scholarly journals Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial

2020 ◽  
Vol 17 (2) ◽  
pp. 195-201
Author(s):  
Adam R Glassman ◽  
Wesley T Beaulieu ◽  
Cynthia R Stockdale ◽  
Roy W Beck ◽  
Neil M Bressler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Confidence Interval ◽  
Risk Ratio ◽  
Primary Outcome ◽  
Completion Rates ◽  
Contact Group ◽  
Phone Calls ◽  
Participant Retention ◽  
To Receive

Background/Aims: In clinical trials, participant retention is critical to reduce bias and maintain statistical power for hypothesis testing. Within a multi-center clinical trial of diabetic retinopathy, we investigated whether regular phone calls to participants from the coordinating center improved long-term participant retention. Methods: Among 305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants were randomly assigned to receive phone calls at baseline, 6 months, and annually through 3 years (annual contact group) while 153 participants were assigned to receive a phone call at baseline only (baseline contact group). All participants could be contacted if visits were missed. The main outcomes were visit completion, excluding deaths, at 2 years (the primary outcome time point) and at 5 years (the final time point). Results: At baseline, 77% (117 of 152) of participants in the annual contact group and 76% (116 of 153) in the baseline contact group were successfully contacted. Among participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125) were contacted successfully by telephone around the time of the 1-, 2-, and 3-year visits, respectively. In the annual and baseline contact groups, completion rates for the 2-year primary outcome visit were 88% (129 of 147) versus 87% (125 of 144), respectively, with a risk ratio of 1.01 (95% confidence interval: 0.93–1.10, p = .81). At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85–1.19, p = .93). At 2 years, the completion rate of participants successfully contacted at baseline was 89% (202 of 226) versus 80% (52 of 65) among those not contacted successfully (risk ratio = 1.12, 95% confidence interval = 0.98–1.27, p = .09); at 5 years, the completion percentages by baseline contact success were 69% (148 of 213) versus 56% (36 of 64; risk ratio = 1.24, 95% confidence interval = 0.98–1.56, p = .08). Conclusion: Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention.

scholarly journals Lung Cancer Mortality in the Lung Screening Study Feasibility Trial

2018 ◽  
Vol 2 (3) ◽  
Author(s):  
Maryam Doroudi ◽  
Paul F Pinsky ◽  
Pamela M Marcus
Keyword(s):  
Lung Cancer ◽  
Confidence Interval ◽  
Risk Ratio ◽  
Feasibility Trial ◽  
Lung Cancer Death ◽  
All Cause Mortality ◽  
Screening Study ◽  
Lung Screening

Abstract The Lung Screening Study was a multicenter controlled feasibility trial that randomly assigned subjects to undergo two rounds of screening with either low-dose spiral computed tomography (LDCT) or chest X-ray (CXR). Long-term follow-up was performed to evaluate any differences in lung-cancer-specific and all-cause mortality between arms. In 2000, subjects were randomly assigned at six screening centers. Linkage with the National Death Index was performed to ascertain long-term mortality for subjects. Median follow-up for mortality of the 1660 and 1658 subjects randomly assigned to LDCT and CXR, respectively, was 5.2 years. There were 32 and 26 deaths from lung cancer in the two groups, respectively, corresponding to lung cancer death rates of 3.84 and 3.10 per 1000 person-years, and a risk ratio of 1.24 (95% confidence interval = 0.74 to 2.08). The risk ratio for all-cause mortality was 1.20 (95% confidence interval = 0.94 to 1.54). These findings can contribute to the overall knowledge on LDCT lung cancer screening.

scholarly journals Tepid sponging plus dipyrone versus dipyrone alone for reducing body temperature in febrile children

2008 ◽  
Vol 126 (2) ◽  
pp. 107-111 ◽  
Author(s):  
João Guilherme Bezerra Alves ◽  
Natália Dornelas Câmara Marques de Almeida ◽  
Camila Dornelas Câmara Marques de Almeida
Keyword(s):  
Clinical Trial ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Control Group ◽  
Emergency Ward ◽  
Axillary Temperature ◽  
Secondary Outcomes ◽  
To Receive

