurally sound representations were selected from each questionnaire and their internal consistency reliability computed as a summary of their precision. Lastly, questionnaire scores were correlated to each other to evaluate their convergent and discriminant validity. Our results supported that SF-36 is an acceptable measure of two independent constructs of physical and mental health. In contrast, although the approach to summarize the HRQoL construct of EQ-5D as a unidimensional score was valid, its low reliability rendered practical model implementation of doubtful utility. Finally, rather than being separated into two subscales of anxiety and depression, HADS was a valid and reliable measure of overall emotional distress. In support of convergent and discriminant validity, correlations between questionnaires showed that theoretically similar traits were highly associated whereas unrelated traits were not. Our models can be applied to score SF-36 and HADS in chronic pain patients, but we recommend against using the EQ-5D model due to its low reliability. These results are useful for researchers and clinicians involved in chronic pain populations, as questionnaires' properties determine their discriminating ability in patient status assessment.

Objectives This study aimed to evaluate the long-term impact (3-year follow-up) of a culturally tailored parenting support programme (Ladnaan) on the mental health of Somali-born parents and their children living in Sweden. Methods In this longitudinal cohort study, Somali-born parents with children aged 11-16 were followed up 3 years after they had participated in the Ladnaan intervention. The Ladnaan intervention comprises two main components: societal information and the Connect parenting programme delivered using a culturally sensitive approach. It consists of 12 weekly group-based sessions each lasting 1-2 hours. The primary outcome was improved mental health in children, as measured by the Child Behaviour Checklist (CBCL). The secondary outcome was improved mental health in parents, as measured by the General Health Questionnaire-12. Data were collected from the parent's perspective. Results Of the 60 parents who were originally offered the intervention, 51 were included in this long-term follow-up. The one-way repeated measures (baseline to the 3-year follow-up) analysis of variance for the CBCL confirmed maintenance of all the treatment gains for children: total problem scores (95% CI 11.49 to 18.00, d=1.57), and externalising problems (95% CI 2.48 to 5.83, d=0.86). Similar results were observed for the parents' mental health (95% CI 0.40 to 3.11, d=0.46). Conclusion Positive changes in the mental health of Somali-born parents and their children were maintained 3 years after they had participated in a parenting support programme that was culturally tailored and specifically designed to address their needs. Our findings highlight the long-term potential benefits of these programmes in tackling mental health issues in immigrant families.

Background

Patients with chronic pain often struggle to engage in physical activity despite its health benefits. The eVISualisation of physical activity and pain intervention (eVIS) was developed to support adherence to physical activity plans in Interdisciplinary Pain Rehabilitation Programs (IPRPs) by visualising activity, pain levels, pain interference, and pharmacological use. This pilot study assesses the feasibility and acceptability of trial design and trial conduct of a registry-based randomised clinical trial (R-RCT).

Method

This randomised clinical pilot study included the first 10% (n = 39, mean age 43.5, 74.4% females) of the R-RCT sample (n≈400). Participants with non-cancer chronic pain from six IPRP units were randomly assigned to either the intervention group (IPRP + eVIS, n = 19) or the control group (IPRP, n = 20). Feasibility and acceptability were evaluated using pre-defined criteria on recruitment- and data collection procedures (e.g., inclusion rates, representativeness, adverse events), physiotherapists’ ratings of trial design and conduct (e.g., acceptability, feasibility), and outcome data characteristics and completeness (e.g., adherence, data accessibility).

Results

Recruitment was largely feasible, though attrition differences and the need for refined eligibility screening were noted. Physiotherapists cited time and implementation challenges. Both groups had satisfactory data completeness, but the control group showed lower adherence to daily reporting in the final third of the study. The intervention group had greater improvements in physical health, with 19.5% more participants achieving the minimum clinically important difference (≥3) on the physical component summary scale (PCS). No adverse events occurred.

Conclusion

With minor adjustments, the R-RCT design is mostly feasible, though some challenges to feasibility were identified and addressed.

