scholarly journals Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study)

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e051656
Author(s):  
Ole Marius Ekeberg ◽  
Stein Jarle Pedersen ◽  
Bård Natvig ◽  
Jens Ivar Brox ◽  
Eva Kristin Biringer ◽  
...  
Keyword(s):  
General Practice ◽  
Cost Effectiveness ◽  
Shoulder Pain ◽  
Indirect Costs ◽  
Hybrid Design ◽  
Evidence Based ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Evidence Based Guideline

IntroductionResearch suggests that current care for shoulder pain is not in line with the best available evidence. This project aims to assess the effectiveness, cost-effectiveness and the implementation of an evidence-based guideline for shoulder pain in general practice in Norway.Methods and analysisA stepped-wedge, cluster-randomised trial with a hybrid design assessing clinical effectiveness, cost-effectiveness and the effect of the implementation strategy of a guideline-based intervention in general practice. We will recruit at least 36 general practitioners (GPs) and randomise the time of cross-over from treatment as usual to the implemented intervention. The intervention includes an educational outreach visit to the GPs, a computerised decision tool for GPs and a self-management application for patients. We will measure outcomes at patient and GP levels using self-report questionnaires, focus group interviews and register based data. The primary outcome measure is the patient-reported Shoulder Pain and Disability Index measured at 12 weeks. Secondary outcomes include the EuroQol Quality of Life Measure (EQ5D-5L), direct and indirect costs, patient’s global perceived effect of treatment outcome, Pain Self-Efficacy and Brief Illness Perception Questionnaire. We will evaluate the implementation process with focus on adherence to guideline treatment. We will do a cost–minimisation analysis based on direct and selected indirect costs and a cost–utility analysis based on EQ5D-5L. We will use mixed effect models to analyse primary and secondary outcomes.Ethics and disseminationEthics approval was granted by the Regional Committee for Medical and Health Research Ethics-South East Norway (ref. no: 2019/104). Trial results will be submitted for publication in a peer-reviewed medical journal in accordance with Consolidated Standards of Reporting Trials.Trial registration numberNCT04806191.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Cost-effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: economic evaluation alongside a stepped-wedge cluster-randomised trial

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e017782
Author(s):  
Esther V A Bouwsma ◽  
Judith E Bosmans ◽  
Johanna M van Dongen ◽  
Hans A M Brölmann ◽  
Johannes R Anema ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Perioperative Care ◽  
Cost Effective ◽  
Stepped Wedge ◽  
Gynaecological Surgery ◽  
Care Programme ◽  
Societal Costs ◽  
Cluster Randomised

ObjectivesTo evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients.DesignEconomic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up.SettingSecondary care, nine hospitals in the Netherlands, 2011–2014.Participants433 employed women aged 18–65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery.InterventionThe intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227).Main outcome measuresThe primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery.ResultsAt 12 months, there were no statistically significant differences in total societal costs (€−647; 95% CI €−2116 to €753) and duration until RTW (−4.1; 95% CI −10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs.ConclusionsConsidering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery.Trial registration numberNTR2933; Results.

scholarly journals Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study)

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e050101
Author(s):  
Pieter F van Doorn ◽  
Evelien I T de Schepper ◽  
Dieuwke Schiphof ◽  
Ramon P G Ottenheijm ◽  
Marloes Thoomes-de Graaf ◽  
...  
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Cost Effectiveness ◽  
Pain Intensity ◽  
Shoulder Pain ◽  
Exercise Therapy ◽  
Corticosteroid Injection ◽  
Repeated Measurements ◽  
Life Years

IntroductionShoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care.Methods and analysisThe SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient’s reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient’s global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective.Ethics and disseminationThis study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain.Trial registration numberDutch Trial Registry (NL8854).

scholarly journals Optimising personal continuity for older patients in general practice: a study protocol for a cluster randomised stepped wedge pragmatic trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lex J. J. Groot ◽  
Henk J. Schers ◽  
Jako S. Burgers ◽  
Francois G. Schellevis ◽  
Martin Smalbrugge ◽  
...  
Keyword(s):  
General Practice ◽  
General Practitioners ◽  
Continuity Of Care ◽  
Older Patients ◽  
Pragmatic Trial ◽  
Complex Interventions ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Stepped Wedge ◽  
Cluster Randomised