CONTEXT AND OBJECTIVE: The role of tepid sponging to promote fever control in children is controversial. We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone. The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever. DESIGN AND SETTING: A randomized clinical trial was undertaken at Instituto Materno-Infantil Professor Fernando Figueira, Recife, Pernambuco. METHODS: Children from six months to five years old with axillary temperature greater than 38 ºC in the emergency ward between January and July 2006 were eligible. One hundred and twenty children were randomly assigned to receive oral dipyrone (20 mg/kg) or oral dipyrone and tepid sponging for 15 minutes. The primary outcome was mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes were crying and irritability. RESULTS: 106 children finished the study. After the first 15 minutes, the fall in axillary temperature was significantly greater in the sponged group than in the control group (p < 0.001). From 30 to 120 minutes, better fever control was observed in the control group. Crying and irritability were observed respectively in 52% and 36% of the sponged children and in none and only two of the controls. CONCLUSIONS: Tepid sponging plus dipyrone cooled faster during the first 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.

scholarly journals Effects of Including Information about Hidden Hearing Loss in an Adopt-A-Band Program on College Band Members' Attitudes toward Healthy Hearing Behaviors

2018 ◽  
Vol 39 (02) ◽  
pp. 210-220 ◽  
Author(s):  
Carole Johnson ◽  
Jonathan Baldwin ◽  
Jeffrey Danhauer ◽  
Brian Wolfe ◽  
Stevana Jeannont ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hearing Loss ◽  
Confidence Interval ◽  
Self Efficacy ◽  
Future Research ◽  
Long Term Effects ◽  
Marching Bands ◽  
Hidden Hearing Loss ◽  
College Band

AbstractYoung musicians may be at risk for developing cochlear synaptopathy (CS), or hidden hearing loss (HHL), that could lead to permanent music-induced hearing loss (MIHL). Patients with CS often complain of tinnitus and/or difficulty understanding speech in noisy situations, even though traditional audiometric testing indicates normal hearing. The aim of this article was to determine the effects of including information about HHL on an Adopt-A-Band program involving college band members' concern about and self-efficacy toward the prevention of MIHL. We conducted a single-blinded, randomized clinical trial. Forty-eight band members participated in this study. Band members were randomly assigned to two Adopt-A-Band presentations, one with and one without information on HHL. Including information about HHL had no effect on these band members' concerns about and self-efficacy toward the prevention of MIHL. However, the Adopt-A-Band program resulted in significantly increased concern for MIHL by 39.5% (p < 0.0001, 95% confidence interval [CI]: 25–54.2), self-efficacy in its prevention by 79.1% (p < 0.0001, 95% CI: 66.9–91.2), and plans to use musicians' earplugs while playing by 67.4% (p < 0.0001, 95% CI: 53.4–81.45). Although inclusion of information about HHL did not have a significant effect, the Adopt-A-Band program, in general, significantly increased the immediate intent of these students to practice healthy hearing behaviors. Future research is needed to determine the long-term effects of using the Adopt-A-Band program with university marching bands' use of healthy hearing behaviors.

scholarly journals Role of Diabetes Mellitus in Acute Coronary Syndrome Patients with Heart Failure With Mid-Range Ejection Fraction Underwent Percutaneous Coronary Intervention: A 3-Year Case Series Follow-Up Retrospective Study

2020 ◽  
Author(s):  
Lieyou Li ◽  
Ganyang Li ◽  
Huang Chen ◽  
Zhihai Feng ◽  
Yifan Chen ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Confidence Interval ◽  
Primary Outcome ◽  
Coronary Intervention ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Patients With Heart Failure

Abstract Backgroud Data are limited about the effect of diabetes mellitus (DM) on prognosis of acute coronary syndrome (ACS) patients with heart failure with mid-range ejection fraction (HFmrEF) underwent percutaneous coronary intervention (PCI). This study aimed to investigate the relationship between type 2 diabetes mellitus(T2DM) and the 3-year outcomes in such population.Methods 377 ACS patients with HFmrEF (left ventricular EF 40–49%) underwent PCI (132 diabetic and 245 nondiabetic patients) were included into analysis. The primary outcome was a composite endpoint of all-cause death or HF rehospitalization. Cox proportional-hazards regression analysis and Kaplan–Meier test were used to assess the effect of diabetes on the primary outcome. Sensitivity analysis was conducted with propensity score-matching analysis.Results During a follow-up of three years, diabetic patients had a higher incidence rate of the primary outcome than nondiabetic patients (96.1 vs. 44.6 per 1000 patient-years, incidence rate ratio 2.301, 95% confidence interval 1.334–3.969; P=0.002). Multivariate analysis showed that diabetes mellitus was associated with a significant increase in the composite outcome of all-cause death or HF rehospitalization (adjusted hazard ratio 2.080, 95% confidence interval 1.115–3.878, P=0.021). Sensitivity analysis further confirmed that diabetes mellitus was an independent prognostic factor of long-term adverse outcome for ACS patients with HFmrHF who underwent PCI (adjusted hazard ratio 3.792, 95% confidence interval 1.802-7.980, P＜0.001).Conclusions Among ACS patients with HFmrEF underwent PCI, complicating with T2DM was significantly associated with worse long-term outcomes.