Background and aims: *Low physical health is one consequence that chronic pain encompasses. To improveeffectiveness of Interdisciplinary pain rehabilitation programs (IPRP) theeVISualisation of physical activity and pain (eVIS) intervention was developed. Thepurpose of this study was to evaluate eVIS validity by the aspects of content validityand clinical feasibility in IPRP-context.Methods: *This observational study was performed in 3 phases. Twenty-two field experts (patients,caregivers, researchers) participated, and provided quantitative scores and qualitativecomments on eVIS and its included elements (data collection, visualization,communication). In phase 1, ratings on a four-point Likert scale of each element´scontent validity (relevance, simplicity, safety) were collected through digitalquestionnaires. Three iterative assessment loops were completed, each followed byconsensus panel protocol revisions. Item-level content validity index (I-CVI), averageand overall CVI were calculated, and free-text comments were analyzed. In phase 2,ratings of content validity and elements’ clinical feasibility categorized in 5 focus areas(acceptability, demand, implementation, limited efficacy, practicality), were collectedfrom patients and caregivers after 2-3 weeks test trial. Phase 3 involved follow-up focusgroup interview with caregivers on specific ratings, as well as interviews with expertsin clinical pain management pharmacology.Results: *CVI for relevance, simplicity and safety improved over time and were all rated abovecut-off (0.78). Revisions were mainly made in the visualization element. In phase 2,participants rated eVIS as relevant and feasible to use in clinical IPRP-context.Conclusions: *Patients, caregivers, and researchers found eVIS valid in IPRP-context. Methodicalvalidation was essential to ascertain eVIS’ substantiality before clinical trial.

Background and aims: * Interdisciplinary Pain Rehabilitation Programs (IPRPs) are considered to be superior to single-treatment measures in chronic pain treatment. However, the effects of IPRPs are moderate and as many as 30% of patients deteriorate in some outcomes. Although physical activity and exercise are central components in IPRPs, many patients struggle to achieve and maintain the recommended levels. An intervention, entitled eVISualisation of physical activity and pain (eVIS), has now been systematically developed and designed to facilitate patients with chronic pain in achieving and maintaining recommended physical activity levels. The aim of the present study protocol is to transparently report on the methodology, outcomes, and processes for an initiated registry-based randomized controlled trial (R-RCT), which will evaluate the effectiveness of eVIS on the primary outcome physical health and defined secondary outcomes. Methods: * Participants (approximately 400) will be recruited from IPRP units and randomly allocated to either IPRP with an addition of eVIS or to treatment as usual by IPRP. eVIS entails objectively measured physical activity and patient-reported outcomes of pain intensity, effect on daily activities and pharmaceutical consumption. Data is collected and visualized in a web application, PATRON. Pilot analyses evaluating the feasibility of the R-RCT will be performed on data from initial 30 participants. Outcomes will be extracted from PATRON and from six national registries. Multivariate statistics and repeated measures analyses will be performed. Results: * Recruitment will be initiated in late 2021. ClinicalTrials.gov identifier: NCT05009459. Conclusions: * This study protocol describes a R-RCT that is designed to provide robust data on the feasibility and effectiveness of eVIS as an addition to IPRPs.

Introduction Living with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programmes (IPRP) is considered superior to single-treatment measures in patients with chronic pain. Despite this, effects emerge suboptimal and more than 20% of patients deteriorate in patientreported physical health outcomes after IPRP. A novel e-Health intervention, eVISualisation (eVIS) of physical activity and pain, was systematically developed to facilitate individualisation of physical activity levels. By adding elements of data collection, visualisation and communication of objectively measured physical activity and patient-reported outcomes (pain intensity, interference of pain, pharmaceutical consumption) to existing treatment modalities in IPRP, the IPRP team acquires prerequisites to adapt advice and physical activity prescriptions and to evaluate set activity goals. The overall aim is two fold. First, the aim is to evaluate the feasibility of the subsequent registry-based randomised controlled clinical trial (R-RCT). Second, the aim is to prospectively evaluate the effectiveness of the eVISintervention as a supplement to IPRP on our defined primary (physical health) and secondary outcomes.

