Controlled Trial In Primary Care Research Articles

Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): short term effects of a randomised controlled trial in primary care

Purpose To evaluate short-term effects of the PREVention of Sickness Absence for Musculoskeletal disorders (PREVSAM) model on sickness absence and patient-reported health outcomes. Methods Patients with musculoskeletal disorders were randomised to rehabilitation according to PREVSAM or treatment as usual (TAU) in primary care. Sickness absence and patient-reported health outcomes were evaluated after three months in 254 participants. Results The proportion of participants remaining in full- or part-time work were 86% in PREVSAM vs 78% in TAU (p = 0.097). The PREVSAM group had approximately four fewer sickness benefit days during three months from baseline (p range 0.078–0.126). No statistically significant difference was found in self-reported sickness absence days (PREVSAM 12.4 vs TAU 14.5; p = 0.634), nor were statistically significant differences between groups found in patient-reported health outcomes. Both groups showed significant improvements from baseline to three months, except for self-efficacy, and only the PREVSAM group showed significantly reduced depression symptoms. Conclusions The findings suggest that for sickness absence, the PREVSAM model may have an advantage over TAU, although the difference did not reach statistical significance at the p < 0.05 level, and similar positive effects on patient-reported health outcomes were found in both groups. Long-term effects must be evaluated before firm conclusions can be drawn.

Effects of an interactive web-based support system via mobile phone on preference-based patient participation in patients living with hypertension – a randomized controlled trial in primary care

Objective To estimate the effects of an interactive web-based support system via mobile phone on preference-based patient participation in patients with hypertension treated in primary care (compared with standard hypertensive care only). Design A parallel group, non-blinded, randomized controlled trial, conducted October 2018–February 2021. Besides standard hypertensive care, the intervention group received eight weeks of support via mobile phone to facilitate self-monitoring and self-management, tentatively providing for augmented patient engagement. Setting 31 primary healthcare centers in Sweden. Subjects 949 patients treated for hypertension. Main outcome measures The effects on preference-based patient participation, that is, the match between a patient’s preferences for and experiences of patient participation in their health and healthcare. This was measured with the 4Ps (Patient Preferences for Patient Participation) tool at baseline, after 8 weeks, and at 12 months. Data were registered electronically and analyzed with multilevel ordinal regression. Results At baseline, 43–51% had a complete match between their preferences for and experiences of patient participation. There was an indication of a positive effect by a higher match for ‘managing treatment myself’ at 8-weeks in the intervention group. Such preference-based participation in their health and healthcare was reversed at 12 months, and no further effects of the intervention on preference-based patient participation persisted after 12 months. Conclusion The interactive web-based support system via mobile phone had a wavering effect on preference-based patient participation. There is a prevailing need to better understand how person-centered patient participation can be facilitated in primary care.

Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers

BackgroundConducting effective and translational research can be challenging and few trials undertake formal reflection exercises and disseminate learnings from them. Following completion of our multicentre randomised controlled trial, which was impacted by the COVID-19 pandemic, we sought to reflect on our experiences and share our thoughts on challenges, lessons learned, and recommendations for researchers undertaking or considering research in primary care.MethodsResearchers involved in the Prediction of Undiagnosed atriaL fibrillation using a machinE learning AlgorIthm (PULsE-AI) trial, conducted in England from June 2019 to February 2021 were invited to participate in a qualitative reflection exercise. Members of the Trial Steering Committee (TSC) were invited to attend a semi-structured focus group session, Principal Investigators and their research teams at practices involved in the trial were invited to participate in a semi-structured interview. Following transcription, reflexive thematic analysis was undertaken based on pre-specified themes of recruitment, challenges, lessons learned, and recommendations that formed the structure of the focus group/interview sessions, whilst also allowing the exploration of new themes that emerged from the data.ResultsEight of 14 members of the TSC, and one of six practices involved in the trial participated in the reflection exercise. Recruitment was highlighted as a major challenge encountered by trial researchers, even prior to disruption due to the COVID-19 pandemic. Researchers also commented on themes such as the need to consider incentivisation, and challenges associated with using technology in trials, especially in older age groups.ConclusionsUndertaking a formal reflection exercise following the completion of the PULsE-AI trial enabled us to review experiences encountered whilst undertaking a prospective randomised trial in primary care. In sharing our learnings, we hope to support other clinicians undertaking research in primary care to ensure that future trials are of optimal value for furthering knowledge, streamlining pathways, and benefitting patients.