scholarly journals Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001047 ◽  
Author(s):  
Emilie Ducourau ◽  
Theo Rispens ◽  
Marine Samain ◽  
Emmanuelle Dernis ◽  
Fabienne Le Guilchard ◽  
...  
Keyword(s):  
Treatment Duration ◽  
Primary Outcome ◽  
Axial Spondyloarthritis ◽  
Randomised Trial ◽  
Follow Up Study ◽  
Study Completion ◽  
To Receive ◽  
Term Maintenance

ObjectivesAnti-drug antibodies (ADA) are responsible for decreased adalimumab efficacy in axial spondyloarthritis (SpA). We aimed to evaluate the ability of methotrexate (MTX) to decrease adalimumab immunisation.MethodsA total of 110 patients eligible to receive adalimumab 40 mg subcutaneously (s.c.) every other week were randomised (1:1 ratio) to receive, 2 weeks before adalimumab (W-2) and weekly, MTX 10 mg s.c. (MTX+) or not (MTX−). ADA detection and adalimumab serum concentration were assessed at weeks 4 (W4), 8 (W8), 12 (W12) and 26 (W26) after starting adalimumab (W0). The primary outcome was the proportion of patients with ADA at W26. Four years after the study completion, we retrospectively analysed adalimumab maintenance in relation with MTX co-treatment duration.ResultsWe analysed data for 107 patients (MTX+; n=52; MTX-; n=55). ADA were detected at W26 in 39/107 (36.4%) patients: 13/52 (25%) in the MTX+ group and 26/55 (47.3%) in the MTX− group (p=0.03). Adalimumab concentration was significantly higher in the MTX+ than MTX− group at W4, W8, W12 and W26. The two groups did not differ in adverse events or efficacy. In the follow-up study, MTX co-treatment >W26 versus no MTX or ≤W26 was significantly associated with adalimumab long-term maintenance (p=0.04).ConclusionMTX reduces the immunogenicity and ameliorate the pharmacokinetics of adalimumab in axial SpA. A prolonged co-treatment of MTX>W26 seems to increase adalimumab long-term maintenance.

A Brief Intervention of Physical Activity Education and Counseling in Community Rehabilitation: A Feasibility Randomized Controlled Trial

2021 ◽  
pp. 1-8
Author(s):  
Emily T. Green ◽  
Narelle S. Cox ◽  
Anne E. Holland
Keyword(s):  
Physical Activity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Stage Of Change ◽  
Or Education ◽  
Randomized Controlled ◽  
Education Material ◽  
Community Rehabilitation ◽  
To Receive

This study aimed to assess the feasibility of delivering a brief physical activity (PA) intervention to community rehabilitation clients. Participants were randomized to receive one session of stage-of-change-based PA education and counseling in addition to written educational material, or education material alone. Outcomes were measured at baseline and 3 months; the primary outcome was feasibility, measured by the percentage of those who were eligible, consented, randomized, and followed-up. A total of 123 individuals were both eligible and interested in participating, 32% of those screened on admission to the program. Forty participants consented, and 35 were randomized, with mean age 72 years (SD = 12.2). At baseline, 66% had recently commenced or intended to begin regular PA in the next 6 months. A total of 30 participants were followed-up. It is feasible to deliver education and counseling designed to support the long-term adoption of regular PA to community rehabilitation clients. Further refinement of the protocol is warranted (ACTRN12617000519358).

Analysis of PFS2 by subsequent therapy in KEYNOTE-361: Pembrolizumab (pembro) plus chemotherapy (chemo) or pembro alone versus chemo as 1L therapy for advanced urothelial carcinoma (UC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 448-448
Author(s):  
Mustafa Ozguroglu ◽  
Ajjai Shivaram Alva ◽  
Tibor Csőszi ◽  
Nobuaki Matsubara ◽  
Lajos Geczi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Urothelial Carcinoma ◽  
Progressive Disease ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Treatment Sequence ◽  
Advanced Urothelial Carcinoma ◽  
To Receive ◽  
Clinical Trial Information