Methods and analysis In the R-RCT, recruitment of 400 patients with chronic pain will be performed at 15 IPRP units. A random allocation to either IPRP + eVIS or to control group that will receive IPRP only will be performed. Data from the initial 30 participants completing the study period (6 months) will be included in a pilot study, where key feasibility outcomes (recruitment, randomisation, implementation, treatment integrity, data collection procedure, preliminary outcome measures) will be evaluated. Outcome variables will be extracted from the web application Pain And TRaining ON-line (PATRON) and from six national registries. Multivariate statistics and repeated measure analyses will be performed. Quality-adjusted life years and incremental cost-effectiveness ratio will be calculated for cost-effectiveness evaluation.

Ethics/dissemination The Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-reviewed journals.

Trial registration number NCT05009459. Protocol V.1

Chronic pain is a leading cause of disability globally. Interdisciplinary multimodal pain rehabilitation (IMPR) targets pain with a bio-psycho-social approach, often delivered as composite programs. However, evidence of optimal program duration for the rehabilitation to succeed remains scarce. This study evaluated the effectiveness of different duration IMPR-programs-using within- and between-effects analyses in a pragmatic multicenter register-based controlled design. Using the Swedish Quality Registry for Pain Rehabilitation, data from fifteen clinics specialized in chronic pain rehabilitation across Sweden were retrieved. Participants were patients with chronic musculoskeletal pain who had taken part in short (4-9 weeks; n = 924), moderate (10 weeks; n = 1379), or long (11-18 weeks; n = 395) IMPR programs. Longitudinal patient-reported outcome data were assessed at baseline, post-intervention, and at a 12-month follow-up. Primary outcomes were health-related quality of life, presented as perceived physical and mental health (SF-36). Secondary outcomes included the Hospital Anxiety and Depression Scale (HADS), pain intensity (NRS 0-10), the Multidimensional Pain Inventory (MPI), and perceived health (EQ-5D). Overall, all groups showed improvements. No clinically important effect emerged for different duration IMPR. In conclusion, while our results showed that patients following IMPR report improvement across a bio-psycho-social specter, a longer program duration was no more effective than a shorter one.

BACKGROUND: When establishing Physical Employment Standards, validity is dependent on the correct identification and characterisation of critical job tasks.

OBJECTIVE: To develop and validate a standardised protocol for the identification, characterisation, and documentation of critical physical job tasks in military occupational specialities in the Swedish Armed Forces (SwAF), and propose a definition of critical physical job tasks for use in the SwAF.

METHODS: A protocol was drafted with three content domains, including a preliminary definition. Protocol content validity was iteratively assessed in two consecutive stages where ten subject experts rated relevance and simplicity. A consensus panel revised the protocol after each stage. Content validity index (CVI) was calculated as item-CVI (I-CVI) per each feature and as scale average (S-CVI/Ave) per content domain. Acceptable content validity thresholds were 0.78 and 0.90, respectively.

RESULTS: The validated protocol consisted of 35 items with an I-CVI≥0.90 and≥0.80 for relevance and simplicity, respectively. The S-CVI/Ave was 0.97 for relevance and 0.98 for simplicity. The protocol was language reviewed, reorganised for easy use, and approved by the consensus panel. The final protocol includes: background and aim of the protocol, the accepted generic and critical physical job task definitions, protocol instructions, subject expert-qualifications, job task source and characteristics.

CONCLUSION: A standardised protocol for identification and characterisation of critical job tasks in SwAF military occupational specialties was developed. The protocol content was rated relevant and simple by experts and will be of importance in future work establishing physical requirements in the SwAF.

OBJECTIVE: To investigate prognostic factors for physical and emotional functioning following interdisciplinary multimodal pain rehabilitation, by targeting patients' baseline characteristics and health measures.

METHODS: A prospective cohort of 2,876 patients from 38 specialist clinics across Sweden, who were completing interdisciplinary multimodal pain rehabilitation programmes, was followed through the Swedish Quality Registry for Pain Rehabilitation, from initial assessment to 12-month follow-up. Using logistic regression, baseline data were regressed to predict improvement in Physical functioning and Emotional functioning, fused by principal component analyses using the 36-item Short Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS).