Abstract Background Continuity of care, in particular personal continuity, is a core principle of general practice and is associated with many benefits such as a better patient-provider relationship and lower mortality. However, personal continuity is under pressure due to changes in society and healthcare. This affects older patients more than younger patients. As the number of older patients will double the coming decades, an intervention to optimise personal continuity for this group is highly warranted. Methods Following the UK Medical Research Council framework for complex Interventions, we will develop and evaluate an intervention to optimise personal continuity for older patients in general practice. In phase 0, we will perform a literature study to provide the theoretical basis for the intervention. In phase I we will define the components of the intervention by performing surveys and focus groups among patients, general practitioners, practice assistants and practice nurses, concluded by a Delphi study among members of our group. In phase II, we will test and finalise the intervention with input from a pilot study in two general practices. In phase III, we will perform a stepped wedge cluster randomised pragmatic trial. The primary outcome measure is continuity of care from the patients’ perspective, measured by the Nijmegen Continuity Questionnaire. Secondary outcome measures are level of implementation, barriers and facilitators for implementation, acceptability and feasibility of the intervention. In phase IV, we will establish the conditions for large-scale implementation. Discussion This is the first study to investigate an intervention for improving personal continuity for older patients in general practice. If proven effective, our intervention will enable General practitioners to improve the quality of care for their increasing population of older patients. The pragmatic design of the study will enable evaluation in real-life conditions, facilitating future implementation. Trial registration number Netherlands Trial Register, trial NL8132. Registered 2 November 2019.

Healthy ageing among older Aboriginal people: the Ironbark study protocol for a cluster randomised controlled trial

2020 ◽  
Vol 26 (6) ◽  
pp. 581-587
Author(s):  
Rebecca Ivers ◽  
Julieann Coombes ◽  
Catherine Sherrington ◽  
Tamara Mackean ◽  
Anne Tiedemann ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Fall Prevention ◽  
Aboriginal People ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Fall Prevention Programme

IntroductionOlder Aboriginal people have a strong leadership role in their community including passing on knowledge and teachings around culture and connections to Country. Falls significantly affect older people and are a growing concern for older Aboriginal people and their families. Regular participation in balance and strength exercise has been shown to be efficacious in reducing falls. A pilot study developed in partnership with Aboriginal communities, the Ironbark: Standing Strong and Tall programme, demonstrated high community acceptability and feasibility, and gains in balance and strength in Aboriginal participants. This cluster randomised controlled trial will assess the effectiveness of the programme in reducing the rate of falls in older Aboriginal people.MethodsWe will examine the effectiveness and cost-effectiveness of the Ironbark group-based fall prevention programme compared with a group-based social programme, with Aboriginal people aged 45 years and older in three Australian states. The primary outcome is fall rates over 12 months, measured using weekly self-reported data. Secondary outcomes measured at baseline and after 12 months include quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity. Differences between study groups in the primary and secondary outcomes at 12 months will be estimated.ConclusionThis is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years. The study has strong cultural and community governance, including Aboriginal investigators and staff, and is guided by a steering committee that includes representatives of Aboriginal community-controlled services.Trial registration numberACTRN12619000349145.

scholarly journals Effectiveness of workplace active rest programme on low back pain in office workers: a stepped-wedge cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e040101
Author(s):  
Yamato Tsuboi ◽  
Tomohiro Oka ◽  
Kiyomasa Nakatsuka ◽  
Tsunenori Isa ◽  
Rei Ono
Keyword(s):  
Physical Activity ◽  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Office Workers ◽  
Secondary Outcome ◽  
Low Back ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
Secondary Outcomes

ObjectiveThis study aimed to investigate the effectiveness of workplace active rest programme (WARP) on chronic low back pain (LBP) among office workers.DesignA closed cohort, stepped-wedge cluster randomised trial was conducted. The total duration of the study was 16 weeks (4 weeks for each step). Sequence allocation was randomised, but no one was blinded.SettingThis study was conducted in three offices in a Japanese electronics company. One office was for the administrative department, the others are for the engineering department.ParticipantsWe recruited 29 office workers with LBP greater than 3 months. LBP due to specific injury or disease was excluded. The median age was 38 years, and 26 (90%) were male. All participants completed the study.InterventionsIn the intervention phase, participants performed WARP comprising frequent stand-up and individualised brief exercise/physical activity during work. Physical therapists held an LBP workshop and developed tailor-made programmes before introducing WARP. We instructed participants to perform WARP at five timings during work. Control phase was set before the intervention and participants stayed as usual.Primary and secondary outcome measuresThe primary outcome was pain intensity of LBP assessed using the Brief Pain Inventory. The secondary outcomes were work productivity loss measured using the Work Limitations Questionnaire, LBP disability assessed using the Roland-Morris Disability Questionnaire, psychosocial subscale assessed using the STarT Back Screening Tool and physical activity measured using triaxial accelerometers. These outcomes were collected at baseline and at 4-month follow-up evaluation.ResultsIn the intention-to-treat analysis, WARP did not show any significant effects on pain intensity (β, 0.01; 95% CI −0.50 to 0.52) and on the secondary outcomes. The median adherence to WARP was 28.6% (IQR, 16.8–41.1), which was equal to 1.43 times per day. No adverse effect was observed.ConclusionsThe present study was unable to confirm the effectiveness of active rest in improving LBP. Hence, further study needs to investigate its effectiveness.Trial registration numberUMIN000033210.

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