448 Background: 1L pembro + chemo did not show statistically superior PFS and OS vs chemo for pts with advanced UC in the phase III KEYNOTE-361 study; OS for pembro vs chemo was not formally tested. We analyzed PFS2 (time from randomization to progressive disease [PD] on first subsequent therapy, or death from any cause, whichever occurs first) by study treatment and subsequent therapy in KEYNOTE-361 (NCT02853305) to determine the effects, if any, of therapy sequence on PFS2. Methods: PFS2 was estimated for pts in each treatment arm, who received any subsequent therapy including any anti–PD-(L)1, any therapy other than anti–PD-(L)1, or no therapy. These were exploratory analyses; no formal comparisons were done. Results: 1010 pts were randomized: 351 pts to receive pembro + chemo, 307 to pembro, and 352 to chemo. As of Apr 29, 2020, the median (range) time from randomization to data cutoff was 31.7 (22.0-42.3) mo. Subsequent therapy was received by 124/351 (35%), 126/307 (41%), and 215/352 (61%) pts in the pembro + chemo, pembro, and chemo arms, respectively. Subsequent anti–PD-(L)1 therapy was received by 169/352 (48%) pts in the chemo arm vs 23/351 (7%) in the pembro + chemo arm and 14/307 (5%) in the pembro arm. Of pts in the pembro arm who received subsequent therapy, >90% received 2L cisplatin-based or carboplatin-based treatment. Median (m) PFS2 (95% CI) for all pts by treatment arm was 14.1 mo (12.6-16.2) with pembro + chemo, 10.9 mo (9.5-12.9) with pembro, and 10.4 mo (9.8-11.2) with chemo. Across treatment arms, pts in the pembro + chemo arm had the longest mPFS2 with any subsequent therapy (14.5 mo [95% CI 13.1-16.6]) (Table). Pts in the pembro arm who received no subsequent therapy had a longer mPFS2 (12.9 mo [95% CI 8.1-17.9]) vs pts in the chemo arm who received no subsequent therapy (9.4 mo [95% CI 7.6-10.6]). Finally, pts treated with 1L pembro in the trial followed by 2L therapy other than anti−PD-(L)1 had comparable mPFS2 (10.2 mo [95% CI 8.6-12.1]) to pts treated with 1L chemo in the trial followed by 2L anti−PD-(L)1 (11.1 mo [95% CI 10.2-12.9]). Conclusions: In this exploratory analysis, treatment sequence of chemo followed by anti−PD-(L)1 upon PD vs anti–PD-(L)1 followed by chemo upon PD did not appear to impact mPFS2. Among pts who did not receive 2L therapy, 1L pembro appeared to be associated with longer mPFS2 than chemo, potentially driven by long-term responders to pembro. Clinical trial information: NCT02853305 . [Table: see text]

scholarly journals Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network’s Marfan Trial experience

2020 ◽  
Vol 17 (6) ◽  
pp. 684-695
Author(s):  
Michelle S Hamstra ◽  
Victoria L Pemberton ◽  
Nicholas Dagincourt ◽  
Danielle Hollenbeck-Pringle ◽  
Felicia L Trachtenberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Young Adults ◽  
Medication Adherence ◽  
Primary Outcome ◽  
Holter Monitoring ◽  
Outcome Data ◽  
Completion Rates ◽  
Medication Regimen ◽  
Ambulatory Electrocardiography ◽  
Barriers To Enrollment

Background/Aims: The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies. Methods: Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence. Results: Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation’s resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence. Conclusion: Overall adherence was excellent for this trial conducted within a National Institutes of Health–funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.

Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial.

1998 ◽  
Vol 16 (7) ◽  
pp. 2445-2451 ◽  
Author(s):  
D W Northfelt ◽  
B J Dezube ◽  
J A Thommes ◽  
B J Miller ◽  
M A Fischl ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Partial Response ◽  
Confidence Interval ◽  
Combination Chemotherapy ◽  
Kaposi's Sarcoma ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
To Receive

PURPOSE Kaposi's sarcoma (KS), the most common neoplasm in patients with AIDS, is a significant clinical problem for which current therapies are frequently unsatisfactory. We conducted a randomized phase III clinical trial to compare the efficacy and toxicities of a new form of therapy, pegylated-liposomal doxorubicin, with standard combination chemotherapy in patients with advanced AIDS-related KS (AIDS-KS). PATIENTS AND METHODS Two hundred fifty-eight patients with advanced AIDS-KS were randomly assigned to receive either pegylated-liposomal doxorubicin (20 mg/m2) or the combination of doxorubicin (20 mg/m2), bleomycin (10 mg/m2) and vincristine (1 mg) (ABV) every 14 days for six cycles. Standard response criteria, toxicity criteria, and predefined indicators of clinical benefit were examined to evaluate outcomes. RESULTS Among 133 patients randomized to receive pegylated-liposomal doxorubicin, one achieved a complete clinical response and 60 achieved a partial response for an overall response rate of 45.9% (95% confidence interval [CI], 37% to 54%). Among 125 patients randomized to receive ABV, 31 achieved a partial response (24.8%; 95% confidence interval [CI], 17% to 32%). This difference was statistically significant (P < .001). In addition to objective responses, prospectively defined clinical benefits and toxicity outcomes also favored pegylated-liposomal doxorubicin. CONCLUSION Pegylated-liposomal doxorubicin is more effective and less toxic than the standard combination chemotherapy regimen ABV for treatment of AIDS-KS.