RESULTS: Employment status emerged as having the largest effect sizes in both Physical functioning and Emotional functioning; Working: odds ratio (OR) 2.05 (95% confidence interval (95% CI) 1.64-2.56) and OR 1.59 (95% CI 1.27-1.98), respectively. Strong beliefs in restored health, better initial emotional health, lower levels of pain and pain interference, and younger age all predicted Physical functioning. European origin, higher levels of general activity, and sense of life control all predicted Emotional functioning. Worse initial physical and emotional health predicted the corresponding dependent outcomes.

CONCLUSION: Employment was consistently found to be an important prognostic factor, suggesting the significance of avoiding delay in interdisciplinary multimodal pain rehabilitation. A positive treatment expectancy was of importance. In general, multidimensional measures indicated that better initial status was more favourable; however, inconsistency implies a complex prognostic picture.

INTRODUCTION: Chronic musculoskeletal pain (CMSP) severely affects the individual's quality of life, functioning and ability to work, and comes with significant societal costs for sick leave and productivity loss. After rehabilitation, patients with CMSP often experience lack of support when responsibility for the return-to-work process is taken over by the employer. Therefore, we aim to evaluate the effectiveness of a digital support (Sustainable WorkEr digital support for Persons with chronic Pain and their Employers (SWEPPE)) for promoting a sustainable return-to-work for persons with CMSP and to facilitate the employers' supportive role and responsibilities in the process.

METHODS AND ANALYSIS: In this registry-based multicentre randomised controlled trial, 360 patients with CMSP will be randomised to either receive the smartphone application SWEPPE (n=180) or to a control group (n=180). The intervention group will use SWEPPE for 1 year and the control group will not receive any intervention for return to work (RTW). Participants will be recruited from approximately 10 specialist and primary care level units connected to the Swedish National Quality Registry for Pain Rehabilitation providing Interdisciplinary Pain Rehabilitation Programmes (IPRP) for CMSP. Eligibility criteria are age 18-65 years and a need for support in RTW or continued support at work for creating a sustainable work situation. Baseline data will be collected when the participants have completed the IPRP. Final assessment will be performed after 12 months. The primary outcome will be a number of days with sickness cash benefit. Secondary outcomes and explanatory variables including important domains affected by CMSP such as health-related quality of life, functioning and work ability will be collected.

ETHICS AND DISSEMINATION: The Swedish Ethics Review Board approved the study (Dnr 2020-01593, Dnr 2021-01854). The study findings will be disseminated through publication, national and international conferences, and meetings to be available for patients, healthcare providers or stakeholders.

TRIAL REGISTRATION NUMBER: NCT05058547.

Background: Acupuncture involves puncturing the skin with thin sterile needles at defined acupuncture points. Previous studies are inconclusive regarding the effect of acupuncture on labour pain, but some studies have found a reduction in the use of pharmacological pain relief when acupuncture is administered. The appropriate dose of acupuncture treatment required to elicit a potential effect on labour pain has not been fully explored. The dose is determined by many different factors, including the number of needles used and the intensity of the stimulation. In Sweden, manual stimulation of the needles is common practice when acupuncture is used for labour pain, but electrical stimulation of the needles, which gives a higher dose, could possibly be more effective. The overall aim of this thesis was to evaluate the effectiveness of acupuncture with manual stimulation (MA) of the needles as well as acupuncture with a combination of manual and electrical stimulation (EA) in reducing labour pain, compared with standard care without any form of acupuncture (SC).

Methods: The study was designed as a three-armed randomised controlled trial in which 303 nulliparous women with normal pregnancies were randomised to MA, EA, or SC. The primary outcome was labour pain, assessed using the Visual Analogue Scale (VAS). Secondary outcomes were relaxation during labour, use of obstetric pain relief, and associations between maternal characteristics and labour pain and use of epidural analgesia respectively. Also, labour and infant outcomes, recollection of labour pain, and maternal experiences, such as birth experience and experience of the midwife, were investigated two months after the birth. The sample size calculation was based on the potential to discover a difference of 15 mm on the VAS. Data were collected during labour before the interventions, the day after birth, and two months later. Besides using the VAS, information was collected by means of study specific protocol, questionnaires and medical records.

