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ObjectiveThe Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder.DesignMulticentre, randomised feasibility trial, with embedded qualitative study.SettingFour UK National Health Service (NHS) musculoskeletal and related physiotherapy services.ParticipantsAdults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder.InterventionsParticipants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2–3 weeks later.Primary feasibility objectives(1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months.ResultsBetween 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%.ConclusionThis study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment.Trial registration numberISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214).

To systematically review and critically appraise the methodology of developing modified obstetric early warning scores (MOEWSs). We searched Medline, CINAHL, EMBASE, and the Web of Science for MOEWS studies published between January 1, 2000, and December 31, 2022. Eligible studies included models predicting maternal death, intensive care unit (ICU) admission, and/or a composite of two or more maternal morbidities occurring in a hospital setting in women of any gestational age and up to 1 week after the end of pregnancy. Models were critically appraised using the Prediction Model Risk of Bias Assessment Tool (PROBAST) and adherence to the transparent reporting of prediction models (TRIPOD). 20 studies were included: five (25%) were model development studies, five (25%) were model development and validation, and ten (50%) were validation only. Four development studies used statistical methods, and the remaining six studies used clinical consensus (ie, expert opinion). The four data-driven model development studies did not address key statistical challenges, such as repeated measures or missing data, nor did they assess the performance adequately or dataset characteristics clearly. All but one study (95%) were rated at high risk of bias due to data sources, poor reporting, and analysis limitations. The fifteen validation studies were poorly reported and eleven (73%) were at high risk of bias. None of the data-driven models were independently validated, a key step toward implementation. There is a lack of MOEWSs developed using methods that follow recommended statistical guidelines. Substantial problems with the methodological quality of included development and validation studies, along with high risk of bias,indicating published scores could perform poorly or be potentially harmful if used in clinical practice. Future work should address handling missing data and repeated measures and consider how an MOEWS will perform in different populations and key subgroups. •Several MOEWSs have been developed, but most models were not derived using statistical methods.•Developed models are rarely implemented, even if they have been externally validated.•Methodological deficiencies and poor reporting led to nearly all studies being at high risk of bias.