scholarly journals Immediate versus delayed short-term integrated palliative care for advanced long-term neurological conditions: the OPTCARE Neuro RCT

2020 ◽  
Vol 8 (36) ◽  
pp. 1-80
Author(s):  
Nilay Hepgul ◽  
Rebecca Wilson ◽  
Deokhee Yi ◽  
Catherine Evans ◽  
Sabrina Bajwah ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cost Effectiveness ◽  
Confidence Interval ◽  
Qualitative Data ◽  
Primary Outcome ◽  
Physical Symptoms ◽  
Short Term ◽  
Neurological Conditions ◽  
Care Satisfaction

Background Palliative care is recommended to help meet the needs of patients with progressive non-cancer conditions, such as long-term neurological conditions. However, few trials have tested palliative care in this population. Objectives To determine the effectiveness and cost-effectiveness of short-term integrated palliative care in improving symptoms, improving patient- and caregiver-reported outcomes and reducing hospital use for people severely affected by long-term neurological conditions. Design Pragmatic, randomised controlled, multicentre, fast-track trial, with an embedded qualitative component and surveys. Setting Seven UK centres (South London, Nottingham, Liverpool, Cardiff, Brighton, Ashford and Sheffield) with multiprofessional palliative care teams and neurology services. Participants People living with multiple sclerosis, idiopathic Parkinson’s disease, motor neurone disease, multiple system atrophy or progressive supranuclear palsy, with unresolved symptoms and/or complex psychosocial needs. The qualitative study involved patients, caregivers and health-care staff. Interventions Participants were randomised to receive short-term integrated palliative care, delivered by multiprofessional teams, immediately or after a 12-week wait (standard care group). Main outcome measures The primary outcome was a combined score of eight symptoms measured by the Integrated Palliative care Outcome Scale for Neurological conditions 8 symptom subscale (IPOS Neuro-S8) at 12 weeks. Secondary outcomes included patients’ other physical and psychological symptoms, quality of life (EuroQol-5 Dimensions, five-level version), care satisfaction, caregiver burden, service use and cost, and harms. Data were analysed using multiple imputation, generalised linear mixed models, incremental cost-effectiveness ratios (threshold was the National Institute for Health and Care Excellence £20,000 per quality-adjusted life-year) and cost-effectiveness planes. Qualitative data were analysed thematically. Results We recruited 350 patients and 229 caregivers. There were no significant between-group differences for primary or secondary outcomes. Patients receiving short-term integrated palliative care had a significant improvement, from baseline to 12 weeks, on the primary outcome IPOS Neuro-S8 (–0.78, 95% confidence interval –1.29 to –0.26) and the secondary outcome of 24 physical symptoms (–1.95, 99.55% confidence interval –3.60 to –0.30). This was not seen in the control group, in which conversely, care satisfaction significantly reduced from baseline to 12 weeks (–2.89, 99.55% confidence interval –5.19 to –0.59). Incremental cost-effectiveness ratios were smaller than the set threshold (EuroQol-5 Dimensions index score –£23,545; IPOS Neuro-S8 –£1519), indicating that the intervention provided cost savings plus better outcomes. Deaths, survival and hospitalisations were similar between the two groups. Qualitative data suggested that the impact of the intervention encompassed three themes: (1) adapting to losses and building resilience, (2) attending to function, deficits and maintaining stability, and (3) enabling caregivers to care. Conclusions Our results indicate that short-term integrated palliative care provides improvements in patient-reported physical symptoms at a lower cost and without harmful effects when compared with standard care. Limitations Outcome measures may not have been sensitive enough to capture the multidimensional changes from the intervention. Our surveys found that the control/standard and intervention services were heterogeneous. Future work Refining short-term integrated palliative care and similar approaches for long-term neurological conditions, focusing on better integration of existing services, criteria for referral and research to improve symptom management. Trial registration Current Controlled Trials ISRCTN18337380. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 36. See the NIHR Journals Library website for further project information.

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