Results: The mean VAS scores were 66.4 in the MA group, 68.5 in the EA group, and 69.0 in the SC group (mean differences: MA vs. SC 2.6 95% CI -1.7 to 6.9, and EA vs. SC 0.6 95% CI -3.6 to 4.8). Other methods of pain relief were used less frequently in the EA group, including epidural analgesia, MA 61.4%, EA 46%, and SC 69.9%. (EA vs. SC OR 0.4 95% CI 0.2 to 0.7). No statistically significant differences were found in the recollection of labour pain between the three groups two months after birth (mean VAS score: MA 69.3, EA 68.7 and SC 70.1). A few maternal characteristics were associated with labour pain (age, dysmenorrhea, and cervix dilatation), but none of the investigated characteristics predicted the outcome of the acupuncture treatment in MA or EA. Women in the EA group experienced acupuncture as being effective for labour pain to a higher extent than women who received MA, MA 44.4%, EA 67.1% (EA vs. MA OR 2.4 95% CI 1.2 to 4.8). Women in the EA group also spent less time in labour (mean 500 min) than those who received MA (mean 619 min) and SC (mean 615 min) (EA vs. MA HR 1.4 95% CI 1.0 to1.9, EA vs. SC HR 1.4, 95% CI 1.1 to 2.0), and had less blood loss than women receiving SC, (EA vs. SC OR 0.1 95% CI 0.3 to 0.7). The women’s assessment of the midwife as being supportive during labour (MA 77.2%, EA 83.5%, SC 80%), overall satisfaction with midwife care (MA 100%, EA 97.5%, SC 98.7%), and having an overall positive childbirth experience (MA 64.6%, EA 61.0%, SC 54.3%) did not differ statistically. No serious side effects of the acupuncture treatment were reported.

Conclusion: Acupuncture, regardless of type of stimulation, did not differ from standard care without acupuncture in terms of reducing women’s experience of pain during labour, or their memory of pain and childbirth overall two months after the birth. However, other forms of obstetric pain relief were less frequent in women receiving a combination of manual and electrical stimulation, suggesting that this method could facilitate coping with labour pain.

Background Acupuncture using manual stimulation (MA) of the needles is commonly used to reduce labour pain despite contradictory results from studies of its effectiveness. A combination of manual and electrical stimulation (EA) could reduce labour pain more effectively than MA alone, by a higher treatment intensity.The aim was to evaluate the effectiveness of MA and EA compared with standard care without any acupuncture (SC) in reducing labour pain. Our hypothesis was that both acupuncture stimulation techniques were more effective than SC, and that EA was the most effective.

Methods

Nulliparous women (n=303) with a normal pregnancy were equally randomized to three groups receiving 40 minutes of either MA, EA or to SC. The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals.

The primary outcome was women’s assessment of labour pain; before and after the first treatment, every 30 minutes for five hours, and thereafter every hour until birth, or until epidural analgesia was administered. For the primary outcome, a linear mixed model for repeated measures was performed to investigate associations between treatment (MA, EA, SC) and pain scores on VAS over time. A difference of 15 mm on the visual analogue scale (VAS) was regarded as clinically relevant, and this required 41 women per group, and compensating for dropouts, in total 101 women in each group.

Data on the primary outcome were obtained from 253 women: MA n=83, EA n=87, and SC n=83.

Results

Primary outcome:

Mean estimated pain scores on VAS (SC: 69.0, MA: 66.4 and EA: 68.5), adjusted for: treatment, age, education, and time from baseline, with no interactions did not differ between the groups (SC vs MA: mean difference 2.6, 95 % confidence interval [CI] -1.7-6.9 and SC vs EA: mean difference 0.6 [95%CI] -3.6-4.8).

Secondary outcomes:

Use of epidural analgesia: MA 61%, EA 46%, SC 70%. EA vs SC: odds ratio (OR) 0.35; (95% CI) 0.19-0.67.

EA vs MA: OR 0.57 (95% CI) 0.31-1.06.

Duration of labour (min): MA 619, EA 500, SC 615. EA vs SC: Hazard Ratio (HR) 1.44; (95% CI) 1.06-1.97. EA vs MA: HR 1.41; (95% CI) 1.03-1.91.