Statins for extension of disability-free survival and primary prevention of cardiovascular events among older people: protocol for a randomised controlled trial in primary care (STAREE trial)

IntroductionThe world is undergoing a demographic transition to an older population. Preventive healthcare has reduced the burden of chronic illness at younger ages but there is limited evidence that these...

Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care

ObjectiveTo evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS). MethodsWe conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6–12 sessions delivered by specialised exercise- and physiotherapists. Primary outcome measure: patient's level of functioning. Secondary outcomes: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts. ResultsCompared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference − 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference − 1.93 [95% CI -3.81 to −0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference − 0.91 [95% CI -1.78 to −0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups. ConclusionWe only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study.Trial registration: the trial is registered in the Netherlands Trial Registry, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7356 under ID NTR7356.

Stepwise treatment of uncontrolled HyperTensioN (Stepwise-HTN): Study design of a cluster randomised controlled trial in primary care

BackgroundUncontrolled hypertension is a major health problem, and a key risk factor for cardiovascular disease. Most patients are detected and managed in primary care, but approximately 50% remains uncontrolled.Our aim is to assess whether a guided stepwise work-up management strategy for patients with uncontrolled hypertension in primary care would result in better blood pressure control in these patients compared to usual care. MethodsA cluster randomised controlled trial aiming at randomizing 40 general practices to either “a protocolised stepwise work-up” or to “usual care”.Uncontrolled hypertension is defined as an office blood pressure (BP) >140/90 mmHg while being prescribed three or more antihypertensive drugs simultaneously from different therapeutic classes for three or more months in an adequate dose. In the intervention arm, patients with uncontrolled hypertension will receive the stepwise approach, consisting of (i) excluding a white coat effect, (ii) re-evaluation of lifestyle, (iii) re-evaluation of drug adherence, (iv) optimalisation of antihypertensive treatment and (v) referral if the office BP is still >140/90 mmHg. The control group receives usual care in a regular program for cardiovascular risk management.The primary outcome is the absolute difference in the mean 24-h systolic BP between intervention and control arm after 8 months. Secondary outcomes include differences in the percentage of patients achieving a controlled BP, and time to reach a controlled BP. ConclusionIf stepwise treatment of uncontrolled hypertension is proven effective, the strategy could be implemented by blending the approach to the cardiovascular risk management already applied in general practice.Trial registrationNTR7304, https://www.trialregister.nl/trial/7099

Advance care planning engagement in patients with chronic, life-limiting illness: baseline findings from a cluster-randomised controlled trial in primary care.

Advance care planning (ACP) has been characterised as a complex process of communication and decision making. For ACP behaviour change, underlying processes such as self-efficacy and readiness are needed. However, studies about which patient characteristics are associated with ACP have mainly focused on whether ACP actions are completed, leaving behaviour change processes unexplored. To assess whether patients' characteristics and patient-perceived quality of GP ACP communication were associated with patients' ACP engagement. Baseline data were used from the ACP-GP cluster-randomised controlled trial in patients with chronic, life-limiting illness (n = 95). Patients completed questionnaires detailing demographic and clinical characteristics, and their perception about their GPs' ACP information provision and listening. Engagement was measured using the 15-item ACP Engagement Survey, with self-efficacy and readiness subscales. Linear mixed models tested associations with engagement. Demographic and clinical characteristics were not associated with engagement; nor was how much ACP information patients received from their GP or the extent to which the GP listened to what was important for the patient to live well or important to the patient regarding future care. Higher overall ACP engagement (P = 0.002) and self-efficacy (P<0.001) were observed in patients who gave a high rating for the extent to which their GP listened to their worries regarding future health. This study suggests that GPs providing information about ACP alone is not associated with a patient's ACP engagement; an important element is to listen to patients' worries regarding their future health.