Sufficient pain relief (day after partus): MA 77%, EA 81%, SC 74% (ns).

Positive experience of the midwife (day after partus): MA 100%, EA 97.5%, and SC 98.7% (ns).

Support from the midwife to a high extent (day after partus): MA 77.2%, EA 83.5%, and SC 80% (ns).

Conclusions

Acupuncture does not reduce women’s experience of labour pain, however, women receiving a combination of manual and electro-acupuncture (EA) used less additional pain relief, including epidural analgesia, and had shorter labour than women in the standard care group (SC). Despite the lower use of other pain relief, a majority of the women who used EA were equally satisfied with their pain relief as the women receiving manual acupuncture alone (MA) or SC. They were also equally satisfied with the support from the midwife.

Background Patient characteristics are modulators of pain experience after acupuncture treatment for chronic pain. Whether this also applies to labour pain is unknown.

Aim To examine for associations between maternal characteristics and response to acupuncture in terms of labour pain intensity in close proximity to the treatment (within 60 min) and over a longer time period (up to 240 min), and whether or not epidural analgesia is used, before and after adjustment for obstetric status upon admission to the labour ward.

Methods Cohort study (n=253) using data collected for a randomised controlled trial. Associations were examined using linear mixed models and logistic regression analyses. Tests of interactions were also applied to investigate whether maternal characteristics were influenced by treatment group allocation.

Results In close proximity to the treatment, advanced age and cervical dilation were associated with lower pain scores (mean difference (MD) −13.2, 95% CI −23.4 to −2.9; and MD −5.0, 95% CI −9.6 to −0.5, respectively). For the longer time period, labour pain was negatively associated with age (MD −11.8, 95% CI −19.6 to −3.9) and positively associated with dysmenorrhoea (MD 5.5, 95% CI 1.6 to 9.5). Previous acupuncture experience and advanced cervical dilatation were associated with higher and lower use of epidural analgesia (OR 2.7, 95% CI 1.3 to 5.9; and OR 0.3, 95% CI 0.1 to 0.5, respectively). No interactions with treatment allocation were found.

Conclusions This study did not identify any maternal characteristics associated with women's responses to acupuncture during labour.

Trial registration number NCT01197950; Post-results.

Introduction: Results from previous acupuncture studies for labour pain are contradictory and lack important information on methodology. The sample sizes are in general small, information about the intervention such as needle placement, number of acupuncture points, type of stimulation, and duration of treatment, is often sparse or lacking However, studies indicate that acupuncture has a positive effect on women’s experiences of labour pain.

Aim: The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain. Our hypothesis is that acupuncture with manual or electrical stimulation is more effective than standard care in the relief of labor pain, and that acupuncture with electrical stimulation is the most effective.

Outcome measures: Primary outcome: Labour pain measured with visual analogue scale (VAS). Secondary outcomes are use of epidural analgesia, experience of relaxation, labour outcomes and infant outcomes. Biochemical markers of proinflammatory cytokines, memory of labour pain and overall childbirth experience.

Methods: The study was designed as a randomized controlled trial based on Western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. VAS was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment.

At the conference, information on the design of the study will be presented and the considerations of whether to use placebo controls or not will be discussed.

ClinicalTrials.gov: NCT01197950

Background Pain increases the risk for cardiovascular diseases, including myocardial infarction (MI). However, the impact of pain on mortality after MI has not yet been investigated in large studies with long-term follow-up periods. Thus, we aimed to examine various levels of pain severity 1 year after an MI as a potential risk for all-cause mortality. Methods and Results We collected data from 18 376 patients, aged <75 years, who had a registered MI event during the period from 2004 to 2013 and with measurements of potential cardiovascular risk indicators at hospital discharge from the Swedish quality register SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies). Self-reported levels of experienced pain according to EuroQol-5 dimension instrument were recorded in secondary prevention clinics 1 year after hospital discharge. We collected all-cause mortality data up to 8.5 years (median, 3.4 years) after the 1-year visit. The Cox proportional hazard regression was used to estimate hazard ratio (HR) and 95% CI. Moderate pain and extreme pain were reported by 38.2% and 4.5%, respectively, of included patients. There were 1067 deaths. Adjusted HR was 1.35 (95% CI, 1.18-1.55) and 2.06 (95% CI, 1.63-2.60) for moderate and extreme pain, respectively. Pain was a stronger mortality predictor than smoking. Conclusions Pain 1 year after MI is highly prevalent, and its effect on mortality 1 year after MI was found to be more pronounced than smoking. Clinicians managing patients after MI should recognize the need to consider experienced pain when making prognosis or treatment decisions.

BACKGROUND: In a previous randomised controlled trial we showed that acupuncture with a combination of manual- and electrical stimulation (EA) did not affect the level of pain, as compared with acupuncture with manual stimulation (MA) and standard care (SC), but reduced the need for other forms of pain relief, including epidural analgesia. To dismiss an under-treatment of pain in the trial, we did a long-term follow up on the recollection of labour pain and the birth experience comparing acupuncture with manual stimulation, acupuncture with combined electrical and manual stimulation with standard care. Our hypothesis was that despite the lower frequency of use of other pain relief, women who had received EA would make similar retrospective assessments of labour pain and the birth experience 2 months after birth as women who received standard care (SC) or acupuncture with manual stimulation (MA).

METHODS: Secondary analyses of data collected for a randomised controlled trial conducted at two delivery wards in Sweden. A total of 303 nulliparous women with normal pregnancies were randomised to: 40 min of MA or EA, or SC without acupuncture. Questionnaires were administered the day after partus and 2 months later.

RESULTS: Two months postpartum, the mean recalled pain on the visual analogue scale (SC: 70.1, MA: 69.3 and EA: 68.7) did not differ between the groups (SC vs MA: adjusted mean difference 0.8, 95 % confidence interval [CI] -6.3 to 7.9 and SC vs EA: mean difference 1.3 CI 95 % -5.5 to 8.1). Positive birth experience (SC: 54.3 %, MA: 64.6 % and EA: 61.0 %) did not differ between the groups (SC vs MA: adjusted Odds Ratio [OR] 1.8, CI 95 % 0.9 to 3.7 and SC vs EA: OR 1.4 CI 95 % 0.7 to 2.6).

CONCLUSIONS: Despite the lower use of other pain relief, women who received acupuncture with the combination of manual and electrical stimulation during labour made the same retrospective assessments of labour pain and birth experience 2 months postpartum as those who received acupuncture with manual stimulation or standard care.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT01197950.

Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women's experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.

Background: Acupuncture is commonly used to reduce pain during labour despite contradictory results. The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation (electro-acupuncture) compared with standard care in reducing labour pain. Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care, and that electro-acupuncture was most effective. 

Methods: A longitudinal randomised controlled trial. The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals. 303 nulliparous women with normal pregnancies were randomised to: 40 minutes of manual acupuncture (MA), electro-acupuncture (EA), or standard care without acupuncture (SC). Primary outcome: labour pain, assessed by Visual Analogue Scale (VAS). Secondary outcomes: relaxation, use of obstetric pain relief during labour and post-partum assessments of labour pain. The sample size calculation was based on the primary outcome and a difference of 15 mm on VAS was regarded as clinically relevant, this gave 101 in each group, including a total of 303 women. 

Results: Mean estimated pain scores on VAS (SC: 69.0, MA: 66.4 and EA: 68.5), adjusted for: treatment, age, education, and time from baseline, with no interactions did not differ between the groups (SC vs MA: mean difference 2.6, 95% confidence interval [CI] -1.7-6.9 and SC vs EA: mean difference 0.6 [95% CI] -3.6-4.8). Fewer number of women in the EA group used epidural analgesia (46%) than women in the MA group (61%) and SC group (70%) (EA vs SC: odds ratio [OR] 0.35; [95% CI] 0.19-0.67). 

Conclusions: Acupuncture does not reduce women's experience of labour pain, neither with manual stimulation nor with combined manual and electrical stimulation. However, fewer women in the EA group used epidural analgesia thus indicating that the effect of acupuncture with electrical stimulation may be underestimated. These findings were obtained in a context with free access to other forms of pain relief.