Cost-effectiveness of physiotherapy in childhood functional constipation: a randomized controlled trial in primary care.

Health care expenditures for children with functional constipation (FC) are high, while conservative management is successful in only 50% of the children. The aim is to evaluate whether adding physiotherapy to conventional treatment (CT) is a cost-effective strategy in the management of children with FC aged 4-18 years in primary care. A cost-effectiveness analysis was performed alongside a randomized controlled trial (RCT) with 8-month follow-up. Costs were assessed from a societal perspective, effectiveness included both the primary outcome (treatment success defined as the absence of FC and no laxative use) and the secondary outcome (absence of FC irrespective of laxative use). Uncertainty was assessed by bootstrapping and cost-effectiveness acceptability curves (CEACs) were displayed. One hundred and thirty-four children were randomized. The incremental cost-effectiveness ratio (ICER) for one additional successfully treated child in the physiotherapy group compared with the CT group was €24,060 (95% confidence interval [CI] €-16,275 to €31,390) and for the secondary outcome €1,221 (95% CI €-12,905 to €10,956). Subgroup analyses showed that for children with chronic laxative use the ICER was €2,134 (95% CI -24,975 to 17,192) and €571 (95% CI 11 to 3,566), respectively. At a value of €1,000, the CEAC showed a probability of 0.53 of cost-effectiveness for the primary outcome, and 0.90 for the secondary outcome. Physiotherapy added to CT as first-line treatment for all children with FC is not cost-effective compared with CT alone. Future studies should consider the cost-effectiveness of physiotherapy added to CT in children with chronic laxative use. The RCT is registered in the Netherlands Trial Register (NTR4797), on the 8th of September 2014. The first child was enrolled on the 2nd of December 2014. https://www.trialregister.nl/trial/4654.

Process Evaluation of MAPS: A Highly Tailored Digital Intervention to Support Medication Adherence in Primary Care Setting.

Background: Medication adherence can prevent health risks, but many patients do not adhere to their prescribed treatment. Our recent trial found that a digital intervention was effective at improving medication adherence in non-adherent patients with Hypertension or Type 2 Diabetes; but we do not know how it brought about behavioural changes. This research is a post-trial process evaluation of the mechanism by which the intervention achieved its intended effects.Methods: A mixed methods design with quantitative and qualitative evidence synthesis was employed. Data was generated by two studies. Study 1 used questionnaires to measure the underlying mechanisms of and the medication adherence behaviour, and digital logfiles to objectively capture intervention effects on the process of behaviour change. Multilevel regression analysis on 57 complete intervention group cases tested the effects of the intervention at modifying the mechanism of behaviour change and in turn at improving medication adherence. Study 2 used in depth interviews with a subsample of 20 intervention patients, and eight practise nurses. Thematic analysis provided evidence about the overarching intervention functions and recommendations to improve intervention reach and impact in primary care.Results: Study 1 found that intervention effectiveness was significantly associated with positive changes in the underlying mechanisms of behaviour change (R2 = 0.26, SE = 0.98, P = 0.00); and this effect was heightened twofold when the tailored intervention content and reporting on medication taking (R2 = 0.59, SE = 0.74, P = 0.00) was interested into the regression model. Study 2 suggested that the intervention supported motivation and ability to adherence, although clinically meaningful effects would require very brief medication adherence risk appraisal and signposting to ongoing digitally delivered behavioural support during clinical consultations.Conclusion: This post trial process evaluation used objective methods to capture the intervention effect on the mechanisms of behaviour change to explain intervention effectiveness, and subjective accounts to explore the circumstances under which these effects were achieved. The results of this process evaluation will inform a large scale randomised controlled trial in primary care.