OBJECTIVE: To investigate whether advanced maternal age is associated with preterm birth, irrespective of parity.

DESIGN: Population-based registry study.

SETTING: Swedish Medical Birth Register.

POPULATION: First, second, and third live singleton births to women aged 20 years or older in Sweden, from 1990 to 2011 (n = 2 009 068).

METHODS: Logistic regression analysis was used in each parity group to estimate risks of very and moderately preterm births to women at 20-24, 25-29, 30-34, 35-39, and 40 years or older, using 25-29 years as the reference group. Odds ratios (ORs) were adjusted for year of birth, education, country of birth, smoking, body mass index, and history of preterm birth. Age-related risks of spontaneous and medically indicated preterm births were also investigated.

MAIN OUTCOME MEASURES: Very preterm (22-31 weeks of gestation) and moderately preterm (32-36 weeks) births.

RESULTS: Risks of very preterm birth increased with maternal age, irrespective of parity: adjusted ORs in first, second, and third births ranged from 1.18 to 1.28 at 30-34 years, from 1.59 to 1.70 at 35-39 years, and from 1.97 to 2.40 at ≥40 years. In moderately preterm births, age-related associations were weaker, but were statistically significant from 35-39 years in all parity groups. Advanced maternal age increased the risks of both spontaneous and medically indicated preterm births.

CONCLUSIONS: Advanced maternal age is associated with an increased risk of preterm birth, irrespective of parity, especially very preterm birth. Women aged 35 years and older, expecting their first, second, or third births, should be regarded as a risk group for very preterm birth.

Introduction

Chronic musculoskeletal pain is a highly prevalent, complex and distressing condition that may negatively affect all domains of life. In view of an active inference framework, and resting on the concept of allostasis, human movement per se becomes a prerequisite for health and well-being while chronic pain becomes a sign of a system unable to attenuate an allostatic load. Previous studies on different subgroups of chronic pain conditions have demonstrated alterations in gait kinematics and muscle activity, indicating shared disturbances in the motor system from long-term allostatic load. We hypothesise that such alterations exist in heterogenous populations with chronic musculoskeletal pain, and that exposure to acute and controlled exercise may attenuate these alterations. Therefore, the main aim of this study is to investigate the acute effects of exercise on gait kinematics and activity of the back and neck muscles during diverse walking conditions in patients with chronic musculoskeletal pain compared with a reference sample consisting of healthy participants.

Methods and analysis

This two-sample two-armed parallel randomised controlled laboratory trial will include 40 participants with chronic musculoskeletal pain (>3 months) and 40 healthy participants. Participants will be randomly allocated to either 30 min of aerobic exercise or rest. Primary outcomes are gait kinematics (walking speed, step frequency, stride length, lumbar rotation, gait stability) and muscular activity (spatial and temporal) of the back and neck during diverse walking conditions. Secondary outcomes are variability of gait kinematics and muscle activity and subjective pain ratings assessed regularly during the trial.

Ethics and dissemination

The study has been approved by the Regional Ethics Review Board in Uppsala, Sweden (#2018/307). Findings will be disseminated via conference presentations, publications in peer-reviewed journals and engagement with patient support groups and clinicians.

Trial registration number

NCT03882333.

Interdisciplinary pain rehabilitation (IPR) is a recommended treatment for people with chronic pain. An inadequate description of the content of IPR programs makes it difficult to draw conclusions regarding their effects. The purpose of this study was to describe the perceptions and attitudes of healthcare professionals toward a content description of IPR programs for patients with chronic pain. Individual interviews with healthcare professionals (n = 11) working in IPR teams in Sweden were conducted between February and May 2019. Analysis of the interviews resulted in a theme: interdisciplinary pain rehabilitation is a complex intervention, with three categories: limitations in the description of IPR programs; lack of knowledge about IPR and chronic pain; and facilitating and hindering factors for using the content description of IPR programs. Conclusion: Healthcare professionals perceived that IPR programs could be described through a general content description. A general content description could enhance the quality of IPR programs through a better understanding of their content and a comparison of different IPR programs. Healthcare professionals also expressed the importance of a content description being a guide rather than a steering document.