Urine collection devices to reduce contamination in urine samples for diagnosis of uncomplicated UTI: a single-blind randomised controlled trial in primary care

BackgroundUrine collection devices (UCDs) are being marketed and used in clinical settings to reduce urine sample contamination, despite inadequate supporting evidence.AimTo determine whether UCDs, compared with standardised instructions for urine sample collection, reduce the proportion of contaminated samples.Design and settingSingle-blind randomised controlled trial in general practices in England and Wales.MethodWomen aged ≥18 years presenting with symptoms attributable to urinary tract infection (UTI) were randomised (1:1:1) to use either a Peezy UCD or a Whiz Midstream UCD, or were given standardised verbal instructions (SVI) for midstream sample collection. The primary outcome was the proportion of urine samples reported as contaminated by microbiology laboratory analysis.ResultsA total of 1264 women (Peezy UCD: n = 424; Whiz Midstream UCD: n = 421; SVI: n = 419) were randomised between October 2016 and August 2018. Ninety women were excluded from the primary analysis as a result of ineligibility or lack of primary outcome data, leaving 1174 (Peezy UCD: n = 381; Whiz Midstream UCD: n = 390; SVI: n = 403) for intention-to-treat analysis. The proportion of contaminated samples was 26.5% with the Peezy UCD, 28.2% with the Whiz Midstream UCD, and 29.0% with SVI (relative risk: Peezy UCD versus SVI = 0.91, 95% CI = 0.76 to 1.09, P = 0.32; Whiz Midstream UCD versus SVI = 0.98, 95% CI = 0.97 to 1.20, P = 0.82). There were 100 (25.3%) device failures with the Peezy UCD and 35 (8.8%) with the Whiz Midstream UCD; the proportion of contaminated samples was similar after device failure samples were excluded.ConclusionNeither the Peezy UCD nor the Whiz Midstream UCD reduced urine sample contamination when used by women presenting to primary care with suspected UTI. Their use cannot be recommended for this purpose in this setting.

The effect of nicotine dependence and withdrawal symptoms on use of nicotine replacement therapy: Secondary analysis of a randomized controlled trial in primary care

IntroductionNicotine replacement therapy (NRT) is effective for smoking cessation, but the optimal method of using NRT to maximize benefit is unclear. We examined whether nicotine dependence was associated with consumption of NRT, whether this was mediated by withdrawal symptoms, and the impact of these factors on cessation, in a population advised to use as much NRT as needed. MethodsSecondary analysis of data from an open label, parallel group randomized controlled trial. Participants (n = 539) attended a smoking cessation clinic in primary care and remained engaged with treatment for at least one week following a quit attempt. Baseline dependence was measured by the Fagerström Test for Cigarette Dependence (FTCD), with tobacco exposure assessed via an exhaled carbon monoxide test. At one week after quit day, mean daily consumption of NRT was measured for all participants; withdrawal (Mood and Physical Symptoms Scale (MPSS)) was also assessed in the subsample who reported being completely abstinent to that point (n = 279). Abstinence was biochemically assessed at four weeks for all participants as the principal smoking cessation outcome. ResultsEach point higher on the FTCD was associated with 0.83 mg/day more NRT consumption, controlling for tobacco exposure. This relationship was diminished when withdrawal was controlled for, and withdrawal was associated with NRT consumption, with each point higher on the MPSS associated with a 0.12 mg/day increase. Increased consumption of NRT directly predicted subsequent smoking cessation. ConclusionsHigher dependence appears to lead to greater withdrawal, which appears to drive greater use of NRT. This effect may partly offset lower abstinence rates in people with higher dependence. Advice to use sufficient NRT to suppress withdrawal may increase abstinence rates.

Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75\u2009years: a cluster randomized controlled trial in primary care (EIRA study)

BackgroundMultiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction.MethodsAn economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results.ResultsThe study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (− 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis.ConclusionThe efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects.Trial registrationClinicaltrials.gov NCT03136211. Registered 02 May 2017 – Retrospectively registered

A single Epley manoeuvre can improve self-perceptions of disability (quality of life) in patients with pc-BPPV: A randomised controlled trial in primary care

Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment is the Epley manoeuvre (EM). ObjectiveThe purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability. DesignRandomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. ParticipantsPatients aged ≥18 years old diagnosed with pc-BPPV according to the Dix–Hallpike test (DHT) were randomised to: InterventionsIntervention (EM) group or a control (sham manoeuvre) group. Main measurementsThe main study covariates were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory – screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. ResultsOverall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years. standard deviation, 16.98) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<.001). Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. ConclusionsPc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale.

Effect of physician attire on patient perceptions of empathy in Japan: a quasi-randomized controlled trial in primary care

BackgroundThere is limited quantitative research on the effect of physician attire on patient–physician relationships. This study aimed to measure the influence of Japanese family physicians’ attire on the “human” aspects of medical care in terms of patient-perceived relational empathy.MethodsThis was a multicenter, prospective, controlled trial conducted in primary clinics in Japan. We explored the effects of family physician attire (white coat vs. casual attire) on patient-perceived empathy. Family physicians were allocated to alternate weeks of wearing a white coat or casual attire during consultations. Patients’ perceptions of physician empathy were evaluated using the self-rated Japanese Consultation and Relational Empathy (CARE) Measure. We used a linear mixed model to analyze the CARE Measure scores, adjusting for cluster effects of patients nested within doctor, age, and sex of patients, and doctors’ sex and years of clinical experience. We used the same method with Bonferroni adjustment to analyze patient sex differences in perceived empathy.ResultsA total of 632 patients of seven family physicians were allocated to white coat-wearing consultations (n = 328), and casual attire-wearing consultations (n = 304). There was no difference in CARE Measure scores between white coat and casual primary care consultations overall (p = 0.162). Subgroup analysis of patient sex showed that CARE Measure scores of male patients were significantly higher in the Casual group than in the White coat group (adjusted p-value = 0.044). There was no difference in female patient scores between White coat and Casual groups (adjusted p-value = 1.000).ConclusionsThis study demonstrated that physician attire (white coat or casual attire) in a primary care setting did not affect patient-perceived relational empathy overall. However, male patients of physicians wearing casual attire reported higher physician empathy. Although empathy cannot be reduced to simple variables such as attire, white coats may have a negative effect on patients, depending on the context. Family physicians should choose their attire carefully.Trial registrationJapanese University Hospital Medical Information Network (UMIN-ICDR). Clinical Trial identifier number UMIN000037687 (Registered August 14, 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042749). The study was prospectively registered.

Cost-effectiveness of a stepwise cardiometabolic disease prevention program: results of a randomized controlled trial in primary care

BackgroundCardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care.MethodsA randomized controlled trial in a primary care setting in which 1934 participants aged 45–70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (− 2.26 mmHg; 95% CI − 4.01: − 0.51) and total cholesterol (− 0.15 mmol/l; 95% CI − 0.23: − 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective.ResultsAfter 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (− 0.0154; 95% CI − 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention.ConclusionsImplementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended.Trial registrationDutch Trial Register NTR4277, registered on 26 November 2013

Neuromuscular exercise for chronic musculoskeletal pain in older people: a randomised controlled trial in primary care in Hong Kong.

BackgroundExercise therapy is commonly prescribed by primary care physicians (PCPs) in the management of chronic musculoskeletal (MSK) pain.AimTo evaluate the clinical effectiveness of a supervised neuromuscular (NM) exercise programme in older people with chronic MSK pain.Design and settingThis was a 12-week, two-arm, randomised controlled trial comparing 6 weeks of supervised NM exercise versus waiting list controls. The authors enrolled 72 participants with chronic MSK pain at seven public primary care clinics.MethodParticipants were randomly allocated in block sizes of 12 to the NM (n = 36) and control groups (n = 36) in a 1:1 ratio. Data were collected at baseline, 6, and 12 weeks. The primary outcome was the Brief Pain Inventory (BPI) pain severity score at 6 weeks post-intervention. Secondary outcomes included the BPI interference score; Pain Self-Efficacy Questionnaire (PSEQ), Short Form Health Survey (SF-12), 7-item Generalised Anxiety Disorder (GAD-7), and 9-item Patient Health Questionnaire (PHQ-9) scores; and functional measurements using the Timed-Up- and-Go test and handgrip strength.ResultsAt 6 weeks, the NM group demonstrated a significantly greater improvement in the BPI pain severity score (between-group difference = −1.27; 95% confidence interval [CI] = −2.08 to −0.45; P<0.01), PSEQ (between-group difference = 6.5; 95% CI = 2.22 to 10.77; P<0.01), and SF-12 physical scores (between-group difference = 3.4; 95% CI = 0.05 to 6.75; P<0.05) compared with the control group. Statistically significant overall trends of improvement were also observed for the BPI interference and PHQ-9 scores.ConclusionNM exercise has the potential to reduce pain and improve self-efficacy and physical function in older people with chronic MSK pain. It can be an option for PCPs in exercise prescriptions.

Impact of COPD case finding on clinical care: a prospective analysis of the TargetCOPD trial

ObjectivesTo investigate the impact of chronic obstructive pulmonary disease (COPD) case finding on clinical care.DesignWe conducted a prospective observational analysis of data from a pragmatic cluster randomised controlled trial in...

Does a work-stress intervention prevent sick leave? A randomized controlled trial in primary care

Abstract Background Work-related stress (WRS) clearly presents a risk for sick-leave. A brief preventive intervention aiming to identify people at risk for WRS was tested in a RCT study in primary health-care centers (PHCC). At the 12-month follow-up there were differences regarding sick leave between the intervention and the control group, however they did not become statistically significant. Evaluating the intervention in a longer perspective is thus warranted. Purpose This study aims to evaluate whether a systematic early identification of work-related stress can prevent sickness absence over 18 to 24 months after the intervention. Methods The RCT-study had follow-ups at 18 and 24 months. The participants (N = 271) were employed, non-sick-listed women and men (18 to 64 years) seeking care at PHCCs for mental and physical health complaints. 132 patients were allocated to the intervention and 139 patients were allocated to treatment as usual. The preventive intervention included early identification of WRS by the Work Stress Questionnaire (WSQ), general practitioner (GP) awareness supported by a brief training session, patients' self-reflection by WSQ completion, GP giving the patient feedback at consultation, and identifying appropriate preventive measures. Sick leave data from the Swedish Social Insurance Agency register constituted the outcome comparing the preventive intervention by the GP versus treatment as usual. Results The preliminary results showed that there were differences in median sick days between the intervention group (68, 72) and the control group (80, 81) at 18 months and at 24 months, however these differences did not become statistically significant. Conclusions The WSQ brief intervention was not proven effective in preventing sick leave in the following 18 and 24 months compared to treatment as usual. The study may have been under-powered and the lack of statistical difference between the groups might be due to a type II error. Key messages Work-related stress is a predictor for sick-leave. Further research on how to identify those at high risk for sick-leave, give advice and treat this group in primary health care is needed. A study of the WSQ brief intervention with a larger sample seems warranted.

Cost effectiveness of an intervention to increase uptake of hepatitis C virus testing and treatment (HepCATT): cluster randomised controlled trial in primary care

ObjectiveTo evaluate the effectiveness and cost effectiveness of a complex intervention in primary care that aims to increase uptake of hepatitis C virus (HCV) case finding and treatment.DesignPragmatic, two armed,...

QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with coronary heart disease (QUEL): protocol for a 24-month cluster randomised controlled trial in primary care

BackgroundCardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months.MethodsCluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using log-binomial regression or robust Poisson regression, if necessary.DiscussionDespite extensive research with surrogate outcomes, to the authors’ knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).